[Senate Hearing 110-400]
[From the U.S. Government Publishing Office]




                                               S. Hrg. 110-400, Pt. 1

                                                        Senate Hearings

                                 Before the Committee on Appropriations

_______________________________________________________________________


Departments of Labor,

Health and Human Services,

and Education, and Related

Agencies Appropriations

                                                            Fiscal Year
                                                                   2008

         th CONGRESS, FIRST SESSION                                110 

                                                      H.R. 3043/S. 1710

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  Departments of Labor, Health and Human Services, and Education, and 
  Related Agencies Appropriations, 2008 (H.R. 3043/S. 1710)--Part 1
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                                           S. Hrg. 110-400, Pt. 1 deg.
 
  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

=======================================================================

                                HEARINGS

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                                   on

                           H.R. 3043/S. 1710

 AN ACT MAKING APPROPRIATIONS FOR THE DEPARTMENTS OF LABOR, HEALTH AND 
  HUMAN SERVICES, AND EDUCATION, AND RELATED AGENCIES, FOR THE FISCAL 
         YEAR ENDING SEPTEMBER 30, 2008, AND FOR OTHER PURPOSES

                               __________

                         Part 1 (Pages 1-572)

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                          Department of Labor
                       Nondepartmental witnesses
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                               __________

                      COMMITTEE ON APPROPRIATIONS

                ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii             THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont            TED STEVENS, Alaska
TOM HARKIN, Iowa                     ARLEN SPECTER, Pennsylvania
BARBARA A. MIKULSKI, Maryland        PETE V. DOMENICI, New Mexico
HERB KOHL, Wisconsin                 CHRISTOPHER S. BOND, Missouri
PATTY MURRAY, Washington             MITCH McCONNELL, Kentucky
BYRON L. DORGAN, North Dakota        RICHARD C. SHELBY, Alabama
DIANNE FEINSTEIN, California         JUDD GREGG, New Hampshire
RICHARD J. DURBIN, Illinois          ROBERT F. BENNETT, Utah
TIM JOHNSON, South Dakota            LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana          KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island              SAM BROWNBACK, Kansas
FRANK R. LAUTENBERG, New Jersey      WAYNE ALLARD, Colorado
BEN NELSON, Nebraska                 LAMAR ALEXANDER, Tennessee
                    Charles Kieffer, Staff Director
                  Bruce Evans, Minority Staff Director
                                 ------                                

 Subcommittee on Departments of Labor, Health and Human Services, and 
                    Education, and Related Agencies

                       TOM HARKIN, Iowa, Chairman
DANIEL K. INOUYE, Hawaii             ARLEN SPECTER, Pennsylvania
HERB KOHL, Wisconsin                 THAD COCHRAN, Mississippi
PATTY MURRAY, Washington             JUDD GREGG, New Hampshire
MARY L. LANDRIEU, Louisiana          LARRY CRAIG, Idaho
RICHARD J. DURBIN, Illinois          KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island              TED STEVENS, Alaska
FRANK R. LAUTENBERG, New Jersey      RICHARD C. SHELBY, Alabama
ROBERT C. BYRD, West Virginia, (ex 
    officio)

                           Professional Staff

                              Ellen Murray
                              Erik Fatemi
                              Mark Laisch
                            Adrienne Hallett
                             Lisa Bernhardt
                       Bettilou Taylor (Minority)
                    Sudip Shrikant Parikh (Minority)

                         Administrative Support

                              Teri Curtin
                         Jeff Kratz (Minority)


                            C O N T E N T S

                              ----------                              

                         Monday, March 19, 2007

                                                                   Page

Department of Health and Human Services: National Institutes of 
  Health.........................................................     1

                         Monday, March 26, 2007

Department of Health and Human Services: National Institutes of 
  Health.........................................................    93

                       Wednesday, March 28, 2007

Department of Labor: Office of the Secretary.....................   169

                        Tuesday, April 17, 2007

Department of Health and Human Services:
    Centers for Disease Control and Prevention...................   259
    National Institutes of Health: National Institute of Mental 
      Health.....................................................   268

                         Friday, April 20, 2007

Department of Health and Human Services: National Institutes of 
  Health.........................................................   327

                          Monday, May 7, 2007

Department of Health and Human Services: National Institutes of 
  Health.........................................................   391

                          Monday, May 21, 2007

Department of Health and Human Services: National Institutes of 
  Health.........................................................   451

                         Friday, June 22, 2007

Department of Health and Human Services: National Institutes of 
  Health.........................................................   521
Nondepartmental witnesses........................................   583


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              


                         MONDAY, MARCH 19, 2007

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 1 p.m., in room SH-216, Hart Senate 
Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin and Specter.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENT OF HON. ELIAS A. ZERHOUNI, M.D., DIRECTOR


                OPENING STATEMENT OF SENATOR TOM HARKIN


    Senator Harkin. The Subcommittee on Labor, Health and Human 
Services, Education, and Related Agencies will come to order. I 
welcome you today to the hearing on the fiscal year 2008 budget 
for the National Institutes of Health.
    Whenever I talk about NIH, it is always a pleasure to sit 
with my good friend Senator Specter, who will join us very 
shortly. Maybe I should wait till he gets here so he can hear 
all the good things I've got to say about him.
    But I'll just say that no one has fought harder to improve 
biomedical research in this country. He and I worked in 
lockstep to double funding for NIH between fiscal years 1998 
and 2003, covering two different administrations. I always say 
it's one of my proudest accomplishments in my entire career in 
the Senate. I know he shares my disappointment that the NIH has 
fallen on tougher budgetary times since then.
    The fiscal year 2007 joint funding resolution that Congress 
passed a few weeks ago brought some good news. We increased NIH 
funding by $637 million, enough to launch the National 
Children's Study. We added another 500 research grants and 
provided additional funding for high-risk grants and young 
investigators.
    Even with that increase, however, fiscal year 2007 marked 
the fourth year in a row that NIH funding failed to keep up 
with the cost of inflation. In fact, since the end of the 
doubling period in fiscal year 2003, NIH funding has dropped by 
about 8 percent in real terms. That cut threatens to squander 
our Nation's investment in biomedical research, delay new cures 
and treatments, and discourage the next generation of young 
investigators from entering the field.
    The President's fiscal year 2008 budget would make matters 
even worse. On paper, it would seem to cut NIH funding by $328 
million. But the actual reduction is about $200 million more, 
so a total of about $529 million, because, under this budget, 
NIH would pick up the entire tab for the Global AIDS Fund, 
rather than sharing it with the State Department.
    So, as a result of this, comparable funding for the 
National Cancer Institute would drop by $79 million, funding 
for the National Heart, Lung, and Blood institute, by $36 
million, and the National Children's Study, which we just 
launched, would be stopped cold. I'm not ever in the habit of 
ever speaking for my good friend Senator Specter, but I think I 
can say we will not allow those cuts to take place.
    This is the first of six budget hearings on NIH that this 
subcommittee will hold this spring. At today's hearing, we'll 
hear first from Dr. Elias Zerhouni, the Director of NIH. Our 
second panel today will consist of four leading scientists who 
have received NIH grants. They will discuss the impact of 
Federal funding on their areas of research, and why it's so 
important to increase our investment in NIH. All four of these 
scientists helped produce a new report on NIH, which I got last 
week, and it's entitled, ``Within Our Grasp--or Slipping Away? 
Assuring a New Era of Scientific and Medical Progress.'' So, 
we're going to be discussing that in our second panel. This 
report will be released at a press conference immediately 
following this hearing.
    Next Monday, we'll hold a hearing with the directors of 
five NIH institutes: NINDS, NIDA, NIAAA, NIMH, and NIDCD. 
Before the spring is over, the subcommittee will hear from the 
directors of each institute and center at NIH.
    So, that's the agenda. Before I introduce Dr. Zerhouni, 
I'll yield to my good friend Senator Specter.


               OPENING STATEMENT OF SENATOR ARLEN SPECTER


    Senator Specter. Thank you very much, Mr. Chairman.
    This is a very important hearing by this subcommittee to 
hear from the director of the National Institutes of Health, 
our premier health agency in the United States, and he's the 
number-one administrator. Health is our most important capital 
asset. Without health, there is nothing any of us can do. I can 
attest to that, personally, from the medical problems that I 
have worked through.
    In 1970, President Nixon declared war on cancer, and, had 
that war been pursued with the intensity of our other wars, my 
chief of staff, a beautiful young woman, 48 years old, Carie 
Lachman, wouldn't have died of breast cancer. One of my best 
friends, a very distinguished Federal judge, Judge Edward 
Becker, wouldn't have died last year from prostate cancer. We 
all know, within our immediate circle of friends and family, of 
fatalities which have occurred because of the maladies of one 
sort or another. It is within reach to cure cancer, to find 
ways on a breakthrough on Parkinson's and Alzheimer's and heart 
disease and juvenile diabetes, and the other maladies, with 
sufficient funding.
    Senator Harkin and I, who have transferred this gavel with 
seamless efficiency from time to time, have worked on this 
matter together for decades, and we've taken the lead to 
increase in funding, sometimes on an annual basis in excess of 
$3 billion, to do the job. Well, it is simply unacceptable to 
have a $500+ million cut in NIH funding, as proposed by the 
administration this year. When you have a Federal budget of 
$2.9 trillion, an enormous sum of money, this large hearing 
room insufficient to stuff $10,000 bills into it to make, to 
make that kind of funding, to have an allocation of less than 
$30 billion, candidly, is scandalous. In an era when we are 
beset in the Congress all the time on how to reduce healthcare 
costs from the smallest of businesses to individual families to 
the biggest corporations, and the best way to reduce healthcare 
costs is to eliminate these major maladies, to prevent illness. 
We are blind, really, to this very, very, important objective.
    Earlier today I called Dr. Zerhouni and asked that he focus 
on the issue of cost savings. That seems to be an item which 
has special appeal on Capitol Hill. Elimination of disease, and 
the suffering that goes with it, ought to be our primary 
concern, but somehow if it saves dollars, it attracts more 
attention.
    We also have the issue of stem cell research which we've 
been fighting. We found out about stem cells, and their 
potential, in November 1998, and, within 10 days, this 
subcommittee held a hearing, and we've since had 20 hearings. 
Stem cells have the potential to be a veritable fountain of 
youth. We, regrettably, cannot use Federal funding on stem cell 
research, except for a few lines, which were available back on 
August 9, 2001. But if these embryotic stem cells were to be 
used to create life, no one would want to use them for 
research, but there are 400,000 available, and they're going to 
be discarded unless they're used to save lives.
    Here again, Senator Harkin and I took the lead to 
appropriate $2 million for adoption, and a few have been 
adopted, but a very few, in the range of 100, contrasted with 
400,000, which will be thrown away. So, our work is cut out for 
us.
    You have two strong allies in Senator Harkin and myself, 
Dr. Zerhouni, and you have the potential to have 533 more if 
there's sufficient political pressure brought to bear on 
Washington, DC. I've talked about a million-person march on the 
Mall. A million people could be heard in the living quarters of 
the White House. Attitudes are changed in Washington, with 
political pressure. With 110 million people affected, directly 
or indirectly by disease, that group of public opinion could 
write its own ticket. Senator Harkin and I want to be the 
scriveners.
    Thank you, Mr. Chairman.
    Senator Harkin. Thank you very much, Senator Specter.
    Dr. Elias Zerhouni has served as Director of the National 
Institutes of Health since May 2002. Prior to that, Dr. 
Zerhouni was the executive vice dean of Johns Hopkins 
University School of Medicine, chair of the Department of 
Radiology and Radiological Science, and Martin Donner professor 
of radiology and professor of biomedical engineering. Dr. 
Zerhouni received his medical degree from the University of 
Algiers School of Medicine, completed his residency in 
diagnostic radiology at Johns Hopkins.
    I might just add that since May 2002, every report that 
we've gotten, every indication, all the people that we've 
talked to, both in NIH and out in the countryside, have 
basically reported that Dr. Zerhouni has done an outstanding 
job of leading NIH since he's been there.
    With that we welcome you back to the committee, Dr. 
Zerhouni. Your statement will be made a part of the record in 
its entirety. They had set it for 5 minutes; I said boost it up 
to 10, and, if you need more than that, we'll give you more 
than that.
    So, please proceed as you so desire.


              SUMMARY STATEMENT OF HON. ELIAS A. ZERHOUNI


    Dr. Zerhouni. Thank you very much.
    It's my pleasure to appear before you, Mr. Chairman and 
Senator Specter. There couldn't be more passionate supporters 
of science and research than both of you. As I've worked with 
you over the past 5 years, I have to be, also, a witness to not 
only your passionate support, but also your profound 
understanding of what makes science, and what makes medical 
research, work, and why it is so important to the Nation.
    I also would like to thank you and the committee for your 
personal support for the increased funding for NIH in 2007 and 
the focus that you have brought towards supporting the next 
generation of scientists, and making sure that we do not become 
stale in our research, that our momentum is kept, in terms of 
new breakthroughs.
    What I'd like to do is attract your attention to the slide 
and give you a very short summary of the essence of where we 
think NIH as a whole is going and why we're directing our 
efforts into what we would call a new era in medicine.


                         VISION FOR THE FUTURE


    We need to have a vision for the future as a country. I 
think it is absolutely clear that the 21st century will be for 
the life sciences what the 20th century has been for the 
physical sciences. Mastery of the biological world will impact 
not just health, but also our ability to develop sensitive 
solutions to our environmental and energy challenges, and will 
be, in my opinion, a key determinant of national 
competitiveness for the 100 years in front of us. It is 
important to sustain our momentum in that regard.
    I'd like to, first, point out to you that NIH has been, and 
continues to be, a very, very productive investment for the 
American people. We are living longer and healthier. Let me 
give you some specifics.
    For the second consecutive year, annual cancer deaths in 
the United States have fallen. This is an unprecedented event. 
This has not occurred in any other country. It has not occurred 
for the time that we've had records. The absolute number of 
deaths decreasing is happening at the same time that our 
population is increasing in number and aging, at the same time.
    What has been the investment that each one of us has made 
in that regard, in the war on cancer? On average, each American 
has spent about $9 per year, from 1974 to 2004, to accomplish 
these results, which are still insufficient. The complexity of 
cancer is such that we need to accelerate our research, not 
slow it down.
    If you look at heart disease, there's been a remarkable 
drop in mortality from heart disease and stroke. In 2004, for 
example, a drop in death for women with heart disease has 
dropped from 1 in 3 to 1 in 4. More importantly, as Senator 
Specter was pointing out, the economic value of this drop in 
mortality and morbidity is estimated at $1.5 trillion to $2.5 
trillion per year. This is the kind of result that I think we 
can foresee for the future. What has been the investment? About 
per year per American for each year over the past 30 years.
    More importantly, I think it is clear that disability is 
decreasing among older Americans. It has dropped by 30 percent 
in the past two decades. Life expectancy has risen to 78 years, 
up 6 years since 1974. What has been the average total 
investment per American per year at NIH? Only $44 per year for 
medical research.
    I think we can say that NIH has been a good investment, and 
continues to see itself as the vanguard for changing--changing, 
not just how we cure disease once the disease has struck us, 
but how we really advance our research to make a profound 
difference in what I think is our concern today, and that is 
the challenge of rising U.S. health expenditures. Biomedical 
research must deliver, and NIH is poised to deliver.
    If you look at the percent of GDP consumed by healthcare 
costs, and its upward curve, it is clear that this will be one 
of the greatest challenges facing our society, because this 
growth rate of healthcare expenditures is not sustainable in 
the long run.
    Historically, medicine has been reactive, and patients did 
not seek attention until an acute event required them to seek a 
doctor's cure. But our system of care has been based on 
managing these late events on an episodic basis. Is there a 
better vision? Is there a way science can help the country 
tackle this problem? I think there is. When you look at the 
projection of doubling of our costs in 10 years, to $4.1 
trillion a year, I think one cannot but feel that there is a 
real race against time to discover new ways of practicing 
medicine.
    Let me be clear. If we practice medicine in 25 years the 
way we practice it today, we will have lost the game of the 
century. It is very important that we understand that. Is there 
a paradigm in the future that will change that? The answer is 
yes. We need to advance the science that will allow us to pre-
empt disease.


                        PARADIGM FOR THE FUTURE


    I think if you look at this chart, you can divide any 
disease into three stages. One is what we call the preclinical 
stage, the bottom yellow band, where people do not know that 
they have a disease. We may not know that someone has a 
disease, because chronic diseases, which are the dominant 
factor in our healthcare cost, can begin 20-25 years before 
they become clinically obvious. Then symptoms start to appear, 
and we can intervene at that time. This is what we call the 
tolerable or compensated phase of a disease. Last, but not 
least, is the uncompensated phase, where, typically, curative 
treatment tends to occur.
    What we've done over the past 30 years is try to move back 
in time to try to address diseases before the critical phase. 
But, in the future, what we see with the advances we've made in 
the past 10 years is, that for the first time--the complexity 
of biology and the advances we've made in science tell us that 
we could start to understand disease years before it strikes by 
understanding the first molecular events that lead to disease 
and intervening at that time. The potential cost savings are 
enormous, because, as the white curve shows, costs increase 
exponentially with the typically late interventions that we 
today practice. It is much more expensive to take care of heart 
disease in the late stages than to try to prevent it with an 
intervention very early in the life cycle of the disease.
    That is, in my view, the vision of the future. This is how 
NIH research can potentially provide new insights, which we do 
not have today. But it is clear that the opportunities are 
there. Our scientists are doing an enormous amount of work in 
discovering, every day, new targets to understand the complex 
diseases that harm our people. We need to maintain the momentum 
of that research.
    Let me just show you an example here of a disease called 
rheumatoid arthritis. This is a patient's hands at early stage, 
middle stage, and late stage. How are we going to improve 
costs? How are we going to make a change in the natural history 
of this disease? Obviously, in the late stage, not much can be 
recovered, and managing that late stage is quite expensive. 
We've made progress over the past 10 years. There's a new class 
of antirheumatic drugs that dramatically slows disease 
progression by focusing on a factor called tumor necrosis 
factor and reducing the impact of that factor. But that is not 
enough. We really need to go earlier in the disease process. 
That's why, in 2006, for example, genetic discoveries have 
revealed new genes, which we didn't know about 3 years ago, 
before the--at the end of the doubling of the NIH budget. The 
completion of the human genome in 2003 has allowed us to 
accelerate this kind of discovery. But every time we find a 
gene, that means more research has to be done on that gene, 
because the gene is only the code of what may be wrong in that 
disease. Much more research lies ahead of the discovery of a 
gene. Therefore, it is important for us to see that this 
research continues so that, in the future, we will pre-empt by 
intervening on the very fundamental factors that lead to that 
disease, and hopefully eliminate the costs of that disease.


     4 P'S--PREDICTIVE, PRE-EMPTIVE, PREVENTIVE, AND PARTICIPATORY


    So, the future paradigm, if you will, if I can summarize 
it, is what we call the 4 P's.
    One, using the new technologies we've developed, the new 
insights we've developed over the past 10 years, there is 
potential for us to be much more predictive about to whom, how, 
when a disease will occur. By using gene-chip technology, we 
can, today, do that in several diseases.
    Second, treatments are going to have to be personalized. 
Every one of us is different, and we react differently to 
different therapies. That's the second P.
    Third, we have--through that knowledge, we have to become 
pre-emptive. But this will also require a revolution in the way 
we conceive of healthcare. Instead of a disease-based 
healthcare system, or healthcare system driven by disease, we 
should focus on a healthcare system drive by health, where 
patients are not sick, patients are healthy when they come in 
contact with us. That will mean people will have to participate 
a lot more in their care than ever before. That means 
transformation of the healthcare system, driven by new science. 
This is what I call the Era of Precision Medicine. This is what 
we're working for. This is what NIH's vision has been, and 
continues to be. More importantly, we feel that we are at the 
edge of being able to do that.


                           PREPARED STATEMENT


    NIH and its scientists deeply believe that we are in the 
transformative phase of the biomedical and behavioral sciences, 
where opportunities for discoveries and their translations--
translation have never been greater. We believe that we're on 
the path to do that. We want to encourage not only the current 
generation of scientists, but the future generation of 
scientists, to come unhampered, and to be supported, because 
this is the race of the century. In the 21st century, no nation 
will prevail unless it prevails in the life sciences.
    Thank you very much.
    [The statement follows:]

              Prepared Statement of Dr. Elias A. Zerhouni

    Good afternoon, Mr. Chairman and distinguished members of the 
subcommittee. It is an honor and a privilege to appear before you today 
to present the National Institutes of Health (NIH) budget request of 
$28.9 billion for fiscal year 2008, and to discuss the priorities of 
NIH for this year and beyond.
    I would first like to thank the Committee for your longstanding 
support of NIH, including in the fiscal year 2007 Joint Resolution that 
provided additional support.

                              INTRODUCTION

    The 21st century will be for the life sciences what the 20th 
century has been for the physical sciences. Mastery of the biological 
world will impact not just health, but also our ability to develop 
sensitive solutions to environmental and energy challenges and will be 
a key determinant of national competitiveness. One of the greatest 
challenges facing our society is the unsustainable growth rate of 
healthcare expenditures. NIH and its scientists deeply believe that we 
are in a transformative phase of the biomedical and behavioral 
sciences, where opportunities for discoveries and their translation 
have expanded considerably. We believe that we are on a path to 
transform medicine from the current practice of intervening often too 
late in a disease process, to a new era when medicine will be more 
predictive, personalized and preemptive, through a broader scientific 
understanding of the fundamental mechanisms that lead to disease years 
before it strikes the patient. In a relatively constant budget, we made 
the tough but necessary choices to ensure that the investment and 
momentum of biomedical research continues.
    A more predictive, personalized and preemptive form of medicine is 
no longer just a dream but a vision to strive for, because it can 
reduce disease burden and its costs while improving individual quality 
of life.
    Last year, I discussed the return on the Nation's investment in 
biomedical research. Today, I will highlight some of the progress we've 
made in the last 12 months and where we must be in the future to create 
a sustainable environment for the discoveries needed to transform 
people's health.

                    THE IMPACT OF PAST NIH RESEARCH

    NIH-supported research of the past several decades has contributed 
to dramatically improved health outcomes across many diseases and 
conditions. For instance, we have made remarkable advances in coronary 
heart disease, the leading cause of death in the United States for the 
past 80 years. Were it not for ground-breaking research on the causes 
and treatment of heart disease, supported in large part by NIH, heart 
attacks would still account for an estimated 1.6 million deaths per 
year instead of the actual 452,000 deaths experienced in 2004. Our 
Nation has had particular success in reducing fatal heart disease in 
women. In February of this year, NIH's National Heart, Lung and Blood 
Institute announced that the number of women who died from heart 
disease decreased by nearly 18,500 deaths from 2003 to 2004. Part of 
this success is attributed to NIH's efforts to increase awareness among 
women that heart disease is their number one killer.
    The mortality rates of cancer, the second-leading cause of death in 
the United States, have been steadily falling. This year, for the 
second year in a row, the absolute number of cancer deaths in the 
United States has declined despite the growth and aging of our 
population--a truly unprecedented event in medical history. More 
effective therapies have also led to improved outcomes for more than 10 
million American cancer survivors. In 2006, new clinical guidelines 
were announced for the treatment of advanced ovarian cancer. And for 
another of our most deadly cancers, melanoma, a new gene therapy 
approach resulted in sustained regression of advanced disease in a 
study of 17 patients, whose own white blood cells were genetically 
engineered to recognize and attack cancer cells.
    Nearly 21 million Americans have diabetes, a disease that can 
damage multiple organs and lead to death. Without NIH research, the 
improvements of the past two decades in the therapies for diabetes 
would not have occurred, and we would have many more cases of the 
dreaded complications of diabetes, including blindness and end-stage 
kidney disease. Our research has shown the enormous benefits to be 
gained by tightly controlling blood glucose levels in diabetes. The 
NIH-funded Diabetes Control and Complications Trial confirmed that 
individuals with diabetes can cut their risk for nerve disease by 60 
percent, and half their risk for kidney disease and cardiovascular 
disease by intensively controlling their blood glucose levels. Our 
diabetes research has also shown that tight glucose control can slash 
the risk for eye disease by more than 75 percent--a critical finding 
for the estimated 24,000 Americans who lose their sight to diabetes 
each year. In fact, diabetic retinopathy is the leading cause of 
blindness in adults under age 65.
    The treatment of cognitive decline and mental disorders continues 
to improve at an incredibly rapid pace. In 2006, NIH supported the 
development of new strategies that helped depressed patients become 
symptom-free and prevented disease recurrence in older adults with 
single-episode depression.
    Other noteworthy advances from 2006 included the development of 
promising new drugs for tuberculosis, inflammatory disease and muscular 
dystrophy, as well as exciting experimental results of vaccines against 
increasingly dangerous staph infections and against the H5N1 avian flu 
virus. Last year we also launched a trial for a new and promising 
vaccine against HIV/AIDS, and just last month, our scientists' 
discovered a unique molecular weak spot in the armor of the HIV virus, 
which could have profound implications for vaccine development.
    In brief, thanks to the Nation's investment in biomedical research, 
we have learned to diminish the harmful impact of many diseases and 
disabilities for all Americans. The estimated total cumulative 
investment at the NIH per American over the past 30 years--including 
the doubling period--is about $1,334, or about $44 per American per 
year over the entire period. Over the same time period, Americans have 
gained over 6 years of life expectancy and are aging healthier than 
ever before. New industries such as biotechnology, based on NIH-funded 
discoveries, have led to the creation of thousands of companies in the 
life sciences with impact beyond health. The American people's return 
on their investment in NIH is truly spectacular.

                           CURRENT CHALLENGES

    In short, the many scientific advances achieved by NIH-funded 
researchers--over many decades--now allow our population to live longer 
and healthier lives. But as our population continues to age, a striking 
change becomes evident. The burden of our Nation's health problems has 
dramatically shifted from acute to chronic diseases. Chronic diseases 
now consume over 75 percent of healthcare costs and continue to grow at 
a rapid pace. Profound lifestyle changes have led to the emergence of 
non-communicable diseases such as obesity and attendant growth in the 
prevalence of associated conditions, such as diabetes and heart, kidney 
and musculoskeletal diseases. It is important to note that the burden 
of these chronic diseases is not uniformly distributed among our 
population; health disparities remain a critical health issue that 
requires new and continuing efforts.
    Let me now present a sobering reality. Despite medical progress, 
healthcare costs in the United States have risen to more than $2 
trillion, or about 16 percent of the Gross Domestic Product (GDP), and 
they grow at a rate greater than the GDP. The average amount spent on 
healthcare per person is about $7,100 today. The causes of healthcare 
inflation are varied and complex, but it is clear that this growth rate 
is unsustainable in the long term and will impose an enormous burden on 
our people and the competitiveness of our Nation. Biomedical research 
alone will not solve all of these problems, but it is an essential 
component toward a sustainable future. NIH and its scientists 
understand the need to reduce the impact of this great challenge 
through transformative discoveries and their rapid translation from 
laboratory to patients.
    While seeking medical discoveries that will address ongoing 
concerns, we must also be prepared to confront new and unpredictable 
threats. Emerging and re-emerging infectious diseases are on the rise, 
as micro-organisms develop strategies for evading our best drugs. We 
face the rapid globalization of mass transportation and the staggering 
worldwide threat of HIV/AIDS and other familiar foes. We must stand 
ready for the threat of pandemic influenza and of man-made bioweapons 
for which we have greatly expanded our investments in the past several 
years. Addressing these many new threats will require sustained 
scientific efforts and further breakthroughs.
 strategic vision for the future: from curative to preemptive medicine
    Historically, medicine has been reactive, and patients did not seek 
attention until an acute event required them to seek a doctor's cure. 
Our system of care is based on managing these late events on an 
episodic basis--an increasingly costly and unsustainable approach. What 
then is the scientific vision for change? Our goal at NIH is to usher 
in an era where medicine will be predictive, personalized and 
preemptive. This trend will also require a transformation in the 
fundamental relationship between healthcare providers and patients, 
necessitating continuous participation of individuals, communities and 
healthcare institutions as early as possible in the natural cycle of a 
disease process.
    Based on NIH-supported research, we now know that many of the most 
prevalent diseases of our time begin silently, many years before they 
inflict their obvious damage to patients. Increasingly, we are able to 
identify biomarkers that are predictive of the likelihood of developing 
a serious condition later in life. Just in the past year, we have 
discovered genetic variations that help predict the development of age-
related macular degeneration, a major cause of late-life blindness. We 
also discovered a new gene associated with Alzheimer's disease, a major 
control gene for diabetes and a marker of genetic susceptibility to 
prostate cancer. The genetic marker for prostate cancer risk came from 
the NIH-supported Cancer Genetic Markers of Susceptibility (CGEMS) 
study. Through the CGEMS database, genetic information about prostate 
cancer risk will be shared with cancer researchers across the country. 
The mining and sharing of genetic information will provide much-needed 
information to help us develop new strategies for the early detection 
and prevention of prostate cancers, which take the lives of nearly 
27,000 American men each year and disproportionately affect African 
Americans.
    Just consider, for a moment, how more predictive and personalized 
treatments could improve the safety and effectiveness of drugs. We know 
that drugs do not fall into the ``one size fits all'' category. The 
same drug can help one patient and harm another. Recent research shows 
that we will be increasingly able to know which patients will benefit 
from treatment and which patients might be harmed. This field of study 
is known as pharmacogenetics. Using the latest genomic data--acquired 
thanks to the doubling of the NIH budget--the NIH established a 
Pharmacogenetic Research Network, which is studying the interactions of 
drugs and molecules, as well as the biological processes that eliminate 
compounds from the body.
    As an example of emerging personalized medicine, cancer researchers 
have developed a test that helps to determine the risk of recurrence 
for women who were treated for early-stage, estrogen-dependent breast 
cancer. This information can help a woman and her doctor decide whether 
she should receive chemotherapy, in addition to standard hormonal 
therapy. The test has the potential to change medical practice by 
identifying tens of thousands of women each year who are unlikely to 
benefit from chemotherapy, sparing them from unnecessary and costly 
treatments and their harmful side effects. Such a test is now being 
readied for FDA review and is being evaluated in a long-term clinical 
trial sponsored by the NIH's National Cancer Institute.
    Ultimately, this individualized approach--completely different than 
how we treat patients today--will allow us to preempt disease before it 
occurs. We have already benefited greatly from these insights. For 
example, we know that controlling blood pressure, cholesterol levels, 
weight and diet, and eliminating smoking, greatly reduce the risk of 
heart disease and lung cancer. Mortality from colon cancer has dropped 
because our scientists have shown that such cancers evolve from 
accumulated genetic mutations in initially benign colon polyps which, 
if removed, preempt the development of lethal cancers.
    Because of a hundredfold reduction in the unit cost of genomic 
technology, we can now study, at affordable costs, the differences 
between patients who have a disease and their normal counterparts. 
These breakthroughs form the basis of our budget request for the 
continuation of the Genes, Environment and Health Initiative started in 
2007 and strongly supported by Secretary of Health and Human Services 
Michael Leavitt, who is also championing the concept of personalized 
medicine across all of HHS. With this new initiative, we expect to 
uncover--within three years--the potential molecular causes of the 10 
most common diseases afflicting the U.S. population. As part of this 
initiative, we will also launch a technology development effort that 
will enable scientists to measure many types of environmental exposures 
at the individual level.
    Taken together, these studies will lead to better understanding of 
the environmental and genetic factors that affect the development of 
many diseases. Imagine that your heart rhythm, brain activity, blood 
pressure and many other variables could be remotely monitored through a 
device like your cell phone and sent to a secure web-based analyzer 
with direct access to experts and a modern health information system. 
Suppose, for example, that these technologies could identify dangerous 
patterns in your heart rhythms or key biomarkers and warn you of an 
impending heart event or stroke or other complications. Imagine your 
doctor could tell--based on your genes--whether you need to take 
preemptive action to thwart a costly or painful disease, or whether you 
can avoid taking expensive medications for life because you are not at 
risk. This is not some science fiction. NIH is supporting the 
development of that future today.

      MAINTAINING MOMENTUM TOWARD 21ST CENTURY MEDICINE AND HEALTH

    Building toward the future involves innovations in multiple areas, 
including technology, research and training paradigms, information 
interoperability, and greater knowledge and resource management. We 
have seen an explosion of new discoveries and novel opportunities for 
progress across all areas of science--from the most basic discoveries 
to the sequencing of the human genome, to the development of fields 
that simply did not exist a few years ago. These emerging fields 
include proteomics, computational biology, or more recently the 
discovery of RNA interference, for which two NIH-funded scientists--
Drs. Craig Mello and Andrew Fire--received the 2006 Nobel Prize in 
Physiology or Medicine.
    The greatly expanded scope of research and new health challenges 
have necessitated a dramatic expansion of the Nation's research 
capacity, which was a primary outcome of the doubling of the NIH 
budget. This remarkable growth in research capacity was accomplished by 
leveraging NIH resources with private sector resources to nurture more 
investigators, develop new technologies and build infrastructure.
    The United States is now the preeminent force in biomedical 
research, and continues to lead the highly competitive biotech and 
pharmaceutical sectors, but it is also the focus of increasing 
challenges from government-supported research in Europe and Asia. NIH 
basic research and training programs produce steady streams of novel 
discoveries and innovative people that flow into our industries, making 
them more competitive. Multi-national corporations often choose to set 
up facilities here, to tap into the American pool of talent and 
research nexus, both largely developed through NIH funding.
    NIH-funded research leads to patents and spin-off companies across 
the Nation. Through the Small Business Innovation Research (SBIR) and 
Small Business Technology Transfer (STTR) programs, NIH helps to 
support entrepreneurs, as they bring to the international market 
products that improve health and help to maintain American economic 
leadership. Thus, NIH research and training dollars leverage state and 
private investment, resulting in powerful academic research centers and 
entire geographic regions for greater creativity and productivity.
    The American health research enterprise now has the capacity to 
achieve extraordinary medical advances and economic benefits for the 
Nation, and we must continue this momentum. We must sustain the 
capacity we have worked so hard to build and harness its potential.
    The talented scientists and institutions we have nurtured are 
stepping up to the challenge. For example, NIH now receives twice as 
many applications for grants than before the doubling of its budget. 
Due to the marked competition for funds across so many novel areas of 
research and health challenges, competition for grants and the quality 
of projects submitted to NIH is better than ever. We anticipate that 
the fiscal year 2008 budget will again support about one-fifth of 
applications submitted, as opposed to one-third in fiscal year 2003. We 
focused our budget request on maximizing the number of competing grants 
for new and established scientists. To encourage innovation and sustain 
the next generation of scientists to the greatest extent possible, we 
have also developed programs for new investigators and for pioneering 
high-risk/high-impact investigator-initiated research, the mainstay of 
fundamental discoveries.
    To achieve our vision of modern medicine, we also need research 
scientists with broad expertise, from widely varied disciplines, coming 
together in highly cooperative and efficient teams to answer ever-more 
complex questions. To this end, NIH recently changed a long-held policy 
of having only a single principal investigator on any NIH grant to a 
new policy that allows, when appropriate to the science, multiple 
principal researchers to apply for a grant together. This new policy is 
encouraging collaboration across disciplines and enabling academic 
scientists to exercise creative leadership in a project while bringing 
more of the best and brightest from physical, biological and behavioral 
sciences to the task of solving the multifaceted and complex health-
related problems.
    As biomedical research becomes more comprehensive, and we recognize 
that complex diseases come under the purview of more than one or a few 
NIH Institutes and Centers, we have been stimulating collaborative 
endeavors through multiple trans-NIH activities, such as the NIH 
Roadmap for Biomedical Research. These trans-NIH activities focus on 
providing the impetus and support for high-risk/high-impact research 
through Pioneer Grants; developing tools and new scientific teams for 
furthering our understanding of the complexity of biological systems; 
and stimulating a large effort to re-engineer the Nation's clinical and 
translational research enterprise to support more effective 
interactions between laboratory research and its clinical translation.
    In 2006, we launched the Clinical and Translational Science Awards 
(CTSA) Program, which is the first in-depth redesign of our system of 
applied research in 50 years. The CTSA Program is stimulating research 
institutions to foster more productive collaboration among 
investigators in different fields. The program also encourages creative 
organizational models and programs for training the next generation of 
clinician scientists, without whom much basic research cannot be 
applied to human populations. Ultimately, patients will be better 
served because new prevention strategies and treatments will be 
developed, tested and brought into medical practice more rapidly.
    In addition, the NIH Intramural Research Program is launching 
several initiatives to make even more effective use of the highly 
talented scientists and state-of-the-art resources in our federal 
laboratories.
    We have made every effort to generate greater synergies between NIH 
Institutes and Centers. For example, the NIH Strategic Plan for Obesity 
Research was launched in 2003 and involves 19 Institutes. The 
Neuroscience Blueprint brings together 15 NIH Institutes and Centers 
and the Office of the Director, pooling resources and expertise to 
confront challenges in neuroscience research that transcend any single 
Institute or Center.
    NIH is also taking advantage of emerging information technologies 
and is making management changes in response to public health needs. We 
are working to modernize our governance and improve efficiency. For 
example, the Office of Portfolio Analysis and Strategic Initiatives 
(OPASI) is developing a new knowledge management-based system, which 
performs text mining on NIH projects for more efficient research 
portfolio analysis. This tool will provide our Institutes and Centers 
with the information needed to more effectively manage their large and 
complex scientific portfolios, identify important emerging scientific 
opportunities and public health challenges, and target investments to 
those areas. OPASI will be invaluable for supporting key trans-NIH 
initiatives being incubated through the NIH Common Fund, which is a 
central feature of the NIH Reform Act of 2006.
    We would like to take this opportunity to thank Congress for 
passing this landmark legislation, which will enable NIH to modernize 
its organization; incubate innovative ideas and potentially ground-
breaking research; address emerging areas of scientific opportunities; 
stimulate support of cross-cutting science; and encourage collaborative 
efforts while preserving the ability of Institutes and Centers to 
continue their outstanding record in fulfilling their specific 
missions. We are diligently working to implement this legislation.

    BUDGET PRIORITIES: NURTURING A NEW GENERATION OF SCIENTISTS AND 
                         SUSTAINING INNOVATION

    New visions require new talent. One of NIH's highest priorities 
will be to preserve the ability of new and junior scientists with fresh 
ideas to enter the competitive world of NIH funding. We plan to use the 
additional funding provided to NIH in the fiscal year 2007 Joint 
Resolution on these valuable initiatives. In fiscal year 2007 and 2008, 
we will make every effort to maintain an average yearly number of 
approximately 1,500 new investigators receiving their first NIH R01-
equivalent grants to create the vital next generation of scientific 
leaders.
    Also in fiscal year 2008, the NIH budget proposes to continue to 
grow fresh talent through the new ``Pathway to Independence'' program 
and to support 175 recently trained scientists in their quest to become 
independent researchers at an earlier point in their careers. These 
efforts, however, cannot come at the expense of the need to provide 
continuing support to our most productive and already established 
scientists. History shows that no one can predict from whom and from 
where the next great discovery or life-saving breakthrough will occur. 
It is therefore critical that NIH maintain a large variety of 
approaches to science and continue to work hard to encourage diversity 
among its scientists across all strata of our society.
    We also strive to maintain the historical balance between the 
critically important investigator-initiated research portfolio and 
agency-driven priorities. Our successful model of research is based on 
creative and unconstrained scientists who propose their best ideas, so 
we can subject those ideas to rigorous and independent peer review, and 
then support the most promising and high-quality projects. Our budget 
targets resources to providing as large a number of competing Research 
Project Grants for individual scientists as possible. To support our 
vision and initiatives in the current budget environment, we made 
difficult but strategic decisions, like maintaining the average cost 
for competing grants at the fiscal year 2007 level and not providing 
inflationary increases for direct reoccurring costs in non-competing 
grants. Our budget also proposes to reduce intramural research 
expenses.
    Our basic science projected percentage in fiscal year 2008 is 54.1 
percent, and applied science is projected at 42.1 percent. The percent 
of NIH's budget designated for infrastructure support will increase 
slightly in fiscal year 2008, to 3.2 percent. In total, the budget 
provides $144 million to enhance our infrastructure stewardship to 
provide robust, modern, energy-efficient, and environmentally safe and 
secure facilities to conduct basic and clinical research.

                                SUMMARY

    In closing, let me emphasize--we are at a critical point in 
biomedical research and must maintain the momentum to reach our vision. 
The opportunities for significant advances exist on virtually every 
front. We must not let these opportunities slip away. We do not want to 
lose the scientific capacity that we have developed in the recent past 
across the entire country. The transformation of health and medicine 
from the curative paradigm of the past to the preemptive paradigm of 
the future is within our grasp. As an example, in the past year alone, 
we realized a huge victory against cervical cancer, a disease that 
affects hundreds of thousands of women worldwide--a victory that we 
only dreamed about 10 or 15 years ago. The discoveries of Drs. Doug 
Lowy and John Schiller of NIH's National Cancer Institute on the human 
papilloma virus and the hard work of our private-industry partners have 
led to the development of the first FDA-approved vaccine against 
cancer. This is the kind of preventive intervention that will help us 
transform medicine in this century. The development of this vaccine 
represents just a small example of the NIH contribution to 
biotechnology and its transfer to the bedside--in this case before the 
``bedside'' is ever needed.
    We are also working to preempt disease through evidence-based 
education that draws on the best behavioral and social science 
research. Let me give you just one of the many examples of how NIH 
translates research results into practical health interventions for the 
public. In 2005, NIH launched the WE CAN (Ways to Enhance Children's 
Activity & Nutrition) program. WE CAN is a behavioral intervention at 
the level of communities aimed at preventing childhood obesity. The 
overwhelming response from around the country has been gratifying. In 
less than two years, individuals and groups--ranging from schools and 
youth organizations to community and recreation centers--have joined 
with NIH and our partners in 36 states to energize WE CAN. This is what 
I mean when we talk about the necessary participation of communities 
and individuals in their own health in a future redesigned healthcare 
system.
    NIH also continues to expand its outreach and participatory efforts 
through its website, one of the most-visited in the word. The NIH 
website averages about 47 million visits each month, with more than 330 
million page views.
    I ask you to consider the challenges and the opportunities before 
us today in medicine and health, and the essential role of biomedical 
research. We have the key elements in place for overcoming a host of 
diseases and conditions and their societal burden, and momentum is on 
our side. Our research efforts have ushered in revolutionary changes in 
the diagnosis, treatment and prevention of disease. Sustaining the pace 
of biomedical discovery is essential to realizing a true and necessary 
transformation of medicine and health in our country.
    I will be happy to answer any questions you may have. Thank you.

    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    
    

    Senator Harkin. Dr. Zerhouni, thank you very much for a 
very enlightening and succinct presentation.
    I've been fond of saying a lot in the past that in America 
we don't have a healthcare system, we have a sickcare system. 
When you get sick, you get care. There's not much up front to 
help keep you from getting sick. A statistic I saw recently was 
that 75 percent of all medical cost in Medicare is due to the 
treatment of chronic illnesses which have reached their later 
stages. So, a lot of these are preventable, if you get to them 
early on. That's what you're showing here, to get to a true 
healthcare system, where you keep people healthy in the first 
place.
    So, I really appreciate that presentation. I think that's a 
good note on which to begin our questioning.

                           STEM CELL RESEARCH

    Dr. Zerhouni, I have a series of questions, and then I'll 
yield to Senator Specter. We may go back and forth here for a 
while. But the first thing I want to get into is something that 
Senator Specter brought up. Both of us worked together on this, 
very hard. Senator Specter had the chairmanship during all 
those years when we first isolated embryonic stem cells, in 
Wisconsin, at the University of Wisconsin. Senator Specter had 
the first hearings on that. As he said, we've had 20 since 
then. He and I have worked together harmoniously on this to try 
to push the frontiers of this and to get around the 
restrictions.
    But when you were appointed to your position 5 years ago, a 
lot of people were anxious about what we were going to do about 
embryonic stem cell research and about the restrictions that 
were placed on August 9, 2001, at 9 p.m. At that time, you 
know, there was a limit of how many stem cell lines could be 
financed through Federal funds for research. We were told, at 
that time, there were 78. But then, we've found out a lot since 
then.
    Now, again, when you first came before this committee, you 
said you wanted to let science take its course. Well, over the 
last 5 years, science has taken its course. I thought that was 
profound on your part to do so, to say that, because what we've 
discovered is that those 78 lines are not 78, they're really 
about 21. At least that's the latest I've been told. Only a 
handful are used on a regular basis, limiting their genetic 
diversity. We know, also, that all of them have been 
contaminated, because they were grown on mouse feeder cells. 
So, the likelihood that they would ever be used for any human 
intervention is unlikely. We now know that there are much 
better ways of deriving and growing stem cells than what we 
knew in 2001. However, the lines derived from these new methods 
are not eligible for Federal funding.
    So, given all that's happened in the last 5 years, I'd just 
like to revisit this issue with you. With everything you've 
told us about the vision for the future and getting in front of 
this, would scientists have a better chance of finding these 
new cures, new interventions for diseases, if the current 
restrictions on embryonic stem cell research were lifted?
    Dr. Zerhouni. I think the answer is yes. My experience has 
been this. In 2001, I think the policy that was put in place 
was the first one to fund embryonic stem cell research. I think 
NIH has done a great job in the first 3 years of that in 
establishing infrastructure, funding new scientists, which 
weren't fundable before. Since 2004, I think it's very clear, 
from the point of view of science and what I have overseen, 
that these cell lines will not be sufficient to do all the 
research we need to do, for the reasons that you mentioned, but 
the most important one is that these cell lines have exhibited 
instability, from the genetic standpoint, and it's not possible 
for me to see how we can continue the momentum of science in 
stem cell research with the cell lines that we have currently 
at NIH that can be funded. So, from my standpoint, it is clear 
today that American science is--would be better served, and the 
Nation would be better served, if we let our scientists have 
access to more cell lines, because they can study with the 
different methods that have emerged since 2001, the different 
strategies that we now understand, underlie the fundamental 
issue, which is nuclear programming, or DNA programming, or 
reprogramming.
    So, the answer is yes.
    Senator Harkin. Well, Dr. Zerhouni, let me ask you to 
comment on two things, then.
    We're hearing a lot now in the popular press, not so much 
in the scientific journals, that we don't have to do this, that 
adult stem cells can take care of it all, then we have amniotic 
stem cells, and then we have umbilical cord stem cells, and 
that we don't need embryonic stem cells, that all these others 
will handle it, will take care of it.
    Second, on the issue of stem cell research itself, why is 
it so important that NIH do this? Already, California is doing 
it. I think Missouri just passed a constitutional amendment on 
it. In Iowa, my own State, the legislature just voted, and the 
Governor signed a law lifting the ban, in Iowa. Wisconsin, of 
course, New York. So, different States are doing different 
things. A lot of times when I talk about this, people say, 
``Well, if the States are doing it, there's no real reason for 
NIH to be involved in this.'' So, if you could address both--
why is it important for NIH? What about adult stem cells and 
all these others being sufficient?
    Dr. Zerhouni. Well, let me give you my point of view, and, 
I think, the scientific point of view here. Again, my statement 
that I--as I made 5 years ago, is that I will always stick to 
the scientific truth, and disease knows no politics. So, let me 
say this. The presentations about adult stem cells having as 
much, or more, potential than embryonic stem cells, in my view, 
do not hold scientific water, if you will. I think they are 
overstated. I think we do not know, at this point, where the 
breakthroughs will come from. I think scientists who work in 
adult stem cells, themselves, will tell you that we need to 
pursue, as vigorously, embryonic stem cells.
    My point of view is that all angles in stem cell research 
should be pursued. I think people sometimes misunderstand what 
the fundamental challenge is in stem cell research. It's not 
solely to use it to replace things, like in adult stem cell 
transplantation, but it's to really understand, for the first 
time in the history of mankind, how DNA is programmed and 
reprogrammed. Well, to do that, you need to have copies of 
cells that have been programmed--adult stem cells--but also 
copies of cells that have never been programmed forward--
embryonic stem cells. The key thing here is that the nation 
that understands that will be as--in the stronger position, as 
we were in the 20th century for the information revolution, for 
computers. It's basically the software of life that we're 
talking about. So, from my standpoint as NIH Director, it is in 
the best interests of our scientists and our science, our 
country, that we find ways, that the Nation finds a way, to 
allow the science to go full speed across adult and embryonic 
stem cells equally.
    Senator Harkin. Why is it so important for NIH?
    Dr. Zerhouni. Right. So, why is it important? As the NIH 
Director, I can tell you that the role that NIH has played in 
this country over the years has been second to none. There is 
no State that can really provide the depth of oversight and 
stimulation of this research over the long run. This is not a 
1-mile race; this may be a marathon. It is important, I think, 
for NIH to play its historical role. I think that we have done 
that. We can do this, with appropriate oversight, a lot of 
safeguards, to make sure that this research is not misused.

                 NIH'S LEADERSHIP IN STEM CELL RESEARCH

    Senator Harkin. Ethical guidelines.
    Dr. Zerhouni. Ethical guidelines. You know, Senator, we've 
done this. We've done this with the Recombinant DNA Advisory 
Committee in 1976, 1977, 1978. At that time, as you know, 
genetic engineering came on the scene. There was a huge 
question about both the safety and the ethics of using genetic 
engineering. Well, NIH took the lead, and set up a Committee 
called the Recombinant DNA Advisory Committee. We've been 
probably the most successful country in biotechnology. We've 
created a completely new industry. I think that this is the 
kind of role NIH can play. If you have a patchwork of policies, 
a patchwork of different approaches, you may not have the same 
standards. It will be very difficult for our country to muster 
its strength unless we have some sort of moving--of move 
forward in this area. We cannot, I think, be second-best in 
this area. I think it is important for us not to fight with one 
hand tied behind our back here.
    Senator Harkin. I also----
    Dr. Zerhouni. NIH is key to that.
    Senator Harkin. I also see what's happening out there now 
in California, where they're in a bidding warfare to get 
scientists to come there. Missouri's now going to do some 
bidding. Wisconsin. I suppose Iowa will probably get in the 
game now that we've lifted the law. So, it just seems that--to 
me, anyway--by providing NIH with this authority, which--you 
have the experience, the oversight, you are the world's leader. 
Everyone recognizes NIH as being the gold standard of unbiased 
research--that if you put NIH's blanket over the thing, I think 
it would reduce, a lot, this kind of bidding warfare between 
States, and then we'd have a national kind of an approach on 
this. Plus, NIH could reach out to other countries and 
coordinate other countries in doing this research, also. Is 
that, sort of, the kind of process would take place?
    Dr. Zerhouni. My view is that I think it's time to move 
forward on--in this area. It's time for the Nation's 
policymakers to find common ground to make sure that NIH does 
not lose its historical leadership. I think we've maintained 
that leadership all the way to 2004-2005. But, as we've 
discovered, the lines that we have are less viable than we 
would have liked them to be--as these lines are older, I think 
it's important to realize that we need to move forward here, 
and NIH needs to continue its historical role as the leader of 
biomedical research in the world. To sideline NIH on an issue 
of such importance, in my view, is shortsighted. I think it 
wouldn't serve the Nation well in the long run. We'd need to 
find a way to move forward. I look at--obviously----
    Senator Harkin. Yeah.
    Dr. Zerhouni [continuing]. It's more than science that is 
involved here, but I hope that we can find that way forward 
soon.
    Senator Harkin. Well, Dr. Zerhouni, let me thank you for a 
very profound and courageous statement that you've made here 
today.
    Dr. Zerhouni. Thank you.
    Senator Harkin. Thank you.

                      DECLINE IN CANCER DEATH RATE

    Senator Specter.
    Senator Specter. Dr. Zerhouni, as you have testified, the 
deaths due to cancer have declined in the last 2 years. To what 
extent would you attribute that to research done by NIH?
    Dr. Zerhouni. It's difficult to figure out exactly what is 
contributing to what, but I can be somewhat specific. Most 
scientists look at this decrease and feel that the main cause 
has been the decrease in smoking, that behavioral changes--
social and behavioral sciences have contributed to epidemiology 
and prevention a great amount. The second cause has been early 
screening. If you look, for example, at colon cancer, the rates 
of colon cancer, and the death rates, have come down. Why? 
Because we have promoted the early detection of polyps. Now, 
how does NIH play into that? Well, it turns out that the 
discovery that told us that polyps are really the pre-emptable, 
the preventable cause of the cancer, was that the genetic 
changes that lead to cancer start with a polyp. So, it's a----
    Senator Specter. So, it is the NIH research which has 
identified a way for early screening to treat cancer at an 
early stage.
    Dr. Zerhouni. But the basic research----
    Senator Specter. Is that correct?
    Dr. Zerhouni. That is correct, Senator. The most important 
is the NIH basic research, the study--the findings of Dr. 
Vogelstein, for example, who discovered that cancer of the 
colon does not happen overnight, but happens through a cascade 
of genetic changes that start with a polyp. That's what then 
led to the development of screening, and its impact on the 
reduction of cancer rates.
    Senator Specter. NIH has researched and found treatments 
for various strains of cancer, isn't that correct?
    Dr. Zerhouni. Absolutely.

                          UNDERSTANDING CANCER

    Senator Specter. How many strains of cancer are there? We 
talk about cancer as one generalized term, but approximately 
how many different strains of cancer are there?
    Dr. Zerhouni. That's an excellent question, Senator. Most 
people will say 200 types of cancer are known. But my view is 
that, as I've followed this field very closely--is even within 
breast cancer, for example, there are many subtypes of breast 
cancer. So, if you look at cancer, it's not one disease, it's 
200 separate diseases, and the molecular changes that occur in 
each one of them may actually be different from one to the 
other. This is why we need to do more research, to understand 
what's different between a cancer that kills and a cancer that 
doesn't, and how do you treat this one versus that one?
    Senator Specter. We have had estimates, on prior hearings 
by this subcommittee, on how long it would take to cure 
Parkinson's. Would you say that it would be realistic to give 
an approximation as to what it would cost to cure cancer, and 
how long it would take?
    Dr. Zerhouni. Very difficult to do that, as you know.
    Senator Specter. Well, that's why I'm asking you, Dr. 
Zerhouni.
    Dr. Zerhouni. I appreciate that, Senator. I think it's 
clear that if you look at the advances that we're making today, 
that the--the challenge in front of us is to understand the 
complexity of cancer treatments relative to the complexity of 
the biology of cancer. Most people would say that in the area 
of Parkinson's disease, for example, that there are--we need to 
make progress at the basic level to understand what are the--
what is the first mechanism of disease. We have several 
mechanisms of disease that we are working on. As long as you 
don't know that, it's very hard to predict when you're going to 
cure Parkinson's disease. But we're already studying--knowing, 
for example, which genes are involved in Parkinson's disease. 
We've made discoveries that tell us that Parkinson's disease 
relates to abnormalities in the neurons. Some people think it's 
because there's accumulation of abnormal protein mechanisms. 
But here is the answer. The answer is, I can assure you that 
with less research, the cure will take much longer than with 
more research.
    Senator Specter. Well, that's a pretty obvious conclusion, 
Dr. Zerhouni----
    Dr. Zerhouni. I know. Well, it's like the question----
    Senator Specter [continuing]. But----
    Dr. Zerhouni [continuing]. You posed, Senator.

                       QUANTIFY FUNDING DECISIONS

    Senator Specter [continuing]. But what we are looking for, 
within reason, is finding some way to quantify it. Now, I've 
had some experience with Hodgkins, and I have been informed of 
a variety of advances in the treatment of Hodgkins. Different--
they call it a cocktail--that wasn't my idea of a cocktail 
before I had Hodgkins--and they told me a complex 
categorization and various substances. I've talked to others, 
and the field has progressed tremendously. All for the better. 
What would be very meaningful, as we approach your budget, 
would be to try to get some way to quantify, as best you can--
now, I know this is not going to work out to be a mathematical 
formula, but, when we talk about the various strains of cancer, 
it is important to know how many research projects are 
undertaken, and how many you are turning away.
    We moved, on this committee, to appropriate very 
substantial sums over a 4-year period of time. From fiscal year 
1999, we increased the budget to slightly under $2 billion--
$1.950 billion. The next year, we appropriated the increase was 
$2.190 billion. The year following a $2.630 billion increase. 
The year following, an increase of $2.830 billion. The year 
following, an increase of $3.770 billion. So that we are able 
to increase funding over a 5-year period, some $13 billion.
    Now, how did we do that? We took a budget in the range of 
$140 billion, which the subcommittee has, which funds three 
very important departments, Health and Human Services, 
Education and Labor and we pruned through the budget, found, 
with very sharp pencils, where we could establish priorities to 
increase the funding for NIH.
    Now, you've testified, in the past, that increase in 
funding enabled you to grant many, many more applications for 
funding. More recently, we have seen a decrease. Senator Harkin 
and I had to fight like tigers last year to add a little over 
$600 million to stop a $50 million cut in the National Cancer 
Institute. Now, what catches the attention of our colleagues 
would be specifics. So, my request to you--and I've made 
similar requests in the past--is to go back and make an 
analysis, and give us your best judgment as to what is 
happening with the decrease in the funding. The President's 
budget now is more than $500 million below last year, without 
considering an inflationary increase. We would like to know 
what effect that's going to have on research, so that--tell us, 
number one, your best judgment as to what it would cost to cure 
cancer, or as close as you can to that analysis, taking the 
strains of cancer and how many research projects you need, and 
over what period of time; and then, second, what's going to 
happen to NIH if the budget is cut by more than $500 million. 
If you take an inflationary factor of 2 percent, it's several 
billion dollars that it's being cut. Then, the third factor 
that would be very helpful would be to tell us what would be 
done by way of prevention. It's very expensive to treat 
somebody with Hodgkins. I can tell you that personally. Your 
statistics are also impressive when you say that the second 
year in a row there's been a 60-percent drop in mortality for 
heart disease and strokes. That means 60 percent fewer people 
have died. The drop in deaths of women from heart disease, from 
one-third to one-fourth, reported.
    [The information follows:]

               Professional Judgment Cost to Cure Cancer

    If I may: ``What will it cost if we do not cure cancer?''. The 
National Institutes of Health estimate overall costs for cancer in 2006 
as $206.3 billion: $78.2 billion for direct medical costs (total of all 
health expenditures); $17.9 billion for indirect morbidity costs (cost 
of lost productivity due to illness); and $110.2 billion for indirect 
mortality costs (cost of lost productivity due to premature death).\1\  
Between 1974 and 2004, on average, each American has spent about $9.00 
per year on cancer.\2\  Moreover, economists at the University of 
Chicago, Graduate School of Business have estimated that a 1 percent 
reduction in cancer mortality would be worth $500 billion to current 
and future Americans. A ``war on cancer'' that would spend an 
additional $100 billion on cancer research and treatment would be 
worthwhile if it has a 1-in-5 chance of reducing mortality by 1 percent 
and a 4-in-5 chance of doing nothing at all.\3\ 
---------------------------------------------------------------------------
    \1\ American Cancer Society, Cancer Facts and Figures 2007.
    \2\ Congressional Transcripts, Congressional Hearings, March 19, 
2007, page 5: Senate Committee on Appropriations, Subcommittee on 
Labor, Health and Human Services, Education and Related Agencies Holds 
Hearing on the Fiscal year 2008 Budget for the National Institutes of 
Health.
    \3\ Murphy KM, Topel RH: The value of health and longevity, J 
Political Economics: vol. 114, no. 5, pages 871-904.
---------------------------------------------------------------------------
    The primary focus of the NCI is on research and developing 
prevention and treatment options; it is necessary for others in the 
cancer community to ensure that the results of our efforts are 
disseminated and applied.

                          COST TO CURE CANCER

    It is probably unrealistic to predict when cancer will be cured. 
Cancer is not one disease, but represents over 200 diseases and as a 
result is an exceptionally complex health care problem. Eliminating 
cancer as a significant burden will require step-wise gains in 
scientific knowledge and innovative ways for translation of this 
knowledge to the clinic. Progress is made by building upon pre-existing 
discovery, and the pace of scientific advances is, of course, driven by 
the amount of resources available for laboratory research and clinical 
translation. The NCI has never been at a more exciting place in terms 
of understanding the molecular mechanisms causing cancer and 
determining its progression. We have made tremendous progress over the 
last decade that has resulted in a measurable decline in cancer deaths 
for both men and women. Three decades ago there were 3 million caner 
survivors; today there are over 10 million.
    What can also be said with certainty is that we are rapidly moving 
toward an era when cancer treatment will involve a molecular diagnosis 
of each tumor followed by highly personalized recipes of therapy. We 
are identifying the underlying genetic changes identified with the risk 
of developing cancer, we are increasingly able to detect cancer before 
clinical symptoms, we are learning how to use the immune system to keep 
cancer from progressing, and we are developing therapies that 
specifically target cancer cells. Using these combinations of 
approaches to prevention, diagnosis and treatment, we are beginning to 
see some cancers as manageable chronic diseases.
    Of great concern is the knowledge that cancer incidence is 10 times 
greater for those 65 and older than for those under 65, and the death 
rate is 16 times higher. By 2030, 20 percent of the U.S. population 
will be over age 65 compared with 12 percent in 2004. Therefore, it is 
imperative that we maintain, if not accelerate, the momentum of 
scientific discovery.

                  BUDGET CUT BY MORE THAN $500 MILLION

    The following examples illustrate what NIH can't do with the fiscal 
year 2008 President's Budget, relative to the fiscal year 2007 enacted 
level:
National Cancer Institute
    Despite many fruitful studies on prostate cancer initiation and 
progression, the prostate cancer cell of origin has not been 
conclusively identified. NCI will not be able to fund an R01 on the 
``Study of the Cell-of-Origin and Cancer Stem Cells in Prostate 
Adenocarcinoma'' which seeks to identify the prostate cancer cell of 
origin--an understudied area in cancer biology. In this highly focused 
application, the investigator would test the hypothesis that, in the 
prostate, there is a specific progenitor cell population that is 
sensitive to oncogenic transformation, and that this cell population is 
also responsible for hormone resistant prostate cancer formation. The 
application is innovative, timely, and likely to yield significant 
meaningful data that will drive the future of the field. Because most 
current therapeutics target what may be a more differentiated cell 
type, the success of this proposal could lead to novel strategies for 
treating prostate cancer. There are very few applications currently 
funded to identify cancer stem cells in prostate cancer.
National Institute on Alcohol Abuse and Alcoholism
    The most serious adverse consequence of prenatal alcohol exposure 
is fetal alcohol syndrome (FAS), a devastating developmental disorder 
characterized by craniofacial abnormalities, growth retardation, and 
nervous system impairments that may include mental retardation. 
Preliminary data suggests that pharmacological and nutritional 
interventions may prevent deficits in alcohol-exposed fetuses even when 
administered following the exposure to alcohol. Recently studies in 
animal models have shown that choline is capable of preventing deficits 
due to alcohol exposure in utero. The fiscal year 2008 President's 
budget does not provide sufficient funds to proceed with larger scale 
studies to determine the effectiveness of choline in preventing 
deficits in humans due to in utero alcohol exposure.
National Institute of Child Health and Human Development
    There will be no expansion of research efforts to translate NICHD-
supported basic scientific findings into a new class of antimicrobial 
agents that could prevent bacterial or viral infections in the 
gastrointestinal tract, overcoming a major and growing public health 
problem of bacterial and viral drug resistance. Researchers found that 
oligosaccharides, non-nutritive components of human milk, inhibit the 
toxic effects of Escherichia coli and other gastrointestinal pathogens. 
These pathogens infect thousands of adults, and children, annually, 
causing extreme discomfort and even death. In the U.S., infections due 
to C. jejuni, E. coli, and five other food borne pathogens have been 
estimated to cost $6.5 billion to $34.9 billion annually. The critical 
advantages of developing these amazing antimicrobial products are that 
they: a) can prevent both viral and bacterial infections, and b) do not 
interfere with protein synthesis and bacterial/viral replication. 
Instead, these compounds prevent the pathogens from binding to 
intestinal walls, thus overcoming a major and growing public health 
problem of bacterial and viral drug resistance.
National Institute of Diabetes and Digestive and Kidney Diseases
    NIDDK can provide only very limited funding to solicit applications 
investigating the effect of maternal obesity on mechanisms that could 
potentially contribute to obesity, diabetes, cancer, cardiovascular or 
metabolic disease in the offspring.
    NIDDK has not been able to initiate an Autoimmune Hepatitis 
Clinical Research Network which would focus upon elucidating the 
pathogenesis and developing means of prevention, treatment and control.
National Institute of Neurological Diseases and Stroke
    The NINDS developed the Spinal Muscular Atrophy (SMA) Project as a 
pilot of how to speed the translation of basic science advances to 
therapies that are ready for clinical testing. The project is 
implementing a systematic drug development plan via a ``virtual pharma 
organization,'' which develops and applies the resources for drug 
development through subcontracts to companies that serve the 
pharmaceutical industry. The project is making encouraging progress, 
enough so to warrant application for a provisional patent on promising 
compounds that have been developed. Although there are other 
neurological disorders that might be ripe for a similar targeted 
therapy development program, NINDS would not be able to undertake such 
an activity under the President's budget.
National Institute on Aging
    Specific examples of the potential impact of budget constraints on 
the momentum of the federally-supported Alzheimer's disease research 
agenda include:
  --NIA may be unable to maximize data collection efforts or to 
        capitalize on the data being generated through studies under 
        its two recently-released Program Announcements aimed at the 
        discovery, development, and preclinical testing of novel 
        compounds for the prevention and treatment of Alzheimer's 
        disease.
  --NIA will fund fewer studies under the Alzheimer's disease 
        Neuroimaging Initiative, a public-private partnership that 
        tests whether imaging techniques, other biological markers, and 
        clinical and neuropsychological assessment can be combined to 
        measure with greater sensitivity the progression of mild 
        cognitive impairment (MCI) and early Alzheimer's disease.
  --Constrained budgets could slow the process of studying and 
        identifying genes through the ongoing Alzheimer's disease 
        Genetics Initiative, which is designed to develop the resources 
        necessary for identifying late-onset Alzheimer's disease risk 
        factor genes, associated environmental factors, and the 
        interactions of genes and the environment. Identification of 
        informative subjects, genetic typing, and data analysis would 
        all be slowed, delaying the identification of genetic and 
        environmental factors that could provide new approaches for the 
        prevention and treatment for Alzheimer's disease.
National Institute of Allergy and Infectious Diseases
    There is an intensified need for the development of a safe, 
effective and acceptable topically applied chemical and /or biologic 
barrier to prevent sexually transmitted HIV infection. Topical 
microbicides hold great promise as a strategy for preventing future HIV 
infections and AIDS-related complications and are designed to allow 
women to protect themselves against HIV and other sexually transmitted 
infections. The NIH supports several research programs and initiatives 
to help develop and advance candidates into human clinical trials, 
including the Integrated Preclinical/Clinical Program for HIV Topical 
Microbicides, Microbicide Innovation Program, and the Microbicide 
Design and Development Teams. There are 38 lead microbicide candidates, 
of which seven are advancing to clinical trials in the next few years, 
and over 100 proposed candidates in the microbicide development 
pipeline. Additional funds would allow NIAID to ensure a vibrant 
pipeline and advance five additional compounds into early clinical 
studies.

                          PREVENTION RESEARCH

    The following examples of prevention research should lead us toward 
the era of personalized medicine, where we will be able to preempt the 
disease early in its process or even before it starts.
National Institute of Mental Health
    NIMH is supporting a prospectively designed research network to 
predict, characterize, and preemptively treat schizophrenia:
  --Schizophrenia is generally diagnosed between ages 18 and 21 when a 
        young person has a psychotic episode that requires 
        hospitalization and intensive treatment.
  --However, most people with schizophrenia are ill for at least 18 
        months before their first psychotic episode--this period is 
        known as the prodromal phase of the illness.
  --The goal of this research network will be to determine whether 
        treating schizophrenia during the prodromal phase can prevent 
        psychosis and functional disability. Researchers will identify 
        genomic and imaging biomarkers to define risk and to develop 
        interventions.
National Institute on Alcohol Abuse and Alcoholism
    NIAAA is supporting research to identify ``trait'' biomarkers which 
are inborn characteristics of increased vulnerability for specific 
types of alcohol-use disorders including alcohol dependence 
(alcoholism).
    Through the identification of trait biomarkers for the specific 
subtypes, early pre-emptive interventions would be feasible in 
individuals at high risk for future alcohol dependence, as would 
interventions in early stages of the disease itself with personalized 
treatment based on subtype.
National Institute of General Medical Sciences
    Part of the difference in how people respond to drugs is due to 
genetic variations, particularly in the pathways that control drug 
metabolism. Such variations can render some drugs ineffective in 
certain individuals or, in other cases, increase the likelihood of 
dangerous adverse drug reactions. Since 2000, NIGMS has led the 
Pharmacogenetics Research Network, a trans-NIH effort to elucidate the 
genetic basis of differences in drug responses and guide the 
implementation of this knowledge into clinical practice. In several 
cases, findings by network scientists have already impacted practice, 
such as by providing genetic tests to support the use (or avoidance) of 
a given drug. Pharmacogenetics is a leading example of how investments 
in the Human Genome Project will broadly affect medical treatment, in 
this case by personalizing drug therapy.
National Eye Institute
    The Age-related Eye Disease Study2:
  --The Age-Related Eye Disease Study (AREDS), a multi-center study of 
        cataract and age-relate macular degeneration (AMD) originally 
        launched in 1992, demonstrated that high-dose antioxidant 
        supplements (beta-carotene, vitamins C and E, and zinc) can 
        slow the progression of AMD. Additional studies have suggested 
        that the nutritional supplements lutein/zeaxanthin and omega-3 
        long chain polyunsaturated fatty acids might have benefit in 
        preventing or slowing the progression of AMD and the formation 
        of cataract. Leveraging these findings, the NEI began the Age-
        Related Eye Disease Study2 (AREDS 2), a multi-center study that 
        will include up to 100 clinical sites.
  --It is hoped that data from ARESD2 will improve therapeutic regimens 
        that can prevent or slow the progression of AMD and cataract. 
        It is further hoped that additional study data from AREDS2 will 
        help create prognostic criteria to determine who will likely 
        benefit from these nutrient supplements.
National Human Genome Research Institute
    To speed research on the causes of common diseases such as asthma, 
arthritis, the common cancers, diabetes, and Alzheimer's disease, the 
Department of Health and Human Services announced in February 2006 two 
related groundbreaking initiatives in which NHGRI will play a leading 
role. Using the newly derived HapMap, both of these initiatives will 
search for the specific DNA variations that are associated with 
increased risk for common illnesses. Finding the DNA variants that 
predispose a person to common disease is one of the highest priorities 
of current biomedical research, since it will enable the identification 
of new drug targets and the development of personalized medicine.
    The Genes, Environment and Health Initiative (GEI) is a trans-NIH 
research effort to combine comprehensive genetic analysis and 
environmental technology development to understand the causes of common 
diseases. GEI will support more than a dozen studies, beginning in 
fiscal year 2007.
    The Genetic Association Information Network (GAIN) is a related 
public-private partnership between the NIH, the Foundation for the NIH, 
and private sponsors including Pfizer and Affymetrix. In 2006, GAIN 
selected six research studies for support: psoriasis, ADHD, 
schizophrenia, bipolar disorder, major depression and diabetic 
nephropathy. Results will begin to appear in June 2007.
National Institute of Neurological Diseases and Stroke
    Research funded by NINDS has identified specific variants of a gene 
called phosphodiesterase 4D (PDE4D) that significantly increase the 
risk of stroke in women aged 15-49. The risk is magnified in women who 
smoke cigarettes. The study is the first to identify a possible 
interaction between this gene and an environmental factor in triggering 
stroke.
    This study is part of a larger effort called the Stroke Prevention 
in Young Women Study2, which is designed to identify genetic and 
environmental risk factors for ischemic stroke (stroke that results 
from blockage in artery) in young women. The NINDS-funded investigators 
are now carrying out a study of risk factors for early-onset stroke in 
young men to help further clarify the role of the PDE4D gene and 
characterize the genetic basis for ischemic stroke. This research could 
help identify those at risk for stroke so that they may modify their 
behavior and eliminate certain environmental influences (e.g., smoking) 
to pre-empt the occurrence of a stroke. The research may also help in 
the development of new types of interventions to prevent stroke in 
those high risk individuals.
National Institute of Dental and Craniofacial Research
    Salivary Diagnostics.--The day is approaching when a tiny computer 
chip glued to a tooth will allow early, personalized diagnosis and 
treatment by closely monitoring levels of proteins associated with 
specific diseases, as well as the medications prescribed to treat them.
  --NIDCR support helped develop the current generation of rapid HIV 
        antibody testing that uses intraoral fluid. The 
        OraQuickTM HIV test reportedly has a 99.8 percent 
        accuracy rate, compared to 99.9 percent for a blood test.
  --Current grantees recently fabricated the first disposable, low-cost 
        miniaturized diagnostic platform to process small amounts of 
        saliva to detect the levels of DNA sequences of interest. The 
        work is proceeding to ultimately create a fully functional 
        hand-held instrument for salivary diagnostic tests that is 
        about the size of a BlackBerryTM.
  --In the future, miniaturization of the technology will allow 
        salivary diagnostic chips to be attached to a tooth for 
        continual personalized monitoring of biomarkers for specific 
        diseases.
 National Institute of Arthritis and Musculoskeletal and Skin Diseases
    The NIAMS places a high-priority on studies to identify risk 
factors and biomarkers of disease. To this end, the Institute will 
continue its commitment to a novel public-private partnership to 
improve prevention of osteoarthritis (OA), or degenerative joint 
disease. The Osteoarthritis Initiative (OAI) is a long-term effort, 
developed with support from numerous NIH components, private sector 
sponsors, and with the participation of the Food and Drug 
Administration, to create a publicly-available research resource to 
identify and evaluate biomarkers of OA for use in clinical research. 
The study has 4,800 participants who are at high risk for knee OA and, 
as of early fiscal year 2007, clinical data from approximately 2,000 of 
them were available for research projects. Over the next 5 years, the 
OAI will provide an unparalleled, state-of-the-art longitudinal 
database of images and clinical outcome information available to 
researchers worldwide to facilitate the discovery of biomarkers for 
development and progression of OA. In this effort, a biomarker would be 
a physical sign or biological substance that indicates changes in bone 
or cartilage. Today, 35 million people--13 percent of the U.S. 
population--are 65 and older, and more than half of them have 
radiological evidence of OA in at least one joint. By 2030, an 
estimated 20 percent of Americans--about 70 million people--will have 
passed their 65th birthday and will be at increased risk for OA.
National Institute of Diabetes and Digestive and Kidney Diseases
    Preempting Risk Factors for Type 2 Diabetes in Children:
  --Previously considered a disease of adults, type 2 diabetes is now 
        increasingly observed in children, particularly minority youth. 
        Identifying new strategies to preempt risk factors for diabetes 
        is extremely important because recent data estimate that 1 in 
        14 children in the U.S. between 12 and 19 years of age has pre-
        diabetes--and many of the children with pre-diabetes have risk 
        factors for cardiovascular disease (CVD).
  --In August 2006, the NIDDK launched a multicenter clinical trial, 
        called HEALTHY, which is aimed at preempting risk factors for 
        type 2 diabetes in middle-school children.
  --Half of the 42 enrolled schools are receiving the intervention, 
        which consists of: environmental changes to school food service 
        and physical education class activities; behavior change 
        activities; and communications and promotional campaigns.
  --Children are being enrolled in the sixth grade and followed for 3 
        years. Importantly, the schools have large (50 percent or more) 
        minority or under-served populations.

                      NIH OFFICE OF WOMEN'S HEALTH

    Senator Specter. Now, we go back to before your time, Dr. 
Zerhouni. It was about 1991, wasn't it, Senator Harkin, when 
the woman's branch of NIH was established? Is that correct?
    Dr. Zerhouni. That's correct. The Office of Women's Health.
    Senator Specter. There wasn't an Office of Women's Health 
before this subcommittee picked it up and found the money for 
it. My wife pointed out to me the difference in heart disease 
for women, and we took the lead, here in this subcommittee, to 
establish a women's unit. So, it's very gratifying to see your 
statistics this year, that heart disease of women dropped from 
one-third to one-fourth.
    Well, you get my point. I'd like to have it in a concrete 
form so that we could tell our colleagues, on the budget 
resolution. As I told you earlier today, Senator Harkin and I 
are going to be going to the floor and asking for an increase 
in the budget resolution on NIH. I'm not sure how much it's 
going to be. We're going to ask for the most we think we can 
get--that is realistic--that we can get adopted, maybe a little 
more than that in terms of bargaining. Last year, we increased 
the budget for the subcommittee by $7 billion. But that's 
confederate money on the budget resolution. Doesn't turn into 
real cash until you have an allocation.
    I had a disagreement with Senator Byrd, back in 1988, on 
the allocation for the budget, and I did the unheard of thing 
for a Senator my age compared to a Senator of his standing, to 
disagree with a chairman's mark. I got three votes. It was 25 
to 3. You may think three votes out of 28's not many, but it's 
a lot. Senator Byrd told me, at that time, ``Someday you'll be 
chairman of the Appropriations Committee.'' It didn't seem 
possible. But now I'm right behind Senator Cochran. With term 
limits and a change in party, I'm getting pretty close to that, 
Dr. Zerhouni. If, and when that happens, you won't have to 
provide all these fancy statistics. But, in the interim, we 
need them--something really concrete that we can point to--to 
show our colleagues, as a way of elevating the status of health 
and how much NIH means to promoting health, our greatest 
capital asset, and how much it means in reducing costs by 
preventing disease.

                SUSTAINING OUR PRESENT RESEARCH CAPITAL

    What do you think, Dr. Zerhouni?
    Dr. Zerhouni. Let me just give you the three points that I 
think are essential, in terms of policy, and then also take the 
opportunity to supplement that answer with specifics for the 
record.
    First and foremost, you asked the question about: What is 
the optimal way for us to accelerate our research to get to 
cures as optimally as possible? It's hard to give an answer for 
any one disease, but I can show you, from my standpoint as a 
science administrator, what I think the optimal point is in our 
ability to sustain research.
    Let me show you, if you don't mind, a slide, here, of what 
has happened to NIH success rates. Historically, we've funded 
about 3 grants in 10 applications. Today, we fund 2 in 10. Our 
experience, as--myself, as a scientist, when I ran my lab; as a 
dean for research at a major institution; and now as NIH 
Director, is that 3 in 10 is the historical percentage where 
NIH has always sustained its success rate, and where we've 
gotten the return that we wanted. I'm concerned that 20 percent 
is too low. I think you will hear, from our scientists, that 
this is straining the enterprise, and it is also discouraging 
new generations.
    So, if you ask me, ``What is the wisdom of science 
administrators worldwide as to: `How do you sustain areas of 
research in cancer,''' or whatever, I think people would say 
that success rates in the 25- or 30-percent range are a minimum 
that you need to sustain research over time so that you can, in 
fact, have a healthy environment.
    Now, in this case--and I published these figures--I'm 
showing you here, in red, the success rate of NIH. If you look, 
historically, it was around 30 percent, if you follow the line. 
Then, in about 2002-2003, it dropped. Why did it drop? Not just 
because we had flat funding. Flat funding did lead to a loss of 
purchasing power. But here is the real story, Senator. More 
scientists are needed to study the complexity of the diseases 
we're dealing with. So, if you look at the curve, the blue 
curve, this is the number of applications we've received at 
NIH. You can see there are more scientists now--there are twice 
as many applications at NIH from twice as many scientists, 
almost, who want to do research. We can't sustain--not even 
one-third, not even 30 percent; we are at about 20 percent 
right now.
    So, that's answer number one. If you don't want to lose 
momentum, that is an objective that you need to look at.
    The second is what you said about: What is the greatest 
impact, and what do we need, to make sure we don't lose? Well, 
first, as you know, we've made some very tough decisions in not 
allowing inflationary increases and focusing, as you've helped 
us this year, on the next generation of scientists. Typically, 
NIH funds 1,500 new scientists a year who get their first major 
grant. Last year, we dropped to 1,400. I want to get back to 
1,500, because if we don't, 10 years from now you won't have 
the researchers to implement the cures that will be discovered 
in the basic research laboratories. So, it's important to 
realize that we need to sustain that. But that cannot be done 
without some compromise or some decrease in other areas.
    So, we have favored, over the past 2 years, what we call 
investigator-initiated research--research project grants to 
individual investigators. At the expense of what? Well, at the 
expense of clinical trials. If you look at our ability to 
conduct clinical trials on patients like yourself, you know we 
want to optimize a protocol for cancer, optimize a protocol for 
prevention of heart disease--prevention of stroke is another 
example--we've had to cut these programs, because they're 
extremely expensive.
    I'll give you an example. Clinical trial costs grow faster 
than inflation, because it's like healthcare, most of the care 
in the clinical trial cost is healthcare. So, it grows at 7-8 
percent. When you have a flat budget, you lose your ability to 
study as many patients. So, that's what we're seeing. This is 
what we're giving up. We're giving up the ability to do 
clinical trials to enable us to change the science and change 
the medicine that we do. So, that's the second answer that I 
think is important here, is that the impact is primarily in our 
ability to translate from the laboratory to the clinic to the 
bedside and to the community what we need to do to prevent 
diseases.
    But I will be happy to provide you very specific answers, 
institute by institute, for the record, Senator.
    [The information follows:]

            REDUCTION IN SOCIETAL BURDEN & HEALTH CARE COSTS

    The following examples illustrate how research funded by NIH 
institutes lead to reduced societal burden and/or healthcare costs:
National Cancer Institute

            Tamoxifen.--A Preventative Agent for Breast Cancer

    In 2006, breast cancer is estimated to have affected 214,640 
Americans. Since 1978, when Tamoxifen was first approved in the 
treatment of breast cancer, the National Cancer Institute has pursued 
further research to exploit the utility of this hormone receptor-
blocker as a cancer preventative agent. Several studies by NCI and 
others, using over 20,000 women, confirm that tamoxifen can be given to 
prevent Estrogen Receptor-positive (ER-positive) breast cancer, and the 
preventative benefits continue for many years after the women stop 
taking the drug. ER-positive breast cancer accounts for about 60 to 70 
percent of breast cancers. This equates to approximately 128,000 to 
150,000 cases of breast cancer that could be prevented annually. NCI 
previously conducted the STAR trial (Study of Tamoxifen and 
Raloxifene), with nearly 20,000 women, that showed the benefit for 
breast cancer prevention when taking either tamoxifen or raloxifene, 
and for the women taking raloxifene, a lower occurrence of blood clots 
or uterine cancer.

            Cancer Survivorship.--Reducing the Societal Burden

    NCI leads the nation in championing research on the health and 
quality of life of our growing population of cancer survivors, 
currently numbering more than 10 million, up from only 3 million in 
1971. While the ultimate goal of eliminating cancer continues to be our 
long term commitment, the capacity to dramatically reduce the societal 
burden caused by cancer, by increasing survivorship rates, is within 
our immediate reach. Advances in out ability to detect, treat and 
support cancer patients have turned this disease into one that is 
chronic or readily managed for many and curable for increasing numbers.

            HPV Vaccine.--Societal Benefits and Cost Savings

    An important public health milestone was realized when the FDA 
approved a vaccine that prevents infection by HPV 16 and HPV 18, the 
two subtypes of the human papillomavirus responsible for up to 70 
percent of cervical cancer cases worldwide. This approval is a 
watershed moment that highlights the very best of biomedical research: 
the translation of basic and population science into an intervention 
that will save lives.
    Widespread vaccination has the potential to reduce cervical cancer 
deaths around the world by as much as two-thirds (about 250,000 women). 
In addition, the vaccine can reduce the need for medical care, 
biopsies, and invasive procedures associated with the follow-up from 
abnormal Pap tests, thus helping to reduce health care costs. This 
advance also allows NCI to stress the continued importance of cervical 
cancer screening and provides an opportunity to educate the public 
about HPV. By monitoring benefits and risks of HPV vaccination, we can 
optimize the use of HPV vaccines to achieve the greatest health benefit 
for women.
The National Heart, Lung and Blood Institute
    During the past several years, American men and women have 
benefited greatly from continued reductions in morbidity and mortality 
due to cardiovascular disease. The following new findings from NHLBI-
supported research have improved our ability to treat and prevent a 
range of cardiovascular conditions:
  --The ALLHAT revealed that diuretic drugs are at least as effective 
        as newer, more expensive medications in treating hypertension, 
        a major risk factor for coronary heart disease, stroke, and 
        congestive heart failure.
  --The AFFIRM trial established the superiority of a heart-rate 
        control approach to treat atrial fibrillation.
  --An emergency-room-based study demonstrated the utility of magnetic 
        resonance imaging in rapidly diagnosing acute myocardial 
        infarction, thereby enabling timely intervention to restore 
        blood flow to the heart muscle.
  --The PREVENT trial established the efficacy and safety of long-term, 
        low-dose warfarin therapy to prevent the recurrence of blood 
        clots in patients with a history of deep-vein thrombosis and/or 
        pulmonary embolism.
  --A community-based trial found that public access defibrillation 
        performed by trained volunteers increases survival for victims 
        of cardiac arrest.
  --The Sudden Cardiac Death in Heart Failure trial reported that an 
        implanted cardiac defibrillator significantly reduces deaths 
        among patients with moderate-to-severe heart failure.
  --The Prevention of Events with Angiotensin-Converting Enzyme (ACE) 
        Inhibition trial revealed that heart disease patients who are 
        already receiving state-of-the-art therapy do not benefit from 
        additional treatment with ACE inhibitors.
  --The Women's Ischemia Syndrome Evaluation study reported a number of 
        important findings regarding diagnosis and prognosis of chest 
        pain in women.
  --The SHOCK trial concluded that treating heart attack patients who 
        develop life-threatening cardiogenic shock with emergency 
        angioplasty or bypass surgery greatly improves the long-term 
        survival.
  --The first totally implantable permanent artificial heart--the 
        culmination of many years of research efforts by the NHLBI and 
        others--received FDA approval for implantation in certain 
        patients with severe heart failure.
  --The Occluded Artery Trial found that late angioplasty after a heart 
        attack offers no advantage over standard drug therapy.
National Institute of Allergy and Infectious Diseases

            Adult male circumcision reduces HIV transmission

    The NIAID supported two clinical trials in Uganda and Kenya that 
found an approximately 50 percent lower risk of heterosexual 
transmission of HIV among adult men who received a medical circumcision 
compared to men who were not circumcised. These results were announced 
in December 2006.
    The study results indicate that HIV transmission from women to men 
could be lowered, though not eradicated, by increased rates of male 
circumcision.
    The impact of increased access to male circumcision would be most 
pronounced in those areas with low rates of male circumcision and high 
rates of heterosexually transmitted HIV.
    Based on the results of these studies, an international expert 
consultation, convened by the World Health Organization (WHO) and the 
UNAIDS Secretariat, recommended that male circumcision now be 
recognized as an additional important intervention to reduce the risk 
of heterosexually-acquired HIV infection in men.
    Modeling studies suggest that male circumcision in sub-Saharan 
Africa could prevent 5.7 million new cases of HIV infection and 3 
million deaths over 20 years.

            Survival benefits of AIDS treatment

    The NIAID supported a study to quantify the cumulative survival 
benefits of AIDS care in the United States. The results were published 
online in The Journal of Infectious Diseases, in June 2006.
    At least 3 million years of life have been saved in the United 
States as a direct result of care of patients with AIDS.
    The study data demonstrate the dramatic impact that advances in 
anti-retroviral therapy have made on the long-term survival of the most 
vulnerable HIV-infected persons, those who develop AIDS.
    The data also underscore the importance of the global 
implementation of HIV treatment in resource-limited countries and the 
potential for huge survival benefits in those countries.

National Institute of Diabetes and Digestive and Kidney Diseases
            Reducing the Burden of Chronic Kidney Disease and Kidney 
                    Failure
    Diabetes is the leading cause of chronic kidney disease and end-
stage renal disease. Research has shown tight control of blood glucose 
levels can dramatically diminish the development of complications of 
diabetes. With good care, fewer than 10 percent of diabetes patients 
develop kidney failure.
    Kidney disease can be detected earlier by standardized blood tests 
to estimate kidney function and monitoring of urine protein excretion. 
NIH research has shown that drugs (ACE inhibitors and ARBs) that better 
control blood pressure can slow the rate of kidney damage by about 50 
percent. As a result of improved treatment, the number of new dialysis 
patients has stabilized, although troubling racial disparities persist.
    The savings to Medicare for each patient who does not progress from 
chronic kidney disease to end-stage renal disease is estimated to be 
$250,000 per patient. Overall, estimated Federal savings from recent 
improvements in preventing kidney disease is approximately $1 billion 
per year.

National Institute on Deafness and Other Communication Disorders
    Over the last three decades, the NIH's support has played a 
significant and important role in the development of cochlear implant 
(CI).
    NIDCD-supported research demonstrates that the sooner a child with 
severe to profound hearing loss receives a CI, the greater the benefit 
showing age``)appropriate speech perception and language production 
within six to nine months after the CI is turned on.
    NIDCD-supported scientists have found that the benefits of the 
cochlear implant far outweigh its costs in children. A cochlear implant 
costs approximately $60,000 (including the surgery, adjustments, and 
training). In comparison, the services, special education, and 
adaptation related to his or her deafness will cost more than $1 
million if a child is born deaf or becomes deaf before the age of 3.

National Institute on Drug Abuse
    Declining cancer deaths, in part due to decreases in cigarette 
smoking, have resulted from better treatment options for tobacco 
addiction and from effective prevention efforts--buttressed by NIDA-
supported research. For the second year in a row, the CDC reported a 
decline in deaths due to cancer, a remarkable accomplishment stemming 
from research-backed treatments and public education campaigns.
  --NIDA-supported research revealed nicotine as the main addictive 
        component in tobacco, enabling the development of first-line 
        therapies such as nicotine replacement, complemented by 
        behavioral approaches.
  --NIDA-supported education and prevention efforts targeting young 
        people have paid off dramatically in falling rates of teen 
        cigarette smoking, now at the lowest point since 1975, when our 
        Monitoring the Future survey of drug use and attitudes among 
        8th, 10th, and 12th graders was initiated.
  --Since most addiction begins in adolescence and even childhood, 
        these declining smoking rates are likely to lead to continued 
        public health dividends as young cohorts with lower smoking 
        initiation rates age.

National Institute of Child Health and Human Development
    Progesterone Injections Reduce Preterm Delivery.--Currently, 12 
percent of all births are premature and two percent are ``very 
preterm.'' Ten percent of the very premature babies will die and 15 
percent will survive with major disabilities, such as cerebral palsy, 
deafness, blindness or mental retardation. The Institute of Medicine 
estimates that the annual societal economic burden associated with 
preterm birth in the United States was over $26.2 billion in 2005. The 
NICHD's dedication to advancing treatments for preterm birth has led to 
the first successful intervention, which has the potential to reduce 
the associated societal burdens and healthcare costs. Clinicians know 
that women who have previously experienced spontaneous premature labor 
are at greater risk than others to experience it again. Findings from a 
groundbreaking clinical trial showed that treating women, who had a 
previous preterm delivery, with 17 alpha-hydroxyprogesterone caproate 
(17P) reduced, by 34 percent, their risk of another preterm birth. The 
study--conducted within the NICHD's Maternal-Fetal Medicine Units 
Network--also showed that infants, who were born prematurely even 
though their mothers were treated with 17P, had significantly lower 
rates of severe complications. 17P holds tremendous promise for 
reducing preterm birth and life-threatening medical complications in 
infants of high-risk women. The therapy will have even greater public 
health impact when it is extended to other women who are at high risk 
of preterm delivery. Building on this significant public health 
advance, researchers are conducting a study to evaluate progesterone 
therapy in high risk women with twin or triplet pregnancies.

National Institute of Neurological Diseases and Stroke
    One of the first systematic studies of the impact of a publicly 
funded research program on public health and health care costs 
evaluated the costs and benefits of all NINDS phase III clinical trials 
from 1977 to 2000. The total cost of the trials was $335 million. The 
study, published in The Lancet in April 2006, found that over 10 years, 
the trials provided economic benefits that exceeded $15 billion and 
were responsible for 470,000 additional healthy years of life. The 
benefits of the clinical trials program for the entire period covered 
by the study were estimated to be more than $50 billion, far greater 
than the total NINDS budget over that period ($29.5 billion). [Johnston 
et al., The Lancet, 2006, 367:1319-1327].

National Institute of Nursing Research
    Program to Improve Knowledge and Coping Helps Improve Quality of 
Life for Parents of Premature Infants and Reduces Hospital Costs.--
Parents of premature infants often endure high levels of stress, 
anxiety, and depression. NINR-supported investigators tested the 
ability of an educational intervention program for parents, implemented 
early in the Neonatal Intensive Care Unit (NICU), to reduce such 
psychological distress. In what is believed to be first randomized 
controlled trial of its kind, researchers found that parents in the 
program, called Creating Opportunities for Parent Empowerment (COPE), 
demonstrated improved parenting behaviors and reported decreased stress 
levels compared to parents in a control group. Infants of parents in 
the COPE program had a 3.8-day shorter NICU length of stay and a 3.9-
day shorter total hospital length of stay than did comparison infants, 
resulting in decreased hospital costs of about $5,000 per infant.
    Transitional Care Improves Outcomes for Elders After Leaving the 
Hospital.--In a randomized controlled trial, NINR-supported 
investigators evaluated the effectiveness of a transitional care 
program in helping to maintain, after hospital discharge, the health 
and function of elders with heart failure. Elders received a three-
month program managed by Advanced Practice Nurses (APNs) that was 
designed to assist the patients in managing their discharge planning. 
The APNs worked with the patients to identify goals, individualize care 
plans, coordinate care across the different settings from hospital to 
home, and implement a protocol to manage the multiple health issues of 
heart failure patients. A follow-up evaluation at one year showed that 
patients who had received the intervention had a longer time before 
first hospital readmission, along with fewer total rehospitalizations, 
hospital days, and deaths than a control group that continued in 
standard care. Improvements were also noted in patient satisfaction and 
quality of life. The total health care costs over the year-long study 
period were lower by almost $3,500 per patient for those in the APN 
intervention group, when compared to a control group.

    Senator Specter. Thank you very much, Dr. Zerhouni.
    Mr. Chairman, we have, on the floor at the moment, the 
legislation involving the U.S. attorneys who have been asked to 
resign. I am ranking on Judiciary, and I'm going to have to 
excuse myself for a few minutes to go to the floor. We are 
taking up the bill to change the authority of the Attorney 
General to replace U.S. attorneys on an indefinite basis, which 
has caused a lot of controversy. That is being debated right 
now, and I'm going to have to excuse myself to go down there to 
take care of other responsibilities. Senator Feinstein is on 
the floor now, and she was scheduled to speak. I'm scheduled to 
speak after her. But I will be back as soon as I can.
    Thank you.
    Dr. Zerhouni. Thank you, Senator.
    Senator Harkin. Thank you, Senator Specter.

                  IMPACT OF AN ADDITIONAL $1.9 BILLION

    Dr. Zerhouni, just a couple of follow-up questions before 
we turn to our next panel.
    As I said earlier, NIH has lost about 8 percent of its 
funding, in real terms, since the end of that doubling period, 
in 2003, which we saw on the screen also. The advocates from 
different disease groups have asked Congress to get NIH back on 
track by appropriating a 6.7-percent increase for the next 3 
years. By fiscal year 2010, that would equal the amount NIH 
would have attained if it had simply received inflationary 
increases. So, this year, a 6.7-percent increase would equate 
to about $1.9 billion. Just what do you think you could 
accomplish with an increase of $1.9 billion? What would be 
different if we could obtain that $1.9 billion?
    Dr. Zerhouni. Well, again, I think that is--it is key, from 
my standpoint, to understand that in flat budgets we have to 
make tradeoffs, and those tradeoffs tend to affect the ability 
to sustain scientists. So, the ability for us to stay at 
inflation translates directly into our ability to sustain the 
scientific workforce of the United States. For example, NIH 
supports, directly and indirectly, about 326,000 scientists in 
the United States. Every year that we fall behind, in terms of 
inflation, we have to make some difficult choices, which 
typically impact our ability to sustain scientists, who are 
really the key to scientific progress. So, the first thing that 
I think staying even with inflation will do is to allow 
laboratories the resources they need to recruit and retain the 
scientists that are needed to address the very complex issues 
that have come to light, from the scientific standpoint, over 
the past few years.
    I think that the other important aspect of it is that we 
will recover our ability to conduct clinical trials at the rate 
that we need to conduct them. As I said, we've had a flat 
funding of clinical trials since 2003--we have not increased 
the dollars in clinical trials. But, because inflation in 
clinical trials is 6-7 percent, our purchasing power in 
clinical trials is 35 percent less than it was 4 years ago.
    So, that would be probably be one of the priority areas 
that we would like to recover, after recovering what I call the 
optimal success rate. I don't think it's good to have success 
rates that are persistently low. I think we need to make sure 
that the opportunities for new scientists and established 
scientists are recovered.
    So, those are the two things. First, maintaining a viable, 
vibrant workforce--a scientific talent pool of both established 
scientists and new scientists, so that the pipeline continues 
as strong as it has been. Second is to be able to do 
translation, especially when it comes to putting the bench 
discoveries to practice.

                              COMMON FUND

    Senator Harkin. The NIH Reform Act that we passed last year 
puts a big emphasis on the common fund----
    Dr. Zerhouni. Yes, sir.
    Senator Harkin [continuing]. Again, to support trans-NIH 
initiatives that benefit all areas of disease research. A 
couple-three, things. One, again, can you just spend a couple 
minutes describing what you hope to attain--accomplish that 
fund, what are some of the examples of the kind of initiatives 
that would be funded through this effort. Last, how about 
initiatives for particular diseases? Some diseases cross many 
institutes and centers. Could they be funded through the common 
fund?
    Dr. Zerhouni. Sir, the common fund is about 1.5 percent of 
the NIH budget today. It really came from the concept of 
having--as I said, institutes are extremely good at fulfilling 
their missions; however, science changes, and often there are 
areas that fall between the cracks, that you need to sustain, 
especially when it comes to high-risk, high-impact research. 
So, we want to sustain our ability, despite tight budget times, 
to fund innovative ideas and innovative scientists. That is a 
role that I see for the Common Fund.
    Second, emerging areas of science that are not necessarily 
in the priority of any one institute. A good example is 
nanotechnology. When I became Director the total investment of 
NIH in nanotechnology was $50 million. There wasn't an 
institute that really focused on that. The new institute, the 
National Institute of Bioimaging and Bioengineering, was just 
created, and that's their mission, but they were too new, and 
clearly you needed to make a large advance across the board. 
That's when we use common fund monies, to sort of launch this 
area.
    Another example is what we call molecular libraries. 
Scientists told us that they needed to have access to more 
molecules to see if they could understand better the diseases 
in their own assays. Well, that was not available to NIH-funded 
scientists. So, the--no institute really has either the mission 
or the interest or the scope to fund that. So, we funded it. 
But what is really important, Senator, is that the common fund 
is like a glue fund. In other words, it's the--you know, NIH is 
like 27 fingers; the common fund is the palm, is the 
coordination, the strategizing of the future of science, 
funding areas that wouldn't be funded otherwise. It is really 
to incubate novel ideas. For example, you could have seen the 
common fund being used in emerging areas of science, like stem 
cells, at the beginning, or RNA interference. RNA interference 
is a new mechanism that was discovered in 1998. The work 
received the Nobel Prize in 2006. When I became Director of the 
NIH, I was very keen on finding monies to support that area of 
research. It was emerging at the time. So, that's the kind of 
uses that you would want to see for the common fund, uses that 
are at the frontier of science, serve all institutes, that are 
not specifically for something that will last forever, but it's 
just like the kickoff fund, if you will. Five years of funding, 
10 years of funding, to get a new area of science started.
    Think of the human genome. In 1991--I think you were on the 
committee at the time----
    Senator Harkin. Chairman.
    Dr. Zerhouni [continuing]. You were the chairman of the 
Committee--the then-Director of NIH came to you and asked you, 
as an exceptional measure, to fund the human genome. The human 
genome was going to be done at the Department of Energy, 
because they had an Opportunity Fund. NIH did not have that. 
So, when I talked to my predecessors, Dr. Varmus, Dr. 
Wyngaarden at that time, they all said the one thing that is 
needed at NIH is some sort of a common fund for common purposes 
that emerge unpredictably that we need to respond to. That 
could apply to a public health emergency, no doubt about it. 
But, again, it's a revolving venture fund to make the agency 
nimble, reactive, not to serve specific interests, but to serve 
the agency as a whole. I don't know if I'm making myself clear.
    Senator Harkin. Can particular diseases, then, be funded 
through this, or not?
    Dr. Zerhouni. I would rather not. I would think that the 
particular diseases that need to be funded should be funded 
through the institutes that have the missions----
    Senator Harkin. But some of these----
    Dr. Zerhouni [continuing]. To serve that.
    Senator Harkin [continuing]. Diseases cross a lot of 
different institutes. That's the problem.
    Dr. Zerhouni. So, what we do in that case, when there are 
diseases that are relevant to the mission of multiple 
institutes, we have other mechanism, where we encourage 
institutes to work together. For example, we've had an obesity 
research plan. It's not funded through the common fund. It's 
the responsibility of different programs in the institutes, so 
that what we do there is, we encourage the institutes to work 
together. For example, the strategic plan for obesity research 
was published and involves over 19 institutes. The neuroscience 
blueprint is another example of addressing diseases that need 
to be served by the institutes whose mission is to serve those 
diseases in their various dimensions.
    Unless it's an area that really requires across-the-board 
stimulus--remember, no initiative in the common fund stays for 
more than 5 to 10 years, max. That is the idea of the common 
fund. It's not to replace, or a new source of funding for 
special diseases that don't find a home somewhere else. Very 
important, I think, to keep that in mind.

                             PUBLIC ACCESS

    Senator Harkin. I appreciate that.
    One last thing, we have to move on to the next panel. It 
concerns public access to NIH-funded research. You have 
proposed that NIH-funded researchers should have to submit 
their final peer-reviewed papers to an NIH database after 
they're accepted by scientific journals, and that these papers 
should be made available through the database within 12 months 
after their publication in the journals. What's the scientific 
value of increasing public access to this research, as you 
propose? Why 12 months? Why not 6 months? You've asked Congress 
to require NIH-funded researchers to adhere to this policy; why 
do we have to do it? Can't you do that on--you know, can't you 
simply require that through NIH? Why do we have to do it?
    Dr. Zerhouni. First of all, I think it's important, in the 
information age that we're in, to make sure that publicly 
funded research be available in a database that we can search 
and connect to all the many other databases that are available 
to us. It is also important not to damage peer review. But it 
is important to realize that NIH needs to have a--the ability 
to do that without damaging journals. That's why 12 months, 
that's why not 6 months. Because most journals will say that 6 
month--for 78 percent of journals, 6 months might be okay, but 
for others that are not published as frequently, it's not--it 
will damage their ability to sustain themselves. So, I think we 
need to be more flexible.
    What I think we can't be flexible on is the mandatory 
nature. We've tried voluntary. I have data about how this is 
working. I mean, you can see here, for example, that the 
publications that are being submitted represent less than 10-15 
percent--the compliance is the red number, the red bar--the 
compliance is not as high as it should be. I think we should--
we need to make this a condition of Federal grant funding, and 
that's why we need you to express the wish of Congress to do 
that, as easily as we can.
    So, my position is, a mandatory policy seems to be the one 
that will be necessary for us to achieve our goals. We've tried 
voluntary. It doesn't seem to be working as well. I think we 
need to be flexible on the time. I don't think that we should 
force a date certain, because it would harm some journals and 
not others.
    Senator Harkin. That's really all the questions I have, Dr. 
Zerhouni. Is there any last thing that we didn't bring up that 
you'd want to get out before I----
    Dr. Zerhouni. Again, I think that what I'd like to say is 
how appreciative of you and Senator Specter and the rest of the 
subcommittee I am. I think that it is key that we continue the 
momentum.
    I have been in--I wanted to give you a perspective about 
international competition. I just came back from Europe. They 
have decided to focus on life sciences, and accelerate their 
investment in life sciences. They've just created a new NIH-
like institution in Europe, $57 billion of funding in 5 years. 
I've been to China; there's a tripling of the research budget. 
I've been to India; and there is also an increase in research. 
There are strong attempts to re-recruit back from the United 
States. I think we definitely need to understand the strategic 
importance of NIH. I think you do, but I just want to be on the 
record to say that nothing is more important than sustaining 
our investment in science and medical research.
    Thank you.
    Senator Harkin. Well, Dr. Zerhouni, thank you very much for 
your leadership, and also, again, I want to thank you for your 
statement concerning embryonic stem cells. Hopefully, we're 
going to move ahead on that, this year, put it behind us, and 
get about funding this much-needed area of research in our 
society. So, I thank you for your statement today.
    Well, Dr. Zerhouni, now, we're going to move to our next 
panel. Respectful of your time, if you'd like to stay, and 
maybe there might be some questions we might have afterward, 
but I----
    Dr. Zerhouni. I'd be happy to stay.
    Senator Harkin [continuing]. It's not part of the deal, so 
if you can stay, we'd appreciate it; if not, then that's fine.
    Dr. Zerhouni. Thank you, Mr. Chairman. I'll be happy to 
stay.
    Senator Harkin. Well, I appreciate that very much, Dr. 
Zerhouni.
    Let's bring our next panel up: Dr. Iverson, Dr. Brugge, Dr. 
Siliciano, and Dr. Strittmatter.
    Again, for all of you, welcome to the subcommittee. All of 
your statements will be made a part of the record in their 
entirety. I'd ask, if you could sum it up in 5 minutes, your 
major point, I'd appreciate that. We can elucidate more of it 
in our questions-and-answer period.
    So, I'll go in the order in which I called you. Dr. Brent 
Iverson, distinguished teaching professor of organic chemistry 
and biochemistry at the University of Texas at Austin, received 
his bachelor's of science degree from Stanford and his Ph.D. 
from the California Institute of Technology.
    Dr. Iverson, welcome to the committee, and please proceed.

STATEMENT OF BRENT IVERSON, Ph.D., UNIVERSITY 
            DISTINGUISHED TEACHING PROFESSOR OF ORGANIC 
            CHEMISTRY AND BIOCHEMISTRY, THE UNIVERSITY 
            OF TEXAS AT AUSTIN, AUSTIN, TEXAS
    Dr. Iverson. Thank you, Mr. Harkin.
    I am here representing NIH-funded scientists at research 
universities. I was an undergraduate business major at Stanford 
until I worked in Professor Jim Coleman's laboratory in 
chemistry research. It was an NIH-funded research laboratory. 
My undergraduate research experience charted the course that 
directly led to my scientific career.
    My research spans the interface of organic chemistry and 
molecular biology on the basic science and of the biomedical 
research spectrum. I am an inventor on 20 patents, many of 
which are being used by companies right now.
    I would like to make three points concerning the importance 
of growing the NIH budget.
    The first point concerns being able to take full advantage 
of what the doubling allowed us to initiate. In my own lab, the 
increased funding provided by the doubling allowed my 
collaborators and I to develop a powerful new method we call 
APEx that allows us to enhance the activity of antibodies. 
Antibodies are the hottest segment of the pharmaceutical 
industry today, with over 20 now approved, such as Avastin and 
Herceptin, for treating colon and breast cancer, and Remicade 
and Humira for treating rheumatoid arthritis and Crohn's 
disease.
    Antibody drugs are so-called targeted therapies because 
they're capable of seeking out and attacking only their 
intended disease targets, with remarkable precision; sort of 
the smart-bomb approach for drugs. The result is a much more 
concentrated therapy, one that limits many of the serious side 
effects of traditional approaches.
    Our APEx allows us to make existing antibodies more 
powerful by a factor of 10 or 100 or more. For example, we 
started with an antibody against anthrax that could delay, but 
not prevent death, in animals exposed to live anthrax spores. 
After making the original anthrax antibody about 20 times more 
potent, our engineered antibody prevented illness and cured 
animals treated with the same lethal dose of live anthrax 
spores. That antibody is being pursued commercially by Elusys, 
Incorporated, of New Jersey, and will hopefully become a 
stockpiled countermeasure that should be effective past the 
point at which Cipro alone works.
    With APEx, we are starting--we are ready to start working 
on engineered antibodies that attack a variety of diseases, 
such as allergies, inflammatory diseases, and cancer. I believe 
there are many, many researchers like me poised to make a 
difference with all the tools now in place, but limited by a 
flat budget. This is not the time to pull back.
    My second point concerns basic science breakthroughs. Flat 
funding, as we have now, has the effect of making grant funding 
decisions overly conservative. Let me bottom-line it for you. 
There is currently too little support for innovative, risk-
taking, basic research without new money, because the money we 
are given largely goes to fund the many worthy older ideas. 
Less than 10 percent of the grants in my research area receive 
money each round of consideration. Less than 10 percent. There 
is simply not enough money left over for new ideas that are not 
yet proven.
    In other words, there is not enough money right now for new 
ideas that could establish new paradigms or provide new 
opportunities for new therapies, exactly the kind of basic 
science research that cannot be done in the commercial sector.
    For example, I want to draw your attention to the green 
panel in our report. This is a molecule from my lab that binds 
to DNA in an entirely new way. It was discovered in the context 
of an exploratory project designed to move in an entirely 
different direction, yet it could someday form the basis for a 
therapy of the target's DNA directly as a point of interaction.
    Conservative funding decisions mean there is also not 
enough money to fund those scientists who have not yet had the 
opportunity to prove themselves; namely, new faculty members. 
Further, our current graduate students are being dissuaded from 
an academic research career by the difficulty young faculty are 
having in receiving funding right now.
    I would like to finish by describing my concerns about 
science education. I hope all of you understand that the 
product of NIH funding is not only the research itself, but, 
additionally, the training of students. For the U.S. 
pharmaceutical and biotech industries, NIH is, by far, the most 
important sponsor of projects that result in scientist 
training. Talk about strategic economic leveraging.
    I generally accept three to four new Ph.D. students in my 
laboratory every year. With the significantly reduced chance of 
getting a grant funded, I am forced to take proportionately 
fewer graduate students. In fact, I am not accepting a single 
new graduate student this year in my antibody engineering 
laboratory.
    Tight funding impacts undergraduate research opportunities, 
as well. I have had over 100 undergraduates work in my lab. 
Across our campus, around 1,000 undergraduates will take part 
in cutting-edge scientific research, many in state-of-the-art 
labs with NIH funding. Fewer research grants means fewer 
opportunities for undergraduate researchers.

                           PREPARED STATEMENT

    Together, I view this as a very ominous combination. Not 
enough money to take advantage of recent advances, a 
conservative research environment that discourages risk-taking, 
and not enough support for state-of-the-art science education. 
I am convinced that a lack of new money today will have a 
crippling effect on our global competitiveness, and will limit 
medical breakthroughs for decades.
    Thank you.
    [The statement follows:]

                Prepared Statement of Dr. Brent Iverson

    My name is Dr. Brent Iverson. I am a Distinguished Teaching 
Professor and the Raymer Professor of Chemistry and Biochemistry at the 
University of Texas at Austin. I am here representing NIH funded 
scientists at research universities, both public and private. I was an 
undergraduate business major at Stanford University until I worked in 
Professor Jim Collman's chemistry research laboratory. My undergraduate 
research experience in that NIH-funded lab charted the course that 
directly led to my scientific career.
    Today, I want to tell you about NIH funding from my individual 
perspective, to help put a face on the budget numbers. My research 
spans the interface of organic chemistry and molecular biology, on the 
basic science end of the medical research spectrum. I have well over 
100 publications, many in the most prestigious scientific journals. I 
hold 20 current or pending patents, most of which are licensed and are 
being used by companies across the country.
    I would like to make three points concerning the importance of 
growing the NIH budget. The first point concerns being able to take 
full advantage of what the budget doubling allowed us to start. In my 
own lab, the increased funding provided by the doubling allowed the 
development of a powerful new method we call APEx that allows us to 
engineer better antibodies.
    Antibodies are the hottest segment of the pharmaceutical industry 
today, with over 20 now approved for the treatment of diseases such as 
cancer (ex. Avastin and Herceptin, for treating colon and breast 
cancer, respectively) and rheumatoid arthritis (ex. Humira). Antibodies 
are even being pursued as a new approach to treating infectious 
diseases. Antibody drugs represent the new generation of so-called 
targeted therapies, because they are capable of seeking out and 
attacking only their intended disease targets with remarkable 
precision. The result is a much more concentrated therapy, one that 
avoids many of the serious side-effects of more traditional approaches 
such as the standard chemotherapeutic agents used to fight cancer.
    Our APEx method allows us to take existing antibodies and make them 
more powerful by factors of 10 or even 100 or more. This can often make 
the difference between an effective or ineffective antibody treatment. 
For example, we started with an antibody against anthrax that could 
delay but not prevent death in animals exposed to live anthrax spores. 
After making the original anthrax antibody about 20 times better, our 
engineered antibody prevented illness and even cured animals treated 
with the same dose of live anthrax spores. That antibody is being 
pursued commercially and may soon become a stockpiled countermeasure.
    With APEx developed, we need continued strong funding to take full 
advantage of it. We are ready to start working on engineered antibodies 
that attack a variety of disorders such as allergies, inflammatory 
diseases, and cancer. I am very worried that in the current funding 
climate, our ability to pursue these diseases is going to be severely 
limited. You can only imagine my frustration at working so hard to 
develop the means of making a difference, then having limited support 
to apply it broadly.
    I would like to make a second important point, this one concerning 
basic science breakthroughs. Tight funding as we currently have now has 
the effect of making grant funding decisions overly conservative. I 
have been on many NIH funding panels and have seen this phenomenon in 
action. Right now, only about 10 percent of the grants in my research 
area receive money, so the panels must choose the ``can't miss, sure 
things'' that represent the obvious next steps of research. It is not 
that the panels are overly conservative, it is just that no panel can 
reject these proposals because they will almost certainly lead to 
advances based on the strong scientific foundation upon which they are 
built. But what about new ideas that are not proven yet? In other 
words, the ideas that come out of nowhere, establish new paradigms and 
change the way we think. With such a limited number of grants 
supported, there is no money in the system for us to work on more 
speculative projects, ones closer to the leading edge of knowledge. 
There is also not enough money to fund those scientists who have not 
yet had the opportunity to generate extensive preliminary results, 
namely new faculty members.
    Scientific breakthroughs rarely come from a research effort aimed 
at the ``can't miss obvious next step''. In my experience, our 
breakthroughs have come when we least expected it while we were 
exploring beyond the boundary of what we understood well. For example, 
I want to draw your attention to the cover of the brochure you have 
been given today. There is an outline of a complicated molecule in the 
green panel. It is actually a molecule from my laboratory that binds to 
a large, specific sequence of DNA using an entirely new type of 
interaction we have named threading polyintercalation. Our molecule is 
the first reported to bind to the DNA double helix with a topology that 
can be described as being similar to how a snake might climb a ladder.
    This new approach came from a highly speculative project in my lab 
intended to make an artificial protein, but once we started analyzing 
the behavior of our molecules, we realized that what we were doing was 
also applicable to targeting DNA. Although not yet ready for commercial 
application, imagine a new class of drugs of the future that target the 
DNA sequences of viruses, bacteria, or cancer cells directly. Talk 
about getting to the heart of the matter!
    Without increased funding, our ability to explore boundaries such 
as these and make startling breakthroughs is going to be severely 
limited. True breakthroughs that move science in new directions often 
take years to turn into a practical new therapy and only occur when 
scientists are given the freedom to take scientific risks. I am deeply 
concerned that a lack of money today to explore beyond conservative 
boundaries will have a crippling effect on medical breakthroughs that 
will be felt for decades.
    As a corollary to this, I am also concerned that the current lack 
of funding support will take a heavy toll on young scientists in two 
ways. The most direct is that they will not receive enough funding to 
launch their careers because there is only enough for the established 
scientists. As a more indirect effect, I am worried that the bleak 
funding picture will dissuade the best and brightest from even pursuing 
a career in academic scientific research.
    I would like to finish by describing my concern about science 
education. I hope all of you understand that the product of NIH 
research funding to University researchers is not only the research 
itself, but additionally, the training of students. It is a very simple 
equation. Limited funding for research now means fewer trained 
scientists for the future and consequently fewer research breakthroughs 
for years to come. As a result, I am very concerned that our place as 
the world leader in medical research is not secure.
    I generally accept 3-4 new PhD students in my laboratory every 
year. My former students now work in academics as professors/
researchers or in many companies around the country. With a 
significantly reduced chance of getting a grant funded, I am forced to 
take proportionately fewer graduate students. In fact, I am not 
accepting a single new graduate student this current year in the 
antibody engineering lab. The bottom line is that limited funding means 
we are also limiting the number of students being trained, and I 
believe our country needs more, not fewer, highly trained scientists to 
maintain a healthy technology-based economy.
    Finally, being on the campus of one of the largest undergraduate 
institutions in the country, I am acutely aware that NIH research 
funding has a tremendous impact on large numbers of undergraduates. I 
have had over 100 undergraduates work in my lab. Across our campus, 
around 1000 undergraduates will take part in state-of-the-art 
scientific research, most of it in state-of-the-art labs with NIH 
funding. The positive impact of this is almost incalculable. Most of 
these individuals will not go on to become scientists like I did, but 
they will be able to articulate to the rest of society what science is, 
and what research means for our country. With every study pointing to 
the frightening inadequacy of scientific education across our 
population, a rare piece of good news is undergraduate research. We 
need leaders in all segments of society who understand science and can 
make appropriate choices as we chart the increasingly technological 
future of our country and our world. Again, it is a simple equation. 
Not enough money for the labs means proportionally fewer undergraduate 
as well as graduate student research opportunities across the country.
    As a University researcher in the prime of my career, I need to see 
enough money in the NIH budget so that I can take full advantage of 
what the doubling allowed me to create. There needs to be enough money 
in the system to help provide an environment that allows risk taking, 
thus making scientific breakthroughs more likely and allowing young 
scientists the opportunity to launch their careers. We also need budget 
growth to continue the essential scientific training of students 
ranging from undergraduates to PhD's. All of this is essential if the 
United States is to remain the world leader in both academic and 
commercial medical research.

    Senator Harkin. Dr. Iverson, thank you very much for that 
statement.
    Now we turn to Dr. Joan. I hope I pronounce that right--
Brugge?
    Dr. Brugge. Perfect.
    Senator Harkin. The chair of the Department of Cell Biology 
at Harvard Medical School. She received her B.A. in biology 
from Northwestern, and her Ph.D. in virology from Baylor 
College of Medicine.
    Dr. Brugge, please proceed.

STATEMENT OF JOAN S. BRUGGE, Ph.D., CHAIR, DEPARTMENT 
            OF CELL BIOLOGY, HARVARD MEDICAL SCHOOL, 
            BOSTON, MASSACHUSETTS
    Dr. Brugge. So, first I'd like to thank Chairman Harkin and 
ranking member Specter and the members of the subcommittee for 
this opportunity to tell you about some of the real remarkable 
advances in biomedical research that have been made possible by 
your strong support for NIH.
    I also hope to convey, as well, my personal excitement for 
the incredible potential that's still to be realized in my 
field of cancer research. Unfortunately, this enthusiasm is 
dampened by my profound concerns that the past 4 years of flat 
funding has significantly compromised our ability to fully 
realize this potential.
    When I was a sophomore math major at Northwestern 
University, my sister was diagnosed with a malignant brain 
tumor. This event, and her subsequent death, redirected me 
towards a career in cancer research. Most of my career has been 
spent in universities and medical schools, but, before becoming 
a professor and then chair at Harvard, I served as the founding 
scientific director of a biotech company in Boston, and that--
the industry experience has significantly shaped my 
understanding of the critical issues that are involved in 
translating basic discoveries into clinical therapies for 
patients.
    So, as you're probably aware, in the early 1970s, when I 
entered cancer research, it was actually a very heady time for 
science. Many of us expected, on the basis of the success of 
the polio vaccine and the congressionally mandated war on 
cancer, that we would very soon have a cure for this horrible 
disease, but we very rapidly learned that cancer is not just 
caused by a single agent, and it's not just a single disease, 
as Mr.--or Senator Specter pointed out earlier. We now know 
that there are hundreds of different forms of cancer. In fact, 
each tumor from an individual patient contains a unique set of 
genetic changes. So, this unexpected complexity, which is 
really unique to cancer, presented a huge challenge in the 
development of effective treatments.
    So, actually, over the last decade there has been an 
enormously rapid pace of discoveries on the causes of cancer, 
but it's really not until recently that I have felt real 
confidence that the year--the congressional investment in 
cancer research was going to pay off much more directly to 
patients.
    So, at this time, our fundamental understanding of the 
causes of this disease, and the molecular underpinnings, have 
led to substantially new and revolutionary new approaches to 
treating cancer. So, as you're probably aware, most cancer 
therapies that are used today are--very nonspecifically target 
any kind of proliferating cell. So, that's why there are 
significant toxicities to blood cells and immune cells, to your 
hair, digestive system. But the recently developed cancer 
therapies are aimed very specifically at what we now understand 
to be the very--the unique vulnerabilities of tumors, the so-
called Achilles' heel of tumor cells. This is leading to much 
more effective and less toxic therapies.
    You're probably familiar with some of the many examples of 
effective drug treatments that are targeting these specific 
subsets of tumors with specific molecular defects. These 
successes are actually providing a blueprint for application to 
many more types of cancer.
    So, I think what we now foresee that is in the near future, 
there--we'll have customized therapies for cancer, that will be 
based on the specific molecular diagnosis of a tumor. So, this 
is already being done in breast cancer, where each tumor tissue 
is evaluated for specific markers that will predict whether a 
specific drug will work or the specific drug will not work. 
Results are really dramatic, so these drugs are adding years to 
the lives of patients--and the most aggressive forms of blood 
cancer--sorry--breast cancer. So, it's an example of the 
precision medicine that Dr. Zerhouni introduced.
    So, these successes are really just the tip of the iceberg. 
Underneath the surfaces, there's a real foundation for much 
more rapid pace of breakthroughs in cancer detection and 
treatment based on the research investment in the past.
    So, this, then, brings me to my profound concerns regarding 
the state of NIH funding today. Four years of flat funding have 
had a very significant impact on the trajectory of cancer 
research. We are losing momentum and the dedicated careers that 
were fueled by the previous investments. We're damaging the 
research capacity, and this will certainly delay relief from 
the cancer burden.
    So, you've seen the statistics indicating a 20-percent 
success rate of grant applications. Let me just give you 
appreciation for what those mean--those numbers mean to the 
team of scientists in the research labs.
    While the reported success rate is 20 percent, this number 
actually represents the success of either first, second, or 
third submission of a grant, or the eventual success. So, 
what--the actual first rate of--the success rate on first 
submissions is actually half of that, around 10 or 12 percent. 
So, basically, 90 percent of the scientists that apply for 
grants are not receiving them the first time around. So, what 
does that mean? That means there's at least a lapse in funding, 
and perhaps the loss of the grant. So, what happens when a lab 
director fails to get a grant? The--a lapse in funding forces 
the lab to cut back, they have to let staff go, and now your 
efforts are redirected on alternate funding and resubmission of 
the grant, instead of moving forward. So, this not only 
forestalls progress, but it also creates an atmosphere of 
insecurity and anxiety, and that actually precludes conduct of 
a creative, innovative exploration.
    Once the scientist does secure funding after this lapse, 
this requires retrenching and retraining, and--basically, a 
loss of continuity is probably the most serious problems for a 
scientist.
    Scientists at all levels are being affected, not just at 
the higher--not just at the lower echelons, but even at 
Harvard. There's two to four investigators in every department 
that I surveyed, that has had a significant lapse or loss of 
grants, that were rated as outstanding by the peer-review 
group.
    The other thing I think it's important to understand is 
that even if one is successful in getting a grant over one of 
these three submissions, each grant is getting cut between 20 
to 30 percent. So, at NCI in the last year, there was a cut of 
24 to 29 percent. So, for instance, a grant that's $200,000 
will now get $140,000. That will barely cover the salary of the 
principal investigator. So, we're now faced with funding labs 
at levels that are 7--at levels that we have 7 to 10 years ago, 
just--with--and that's not--and so, we have to deal with 
inflation at the same time, a 30-percent increase in mandated 
stipends, and also the much higher cost of new technologies for 
state-of-the-art research. So, as a result, every grant is 
severely underfunded and--for achieving the approved goals--and 
scientists are starving.
    As Brent mentioned, the frustration and anxiety of lab 
directors is not get--is not going unnoticed by trainees. Young 
scientists are looking for other venues to exercise their 
talents where their long investment and training won't be 
jeopardized by the lottery, even at the highest--even for the 
most outstanding grants. This has profound implications for 
science of the future, since we won't be able to fill in the 
gaps of that lost generation.
    Then, last, I'd just like to make the point that we really 
can't afford to stand still, because the demographics are 
against us. As you're fully aware, in 2030 there will be twice 
as many Americans over 65 compared to the number today. So, 
given that there's a 10-times higher incidence of cancer in 
individuals over 65, there's going to be a virtual tsunami of 
cancer. This is staggering not only with respect to the 
personal suffering, but also the cost consequences of the 
cancer burden on our economy.
    So, I feel that investment now could have profound savings 
later. According to one report, a 1-percent decrease in cancer 
mortality is reported to be worth $500 billion to our economy.
    So, as Geoff Wahl, who's president of American Association 
of Cancer Research, has pointed out, unlike a real tsunami, 
which we have no time to prepare for, we are well aware of the 
impending crisis, and congressional investment in research has 
positioned us to make much more rapid progress in translating 
basic discoveries into the diagnosis, treatment, and eventually 
prevention of cancer. We really owe it to the public to 
capitalize on these investments.
    I'd just like to finish, then, by making the point that 
it's through your foresight, and those of other members of the 
committee, that the public has generously provided a start 
towards eradicating one of the scourges of human health. But 
now, just as these new therapies, based on our molecular and 
cellular understanding of cancer, is emerging, the opportunity 
to expand them to other types of cancer, to build on them, and 
to provide for a future of more discoveries, has idled. Dr. 
Neiderhuber shared with me some slides that he just presented 
to his Board of Scientific Advisors, and there's this long 
list--long set of--or numerous slides showing missed 
opportunities he's unable to fund. This included a list of very 
important projects, resource development, and clinical trials 
that were canceled because of this cutback. This is very 
distressing. These cutbacks are going to delay benefit to the 
public.

                           PREPARED STATEMENT

    So, we can't retreat now that the--our infrastructure is in 
place, and we're really mobilized to launch a full attack on 
this disease. So, for the sake of the American people, please 
find a political route to keep progress against cancer at a 
sustainable pace. The research findings are clear, there is a 
path to major advances. Help us get these advances to the 
public and fulfill the promises of the best in scientific 
research.
    Thank you.
    [The statement follows:]

                Prepared Statement of Dr. Joan S. Brugge

    First, let me thank Chairman Harkin, ranking member Specter, and 
members of the committee for this opportunity to report to you some 
remarkable advances that have occurred in biomedical research because 
of your strong support for NIH. I hope that I can convey as well my 
personal excitement for the incredible potential still to be realized 
in my own field of cancer research. Unfortunately, this enthusiasm is 
dampened by profound concerns that the four years of flat funding has 
compromised significantly our ability to fully realize this potential.
    When I was a sophomore math major at Northwestern University, my 
sister was diagnosed with a malignant brain tumor. This event and her 
subsequent death redirected me towards a career in cancer research. 
Most of my career has been spent in universities and medical schools. 
However, for five years before I came to Harvard Medical School, I 
served as the Scientific Director of a biotechnology company focused on 
cancer and other diseases. My industry experience significantly shaped 
my understanding of issues critical to the translation of scientific 
discoveries into therapies for patients. It taught me among other 
things, that though the path to treatment can be arduous, today the 
path between basic discovery and successful drugsalso can be remarkably 
short.
    The early 70's, when I entered cancer research, was a heady time in 
science. Many of us expected, based in part on the success of the polio 
vaccine and the Congressionally mandated War on Cancer, that we would 
soon have a cure for this horrible disease. However, it soon became 
evident that cancer, unlike polio, is not a single disease with a 
single cause. There are hundreds of different forms and, indeed, tumors 
from individual cancer patients carry unique sets of genetic changes. 
This unexpected complexity--unique to cancer--precluded rapid 
development of a single vaccine or simple cure.
    Though we certainly underestimated the complexity of cancer, the 
Congressional investment in cancer research is now beginning to pay 
off. We have made enormous progress in understanding the cause of this 
disease and its molecular underpinnings. This fundamental information 
has led to revolutionary approaches to treatment, aimed specifically at 
the unique vulnerabilities of specific tumors; we now know how to 
target a tumor's genetic or molecular Achilles' heel. In addition, new 
imaging modalities and biomarkers provide the potential to identify 
tumors at early stages when treatments are most effective.
    Today, I feel a new confidence that we are poised to make rapid 
progress in developing effective and less toxic treatments for the 
myriad different cancers. This confidence is based on initial evidence 
of success. We now have multiple examples of effective treatments that 
target the molecular alterations of specific subsets of tumors (such as 
Tarceva for a subset of lung tumors, Gleevec for chronic myelogenous 
leukemia, and Tykerb, approved just a week ago for treatment of certain 
breast cancers). These successes provide a blueprint for the 
development of treatments for many more types of cancer.
    Cancer treatment in the future will involve a molecular diagnosis 
of each tumor, followed by customized therapies. Already this is being 
done for breast cancer, in which tumor tissues are probed for several 
markers that predict which tumors will respond to specific drugs (like 
Tykerb, Herceptin, or estrogen antagonists) and which will not. The 
results are dramatic, adding years to the lives of many patients with 
the most aggressive forms of breast cancer, and sparing patients of 
treatments that offer no promise of efficacy. For the first time, we 
are seeing a decrease in deaths associated with cancer. The tip of the 
iceberg is visible, underneath lies the foundation for a rapid pace of 
breakthroughs in cancer detection and treatment based on the research 
investment in the past.
    We cannot afford to stand still--the demographics are against us. 
There is an impending increase in cancer due to the baby boomers aging 
into their cancer-prone years, which has been referred to as an 
impending tsunami. You are all keenly aware of the ramifications for 
government of Medicare entitlements associated with this surge in 
cancer. But unlike a real tsunami, which comes unexpectedly with no 
time for preparation, we are well aware of this impending crisis. And 
We know that the Congressional investment in basic and cancer-focused 
research has positioned the cancer research community to make more 
rapid progress in translating basic discoveries into the diagnosis, 
treatment, and eventually, prevention of cancer. We owe it to the 
public to capitalize on these investments; failure to maintain the pace 
of advancement towards reducing the suffering of cancer is not an 
option the American people should support or will support. We are all 
in this together.
    This brings me to my profound concerns regarding the state of NIH 
funding today. Four years of flat funding have had a devastating impact 
on the trajectory of cancer research. We are losing the momentum and 
the dedicated careers that were fueled by the previous federal 
investments. We are now damaging the research infrastructure, and this 
will certainly delay relief from the cancer burden.
    While you have seen the statistics regarding grant awards presented 
by Dr. Zerhouni and others at NIH and are aware of the inflationary 
erosion of our buying power, the mere numbers mask the profound effects 
on the research community. I would like to give you an appreciation for 
what these numbers mean to the cancer research community, which is 
emblematic of the whole research enterprise. While the eventual success 
rate of grants is 20 percent, this number reflects success of either 
the first, second, or third submission of a grant. The success rate of 
the first submissions is now about half of this; thus the vast majority 
of scientists are subjected to a lapse in funding and the negative 
consequences of this. Not only can a lapse in funding force labs to cut 
back, let staff go, and redirect efforts to finding alternative funding 
and resubmission, it creates an environment of insecurity and anxiety 
that is anathema to the conduct of creative, innovative exploration. 
Recovery after a 6-12 month funding gap requires retrenching and 
retraining of new staff. Many leads will never be followed up. Loss of 
continuity is one of the most serious problems for a scientist. For new 
investigators, repeated failure to launch their research program is 
also demoralizing, and discourages taking original and risky paths.
    Researchers at all levels are affected--those beginning their 
careers and senior investigators with long and sustained track records 
of major discoveries. For example, multiple colleagues at Harvard 
Medical School who are leaders in their field with outstanding 
accomplishments, are suffering lapses in funding or losing grants that 
received priority scores in the 10-20 percentile range. Peer review is 
too imprecise to distinguish differences in the quality of the grants 
in this tight range.
    Second, in order for the success rate of grants to hit the mandated 
target number of grants, NIH has resorted to cutting grant size 
dramatically--at NCI, 24-29 percent (2006). Aggravating this situation 
are reductions in buying power due to inflation and the 30 percent 
increase in mandated stipends for graduate students and postdoctoral 
fellows over the past seven years (an increase that we applaud). Lab 
directors are faced with carrying their labs at funding levels 
equivalent to those 7-10 year years ago, at a time when there is a 
significant increase in cost of the new technologies required for 
state-of-the-art research. As a result, almost every grant is severely 
under-funded for achieving the approved goals, and scientists are 
starving for resources.
    The frustration and anxiety of lab directors is not going unnoticed 
by trainees, and many young scientists are looking for other venues to 
exercise their talents, ones where their long training investment will 
not be jeopardized by this lottery in NIH grant review. This has major 
implications for the science of tomorrow, since we will not be able to 
fill in the gaps of this lost generation.
    I would like to reiterate the long-term implications of the current 
research budget shortfall on the economy. Cancer incidence for those 65 
and older is 10 times greater than for those under 65, and the death 
rate is 16 times higher. By 2030, 20 percent of the U.S. population 
will be over age 65 compared with 12 percent in 2004. The cost 
consequences of this tsunami of baby boomers hitting their cancer-prone 
years could devastate our economy.
    A one percent decrease in cancer mortality is reported to be worth 
$500 billion to our economy according to an NCI report. Getting these 
potential new therapies I have outlined to patients will take a 
significant new investment in translational and clinical research, the 
cost of which can dwarf the cost of basic research. But without the 
most promising basic discoveries, we will not be able to improve early 
stage therapies and more and more translational and clinical endeavors 
will result in dead ends. We can't be shortsighted.
    We recognize the challenges each member of Congress faces in 
balancing worthy priorities, but I can assure you that from a 
scientific perspective there is justification for fully supporting 
basic, translational, and clinical pursuits. Basic science now more 
than ever fuels the success of effective disease diagnosis, treatment, 
and prevention in the future.
    Through the foresight of the members of this committee and others, 
the public has generously provided a start toward eradicating one of 
the scourges of human health. We are in fact in a better place to 
detect, treat, and potentially, prevent cancer. But just as new 
therapies based on our cellular and molecular understanding are 
emerging from our labs, the opportunity to expand them to other types 
of cancer, to build on them, and to provide for a future of more 
discoveries has idled. We can't retreat now that the infrastructure is 
in place and we are mobilized to launch a full force attack on a 
disease that we now understand. For the sake of the American people, 
please find a political route to keep progress against cancer at a 
sustainable pace. The research findings are clear. There is a path to 
major advances in cancer detection, diagnosis, therapy, and prevention. 
Help us get those advances to the public and fulfill the promises of 
the best in scientific research.
    Thank you for your time,

    Senator Harkin. Thank you, Dr. Brugge.
    I now will turn to Dr. Robert Siliciano, professor of 
medicine and molecular biology and genetics at the Johns 
Hopkins University School of Medicine. He received his A.B. 
degree in chemistry from Princeton, his M.D. and Ph.D. from the 
Johns Hopkins University School of Medicine.
    Dr. Siliciano, welcome, and please proceed.

STATEMENT OF ROBERT SILICIANO, M.D., Ph.D., PROFESSOR 
            OF MEDICINE AND PRINCIPAL INVESTIGATOR, 
            HOWARD HUGHES MEDICAL INSTITUTE, JOHNS 
            HOPKINS UNIVERSITY SCHOOL OF MEDICINE, 
            BALTIMORE, MARYLAND
    Dr. Siliciano. Mr. Chairman, thank you for inviting me to 
testify at this important hearing.
    Let me begin by commending you and Senator Specter for your 
foresight and efforts to double the NIH budget between 1998 and 
2003. As Dr. Zerhouni pointed out, we are on the cusp of a 
dramatic transformation in healthcare, which is the direct 
result of the Nation's investment in health science. I'm 
pleased to share with you my own experiences about this 
transformation and the vital role of funding basic research.
    When AIDS first appeared, in 1981, we had no idea what we 
were dealing with. Between 1981 and the present time, 
scientists have identified the virus responsible, deciphered 
its generic code, elucidated its lifestyle, developed a blood 
test, licensed 22 antiviral drugs, and learned a great deal 
about human immunology. A uniformly fatal disease has been 
transformed into one that can now be managed effectively with 
antiretroviral drugs. A recent study suggests that at least 3 
million years of life have been saved in the United States 
alone as a result of these treatments.
    These remarkable advances have come directly from basic 
science research. Many of the big advances came in the last 
decade. Many were funded by the NIH. The doubling in funding 
was central to much of that work. Yet we do not have a vaccine 
or a cure, and we're now struggling to cope with an epidemic of 
drug-resistant HIV.
    My laboratory, and Tony Fauci's lab at the NIH, have 
discovered how HIV hides in the body and escapes from the drugs 
that are being used to combat the infection. We've found that 
HIV can persist indefinitely in a latent state in long-lived 
cells of the immune system. In these cells, the HIV genome, is 
embedded into the host-cell DNA. As a result, the infection can 
never be cured by antiretroviral therapy alone. This discovery 
has changed the overall treatment paradigm from a hit-early-
hit-hard approach aimed at eradication to a more conservative 
approach aimed at maintaining lifelong control of viral 
replication.
    In addition to serving as a barrier to cure, this latent 
reservoir, as we call it, can also store drug-resistant HIV, so 
that if a patient develops resistance, they will always have 
that resistance.
    Right now, drug resistance is the dominant problem in 
treating HIV. At our clinic in Baltimore, half of the 3,000 
patients have multidrug-resistant HIV, and 10 percent of the 
new infections are with drug-resistant HIV. In developing 
countries, the problem of resistance is likely to become even 
more serious.
    Now, many laboratories would like to pursue studies on how 
to eliminate this latent reservoir and how to control drug-
resistant HIV, but, due to flat NIH budgets, research efforts 
are being scaled back. In my own lab, we're having difficulty 
taking on new student, and beginning new projects. In the past, 
I spent about 30 percent of my time applying for grants. Now 
it's up to 60 percent. Prominent investigators that I know in 
the field are getting out of research altogether. Fewer 
scientists want to tackle high-risk problems like this, because 
they know this kind of research will be difficult to fund.
    A colleague of mine has made a major discovery on a unique 
group of patients who control HIV without medication, has been 
unable to get funding.
    Although we have drugs that can control viral replication, 
we don't even know when therapies should be initiated. The 
definitive study of when therapy should be started may not be 
funded. Why? Because of insufficient funds for vaccine and 
treatment trials due to competition for diminishing NIH 
dollars.
    This is particularly unfortunate, because the return on NIH 
investment can be fantastic. For example, the discoveries made 
by AIDS researchers extend well beyond HIV. The discovery of 
how to evaluate levels of virus in the blood has revolutionized 
the treatment of patients with hepatitis B and hepatitis C 
infection, and will eventually be applied to all viral 
infections, including influenza.
    At Johns Hopkins, we've seen a marked decline in the level 
of research grants awarded. Fewer projects are being funded, 
and NIH support for ongoing projects is being cut. In 2002, the 
average funding per grant was approximately $142,000 for the 
School of Medicine; by 2006, it had dropped to $92,000, a 
decline of 34.8 percent.
    America's young researchers are being hit the hardest. I 
fear that we may lose a generation of inquisitive, enthusiastic 
scientists if they conclude that NIH funding is out of reach. 
According to the NIH, 8 out of 10 grant applications are turned 
down. This is a recipe for disaster.
    The situation extends well beyond healthcare. Federal 
investment in biomedical research is also critical to U.S. 
competitiveness.
    The United States has long been regarded as the world 
leader in scientific discovery, thanks, in large measure, to 
policies that encourage innovation. But today we face serious 
threats to this preeminence, as Dr. Zerhouni has mentioned. 
Other nations bring strong educational systems, focused 
government policy, and low-cost workers. Asia and Europe are 
committing unprecedented resources to scientific--to science 
and engineering.

                           PREPARED STATEMENT

    Basic science research is essential to America's ability to 
meet this challenge. In the United States, funding for basic 
research has long been a Government function. Why? Because 
basic research much be sustained for years, and even decades, 
sometimes with no discernible immediate return on the 
investment. No other entity, other than Government, can take on 
this role. Aggressive, stable, and sustained Federal spending 
on NIH and on biomedical research much be understood and 
embraced as a critical component to America's competitiveness.
    Thank you.
    [The statement follows:]

               Prepared Statement of Dr. Robert Siliciano

                              INTRODUCTION

    Mr. Chairman and members of the Committee, thank you very much for 
inviting me to testify today at this important hearing. I am Robert 
Siliciano, and I am a member of the Department of Molecular Biology and 
Genetics at the Johns Hopkins University School of Medicine.
    Let me start by commending you, Mr. Chairman and Senator Specter, 
for your efforts and foresight in doubling the National Institutes of 
Health (NIH) research budget between 1998 and 2003. Many of the amazing 
advances in health care treatment today are the result of federal 
investment in research identifying early indicators and causes of 
diseases. I am convinced we are on the cusp of a dramatic 
transformation in health care, which is a direct result of the nation's 
investments in health science discovery and cures. My fellow 
researchers on the panel and I are pleased to be here today to tell you 
about this transformation.
    On behalf of myself and all my colleagues at Johns Hopkins, I would 
like to recognize the persistence of many on this committee for your 
ceaseless support of NIH's work. I would also take this opportunity to 
invite you to visit our campus in Baltimore to see for yourselves the 
exciting work that my colleagues and I--not to mention our students--
engage in every day. You will find no more persuasive argument for the 
value of investing in research than witnessing innovation firsthand.

                  NIH SUPPORT FOR MY WORK ON HIV/AIDS

    Early in the AIDS epidemic, an AIDS patient could expect to enter 
hospice care within a few years after the diagnosis. However, 
significant research developments in the area of ``Highly Active Anti-
Retroviral Therapy,'' or HAART--that combination of drugs commonly 
referred to as the ``AIDS cocktail'' has lead to increasing the 
survival rate of those diagnosed with HIV. This therapy involves a 
variety of drugs that attack the virus at different stages of its life 
cycle, thus reducing its ability to replicate itself in healthy cells. 
HAART combines drugs that were developed during some of the first 
stages of AIDS research. By 1990, monotherapy--treatment using one 
nucleoside analog--was showing some promise, but debate persisted in 
the research community as to which of this class of drugs were the most 
useful. In 1995, studies showed that treatment with simultaneous use of 
two nucleoside analogs would prove more effective in prolonging life. 
By 1997, combination therapy had expanded to include protease 
inhibitors and non-nucleoside reverse transcriptase inhibitors, both 
classes of drugs that attack HIV as it attempts to insinuate itself 
into healthy cells.
    The result of HAART has been the transformation of AIDS from a 
disease that meant rapid and certain death to a chronic condition that 
can now be managed over a patient's lifetime. When widespread use of 
HAART began in the mid 1990s, U.S. mortality rates immediately 
plummeted--from nearly 41,000 in 1995 to 17,000 in 1997. HAART even 
proved effective for patients who had already reached the terminal 
stages of the disease; many were able to leave hospice care and return 
to relatively normal lives.
    For the more than 40 million people infected with HIV, the best 
current hope for avoiding the fatal consequences of the infection lies 
in treatment with HAART. The benefits of HAART in reducing mortality 
are clear, but major questions remain about how best to use HAART and 
how to make it available to all who need it.
    Our work has shown that current HAART regimens cannot cure the 
infection in most patients because the virus persists in a very stable 
latent reservoir in resting memory CD4+ T cells (cells that control the 
activities of all of the other cells). Because HAART is not curative, 
treatment of HIV infection is a lifelong challenge. Most infected 
individuals will ultimately have to depend upon HAART to avoid fatal 
immunodeficiency. Problems of drug resistance and drug toxicity make 
this an alarming prospect.
    My lab is interested in understanding viral persistence and in 
applying basic studies of viral dynamics in HIV infection to optimizing 
antiretroviral therapy. Our work on viral persistence began in 1994, 
with the idea that the capacity of HIV to establish a state of silent 
or latent infection at the level of individual cells might provide a 
mechanism for viral persistence in the face of immune responses and 
antiretroviral therapy. We hypothesized that HIV might capitalize on an 
extremely fundamental aspect of the immune system, immunologic memory, 
to ensure its persistence in the host.
    At any given time, most of the lymphocytes in the body are in a 
resting state. When a lymphocyte encounters a bacterial or viral 
protein that it is programmed to recognize, it becomes activated and 
begins to proliferate, generating effector cells that eliminate the 
invading microorganism. Most of these effector cells die, but some 
survive and return to a resting state as memory cells. These cells 
persist indefinitely, allowing effective responses to future challenges 
with the relevant microorganism.
    HIV preferentially infects activated CD4+ T lymphocytes, inserting 
its genetic information into the genome of the host cells and directing 
the production of new virus particles in a process that usually leads 
to the death of the infected cells. However, a small subset of the 
activated CD4+ T cells that are infected with HIV survive long enough 
to revert back to a resting memory state. Because the expression of HIV 
genes depends on host transcription factors induced in activated T 
cells, viral gene expression is automatically extinguished when these 
cells return to a quiescent state. The result is a stably integrated 
but transcriptionally silent form of the HIV genome in a memory T cell, 
a cell whose function it is to survive for years in a quiescent state. 
Upon subsequent re-exposure to the relevant microorganism, the latently 
infected cell is reactivated and becomes competent for HIV gene 
expression and virus production. Over the past several years, we have 
been able to demonstrate the presence and persistence of latently 
infected resting memory CD4+ T cells with integrated HIV DNA in 
infected individuals. The cells are present only at low frequencies, 
reflecting the fact that most productively infected CD4+ T cells die 
before they can revert back to a resting memory state. Particularly 
important is whether this small reservoir of latent virus persists in 
patients on HAART. In the years following the advent of HAART, which 
began in the mid-1990s, there was considerable optimism that virus 
eradication might be possible with prolonged treatment, based on 
analysis of the rapid decay of plasma virus to undetectable levels 
following the initiation of HAART.
    We have shown, however, that the frequency of latently infected 
cells does not decrease even in patients on HAART who have had 
suppression of viremia to undetectable levels for as long as seven 
years. As a result of this discovery in 1999, the overall approach to 
the treatment of HIV infection has significantly changed. In 
particular, it became more conservative. Patients were no longer 
started on therapy as soon as they were diagnosed. Initiation of 
therapy was delayed until later stages of disease, since there was no 
hope of eradication. This work raised the possibility that the virus 
could persist indefinitely in all patients on HAART, leading many 
investigators to question the wisdom of beginning aggressive therapy 
with the goal of eradicating the infection, particularly in light of 
the substantial long-term toxicities of HAART regimens.
    Several additional findings add to the seriousness of the problem 
presented by the latent reservoir. We have shown that this reservoir is 
a permanent archive for drug-resistant viruses that are generated by 
inadequate treatment. Once drug-resistant viruses have entered the 
reservoir, they persist there indefinitely, permanently restricting the 
patient's therapeutic options. The problem of stored drug-resistance 
mutations is particularly severe in the case of perinatally infected 
children, who face a lifetime of treatment.
    In 2000, we demonstrated the presence and persistence of this 
latent reservoir in these children. In addition, we have demonstrated 
that latency operates at the transcriptional level. Latently infected 
cells carry integrated HIV DNA but contain little translatable HIV RNA. 
Unfortunately, the last hope for detecting and targeting latently 
infected cells was that the cells might be expressing low levels of 
particular viral proteins, allowing recognition by immune effector 
mechanisms. It now appears that we may be dealing with a completely 
silent form of latent infection that will be difficult to target with 
antiretroviral drugs or HIV-specific immune responses. These findings 
apply not only to children but to all HIV patients.
    In 2001, we became interested in understanding the nature of the 
low-level virus production that continues in patients on HAART whose 
plasma virus levels are below the limit of detection of standard 
assays. We have developed methods for cloning and characterizing the 
extremely low levels of plasma virus that are present in such patients. 
We have shown that this virus is generally archival in nature, is 
devoid of new drug-resistance mutations, and may be derived from the 
activation of latently infected cells. Most importantly, we do not see 
evidence for the continued evolution of drug resistance in most 
patients on suppressive HAART regimens. This provides a counterpoint to 
our disheartening findings on the stability of the latent reservoir. 
Although current HAART regimens cannot produce eradication because of 
the extraordinary stability of the latent reservoir, they can largely 
halt virus evolution, affording patients the possibility of lifelong 
suppression of viremia if the problem of drug toxicity can be overcome.
    It is important to point out that despite the spectacular advances 
that have been made in anti-retroviral therapy--at least 3 million 
years of life have been saved in United States alone--the definitive 
study that would allow us to determine when exactly treatments should 
commence may not be funded because of insufficient funds for vaccine 
and treatment trials. An unfortunate tension exists due to this 
competition for diminishing NIH dollars.
    It is also worth pointing out that the discoveries our community of 
researchers have made extend well beyond HIV. What we have learned from 
studies of HIV can be applied to other viruses. For example, we have 
learned how to measure the amount of virus in the blood. This 
knowledge, which has provided us with a real-time measure of the amount 
of viral replication in a patient, along with the importance of 
utilizing it to treat viruses such as influenza and Hepatitis B and C, 
has revolutionized the success of these treatments.
    In the future, we hope to address several critical questions 
related to the molecular mechanism of HIV latency and the clinical 
implications of this form of viral persistence. We are interested in 
whether it will ever be possible to eliminate this reservoir. 
Furthermore, we hope to translate our findings on mechanisms of viral 
persistence into new approaches for optimizing antiretroviral therapy. 
The correct choice of a HAART regimen is literally a matter of life and 
death for many patients, and we feel basic studies of viral persistence 
can be applied to improving decisions about how and when antiretroviral 
therapy should be given. Over the years, this research has received 
nearly $7 million in support from the NIH.
    I want to emphasize that many labs would like to pursue the problem 
of how to eliminate the latent reservoir, but everyone I know has had 
to scale back research efforts because of flat NIH budgets. In my own 
lab we are now finding it difficult to take on new staff and begin new 
projects. Typically, in the past, I would spend about 30 percent of my 
time applying for grants; now about 60 percent of my time is spent 
preparing applications. Furthermore, some prominent investigators are 
getting out of research. Few scientists want to tackle high-risk 
problems like this because research of this type is more difficult to 
fund. In fact, a very good colleague of mine has made a major discovery 
on a unique group of patients who control HIV without medication. He 
has not been able to get funding even though the potential savings is 
more than $14,000 annually per patient. Additionally, a mentor of mine, 
and one of the most respected people in the field, is thinking of 
getting out of research because he has no funding.

FEDERAL INVESTMENT IN RESEARCH IS A CRITICAL COMPONENT OF OUR NATION'S 
                            COMPETITIVENESS

    The United States has long been the world leader in scientific 
discovery, thanks largely to government policies that encourage 
innovation, improve education, and facilitate the transfer of knowledge 
from the laboratory to the marketplace. Today we face serious threats 
to this preeminence. Other nations bring to the table strong 
educational systems, focused government policies, and low-cost workers.
    Basic research is essential to our ability to meet this challenge. 
William R. Brody, president of The Johns Hopkins University and co-
chair of a national committee on competitiveness, puts it this way: 
``Knowledge drives innovation. Innovation drives productivity. 
Productivity drives economic growth.'' Our ability to compete in the 
global economy depends, first and foremost, on our ability to continue 
making new discoveries. The more we learn about how things work--the 
principles of basic biology, chemistry, physics, and mathematics--the 
more opportunity we have to put that knowledge to work. When we know 
more, we can use that knowledge to make our world better, to build new 
businesses, devise new products, and to improve our standard of living.
    America's most innovative industries are built on decades of basic 
research, research that had no discernable practical application at the 
time it was undertaken. For example, the highly theoretical world of 
quantum mechanics spawned the semiconductor industry and the 
information revolution. Johns Hopkins scientists thinking about the 
principle of physics, called the Doppler effect, used it to invent what 
became today's Global Positioning System. Two Johns Hopkins biologists 
shared a Nobel Prize in 1978 for using restriction enzymes to cut DNA 
into fragments that created today's thriving biotechnology industry, 
which is based on genetics.
    In the United States, funding basic research has long been a 
governmental function. Why? Because it takes a long time to do it, 
because there is always a risk that any single project will come to 
nothing, and because it is difficult to capture an immediate return on 
investment for an idea that has not yet been developed to the stage of 
a marketable invention.
    Despite a societal consensus that basic research is a government 
responsibility, U.S. Federal research and development spending, as a 
percentage of Gross Domestic Product (GDP), peaked 40 years ago in 
1965, at just below 2 percent of GDP. In the past 40 years, that 
percentage has diminished by more than half, to about 0.8 percent of 
GDP. Overall R&D spending, especially in basic sciences, continues to 
decline. We must reverse this trend now, by strengthening the Nation's 
commitment to science related federal agencies and departments.
    The investments in biomedical research being made by rising 
economic powers such as China are increasing. While China lacks a 
central institution like the NIH to oversee its national investment in 
biomedical research, its National Science and Technology Plan for 2006-
2020 emphasizes a long-range strategy to raise its biomedical research 
to world-class standards. This is being supported by a pledge to raise 
R&D spending from 1.3 percent of GDP in 2005 to 2.5 percent by 2020 
(Science 9 March, 2007: Vol. 315. no. 5817).
    If we look to one promising field of the future--that of nanotech--
overall government spending globally grew by 10 percent to $6.4 billion 
in 2006. According to a report released by Lux Research, the United 
States came out on top, with $1.78 billion, followed by Japan and 
Germany. But China actually ranks second when purchasing power parity 
is considered. China's funding is the equivalent of $906 million. (UPI 
9 March, 2007). In this sector, like so many others, China will 
compete.
    The life sciences research funded by the NIH is a key component of 
our overall national science agenda. For example, Johns Hopkins 
University is the nation's leading recipient of federal research 
grants. In fiscal year 2005, our researchers attracted nearly $1.3 
billion in federal R&D funding and $1.4 billion in overall R&D funding, 
a category in which Johns Hopkins has led all U.S. institutions for 27 
consecutive years. This support enables us to improve medical care 
worldwide, advance human knowledge, and train new generations of 
innovative researchers.
    Investment in research universities like Johns Hopkins yields 
tangible economic benefits as well. In 2006, Johns Hopkins researchers 
filed more than 420 U.S. patent applications, received 79 U.S. patents, 
and licensed 72 technologies for commercial development. Some of these 
inventions will be commercialized by Maryland companies. Already, there 
are at least 19 existing Maryland-based start-ups bringing Johns 
Hopkins technology to market. That is a tremendous amount of knowledge 
made available to American business and the American public for an 
incalculable range of benefits.
    While the President and Congress have embraced the notion that 
funding for basic research in the physical sciences is essential to 
strengthening America's competitive standing in the world, and Johns 
Hopkins certainly recognizes and appreciates the significant 
investments included in the fiscal year 2007 Continuing Resolution, we 
remain concerned that funding for biomedical research has not kept pace 
with this commitment. Aggressive, stable, and sustained federal 
spending on the NIH and biomedical research must be understood and 
embraced as a critical component of America's competitiveness.

                      JUSTIFICATION OF NIH FUNDING

    On January 15, 2007, President Bush signed the National Institutes 
of Health Reform Act of 2006. While the law calls for a 6 percent 
increase for fiscal year 2007 and an 8 percent increase for fiscal year 
2008, the reality is that this funding commitment has not fully 
materialized. For fiscal year 2006, the NIH budget was cut in both 
nominal and real terms. For fiscal year 2007, the NIH received a modest 
yet important increase of approximately $620 million. We are very 
grateful that this Congress chose to single out the NIH, along with 
several other science agencies, to be among the few areas of federal 
spending to receive increases. We recognize that budgets are tight and 
we see this as a critical statement of Congress' desire to strengthen 
and preserve the scientific enterprise in this country. Despite this 
increase, however, fiscal year 2007 marks the fourth year in a row, 
when adjusting for inflation, that NIH funding has been cut.
    At Johns Hopkins, we have annually led the nation in NIH research 
dollars and we have seen a marked decline in grants awarded to our 
School of Medicine. Fewer projects are being funded and NIH support of 
on-going investigations is being cut. Recent figures suggest that the 
number of grants and overall funding levels have declined. In fiscal 
year 2002, the average funding level per grant was $142,210 for the 
School of Medicine. By fiscal year 2006, the funding level dropped 
nearly $50,000 per grant to $92,683, a decline of 34.8 percent. Hardest 
hit are America's young researchers. I fear that we may lose a 
generation of enthusiastic, inquisitive scientists if they conclude 
that NIH grants are out of reach.

             FLAT FUNDING THREATENS OUR YOUNG INVESTIGATORS

    One of the first and earliest victims of declining NIH funding has 
been the young investigator. You have heard today, and often over the 
past several years, from Dr. Zerhouni regarding NIH's concern that we 
are potentially sacrificing an entire generation of young scientists. 
The Director's concern is real and very serious.
    Quite simply, we have to do more to support and encourage our young 
investigators. Most ideas that turn into Noble Prizes come from 
investigators before they reach the age of 40. As a country, then, 
shouldn't we be supporting these scientists when they are in their 
professional prime? Unfortunately, the statistics tell an entirely 
different story. In the case of initial R01/R29 awards, between 1970 
and 2004, the average age by which an investigator with a Ph.D gains 
his or her first award has gone from 34.3 years of age to 41.7. In the 
case of MDs, during this same period, that age has gone from 36.7 years 
to 43.3 (AAMC 12 July, 2006). With diminished NIH funding, our young 
scientists are witnessing firsthand the decline in overall success 
rates for grant applications. In 1998, the first year of the doubling, 
overall success rates were about 31 percent for grant submissions. For 
2007, the success rate is projected to drop to only about 19 percent. 
Left unaddressed, there is no question that the current decline in NIH 
funding places an entire generation of young scientists at risk.
    Even at my own institution, where we have many of the best and 
brightest among the current generation of young scientists, we are 
seeing many of these men and women unable to gain funding support. 
Without sustainable and predictable increases in NIH funding, this 
nation is at risk of losing an entire generation of scientists.

                   RESEARCH IMPACTS HEALTH CARE COSTS

    When advocates for increasing biomedical research funding meet with 
members of Congress and their staff, they are often asked: ``What have 
we to show for the money that NIH has received in the past?'' As we 
think about this question, it is important to recognize that the pace 
of biomedical research and science in general is often slow and 
unpredictable. It may be years before we can point to specific 
therapies or new medical devices that can trace their origins to 
recently funded efforts. But the simple answer is: We have a great deal 
to show!
    Here are three powerful examples--there are, of course, many more--
of what Johns Hopkins scientists have accomplished in terms of 
improving healthcare and reducing costs, thanks to NIH support.
Detection of Vision Problems of Diabetics
    Diabetes is the leading cause of blindness in adults, with 12,000 
to 24,000 new cases each year. Early identification of retina disease 
is critical to stave off vision loss, especially for the 10 million 
diabetics who are 60 years or older, most of them on Medicare or 
Medicaid. Yet more than half of all diabetics fail to get an annual eye 
exam as recommended by the American Diabetes Association. To address 
this dilemma, Dr. Ran Zeimer, director of the Ophthalmic Physics 
Laboratory at the Johns Hopkins Wilmer Eye Institute, came up with a 
novel solution after more than a decade of research: Why not develop an 
easy-to-use digital camera that tests for retinopathy when diabetics 
visit their primary care physicians for check-ups?
    Thanks to NIH support, Dr. Zeimer perfected an instrument called 
the DigiScope. The DigiScope takes images of the retina in just minutes 
as patients sit in front of an automated camera and look at a series of 
blinking lights. These images are then transmitted via the Internet to 
a reading center for expert interpretation. More than 20,000 
individuals not under the care of an ophthalmologist have been screened 
to date in the offices of primary care physicians. Those with vision-
threatening disease have been identified and referred to eye 
specialists. In most cases, diabetics without complications are spared 
visits to an ophthalmologist, while Medicare and Medicaid are spared an 
expense.
Advances in Treatment for Sickle Cell Patients.
    Thanks to continuous NIH grants extending back to 1982, Drs. George 
Dover and Samuel Charache of Johns Hopkins spent their careers fighting 
sickle cell disease--a miserable, inherited illness in which sickle-
shaped red blood cells get stuck in narrow channels and block blood 
flow to tissue and vital organs. Patients with sickle cell disease--
72,000 in the United States--suffer frequent bouts of fatigue and 
shortness of breath, joint and body organ pains that turn excruciating 
and lead to frequent hospitalizations. The pneumonia-like conditions, 
chest pains, and fever can be life-threatening. Until fairly recently, 
early death was the norm, with life expectancy for a sickle cell 
patient projected to be only 20 to 30 years.
    In the 1990s, Drs. Dover, Charache, and their Hopkins research team 
found that a cancer drug (hydroxyurea) did remarkable things for sickle 
cell sufferers. A 1995 NIH-supported multi-center study proved that 
hydroxyurea therapy dramatically reduces the frequency and severity of 
painful episodes, hospitalizations and transfusions. In a 2003 study, 
daily doses led to 30 percent fewer hospital days, 58 percent fewer 
transfusions, and a 40 percent reduction in deaths. Today, hydroxyurea 
therapy is recommended for adults and adolescents with moderate-to-
severe recurrent pain. As a result, the life expectancy for sickle cell 
patients has doubled.
    There have been financial benefits, too. According to another NIH-
sponsored study, hydroxyurea therapy saves the U.S. health care system 
$5,210 per sickle cell patient per year. With 72,000 Americans 
suffering from sickle cell disease, the potential annual savings is 
more than $375 million annually.
Faster Diagnoses in Emergency Rooms
    With the existing threat of bioterrorism, it is crucial to find 
ways to swiftly identify patients in hospital emergency rooms who have 
biochemical pathogens or life-threatening infectious diseases, such as 
meningitis, sepsis, and bacterial endocarditis (an infection of the 
inner lining of the heart or heart valves). Current testing methods are 
time-consuming and usually lead to delays in diagnosing and treating 
these diseases. The current blood and culture tests for some diseases 
can take 24 hours or more.
    Dr. Richard E. Rothman of the Johns Hopkins Department of Emergency 
Medicine is working on novel ways to identify quickly multiple blood-
borne and pulmonary infectious diseases and bioterrorism pathogens. His 
patented molecular diagnostic tests involve both exhaled breath and 
body fluids. Early experiments have shown that these new diagnostic 
tools can detect 25 common bacterial infections and five categories of 
bioterrorism agents in fewer than 4 hours. Faster response times are 
expected as the diagnostic tools are fine-tuned.

                               CONCLUSION

    Thank you for your efforts to strengthen America's biomedical 
research community. Johns Hopkins stands ready to support you in this 
important endeavor. I invite you and your staff to visit our campuses, 
explore our facilities, and meet our researchers who are taking the 
lead in these vital fields.

    Senator Harkin. Dr. Siliciano, thank you very much. I'll 
have some questions about the drop in GDP, also.
    Now we'll turn to Dr. Stephen Strittmatter, professor of 
neurology and neurobiology at Yale University School of 
Medicine. Dr. Strittmatter earned his undergraduate degree from 
Harvard and his M.D. and Ph.D. degrees at Johns Hopkins.
    Dr. Strittmatter?

STATEMENT OF STEPHEN M. STRITTMATTER, M.D., Ph.D., 
            PROFESSOR OF NEUROLOGY AND NEUROBIOLOGY, 
            YALE UNIVERSITY SCHOOL OF MEDICINE, NEW 
            HAVEN, CONNECTICUT
    Dr. Strittmatter. Chairman Harkin, I thank you for the 
opportunity to share some of my thoughts on NIH-supported 
science and the NIH budget.
    To be frank, my three decades in clinical neurology and 
basic neuroscience have convinced me that the recently flat NIH 
budget is stifling creative high-risk research. On the one 
hand, the doubling of the NIH budget that was provided by 
Congress and championed by you and the rest of this 
subcommittee has laid the foundation for fantastic advances, 
revolutionizing the care of patients with nervous-system 
diseases; however, for most types of neurologic and psychiatric 
diseases, we still face a crucial hurdle: the translation of 
basic molecular analysis of brain function into effective 
treatments. To leap over this translational hurdle requires the 
most creative and risk-taking experiments, including those that 
may lead to an experimental dead-end before achieving a 
critical insight towards a new therapy.
    Regrettably, the decline of inflation-adjusted NIH spending 
in recent years has produced a marked chilling effect 
specifically on this type of research. If that's not reversed, 
we're going to fail to reap the full benefits of the expansion 
that occurred from 1998 to 2003 in research in the United 
States.
    My own field in neuroscience relates to nerve-fiber growth 
and provides one example of how high-risk research can succeed 
when the environment is appropriate. In humans, single nerve 
cells extend fine threads, called axons, for very long 
distances, up to 3 feet. You can imagine, if the cell body were 
blown up to the size of a baseball, the axon would be the width 
of a pencil and extend for half a mile. When all these nerve 
fibers are correctly connected, this provides the wiring of the 
brain, and the function of the brain is critically dependent on 
all this being connected correctly.
    During the 1990s, molecular insights into the basis of axon 
guidance advanced very rapidly. We identified dozens of axon 
guidance molecules and genes that help put the brain together. 
These molecular insights were fascinating, but they didn't 
immediately improve human health. So, the next step was to 
apply this knowledge to settings of neurologic injury, where 
axonal disconnection occurs. The clearest example of this, 
one--a field that I work in--is traumatic spinal cord injury. 
Despite the profound, and the persistent, neurologic deficits 
that occur after spinal cord injury, such as the inability to 
move or feel below the level of the injury, nearly all of the 
nerve cells remain intact. The primary cause of disability is 
the disconnection of one nerve cell from another, not the loss 
of cells. Very little axon regrowth occurs after injury, and 
this is why there's very little recovery in adults.
    So, here's the translational problem, the hurdle, to 
overcome. How do we use basic knowledge about axon growth to 
restart--during development--how do we use that to restart 
adult axon growth, repair function, and recover ability of 
people to live a productive life? It's certainly a problem that 
I wanted to take on as a neurologist caring for patients while 
running a basic developmental laboratory. However, without the 
sort of environment that was created by the budget doubling 
through the NIH funding, I wouldn't have tackled this problem 
myself. But when I did take it up, in that time period, we 
discovered, in my laboratory, a molecule, termed Nogo, that 
prevents nerve fiber growth. By analyzing the mechanism of 
action of this Nogo molecule, we identified genetic, and then 
pharmacologic means to prevent its function; thereby, 
stimulating nerve fiber growth. Remarkably, therapy with a Nogo 
receptor antagonist allows rats to walk after spinal cord 
injury or to recover better paw use after a stroke. Today, a 
closely related approach using an antibody against Nogo is in 
clinical trials.
    So, I think this illustrates how high-risk research can 
occur. But I'm convinced that similar challenges in Alzheimer's 
or in schizophrenia research are not being tackled today, 
because of the limitations that have occurred in the NIH 
budget. The reason I say that is that when researchers and 
peer-review panels are faced with the idea that junior 
investigators can't be funded at all, or that senior 
investigators are losing funding, everyone shifts towards what 
I'd call ``safe science.'' Scientists pursue those experiments 
that have the highest probability of success in the short term, 
incremental gains. They shy away from the paradigm-shifting 
discoveries that will really move science into the clinic, 
where it will solve the major health problems that we have 
caring for this country.
    Researchers essentially become worriers focused on how to 
maintain their laboratories, rather than explorers seeking to 
solve the crucial issues. High-risk, high-payoff studies are 
what we need most, but they have the most volatile dependence 
on the NIH funding level.

                           PREPARED STATEMENT

    Of course, Dr. Zerhouni and the NIH have recognized the 
need for this kind of research, and they've taken steps to 
achieve it within the confines of the NIH budget. This is 
certainly important and commendable, but it's not a substitute 
for the kind of investment of Federal funds that will encourage 
creativity and reward risk. Specialized programs or set-asides, 
by definition, can only affect a small percentage of all the 
research that's going on. Moreover, creativity cannot be 
dictated by policy alone. Only a reversal of the inflation-
adjusted decline in the NIH budget can reset the community's 
outlook. By establishing an NIH funding level that, at a 
minimum, restores recent net losses to inflation and keeps pace 
with costs in the future, Congress, this committee, can achieve 
the research environment required to promote the health of all 
of our citizens.
    Thank you very much.
    [The statement follows:]

           Prepared Statement of Dr. Stephen M. Strittmatter

    Chairman Harkin, and Members of the committee, I thank you for the 
opportunity to offer my insights on the NIH budget. To be frank, my 
three decades in clinical Neurology and basic Neuroscience research at 
Yale, Harvard and Johns Hopkins have convinced me that the recently 
flat NIH budget is stifling creative, high-risk research endeavors.
    The doubling of the NIH budget provided by Congress, and championed 
by many of you on this committee, laid the foundation to revolutionize 
the care of those suffering with nervous system diseases. However, for 
most types of neurological and psychiatric disease, we still face the 
crucial hurdle: the translation of basic molecular analysis of brain 
function and dysfunction into effective treatments. To leap over this 
translational hurdle requires the most creative and the riskiest 
experiments, including those that may lead to an experimental dead-end 
or multiple failures before achieving the one critical insight that 
will establish a new therapy. Regrettably, the decrease of inflation-
adjusted NIH spending in recent years has produced a marked chilling 
effect on precisely the type of research that is most needed. If this 
chilling effect is not alleviated, we will fail to reap the full 
benefits of the research expansion that occurred from 1998-2003--and we 
will push better treatments farther into the future.
    My own field in Neuroscience relates to nerve fiber growth, and 
provides an example of how high-risk research can succeed in the 
appropriate environment. In humans, single nerve cells extend fine 
threads, called axons, for distances as long as a meter. If the cell 
were magnified to the size of a baseball, the axon would be the width 
of a pencil and extend for half of a mile. These axons conduct 
electricity and provide the ``wiring'' of the brain. There can be no 
useful brain function unless these fibers are correctly connected, and 
failure to connect--or reconnect--contributes to many diseases, from 
strokes, Alzheimer's and Parkinson's to Multiple Sclerosis and Lou 
Gehrig's disease.
    Twenty years ago when I started in this field, little, if anything, 
was clear about how the cells of the developing brain become connected 
over long distances. However, molecular insights into the basis of 
axonal guidance began in the early 1990's and the pace of discovery 
accelerated rapidly during the NIH budget doubling. Basic studies led 
to the identification of dozens of axon guidance molecules and genes 
with defined roles in the developing brain.
    These molecular insights were fascinating from the scientific 
perspective, but did not immediately improve human health. The next 
step was to apply this knowledge to settings of brain injury where 
axonal disconnection occurs. The clearest example is traumatic spinal 
cord injury. Despite the profound and persistent neurological deficits 
after spinal cord injury, such as the inability to move or feel, nearly 
all of the neurons that initiate arm and leg movements and provide skin 
sensation survive injury. The primary cause of disability is the 
interruption of nerve fibers--not the loss of cells. This, we learned, 
has important implications for treatment.
    Inside the brain and spinal cord, very little axon regrowth occurs 
after injury, explaining the poor recovery of adults. Here the 
translational hurdle emerged: how do we use basic knowledge of 
embryonic fiber growth to restart axonal growth and restore proper 
function after injury or disease. As a Neurologist caring for patients 
while directing a brain development laboratory, I was particularly keen 
to attack this hurdle. Despite my interest, I would not have pursued 
this goal in 2000 without the risk-taking climate created by the NIH 
budget doubling.
    We discovered the existence of a molecule, termed Nogo, which 
prevents nerve fiber growth, and mice lacking the gene for Nogo or its 
partner NogoReceptor exhibited significant axonal regeneration. 
Moreover, such animals recover substantial walking after spinal cord 
injury, or improved paw use after stroke. By analyzing the action of 
the Nogo molecule, we identified methods to prevent its function. 
Remarkably, therapy with a NogoReceptor antagonist allowed rats to walk 
after spinal cord injury and those with strokes recovered greater paw 
use. Today, a closely related approach using an antibody directed 
against Nogo is in clinical trials.
    While this story illustrates past progress in high-risk research, I 
am convinced that similar challenges are not being tackled today 
because of the NIH budget situation. When researchers and peer review 
panels are faced with many junior investigators failing to achieve NIH 
research support and established investigators losing support, the 
first change is a retrenchment to ``safe'' science. Scientists pursue 
those experiments that have the highest probability of achieving an 
incremental short-term goal, rather than a chance of generating a 
paradigm-shifting long-term discovery. Researchers have become 
``worriers'' focused on how to maintain their laboratories and jobs, 
rather than ``explorers'' seeking to solve the most crucial 
translational issues. High-risk, high-payoff studies have the most 
volatile dependence on NIH funding levels. Nonetheless, we require 
high-risk endeavors now more than ever to take advantage of basic 
science and research tools developed during the doubling of the NIH 
budget.
    Dr. Zerhouni and the NIH have recognized the need for high-risk, 
high-payoff research and have taken steps to foster such work within 
the confines of restricted NIH budgets. This is important and 
commendable but it is not a substitute for an investment of federal 
funds that encourage creativity and reward risk. Specialized programs 
and set-asides can only affect a small percentage of biomedical 
research by their very nature. Furthermore, creativity cannot easily be 
dictated by policy. Only a reversal of the inflation-adjusted decline 
in the NIH budget can reset the biomedical community's outlook.
    Future health care can be dramatically improved if researchers 
explore the highest risk research areas, allowing researchers to clear 
the translational hurdle and bring the benefits of expanding basic 
science to the public. By setting an NIH funding level that, at a 
minimum, restores recent net loses to inflation and keeps pace with 
costs in the future, Congress can achieve the research environment 
required to improve health for all of our citizens. I would be pleased 
to answer any questions.

    Senator Harkin. Thank you very much, Dr. Strittmatter
    Just some general questions for the panel. We've all heard 
about the drop in the success rates, from 1 in 3 to about 1 in 
5 right now. Some institutes are rated even lower. I'm 
concerned that when you get that low, some scientists, 
especially the young investigators, will just say, ``Why 
bother?'' You've all kind of spoken to that, in one way or the 
other. But what's the minimum success rate that makes sense? 
What should we be aiming for? Is there something we should be 
aiming for? What's the minimum? I just open it up.
    Dr. Strittmatter. Well, I don't know if there's one 
minimum. There's not one answer to the question. I think Dr. 
Zerhouni put forth the notion that, historically, the success 
rate of grants had been around 30 percent. That's one where the 
culture of research in the United States is comfortable with 
the idea that we choose the best grants, we move forward with 
the best ideas. The problem now is that that funding rate has 
gone down, so we not only--the feeling that scientists have is 
not that creativity or risk-taking is rewarding, but that we 
should shut down. We're going backwards, not forward. So, 
perhaps reaching back to that historical level, not 100-percent 
funding, but----
    Senator Harkin. Yeah.
    Dr. Strittmatter [continuing]. 30-percent success rate in 
grants, will restore the kind of driving forward of the 
research, moving science into changing healthcare that we need.
    Senator Harkin. That's----
    Dr. Strittmatter. That's one answer. I don't know----
    Senator Harkin [continuing]. Sort of, overall. Should there 
be some areas where it should be higher than 30 percent?
    Dr. Strittmatter. Well, I think one way to judge that would 
be whether there's--what you'd really want to know is whether, 
on the margin, the grants that are funded discover something 
useful, advance healthcare. If funding levels were at 30 
percent, do the worst 1 percent or 2 percent of the grants help 
the American public? I think you could easily argue that the 
enormous cost of healthcare--they're so large that looking for 
cures, or preventive, pre-emptive medicine, has such a huge 
financial benefit--I think that's what Dr. Zerhouni alluded to 
with his figure of $44 per person in the United States for all 
of the NIH budget. You could easily argue that we should be at 
a higher level, and we would still save immense amounts of 
money compared to the amount that we spend on healthcare and 
insurance otherwise. That's one answer.
    Dr. Iverson. If I could answer that specifically--excuse 
me--I would say that, from my perspective, I think 30 percent 
is a great number. I would also like to see an allocation for a 
common fund that can be targeted at particularly exciting 
opportunities that should not fight each other.
    Senator Harkin. Uh-huh. Anything else?
    All right. The other thing--Dr. Siliciano, you pointed out 
in your statement--you didn't state it, but I read it--and it 
said that--when was it? In 1965, we peaked at the percent of 
our GDP that went for--was that all R&D--I guess, just all R&D 
lumped together? Now it's about eight-tenths of 1 percent.
    Dr. Siliciano. Yes, I believe so.
    Senator Harkin. Then you pointed out that China had just 
recently committed going from 1.3 percent, where they are now--
so, they're even higher than we are as a percent of GDP--to 2.5 
percent of GDP by 2020. I'm going to have my staff find out 
what it would be if we were at 2 percent right now? I just 
wonder what the figure might be. I didn't see it there, but we 
can find that out. I just didn't know if you knew it, off the 
top of your head.
    Dr. Siliciano. I don't--not off the top of my head.
    Senator Harkin. Well, obviously it would, what, at least 
2.5 times where we are right now.
    The other thing that I--you talked about these--about 30-
percent approval rates and what should the right number be, 
what should we aim for. I still don't know if I got a good 
handle on that. But I also wonder about the whole peer-review 
process--and I have brought this up for the last 20 years that 
I've been on this Committee--on the one hand, you want good 
peer reviews, because you want good, legitimate science being 
done. So, you want those that are knowledgeable in those areas 
to look at it and give their evaluation as whether or not it's 
legitimate, sound, and should go forward or not. It's a good 
system. On the other hand--on the other hand, peer reviewers 
tend to be those that have been in that area of scientific 
research for some length of time, they have all pursued certain 
interests. You know, maybe they're looking for the safer 
things, the things that they're comfortable with, that they 
have more understanding of. I'm often wondering, do these sort 
of off-the-wall kinds of things that--the new-paradigm types of 
research that some of you spoke about, do they--what's your 
comfort level that some of these actually get through that 
peer-review process, these kind of really new things that maybe 
a peer-reviewer had never, ever been involved in before--how do 
they get through that?
    Dr. Siliciano. Mr. Chairman, I've had quite a bit of 
experience on these type of review panels, and my overall 
impression is that they do a really excellent job of finding 
the good science. There has been a mandate on these panels, for 
many years, to look for what's called high-risk/high-yield 
types of projects. My own experience is that those types of 
projects do get funding. The biggest--and I think the overall 
system works extremely well. I'd be anxious to hear what my 
colleagues think. But I think the problem is that the amount of 
funding that the system has at its disposal right now is just 
too low to allow the system to work effectively. When you go 
down from 30 percent grants being funded to----
    Senator Harkin. So, the lower the funding level, the----
    Dr. Siliciano. The whole system----
    Senator Harkin [continuing]. The increase in the safety 
factor tends to go up.
    Dr. Siliciano. Yes. So, I don't really think it's a problem 
with the mechanism, I think it's a problem with the funding.
    Senator Harkin. Yeah.
    Yes, Dr. Brugge.
    Dr. Brugge. I completely agree, but I think that, in 
addition, we need visionary leaders, like Dr. Zerhouni was 
pointing out, in terms of the nanotechnology investment. We 
need leaders to be aware of and make opportunities available to 
those individuals that are at the forefront. Because often, as 
you mentioned, they're--these people are--can't really be 
evaluated appropriately by the standing committees. So, for 
instance, if there's technology that is at the interface 
between biology and engineering, there's not really a great 
place--I mean, there is now, but there--initially, there wasn't 
a place for those grants to be reviewed. So, I think it--we do 
have to have extraordinary opportunity kind of funds available 
for the leadership at NIH and the other institutes to have RFAs 
in those areas so that they--we will be able to bring new ideas 
and new--or kind of force new--considering new options.
    Senator Harkin. Well, we had said, when we added that 
money, that $647 million in the continuing resolution, that 
some of that would be used for high-risk, high-impact research. 
Dr. Zerhouni has already announced those awards. New Innovators 
Awards. So, he's already taken that step--Dr. Zerhouni's 
already taken that step, and I just--but I--you know, we've 
often wrestled with this, over a long period of time.
    Dr. Brugge. In our department of Cell Biology, our chairman 
felt very strongly that we needed better technology expertise 
in the Department, and so, he actually encouraged recruitment 
of technology experts that weren't really cell biologists. They 
would never have been recruited if there was a consensus vote 
on those individuals. But, because a slot was made for those 
individuals both are someone who's doing mass spectroscopy and 
cryoelectron microscopy, they've had more impact in our 
Department in our school than any other investigator. They have 
more collaborative papers with other individuals, and their 
papers are all being published in the very top journals. So, 
again, you need visionary leaders to be able to highlight those 
types of individuals and that type of science, and bring them 
in, because--because of the issues that you raised, in terms of 
people being just comfortable where they are.
    Senator Harkin. Dr. Brugge, your statement was something I 
had not focused on, sort of went by me. When we're talking 
about the 20 percent that, for the first submission, it's about 
10 percent. Is that factual now, that about----
    Dr. Brugge. So, if you look at the chart over here--this 
was a chart that was just provided to me by Dr. Neiderhuber, 
the director of the National Cancer Institute. If you look at 
the yellow curve, which might be difficult to see--I asked him 
to specifically give me data on first submission, so all that 
data is on first submission--and then, to break it down into 
competing renewals versus new applications from either new 
investigators or established investigators. If you look at the 
yellow line, those are for competing renewals. Those are for 
teams that are already in place.
    Senator Harkin. Okay.
    Dr. Brugge. Over the long haul, they've been in the range 
of 45 to 50 percent, but, as you can see, since 2003, there's 
just a precipitous drop. So, that shows that 80 percent of 
established investigators that are asking for renewing their 
team's efforts are being turned down on the first submission.
    Senator Harkin. So, that's down----
    Dr. Brugge. And----
    Senator Harkin. But that's 20 percent.
    Dr. Brugge. Twenty percent are being funded, 80----
    Senator Harkin. Right.
    Dr. Brugge [continuing]. Percent are being rejected.
    Senator Harkin. Rejected. But you said for first 
submissions, though, it's 90/10.
    Dr. Brugge. Okay. So, 90/10 is the overall success rate for 
any one cycle. So, that's a combination of the established 
investigators and the new investigators. So, as you can see, 
the new investigators are down to around 5 percent. So, the--
overall 10 percent. So, for instance, NCI is funding new--or 
first awards from competing renewals at some--wait a minute. 
Okay. Maybe somebody from NCI can help with this, because it's 
a little complicated.
    Senator Harkin. Let me see if I can--ask it this way. Okay. 
So, if you take all of the first, second, third submissions and 
all that--so, what's the success rate? Approximately.
    Dr. Brugge. Success rate----
    Senator Harkin. Add'em all up, and then----
    Dr. Brugge. 20 percent.
    Senator Harkin. That's 20 percent. Take out second, third--
you want first submissions. This is the first time they've 
submitted it.
    Dr. Brugge. Yes. Submitted, but it could be a competitive 
renewal.
    Senator Harkin. Competitive renewal.
    Dr. Brugge. It's a--you know, every 5--every 4 or 5 years, 
you have to----
    Senator Harkin. You have to get it renewed, right.
    Dr. Brugge [continuing]. Get renewed. So, it could be the 
first submission of a competitive renewal.
    Senator Harkin. Does anyone know, or maybe Dr. Zerhouni 
could provide it for us--what would the success rate be just 
for first submissions? I don't mean renewals. I mean just for 
the first.

                            NIH SUCCESS RATE

    Dr. Brugge. Oh. That's 5 percent.
    Senator Harkin. Oh, it's 5 percent.
    Dr. Zerhouni. The success rate on first submissions, 
whether you're established or new----
    Senator Harkin. I'm going to ask Dr. Zerhouni to take a 
microphone.
    Dr. Zerhouni. Dr. Brugge is right. If you come in with a 
new grant, the average success rate on the first submission is 
10 percent. But if you are an established investigator, it's 
more like 17 percent.
    Senator Harkin. Yes.
    Dr. Zerhouni. If you're a completely new investigator, it's 
more like 5 percent. So, on average, it's 10 percent; but it's 
much worse for a new investigator versus a new application from 
an established investigator. But, on the average, 90 percent at 
the first submission will have to go back and resubmit again 
and work on finding--on reapplying.
    Senator Harkin. I always thought that it was higher than 
that. I don't know why I thought----
    Dr. Zerhouni. Right. What it is, is this, is that Dr. 
Brugge's talking about the first time that you submit a 
request----
    Senator Harkin. Right.
    Dr. Zerhouni [continuing]. Your chances of being funded, if 
you're a new investigator--and this is why we really thank you 
for the support of new investigators--is between 5 and 7 
percent.
    Senator Harkin. Now, has that been true for a long time?
    Dr. Zerhouni. No, it has been true for the past 2-3 years.
    Senator Harkin. Okay. Good. What was it, back in the 
1980s--late 1980s, early 1990s, in those areas? What happened 
when we doubled the funding?
    Dr. Zerhouni. So, when you doubled the funding, the average 
success rate overall was about 30 percent. If you look at the 
statistics, you can see that the success rate for a new 
investigator was around 15 percent, and the success rate for an 
established investigator was around 40 percent. The two, 
together, made about 30 percent.
    Senator Harkin. So, can I--is this a correct statement I'm 
about to make, that--when we finished the doubling, or during 
that doubling, that first submissions of--first submissions--
not renewals, first submissions--the approval rate would have 
been three times higher than it is right now--15 versus 5?
    Dr. Zerhouni. It would have been three times higher for a 
new investigator.
    Senator Harkin. Yes.
    Dr. Zerhouni. About twice as high for an established 
investigator.
    Senator Harkin. That's it. That--now I understand it. Hmm. 
Three times.
    Dr. Brugge. That's why there's----
    Senator Harkin. Now, see----
    Dr. Brugge [continuing]. A lot of distress.
    Senator Harkin. Now, here's another problem we get into. 
See, that--so, we double the funding, we get more grants out 
there, but obviously these grants are longer than just 3 or 4 
or 5 years. They come in to get renewed. So, all the new ones 
that we got during the bump-up are now in the system, and they 
get renewed, and the new ones can't get in.
    Dr. Zerhouni. Yes, sir, that's why we----
    Senator Harkin. I'll have to think about this one. I mean--
and how we crack that. I mean, that doesn't seem to me to be 
the right course that we ought to be on. Obviously, the correct 
answer that--we talked about this doubling for a long time 
before we started. One of the reasons was, we had seen, over 
the years, how the number of peer-reviewed applications, the 
approval rate had gone down and down and down. We looked at 
each institute. Some were better than others. Some really got 
bad, way down, 1 in 7, 1 in 8, that kind of thing--1 in 10. The 
idea was to get it back up to the level so that the peer-
reviewed grants would be about where we were, I don't know, 25-
30 years ago. That happened. But we also wanted to make room 
and to encourage this new--what was that word I used? High-
risk/high-impact kind of research to be done. Are we now at the 
point where we did the high-risk/high-impact research maybe on 
a one-shot basis or for a couple of years, but now we're not 
doing it? I mean----
    Dr. Strittmatter. I think that's the point that I was 
trying to make. I think there is that influence, that, during 
the doubling, there was an atmosphere created where people took 
high risks, where things advanced rapidly. We made great 
strides. But the retrenchment, a backward progress in the rate 
of grant funding----
    Senator Harkin. Yeah.
    Dr. Strittmatter [continuing]. Has an enormous--the biggest 
influence is on high-risk research and creativity in science, 
more----
    Senator Harkin. Sure.
    Dr. Strittmatter [continuing]. Than steady advance.
    Senator Harkin. Sure.
    Dr. Strittmatter. Even though--whether it's a 9-percent or 
13-percent net decline in total dollars, the effect on high-
risk research might be much, much greater--5, 10 times decline 
in these kind of crucial experiments.
    Senator Harkin. Yeah, I can understand that.
    Well, I just think, Dr. Zerhouni, we're going to have to 
continue to work on that. On the one hand--I mean, it's both 
valuable. I mean, you don't want to cut off people that are in 
the midst of their research project. I mean, you want to 
continue it on, and you want to let new researchers know that, 
if they do get it, they're not going to be cut off at the knees 
once they just get established. On the other hand, you do want 
to encourage new people coming into the system.
    Well, I think the obvious thing that strikes me is that 
we're simply not on a growth pattern like we ought to be on. We 
have to be on a growth pattern on this, and we're just not. I 
get the sense that a lot of people thought, ``Well, we doubled 
it. Now we don't have to do anything for a long time. We can 
just sort of sit there.'' I have to tell you, I hear that 
around here, you know, ``Well, we gave you all that money once. 
You got all that you've got up there, so quit squawking all the 
time.'' But I don't think they realize that we were just making 
up for lost time, that we needed to keep that line going up.
    Well, I've got a lot of questions I could ask. I don't know 
if Senator Specter is coming back or not right now.
    One other question. You're the correct panel to ask this 
question to. One other thing that I want to get a better handle 
on is undergraduate researchers and training scientists. Now, 
we heard a lot during the doubling that this was going to have 
a ripple effect downward, even--maybe down even into high 
schools, getting more high school students taking science if 
they knew they could really become a scientist and have a 
career as a scientist. So, since I think most of you are all--
you're all college-based, one way or the other--tell me about 
undergraduate researchers and scientists, and how does it look 
to you for the future in actually appealing to these young 
people to take up research and be a research scientist as a 
career? Because these are long-term things. That's another 
thing that people ask me about, ``Well, you know, you don't 
need to do all that. I mean, if you''--it's like you can just 
get a researcher--just get someone to take a little time off of 
their practice, and they can be a researcher for a few months, 
and then they can go back to practice again. So, what's 
happening with undergraduate researchers and budding young 
scientists out there? You're in contact with them all the time. 
On the one hand, is there a desire? Do you find young people 
interested in the life sciences that Dr. Zerhouni talked about, 
this new century of life sciences? Is that interest there? Are 
we responding to that? Just an open--just how you feel about 
it.
    Dr. Iverson. Well, thank you. I'm going to take this one.
    It turns out that there's nothing more transformative in 
science education than undergraduate research. The reason is 
that, in an NIH-funded laboratory doing current state-of-the-
art research, an undergraduate is immersed in an environment 
where they finally understand what's really happening. There's 
no way to convey that in the lecture hall. I try my best. You 
can't.
    Senator Harkin. Interesting.
    Dr. Iverson. I'm here today--as I said, I'm here today 
because of a transformative experience. I was on my way to 
business school, and that event changed my thinking--not 
immediately, but it was because I was doing state-of-the-art 
research, or, you know, I was being exposed to it.
    The way it generally operates is that you have laboratories 
that are set up, you have postdocs and graduate students, and 
undergraduates will come in, and they'll be working along with 
a graduate student or a postdoctoral fellow, be brought along 
slowly. What we hope is that, by the end of their second or 
third year, if they're excited about it, they're going to be 
really doing, with their own hands, research that may have an 
impact.
    Senator Harkin. Yeah.
    Dr. Iverson. There is nothing more transformative than 
this. If we don't take graduate students, we don't have those 
opportunities for undergraduates. I wasn't kidding, we put 
1,000 undergraduates in research opportunities at our 
university. We don't attempt to make 1,000 new scientists out 
of them. Whatever they end up doing, if they go to medical 
school, if they go to law school, if they do anything, they 
will finally understand what we have difficulty conveying in 
the classroom or in the media, and that is: what research is 
all about--the excitement, the difficulties, the real 
ramifications of cutting-edge research. I think that when you 
discuss what happens with grant funding pay lines, you have to 
realize that there's a very simple equation that says: fewer 
research opportunities for investigators translates directly 
into fewer research opportunities for undergraduates, as well 
as graduate students.
    Dr. Siliciano. I think there's another dimension to that, 
and that is that the undergraduates are very perceptive, and 
they see the environment, and they see that no matter how 
exciting the science is and how much fun the research is, if 
the principal investigator spends all of their time applying 
for grants and worrying about funding, that it's not an 
appealing sort of career choice. That's my major worry.
    Senator Harkin. Didn't you have something in your statement 
about how much time it took--or may time--how long it takes 
to--for these application processes?
    Dr. Siliciano. Yeah, I mean, traditionally it took me 30 
percent, and now it's 60 percent.
    Senator Harkin. Yeah. That's a lot of time to take out just 
for filling out paperwork and stuff.
    Dr. Siliciano. Yeah, that's right. There's a lot less time 
to interact with undergraduate students, too----
    Senator Harkin. That's right.
    Dr. Siliciano [continuing]. Which is true--it is very true 
in my case.
    Senator Harkin. Any last things before I call a halt to 
this panel? Anything else that you want to bring up? Senator 
Specter just got the floor, I'm told, so he won't be coming 
back.
    Dr. Iverson. Very briefly. I would like to make one 
comment, and that is----
    Senator Harkin. Yes, sir.
    Dr. Iverson [continuing]. We talk about the increased grant 
pressure almost as a burden, and, in fact, I see it as the 
opposite, it's the success of the doubling that allowed us to 
create so many good ideas, collectively, as a scientific 
community that they just demand to be funded. That's what's 
pushing out the new ideas.
    Senator Harkin. That's good.
    Dr. Iverson. This is not a negative thing, it's a very 
positive thing for American science, and we just need to keep 
up the momentum that we've established now, as well as look 
toward the future with new ideas that are, right now, being 
pushed out.
    Senator Harkin. That was good. I like that a lot.
    Well, listen, we'll close this panel down.
    But now we're going to be having a press conference, with 
some of you, to release this study that was done, ``In Our 
Grasp--Or Slipping Away?'' So, we're going to have a press 
conference here. We'll close this down, and we're going to move 
to a press conference within just a couple of minutes.

                     ADDITIONAL COMMITTEE QUESTIONS

    There will be some additional questions which will be 
submitted for your response in the record.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

               Questions Submitted by Senator Tom Harkin

                               VULVODYNIA

    Question. In fiscal year 2006, the Committee called upon the Office 
of Research on Women's Health to implement a national education program 
for primary care health professionals, patients and the general public 
on vulvodynia's symptoms, diagnosis and treatment options. I commend 
ORWH, under the leadership of Dr. Vivian Pinn, for its work so far to 
develop the campaign. Please provide an update on its current status, 
including a brief summary of its components, expected launch date and 
the resources that have been and will be allocated for this effort. 
Information on the resources should include the amount of funds that 
will be used to publicize the campaign and disseminate materials to the 
lay and professional communities. OD/ORWH
    Answer. The Office of Research on Women's Health (ORWH), National 
Institutes of Health (NIH), Department of Health and Human Services 
(HHS), is developing a national education program for primary care 
health professionals, patients and the general public on vulvodynia's 
symptoms, diagnosis and treatment options. The first step was to 
initiate collaborations with relevant HHS/NIH Institutes and Centers 
(ICs) and key consumer and health care professional organizations 
through several planning meetings convened by the ORWH. Participants in 
on-going discussions include representatives from the National 
Institute of Child Health and Human Development (NICHD) and the 
National Institute of Neurological Disorders and Stroke (NINDS) as well 
as other stakeholders such as the National Vulvodynia Association 
(NVA), the National Women's Health Resource Center (NWHRC), the 
American College of Obstetricians and Gynecologists (ACOG) and 
interested researchers. Other Offices of Women's Health across HHS will 
be invited to become partners in this effort as plans for distribution 
of materials and additional educational efforts are developed.
    A tentative launch date of this educational campaign is planned for 
October 2007. An initial list of documents under development includes a 
new ORWH Vulvodynia Fact Sheet with Questions and Answers (Q&As); a 
vulvodynia resource guide with relevant web site information, such as 
the ORWH web site for vulvodynia at http://orwh.od.nih.gov/health/
vulvodynia.html; reprints of current scientific journal articles on 
vulvodynia, such as Vulvodynia--A State-of-the-Art Consensus on 
Definitions, Diagnosis and Management; and the ACOG Vulvodynia 
Guidelines--A Literature Review. Plans are underway to develop 
additional public outreach materials.
    Parallel with the print material campaign will be the expansion and 
enhancement of the current ORWH vulvodynia web page. NICHD, the 
Institute that provides the majority of NIH funding for vulvodynia 
research, will contribute to the development and implementation of this 
educational effort especially through contributions of the NICHD 
Information Resource Center (IRC), where the materials developed will 
be stored and distributed for target audiences. Additionally, NICHD has 
offered the services of the IRC Information Specialists to answer 
questions in English and Spanish related to vulvodynia both online and 
through a 1-800 telephone line. NICHD also plans to track the labor, 
material, and postage for NIH vulvodynia material so that these costs 
can be documented.
    Focus group testing will occur prior to the launch of the education 
campaign, including creating questions related to the materials for 
focus group testing, locating participants, preparing the group 
logistics, conducting small focus groups, and reviewing and sharing the 
results with the group collaborating in this effort.
    Concurrent with the launch of this educational campaign, ORWH will 
dedicate its monthly podcast, Pinn Point on Women's Health Research, to 
vulvodynia, including an announcement of available materials. The 
podcast will also include interviews and Q&As with vulvodynia research 
experts and appropriate web site references for further information. 
The podcast will be the first step in disseminating the educational 
campaign. Additional plans and activities are under development. ORWH 
and its partners will also send html e-mail announcements to targeted 
organizations announcing the start of the campaign to various 
listserves and other internet outlets, as well as to women's magazine 
editors and other similar consumer oriented media outlets. Radio spots, 
produced by the NIH and widely distributed across the nation's 
airwaves, will also be used to focus on vulvodynia.
    ORWH is developing these materials, resources, and educational 
plans utilizing both budgetary expenditures and in-kind contributions. 
For example, the contributions of the NICHD IRC will be in-kind but 
would ordinarily represent a significant budgetary expenditure for this 
project. In addition, ORWH staff time spent in development of the plan, 
materials and implementation of the project are not included in cost 
estimates.
    Note: This estimate does not include dedicated ORWH staff time, 
NICHD staff time, or other in-kind contributions.

------------------------------------------------------------------------
                                                              Amount
------------------------------------------------------------------------
ORWH Preliminary cost estimate:
    Vulvodynia Information Packet and Materials                   $6,000
     Development........................................
    Reproduction of the vulvodynia information packet            115,000
     and materials (5000 copies)........................
    Development of additional consumer information                30,000
     materials..........................................
    Medical journal reprints............................          25,000
    Logistical support for focus groups and direct                10,000
     distribution of materials..........................
                                                         ---------------
      Total Estimated Cost..............................         186,000
------------------------------------------------------------------------

                          BEHAVIORAL RESEARCH

    Question. Behavior and the environment cause more than 70 percent 
of avoidable deaths, suggesting that many instances of disease can be 
prevented. Furthermore, a recent IOM report called for the conduct of 
transdisciplinary research on the interactions across the genetic, 
behavioral, and social environments. While NIH has made great advances 
in understanding the genomic side of health, are there plans now to 
enhance research on the impact of the behavioral, social, and physical 
environment on health?
    Answer. Building on over 50 years of behavioral and social science 
findings, together with recent advances in understanding genetics, NIH 
is poised to more fully examine the complex interactions between 
genetic mechanisms and environmental factors that lead to disease and 
disability. As noted, the recent Institute of Medicine Report, Genes, 
Behavior, and the Social Environment: Moving Beyond the Nature/Nurture 
Debate, recommends a number of ways to foster the necessary 
transdisciplinary research teams to accomplish this. The NIH's Office 
of Behavioral and Social Sciences Research (OBSSR), located in the 
Office of the Director, is leading the implementation of the 
recommendations produced by this report. Working with several NIH 
Institutes and Centers (ICs), OBSSR is currently developing an 
initiative to supplement ongoing research to allow for the addition of 
social environmental information to genetic studies and/or the addition 
of genomic information to behavioral and social science research 
projects. OBSSR has set aside $3 million in fiscal year 2008 for the 
funding of this initiative and is requesting funding contributions from 
the participating ICs.
    OBSSR also is planning an annual genomics training institute for 
behavioral and social scientists. This course will cover basic concepts 
and methods of genomics research to better enable these investigators 
to integrate behavioral, social, and physical environmental factors 
into genomics research and thereby work more effectively with their 
genomics and biomedical colleagues.
    In February 2006, Secretary Mike Leavitt announced the trans-NIH 
Genes, Environment and Health Initiative (GEI), designed to combine 
genetic analysis and environmental technology development to better 
understand the causes of common diseases. As a first step toward 
implementing large scale gene and environment interaction studies, a 
need was identified to invest in the development and improvement of 
tools to assess individual exposures to environmental factors and to 
identify biomarkers which characterize the response of these exposures 
on key biological pathways. OBSSR and other IC staff have been leading 
the effort to include social and behavioral research in this effort, 
resulting in research funding announcements calling for the development 
of measures of diet and physical activity (RFA-CA-07-032) and 
psychosocial stress and addictive substances (RFA-DA-07-005).
    These activities are examples of recent efforts to stimulate 
research at the interface of genetics and the behavioral/social 
sciences that will ultimately allow us to examine how interactions 
between our genes and our environments, broadly defined to include the 
physical, chemical, behavioral and social environments, influence 
health. Nearly all ICs support investigator-initiated behavioral and 
social science research; they also issue funding opportunity 
announcements to solicit research applications on particular topics, 
often in partnership with each other and with OBSSR. Total NIH funding 
for behavioral and social science research is estimated at 
approximately $3 billion annually since fiscal year 2004, roughly 10 
percent of the entire NIH budget.

                         TRANSLATIONAL RESEARCH

    Question. It takes years for research discoveries to reach the 
population at large, suggesting a significant gap in translational 
research. Translation of research takes place across two phases: from 
bench to bedside and from bedside to the population at large. What 
percentage of the NIH budget supports translational research overall, 
and how much is spent on each of the two phases?
    Answer. Presently, NIH does not collect funding levels for 
translational research. However, we do report funding levels for 
clinical research, and for the current year (fiscal year 2007) and the 
budget year (fiscal year 2008), we estimate $8.8 billion will be spent 
on this research category.
                                 ______
                                 
              Questions Submitted by Senator Arlen Specter

                        REVISED MECHANISM TABLE

    Question. The fiscal year 2007 enacted level provided NIH with 
increased funding that was not envisioned in the fiscal year 2008 
Budget submission. It also requires NIH to submit a revised fiscal year 
2007 operating plan. We realize increase funding in one year can impact 
the following year's distribution of competing grants and mechanisms. 
Therefore, please submit for the record a revised mechanism table that 
shows the impact of the fiscal year 2007 enacted level on the fiscal 
year 2008 President's Budget request. Also, please revise and submit 
any of the data in the ``Tabular Data'' section of NIH's Volume I 
Overview section of the CJ that changes to reflect the adjustments to 
fiscal year 2007 enacted level and its impact on the fiscal year 2008 
Budget Request.
    Answer. The requested revised ``Tabular Data'' section follows, 
which includes the NIH total mechanism display.

                                                       FISCAL YEAR 2006 APPROPRIATION ADJUSTMENTS
                                                                [In thousands of dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                           Cong. action                                              Real transfers
                                    --------------------------             -----------------------------------------------------------------
                                            Fiscal year          Subtotal                                                                     Subtotal,
                 IC                 --------------------------    cong.                                                          Director's     Pres.
                                                    2006  1       action    Global AIDS      HHS       Adv. dev.      NIH RM     1 percent      budget
                                         2006       percent                   transfer     transfer     transfer     transfer     transfer     appendix
                                      conference   rescission
--------------------------------------------------------------------------------------------------------------------------------------------------------
NCI................................    4,841,774      -48,418    4,793,356  ...........       -3,293  ...........      -42,834  ...........    4,747,229
NHLBI..............................    2,951,270      -29,513    2,921,757  ...........       -2,007  ...........      -26,109  ...........    2,893,641
NIDCR..............................      393,269       -3,933      389,336  ...........         -267  ...........       -3,479  ...........      385,590
NIDDK..............................    1,722,146      -17,221    1,704,925  ...........       -1,172  ...........      -15,236  ...........    1,688,517
NINDS..............................    1,550,260      -15,503    1,534,757  ...........       -1,054  ...........      -13,715  ...........    1,519,988
NIAID..............................    4,459,395      -44,594    4,414,801      -99,000       -3,033      -49,500      -38,567  ...........    4,224,701
NIGMS..............................    1,955,170      -19,552    1,935,618  ...........       -1,330  ...........      -17,297  ...........    1,916,991
NICHD..............................    1,277,544      -12,775    1,264,769  ...........         -869  ...........      -11,302  ...........    1,252,598
NEI................................      673,491       -6,735      666,756  ...........         -458  ...........       -5,958  ...........      660,340
NIEHS..............................      647,608       -6,476      641,132  ...........         -440  ...........       -5,729       -4,480      630,483
NIA................................    1,057,203      -10,572    1,046,631  ...........         -719  ...........       -9,353  ...........    1,036,559
NIAMS..............................      513,063       -5,131      507,932  ...........         -349  ...........       -4,539  ...........      503,044
NIDCD..............................      397,432       -3,974      393,458  ...........         -270  ...........       -3,516  ...........      389,672
NIMH...............................    1,417,692      -14,177    1,403,515  ...........         -964  ...........      -12,542  ...........    1,390,009
NIDA...............................    1,010,130      -10,101    1,000,029  ...........         -687  ...........       -8,937  ...........      990,405
NIAAA..............................      440,333       -4,403      435,930  ...........         -300  ...........       -3,896  ...........      431,734
NINR...............................      138,729       -1,387      137,342  ...........          -94  ...........       -1,227  ...........      136,021
NHGRI..............................      490,959       -4,910      486,049  ...........         -334  ...........       -4,343  ...........      481,372
NIBIB..............................      299,808       -2,998      296,810  ...........         -204  ...........       -2,652  ...........      293,954
NCRR...............................    1,110,203      -11,102    1,099,101  ...........         -755  ...........       -9,822  ...........    1,088,524
NCCAM..............................      122,692       -1,227      121,465  ...........          -83  ...........       -1,086  ...........      120,296
NCMHD..............................      197,379       -1,974      195,405  ...........         -134  ...........       -1,746  ...........      193,525
FIC................................       67,048         -670       66,378  ...........          -46  ...........         -593  ...........       65,739
NLM................................      318,091       -3,181      314,910  ...........         -216  ...........       -2,814  ...........      311,880
OD.................................      482,895       -4,829      478,066  ...........         -328  ...........      247,292  ...........      725,030
B&F................................       81,900         -819       81,081  ...........          -56  ...........  ...........        4,480       85,505
                                    --------------------------------------------------------------------------------------------------------------------
Total NIH..........................   28,617,484     -286,175   28,331,309      -99,000      -19,462      -49,500  ...........  ...........   28,163,347
Superfund..........................       80,289       -1,181       79,108  ...........  ...........  ...........  ...........  ...........       79,108
                                    --------------------------------------------------------------------------------------------------------------------
      Ttl,w/Supfnd.................   28,697,773     -287,356   28,410,417      -99,000      -19,462      -49,500  ...........  ...........   28,242,455
--------------------------------------------------------------------------------------------------------------------------------------------------------


------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                      HHS comp. transfers       NIH comp. transfers                                     Prog. level
                                                  ----------------------------------------------------    Other       Subtotal  --------------------------   Subtotal    Other NIH     Subtotal
                        IC                         PHSSEF pan.   Other HHS     Roadmap     Other NIH   global AIDS   HHS budg.      Type 1      NLM PHS     HHS table      oblig.       NIH CJ
                                                       flu       transfers    comparable   transfers                   auth.       diabetes      eval.     prog. level    adjust.       table
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NCI..............................................  ...........          -14       42,834       -1,872  ...........    4,788,177  ...........  ...........    4,788,177        6,896    4,795,073
NHLBI............................................  ...........           -3       26,109       -3,824  ...........    2,915,923  ...........  ...........    2,915,923  ...........    2,915,923
NIDCR............................................  ...........           -1        3,479         -404  ...........      388,664  ...........  ...........      388,664  ...........      388,664
NIDDK............................................  ...........           -3       15,236         -601  ...........    1,703,149      150,000  ...........    1,853,149  ...........    1,853,149
NINDS............................................  ...........           -3       13,715         -655  ...........    1,533,045  ...........  ...........    1,533,045  ...........    1,533,045
NIAID............................................       18,000           -9       38,567       -1,060       99,000    4,379,199  ...........  ...........    4,379,199  ...........    4,379,199
NIGMS............................................  ...........           -1       17,297         -244  ...........    1,934,043  ...........  ...........    1,934,043  ...........    1,934,043
NICHD............................................  ...........           -4       11,302         -375  ...........    1,263,521  ...........  ...........    1,263,521  ...........    1,263,521
NEI..............................................  ...........           -1        5,958         -529  ...........      665,768  ...........  ...........      665,768  ...........      665,768
NIEHS............................................  ...........           -4        5,729         -213  ...........      635,995  ...........  ...........      635,995  ...........      635,995
NIA..............................................  ...........           -3        9,353         -708  ...........    1,045,201  ...........  ...........    1,045,201  ...........    1,045,201
NIAMS............................................  ...........           -1        4,539         -166  ...........      507,416  ...........  ...........      507,416  ...........      507,416
NIDCD............................................  ...........           -1        3,516          -76  ...........      393,111  ...........  ...........      393,111  ...........      393,111
NIMH.............................................  ...........           -3       12,542         -735  ...........    1,401,813  ...........  ...........    1,401,813  ...........    1,401,813
NIDA.............................................  ...........           -2        8,937         -482  ...........      998,858  ...........  ...........      998,858  ...........      998,858
NIAAA............................................  ...........           -1        3,896         -150  ...........      435,479  ...........  ...........      435,479  ...........      435,479
NINR.............................................  ...........  ...........        1,227          -98  ...........      137,150  ...........  ...........      137,150  ...........      137,150
NHGRI............................................  ...........           -2        4,343          -58  ...........      485,655  ...........  ...........      485,655  ...........      485,655
NIBIB............................................  ...........  ...........        2,652        1,482  ...........      298,088  ...........  ...........      298,088  ...........      298,088
NCRR.............................................  ...........  ...........        9,822       10,601  ...........    1,108,947  ...........  ...........    1,108,947  ...........    1,108,947
NCCAM............................................  ...........  ...........        1,086         -248  ...........      121,134  ...........  ...........      121,134  ...........      121,134
NCMHD............................................  ...........  ...........        1,746           -8  ...........      195,263  ...........  ...........      195,263  ...........      195,263
FIC..............................................  ...........  ...........          593          -15  ...........       66,317  ...........  ...........       66,317  ...........       66,317
NLM..............................................  ...........         -484        2,814         -133  ...........      314,077  ...........        8,200      322,277            1      322,278
OD...............................................  ...........           -2     -247,292          571  ...........      478,307  ...........  ...........      478,307  ...........      478,307
B&F..............................................  ...........  ...........  ...........  ...........  ...........       85,505  ...........  ...........       85,505  ...........       85,505
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
Total NIH........................................       18,000         -542  ...........  ...........       99,000   28,279,805      150,000        8,200   28,438,005        6,897   28,444,902
Superfund........................................  ...........  ...........  ...........  ...........  ...........       79,108  ...........  ...........       79,108  ...........       79,108
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
      Ttl,w/Supfnd...............................       18,000         -542  ...........  ...........       99,000   28,358,913      150,000        8,200   28,517,113        6,897   28,524,010
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


                                                  FISCAL YEAR 2007 ADJUSTMENTS--JOINT RESOLUTION LEVEL
                                                                [In thousands of dollars]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Comp.      Subtotal,                                                 Prog. level
                                        Joint        trnsf.       Pres.      Other HHS    NIH comp.    Subtotal,  --------------------------  Subtotal,
                 IC                   resolution    advanced      budget     transfers    transfers    HHS budg.      Type I      NLM PHS     HHS prog.
                                                      dev.       appendix                                auth.       diabetes      Eval.        level
--------------------------------------------------------------------------------------------------------------------------------------------------------
NCI................................   $4,797,639  ...........   $4,797,639         -$14      -$2,134   $4,795,491  ...........  ...........   $4,795,491
NHLBI..............................    2,922,929  ...........    2,922,929           -3       -2,946    2,919,980  ...........  ...........    2,919,980
NIDCR..............................      389,703  ...........      389,703           -1         -332      389,370  ...........  ...........      389,370
NIDDK..............................    1,705,868  ...........    1,705,868           -3         -639    1,705,226     $150,000  ...........    1,855,226
NINDS..............................    1,535,545  ...........    1,535,545           -3         -638    1,534,904  ...........  ...........    1,534,904
NIAID..............................    4,417,208     -$49,500    4,367,708           -9       -1,254    4,366,445  ...........  ...........    4,366,445
NIGMS..............................    1,935,808  ...........    1,935,808           -1         -182    1,935,625  ...........  ...........    1,935,625
NICHD..............................    1,254,707  ...........    1,254,707           -4         -559    1,254,144  ...........  ...........    1,254,144
NEI................................      667,116  ...........      667,116           -1         -440      666,675  ...........  ...........      666,675
NIEHS..............................      642,002  ...........      642,002           -4         -225      641,773  ...........  ...........      641,773
NIA................................    1,047,260  ...........    1,047,260           -3         -757    1,046,500  ...........  ...........    1,046,500
NIAMS..............................      508,240  ...........      508,240           -1         -179      508,060  ...........  ...........      508,060
NIDCD..............................      393,668  ...........      393,668           -1         -127      393,540  ...........  ...........      393,540
NIMH...............................    1,404,494  ...........    1,404,494           -3         -921    1,403,570  ...........  ...........    1,403,570
NIDA...............................    1,000,621  ...........    1,000,621           -2         -605    1,000,014  ...........  ...........    1,000,014
NIAAA..............................      436,259  ...........      436,259           -1         -201      436,057  ...........  ...........      436,057
NINR...............................      137,404  ...........      137,404  ...........         -117      137,287  ...........  ...........      137,287
NHGRI..............................      486,491  ...........      486,491           -2          -62      486,427  ...........  ...........      486,427
NIBIB..............................      296,887  ...........      296,887  ...........        1,504      298,391  ...........  ...........      298,391
NCRR...............................    1,133,240  ...........    1,133,240  ...........       10,601    1,143,841  ...........  ...........    1,143,841
NCCAM..............................      121,576  ...........      121,576  ...........         -197      121,379  ...........  ...........      121,379
NCMHD..............................      199,444  ...........      199,444  ...........          -15      199,429  ...........  ...........      199,429
FIC................................       66,446  ...........       66,446  ...........          -24       66,422  ...........  ...........       66,422
NLM................................      320,850  ...........      320,850         -484         -137      320,229  ...........       $8,200      328,429
OD.................................    1,096,401  ...........    1,096,401           -2          586    1,096,985  ...........  ...........    1,096,985
B&F................................       81,081  ...........       81,081  ...........  ...........       81,081  ...........  ...........       81,081
                                    --------------------------------------------------------------------------------------------------------------------
      Total NIH....................   28,998,887      -49,500   28,949,387         -542  ...........   28,948,845      150,000        8,200   29,107,045
Superfund..........................       79,117  ...........       79,117  ...........  ...........       79,117  ...........  ...........       79,117
                                    --------------------------------------------------------------------------------------------------------------------
      Total, w/Supfnd..............   29,078,004      -49,500   29,028,504         -542  ...........   29,027,962      150,000        8,200   29,186,162
--------------------------------------------------------------------------------------------------------------------------------------------------------


                                                       FISCAL YEAR 2008 PRESIDET'S BUDGET REQUEST
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Fiscal year
                                                          ----------------------------------------------------------------------------------------------
                      Appropriation                         2006  actual \1\   2007 Presidet's       2007 joint                          2008 Est. +/-
                                                            \2\ \3\ \4\ \5\     budget \1\ \3\     resolution \1\    2008  Presidet's      2007 joint
                                                                  \6\            \4\ \5\ \6\      \3\ \4\ \5\ \6\       budget \1\         resolution
--------------------------------------------------------------------------------------------------------------------------------------------------------
NCI......................................................     $4,795,073,000     $4,751,461,000     $4,795,491,000     $4,782,114,000       -$13,377,000
NHLBI....................................................      2,915,923,000      2,898,063,000      2,919,980,000      2,925,413,000         +5,433,000
NIDCR....................................................        388,664,000        385,762,000        389,370,000        389,722,000           +352,000
NIDDK \7\................................................      1,853,149,000      1,843,656,000      1,855,226,000      1,858,045,000         +2,819,000
NINDS....................................................      1,533,045,000      1,524,109,000      1,534,904,000      1,537,019,000         +2,115,000
NIAID....................................................            \8\ \9\      4,394,233,000  \9\ 4,366,445,000      4,592,482,000       +226,037,000
                                                               4,379,199,000
NIGMS....................................................      1,934,043,000      1,923,298,000      1,935,625,000      1,941,462,000         +5,837,000
NICHD....................................................      1,263,521,000      1,256,855,000      1,254,144,000      1,264,946,000        +10,802,000
NEI......................................................        665,768,000        660,917,000        666,675,000        667,820,000         +1,145,000
NIEHS....................................................   \10\ 635,995,000        637,094,000        641,773,000        637,406,000         -4,367,000
NIA......................................................      1,045,201,000      1,039,068,000      1,046,500,000      1,047,148,000           +648,000
NIAMS....................................................        507,416,000        504,353,000        508,060,000        508,082,000            +22,000
NIDCD....................................................        393,111,000        391,428,000        393,540,000        393,682,000           +142,000
NIMH.....................................................      1,401,813,000      1,393,882,000      1,403,570,000      1,405,421,000         +1,851,000
NIDA.....................................................        998,858,000        994,222,000      1,000,014,000      1,000,365,000           +351,000
NIAAA....................................................        435,479,000        433,116,000        436,057,000        436,505,000           +448,000
NINR.....................................................        137,150,000        136,433,000        137,287,000        137,800,000           +513,000
NHGRI....................................................        485,655,000        482,878,000        486,427,000        484,436,000         -1,991,000
NIBIB....................................................        298,088,000        296,354,000        298,391,000        300,463,000         +2,072,000
NCRR.....................................................      1,108,947,000      1,108,843,000      1,143,841,000      1,112,498,000        -31,343,000
NCCAM....................................................        121,134,000        120,357,000        121,379,000        121,699,000           +320,000
NCMHD....................................................        195,263,000        194,284,000        199,429,000        194,495,000         -4,934,000
FIC......................................................         66,317,000         66,657,000         66,422,000         66,594,000           +172,000
NLM \12\.................................................        314,078,000        312,648,000        320,229,000        312,562,000         -7,667,000
OD \13\..................................................        478,307,000   \11\ 508,909,000      1,096,985,000        517,062,000       -579,923,000
B&F......................................................    \10\ 85,505,000         81,081,000         81,081,000        136,000,000        +54,919,000
Type 1 Diabetes..........................................       -150,000,000       -150,000,000       -150,000,000       -150,000,000  .................
                                                          ----------------------------------------------------------------------------------------------
      Subtotal, Labor/HHS................................     28,286,702,000     28,189,961,000     28,948,845,000     28,621,241,000       -327,604,000
Interior/Superfund Research Program......................         79,108,000         78,414,000         79,117,000         78,434,000           -683,000
                                                          ----------------------------------------------------------------------------------------------
      Total, NIH Discretioary B.A........................     28,365,810,000     28,268,375,000     29,027,962,000     28,699,675,000       -328,287,000
Type 1 Diabetes \7\......................................        150,000,000        150,000,000        150,000,000        150,000,000  .................
                                                          ----------------------------------------------------------------------------------------------
      Total, NIH Budget Authority........................     28,515,810,000     28,418,375,000     29,177,962,000     28,849,675,000       -328,287,000
NLM Program Evaluation...................................          8,200,000          8,200,000          8,200,000          8,200,000  .................
                                                          ----------------------------------------------------------------------------------------------
      Total, Prog. Level.................................     28,524,010,000     28,426,575,000     29,186,162,000     28,857,875,000       -328,287,000
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Includes funds to be transferred to the Global Fund for HIV/AIDS, Malaria, and Tuberculosis (fiscal year 2006--$99,000,000; fiscal year 2007 PB--
  $100,000,000; fiscal year 2007 Annualized--$99,000,000; fiscal year 2008-- $300,000,000).
\2\ Includes Government-wide 1 percent rescission and HHS 1 percent transfer.
\3\ Comparable for ASAM and ASPA transfer--$62,000.
\4\ Comparable for DBEPS program transfer to NIBIB (fiscal year 2006--$1,496,000; fiscal year 2007--$1,528,000).
\5\ Comparable for CIO transfer to OD (fiscal year 2006--$641,000; fiscal year 2007--$669,000).
\6\ Comparable for K-30 transfer to NCRR ($10,613,000).
\7\ Includes funds for the Type 1 Diabetes Initiative.
\8\ NIAID includes $18,000,000 for Pandemic Influenza from PHSSEF.
\9\ Comparable for transfer of Advance Development Fund to ASPR (-$49,500,000).
\10\ Directors 1 percent transfer NIEHS to B&F ($4,480,000).
\11\ OD comparable (-$159,500,000) to ASPR for Advance Development Fund.
\12\ Comparable for transfer to DHHS for PHS Historian ($480,000).
\13\ Total OD includes Roadmap funds for fiscal year 2006 of $82,170,000; fiscal year 2007 PB of $110,700,000; fiscal year 2007 Annualized Current Rate
  of $82,170; fiscal year 2008 of $121,540,000.


                                                                                     BUDGET MECHANISM--TOTAL
                                                                                     [Dollars in thousands]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                            Fiscal year                                                              Change
                                        ----------------------------------------------------------------------------------------------------------------------------------------------  Percent
               MECHANISM                       2006 actual \1\        2007 revised Pres. budget     2007 joint resolution            2008 estimate                                       change
                                        ------------------------------------------------------------------------------------------------------------------     No          Amount        amount
                                             No          Amount          No          Amount          No          Amount           No          Amount
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
            Research Grants
 
Research Projects:
    Noncompeting.......................    27,366      $11,070,308     26,669      $11,063,137     26,668       $10,896,993     26,573       $10,975,609        -95          $78,616       0.7
    Administrative supplements.........    (1,678)         284,083     (1,254)         145,687     (1,463)          177,707     (1,543)          204,463        (80)          26,756      15.1
    Competing..........................     9,129        3,361,827      9,290        3,384,714     10,154         3,731,558      9,404         3,293,817       (750)        -437,741     -11.7
                                        --------------------------------------------------------------------------------------------------------------------------------------------------------
      Subtotal, RPGs...................    36,495       14,716,218     35,959       14,593,538     36,822        14,806,258     35,977        14,473,889       -845         -332,369       2.2
SBIR/STTR..............................     1,822          616,779      1,829          605,284      1,807           610,998      1,793           606,930        -14           -4,068      -0.7
                                        --------------------------------------------------------------------------------------------------------------------------------------------------------
      Subtotal, RPGs...................    38,317       15,332,997     37,788       15,198,822     38,629        15,417,256     37,770        15,080,819       -859         -336,437       2.2
                                        ========================================================================================================================================================
Research Centers:
    Specialized/comprehensive..........     1,190        2,144,310      1,104        2,147,862      1,114         2,196,970      1,108         2,198,277         -6            1,307       0.1
    Clinical research..................        93          348,476        295          375,986         95           386,898         89           419,123         -6           32,225       8.3
    Biotechnology......................       103          134,862        113          133,797        113           134,345        111           130,550         -2           -3,795      -2.8
      Comparative medicine.............        51          123,032         49          122,294         49           123,019         47           117,735         -2           -5,284      -4.3
    Research Centers in Minority               28           54,213         28           53,289         28            53,819         27            51,727         -1           -2,092      -3.9
     Institutions......................
                                        --------------------------------------------------------------------------------------------------------------------------------------------------------
      Subtotal, Centers................     1,465        2,804,893      1,589        2,833,228      1,399         2,895,051      1,382         2,917,412        -17           22,361       0.8
                                        ========================================================================================================================================================
Other Research:
    Research careers...................     4,192          644,693      4,322          674,060      4,425           693,226      4,540           700,715        115            7,489       1.1
    Cancer education...................        99           34,561         99           34,406        102            35,406        103            35,806          1              400       1.1
    Cooperative clinical research......       353          344,503        351          344,249        368           353,445        364           354,580         -4            1,135       0.3
    Biomedical research support........       140           65,518        139           64,312        212            98,312        139            61,745        -73          -36,567     -37.25
    Minority biomedical research              155          115,032        151          114,470        149           113,810        158           112,630          9           -1,180      -1.0
     support...........................
    Other..............................     1,685          465,044      1,648          469,711      1,722           473,598      1,708           481,691        -14            8,093       1.7
                                        --------------------------------------------------------------------------------------------------------------------------------------------------------
      Subtotal, Other Research.........     6,624        1,669,351      6,710        1,701,208      6,978         1,767,797      7,012         1,747,167         34          -20,630      -1.2
                                        --------------------------------------------------------------------------------------------------------------------------------------------------------
      Total Research Grants............    46,406       19,807,241     46,087       19,733,258     47,006        20,080,104     46,164        19,745,398       -842         -334,706      -1.7
                                        ========================================================================================================================================================
Ruth L. Kirschstein Training Awards:
    Individual awards..................  \2\ 2,976         122,758   \2\ 2,995         124,192   \2\ 3,081          127,983   \2\ 3,078          127,728         -3             -255      -0.2
    Institutional awards...............  \2\ 14,34         625,883   \2\ 14,46         631,604   \2\ 14,66          643,617   \2\ 14,58          641,685        -80           -1,932      -0.3
                                                9                           1                           3                            3
                                        --------------------------------------------------------------------------------------------------------------------------------------------------------
      Total, Training..................  \2\ 17,32         748,641   \2\ 17,45         755,796   \2\ 17,74          771,600   \2\ 17,66          769,413        -83           -2,187      -0.3
                                                5                           6                           4                            1
                                        ========================================================================================================================================================
Research & development contracts.......     3,423        2,667,066      3,460        2,652,882      3,529         2,783,528      3,552         2,975,285         23          191,757       6.9
    (SBIR/STTR)........................       (92)         (23,809)       (98)         (24,504)      (110)          (30,027)      (110)          (29,996)  .........            (-31)     -0.1
Intramural research....................  .........       2,772,036   .........       2,751,751   .........        2,791,706   .........        2,774,311   .........         -17,395      -0.6
Research management and support........  .........       1,108,615   .........       1,122,498   .........        1,132,127   .........        1,142,492   .........          10,365       0.9
Cancer prevention & control............  .........         505,705   .........         502,700   .........          516,565   .........          516,565   .........  ...............  .........
Extramural Construction................  .........          29,700   .........          25,000   .........  ................  .........  ................  .........  ...............  .........
Library of Medicine....................  .........         311,264   .........         308,866   .........          320,229   .........          308,415   .........         -11,814      -3.7
    (Appropriation)....................  .........        (314,078)  .........        (312,648)  .........         (320,229)  .........         (312,562)  .........         (-7,667)     -2.4
Office of the Director.................  .........         393,009   .........         398,209   .........          613,985   .........          395,522   .........        -218,463     -35.6
    (Appropriation)....................  .........        (478,307)  .........        (508,909)  .........       (1,096,985)  .........         (517,062)  .........       (-579,923)    -52.9
Buildings and Facilities \3\...........  .........          93,425   .........          89,001   .........           89,001   .........          143,840   .........          54,839      61.6
    (Appropriation)....................  .........         (85,505)  .........         (81,081)  .........          (81,081)  .........         (136,000)  .........         (54,919)     67.7
NIH Roadmap for Medical Research \4\...  .........        (332,590)  .........        (442,673)  .........         (483,000)  .........         (486,153)  .........          (3,153)      0.7
Type 1 Diabetes \5\....................  .........        -150,000   .........        -150,000   .........         -150,000   .........         -150,000   .........  ...............  .........
                                        --------------------------------------------------------------------------------------------------------------------------------------------------------
      Subtotal, Labor/HHS Budget         .........      28,286,702   .........      28,189,961   .........       28,948,845   .........       28,621,241   .........        -327,604      -1.1
       Authority.......................
Interior Appropriation for Superfund     .........          79,108   .........          78,414   .........           79,117   .........           78,434   .........            -683      -0.9
 Res...................................
                                        --------------------------------------------------------------------------------------------------------------------------------------------------------
      Total, NIH Discretionary B.A.....  .........      28,365,810   .........      28,268,375   .........       29,027,962   .........       28,699,675   .........        -328,287      -1.1
Type 1 Diabetes \5\....................  .........         150,000   .........         150,000   .........          150,000   .........          150,000   .........  ...............  .........
                                        --------------------------------------------------------------------------------------------------------------------------------------------------------
      Total, NIH Budget Authority......  .........      28,515,810   .........      28,418,375   .........       29,177,962   .........       28,849,675   .........        -328,287      -1.1
NLM Program Evaluation.................  .........           8,200   .........           8,200   .........            8,200   .........            8,200   .........  ...............  .........
                                        --------------------------------------------------------------------------------------------------------------------------------------------------------
      Total, Program Level.............  .........      28,524,010   .........      28,426,575   .........       29,186,162   .........       28,857,875   .........        -328,287      -1.1
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Budget Authority 2006 total includes mechanism distribution of NCI breast cancer stamp funds of $6,896.
\2\ FTTPs.
\3\ Includes the B&F appropriation plus the following included in NCI--fiscal year 2006: $7,920; fiscal year 2007: $7,920; fiscal year 2008: $7,840.
\4\ Included in above mechanisms. Roadmap contributions from the NLM and OD are reflected in the mechanisms of award.
\5\ Included in NIDDK--fiscal year 2006: $150,000; fiscal year 2007: $150,000; fiscal year 2008: $150,000.
Numbers of grants identified in fiscal year 2007 and fiscal year 2008 are estimates, and WILL change as applications are received and selected for funding.
Fiscal year 2006 and fiscal year 2007 have been adjusted to display comparably proposed program changes in fiscal year 2008. The fiscal year 2008 President's Budget Appendix reflects an actual
  fiscal year 2006 budget authority total of $28,242 million, a difference of $282 million from the fiscal year 2006 program level reported above. fiscal year 2006 adjustments to the Budget
  Appendix include the addition of Special Statutory Type I Diabetes Funds +$150M); a transfer from the PHSSEF for Pandemic Influenza activities (+$18M); a comparable adjustment for the Global
  Fund for HIV/AIDS actual transfer (+$99M); revenue from the Breast Cancer Stamp (+$7M);and use of the Secretary's evaluation funds transfer authority for NLM (+$8M). The fiscal year 2007
  budget authority in the fiscal year 2008 Budget Appendix is $28,450 million, a difference of $736 million from the fiscal year 2007 Joint Resolution program level reported above. In addition
  to increases provided by the fiscal year 2007 Joint Resolution, fiscal year 2007 program level adjustments include the addition of Special Statutory Type I Diabetes Funds (+$150M); and use
  of the Secretary's evaluation funds transfer authority for NLM (+$8M).


                  FISCAL YEAR 2008 SPECIAL INITIATIVES
                        [In thousands of dollars]
------------------------------------------------------------------------
                                            Pathway to
                                           independence        CTSA
------------------------------------------------------------------------
NCI.....................................           1,800  ..............
NHLBI...................................           1,980  ..............
NIDCR...................................             540  ..............
NIDDK...................................           1,080  ..............
NINDS...................................           1,170  ..............
NIAID...................................             540  ..............
NIGMS...................................           1,350  ..............
NICHD...................................             900  ..............
NEI.....................................             360  ..............
NIEHS...................................             900  ..............
NIA.....................................             630  ..............
NIAMS...................................             360  ..............
NIDCD...................................             360  ..............
NIMH....................................             900  ..............
NIDA....................................             540  ..............
NIAAA...................................             270  ..............
NINR....................................             180  ..............
NHGRI...................................             270  ..............
NIBIB...................................             450  ..............
NCRR....................................              90          10,000
NCCAM...................................             180  ..............
NCMHD...................................             270  ..............
FIC.....................................             180  ..............
NLM.....................................             450  ..............
                                         -------------------------------
      Total.............................          15,750          10,000
------------------------------------------------------------------------
CTSA = Clinical Translational Science Awards


                                                                  APPROPRIATION HISTORY
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                         Budget request to
                     Fiscal year                              Congress             House allowance          Senate allowance        Appropriation \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1999................................................      \2\ $14,763,313,000          $14,862,023,000          $15,622,386,000      \3\ $15,629,156,000
2000................................................       \4\ 15,932,786,000           16,964,547,000           17,613,470,000       \5\ 17,820,587,000
2001................................................       \6\ 18,812,735,000           20,512,735,000           20,512,735,000   \7\ \8\ 20,458,130,000
 2002...............................................           23,112,130,000           22,945,199,000           23,765,488,000            \9\ \10\ \11\
                                                                                                                                          23,296,382,000
 2003...............................................      \12\ 27,343,417,000           27,351,717,000           27,369,000,000      \13\ 27,066,782,000
 2004...............................................           27,892,765,000           28,043,991,000           28,369,548,000      \14\ 27,887,512,000
 2005...............................................           28,757,357,000           28,657,357,000           28,901,185,000      \15\ 28,495,157,000
 2006...............................................           28,740,073,000           28,737,094,000           29,644,804,000      \16\ 28,461,417,000
 2007...............................................           28,578,417,000      \17\ 28,479,417,000      \17\ 28,779,081,000      \18\ 29,228,004,000
 2008...............................................           28,849,675,000  .......................  .......................  .......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Reflects enacted supplementals, rescissions and reappropriations.
\2\ Reflects a decrease of $34,530,000 for the budget amendment for bioterrorism. Includes $1,728,099,000 for HIV research in the NIH Office of AIDS
  Research.
\3\ Includes $1,800,046,000 appropriated to the ICs for HIV research. Includes $10,230,000 for rescission.
\4\ Includes $1,833,826,000 for HIV research in the NIH Office of AIDS Research. Includes $40 million appropriated in fiscal year 1999 for the Clinical
  Research Center.
\5\ Includes $2,024,956,000 appropriated to the ICs for HIV research. Includes $99,883,000 for NIH share of across-the-board reduction and reflects
  $20,000,000 transferred to CDC. Includes $40,000,000 in forward funding appropriated in fiscal year 1999.
\6\ Includes $2,111,224,000 for HIV research in the NIH Office of AIDS Research.
\7\ Includes $2,244,987,000 appropriated to the ICs for HIV research. Reflects NIH share of across-the-board reduction ($8,666,000) and $5,800,000
  transferred to the DHHS.
\8\ In fiscal year 2001, NIH began receiving a separate appropriation for Superfund Research activities at NIEHS.
\9\ Includes $2,535,672,000 appropriated to the ICs for HIV research. Reflects NIH share of across-the-board reduction ($9,273,000), Labor/HHS
  ($22,946,000) and government-wide ($34,243,000) rescissions, and transfer of $100M to the Global Fund for HIV/AIDS, malaria, and tuberculosis.
\10\ Includes $10.5 million appropriated from the Emergency Relief Fund.
\11\ Beginning with the fiscal year 2002 Appropriation, includes amounts authorized to the NIDDK for Type 1 diabetes research.
\12\ Excludes $583,000 transferred to the Department of Homeland Security.
\13\ Includes $2,747,463,000 appropriated to the ICs for HIV research. Reflects NIH share of the across-the-board reduction ($177,085,000), and
  transfers of $99,350,000 to the Global Fund for HIV/AIDS, malaria, and tuberculosis, and $583,000 to the Department of Homeland Security.
\14\ Includes $2,850,581,000 appropriated to the ICs for HIV research. Reflects NIH share of across-the-board reduction ($165,459,000), Labor/HHS
  rescission ($17,492,000), and transfer of $149,115,000 to the Global Fund for HIV/AIDS, malaria, and tuberculosis.
\15\ Includes $2,920,551,000 appropriated to the ICs for HIV research. Reflects NIH share of across-the-board reduction ($229,390,000), Labor/HHS
  rescission ($6,787,000), and transfer of $99,200,000 to the Global Fund for HIV/AIDS, malaria, and tuberculosis.
\16\ Includes $2,903,664,000 appropriated to the ICs for HIV research. Reflects NIH share of the Government-wide rescission ($287,356,000), and transfer
  of $99,000,000 to the Global Fund for HIV/AIDS, malaria, and tuberculosis.
\17\ Reflects funding levels approved by the Appropriations Committees. Neither chamber had passed the Labor/HHS appropriations bill at the time this
  budget was prepared.
\18\ Joint Resolution.


                                                                                     HISTORY OF CONGRESSIONAL APPROPRIATIONS, FISCAL YEARS 1998-2007
                                                                                                        [In thousands of dollars]
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                           Fiscal year                                NCI        NHLBI       NIDCR       NIDDK       NINDS       NIAID       NIGMS       NICHD        NEI        NIEHS        NIA        NIAMS       NIDCD       NIMH
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1998............................................................   2,547,314   1,531,061     209,415     900,860     780,713   1,351,655   1,065,947     674,766     355,691     330,108     519,279     274,760     200,695     750,241
1999............................................................   2,925,247   1,792,509     234,183   1,020,559     902,680   1,569,063   1,197,026     750,485     395,595     375,494     596,126     307,960     229,735     860,638
2000............................................................   3,314,554   2,029,424     268,811   1,168,476   1,029,376   1,778,038   1,354,420     858,291     450,300     442,449     686,479     349,968     263,771     973,146
2001............................................................   3,754,456   2,298,512     306,211   1,399,684   1,175,854   2,041,698   1,535,378     975,766     510,352     564,810     785,590     396,460     300,418   1,106,305
2002............................................................   4,181,233   2,572,667     342,664   1,562,144   1,326,666   2,342,313   1,724,799   1,111,674     580,713     645,422     892,267     448,248     341,675   1,246,640
2003............................................................   4,592,348   2,793,733     371,636   1,722,730   1,456,476   3,606,789   1,847,000   1,205,927     633,148     697,767     993,598     486,143     370,382   1,341,014
2004............................................................   4,739,255   2,878,691     383,282   1,821,803   1,501,207   4,155,447   1,904,838   1,242,361     653,052     710,701   1,024,754     501,066     382,053   1,381,774
2005............................................................   4,825,258   2,941,201     391,829   1,863,584   1,539,448   4,303,641   1,944,067   1,270,321     669,070     724,347   1,051,990     511,157     394,260   1,411,933
2006............................................................   4,793,356   2,921,757     389,336   1,854,925   1,534,757   4,315,801   1,935,618   1,264,769     666,756     720,240   1,046,631     507,932     393,458   1,403,515
2007............................................................   4,797,639   2,922,929     389,703   1,855,868   1,535,545   4,417,208   1,935,808   1,254,707     667,116     721,119   1,047,260     508,240     393,668   1,404,494
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                          Fiscal year                              NIDA        NIAAA       NINR        NHGRI       NIBIB       NCRR        NCCAM       NCMHD        FIC         NLM         OD          B&F         OAR         TOTAL
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
1998..........................................................     527,175     227,175      63,597     217,704  ..........     453,883  ..........  ..........      28,289     161,185     296,373     206,957  ..........  \1\ 13,674,8
                                                                                                                                                                                                                                      43
1999..........................................................     602,874     259,575      69,788     264,707  ..........     554,446  ..........  ..........      35,402     181,189     306,356     197,519  ..........  \2\ 15,629,1
                                                                                                                                                                                                                                      56
2000..........................................................     685,781     292,369      89,522     335,527  ..........     676,557      68,390  ..........      43,494     214,068     282,000     165,376  ..........  \3\ 17,820,5
                                                                                                                                                                                                                                      87
2001..........................................................     780,833     340,453     104,328     382,112  ..........     817,253      89,138     130,096      50,482     246,351     211,800     153,790  ..........  \4\ 20,458,1
                                                                                                                                                                                                                                      30
2002..........................................................     886,718     383,615     120,366     428,758     111,861   1,011,262     104,451     157,563      56,859     276,091     235,113     204,600  ..........  \5\ 23,296,3
                                                                                                                                                                                                                                      82
2003..........................................................     961,721     416,051     130,584     464,995     278,279   1,138,821     113,407     185,714     163,465     300,135     266,232     628,687  ..........  \6\ 27,066,7
                                                                                                                                                                                                                                      82
2004..........................................................     990,953     428,669     134,724     479,073     287,129   1,179,058     116,978     191,471      65,382     317,315     327,504      88,972  ..........  \7\ 27,887,5
                                                                                                                                                                                                                                      12
2005..........................................................   1,006,419     438,277     138,072     488,608     298,209   1,115,090     122,105     196,159      66,632     315,146     358,046     110,288  ..........  \8\ 28,495,1
                                                                                                                                                                                                                                      57
2006..........................................................   1,000,029     435,930     137,342     486,049     296,810   1,099,101     121,465     195,405      66,378     314,910     478,066      81,081  ..........  \9\ 28,461,4
                                                                                                                                                                                                                                      17
2007..........................................................   1,000,621     436,259     137,404     486,491     296,887   1,133,240     121,576     199,444      66,446     320,850   1,096,401      81,081  ..........  \10\ 29,228,
                                                                                                                                                                                                                                     004
----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Funds for HIV research in the amount of $1,607,053,000 appropriated to the ICs. Beginning in fiscal year 1998, includes funds appropriated to NIDDK for Type 1 diabetes research.
\2\ Funds for HIV research in the amount of $1,800,046,000 appropriated to the ICs. Reflects rescission of $10,230,000.
\3\ Funds for HIV research in the amount of $2,024,956 appropriated to the ICs. Reflects NIH share of across-the-board reduction ($99,883,000) and transfer to CDC ($20,000,000). Includes $40,000,000 in forward funding appropriated
  in fiscal year 1999.
\4\ Funds for HIV research in the amount of $2,244,987,000 appropriated to the ICs. Reflects NIH share of across-the-board reduction ($8,666,000) and transfer to DHHS ($5,800,000). In fiscal year 2001, NIH began receiving a separate
  appropriation for Superfund Research activities at NIEHS.
\5\ Funds for HIV research in the amount of $2,535,672,000 appropriated to the ICs. Reflects NIH share of across-the-board reduction ($9,273,000), Labor/HHS ($22,946,000) and government-wide ($34,243,000) rescissions, and transfer
  of $100M to the Global Fund for HIV/AIDS, malaria, and tuberculosis.
\6\ Funds for HIV research in the amount of $2,747,463,000 appropriated to the ICs. Reflects NIH share of across-the-board reduction ($177,085,000), and transfers of $99,350,000 to the Global Fund for HIV/AIDS, malaria, and
  tuberculosis, and $583,000 to the Department of Homeland Security.
\7\ Funds for HIV research in the amount of $2,850,581,000 appropriated to the ICs. Reflects NIH share of across-the-board reduction ($165,459,000), Labor/HHS rescission ($17,492,000), and transfer of $149,115,000 to the Global Fund
  for HIV/AIDS, malaria, and tuberculosis.
\8\ Funds for HIV research in the amount of $2,920,551,000 appropriated to the ICs. Reflects NIH share of across-the-board reduction ($229,390,000), Labor/HHS rescission ($6,787,000), and transfer of $99,200,000 to the Global Fund
  for HIV/AIDS, malaria, and tuberculosis.
\9\ Funds for HIV research in the amount of $2,903,664,000 appropriated to the ICs. Reflects NIH share of the Government-wide rescission ($287,356,000), and transfer of $99,000,000 to the Global Fund for HIV/AIDS, malaria, and
  tuberculosis.
\10\ Joint Resolution.


                          FULL-TIME EQUIVALENTS
------------------------------------------------------------------------
                                                Fiscal year
                                  --------------------------------------
      Institutes and Centers                                     2008
                                   2006 actual   2007 Joint  President's
                                                 resolution     budget
------------------------------------------------------------------------
NCI..............................        2,777        2,835        2,875
NHLBI............................          797          806          817
NIDCR............................          245          252          256
NIDDK............................          638          646          655
NINDS............................          526          539          547
NIAID............................        1,589        1,617        1,639
NIGMS............................          125          126          129
NICHD............................          547          548          557
NEI..............................          207          213          215
NIEHS............................          664          668          677
NIA..............................          378          381          386
NIAMS............................          211          214          217
NIDCD............................          133          136          138
NIMH.............................          616          641          651
NIDA.............................          361          366          371
NIAAA............................          225          227          230
NINR.............................           43           44           45
NHGRI............................          292          301          305
NIBIB............................           48           50           51
NCRR.............................           99          108          109
NCCAM............................           74           76           77
NCMHD............................           25           29           31
FIC..............................           52           54           55
                                  --------------------------------------
      Subtotals, ICs.............       10,672       10,877       11,033
NLM..............................          656          662          671
OD...............................          578          630          638
Central Services.................        4,966        5,037        5,107
                                  --------------------------------------
      Subtotal, NIH..............       16,872       17,206       17,449
Undistributed....................  ...........  ...........  ...........
Ceiling exempt \1\...............            8           10           10
                                  --------------------------------------
      Total, NIH.................       16,880       17,216       17,459
 
------------------------------------------------------------------------
\1\ CRADA FTEs are supported by Cooperative Research and Development
  Agreements


                                         BUDGET AUTHORITY BY OBJECT \1\
----------------------------------------------------------------------------------------------------------------
                                                                     Fiscal year
                                                       --------------------------------------     Increase or
                           Object Classes                   2007 Joint                             decrease
                                                            Resolution       2008 estimate
----------------------------------------------------------------------------------------------------------------
      Personnel Compensation:
    11.1  Full-Time Permanent                              $838,033,000       $881,383,000        $43,350,000
    11.3  Other than Full-Time Permanent                    263,580,000        276,142,000         12,562,000
    11.5  Other Personnel Compensation                       29,783,000         31,112,000          1,329,000
    11.7  Military Personnel                                 26,032,000         27,721,000          1,689,000
    11.8  Special Personnel Services Payments               171,584,000        175,795,000          4,211,000
                                                     -----------------------------------------------------------
            Total, Personnel Compensation                 1,329,012,000      1,392,153,000         63,141,000
                                                     ===========================================================
    12.1  Civilian Personnel Benefits                       311,004,000        326,309,000         15,305,000
    12.2  Military Personnel Benefits                        17,255,000         18,026,000            771,000
    13.0  Benefits for Former Personnel               .................  .................  ..................
                                                     -----------------------------------------------------------
            Subtotal, Pay Costs                           1,657,271,000      1,736,488,000         79,217,000
                                                     ===========================================================
    21.0  Travel & Transportation of Persons                 55,429,000         52,639,000         (2,790,000)
    22.0  Transportation of Things                            5,174,000          4,938,000           (236,000)
    23.1  Rental Payments to GSA                                 64,000             61,000             (3,000)
    23.2  Rental Payments to Others                           1,380,000          1,373,000             (7,000)
    23.3  Communications, Utilities & Miscellaneous          29,949,000         29,770,000           (179,000)
           Charges
    24.0  Printing & Reproduction                            14,418,000         14,093,000           (325,000)
    25.1  Consulting Services                               120,471,000        117,621,000         (2,850,000)
    25.2  Other Services                                    515,643,000        485,772,000        (29,871,000)
    25.3  Purchase of Goods & Services from               2,526,800,000      2,508,161,000        (18,639,000)
           Government Accounts
    25.4  Operation & Maintenance of Facilities             297,892,000        263,545,000        (34,347,000)
    25.5  Research & Development Contracts                2,140,434,000      2,315,525,000        175,091,000
    25.6  Medical Care                                       16,482,000         16,110,000           (372,000)
    25.7  Operation & Maintenance of Equipment               76,450,000         72,506,000         (3,944,000)
    25.8  Subsistence & Support of Persons            .................  .................  ..................
                                                     -----------------------------------------------------------
    25.0    Subtotal, Other Contractual Services          5,694,172,000      5,779,240,000         85,068,000
                                                     ===========================================================
    26.0  Supplies & Materials                              216,416,000        201,809,000        (14,607,000)
    31.0  Equipment                                         126,456,000        119,236,000         (7,220,000)
    32.0  Land and Structures                         .................  .................  ..................
    33.0  Investments & Loans                         .................  .................  ..................
    41.0  Grants, Subsidies & Contributions              21,297,989,000     20,831,478,000       (466,511,000)
    42.0  Insurance Claims & Indemnities                         10,000             10,000  ..................
    43.0  Interest & Dividends                                  117,000            106,000            (11,000)
    44.0  Refunds                                     .................  .................  ..................
                                                     -----------------------------------------------------------
            Subtotal, Non-Pay Costs                      27,441,574,000     27,034,753,000       (406,821,000)
                                                     -----------------------------------------------------------
            Total Budget Authority by Object             29,098,845,000     28,771,241,000       (327,604,000)
 
----------------------------------------------------------------------------------------------------------------
      \1\ Reflects request to Labor/HHS/Education Subcommittee, and includes Type 1 Diabetes funds provided
        through Public Law 107-360.


              BUDGET AUTHORITY BY OBJECT INCLUDING SERVICE AND SUPPLY FUND AND MANAGEMENT FUND \1\
----------------------------------------------------------------------------------------------------------------
                                                                     Fiscal year
                                                       --------------------------------------     Increase or
                           Object Classes                   2007 Joint                             Decrease
                                                            Resolution       2008 Estimate
----------------------------------------------------------------------------------------------------------------
      Personnel Compensation:
    11.1  Full-Time Permanent                            $1,115,616,000     $1,168,343,000        $52,727,000
    11.3  Other than Full-Time Permanent                    339,113,000        353,676,000         14,563,000
    11.5  Other Personnel Compensation                       48,648,000         50,402,000          1,754,000
    11.7  Military Personnel                                 35,988,000         37,905,000          1,917,000
    11.8  Special Personnel Services Payments               175,535,000        179,832,000          4,297,000
                                                     -----------------------------------------------------------
      Total, Personnel Compensation                       1,714,900,000      1,790,158,000         75,258,000
    12.1  Civilian Personnel Benefits                       416,629,000        434,651,000         18,022,000
    12.2  Military Personnel Benefits                        21,800,000         22,647,000            847,000
    13.0  Benefits for Former Personnel                         661,000            672,000             11,000
                                                     -----------------------------------------------------------
            Subtotal, Pay Costs                           2,153,990,000      2,248,128,000         94,138,000
    21.0  Travel & Transportation of Persons                 58,562,000         56,236,000         (2,326,000)
    22.0  Transportation of Things                            6,602,000          6,369,000           (233,000)
    23.1  Rental Payments to GSA                             40,154,000         40,402,000            248,000
    23.2  Rental Payments to Others                          85,139,000         85,657,000            518,000
    23.3  Communications, Utilities & Miscellaneous         148,541,000        149,124,000            583,000
           Charges
    24.0  Printing & Reproduction                            21,749,000         21,448,000           (301,000)
    25.1  Consulting Services                               136,456,000        133,654,000         (2,802,000)
    25.2  Other Services                                  1,002,883,000        974,048,000        (28,835,000)
    25.3  Purchase of Goods & Services from                 858,478,000        821,161,000        (37,317,000)
           Government Accounts
    25.4  Operation & Maintenance of Facilities             415,313,000        381,429,000        (33,884,000)
    25.5  Research & Development Contracts                2,143,108,000      2,318,213,000        175,105,000
    25.6  Medical Care                                       24,463,000         23,703,000           (760,000)
    25.7  Operation & Maintenance of Equipment              173,642,000        170,147,000         (3,495,000)
    25.8  Subsistence & Support of Persons            .................  .................  ..................
                                                     -----------------------------------------------------------
    25.0    Subtotal, Other Contractual Services          4,754,343,000      4,822,355,000         68,012,000
    26.0  Supplies & Materials                              336,691,000        321,810,000        (14,881,000)
    31.0  Equipment                                         194,842,000        188,002,000         (6,840,000)
    32.0  Land and Structures                                    77,000             77,000  ..................
    33.0  Investments & Loans                         .................  .................  ..................
    41.0  Grants, Subsidies & Contributions              21,297,989,000     20,831,478,000       (466,511,000)
    42.0  Insurance Claims & Indemnities                         14,000             14,000  ..................
    43.0  Interest & Dividends                                  152,000            141,000            (11,000)
    44.0  Refunds                                     .................  .................  ..................
                                                     -----------------------------------------------------------
            Subtotal, Non-Pay Costs                      26,944,855,000     26,523,113,000       (421,742,000)
                                                     -----------------------------------------------------------
            Total Budget Authority by Object             29,098,845,000     28,771,241,000       (327,604,000)
----------------------------------------------------------------------------------------------------------------
      \1\ Reflects request to Labor/HHS/Education Subcommittee, and includes Type I Diabetes funds provided
        through Public Law 107-360


                                              SALARIES AND EXPENSES
----------------------------------------------------------------------------------------------------------------
                                                                     Fiscal year
                                                       --------------------------------------     Increase or
                    Object Classes                          2007 Joint                             decrease
                                                            resolution       2008 estimate
----------------------------------------------------------------------------------------------------------------
Personnel Compensation:...............................
    Full-Time Permanent (11.1)........................       $838,033,000       $881,383,000        $43,350,000
    Other Than Full-Time Permanent (11.3).............        263,580,000        276,142,000         12,562,000
    Other Personnel Compensation (11.5)...............         29,783,000         31,112,000          1,329,000
    Military Personnel (11.7).........................         26,032,000         27,721,000          1,689,000
    Special Personnel Services Payments (11.8)........        171,584,000        175,795,000          4,211,000
                                                       ---------------------------------------------------------
      Total Personnel Compensation (11.9).............      1,329,012,000      1,392,153,000         63,141,000
Civilian Personnel Benefits (12.1)....................        311,004,000        326,309,000         15,305,000
Military Personnel Benefits (12.2)....................         17,255,000         18,026,000            771,000
Benefits to Former Personnel (13.0)...................  .................  .................  ..................
                                                       ---------------------------------------------------------
      Subtotal, Pay Costs.............................      1,657,271,000      1,736,488,000         79,217,000
Travel (21.0).........................................         55,429,000         52,639,000         (2,790,000)
Transportation of Things (22.0).......................          5,174,000          4,938,000           (236,000)
Rental Payments to Others (23.2)......................          1,380,000          1,373,000             (7,000)
Communications, Utilities and Miscellaneous Charges            29,949,000         29,770,000           (179,000)
 (23.3)...............................................
Printing and Reproduction (24.0)......................         14,418,000         14,093,000           (325,000)
Other Contractual Services:
    Advisory and Assistance Services (25.1)...........        103,157,000        100,069,000         (3,088,000)
    Other Services (25.2).............................        515,643,000        485,772,000        (29,871,000)
    Purchases from Govt. Accounts (25.3)..............      1,177,590,000      1,146,018,000        (31,572,000)
    Operation & Maintenance of Facilities (25.4)......         62,671,000         62,582,000            (89,000)
    Operation & Maintenance of Equipment (25.7).......         76,450,000         72,506,000         (3,944,000)
    Subsistence & Support of Persons (25.8)...........  .................  .................  ..................
                                                       ---------------------------------------------------------
      Subtotal Other Contractual Services.............      1,935,511,000      1,866,947,000        (68,564,000)
Supplies and Materials (26.0).........................        216,416,000        201,809,000        (14,607,000)
                                                       ---------------------------------------------------------
      Subtotal, Non-Pay Costs.........................      2,258,277,000      2,171,569,000        (86,708,000)
                                                       ---------------------------------------------------------
      Total, Administrative Costs.....................      3,915,548,000      3,908,057,000         (7,491,000)
----------------------------------------------------------------------------------------------------------------


                                SALARIES AND EXPENSES--TOTAL--MODIFIED DEFINITION
----------------------------------------------------------------------------------------------------------------
                                                                            Fiscal year
                                                                 --------------------------------
                     Institutes and centers                                            2008       Percent change
                                                                    2007 Joint      President's
                                                                    resolution        budget
----------------------------------------------------------------------------------------------------------------
NCI.............................................................    $312,200,000    $315,226,000             1.0
NHLBI...........................................................     107,364,000     108,390,000             1.0
NIDCR...........................................................      20,949,000      21,151,000             1.0
NIDDK...........................................................      60,867,000      61,450,000             1.0
NINDS...........................................................      54,003,000      54,561,000             1.0
NIAID...........................................................     229,065,000     231,142,000             0.9
NIGMS...........................................................      47,317,000      48,300,000             2.1
NICHD...........................................................      57,594,000      58,425,000             1.4
NEI.............................................................      22,905,000      23,098,000              .8
NIEHS...........................................................      22,141,000      22,313,000              .8
NIA.............................................................      37,554,000      37,942,000             1.0
NIAMS...........................................................      23,537,000      23,737,000              .8
NIDCD...........................................................      18,434,000      18,624,000             1.0
NIMH............................................................      73,171,000      73,901,000             1.0
NIDA............................................................      57,628,000      58,205,000             1.0
NIAAA...........................................................      26,946,000      27,179,000              .9
NINR............................................................       9,367,000       9,464,000             1.0
NHGRI...........................................................      18,412,000      18,581,000              .9
NCRR............................................................      27,957,000      28,235,000             1.0
NCCAM...........................................................      12,698,000      12,824,000             1.0
NCMHD...........................................................      10,154,000      10,260,000             1.0
NIBIB...........................................................      17,155,000      17,353,000             1.2
FIC.............................................................      12,582,000      12,708,000             1.0
NLM.............................................................       9,875,000       9,855,000            -0.2
OD..............................................................     114,136,000     107,471,000            -5.8
Clinical Center.................................................      18,248,000      18,431,000             1.0
                                                                 -----------------------------------------------
      Total.....................................................   1,422,259,000   1,428,826,000             0.5
Public Health Education Excluded from above.....................    (28,384,000)    (28,779,000)             1.4
 
----------------------------------------------------------------------------------------------------------------
Note.--Section 408 of the PHS Act, as amended, defines administrative expenses as expenses incurred for the
  support of activities relevant to the award of grants, contracts, and cooperative agreements and expenses
  incurred for general administration of the scientific programs and activities of the National Institutes of
  Health.
In collaboration with staff of the General Accounting Office (GAO), a methodology was developed to account for
  administrative expenses as defined in Section 408. This methodology includes obligations in the RMS budget
  activity (except for Program Evaluation costs), obligations directly related to the administrative
  responsibilities of the Office of the Scientific Director in the Intramural budget activity, and
  administrative expenses in the Cancer Control program.
In addition, direct program costs in the Office of the Director (those for the Director's Discretionary Fund,
  AIDS research, the Office of Women's Health Research, the Office of Education, the Office of Behavioral and
  Social Science Research, the Office of Dietary Supplements, the Loan Repayment Programs, and the Office of
  Rare Diseases Research) have been excluded.
The definition of administrative expenses has been further modified to include those activities specifically
  excluded by the law (NINR, FIC, NLM, and the Clinical Center), and to exclude public health education
  activities. This is consistent with previous House Appropriations subcommittee requests on administrative
  costs using this definition.
Major cost categories excluded from this definition but included in the OMB/HHS definition of administrative
  costs: salaries and benefits for researchers; travel for patients undergoing treatment at the Clinical Center
  and travel to scientific workshops and conferences; costs associated with laboratory facilities; contractual
  support for R&D activities in the Intramural program; and scientific supplies.


                                               STATISTICAL DATA--GRANTS, DIRECT AND INDIRECT COSTS AWARDED
                                                                  [Dollars in millions]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                         Percent to total in        Percent growth in
                                                                  Direct      Indirect      Total              dollars                   dollars
                         Fiscal year                              costs        costs       dollars   ---------------------------------------------------
                                                                 awarded      awarded      awarded       Direct      Indirect      Direct      Indirect
--------------------------------------------------------------------------------------------------------------------------------------------------------
1996.........................................................       $6,214       $2,627       $8,840         70.3         29.7  ...........  ...........
1998.........................................................        7,246        3,038       10,284         70.5         29.5  ...........  ...........
1999.........................................................        8,391        3,421       11,811         71.0         29.0         15.8         12.6
2000.........................................................        9,787        3,881       13,668         71.6         28.4         16.6         13.5
2001.........................................................       11,210        4,425       15,634         71.7         28.3         14.5         14.0
2002.........................................................       12,721        4,937       17,658         72.0         28.0         13.5         11.6
2003.........................................................       14,337        5,410       19,747         72.6         27.4         12.7          9.6
2004.........................................................       14,780        5,760       20,540         72.0         28.0          3.1          6.5
2005.........................................................       15,299        5,915       21,214         72.1         27.9          3.5          2.7
2006.........................................................       15,095        5,905       21,000         71.9         28.1         -1.3         -0.2
2007 Joint Resolution........................................       15,290        5,982       21,272         71.9         28.1          1.3          1.3
2008 President's Budget......................................       15,049        5,887       20,936         71.9         28.1         -1.6         -1.6
 
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note.--Fiscal year 2007-2008 data is preliminary, and will change as actual data is received.


                                                                   RESEARCH PROJECT GRANTS--TOTAL NUMBER OF AWARDS AND DOLLARS
                                                                                     [Dollars in thousands]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                Fiscal year
                                         -------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                                                         2008
                                                                                                                                                                            2007       revised
                                             1995       1996       1997       1998       1999       2000       2001      2002      2003      2004      2005      2006       joint    President's
                                                                                                                                                                         resolution     budget
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Awards:
    Competing...........................      6,759      6,653      7,390      7,578      8,566      8,765      9,101     9,396    10,411    10,020     9,599     9,129     10,154        9,404
    Noncompeting........................     17,069     17,854     18,248     19,495     20,149     21,779     23,322    24,921    25,776    27,040    27,385    27,366     26,668       26,573
                                         -------------------------------------------------------------------------------------------------------------------------------------------------------
      Subtotal (includes Non-  comp)....     23,828     24,507     25,638     27,073     28,715     30,544     32,423    34,317    36,187    37,060    36,984    36,495     36,822       35,977
SBIR....................................      1,071      1,012      1,298      1,326      1,508      1,640      1,699     1,889     2,032     2,181     1,924     1,822      1,463        1,543
                                         -------------------------------------------------------------------------------------------------------------------------------------------------------
      Total.............................     24,899     25,519     26,936     28,399     30,223     32,184     34,122    36,206    38,219    39,241    38,908    38,317     38,285       37,520
                                         =======================================================================================================================================================
Average Annual Cost:
    Competing...........................     $231.2     $244.6     $245.9     $255.9     $293.6     $332.2     $333.1    $338.8    $337.8    $355.7    $354.8    $368.3     $367.5       $350.3
                                         -------------------------------------------------------------------------------------------------------------------------------------------------------
      Total (includes noncomp)..........     $252.7     $262.1     $269.3     $277.7     $294.8     $319.4     $344.7    $365.5     $79.9    $392.9    $401.8    $403.2     $402.1       $402.3
                                         =======================================================================================================================================================
Percent Change over prior year average
 costs:
    Competing RPGs......................        2.8        5.8        0.5        4.0       14.7       13.2        0.3       1.7      -0.3       5.3      -0.2       3.8       -0.2         -4.7
                                         -------------------------------------------------------------------------------------------------------------------------------------------------------
      Total RPGs........................        3.8        3.7        2.7        3.1        6.2        8.4        7.9       6.0       3.9       3.4       2.3       0.4       -0.3   ...........
Average Length of Award in Years........        3.8        3.8        3.8        3.8        3.9        3.9        3.9       3.9       3.8       3.7       3.7       3.8        3.7          3.8
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ As a policy, no inflationary increases were provided for competing RPGs. The apparent decrease in average cost in fiscal year 2008 is the result of an extremely large cohort of AIDS
  clinical trials cycling from competing into noncompeting status. (77 awards, average cost $1.8 million per award). While there will be no inflationary increases for direct, recurring costs
  in Noncompeting continuation RPGs, where the NIH has committed to a programmatic increase in an award, such increases will be provded.
Numbers of grants identified in fiscal year 2007 and fiscal year 2008 are estimates, and WILL change as applications are received and selected for funding.


                                                                         RESEARCH PROJECT GRANTS--FISCAL YEARS 1999-2008
                                                                                   [Percent of success Rates]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                           Fiscal year
                                                               ---------------------------------------------------------------------------------------------------------------------------------
                    Institutes and centers                                                                                                                                               2008
                                                                    1999         2000         2001         2002         2003         2004         2005         2006      2007 joint  President's
                                                                                                                                                                         resolution     budget
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NCI...........................................................           32           26           27           28           27           24           20           19           19           17
NHLBI.........................................................           36           35           36           33           34           29           24           20           19           18
NIDCR.........................................................           24           27           34           29           27           30           24           19           20           15
NIDDK.........................................................           33           28           29           34           33           27           24           21           19           17
NINDS.........................................................           35           37           32           29           30           25           22           18           19           18
NIAID.........................................................           34           36           38           36           35           24           25           21           22           21
NIGMS.........................................................           39           37           37           39           38           30           27           26           31           25
NICHD.........................................................           30           29           27           28           27           17           18           15           19           15
NEI...........................................................           40           42           40           41           33           30           26           23           23           23
NIEHS.........................................................           27           29           29           29           25           19           19           22           19           11
NIA...........................................................           28           26           32           28           29           21           19           17           19           17
NIAMS.........................................................           24           27           29           23           20           20           20           19           17           17
NIDCD.........................................................           34           40           42           39           38           35           27           28           29           25
NIMH..........................................................           27           29           31           28           27           24           21           20           22           19
NIDA..........................................................           34           38           36           31           35           27           22           20           19           18
NIAAA.........................................................           30           31           33           32           27           29           31           27           31           30
NINR..........................................................           14           32           26           26           27           21           24           18           21           17
NHGRI.........................................................           38           43           42           15           30           23           18           34           38           32
NIBIB.........................................................          N/A          N/A          N/A          N/A           19           17           20           17           18           16
NCRR..........................................................           34           18           29           30           28           21           14           13           21           17
NCCAM.........................................................           57           29           17           14           14           17           17           14           17           21
NCMHD \1\.....................................................          N/A          N/A          N/A          N/A          N/A          N/A          N/A          N/A          N/A          N/A
FIC...........................................................           39           23           30           28           19           22           24           19           20           18
ROADMAP.......................................................          N/A          N/A          N/A          N/A          N/A           13           17           10           18           10
                                                               ---------------------------------------------------------------------------------------------------------------------------------
      NIH.....................................................           32           32           32           31           30           25           22           20           21          18
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ NCMHD success rate is N/A due to co-funding agreements with other IC's.
 
Note.--Success rates identified in fiscal year 2007 and fiscal year 2008 are estimates, and WILL change as applications are received and selected for funding.


                                                            HISTORY OF OBLIGATIONS BY INSTITUTE OR CENTER \1\--FISCAL YEARS 1999-2008
                                                                                    [In thousands of dollars]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                    Fiscal year
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                                            2007         2008
              Institutes and centers                                                                                                                           2006       revised      revised
                                                       1999         2000         2001         2002         2003         2004         2005     2006 actual    comp.\1\      joint     President's
                                                                                                                                                                         resolution     budget
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
NCI..............................................    2,918,050    3,314,580    3,758,566    4,177,830    4,595,477    4,727,365    4,797,731    4,754,121    4,795,073    4,795,491    4,782,114
NHLBI............................................    1,788,008    2,027,286    2,298,035    2,569,794    2,793,681    2,882,601    2,922,573    2,893,527    2,915,923    2,919,980    2,925,413
NIDCR............................................      233,605      268,521      306,152      342,292      371,630      382,013      389,346      385,589      388,664      389,370      389,722
NIDDK............................................    1,018,063    1,167,110    1,399,184    1,560,013    1,712,959    1,829,473    1,852,592    1,838,511    1,853,149    1,855,226    1,858,045
NINDS............................................      900,245    1,028,204    1,175,591    1,325,193    1,456,426    1,498,203    1,529,654    1,519,971    1,533,045    1,534,904    1,537,019
NIAID............................................    1,565,201    1,777,154    2,041,311    2,339,779    3,606,789    4,141,769    4,276,433    4,274,201    4,379,199    4,366,445    4,592,482
NIGMS............................................    1,203,079    1,366,994    1,535,056    1,722,890    1,846,917    1,915,130    1,931,690    1,916,927    1,934,043    1,935,625    1,941,462
NICHD............................................      748,626      857,354      975,537    1,110,459    1,205,908    1,247,939    1,262,273    1,252,598    1,263,521    1,254,144    1,264,946
NEI..............................................      394,601      449,759      510,241      580,047      633,109      650,961      664,840      660,340      665,768      666,675      667,820
NIEHS............................................      374,527      441,960      501,813      574,518      614,183      630,254      640,405      630,447      635,995      641,773      637,406
NIA..............................................      594,556      685,695      785,413      891,282      993,595    1,021,376    1,045,339    1,036,559    1,045,201    1,046,500    1,047,148
NIAMS............................................      307,160      349,555      396,305      447,682      486,031      499,368      507,843      502,954      507,416      508,060      508,082
NIDCD............................................      229,162      263,448      300,282      341,260      370,330      380,737      391,679      389,623      393,111      393,540      393,682
NIMH.............................................      858,520      972,127    1,106,095    1,245,292    1,341,014    1,379,225    1,403,007    1,390,009    1,401,813    1,403,570    1,405,421
NIDA.............................................      611,061      694,561      790,185      892,639      965,721      991,510    1,000,056      990,405      998,858    1,000,014    1,000,365
NIAAA............................................      258,874      291,928      340,151      383,174      415,960      427,223      435,503      431,726      435,479      436,057      436,505
NINR.............................................       69,600       89,415      104,294      120,217      130,537      134,279      137,199      136,020      137,150      137,287      137,800
NHGRI............................................      279,030      335,129      381,971      428,248      464,960      490,546      485,500      481,339      485,655      486,427      484,436
NIBIB............................................  ...........  ...........  ...........      111,740      278,279      286,684      296,324      293,954      298,088      298,391      300,463
NCRR.............................................      562,082      676,077      817,098    1,010,169    1,138,820    1,191,556    1,108,028    1,088,500    1,108,947    1,143,841    1,112,498
NCCAM............................................       40,464       77,808       89,120      104,334      113,405      116,590      121,333      120,294      121,134      121,379      121,699
NCMHD............................................  ...........  ...........      130,070      157,364      185,674      190,824      194,904      193,522      195,263      199,429      194,495
FIC..............................................       35,307       43,446       50,430       56,787       63,425       65,160       66,164       65,726       66,317       66,422       66,594
NLM..............................................      181,014      213,730      239,068      275,395      299,771      310,165      312,980      311,721      314,078      320,229      312,562
OD...............................................      255,584      281,587      212,482      234,784      266,161      327,267      533,673      724,831      478,307    1,096,985      517,062
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
      Subtotal...................................   15,426,419   17,673,428   20,244,450   23,003,182   26,350,762   27,718,218   28,307,069   28,283,415   28,351,197   29,017,764   28,635,241
B&F..............................................      216,856      140,311      205,756      114,839      305,628      303,254      239,246      170,456       85,505       81,081      136,000
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
      TOTAL......................................   15,643,275   17,813,739   20,450,206   23,118,021   26,656,390   28,021,472   28,546,315   28,453,871   28,436,702   29,098,845   28,771,241
Interior/Superfund...............................  ...........  ...........       62,850       70,212       83,515       78,300       79,836       79,108       79,108       79,117       78,434
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
      Total, Budget Authority....................   15,643,275   17,813,739   20,513,056   23,188,233   26,739,905   28,099,772   28,626,151   28,532,979   28,515,810   29,177,962   28,849,675
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Obligations for actual years exclude lapse. Includes funds for Type I Diabetes Initiative.
\2\ Fiscal year 2006--Comparable includes all comparable adjustments.


                                                              HISTORY OF OBLIGATIONS BY TOTAL MECHANISM \1\--FISCAL YEARS 1999-2008
                                                                                    [In thousands of dollars]
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                    Fiscal year
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                                                            2007         2008
                 Budget mechanism                                                                                                             2006 actual      2006       revised      revised
                                                       1999         2000         2001         2002         2003         2004         2005         \2\        comp.\3\      joint     President's
                                                                                                                                                                         resolution     budget
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Res. Project Grants..............................    8,779,019   10,118,249   11,557,511   12,995,051   14,239,043   15,165,836   15,426,097   15,313,663   15,332,997   15,417,256   15,080,819
Research Centers.................................    1,380,117    1,547,152    1,859,600    2,123,723    2,425,448    2,545,972    2,647,355    2,659,653    2,804,893    2,895,051    2,917,412
Other Research...................................      808,100    1,013,499    1,218,906    1,450,750    1,587,841    1,651,823    1,655,743    1,650,974    1,669,351    1,767,797    1,747,167
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
      Subtotal Res. Grants.......................   10,967,236   12,678,900   14,636,017   16,569,524   18,252,332   19,363,631   19,729,195   19,624,290   19,807,241   20,080,104   19,745,398
Research Training................................      509,185      539,510      589,624      650,686      711,441      740,506      743,861      731,121      748,641      771,600      769,413
R & D Contracts..................................    1,067,197    1,147,672    1,387,989    1,642,046    2,299,140    2,691,897    2,516,611    2,582,606    2,667,066    2,783,528    2,975,285
Intramural Research..............................    1,564,547    1,746,220    1,950,859    2,225,292    2,564,664    2,658,853    2,737,865    2,745,676    2,772,036    2,791,706    2,774,311
Res. Mgt. & Support..............................      542,188      600,203      690,929      786,647      927,297      977,771    1,014,754    1,098,953    1,108,615    1,132,127    1,142,492
Cancer Control...................................      306,734      389,425      459,482      501,208      533,173      529,980      531,634      505,705      505,705      516,565      516,565
Construction.....................................       32,734       76,181       78,000      117,600      496,782      118,148      178,560       29,700       29,700  ...........  ...........
Library of Medicine..............................      181,014      213,730      239,068      275,395      299,771      310,165      312,980      311,721      311,264      320,229      308,415
Office of the Director...........................      255,584      281,587      212,482      234,784      266,161      327,267      533,673      724,831      393,009      613,985      395,522
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
      Subtotal...................................   15,426,419   17,673,428   20,244,450   23,003,182   26,350,761   27,718,218   28,299,133   28,354,603   28,343,277   29,009,844   28,627,401
Buildings & Facilities...........................      216,856      140,311      205,756      114,839      305,628      303,254      247,182      178,376       93,425       89,001      143,840
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
      Total......................................   15,643,275   17,813,739   20,450,206   23,118,021   26,656,389   28,021,472   28,546,315   28,532,979   28,436,702   29,098,845   28,771,241
Interior--Superfund..............................       62,850       70,212       83,515       78,300       79,836       79,108       79,108       79,117       78,434
                                                  ----------------------------------------------------------------------------------------------------------------------------------------------
      Total Budget Authority.....................   15,643,275   17,813,739   20,513,056   23,188,233   26,739,904   28,099,772   28,626,151   28,532,979   28,515,810   29,177,962   28,849,675
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Obligations for actual years exclude lapse.
\2\ Fiscal year 2006 Actual Obligations include Interior (previously VA/HUD) Superfund activities within the Mechanism amounts.
\3\ Fiscal year 2006 Comparable includes all transfers and comparable adjustments.
\4\ B&F Budget Mechanism includes the B&F appropriation plus the following included in NCI: Fiscal year 2005--$7,936,000; fiscal year 2006--$7,920,000; fiscal year 2007 (est.)--$7,920,000;
  fiscal year 2008 (est)--$7,840,000.
 
Note.--All amounts include funds for Type I Diabetes Initiative.


                                 OPASI

    Question. I understand that you envision a significant role for the 
Office of Portfolio Analysis and Strategic Initiatives in future NIH 
activities. At present, the Office has a relatively small dedicated 
budget and workforce. Please provide us with an updated mechanism table 
for OPASI showing the enacted fiscal year 2007 enacted level and the 
fiscal year 2008 President's budget request. Please also provide 
narrative regarding your vision for OPASI's future role at NIH 
including, but not limited to, the following: The activities you 
envision OPASI performing.
    Answer. The Office of Portfolio Analysis and Strategic Initiatives 
(OPASI) is a policy office within the NIH Office of the Director. 
Related grant-making activities are carried out within the Common Fund/
Roadmap.
    The goal of the Office is to support the ICs in their collaborative 
efforts. OPASI accomplishes its mission through the efforts of three 
Divisions: the Division of Resource Development and Analysis, the 
Division of Strategic Coordination, and the Division of Evaluation and 
Systemic Assessments. These divisions work together to analyze the 
existing NIH research portfolio, collaborate with the ICs to plan and 
manage new research initiatives via the Common Fund, and provide 
evaluation support to the ICs so that future programs can be improved. 
The NIH has also established a Council of Councils (CoC) to give advice 
on OPASI activities. The CoC is composed of scientific and lay council 
members from the IC Advisory Councils and the NIH Council of Public 
Representatives who simultaneously serve on the CoC and their home 
councils.
    Division of Resource Development and Analysis: This Division 
develops tools, analyses, and resources that can be used within OPASI 
and in the ICs to monitor and report on spending in specific areas; 
performs portfolio analyses, particularly with respect to a wide 
variety of scientific areas in which multiple ICs are active; collects, 
distributes, and analyzes data on public health burden of disease as 
well as the impact of research on disease burden. One portfolio 
analysis tool being developed by this division, is the RCDC (Research, 
Condition and Disease Categorization system, formerly known as the 
Knowledge Management and Disease Coding system, KMDC) This system is a 
state of the art reporting tool that streamlines the process of 
identifying grants, contracts, and intramural research projects that 
are relevant to particular diseases, conditions, or scientific topics. 
The tool will first be used for category reporting for the fiscal year 
2010 budget.
    The RCDC use as a portfolio analysis tool for planning purposes 
will expand beyond OPASI to the ICs in fiscal year 2008 as personnel 
are trained in the use of the system.
    Division of Strategic Coordination.--This Division works closely 
with the ICs to manage the Common Fund, which funds the NIH Roadmap. 
Since many cross-cutting areas are funded through IC collaborations 
outside the context of the Common Fund, special criteria have been 
established for Common Fund initiatives. OPASI staff in this Division 
work closely with ICs to gather ideas for possible Common Fund 
initiatives, to determine the responsiveness of these ideas to the 
Common Fund/Roadmap criteria, and to prioritize the ideas based in part 
on analysis of current funding in these areas using tools from the 
Division of Resource Development and Analysis. Those areas not selected 
for Roadmap emphasis may be addressed through multi-IC collaborations 
outside the scope of OPASI management. Staff in this Division will also 
increasingly be involved in post-award management of Common Fund 
initiatives, reviewing progress of individual projects as well as 
providing an overall assessment of whether program goals and milestones 
are being met.
    Division of Evaluation and Systemic Assessments.--This Division 
manages the NIH portion of the PHS Evaluation Set-Aside funds and works 
with ICs to develop evaluation plans for their programs. In addition, 
the Division provides expertise for the evaluation of multi-IC-
supported programs, including those that are supported via the Common 
Fund. This activity will expand in future years to include an In-House 
studies team that will conduct evaluations of Common Fund/Roadmap and 
other trans-NIH programs. This Division also manages the coordinated 
development and submission of Systemic Assessment documents in response 
to the Government Performance Results Act (GPRA) and the Office of 
Management and Budget's Performance Assessment Rating Tool (PART).
    Question. Any grant-making or grant-administering activities you 
envision OPASI performing?
    Answer. A fundamental tenet of the Common Fund is that the 
initiatives should benefit and synergize with the missions of multiple 
or all ICs. The management of Common Fund initiatives is therefore 
inherently of interest to the ICs and is best served by highly engaged 
scientific program staff working in the ICs. For this reason, the 
grant-making authority and much of the grant administration of Common 
Fund initiatives lies in the ICs. However, IC staff work on individual 
initiatives that are of particular interest to their IC and therefore 
may not maintain perspective on the program as a whole. The role of 
OPASI throughout the process of Common Fund management is to provide an 
over-arching view and perspective of the Common Fund and the scientific 
goals that all of the initiatives are expected to meet. OPASI staff 
work on teams that consist primarily of IC staff to plan each of the 
initiatives, to review progress, to develop specific budgetary plans, 
and to develop evaluations for individual initiatives; their 
participation in all of the teams provides an overarching central level 
of management that insures that the trans-NIH nature of the initiatives 
is maintained.
    In addition to the Common Fund, OPASI oversees funding available to 
NIH from the PHS Evaluation Set-Aside. These funds are administered and 
managed by the Division of Evaluation and Systemic Assessment. The 
Division assesses funding requests from ICs for technical and 
conceptual merit as well as policy relevance. This is an internal 
process designed to ensure high quality program evaluations rather than 
a grant-making authority.
    Question. Broad strokes estimates for future growth of the office 
in terms of FTE's and budget (not including amounts appropriated 
separately for the Common Fund).
    Answer. OPASI future growth will occur in all three Divisions. 
Recruitment is underway in the Division of Strategic Coordination to 
allow central scientific staff involvement in all of the Common Fund 
initiatives. The current staffing level will be re-evaluated in fiscal 
year 2008 after the second cohort of initiatives is funded and while a 
third cohort is being planned to determine whether additional staff are 
needed in fiscal year 2009 and beyond. The Division of Resource 
Development and Analysis is expected to grow in fiscal year 2008 to 
accommodate increased portfolio analysis and planning both within OPASI 
and in the ICs. Its growth beyond fiscal year 2008 will involve the 
recruitment of staff to develop new tools to enhance the ability to 
plan for, assess, and manage complex portfolios and to expand the 
capacity to analyze Public Health Burden. The Division of Evaluation 
and Systemic Assessment will expand in fiscal year 2008 to increase the 
capability of doing evaluations in-house. FTEs are expected to grow 
consistent with the funds available for OPASI, currently funded at 
$7,826,000 (includes one-time funding of $4,550,000 for Research, 
Condition and Disease Categorization) in fiscal year 2007 to $4,450,000 
in fiscal year 2008, a decrease of $3,376,000 over fiscal year 2007.
                                 ______
                                 
             Question Submitted by Senator Daniel K. Inouye

                          BEHAVIORAL RESEARCH

    Question. Every year since fiscal year 1999, this Subcommittee has 
urged the NIH to support basic behavioral research and to find an 
organizational home for this activity. Basic research is the building 
block for subsequent discoveries that lead to improved treatments and 
cures. This, of course, is also true for behavioral research. How do 
you intend to ensure dedicated scientific leadership for basic 
behavioral research at the NIH?
    Answer. Basic behavioral and social sciences research (BSSR) is 
critical to the NIH mission and the Agency will continue to support 
work in these disciplines. We estimate that NIH support for basic BSSR 
has been over $1.0 billion annually since fiscal year 2004. NIA, NIDA, 
NICHD, NIMH and NIAAA have provided particularly strong funding in this 
area.
    The Office of Behavioral and Social Sciences Research (OBSSR), 
located within the Office of the Director, is key to leading, 
coordinating and participating in NIH BSSR activities, including basic 
BSSR. OBSSR participates in funding opportunity announcements developed 
by individual or small groups of Institutes and Centers (ICs) and also 
leads in the development of such initiatives. However, OBSSR does not 
fund initiatives directly or entirely and is dependent on individual 
ICs for support and funding of specific programs. The Office 
participates in the Genes, Environment and Health Initiative, the NIH 
Blueprint for Neuroscience Research, and the NIH Roadmap for Medical 
Research. It has taken the lead on several Roadmap initiatives, 
including RFA RM 07-004, Facilitating Interdisciplinary Research via 
Methodological and Technological Innovation in the Behavioral and 
Social Sciences (R21) (http://grants.nih.gov/grants/guide/rfa-files/
RFA-RM-07-004.html). Slated for funding in fiscal year 2007, this 
initiative seeks to foster better integration of the behavioral and 
social sciences with biomedical research with the ultimate goal of 
improving health.
    Under the leadership of its Director, Dr. David Abrams, OBSSR has 
recently completed a two-year strategic planning process that 
identified four major programmatic directions for the Office. As 
articulated in the Strategic Prospectus (http://www.conceptsystems.com/
OBSSR/OBSSR-Prospectus-final.pdf), the first programmatic direction is 
``next generation'' basic BSSR that will be informed by breakthroughs 
in complementary areas such as genetics, informatics, and multilevel 
analyses. Specific priority areas include but are not limited to the 
following:
  --Gene-Environment interactions.--How are genetic traits and early 
        life experiences linked to physical and emotional health later 
        in life?
  --Biosocial stress markers.--What are the biological sequelae of 
        stress, and how do they relate to long-term mental and physical 
        health?
  --Technology, Measurement and Methodology.--How can we improve 
        biomarker, behavioral and environmental data collection to 
        better understand pathways linking biology, behavior, 
        environment, and society?
  --Spirituality and health.--How do individual belief systems or 
        social religious norms affect health?
  --Work-related stresses.--How are conflicts between work and family 
        associated with social stress and health?
  --Social integration and social capital.--How have advances in 
        technology and mobility affected neighborhood social networks, 
        health behaviors and health outcomes?
  --Inequality and health outcomes.--How do large-scale societal 
        structures (e.g., racial segregation, immigration and 
        acculturation patterns, socioeconomic status) impact health?
    As a first step in the realization of ``next generation'' basic 
BSSR, OBSSR is currently leading a partnership among several ICs and 
the Centers for Disease Control and Prevention to issue new funding 
opportunity announcements to support behavioral and social science 
research on understanding and reducing health disparities (see http://
grants.nih.gov/grants/guide/notice-files/NOT-OD-07-063.html). The 
Office is also working with IC partners on activities to support 
research on gene-social environment interactions and in fiscal year 
2008 plans to sponsor a summer institute to train behavioral and social 
scientists in genetics/genomics.
    The senior leadership at NIH believes that the current NIH-wide 
approach of having basic BSSR within and across many ICs, and having 
OBSSR play a coordinating or leadership role, is the optimal 
arrangement for this area of research. Moreover, the NIH Reform Act of 
2006 established the new Division of Program Coordination, Planning, 
and Strategic Initiatives, of which OBSSR will be a part. This change 
will enhance OBSSR's coordinating and leadership roles, working in the 
new Division and with ICs to ensure the support of the highest quality 
basic and applied BSSR throughout the NIH.

                          SUBCOMMITTEE RECESS

    Senator Harkin. So, thank you all for being here. The 
subcommittee will stand in recess to reconvene at 3:30 p.m., 
Monday, March 26, in room SD-116.
    [Whereupon, at 3:05 p.m., Monday, March 19, the 
subcommittee was recessed, to reconvene at 3:30 p.m. Monday, 
March 26.]


DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED 
              AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              


                         MONDAY, MARCH 26, 2007

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 3:30 p.m., in room SD-116, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin and Specter.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENT OF HON. THOMAS R. INSEL, M.D., DIRECTOR, 
            NATIONAL INSTITUTE OF MENTAL HEALTH

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. The Appropriations Subcommittee on Labor, 
Health and Human Services, and Education and Related Agencies 
will come to order. This is the subcommittee's second hearing 
on the National Institutes of Health this year. Last week we 
heard from NIH Director Elias Zerhouni and several top 
extramural scientists as we discussed the need for more NIH 
funding. Starting today and over the course of the 
subcommittee's next five NIH hearings, we will hear from each 
of the Institute and center Directors, usually in groups of 
four or five.
    We had actually done this before. I like this room, I like 
the setting, I like the way that we are at a table here, which 
makes it more conversational, rather than just sitting at a 
podium, that type of thing. So I like this much better. This is 
one of our Appropriations rooms. In fact, our predecessor on 
this when I first came to this committee used this room and we 
had those hearings at that time. I like the idea. I like the 
setting of it, so I am going to try to use this room as often 
as possible for these kinds of hearings. It is not as formal, 
it is more relaxed, and we can have a conversation.
    I will ask each of the Directors to speak for about 5 
minutes. We have your statements. We will make them a part of 
the record in their entirety. So I am just going to ask you for 
about 5 minutes to talk about some of the most important 
functions that you see in what you are doing, and then we will 
have a discussion with you, and we will do each Director's 
time. So I am thinking about 15 minutes per person, and we will 
do it that way. Then at the end, maybe if there are some wrap-
up things, then we will just kind of open it for a general 
thing at that time.
    So the five Institutes that are here today--NIMH, Mental 
Health; National Institute on Drug Abuse, NIDA; the National 
Institute on Alcohol Abuse and Alcoholism, otherwise known as 
NIAAA; National Institute on Deafness and Communication 
Disorders; and the National Institute of Neurological Disorders 
and Stroke, Dr. Landis. We grouped these together because all 
of these have to do with mind-brain behavior, and I am going to 
try to continue this kind of lumping together of different 
Institutes as we have these hearings.
    However, I just say that if you have other things you want 
to bring up, please do. Anything happening in your Institutes 
is fair game for us to discuss.
    With that, I turn to Senator Specter if you have anything 
in opening.

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Thank you, Mr. Chairman.
    We continue our hearings on the National Institutes of 
Health, and I consider this to be a matter of priority second 
to none in our budget. Health is our principal capital asset 
and the work which has been done by NIH has been truly 
spectacular. Senator Harkin and I have taken the lead, as is 
fairly well known, in increasing the funding for NIH from $12 
billion to almost $30 billion, and we have done that by taking 
a very sharp pencil and establishing priorities and eliminating 
items from a very important budget in deference to the greater 
importance of health care.
    We have three major Departments that we are responsible for 
funding: Health and Human Services, Education, and Labor. So 
that we have had to evaluate education priorities and worker 
safety priorities and health care priorities. But NIH has the 
potential to be a fountain of youth, in my opinion, and to 
really find ways to fund cures for many, many ailments.
    I say with some frequency, but not often enough, that when 
President Nixon declared war on cancer in 1970--had that war 
been pursued with the same intensity as other wars--my chief of 
staff, a beautiful young woman named Carie Lackman, at 48 would 
not have died of breast cancer, and last year one of my best 
friends, the Chief Judge of the Third Circuit emeritus, would 
not have died of prostate cancer; and I would not have gotten 
Hodgkins.
    When we talk about containing costs, the best way to 
contain costs is to prevent disease and to prevent illness. 
Senator Harkin and I are leading the fight for embryonic stem 
cells. It is scandalous when you have the major responsibility 
for funding health programs in the Federal Government but are 
not able to use any funds for stem cell research. Now, if these 
embryos would produce children we would be the last to suggest 
they be used. But we have taken the lead in putting up $2 
million to have adoptions, but only about 100 of some 400,000 
have been adopted. So it is a matter of useing them to save 
lives or having them ultimately discarded.
    Senator Harkin and I added an amendment to the budget 
resolution last week for $2.2 billion and that is only to stay 
afloat and tread water from the cost of living adjustments. But 
do not draw too much encouragement from it because the budget 
resolution is only Confederate money. The money does not 
materialize until there is an allocation. Then it does not 
materialize until there is an appropriation, and to call it 
Confederate money may be giving it too much credit. It may be 
more accurately called Monopoly money.
    But we are determined to fight this through. You can help 
us. As we said to Dr. Zerhouni last week, we need to have the 
best estimates you can make as to what this research means in 
terms of saving lives and quantifying--I know it is hard to 
do--how long it will take to find a cure for a given malady and 
how much it will save. For example--if you delay the onset of 
Alzheimer's--I have seen some statistics that shows health care 
cost savings into the billions of dollars. But that is what 
motivates the other 535 Members of Congress, if you can be 
specific and show them some savings.
    So thank you for what you are doing and I look forward to 
your testimony.
    Thank you, Mr. Chairman.
    Senator Harkin. Thank you, Senator Specter.
    So we will start with Dr. Insel, then Dr. Volkow, Dr. 
Battey, and then Dr. Landis.
    Dr. Thomas Insel has been the Director of the National 
Institute of Mental Health since September 2002, received his 
B.A. and M.D. degrees both from Boston University. So Dr. 
Insel, welcome. As I said, your statement is part of the 
record. Tell us what you are doing, what is important, and what 
we ought to know about.

                SUMMARY STATEMENT OF DR. THOMAS R. INSEL

    Dr. Insel. Thank you. First of all, Mr. Chairman, let me 
say how much we all appreciate being here. I have been in my 
job now for about 4\1/2\ years. I think this is the first time 
I have had a chance to talk with this subcommittee and update 
you with the kinds of things we are interested in.
    At the beginning, I would like to just very quickly run 
through where we see the biggest needs and then tell you a 
little bit about what we hope to do about them. There is no 
question that the needs across all of these Institutes in terms 
of the public health burden is very great. You will be hearing 
from all five of these NIH Institutes that focus on 
neuroscience and behavior. Together we cover about 1,000 
disorders of the nervous system affecting about 70 million 
Americans. These result in more hospitalizations than any other 
class of illnesses, including cancer and heart disease. You 
will hear about some of the costs, which in aggregate are about 
$800 billion per year. For my Institute, the mental health 
piece of this alone, represents for all health care about 6.2 
percent of the overall cost, and some parts of that are going 
up, such as medications, at a rate of about 20 percent per 
year.

                           PREPARED STATEMENT

    I think you know that the health care costs have now become 
about 16 percent of the GDP, predicted to go up to 20 percent 
by 2016. So these are very significant costs in the entire 
economy.
    [The statement follows:]

               Prepared Statement of Dr. Thomas R. Insel

    Mr. Chairman, and members of the Committee: I am pleased to present 
the fiscal year 2008 President's budget request for the National 
Institute of Mental Health (NIMH). The fiscal year 2008 budget includes 
$1,405,421,000. In my statement, I will call to your attention our 
Nation's most prevalent mental and behavioral disorders and include a 
brief review of our research activities and accomplishments.

              MENTAL DISORDERS ARE CHRONIC BRAIN DISORDERS

    The NIMH mission is to reduce the burden of mental and behavioral 
disorders, such as depression, schizophrenia, autism, and bipolar 
disorder, through research on mind, brain, and behavior. Research is 
demonstrating that these illnesses are brain disorders, accessible by 
the tools of modern neuroscience. These disorders frequently begin in 
childhood and are chronic,\1\ affecting people of all races and 
ethnicities, in both rural and urban settings. To prevent a lifetime of 
disability for millions of Americans, NIMH research is identifying the 
biological basis of mental disorders, and pinpointing targets for 
diagnosis, prevention, and treatment.
---------------------------------------------------------------------------
    \1\ Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters 
EE. Lifetime prevalence and age-of-onset distributions of DSM-IV 
disorders in the National Comorbidity Survey Replication. Archives of 
General Psychiatry. 2005 Jun;62(6):593-602.
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                 PUBLIC HEALTH BURDEN OF MENTAL ILLNESS

    In the most recent national household survey, as many as 44 million 
Americans met criteria for some mental disorder, with roughly 12 
million reporting symptoms so severe as to cause significant disability 
in the past year.\2\ According to the World Health Organization, mental 
disorders are also the leading cause of medical disability in the 
United States and Canada for people ages 15-44. The annual economic 
cost of mental illness in the U.S. is estimated at well over $150 
billion, with most due to the indirect costs of social services.\3\ The 
direct costs of mental health care represent 6.2 percent of the overall 
health care costs,\4\ which totaled 14.5 percent of the gross domestic 
product in 2001 according to the Centers for Medicare and Medicaid 
Services (CMS).
---------------------------------------------------------------------------
    \2\ Kessler, RC, Chiu, WT, Demler, O, Merikangas, KR, Walters, EE. 
Prevalence, severity, and comorbidity of 12-month DSM-IV disorders in 
the National Comorbidity Survey Replication. Archives of General 
Psychiatry. 2005 Jun: 62, 617-627.
    \3\ New Freedom Commission on Mental Health, Achieving the Promise: 
Transforming Mental Health Care in America. Final Report. DHHS Pub. No. 
SMA-03-3832. Rockville, MD: 2003.
    \4\ Mark TL, Coffey RM, Vandivort-Warren R, Harwood HJ, King EC; 
MHSA Spending Estimates Team. United States spending for mental health 
and substance abuse treatment, 1991-2001. Health Affairs (Millwood). 
2005 Jan-Jun;Suppl Web Exclusives:W5-133-W5-142.
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              ADVANCING CLINICAL RESEARCH IN MENTAL HEALTH

    New tools in genomics, imaging, and behavioral science have given 
us traction for progress towards reducing this tremendous public health 
burden. NIMH has adopted the NIH clinical research vision, which 
focuses on the four P's of medical research: increasing the capacity to 
Predict who is at risk for developing disease; developing interventions 
that Pre-empt the disease process; using knowledge about individual 
biological, environmental, and social factors to Personalize 
interventions; and, ensuring that clinical research involves 
Participation from the diversity of people and settings affected.
    The Institute's focus on practical, or ``effectiveness,'' clinical 
trials embodies this research vision. Although traditional clinical 
trials are useful in determining if groups of patients respond to a 
treatment, NIMH's practical clinical trials, conducted with 10,000 
patients at 200 sites across the nation, have helped us to understand 
individual responses to treatment. DNA collected from participants in 
one such trial, the Sequenced Treatment Alternatives to Relieve 
Depression (STAR*D), led to the discovery of genetic variations 
associated with response to antidepressants. Through the inclusion of a 
diverse population, this research also found that the genetic variation 
that predicted a favorable response was less commonly found in African-
Americans. This pharmacogenomic approach can transform the treatment of 
mental disorders, allowing clinicians to personalize therapy choices 
based on a patient's unique biology.
    Results from these practical trials and related studies have taught 
us that current medications are helpful but not sufficient for most 
people with schizophrenia, depression, and bipolar disorder. While 
research on non-drug therapies is showing impressive results in 
treating a variety of mental illnesses, we clearly need a new 
generation of medications that are more effective and better tolerated. 
NIMH research during the past year reported on new classes of 
antidepressants that work within hours rather than weeks. These 
findings suggest that we can expect new medications that will transform 
the treatment of mental illnesses by influencing recently discovered 
targets in the brain.
    New treatments like these antidepressants are based on the emerging 
science of pathophysiology, the study of how brain structure and 
functioning are involved in mental disorders. For instance, research on 
fear has revealed a class of brain receptors and specific brain 
circuits involved in traumatic memories. Clinical trials with 
medications that specifically target those receptors and circuits have 
shown positive effects in reducing stress in response to reminders of 
trauma and, thereby, offer a new treatment for PTSD. Working with the 
Department of Defense and the Department of Veterans Affairs, NIMH is 
supporting research that will treat PTSD and may also prevent the 
persistence of fearful memories, thus pre-empting the development of 
PTSD altogether. With 13 percent of returning soldiers diagnosed with 
PTSD,\5\ we recognize the urgent need for safe and effective pre-
emptive interventions.
---------------------------------------------------------------------------
    \5\ Seal KH, Bertenthal D, Miner CR, Sen S, Marmar C. Bringing the 
War Back Home: Mental Health Disorders Among 103,788 U.S. Veterans 
Returning From Iraq and Afghanistan Seen at Department of Veterans 
Affairs Facilities. Archives of Internal Medicine. 2007 Mar 
12;167(5):476-482.
---------------------------------------------------------------------------
                   PARTNERSHIPS FOR RESEARCH PROGRESS

    NIMH also aims to accelerate research discoveries through 
collaborative partnerships. Fifteen NIH Institutes invested in research 
on the nervous system have pooled resources to create the NIH Blueprint 
for Neuroscience Research, a framework to enhance collaboration in the 
development of research tools, resources, and training, all of which 
will be made available to the neuroscience research community. 
Initiatives will focus on neurodegeneration in 2007, neural development 
in 2008, and neural plasticity in 2009.
    Through public-private partnerships and additional grants 
coordinated by the Foundation for the National Institutes of Health 
(FNIH), the Genetic Association Information Network (GAIN) program will 
investigate the genetic roots of several common diseases and to provide 
the immediate, broad release of scientific information through a 
publicly accessible database. Four of the six current GAIN initiatives 
are related to brain disorders: attention deficit/hyperactivity 
disorder, schizophrenia, bipolar disorder, and major depressive 
disorder.
    The Biomarkers Consortium is a public-private research partnership 
of the FNIH that includes NIH, CMS, the Food and Drug Administration, 
and industry and advocacy organizations to help identify new and valid 
biomarkers that will advance the creation of innovative technologies 
and therapies for early detection, diagnosis, and treatment of disease. 
Some of the first research findings from the Biomarkers consortium and 
GAIN are expected later in 2007.
    These joint initiatives offer translational opportunities for 
further developing interventions and treatment options that can deliver 
more effective, personalized care across diverse populations and 
settings.
    In summary, this is a time of unprecedented excitement in mental 
health research. Neuroscience and genomics are yielding new insights 
and new treatments, providing great hope for the future. Large-scale, 
practical trials are helping us optimize the treatments available 
today. I appreciate this opportunity to tell you about those exciting 
breakthroughs in the science of mental illness. I look forward to your 
questions.

                   INDIRECT COSTS OF MENTAL ILLNESSES

    Senator Harkin. You are saying that mental health is 6.2 
percent overall? It is not--
    Dr. Insel. It is 6.2 percent of the overall costs of health 
care.
    Senator Harkin. Of the 16 percent.
    Dr. Insel. Of the 16 percent, right, of the GDP.
    Now, you have to recognize that when I talk about the costs 
of health care for mental illness, that is telling you a very 
small part of the story. Many of the costs here are not in the 
health care system per se, but in the social services, what we 
call the indirect costs of these disorders. According to the 
President's New Freedom Commission, which was a report issued 
in 2003, people with mental illness are the largest single 
group of patients in our public assistance programs, like SSI 
and SSDI. They are a large part of our homeless population and, 
according to the Department of Justice program on statistics 
there, our prisons and jails have increasingly become really 
the institutions for those with chronic mental illness, at 
least half of the people incarcerated having a serious mental 
illness, which is just extraordinary.
    Now, how you capture those costs is quite difficult. None 
of them are captured when we talk about the costs of health 
care. At the very least, I think it is fair to say that these 
indirect costs of mental health care swamp whatever it is that 
we are paying in the direct costs of providing medical care to 
those with mental illnesses. As you will hear, this is also 
true for addiction and alcoholism.

                            CHRONIC DISEASE

    It is probably equally important for you to realize that 
the real costs are not just in dollars, but in lives lost. As 
Senator Specter was saying, this is really a question of saving 
lives. You probably heard from Dr. Zerhouni that we are now 
thinking of the 21st century as the era of chronic disease, and 
that is undoubtedly true. Diabetes, hypertension, and heart 
disease are all chronic diseases which will become the big 
challenge of this century.
    But as you will hear from Dr. Volkow and others, mental and 
addictive disorders, are also chronic diseases. What sets them 
apart is they begin early in life. In a recent study, 50 
percent of adults with mental illness reported onset by age 14, 
75 percent by age 24.
    What that really means is that these are in fact the 
chronic disorders of young people in this country, mental 
illness and addictive disorders. They start early. Many are 
chronically disabling. This is why the World Health 
Organization, when it was looking at the largest sources of 
medical disability, ranked these disorders--mental illness and 
addiction--the number one cause of disability for Americans 
between 15 and 44. So it is an extraordinary saga that is 
largely untold. We often say that the costs in dollars and in 
lives are unacceptably large and largely unrecognized.
    Finally, let me just say before I turn this over is that 
one of the aspects of this, of these disorders being recognized 
as brain disorders, is that the group of people who are here at 
the table are now very much all of one mind. We can work 
together and collaborate in a way that was not as obvious a 
decade ago. You can see that in a number of ways. Not only do 
we recognize that there is a lot of comorbidity--Parkinson's 
and depression, certainly PTSD and addiction, bipolar illness 
and alcohol abuse--but it is also in the tools that we need.

                         NEUROSCIENCE BLUEPRINT

    So we have come together to form the Neuroscience 
Blueprint, which I believe Dr. Zerhouni may have mentioned. It 
is an attempt to collaborate and to develop resources and tools 
that will serve all these Institutes and will make a difference 
for people with brain disorders. We have also got the 
embodiment of this collaborative effort in a new facility, the 
Porter Neuroscience Building, under the NIH intramural program, 
which is a very exciting effort that I hope I can tell you more 
about during the question period.
    So I am going to stop here so we have more time, but I do 
want to say how much we appreciate the opportunity to be here.

                        DRUGS AND MENTAL HEALTH

    Senator Harkin. Dr. Insel, thank you very much.
    Let me just lead this off. First of all, just a general 
question. On mental health, are we putting too many eggs in the 
basket of finding a drug that masks, that perhaps gets someone 
through a tough time to respond to the immediacy of a mental 
illness? Are we putting too much in just finding these kind of 
drugs rather than getting to the underlying cause and taking 
the time and research to understand what led to that point?
    I say that because it just seems to me that more and more 
people with mental illness are just taking more and more drugs. 
I will tell you of a case I know vaguely, someone I happen to 
know. I do not want to get too specific because I want to 
protect privacy. Someone who is on a drug that was--I wish I 
could remember the name. I came here equipped to ask you about 
it. But it was a powerful anti-depressant type drug. When that 
person decided to get off that drug, it was like getting off of 
heroin or something. The bodily reactions and the mental 
reactions of that person getting off that drug was just awful. 
I wondered, why would a doctor prescribe this in the first 
place?
    So again, general question: Are we putting too much into 
just going after drugs or should we be looking at some of the 
underlying causes?
    Dr. Insel. The quick answer is yes. Let me explain that. 
This field in some ways has been cursed by having medications 
that are pretty good. These were not designed rationally. They 
were all discovered by serendipity. But surprisingly, some of 
them actually helped quite a few people. The down side is that 
much of the field of research has really focused on trying to 
improve the existing drugs instead of trying to understand the 
basic pathophysiology of the disorders. Understanding that 
would allow us to know how to design medications that really go 
after the core lesion, the core problem here. It also gives us 
some hints about how to get into preemptive care, how to get 
there before the psychotic part of schizophrenia emerges. We 
know schizophrenia is an illness that has many phases, just 
like heart disease. But we tend to intervene with heart disease 
before a myocardial infarction. We do not wait for someone to 
have a heart attack.
    In this field, we are waiting for someone to have a 
psychotic break before we really intervene. We do not need to 
do that.

                            EATING DISORDERS

    Senator Harkin. You and I discussed this once before, but I 
was told--I am going to repeat this without knowing whether it 
is factual or not, but I was told on more than one time or 
occasion that what I am about to say is true: that the single 
largest cause of young women dropping out of college is eating 
disorders. A lot of this has to do with mental health problems.
    So what is happening here? What is the Institute doing on 
this? Are you looking into eating disorders and the underlying 
mental health problems that either lead to it or exacerbate it?
    Dr. Insel. This is one of the places where, in contrast to 
what I just said about having pretty good medications that work 
for most people, we actually do not have medications that work 
for most people with eating disorders, nor do we have very 
rapid effective targeted psychotherapies or psychosocial 
therapies. This is one of the areas where we have the greatest 
difficulty with treatment.
    Dr. Volkow and I have talked a lot about this and in some 
ways eating disorders resemble an addictive disorder, where a 
lot of women diet, only a few get hooked and start dieting to 
the point where they actually become--it becomes a life-
threatening problem. We do not know how to treat that in a 
quickly targeted way, effectively, as well as we do many other 
disorders.
    We also do not know how to predict who is at risk, and that 
is one of the biggest questions for us. What we would like to 
do is not come up with necessarily the optimal treatment after 
somebody is already down to 65 or 70 percent of their normal 
body weight. We would like to be able to find out how do you 
keep them from getting to that point by intervening very early 
in the process, perhaps before this kind of addictive component 
gets started.

                              EPIGENETICS

    Senator Harkin. The last question before I turn it over to 
Senator Specter. You are expanding a program called Human 
Genetics, Epigenetics, and Genomics Underlying Mental 
Disorders. I know what genetics means, I think I know what 
genomics means, but I do not know what epigenetics is. What is 
that?
    Dr. Insel. It is a new and exciting area which several 
people at this table care a lot about. In a word or in a 
sentence, genetics and genomics have to do with the sequence of 
the genome, so what is the text. Epigenetics are those things 
that modify the text. Think of it as a highlighting pen that 
causes certain parts of the genome to be expressed in a certain 
cell. In any given cell, only about 20 percent of your genes 
get expressed. Now, why is that?
    Now, we partially know there are things that lay on top of 
the sequence. In some cases they reduce expression, in some 
cases they enhance it. That is the epigenetic tag or those are 
the modifiers to gene expression. We want to understand much 
more about how they work.
    Senator Harkin. Have you done much in that area in the 
past?
    Dr. Insel. Well, we have done quite a bit because we are 
interested in those parts--and we know that early experience 
does have something to do with whether you become addicted 
later, whether you develop depression or some of these 
illnesses. But we do not have the tools yet to do this at the 
kind of high throughput, high resolution stage of what we can 
do with genomic sequence. So right in that area we are a little 
bit inhibited from being able to make the kind of progress we 
like. So the next step is going to be tool development.
    Senator Harkin. Senator Specter.
    Senator Specter. Well, thank you, Mr. Chairman. If I may 
say so, I would prefer to hear what the witnesses have to say. 
I am going to have to excuse myself at about 4:30, and my 
preference, if it is acceptable to the chair, would be to hear 
them and then ask a question or two.
    Senator Harkin. Well, the only reason I wanted to do it 
this way is because then it is fresh on our minds. When he says 
something, I can interact with him. I thought we would go down 
each one. I would rather, if you do not mind, do it this way. 
But if you have to leave--and believe me, I understand 
everybody has got different schedules--if you have something 
for one of the directors, if you want to direct it, that would 
be fine.
    Senator Specter. Okay. When it is more pressing than 
hearing them, I will do so. If that arises, I shall.
    Senator Harkin. No, but if you had something you wanted to 
ask someone now, if you have got to go, if you want to ask 
someone now, that would be fine.
    Senator Specter. Well, let me hear Dr. Volkow. I do have 
one question which is very much on my mind, and there may be 
others. But let me defer to Dr. Volkow.
    Senator Harkin. Well, then next we will turn to Dr. Volkow, 
Director of the National Institute on Drug Abuse. Dr. Volkow 
received her B.A. from the Modern American School in Mexico 
City, Mexico, her M.D. from the National University of Mexico, 
Mexico City. Dr. Volkow, welcome. Please take 5 minutes and let 
us know what you are doing out there.

STATEMENT OF NORA D. VOLKOW, M.D., DIRECTOR, NATIONAL 
            INSTITUTE ON DRUG ABUSE
    Dr. Volkow. Mr. Chairman, it is a privilege for me to be 
here with my colleagues to share some of our initiatives at the 
National Institute on Drug Abuse. As you know, the social and 
individual costs of substance abuse and addiction to the 
society are nothing less than staggering and utterly 
unacceptable. On economic costs alone, the Institute of 
Medicine estimated that substance abuse, legal and illegal, 
including nicotine and alcohol, costs this country over half a 
trillion dollars annually, which includes not only medical 
costs but costs associated with the criminal system.
    NIDA's strategy to alter the course of this epidemic is 
based on a multi-pronged approach designed to understand how 
genes shape our brain, how environmental factors affect this 
process, and how brain function links to behavior, including 
that which characterizes addiction, which is the compulsive 
intake of the drug despite its catastrophic consequences.
    From the science we have learned that repeated drug use 
affects the function of multiple systems in the brain, 
including those involved with reward and pleasure, which 
motivate our behaviors on a daily basis, systems involved with 
learning and memory, which change our behavior as a function of 
experience, and systems involved with inhibitory control, which 
allow us to exert volitional control of our behaviors and 
emotions.
    Today I will stress and highlight how stress, one of the 
key environmental factors influencing the vulnerability for 
addiction, affects brain development and how in turn that 
affects the propensity for taking drugs. We have learned that 
addiction is not just a result of chronic drug use, but that 
genetics and, as I say, environmental factors play an 
extraordinarily important role. However, because we can 
currently not change our genes, which actually account for 50 
percent of the vulnerability to become addicted, a better 
understanding about how environment affects how our genes and 
brain develop offers an extraordinary opportunity for 
prevention.
    It is particularly relevant because drug addiction is fully 
preventable even in those that have a genetic predisposition to 
become addicted, provided they do not get exposed to drugs. 
However, the challenge is how you interfere with young people's 
taking drugs. I say young people, and that is because drug 
experimentation basically starts in adolescence and the earlier 
you start taking drugs the greater the vulnerability to become 
addicted. Why is that so? Multiple factors.
    One of them is that the brain when you are an adolescent is 
still in full development and many of the connections that link 
it with one another are not there. For example, the connections 
that associate your limbic brain, that is responsible for 
emotions and desires, with the thinking part of your brain, the 
prefrontal cortex, will not be fully formed until you are in 
your early 20s. As a result of that, adolescents are much more 
prone to engage in risky behaviors such as substance abuse.
    Unfortunately, the consequences of environmental stressors 
that influence the vulnerability for drug abuse start as early 
as in utero. Now we know, for example, from studies in 
laboratory animals that early exposure during pregnancy of 
animals to marijuana leads to a dysfunction of the newborn that 
continues to adulthood.
    Also, some very simple social stressors, such as we now 
know that if there is no physical contact between the newborn 
and the mother, physical contact, that will lead to silencing 
of a gene, what you were speaking about, epigenetics. That lack 
of physical contact silences a gene that is important in 
regulating our response to stress. These newborns then grow up 
to be very, very sensitive to stress, which is one of the 
factors that makes them vulnerable to addiction.
    Unfortunately, we know too well that childhood exposure to 
social and environmental stressors are extremely deleterious. 
Indeed, our studies, for example, show that children that were 
exposed to five or more social stressors that include a parent 
in jail, a parent that takes drugs, physical sexual abuse, 
neglect, are 10 times, 10 times more likely to become addicted 
than those that are not.
    Unfortunately, social stressors occur throughout all of our 
lives and at any age can lead to substance abuse, to the 
transition between substance abuse and addiction, and to 
relapse to those in recovery. Why? Because the systems that 
project stress have tremendous overlap with the systems in the 
brain that project these drugs.

                           PREPARED STATEMENT

    So in summary, we know, we recognize that drug addiction is 
a chronic disease that changes the brain in long-lasting ways, 
that profoundly affect behavior. We know that it is fully 
preventable, even in those that have a genetic vulnerability. 
Inasmuch as predisposition does not equate with 
predetermination, that knowledge about how environment affects 
our genes and our brain biology provides an extraordinary 
opportunity to tailor preventions to those that are at high 
risk because of their genetics or because of their 
environmental factors.
    So thank you for your attention. I will be happy to answer 
any questions you may have.
    [The statement follows:]

                Prepared Statement of Dr. Nora D. Volkow

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2008 President's budget request for the National 
Institute on Drug Abuse (NIDA). The fiscal year 2008 budget included 
$1,000,365,000. Today, I will discuss NIDA's multifaceted strategy to 
help reduce the enormous toll that drug abuse and addiction take on 
this Country, highlighting recent scientific accomplishments, novel 
approaches to prevention and treatment, as well as our strong 
collaborations with other NIH institutes and with the Substance Abuse 
and Mental Health Services Administration (SAMHSA).

                              INTRODUCTION

    Drug abuse and addiction are a major burden to society; economic 
costs alone are estimated to exceed half a trillion dollars annually in 
the United States--including health, crime-related costs, and losses in 
productivity.\1\ However, as staggering as these numbers are, they 
provide a limited perspective of the devastating consequences of this 
disease.
---------------------------------------------------------------------------
    \1\ Office of National Drug Policy (2004). The Economic Costs of 
Drug Abuse in the United States: 1992-2002. Washington, DC: Executive 
Office of the President (Publication No. 207303). 2004. Centers for 
Disease Control and Prevention. Annual Smoking--Attributable Mortality, 
Years of Potential Life Lost, and Productivity Losses--United States, 
1997-2001 Morbidity and Mortality Weekly Report 54(25):625-628, July 1, 
2005. Harwood, H. Updating Estimates of the Economic Costs of Alcohol 
Abuse in the United States: Estimates, Update Methods, and Data Report 
prepared by the Lewin Group for the National Institute on Alcohol Abuse 
and Alcoholism, 2000. 2000.
---------------------------------------------------------------------------
    The National Institute on Drug Abuse, within the National 
Institutes of Health, is pleased to again report continuing declines in 
both licit and illicit drug use, particularly among our Nation's youth. 
In fact, NIDA's latest Monitoring the Future (MTF) survey results show 
a 23 percent decline over the last five years in any past-month illicit 
drug use by students in the 8th, 10th, and 12th grades combined. 
Declines in teen cigarette smoking, now at its lowest rate since the 
survey began in 1975, signal particularly good news since this will 
translate not only into decreases in cancer-related mortality but also 
decreases in deaths associated with the myriad medical consequences of 
smoking (i.e., chronic obstructive pulmonary disease, asthma, premature 
birth, sudden infant death syndrome, and more). 



    Although abuse of most licit or illicit substances has decreased, 
such is not the case for prescription medications, particularly for 
opiate analgesics, which have produced steep increases in abuse-related 
emergency room admissions. The abuse of prescription medications occurs 
at all ages. However, it is particularly problematic in adolescents 
since this is the time when individuals are most vulnerable to 
addiction. The MTF revealed that in 2006, prescription medications, 
along with over-the-counter drugs (cough medicine), accounted for five 
of the top six drug abuse categories reported by 12th graders, 
marijuana still the most frequently abused illegal drug. Second in 
frequency of abuse was the prescription painkiller Vicodin, with 
roughly 1 in 10 seniors reporting abuse during the past year. 
Amphetamines ranked next, followed by over-the-counter cough medicines, 
with roughly 8 and 7 percent of 12th graders, respectively, reporting 
past-year abuse in 2006.

        PREVENTION EFFORTS--GENES, ENVIRONMENT, AND DEVELOPMENT

    Because adolescence is typically when drug abuse and addiction take 
hold, NIDA continues to focus research on this vulnerable period of 
development. Given that the brains of adolescents have not fully 
developed, including the connections between brain areas involved with 
emotions and areas involved with judgment and decision-making, 
adolescents are less able to exert inhibitory control over emotions and 
desires and are hence more likely to engage in risky behaviors, 
including drug experimentation. However, the brain at this stage is 
also inherently more plastic, which offers opportunities for prevention 
interventions that could lead to greater resilience.
    Addiction results from the complex interaction of drugs, genes, and 
environmental and developmental factors. Thus NIDA has made the study 
of these interactions a priority, joining with other Institutes and 
organizations to support relevant research. Particularly relevant to 
substance abuse is the social environment, as genetic and imaging 
studies continue to reveal how the interplay of biological (i.e., 
genes, developmental stage) and social influences (i.e., family, peers, 
culture) affect individual choices and decisions about drugs. This 
knowledge is crucial to our future ability to tailor prevention 
interventions to address the risk areas of a given individual.
    NIDA also encourages and supports the development of next 
generation technologies to identify and catalogue the multiple 
functional changes to the DNA (i.e., ``epigenetic'' modifications) that 
can result from environmental variables, such as quality of parenting, 
stress, and exposure to drugs. This avenue of approach requires support 
of research to develop standardized and comprehensive ``phenotypes'' of 
social environments (including family, peers, school, neighborhood, 
community, and culture) that can be monitored at various stages of a 
person's life. A better understanding of the neurobiology of social 
behaviors is relevant both for the treatment of drug addiction as well 
as mental illness, which also involves social aspects of human behavior 
and frequently co-occurs with substance abuse.

                      TREATMENTS--NOVEL APPROACHES

    Historically, addiction therapies have targeted the brain's reward 
system to try and interfere with the pleasurable effects of drugs of 
abuse. Now, however, scientists have also identified the broader brain 
circuits that underlie fundamental aspects of drug abuse and addiction, 
such as craving, euphoria, motivation, learning, memory, interoception 
(i.e., sensitivity to internal stimuli such as hunger, pain), and 
inhibitory control--key contributors to addiction. These discoveries 
open wide the range of novel targets for different treatment 
approaches.
    The recent discovery that stroke victims who suffered damage to 
their right insula (a brain area involved in emotional experience and 
interoception) dramatically reduced their smoking behavior points to 
new directions in addiction treatment. Specifically, findings suggest 
that strategies to noninvasively affect activity in the insula may be 
beneficial for addiction. These include use of technologies such as 
rTMS (repetitive transcranial magnetic stimulation), a noninvasive 
method to influence brain activity in specific regions, or 
``neurofeedback,'' where patients learn to regulate specific regions in 
their brains by getting feedback from real-time brain images. Though 
not yet demonstrated for addiction, these techniques have shown 
promising results in depression and in the management of pain. They 
also open up a completely new way to develop psychotherapeutic 
interventions to target specific brain regions or circuits.


    New knowledge of how proteins interact with one another in circuits 
implicated in addiction has prompted the development of novel addiction 
medications. For example, the cannabinoid receptor system, which 
regulates the activity of the dopamine system--the common target for 
the reinforcing effects of all drugs of abuse--holds promise for 
treating various drug addictions and, interestingly, for obesity as 
well.
    Immunotherapeutic strategies offer another unique approach to 
relapse prevention. Such strategies are based on the development of 
vaccines to generate antibodies to the drug that block its entry into 
the brain and thereby interfere with its effects. Cocaine and nicotine 
vaccines are already in clinical trials, and NIDA has requested 
proposals to develop a methamphetamine vaccine.

                     PUTTING RESEARCH INTO PRACTICE

    A major NIDA objective is to translate findings from basic and 
clinical research to guide and inform the design of prevention and 
treatment interventions that can be successfully implemented in real-
world settings. People involved with the criminal justice system (6.9 
million adult Americans) represent one such group. Approximately half 
of prison inmates meet criteria for alcohol/drug abuse or dependence, 
and yet the vast majority return to the community with no treatment.\2\ 
In addition to the resulting high rate of recidivism for drug abuse and 
re-arrest, a recent study of inmates reported that untreated offenders 
were 12.7 times more likely to die within 2 weeks post-release than 
other state residents and that drug overdose accounted for 70 percent 
of those deaths.\3\ Because research has shown that treatment in the 
criminal justice system works, one of NIDA's initiatives is to support 
services research to help develop interventions that will be acceptable 
and sustained in the criminal justice system.
---------------------------------------------------------------------------
    \2\ Mumola CJ and Karberg JC (2006) Drug use and dependence, state 
and federal prisoners, 2004 (NCJ 213530). Washington, D.C.:Bureau of 
Justice Statistics, U.S. Department of Justice.
    \3\ Binswanger IA, Stern MF, Deyo RA, Heagerty PJ, Cheadle A, 
Elmore JG, Koepsell TD (2007) Release from prison--A high risk of death 
for former inmates. New Engl J Med 356:157-65.
---------------------------------------------------------------------------
    To this end, NIDA created and supports the Criminal Justice Drug 
Abuse Treatment Studies (CJ-DATS) initiative, an inter-agency 
collaboration aimed at bringing new treatment models into the criminal 
justice system to improve outcomes for drug-abusing offenders. To 
facilitate the translation of treatments to the criminal justice 
setting NIDA released a landmark publication entitled Principles of 
Drug Abuse Treatment for Criminal Justice Populations, designed to 
advance the concept of addiction as a brain disease and to summarize 
evidence-based principles for treating addiction in criminal justice 
settings.
    NIDA's Drug Abuse Treatment Clinical Trials Network (CTN) also 
plays a key role in bringing evidence-based treatments to community 
settings by testing the effectiveness of new interventions and by 
training providers in the implementation of research based practices in 
order to promote their acceptance and adoption in the community. To 
further enhance the dissemination and utilization of research findings 
and to expand the involvement of the medical community in the screening 
and treatment of drug abuse, NIDA has launched a new ``NIDA Goes to the 
Doctor'' initiative. As part of this initiative, NIDA recently 
established four Centers of Excellence for Drug Abuse Information, in 
collaboration with the American Medical Association, with the aim of 
advancing addiction awareness, prevention, and treatment in primary 
care practices.

                                HIV/AIDS

    Drug abuse plays a significant role in the spread of HIV, not only 
via injection drug use but also by increasing risky sexual behaviors. 
The addictive and intoxicating effects of many drugs can alter judgment 
and inhibition and lead people to engage in impulsive and unsafe 
behaviors. Drug abuse and addiction can also worsen the progression of 
HIV and its consequences, especially in the brain. Thus NIDA is 
supporting preclinical and clinical studies that examine the 
interactions between: drugs of abuse and HIV medication, HIV and 
plasticity (relative to changes that lead to addiction), and HIV and 
neurotoxicity (with regard to the adverse drug effects that result in 
neurodegenerative conditions such as dementia and parkinsonian 
symptoms).
    While all groups are affected by HIV/AIDS, not all are affected 
equally. African Americans bear a disproportionate burden of HIV/AIDS 
in the United States, which may in part reflect data showing that 
African Americans are predominant among those who become aware of their 
infection at later stages in the disease process, and who therefore 
represent lost opportunities for treatment. Because early HIV detection 
helps prevent its transmission and increase health and longevity--and 
is as cost-effective as screening for other conditions such as breast 
cancer and high blood pressure--NIDA is supporting research to make 
testing more acceptable in communities nationwide. To this end, NIDA 
recently held a meeting aimed at improving the rates of HIV screening, 
and is now incorporating the resulting recommendations, which include 
addressing associated stigma and optimizing early diagnosis and follow-
up linkages to care.

                               CONCLUSION

    NIDA's comprehensive research portfolio is strategically positioned 
to capitalize on new scientific opportunities. Groundbreaking 
developments in the field of genomics signify an exciting era of 
research whereby we will be able to identify genes that make a person 
more vulnerable to drug abuse and addiction and devise counter 
strategies. We work toward a future in which early recognition of risk 
for addiction is no different than early recognition of other chronic 
medical diseases. Innovative use of imaging techniques allow scientists 
to design better treatments and more precisely judge their 
effectiveness, even predicting who would be most likely to benefit from 
selected therapies and who might be expected to relapse, so that 
preemptive interventions can be applied. Finally, advances in 
proteomics will help in designing much more sensitive tools to detect 
drug exposures and their consequences for individuals, heralding a 
future where diagnostic kits may be used to screen for drug abuse in 
the medical setting.
    Thank you, Mr. Chairman. I will be pleased to answer any questions 
the Committee may have.

                           DRUG ABUSE FACTORS

    Senator Harkin. You were talking about adolesents who are 
exposed to a parent who is on drugs. What were the other 
factors that can increase the likelihood of addition?
    Dr. Volkow. A parent that is not there because he or she is 
incarcerated, physically abused, sexually abused, neglected, 
mental health problems in the family, low socioeconomic status, 
or poor access to education. These social stressors are 
increasing the risk of substance abuse.
    Senator Harkin. So a factor of 10 is pretty important.
    Dr. Volkow. It is, dramatically.
    Senator Harkin. That is dramatic. So again it seems that 
drug abuse leads a lot of times I think to mental illness--am I 
correct in assuming that?
    Dr. Volkow. Certainly there is unequivocal evidence that 
early exposure, for example, to nicotine can trigger anxiety 
disorders, even with those that do not have the genetic 
predisposition. There is also evidence that it increases the 
risk of depression. There is an enormous amount of discussion 
about the involvement of marijuana smoke on triggering 
psychosis or schizophrenia.
    The thing is that it is happening, but probably depends 
upon having genetic vulnerability. What we do not know is can 
it trigger a schizophrenia-like disorder in someone that does 
not have the genetics.
    So your answer is yes.

                      ADDICTION IN OTHER COUNTRIES

    Senator Harkin. Well, it seems to me that we ought to be 
paying more attention to this other area also.
    Have you looked at addiction in the United States versus 
other countries?
    Dr. Volkow. Yes, I have looked at this and the data are 
disturbing. The United States is at or near the top of most 
international prevalence comparisons across several types of 
illegal drugs.
    Now, with respect to----
    Senator Harkin. That is illicit drug abuse?
    Dr. Volkow. Illicit drug abuse. For nicotine, for example, 
the United States does much better than other countries in 
Europe and in Latin America. With alcohol there is tremendous 
variability. There the United States is not so high-ranking. 
There are certain countries where the rate of abuse of alcohol 
is higher. It is in illicit substances that we are very, very 
high.

                   DRUG ABUSE BEING A CHRONIC DISEASE

    Senator Harkin. The only other point, just a very basic 
question. You talked about drug abuse being a chronic disease. 
How do we know it is really a disease?
    Dr. Volkow. Well, there have been studies both in 
laboratory animals and in humans. In laboratory animals, for 
example, if you do repeated administration of drugs you can 
lead to compulsive administration of drugs in those animals. In 
animals you can actually sacrifice them and look at the 
biochemical changes linked with drug use and they have been 
shown to persist months after the animal has been discontinued 
from the drug intervention.
    In humans now, with imaging technologies we can 
characterize the changes, both functional and biochemical, in 
the brain of people that are addicted. We followed--I used to 
do that before I became Director--these changes after the 
patients go through rehabilitation, and unfortunately many of 
them persist actually years after the person has stopped taking 
the drugs.
    This is consonant with the phenomenology where we see 
individuals that have been able to stop taking drugs for years 
after rehabilitation, where something happens, usually a 
stressor--social stressors are one of the most powerful--and 
they relapse, even though they had not touched a drug in years, 
accentuating the notion that changes are still there, and so 
you become vulnerable. As long as you can manage the situation 
in your environment, you are okay, but if there is the stressor 
that puts you at very high risk.
    Senator Harkin. Senator Specter.
    Senator Specter. No questions at this time.
    Senator Harkin. Now we move to Dr. T.K. Li. Appointed 
Director of the National Institute on Alcohol Abuse and 
Alcoholism in November 2002, Dr. Li got his undergraduate 
degree from Northwestern University, his M.D. from Harvard. Dr. 
Li, welcome. Please take about 5 minutes.

STATEMENT OF TING-KAI LI, M.D., DIRECTOR, NATIONAL 
            INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
    Dr. Li. Thank you, Senator Harkin, Senator Specter. I am 
pleased to be here with my colleagues to tell you about what 
NIAAA does and to update you on some of the new findings.
    Let me first quantify the burden of illness attributed to 
alcohol. I think you have heard about the burden of illness due 
to mental health disorders and drug abuse. In terms of alcohol, 
let me just tell you that the HHS Centers for Disease Control 
and Prevention rank alcohol as the third highest actual cause 
of death, meaning that it is the third most preventable cause 
of death over this country, the first being tobacco and the 
second being poor diet and inactivity. See figure 1.




    Alcoholism also is worldwide and is ranked as the third 
leading cause of disease in developed countries. It is a common 
disease. In this country, actually 1 out of 4 children are 
exposed in a family that has either alcohol abuse or alcohol 
dependence. Eighteen million people over the age of 18 have 
alcoholism and alcohol abuse. The cost estimated is $185 
billion.
    Now, what I will show is a recent realization. See figure 
2.



    That is the variety and the kinds of alcohol problems 
people have is actually different depending on the stage of 
life. So we have crafted our research mission for alcohol 
across the lifespan, from fetus all the way to seniors. Again, 
as indicated, when ill health or diseases appear early in life, 
the burden of illness is high because of the long duration of 
the illness. That is a very important factor.
    Therefore our mission is really to prevent and reduce harm 
as early in life as possible. This is preventing abnormal or 
high level patterns of drinking in pregnant mothers to those 
harmful patterns of use in children and adolescents, and then 
being able to predict the vulnerability factors as both you and 
Dr. Volkow have talked about and then target intervention for 
those who are at high risk for alcohol use disorders. Finally, 
we also want to personalize treatment in the afflicted 
individuals.
    I will give you three examples of what it has been and what 
it is now and what we have for the future. First is that we 
have always thought--that is what I was taught and I think all 
of us at the table probably were--that alcoholism is a disease 
of mid-life, in other words people in their 40s and in their 
50s. We now know that is not so. The highest prevalence of 
alcoholism is actually in our young people from age 18 to 24.
    So in order to be able to be effective in treating and 
preventing the problem, we really should be looking to even the 
younger population. Therefore we are concentrating on and have 
a major initiative to study under-age drinking problems and how 
to prevent the problem. We are pleased to announce that on 
March 6 the Surgeon General issued a call to action to prevent 
and to reduce under-age drinking problems and our Institute was 
responsible for providing the science base for that report and 
we are going to be working with the Surgeon General in 
disseminating the actions that are proposed in that call to 
action.
    Now, what is in the future? In the future, we are working 
actually with NIDA and with NIMH to look at what are the 
personality and temperament characteristics that predispose to 
harmful patterns of behavior in adolescence. I think this is an 
important common thread that speaks to comorbidity in this 
regard.
    The other thing, the second thing we are trying to do, is 
to improve our way of diagnosing the problem. Again, the 
criteria we use to diagnose alcohol, drug and mental health 
disorders is really 1990s vintage. For example, for alcoholism 
it is called a maladaptive pattern of drinking that leads to 
significant impairment and stress, but it does not say what 
pattern or how much, nor can the diagnostic criteria be scaled.
    Our research shows convincingly that we can scale it, the 
way of scaling both alcohol use and alcohol abuse and alcohol 
dependence by current diagnostics criteria and, as you can see 
in the figure here there is a single continuum of severity. See 
figure 3.




    Shown here in red and yellow are the different criteria for 
abuse and dependence, scaled by severity.
    The important question then is what pattern of drinking 
will predict this kind of severity of alcohol dependence? From 
our database we can say that if one drinks in a certain 
pattern, like drinking five or four drinks on an occasion, and 
you repeat this, then you can tap into the severity of alcohol 
use disorder scale, and this may be an important way of 
identifying those who are susceptible from their pattern of 
drinking.
    How does this compare to the rest of medicine? Well, it is 
similar to being able to measure blood pressure and to measure 
cholesterol as a risk for having a future heart attack. 
Therefore, knowing what the blood pressure and cholesterol is, 
then you can treat that and you can interdict in terms of 
future problems.
    So these are some of our current state of knowledge. We 
hope that we can be able to verify this pattern in the future 
and to use this in a clinical setting.

                           PREPARED STATEMENT

    Finally, just to talk a bit about personalized medicine. 
Because of the advances in knowledge of molecular medicine, we 
are developing better and better medications to treat alcohol 
dependence once it has developed. These are our goals for the 
future. Thank you very much.
    [The statement follows:]

                 Prepared Statement of Dr. Ting-Kai Li

    Mr. Chairman and Members of the Committee, thank you for giving me 
the opportunity to update you on the activities of the National 
Institute on Alcohol Abuse and Alcoholism. I am Ting-Kai Li, Director 
of NIAAA, the lead agency for research on the health effects of 
alcohol. I am pleased to be here today with my distinguished colleagues 
from NINDS, NIMH, NIDA, and NIDCD to speak to the theme of Mind, Brain 
and Behavior. Those of us addressing you today have a fundamental 
mission--to reduce the substantial burden of illness caused by 
neurological and mental disorders, and by drug and alcohol abuse. Many 
of these disorders tend to manifest early in life, produce lifelong 
disability, derail individual potentials, and create tremendous burdens 
for families and significant cost to society. In fact, excessive 
alcohol use alone costs the United States an estimated $185 billion 
annually.\1\ The fiscal year 2008 budget for NIAAA includes 
$436,505,000.
---------------------------------------------------------------------------
    \1\ Harwood, H. Updating Estimates of the Economic Costs of Alcohol 
Abuse in the United States: Estimates, Update Methods and Data (2000). 
http://pubs.niaaa.nih.gov/publications/economic-2000/
---------------------------------------------------------------------------
    The HHS Centers for Disease Control and Prevention ranks alcohol as 
the third leading cause of preventable death in the United States 
(figure 1), and the World Health Report ranks alcohol as the third 
leading risk factor for disease in developed countries. Although 
alcohol primarily targets two organs, the brain and liver, it has a 
wide range of effects throughout the body and NIAAA's research 
portfolio encompasses all aspects of alcohol and health. In keeping 
with the theme of this Hearing, I will focus on the brain and behavior.


    As illustrated in figure 2, alcohol can negatively affect the body 
and brain at all stages of life resulting in a range of consequences, 
including consequences from maternal alcohol consumption on the 
developing embryo/fetus to alcoholic liver disease and dementia in 
later life. Throughout the lifespan, it is important to recognize the 
contribution of developmental stage, individual differences--both 
genetic and environmental, and dose and duration of alcohol exposure to 
potential outcomes. The substantially different effects and 
consequences of alcohol exposure at different stages of life 
necessitate different research strategies.



    Today I would like to give you an overview of NIAAA's progress in 
three areas to reduce the burden of illness due to alcohol. First, I 
will describe prevention efforts focused on early life stages. Second, 
I will describe new findings that can be used to improve the diagnosis 
and early detection of alcohol use disorders (AUDs). Finally, I will 
describe efforts to personalize medicine for those suffering from 
alcohol dependence.

                               PREVENTION

    Prevention is a key focus of NIAAA, especially for pregnant women, 
children and adolescents. By altering harmful drinking behavior we can 
significantly reduce the burden of illness due to alcohol. Exposure of 
the developing embryo/fetus can result in alcohol-induced birth 
defects, the most severe of which is fetal alcohol syndrome (FAS), a 
devastating developmental disorder that may include mental retardation. 
Individuals who do not exhibit the extent of symptoms characteristic of 
FAS may still have lifelong physical and/or neurological deficits as a 
result of in utero alcohol exposure. In addition, prenatal alcohol 
exposure itself may be a risk factor for subsequent alcohol dependence 
later in life. Therefore, NIAAA is supporting research to develop 
effective outreach to pregnant women, and approaches to intervene to 
protect against injury in the affected fetus and ameliorate deficits in 
the affected child.
    Prevention in young children is also important, especially for 
those at high risk for early alcohol use. The period from birth to age 
10 is a remarkable period of development, and although relatively few 
children in this age group are drinking alcohol, much is happening that 
will influence their path toward or away from early alcohol use. A 
number of the factors that put children at risk for early alcohol use 
are common to a wide range of adverse behavioral outcomes such as 
delinquency and other substance use. Even as young as preschool age, 
such children often have difficulties with impulse control and exhibit 
unusually high levels of aggression. NIAAA, NIMH, and NIDA are working 
to understand the personality/temperament characteristics that 
predispose to early-onset mental and alcohol/drug use disorders.
    It is also essential to prevent and reduce underage alcohol use. 
Analyses of NIAAA's National Epidemiologic Survey on Alcohol-Related 
Conditions (NESARC) showed that 40 percent of individuals who reported 
drinking before the age of 15 also described their drinking behavior in 
a way consistent with a diagnosis of alcohol dependence. In fact, the 
highest prevalence of alcohol dependence in the United States occurs in 
the 18-24 year old age group. In addition, binge-drinking (i.e. 
drinking five or more drinks per occasion), which is popular with 
today's young people, results in acute consequences such as traffic 
fatalities, alcohol poisoning, suicides, homicides and drownings. Non-
fatal, but potentially life altering consequences such as sexual 
assault and violence also result. As part of a larger effort focused on 
underage drinking research, NIAAA provided the scientific foundation 
for the Surgeon General's Call to Action to Prevent and Reduce Underage 
Drinking and continues to inform the work of the Interagency 
Coordinating Committee on the Prevention of Underage Drinking.
    Recognizing that the brain continues to develop throughout 
adolescence and into early adulthood, NIAAA is investing in research to 
determine the short and long-term effects of alcohol on the developing 
brain and the degree to which it can recover from these insults. Such 
studies, including one in collaboration with NIMH intramural 
scientists, may identify changes in brain wiring that are associated 
with dependence or affect cognitive functioning. In addition, given the 
difference in patterns of alcohol use between boys and girls as they 
move through adolescence, NIAAA is investigating the interplay of 
hormones, brain development and alcohol use.

                               DIAGNOSIS

    It is important to identify individuals who are at risk for adverse 
alcohol-related health outcomes because of their drinking behavior. 
Excessive alcohol intake over time leads to cumulative organ damage, 
especially alcoholic liver disease and increased risk of coronary 
artery disease, stroke and dementia. Early diagnosis of harmful 
drinking would enable health care providers to intervene to prevent a 
range of adverse health outcomes.
    As shown in figure 3, diagnostic criteria for Alcohol Abuse 
currently rely on an individual experiencing one or more alcohol-
related problems associated with either the social or legal system, 
such as being cited for Driving While Intoxicated or problems with a 
spouse or family member. Diagnosis of Alcohol Dependence requires 
meeting three of seven criteria relating to physiological changes such 
as the development of tolerance to increased amounts of alcohol or the 
experience of withdrawal symptoms, behavioral maladaption characterized 
by loss of control and compulsion to drink, and negative consequences 
from this drinking pattern. This categorical approach does not favor 
early diagnosis and intervention.



    Today I report recent findings from analyses of NESARC that will 
improve the diagnosis of alcohol dependence. Further, alcohol abuse and 
dependence have long been treated as independent disorders. New 
findings indicate that they represent a continuum of severity of 
alcohol use problems. The analyses suggest we may be able to use 
questions that reveal an individual's pattern of drinking to identify 
the risk of developing AUDs. In much the same way that numerical 
measurements of blood pressure, cholesterol and triglycerides relate to 
relative risk for cardiovascular disease, the best indicators of 
developing alcohol problems are measures of how frequently an 
individual engages in a harmful pattern of drinking. Specifically, 
recent findings relate data on the frequency of binge drinking and the 
maximum number of drinks consumed to risk for organ damage and to 
alcohol dependence. Through clinical studies, we may be able to 
determine appropriate cut points to define AUDs and also to gauge one's 
risk of developing alcohol problems. Just as physicians treat high 
cholesterol before an individual experiences a heart attack, they will 
be able to intervene before an individual loses control of drinking. 
Diagnosis centered on harmful drinking patterns should also help health 
care providers differentiate between alcohol related neurocognitive 
deficits in the elderly and Alzheimer related dementia.

                        MEDICATIONS DEVELOPMENT

    NIAAA is supporting research on a number of fronts to improve 
treatment options for alcohol dependence. Studies in animal models 
focusing on signaling pathways in the brain have produced additional 
targets for human studies. For example, the anxiety that people with 
alcohol dependence experience when they stop drinking is a powerful 
motivator for them to resume. In addition, stress can trigger relapse 
to heavy drinking after a period of abstinence. Therefore, medications 
are being tested that target molecules involved in biological pathways 
that mediate stress and anxiety such as corticotrophin-releasing 
factor, neuropeptide Y, and nociceptin receptors. Also being tested are 
medications that target the metabolism of endocannabinoids, naturally 
occurring substances in the brain that act on the same receptors as the 
active ingredients of marijuana and have been shown to play a role in 
regulating appetite for alcohol.

                           TREATMENT RESEARCH

    In addition to developing new medications and determining the 
genetic and environmental factors that contribute to the initiation and 
escalation of drinking, it is equally important to understand how 
individuals change harmful drinking patterns. The majority of young 
adults change harmful drinking behaviors without treatment. Adults seek 
treatment when alcohol dependence becomes chronic and relapsing, 
generally in the period of midlife. Data from clinical trials raise the 
question of whether treatment itself is responsible for the improvement 
in drinking behavior or if the positive motivation to seek treatment 
actually underlies a substantial part of the treatment success. 
Further, evidence has shown that a wide array of available therapeutic 
approaches yields similar results, suggesting that it is not the 
particular technique that is responsible for change but other common 
underlying factors. As a result, NIAAA is focusing on addressing 
underlying mechanisms of change across all behavioral treatments, 
identifying the factors that contribute to behavioral change and lead 
to sustained recovery. This research will improve clinical practice 
both by identifying key aspects of therapy that must be present for 
maximum effectiveness and by facilitating the delivery of more finely 
tuned individualized treatment. We also need to be particularly mindful 
of health disparities. A recent study suggests that Hispanics and 
Blacks with higher levels of problem severity were less likely to have 
used treatment services than Whites with problems of comparable 
severity.
    Taken together, these strategies of improved prevention, better 
diagnosis and personalized treatment are expected to reduce the burden 
of alcohol-related illnesses over the long term and lead to better 
health outcomes for the nearly 18 million American adults who, in any 
year, struggle with alcohol use disorders.\2\
---------------------------------------------------------------------------
    \2\ Grant BF, Dawson DA, Stinson FS, Chou SP, Dufour MC, and 
Pickering RP. Drug and Alcohol Dependence 2004. 74: 223-234.
---------------------------------------------------------------------------

                   MEDICATIONS FOR ALCOHOL DEPENDENCE

    Senator Harkin. Well, now that you are on that, what 
medications?
    Dr. Li. Well, we have several. Fifteen years ago all we had 
was Antabuse. Now in the last 8 years or so we have approved 
two other medications. One is Naltrex, both orally taken and 
also by injection; and third is a medication called 
Acamprosate. So these drugs seem to work better for certain 
aspects of alcohol dependence based on severity. We have others 
in the pipeline being developed that will target different 
molecules, different receptors, and these are an important 
vision for the future.

                             NIAAA OUTREACH

    Senator Harkin. Doctor, every Institute out there needs to 
do outreach. Every Institute does outreach to the communities 
around the country.
    Dr. Li. Yes, sir.
    Senator Harkin. How well are you doing in reaching out to 
States and local communities to put into practice some of your 
findings?
    Dr. Li. The three so-called ADM Institutes, we are 
fortunate in that we have a partner in this regard. That is 
SAMHSA. This was created before the three Institutes joined 
NIH. So we do have a partner out there that does the outreach. 
We work with them as well as ourselves in promoting, providing 
the outreach to the public. I think that we do this together. 
There is an inter-agency group that does this.
    Senator Harkin. So you are doing outreach?
    Dr. Li. Yes, sir.

                          ALCOHOL ADVERTISING

    Senator Harkin. Well, I would like to know more about how 
that is done. I will get my staff to get some more information 
on it.
    I wonder about messages that young people receive about 
drinking, all the advertising about the glamorizing of drinking 
alcohol. Of course, it is a free country. People can advertise. 
But I just wonder about the impact of these messages and how 
they are reinforcing young people that it is all right to drink 
and it is all right to maybe even drink a lot, although I 
noticed that some of the beverage companies, if they want to be 
called that, are now putting out things about being responsible 
in drinking. I see a lot of that advertising going on.
    But I am just wondering about the messages young people get 
about drinking. What have you looked into that? How have you 
looked into that?
    Dr. Li. I think this is a very complex issue because there 
are a lot of background of messages coming in, and the 
advertising is only one part of it. So how children respond to 
advertising is a little different depending on how old they are 
and what their context.
    Senator Harkin. Are you doing any research into this?
    Dr. Li. Yes, sir.
    Senator Harkin. You are doing some research in that, the 
different messages and how young people are affected by this?
    Dr. Li. Yes.
    Senator Harkin. Any results?
    Dr. Li. Well, we have some, but as I said, it is difficult 
to be able to dissect out which part is advertising that causes 
an increase in drinking or whether all they are doing is 
changing brands. I think the issue is whether there is an 
increase in drinking because of advertising but data on that is 
very, very slim. I mean, the result is that it is not a major 
influence.

                             BINGE DRINKING

    Senator Harkin. What kind of research are you doing into 
binge drinking, especially among college students?
    Dr. Li. Binge drinking on that model there is the most 
harmful pattern, because physiologically it makes sense. You 
need that much drinking in order to get your blood alcohol to a 
level that is impairing and that is the nature of binge 
drinking, namely drinking to intoxication. Why people do it is 
something we would love to find out.
    Senator Harkin. Are you doing research into this?
    Dr. Li. Yes, we are. It has to do with expectancies, it 
relates to problems which are stress and stressors. When we 
talk to people, young people, why are you drinking, they say, I 
want to drink because I want to get drunk. So it is a different 
approach.
    You must understand that alcohol is the most ancient 
intoxicant, mind-altering drug. There is a lot of history 
there, and to be able to change the culture and what people 
think of it is not easy.
    Senator Harkin. One of the biggest fears that parents have 
when their kids go off to college is just this, binge drinking. 
I do not know the answer to it, but I just wonder if we are 
doing any research into that, what is happening, how it is 
happening, what is motivating young people to do this. I do not 
know. I do not have the answer to that.
    Dr. Li. We have, for example, a site demonstration project 
on college drinking. This is a cooperative agreement. It is a 
demonstration project to look into that, and the study is now 
in its fourth year. I have been on the job 4 years. This is 
something we started when I took over.
    We also have eight or more sites to study under-age 
drinking, meaning in adolescents, in high school level and 
middle school level.

                        CRIMINAL JUSTICE SYSTEM

    Senator Specter. A few questions now, Mr. Chairman.
    Dr. Volkow, since I was district attorney in Philadelphia 
many years ago the incidence of drug addiction has been a 
causative factor in 70 percent of the crimes, and we have not 
been willing to invest in realistic rehabilitation to try to 
stop the chain of recidivism. Is there any answer from your 
research to deal with drug addiction which is within the 
financial reach of what society is prepared to spend on 
corrections?
    Dr. Volkow. Absolutely. In part one of our priorities is 
the criminal justice system, because----
    Senator Specter. You said absolutely not?
    Dr. Volkow. No. Absolutely. It is extraordinarily important 
to actually target substance abuse treatment in the criminal 
justice system. Data have----
    Senator Specter. How do we deal with it effectively within 
some reasonable cost parameter?
    Dr. Volkow. You save out of every $4--out of every $1 that 
you spend on treatment in the criminal justice system, you save 
$4.
    Senator Specter. I am not interested in how much you save. 
I am interested in how much we spend. I am interested in how we 
get my colleagues to spend money for corrections, and the 
inquiry goes to whether there is any answer within what the 
cheapskates in government are willing to spend, to ask the 
question more specifically.
    Dr. Volkow. The cost, what I can tell you, the cost for a 
treatment program on substance abuse is around $10,000 in the 
criminal justice system, and it is $20,000 to incarcerate an 
individual, correct, more or less, on average? So that gets you 
an idea.
    Senator Specter. There is a willingness to spend money for 
incarceration.
    Dr. Volkow. Correct.

                        BRAIN INJURY AND ALCOHOL

    Senator Specter. But not for rehabilitation.
    Dr. Li, I have heard martini drinkers, illustratively, 
express concern about killing brain cells with the alcohol. Is 
that a real risk?
    Senator Harkin. Just martinis?
    Senator Specter. That is what I drink.
    Dr. Li. We know alcohol kills brain cells.
    Senator Specter. It does kill brain cells?
    Dr. Li. Yes, sir.
    Senator Specter. How many and at what rate?
    Dr. Li. I do not know the rate or the number. But we 
certainly----
    Senator Specter. Is it a real danger?
    Dr. Li. It is a result. Is it a real danger to whom?
    Senator Specter. To the people who drink the martinis.
    Dr. Li. Certainly over long periods of time, yes, sir.
    Senator Specter. What would be consumption so that you do 
not become an alcoholic or to a lesser extent impair your 
brain?
    Dr. Li. Well, this is exactly the kind of research we want 
to do, to be able to do to put a quantitative basis to the 
clinical observations----
    Senator Specter. How much more money do you need than $30 
billion that Senator Harkin has provided for you?
    Dr. Li. We have just over $400 million for our Institute's 
appropriation.
    Senator Specter. Dr. Landis, you are the chairman of the 
stem cell----
    Senator Harkin. Could we just finish their testimony so I 
can get their testimony before?
    Senator Specter. That was my suggestion.
    Senator Harkin. I would like to turn to the other 
Institutes and have them at least make their presentations 
before we ask for questions.

                         TRAUMATIC BRAIN INJURY

    Senator Specter. All right. I will go to Dr. Insel.
    We talk a lot about the 3,200 or more men and women killed 
in Iraq. We now find that there are an enormous number coming 
back from Iraq with brain injuries. We do not focus as much on 
the 24,000-plus who have been injured in Iraq. Now medical 
procedures can save lives, but with very material brain 
impairment. There are reports that these young men and women 
are coming back in their 20s, teens, and that they are going to 
need care for a lifetime.
    To what extent can you evaluate those kinds of brain 
injuries and what might be done to provide therapy from the 
kind of research you are undertaking?
    Dr. Insel. I am going to leave the traumatic brain injury 
question to Dr. Landis, whose Institute is more involved with 
that. Let me add what you did not say, which was that the 
greatest proportion are coming back with what looks like post-
traumatic stress disorder. The numbers are significant: 1.4 
million individuals have served in Iraq and Afghanistan. The 
rate now already is about 12-13 percent PTSD. My calculation is 
about 170,000 people who will have PTSD currently or in the 
next couple of years.
    We know that after the Vietnam War the rate went up to 
between 20 and 30 percent overall, so even higher than where we 
are now. So you are talking about a very significant amount of 
disability and high cost. Eighty percent of the time in the 
Vietnam case this was associated with substance abuse, usually 
drug addiction, often leading to criminal behavior as well--a 
tremendous disability at a very high rate from a mental 
disorder that is trauma-induced.
    Senator Specter. Well, what should be the governmental 
response, either through the Veterans Administration of the 
Department of Defense, so that these young men and women and 
their families do not have to bear the burden and the cost when 
it is really not a war of their choosing and their making, but 
a war for the Government, that ought to be borne by the 
Government? What is an equitable response by the Government to 
these kinds of injuries?
    Dr. Insel. Let me talk about what the science can tell us, 
because I think that is where the biggest hope may be. I think 
we can use the science we have now to develop better 
treatments, and that is part of why we have got a major effort 
with the VA and DOD to do just that. More importantly, what we 
do not know is who is going to be sensitive to this. So if 100 
people come back, 13 of them will develop PTSD currently. We 
would like to know who those 13 are and be able to preempt 
this, actually help them to recover before they develop the 
full syndrome. That is right now the target for the 
intervention.
    Senator Specter. Thank you very much.
    Thank you, Mr. Chairman. Let me comment that I think this 
procedure is a good one and the informality is conducive to a 
little easier reparte. I regret that I have to excuse myself. 
We are very heavily engaged right now with the U.S. Attorneys 
and I have to tend to that this afternoon. But Senator Taylor 
will be here in my place and I will be following it closely. I 
know that Senator Harkin joins me in this. We will provide the 
kinds of resources you need to the maximum extent of our 
capabilities, which is now more limited than it used to be. 
Thank you.
    Senator Harkin. That is true. That is very true. Well, 
thank you very much.
    Now we will turn to Dr. James Battey, who has served as 
Director of the National Institute on Deafness and Other 
Communications Disorder since 1998. Dr. Battey got his B.S. 
from the California Institute of Technology and his M.D. and 
Ph.D. degrees from Stanford.
    Dr. Battey, please proceed.

STATEMENT OF JAMES F. BATTEY, JR., M.D., DIRECTOR, 
            NATIONAL INSTITUTE ON DEAFNESS AND OTHER 
            COMMUNICATIONS DISORDERS
    Dr. Battey. Thank you very much, Mr. Specter and Mr. 
Harkin. It is a pleasure to be here today and I would like to 
begin by thanking you for your time, interest, and support over 
the years. It is deeply appreciated by those of us at NIH and 
in particular by the research community that we serve.
    If I could direct your attention to figure 1. I am going to 
refer to some things on them.
    Senator Harkin. By the way, I want you to know I appreciate 
the fact that all of you gave me your testimony last week. I 
was able to look at it over the weekend. I appreciate that very 
much.
    Dr. Battey. It is a particular pleasure to be here with my 
colleagues with whom I work every single day and to share the 
wonderful things that are happening in their Institutes and 
tell you a little bit about what is happening with NIDCD.
    If you turned back the clock to the beginning of the 20th 
century, most Americans made their living with physical labor 
and did not really need great communications skills or a well-
trained mind. But here as we enter the 21st century the 
situation is entirely different. The good jobs, the interesting 
jobs, the important jobs, the high-paying jobs, all involve an 
intact mind that is not impaired by drugs or alcohol, that is 
not bedeviled by mental illness, that allows one to communicate 
effectively.
    One of the most important issues with communicating 
effectively is hearing impairment. It is one of the most common 
causes of a communication disorder and we estimate that roughly 
one American in six has a significant communication disorder 
that compromises their ability to access these high-paying, 
high quality jobs.

                          HOW HEARING HAPPENS

    Now, to help you understand what we are trying to do about 
this problem, I would like to introduce you to the science 
behind how we hear. Now, if you can focus your attention for a 
moment on the center image, you will see a pink snail-shaped 
structure. See figure 1. That is the cochlea. A cross-section 
across that cochlea is shown in the right-hand image. 



    You will see four little blue cells with some little 
projections coming out of the top of them. Those four cells are 
called hair cells, and it is nanometer deflections of those 
little tufts that signal hearing and tell those cells to send 
an electrochemical impulse to the brain. That is how we hear.
    These hair cells are the weak link. They are the vulnerable 
aspect of the hearing organ. They are what is generally lost or 
never developed in individuals who either cannot hear from 
birth or lose their hearing progressively throughout their 
life.
    As long as there are some hair cells left we can amplify 
sound with a hearing aid and help those individuals hear. But 
when virtually all the hair cells are gone, amplification 
simply does not work. That is where research, supported 
initially by NINDS and then by NIDCD after we became an 
institute in 1988, on the cochlear implant has changed 
everything.

                           COCHLEAR IMPLANTS

    There is a picture of a child on the left-hand side wearing 
a cochlear implant, which is also shown in an image in the 
center. It is an array of 22 electrodes that a surgeon inserts 
into that snail-shaped cochlea. See figure 1. It coils around 
and bypasses the damaged hair cells, stimulating the hearing 
nerve directly.
    In an adult that loses their hearing, the cochlear implant 
can often restore the ability to understand speech to the point 
where that deaf individual can now use the telephone. In a 
young child who is born unable to hear, cochlear implantation 
before the second year of life can result in that child being 
mainstreamed in normal schools and be on grade level for 
language literacy and spoken skills. This is really an enormous 
testament to the plasticity of the human brain, to be able to 
go from losing 30,000 hair cells, replace it by stimulation 
from 22 electrodes, and still have the brain be able to 
interpret what it hears as speech. I consider this to be simply 
remarkable.

                         HAIR CELL REGENERATION

    But it would be far better to replace the hair cells that 
have been lost, to undo the damage, rather than simply bypass 
it with an array of electrodes. Birds and fish can regenerate 
their hair cells if they are damaged. Mammals and humans 
cannot. We are looking to understand why there is this 
difference between species who can regenerate hair cells and 
why others cannot. We are beginning to understand the molecular 
mechanisms that underlie how hair cells develop in the first 
place and also how potentially regenerated.

                           PREPARED STATEMENT

    For example, recent studies supported by NIH have shown 
that there is a master regulatory gene called Math-1 whose 
expression is necessary and sufficient for hair cells to 
develop in the first place. Animal models missing the Math-1 
gene never develop hair cells and are deaf. We have preliminary 
data from one laboratory that they can, by stimulating the 
expression of Math-1 in an animal model that has been deafened 
by damaging the hair cells, that partial hair cell regeneration 
could take place and perception of sound can be restored, which 
gives us the hope that the day may come some day when, instead 
of simply bypassing damaged hair cells, we can regenerate new 
ones and provide a whole new approach to helping individuals 
who have lost their hearing.
    Thanks very much for your attention and I will do the best 
I can to answer any questions you might have.
    [The statement follows:]

             Prepared Statement of Dr. James F. Battey, Jr.

    Mr. Chairman and Members of the Subcommittee: I present the 
President's budget request for the National Institute on Deafness and 
Other Communication Disorders (NIDCD). The fiscal year 2008 budget for 
NIDCD includes $393,682,000. The NIDCD conducts and supports research 
and research training in the normal and disordered processes of 
hearing, balance, smell, taste, voice, speech, and language. These 
processes are fundamental to the way we perceive the world and to our 
ability to communicate effectively in modern society. Disorders of 
communication impose significant economic, social, and personal costs. 
Accordingly, the goal of the NIDCD strategy is to produce outcomes with 
a significant impact on the health of Americans. Driven by the public 
health need and scientific opportunity identified in the NIDCD 
Strategic Plan, NIDCD prioritizes its research investment to fund the 
most promising scientific opportunities in diagnosis and treatment of 
communication disorders. The following are notable highlights from the 
past year that are the result of NIDCD support:

                   GENES AND COMMUNICATION DISORDERS

    The NIDCD recognizes that functional genomics--determining the 
identity, structure, and function of genes--is one of the most rapidly 
developing areas of research. Inherited genes account for approximately 
50-60 percent of the severe to profound cases of childhood hearing 
loss. NIDCD scientists are working to understand the normal function of 
these genes, and how they are altered in individuals with communication 
disorders (such as hearing loss, stuttering, speech-sound disorders, 
autism, and dyslexia). These research investments to understand the 
genetic basis of communication disorders will help scientists develop 
diagnostic tests and better treatments for the millions of Americans 
with hereditary hearing impairment.

           PREVENTING AND DIAGNOSING COMMUNICATION DISORDERS

    The Centers for Disease Control and Prevention (CDC) reports that 
two to three out of 1,000 babies born each year in the United States 
have a detectable hearing loss, and estimates the average lifetime cost 
for one individual with hearing loss to be $417,000 (in 2003 dollars). 
Accordingly, NIDCD places a high priority on understanding causes, 
possible treatments, and progression of hearing loss during early 
childhood. NIDCD-supported research demonstrates that children not 
exposed to language during their first 3 years of life due to hearing 
loss will have more difficulty developing spoken or signed language and 
reading skills. Early identification of hearing loss enables parents to 
pursue interventions early enough that their child can learn to 
communicate on par with his or her hearing peers.
    However, childhood hearing loss does not always show up right away. 
Congenital cytomegalovirus (CMV) is the most common viral infection 
passed from a mother to her unborn child, with 40,000 infants born 
infected each year. According to the CDC, approximately 10 to 15 
percent of these children have some degree of hearing loss. Scientists 
believe that CMV infection present at birth is a leading cause of 
sensorineural hearing loss in children. Hospitals do not test newborns 
for CMV unless they already show signs of the disease. NIDCD is funding 
the CMV and Hearing Multicenter Screening (CHIMES) Study to identify 
asymptomatic children and follow them to determine if hearing loss 
develops. Scientists will screen approximately 100,000 children at 
birth for CMV infection, and those who test positive will undergo 
follow-up diagnostic hearing testing to determine the onset, severity, 
and progression of hearing loss. The scientists will use these data to 
understand the relationship between CMV infection and hearing loss and 
to determine whether CMV screening together with hearing testing can 
improve the detection and prediction of permanent hearing loss in 
children.
    Although success in establishing early screening programs has 
identified a new population of children with hearing loss, we do not 
know which interventions provide the best outcomes. Current 
intervention and outcome data are limited to those children whose 
hearing loss was detected later in life. Hearing health specialists 
need research data that considers not only the intervention strategy 
but also the parent-child interaction, socio-economic factors, and 
language exposure. To address this need, NIDCD held a workshop on 
``Outcomes in the Child with Hearing Loss'' in December 2006. NIDCD is 
using information from this workshop to develop fiscal year 2008 
initiatives focused on prospective and longitudinal research. These 
initiatives will be part of a multi-agency collaboration designed to 
close the gap between children with hearing loss and their hearing 
peers, and will provide sorely-needed information on the best 
strategies to achieve this goal.

                      DEVELOPING ASSISTIVE DEVICES

    NIDCD-supported basic research on the ears of the tiny fly Ormia 
ochracea has inspired a new generation of hearing aids. The fly's ear 
structure permits ultra-sensitive time coding and localization of 
sound, and scientists used it as a model to develop miniature 
directional hearing aid microphones that can selectively amplify speech 
rather than amplifying all sounds. NIDCD-supported scientists are now 
working to make these directional hearing aids widely available. 
Individuals with hearing loss who use hearing aids fitted with these 
improved directional microphones will experience improved quality of 
life because the aids will do a better job of helping them to 
understand spoken language amidst background noise.
    Some individuals with severe to profound sensorineural hearing loss 
may benefit from a cochlear implant (CI). The NIH's support has played 
a significant and important role in the development of CI technology 
over the last three decades. A CI converts sound into electrical 
impulses on an array of electrodes surgically inserted into the inner 
ear, bypassing the damaged hair cells that normally detect sound. The 
CI stimulates the auditory nerve directly and restores the perception 
of sound to individuals who are deaf.
    The Food and Drug Administration (FDA) estimates that approximately 
36,000 Americans have received CIs, and one-half of the recipients were 
children. The FDA approved the use of CIs in children as young as 12 
months of age. NIDCD-supported research demonstrates that the sooner a 
child with profound hearing impariment receives the benefit of a CI, 
the greater the benefits and improvements in speech perception and 
language production. Because of the rapid development and plasticity of 
their brains, young children implanted with a CI usually show age-
appropriate brain responses within 6 to 9 months after the CI is turned 
on.
    CIs are expensive (costing approximately $60,000 for the device, 
associated surgical expenses, and postoperative fitting and training) 
and many insurance companies were initially unwilling to reimburse for 
this cost, citing a lack of evidence that the device is cost-effective. 
To address this concern, NIDCD-supported scientists conducted an 
initial cost-utility analysis of the CI in children to examine whether 
the benefits of the implant outweigh its costs. The study showed that 
CIs improve the children's quality of life, and result in a net saving 
to society. The cost benefit is the result of fewer demands on special 
education and greater wage-earning opportunities for CI recipients, 
providing an estimated life savings per child at $53,198. This landmark 
study has helped make CIs a standard treatment for severe-to-profound 
nerve deafness, and many insurance companies now cover them.
    An NIDCD-supported study assessed the sound-localization abilities 
of children (ages 5 to 14 years) wearing two cochlear implants as 
compared to one. Children in the study located the source of a sound 
more accurately when they were wearing two implants as opposed to one. 
The greater the experience with two implants, the more adept he or she 
became at localizing sound. The research team is now investigating the 
effects of bilateral implants on word learning and language acquisition 
in infants and toddlers receiving CIs at a young age.
    NIDCD-supported scientists are currently using lessons learned from 
their cochlear implant research experiences to develop an implanted 
device to help restore the sense of balance. The prototype vestibular 
implant has the potential to benefit over 90 million Americans who have 
experienced a dizziness or balance problem.

                   STRATEGIES TO PROTECT YOUR HEARING

    The NIDCD shares Congress's concerns that approximately 10 percent 
(over 22 million) of American adults have suffered permanent damage to 
their hearing from exposure to loud sounds or noise at work or in 
leisure activities (CDC NHANES). In 1999, the NIDCD collaborated with 
the National Institute for Occupational Safety and Health (NIOSH) to 
launch WISE EARS!. WISE EARS! is a national campaign to prevent noise-
induced hearing loss (NIHL) in the general public, including the 
workplace. NIDCD has built a coalition of nearly 90 partner 
organizations and disseminated information and promotional materials 
through the media, at professional conferences and health fairs, and 
over the Internet. In 2006, the NIDCD conducted an evaluation on the 
WISE EARS! Public Health Campaign to obtain an accurate picture of how 
far WISE EARS! has progressed in achieving its goals and to identify 
those needs that have not yet been addressed through current 
educational and promotional methods.
    Finally, Mr. Chairman, I would like to thank you and members of 
this subcommittee for giving me the opportunity today to present 
exciting scientific advances from the NIDCD. I am pleased to answer any 
questions that you have.

                       REGENERATION OF HAIR CELLS

    Senator Harkin. Dr. Battey, thank you very much.
    Let us get into the whole thing of regeneration of hair 
cells. I do not remember the exact year, but somewhere around 
1990, 1991, I remember getting a paper on the regeneration of 
hair cells and how certain birds exhibited the fact that they 
could regenerate hair cells.
    I engaged in questions with the then-Director----
    Dr. Battey. Is that James Snow?
    Senator Harkin. Dr. Snow, thank you very much. Dr. Snow, 
about that. Yes, and I have asked that question repeatedly. 
That is at least 17 years ago and almost what I hear you saying 
is what I heard 17 years ago. Are you telling me----
    Dr. Battey. Seventeen years ago we were not regenerating 
hair cells in mammals.
    Senator Harkin. Are you now?
    Dr. Battey. Yes, we are. In a guinea pig model----
    Senator Harkin. I thought you told me that it was just 
birds.
    Dr. Battey. They can do it spontaneously. In a guinea pig 
animal model that is deafened--I do not do it; Yehoash Raphael 
does it at the University of Michigan--that deafens the animal 
in one ear by administering a drug called gentomycin, he can 
then express Math-1 in that inner ear and see hair cells 
regenerate, and can show physiological evidence of auditory 
percept in the ear that had been deafened.
    Senator Harkin. How long has he been doing this?
    Dr. Battey. I would have to go back to look. I think 
Yehoash's paper is from 2005.
    Senator Harkin. Recent.
    Dr. Battey. Yes.
    Senator Harkin. Is there more than one locus of this 
research going on right now?
    Dr. Battey. It is now being studied in other laboratories 
and others are hopefully going to replicate his findings. And 
then maybe if that works out we will move forward to non-human 
primates, with the hope of ultimately moving into phase 1 
clinical trials.
    Senator Harkin. When do you think you will be ready to go 
to higher mammals?
    Dr. Battey. I really do not know. I could give you a guess, 
but it would be nothing better than a guess.
    Senator Harkin. Well, you are funding this research?
    Dr. Battey. Yes.
    Senator Harkin. Where is that? University of where?
    Dr. Battey. University of Michigan.
    Senator Harkin. Michigan. Well, if they have been doing 
guinea pigs for a couple years and they have gotten some pretty 
good results, I am just wondering how soon they might be ready 
to take it to a higher order of mammals.
    Dr. Battey. I would say if it replicates nicely in several 
other laboratories, which is the cornerstone of good science, 
then we would be ready to try to stimulate research in non-
human primates. It is a couple of years.
    Senator Harkin. This is a genetic intervention?
    Dr. Battey. Yehoash's work--I am going to get technical 
here a little bit--it is a viral vector that expresses a gene 
called Math-1, which is a master regulatory gene.
    Senator Harkin. Are you saying ``MATH?''
    Dr. Battey. MATH, M-A-T-H, dash 1.
    Senator Harkin. Math-1.
    Dr. Battey. It stands for Mouse Atonal Homolog 1.
    Senator Harkin. That is a little bit hard for me, okay.
    Dr. Battey. I warned you.
    Senator Harkin. It is a viral vector. I understand that. 
Yes, I do have a good feel for that. But I do not know that 
much about how much regeneration they have had and a 
percentage. Is it like 10 percent of the hair cells are 
restored, is it 20, 30? Do you have any idea?
    Dr. Battey. Roughly a third.
    Senator Harkin. About a third?
    Dr. Battey. Yes. Again, it varies from animal to animal 
exactly how well this works.
    Senator Harkin. I thought you said they were just doing it 
in guinea pigs.
    Dr. Battey. I am sorry, from guinea pig to guinea pig.
    Unfortunately, you have to do it in a number of guinea pigs 
to show if the result is reproducible.
    Senator Harkin. A big question then, why is it more in some 
and less than others.
    Dr. Battey. It is a great question. Probably there are 
other genes involved as well. The genetic background may be 
different in one guinea pig than another.
    Senator Harkin. But that is kind of the holy grail of this, 
of what we are looking at in terms of deafness, right?
    Dr. Battey. Hair cell regeneration would be wonderful, not 
just for hearing impairment, but also for balance disorders, 
because there are another class of hair cells in the balance 
organ, which is that part of the inner ear that is right next 
to the snail-shaped cochlea.
    Senator Harkin. Which is why so many older people fall and 
break hips and stuff. As you get older you lose your sense of 
balance.
    Dr. Battey. Yes, roughly--well, dizziness is the most 
common reason why an elderly person consults a physician.
    Senator Harkin. Well, I would like to know more. Anything 
that you have got on what they are doing at Michigan in any 
kind of a form that I can halfway understand, I would 
appreciate seeing it.
    Dr. Battey. I will have my staff abstract something in 
educated lay terms describing the results from the University 
of Michigan.
    Senator Harkin. I appreciate that. How many more 
universities are doing this? What is their timetable, that type 
of thing.
    Dr. Battey. We will get that information for you.
    Senator Harkin. I would like to know about that. Understand 
my concern. I have been hearing about this. Seventeen years I 
have been hearing about regenerating hair cells.
    Dr. Battey. It is a hard problem.
    Senator Harkin. Well, I understand.
    Dr. Battey. I wish that science progressed faster, but 
usually our understanding is incremental and often it is 
serendipitous. For example, the discovery of the importance of 
the Math-1 gene took place in a lab that was not interested in 
hearing at all. They simply knocked the gene out in a mouse and 
the mouse was deaf.
    Senator Harkin. Fascinating.
    Well, that is all I have for right now. I may have others. 
Now we will turn to the National Institute of Neurological 
Disorders and Stroke. Dr. Story Landis has been Director since 
September 2003. Dr. Landis received her undergraduate degree in 
biology from Wellesley and her master's and Ph.D. from Harvard.
    Dr. Landis, welcome and please proceed.

STATEMENT OF STORY LANDIS, Ph.D., DIRECTOR, NATIONAL 
            INSTITUTE OF NEUROLOGICAL DISORDERS AND 
            STROKE
    Dr. Landis. Thank you very much. I, like my colleagues, am 
delighted to have this opportunity to be able to testify today 
about research on mind, brain, and behavior. As I have heard 
from each of us, disorders of brain function are leading causes 
of disability in the modern age, and I think that Dr. Batte did 
a very good job of pointing out some of the issues.
    NINDS is responsible for reducing the burden of several 
hundred neurological disorders. These range from very common 
disorders, like stroke, Parkinson's, epilepsy, to relatively 
rare but individually devastating disorders like ALS--
amyotrophic lateral sclerosis--and spinal muscular atrophy. So 
in addition to the burden in terms of lost life, disability and 
suffering, neurological diseases cause billions of dollars each 
year in medical expenses and reduced productivity.
    Neurological disorders affect people of all ages. We have 
increasing disability in children as a growing problem because 
of brain injury in premature infants who now survive when they 
would not have before. As Americans live longer lives, age-
related disorders like dementia, stroke, Parkinson's, and 
epilepsy are increasing in incidence. Meeting the challenge of 
neurological disorders therefore has never been more important. 
The good news is that the advances in basic and clinical 
neuroscience provide enormous opportunities.
    Now, 20 years ago neurology was really regarded as a 
diagnostic discipline because neurologists had relatively few 
therapies to offer patients. They could tell you what the 
lesion was, but they could not necessarily do anything about 
it. Through NINDS-funded research we have actually made 
extraordinary progress. For example, there used to be only a 
handful of drugs to treat epilepsy and now we have more than 
20. Steroids used to be the only treatment for multiple 
sclerosis, but now there are three FDA-approved drugs and more 
in the pipeline. Deep brain stimulation (DBS) dramatically 
helps many people with Parkinson's disease who are no longer 
benefited by medicines. Turn off the stimulator and they are 
frozen, unable to walk. Turn on the stimulator and in the best 
cases, the ones that make it to ``Dateline'', they can dance.
    Now, while DBS is very exciting, it, like other treatments 
for Parkinson's disease, addresses the symptoms but not the 
underlying causes. The underlying cause is death of brain 
cells. So we need desperately to figure out treatments that 
will protect the neurons that remain. Just last week, NINDS 
began to enroll patients in large phase 3 clinical trials to 
determine whether we can slow the loss of brain cells and 
prevent the slow decline of patients with Parkinson's. We hope 
to begin a second trial of a neuroprotective agent soon.
    As you or someone else alluded to, even just the small 
change in the rate of progression of any of these chronic 
neurodegenerative diseases would make a very big difference in 
the quality of life and how people fared.
    Now, the scientific rationale for the two drugs that we are 
studying in these neuroprotective trials is strong or else we 
would not be funding them. But we really believe, because of 
the discovery of eight genes that cause familial Parkinson's 
disease and our ability to understand how the proteins that 
those genes encode for, we should have much better and more 
targeted drugs soon, and we would then put these drugs into 
neuroprotective trials that would prevent neuron loss.
    So I would like to talk a little bit about stroke. NINDS is 
the lead Institute for stroke. It is in our name. Stroke is the 
third leading cause of death and disability in the United 
States. The good news is that CDC data demonstrate that age-
adjusted stroke deaths have declined from 180 per 100,000 in 
1950 to 50 in 2004. That is age-adjusted, though. So the bad 
news is actually that because our population is aging we are 
barely keeping pace in terms of incidence of stroke.
    NINDS has three strategies for stroke. First is prevention, 
then minimizing damage when a stroke occurs, and finally 
developing better strategies for recovery. In terms of 
prevention, the most important thing is to know what increases 
your risk of a stroke. NINDS has a number of epidemiological 
studies that look at that. The largest of these is called 
REGARDS which has recruited over 30,000 people, half of them 
African American, many in the stroke belt. The goal is to study 
how race and geography influence the incidence of stroke.
    Now, there are already two important findings in this 
study. The first is that there are many more silent strokes--
that is a stroke that does not take someone to the hospital or 
give you an obvious disability--than anybody expected, 
particularly in the middle aged population. The second is that, 
while we have always thought of hypertension as the principal 
risk factor for stroke, we now, based on this REGARDS study, 
understand that diabetes is also very important. So obviously 
NINDS not only needs to partner with NHLBI and the American 
Heart Association for reducing hypertension, but we also need 
to look at partnering with NIDDK and diabetes groups for 
reducing diabetes.

                          DIABETES AND STROKE

    Senator Harkin. Excuse me for interrupting at this point. 
Are you saying that diabetes is a leading indicator for having 
a stroke?
    Dr. Landis. In this population, being diabetic 
significantly increases your risk of having a stroke.
    Senator Harkin. In this population.
    Dr. Landis. In this population of 30,000 people, many of 
them who are not patients yet. We did not expect that but we 
knew about hypertension and not about diabetes. This is not 
surprising. Diabetics are often overweight and do not exercise 
so it is not surprising, but it had not actually been 
demonstrated.
    Senator Harkin. I am just curious again to take this a step 
further. Okay, diabetic, but then have you screened all those 
to look at what has been their cholesterol levels, all the 
other factors?
    Dr. Landis. This has been a recent study, 4 years old, and 
we are just beginning to see the fruits of these initial 
analyses of data. So the first publications are just beginning 
to come out and we are in the process now of accepting an 
application to refund the study. Obviously, the more things 
that we could look at, the better data we would get in terms of 
identifying risk factors and being able then to think about 
interventions.
    So if prevention fails, obviously we want to minimize 
damage when someone has a stroke. The NINDS Institute a decade 
ago had a clinical trial that showed that the clot-busting 
drug, TPA, could restore blood flow to the brain and prevent 
brain damage if it was given within 3 hours of stroke onset. I 
can tell you very honestly that this transformed acute stroke 
care in this country. You did not get shuttled off to a dark 
room and given an aspirin. You actually got aggressively 
treated. I think it has been a model for how other neurological 
diseases can be treated.
    Now, this treatment really benefits patients, obviously. A 
third of the patients who get this treatment leave the hospital 
with no sequelae whatsoever. It reduces long-term disability-
related costs and there is a net savings of more than $4 
million for each 100 patients treated because you do not have 
to do long-term care and rehabilitation.
    We are currently running clinical trials to boost the 
effectiveness of TPA, to select patients who might benefit 
beyond the current 3-hour limit, and to determine whether if 
you inject the TPA into the blocked brain artery you get more 
benefit than if you just do it intravenously.
    Now, if you have a stroke, we need to help people recover 
from it. Because of animal studies, we know that there is 
remarkable plasticity in the adult brain. Because of that 
plasticity, investigators that were funded both by NINDS and 
NICHD forced stroke patients to use the affected arm and this 
stimulated the formation of new brain connections, and a 2-week 
study of rehabilitation based on this insight showed lasting 
clinical improvement in arm function for stroke survivors.
    So it is very clear that increasing the brain's latent 
capacity to rewire and/or repair itself is an extremely 
exciting area for research in NINDS, and will also impact many 
other brain disorders.
    I want to, in closing, underscore two points that were made 
by the panel of outside scientists at last week's hearing. I 
thought they were very impressive. I watched it on C-SPAN. The 
first is we need to encourage new ideas and new investigators. 
You go to any scientific meeting and most of the people in the 
audience, who are speaking and presenting have grey hair and, 
while they will make advances--I mean no offense to the grey 
hair because I have it myself--they will make advances over the 
next decade, but we will not cure many of our diseases. We will 
improve treatment, but not cure them in the next 10 years so 
that is a very important issue.
    The second is the importance of NIH basic research, both 
for the public health of the Nation and the competitiveness of 
our private sector. Now, while each of the institutes that we 
represent has a distinct mission, the structure requires that 
we answer fundamental and shared questions about the brain, 
such as how genes and the environment shape the brain and how 
the brain represents thoughts, emotions, memories, sounds, and 
leads to behavior. Answers to these questions are key to 
preventing all kinds of brain diseases, as well as learning how 
to optimize brain health and help all our citizens realize 
their full potential.

                           PREPARED STATEMENT

    So recognizing that we share the brain and the significant 
synergy that will come from collaboration, the institutes 
represented here along with others who will testify in 
different hearings created the Neuroscience Blueprint for the 
extramural community and the Porter Neuroscience building in 
the intramural program, which I would say is not completed. We 
would be pleased to tell you more about the blueprint and the 
Porter building during the question period.
    I would like to thank you very much for your attention and 
your support.
    [The statement follows:]

               Prepared Statement of Dr. Story C. Landis

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2008 President's budget request for NINDS. The mission 
of NINDS is to reduce the burden of neurological disorders by 
developing ways to prevent or to treat these diseases. The fiscal year 
2008 budget is $1,537,019,000.
    Disorders of the nervous system, common and rare, affect people of 
all ages. They cause an enormous burden in lost life, disability, and 
suffering, as well as billions of dollars each year in medical expenses 
and reduced productivity. Because Americans are living longer, stroke, 
dementias, Parkinson's disease, epilepsy, and other neurological 
disorders that rise in frequency with age are increasing. Abnormalities 
in nervous system development rob many children of a normal life. As 
more premature infants survive through intensive care, neurological 
disability in children is a growing problem. Many people, often young 
adults, now survive trauma to the spinal cord or brain, but confront a 
lifetime of disability. Meeting the challenge of neurological disorders 
has never been more important, but the opportunities for progress have 
never been greater. Advances in neuroscience are transforming the 
practice of neurology from diagnosing patients, with only inadequate 
treatments to offer, to intervening to stop or prevent disease, with 
treatments tailored to each person. Neurosurgery is likewise 
increasingly capable of preventing or repairing damage to the brain.

                      IMPACT OF CLINICAL RESEARCH

    NINDS has its most immediate impact on public health through phase 
III clinical trials, which test the safety and efficacy of 
interventions. It is essential to assess the return on this investment 
in improving quality of life. At the request of the National Advisory 
Neurological Disorders and Stroke Council, the institute contracted for 
an independent evaluation of the costs and benefits of all NINDS phase 
III clinical trials conducted from 1977 to 2000 [The Lancet 367:1319-
27, 2006]. The total cost of the clinical trials in the study was $335 
million (adjusted to 2004 dollars). Over 10 years, the benefits 
exceeded $15 billion and added 470,000 healthy years of life to people 
in the United States. For the entire period of the study, the benefits 
surpassed $50 billion, which was greater than the total NINDS budget 
over that period ($29.5 billion). Advances in neuroscience are yielding 
more clinical trial opportunities than ever before, but trials are 
expensive and take years to complete. NINDS is developing computer 
models to estimate in advance which trials would have the most impact 
on public health.

                   TRANSLATING PROMISE INTO PROGRESS

    Because of progress over the last decades, thousands of strokes are 
prevented each year and emergency treatment lessens chronic disability 
for many people who do have a stroke. Data this year from the Centers 
for Disease Control and Prevention (CDC) show that age-adjusted stroke 
deaths are continuing to decline, from 65.3/100,000 in 1990 to 50.0/
100,000 in 2004, compared with 180/100,000 in 1950. Better surgical 
treatments and drugs also help people who have chronic pain, dystonia, 
epilepsy, migraine, multiple sclerosis, neuropathies, Parkinson's 
disease, and many other diseases. Brain imaging has revolutionized 
neurology and neurosurgery. For many people, genetic testing eliminates 
arduous and expensive diagnostic odysseys to determine which of the 
hundreds of neurological disorders is responsible for their problems. 
NIH research drives this progress.
    A decade ago an NINDS clinical trial showed that the clot busting 
drug tPA was the first emergency treatment that could improve the 
outcome from stroke. This engaged the community in stroke education, 
stimulated the organization of more than 250 certified primary stroke 
centers nationally, and energized researchers to develop even better 
emergency care. In the future, combinations of tPA and neuroprotective 
therapies will rescue brain tissue from permanent damage, and rapid 
diagnosis will identify which patients will benefit from what 
interventions while the critical time window for intervention is still 
open. This year NINDS investigators showed how MRI brain imaging can 
improve diagnosis for patients who come into emergency rooms with 
suspected strokes, and other scientists are developing rapid blood 
tests for stroke using genomic fingerprinting. Several strategies to 
boost tPA's effectiveness are in development, including clinical trials 
of ultrasound to help break clots quickly, and direct injection of tPA 
through a catheter threaded into the blocked brain artery for patients 
with large clots that are difficult to clear. Clinical trials of 
interventions, studies of risk factors, and gene studies will also 
continue the momentum of stroke prevention, with increasingly 
personalized guidance. This year, to illustrate that trend, NINDS-
funded researchers discovered a gene variation, more common in African-
Americans, that predisposes young women who smoke to have strokes.
    For people who do have a stroke, neuroscience is offering new 
approaches to recover lost functions. New understanding of brain 
plasticity suggested that, counter to intuition, forcing patients to 
use an affected arm would stimulate adaptive changes in the brain. A 
two week behavioral rehabilitation regimen based on this insight 
yielded lasting clinical improvements for stroke survivors who had 
chronic weakness in one arm. Studies are building on this strategy, 
using behavioral methods, drugs, and brain stimulators to engage the 
brains' natural capacity to adapt, and even generate new brain cells. 
Enhancing the brain's latent capacity to repair itself may also help 
people recover from traumatic brain injury and many other disorders.
    A decade ago, spinal muscular atrophy (SMA) was one of hundreds of 
poorly understood inherited disorders that affect the nervous system, 
and the outlook for developing treatments was bleak. The discovery of 
the gene defect that causes SMA revealed a rational strategy for 
developing drug therapy. In just a few years, the NINDS SMA Project 
developed a detailed drug development plan and tested hundreds of new 
compounds in laboratory tests. Most recently, some of these potential 
drugs increased the amount of the critical missing protein to normal 
levels in cultured cells from patients who have SMA. The SMA Project is 
testing the effectiveness of these compounds in animals with SMA and 
assessing their safety to bring these potential drugs to clinical 
trials, offering significant promise for helping people who have SMA.
    Research on SMA illustrates the path from gene to understanding to 
treatment. Researchers have now characterized well over 200 mutations 
that cause neurological disorders. For inherited ataxias, Batten 
disease, Down syndrome, Huntington's disease, muscular dystrophy, Rett 
syndrome, neurofibromatosis, and many other previously baffling 
disorders, researchers have genetically engineered animals that mimic 
the human disorder and then replaced genes, turned harmful genes off, 
turned up compensatory genes, or counteracted gene defects with drugs 
that target the affected cellular functions. In the future, application 
of these strategies to patients could preempt or even reverse the 
damage caused by gene defects. NINDS is aggressively pursuing 
opportunities to translate science advances such as these to 
treatments.
    The goal for epilepsy is ``no seizures, no side effects,'' or 
better yet, to prevent epilepsy from developing. In the 1960's only a 
handful of drugs were available to treat epilepsy. Today there are more 
than 20, which control seizures in about two-thirds of people who have 
epilepsy. Ten were developed with special programs at the NIH, and the 
NINDS Anticonvulsant Screening Program continues to catalyze academic 
and industry efforts. New animal models will allow screening potential 
drugs for people who have treatment-resistant epilepsy and for blocking 
epilepsy development. Clinical trials are now testing interventions to 
prevent epilepsy after head trauma, a major risk factor. Gene studies, 
now underway, will enable physicians to personalize treatment, choosing 
the best drugs or other therapies for each person with epilepsy, 
avoiding the current trial and error process.
    Drugs that are the mainstay of Parkinson's disease treatment mask 
symptoms but ultimately fail because they do not slow the underlying 
neurodegeneration. Deep brain stimulation (DBS) dramatically helps many 
people with advanced Parkinson's disease. NIH research, from technology 
development to clinical trials, is improving DBS and expanding its use 
for other neurological and psychiatric diseases. Researchers are also 
developing drugs to slow neurodegeneration itself. NINDS assessed 
candidate neuroprotective drugs for Parkinson's disease, conducted 
early phase clinical trials, and is beginning a large clinical trial of 
a neuroprotective drug. Even a modest slowing of Parkinson's or other 
neurodegenerative diseases would have an immense impact on public 
health, so drugs to forestall neurodegeneration are a high priority.
    Stem cell research has captured the public's attention. Research on 
animals with Parkinson's-like disease illustrates the promise and 
challenge of stem cell therapy. In recent tests, stem cell-derived 
transplants dramatically improved movement, but also produced tumors in 
some animals. Stem cell therapies for spinal cord injury, muscular 
dystrophy, and many other neurological disorders continue to advance 
toward the clinic. However, better control of stem cells is necessary 
before these therapies are ready for people, so understanding the basic 
biology of stem cells is essential.
    Scientists are also making progress in answering fundamental 
mysteries, such as how genes and the environment shape the brain and 
how the brain represents thoughts, emotions, and memories. Answering 
basic questions such as these is the key to not only treating disease, 
but knowing how people can maintain a healthy brain and realize their 
full potential at every age.

                        PLANNING FOR THE FUTURE

    NINDS continuously monitors research needs and opportunities. The 
institute recently posted a mid-course review of the Stroke Progress 
Review Group and a new plan for Parkinson's disease. An epilepsy 
conference this month will follow up the meeting that launched the 
epilepsy benchmarks planning process. More broadly, NINDS is beginning 
a process to update its strategic plan. With input from all 
stakeholders, we will identify aspirational goals that will guide us to 
best achieve our mission and then focus on what steps NINDS can take to 
realize this vision. In order to achieve our paramount goal of reducing 
the burden of neurological disorders, we must certainly continue to 
support young scientists, to engage the ingenuity of the scientific and 
medical community, to work with the private sector, and to collaborate 
with other components of the NIH, as we now do through the NIH Roadmap, 
the NIH Blueprint for Neuroscience, working groups on specific 
diseases, as well as dozens of specific inter-institute initiatives.
    Thank you, Mr. Chairman. I would be pleased answer questions from 
the Committee.

    Senator Harkin. Dr. Landis, thank you very much.
    Let me--I have got quite a few questions here. First of 
all, talk to me about something that you mentioned in your 
written statement. I am hearing more and more about the 
debilitating effects of migraine headache.
    Dr. Landis. Right.

                           MIGRAINE HEADACHES

    Senator Harkin. I saw some figures, I cannot repeat them 
here because I do not have them here, but just how prevalent 
migraine headaches are. More and more I am meeting people who 
have migraine headaches. I have had some people who have worked 
for me in the past who have had them and it is just very 
debilitating.
    So what is happening? Why? What is the story?
    Dr. Landis. It is not completely clear. What is completely 
clear is that there are several different causes of migraine 
headaches and that if you have mutations in particular kinds of 
ion channels you can have migraine, and that it can be a 
spreading depression. We have, fortunately, over the past 
decade developed a number of treatments which can forestall a 
migraine once it begins. We also have learned in some cases 
that long-term treatment with calcium channel blockers can 
prevent migraines.
    We do not know as much as we should. It is an area that has 
not received as much attention as it might. NINDS recently 
released a request for applications specifically in the area of 
migraine headaches. We recognize it is an underserved area and 
hope to stimulate research in it.
    Senator Harkin. I do not know whether I am just hearing 
more about it now and finding more people. Is it increasing in 
prevalence?
    Dr. Landis. I do not think it is increasing. I think people 
are more attentive to it than they have been before. One of the 
problems with being an Institute like NINDS is making choices 
between stroke and Parkinson's and migraine. We are hoping in 
our planning process to undertake over the next 2 years, a look 
across all the diseases that we are responsible for and see the 
ones that we have perhaps not invested in as much as we might.
    Senator Harkin. One disease that you know that I have been 
interested in, I did not even know about it until a few years 
ago, but the more I have looked at it the more I have seen what 
you have been doing at the Institute on it. It seems to me that 
you are making great progress in understanding spinal muscular 
atrophy, which I had not heard of until a few years ago. I have 
met with some people in my home State with children who have 
that and others.
    The more I have learned about it, the more I think that 
there may be in this research area applicability to other 
diseases. You have identified the gene, I think.
    Dr. Landis. We did not, but it has been identified.
    Senator Harkin. It has been identified. Somebody did.
    Dr. Landis. Right. The Europeans actually, I think.

                        SPINAL MUSCULAR ATROPHY

    Senator Harkin. Oh, is that right? Sorry to hear that. But 
that is all right.
    Tell me about the progress on spinal muscular atrophy, 
because I keep hearing that this has some connectivity to other 
types of diseases.
    Dr. Landis. There are two pieces of our investment in 
research in spinal muscular atrophy that I think are important. 
The first was the Institute decided a number of years ago that 
we would try an experiment, which was to identify a particular 
disease, a devastating disease. In SMA, kids lose their motor 
neurons, and in babies many of them die within the first year. 
Some of them die within 4 to 5 years depending on the type. We 
would try to identify a particular disease which was amenable 
to a concentrated investment, a focused effort in therapeutics 
development.
    After a survey of many of the diseases that we were 
responsible for, SMA emerged as the likeliest candidate for 
this experiment. Mutation occurs in the SMN-1 gene. There is a 
second gene, SMN-2, which codes for the same protein, but does 
it much less effectively. We had compounds which we knew could 
increase the levels of SMN, Survival of Motor Neuron protein. 
So we put a big chunk of money, $20 million, into a contract to 
actually come up with at least one drug that would have an 
investigational new drug designation within 4 years, or the end 
of 2007. We are not going to make the end of 2007 because it 
turned out that what we had to do is actually create a virtual 
biotechnology company through this contract.
    But we are making significant progress. We recently filed a 
patent for one chemical backbone and have a number of compounds 
in there which cross the blood-brain barrier which 
significantly increase the amount of SMN protein. We are taking 
those compounds to animal studies to see which is the most 
effective in increasing the survival of these animals.
    So it is an experiment for the Institute to see if we can 
actually push forward therapeutics in a very significant way 
and make a difference. Then the other issue is that these are 
the same neurons that die in ALS. The kinds of things that 
might promote survival of motor neurons in SMA might also be 
instructive for ALS. The mechanism--the failure to make a 
splice--again a technical term--is apparent in a number of 
other diseases we are responsible for. If we can figure out a 
way to make the splice work, we might use that same strategy in 
other diseases.
    So it has a number of very interesting implications for the 
Institute in how we manage rare diseases and how we move from 
one rare disease to another.

                                 STROKE

    Senator Harkin. You mentioned that deaths have declined due 
to stroke, but I just wonder about the incidence of stroke. I 
do not think the instance of stroke is down.
    Dr. Landis. No. Age-corrected deaths due to stroke have 
decreased. The incidence is not decreasing because our 
population is aging.
    Senator Harkin. Well, also I think we have better 
interventions, too, for stroke.
    Dr. Landis. Right.
    Senator Harkin. I think stroke remains still one of the 
feared things that can happen to someone. They are just so 
unexpected and can happen to anyone at any time. It is that 
early intervention if you can get to it right away that helps, 
if you get that----
    Dr. Landis. TPA.
    Senator Harkin. What is it called? TPA.
    Dr. Landis. Tissue Plasminogen Activator.
    Senator Harkin. TPA.
    Dr. Landis. TPA.
    Senator Harkin. I am also interested in Parkinson's 
disease. In your testimony you talked about deep brain 
stimulation for Parkinson's disease. Again, how much progress 
is being made in this?
    Dr. Landis. We are presently conducting with the Veterans 
Administration a clinical trial to determine whether deep brain 
stimulation is better than best medical treatment. A group in 
Europe has already produced some data that are consistent with 
that, but we want to make sure that that is in fact true.
    The second issue is where do you put the stimulating 
electrode. So some people, some surgeons, put it in something 
called the GPI and others put it in the STN, and we do not know 
which locus is better. So the second part of this NINDS-VA 
study is to determine where is the best place to put it.
    One of the most surprising things is that deep brain 
stimulation actually works for a number of other neurological 
diseases--dystonia, Tourette's--and has shown to have benefit 
for chronic untreatable depression. So the notion of putting 
stimulating electrodes in the brain and altering patterns of 
brain activity may be applicable to more than just neurological 
diseases.

                   TRANS-CRANIAL MAGNETIC STIMULATION

    Senator Harkin. A year ago or so maybe, I was visiting my 
office. A friend of mine brought a person in, a woman who had 
been to Greece--she had Parkinson's disease--to undergo some 
new therapies. The way she described it to me, she had pictures 
of it. It was some doctors in Greece, some scientists, had 
developed like a helmet they put over her head, but it did not 
penetrate the skull, but it was like----
    Dr. Landis. Trans-cranial magnetic stimulation probably.
    Senator Harkin. Thank you. I had no idea. Probably so if 
you say so.
    Dr. Landis. Well, that is a strategy that we are looking at 
in this country as well.
    Senator Harkin. This woman came back, and it did not cure 
her of Parkinson's, but it really alleviated the symptoms 
greatly for her. So I do not know if you are looking at 
anything like that.
    Dr. Landis. Obviously, if you could get changes in 
activity, circuitry, without having to stick electrodes in the 
brain, that would be preferable. NINDS and the Department of 
Defense are exploring the use of trans-cranial magnetic 
stimulation as an alternative to deep brain stimulation.
    Now, the problem with deep brain stimulation is it does not 
stop neuron cell death. I think Dr. Fischbach when he testified 
and said that we would have a cure for Parkinson's in 5 or 
maybe 10 years actually really believed in his heart that the 
change in activity from deep brain stimulation would promote 
survival of neurons in Parkinson's, and that has been a 
disappointment. It has not done that. But it does provide 
symptomatic relief.

                     POST-TRAUMATIC STRESS DISORDER

    Senator Harkin. Dr. Insel, I have been told that 1 out of 
every 3 returning Iraqi veterans--this is sort of a follow-up 
on what Senator Specter asked--1 out of 3 seeks mental health 
help some time during the first year. Now, whether that is 1 
out of 3 or 1 out of 4, it is very high. That is just those who 
actually seek it. What about those that do not? How many more 
out there that are trying to tough it out?
    Any thoughts on why it is so prevalent and why these 
returning vets are having mental health problems and why the 
incidence? It seems to me--now, maybe I am wrong, but the 
incidence of post-traumatic stress disorder is going up, and 
sometimes PTSD does not exhibit itself for months afterward, 5 
months, 6 months, 7 months afterward.
    Talk to me a little bit more about post-traumatic stress 
disorder. What is it? Is it more prevalent now than in the 
past? How about all these returning veterans who are having 
mental health problems? Is this more than any war in the past? 
Do we know? Maybe we do not even know that. I do not know.
    Dr. Insel. We do not know yet. Post-traumatic stress 
disorder plays out over many, many months and sometimes years. 
We often now think about post-traumatic stress disorder as a 
failure of recovery. Everyone after a traumatic event is, in 
lay terms, shell-shocked. They have symptoms. They have trouble 
sleeping. They may be preoccupied by the event. They have a 
need to talk about it all the time. We would all feel negative 
impactly if the event is traumatic enough, and it does not have 
to be combat. It could be a car accident. We have all 
experienced this.
    Most people can talk it through and recover and 6 months 
later, it is a distant memory. They are able to sleep and not 
use alcohol or illicit drugs to cope with this. For some 
reason, and it is not due necessarily to the degree of trauma. 
It has more to do with the individual vulnerability to 
traumatic events and their psychological sequelae. Some people 
do not recover in the way that most of us do. Those are the 
people who develop PTSD. The numbers range from 13 to 16 
percent in the current war. In the Vietnam War the numbers were 
higher. But that is over a longer period of time.
    We will have to see. The assumption would be that if the 
numbers are 13 percent now--and as I mentioned before, that 
equates to about 170,000 affected individuals. One would think 
that they will go up even further over the next year or so. 
Often the way it happens is that people are coping well enough 
until there is a second hit. They watch a movie that reminds 
them of the trauma. They have a loss in their life. They have 
some stressor that then tips the balance, and they then emerge 
with full-blown symptoms.
    Senator Harkin. Of course, your institute is actively doing 
research in post-traumatic stress disorder?
    Dr. Insel. Absolutely. We have decided through much of this 
effort to collaborate with DOD and with the VA. So we have a 
large effort. Actually we have a joint RFA, a request for 
applications, that has been funded, where we have half the 
grants and they have the other half. We work together with them 
because this is where we think the need is greatest.
    Where we would really like to go with this is to understand 
this individual pattern of vulnerability, to identify who needs 
the early intervention, before the point where someone develops 
all of the secondary aspects of PTSD, the depression, the 
alcohol abuse, the substance abuse, and at that point preempt 
all of that by being able to get to them early.

                              NIMH BUDGET

    Senator Harkin. Your Institute's budget for next year is 
$1.4 billion.
    Dr. Insel. Right.

                           BASIC NEUROSCIENCE

    Senator Harkin. What would be the largest sector where that 
money would go for research?
    Dr. Insel. The single largest--we have five research 
divisions and the largest one of them is in the basic 
neuroscience arena. We really are trying to get at the question 
you asked before, actually the critical question, understanding 
the pathophysiology of these illnesses. It is not just a matter 
of tweaking the drugs that we have now and figuring out how to 
use them best. That is important, but we want to get to a point 
where we have a new generation of compounds that we can think 
of as either preventive interventions or cures, really raising 
the bar on what we expect for interventions. That is going to 
require having a much better fundamental understanding at the 
level of molecules and cells and brain systems about how 
something goes wrong to give you the psychosis of 
schizophrenia, the hopelessness of depression, the symptoms of 
PTSD. We do not know that. We know a little bit about how to 
treat them, but we need to know a lot more of the fundamentals.
    That has been our biggest effort.

                                 STRESS

    Senator Harkin. Dr. Insel, would you be the proper person 
that I would ask this question of? I am going to ask it, but 
maybe it is another Institute. I do not know. The effect that 
stress plays in diseases. I have read a lot about in science 
magazines and other things that more and more the high factor 
of stress, both in perhaps getting a disease, but in the 
generation of that disease after you get it and how it 
progresses, that stress is an indicator for how ill you might 
become.
    So are you looking at stress? Is this part of your $1.4 
billion, looking at stress and how stress levels affect a 
person's ability to ward off diseases and illnesses or become 
more susceptible because they have a higher level of stress? Is 
that you or is that somebody else?
    Dr. Insel. That is a number of us. Dr. Volkow talked about 
that at great length and her specific interest is on 
developmental stress and how it can tease up an individual to 
be responsive later with pathological behaviors like addiction. 
NIMH has a similar interest, but it is more focused on 
depression, where we know that children who have been stressed, 
particularly at certain vulnerable times in development, are at 
much, much greater risk for depression after puberty or even 
into young adulthood.
    The mechanism by which that happens is where our interest 
now is taking us. We want to know, what is it about stress that 
affects one individual to make them subsequently very depressed 
or drug addicted and the next individual takes the same event 
and they somehow get immunized, they get stronger from having 
been challenged in some way. We do not know enough to 
understand those individual differences.
    So that is where a lot of our effort is going, finding 
again the molecular and cellular substrates of how stress 
affects the brain is we think one of the ways to get there.
    Senator Harkin. But you are--somewhere in this whole big 
$1.4 billion, you do have research on stress that is ongoing, 
dealing with how stress relates to physiological problems?
    Dr. Insel. Absolutely. It is a big part of our effort in 
terms of mechanisms, understanding mechanisms, and a lot of 
that is going on in animal research, where we can really 
control many of the variables and look specifically at what 
stress is doing. Dr. Volkow can tell you about some of the work 
they are doing as well in looking at the long-term effects of 
stress.

                     GENETIC FACTORS FOR ADDICTION

    Senator Harkin. I was going to ask Dr. Volkow about that. 
Oh, yes, I know. You were talking about the environmental 
factors to drug abuse, but you said that genes--I wrote this 
down because it really sounded almost too neat--50 percent of 
the factors are genetic for addiction.
    Dr. Volkow. Correct.
    Senator Harkin. You really hold that it is 50 percent?
    Dr. Volkow. 50 percent, and actually this is very 
consistent and reproducible. The vulnerabilities for becoming 
addicted is at least 50 percent, analytically determined. The 
other 50 percent is your environmental factors involved with 
it. You know, with animal experiments what we are trying to do, 
of course, is identify which genes make you vulnerable. We have 
come to recognize that there are going to be genes that make 
you vulnerable to experiment with drugs which are going to be 
different from those genes that are going to make you 
vulnerable--if you get repeated exposure, you may or may not 
become addicted. Approximately 10 percent of people will. Those 
genes that we identified evidently are linked with the process 
of plasticity and also involving learning and memory.
    So it appears that for you to have the vulnerability, you 
have the genes that will be much more likely to be modified by 
environmental exposure to drugs to create new connections, but 
then are likely to be driving the compulsive intake of drugs.

                          STRESS AND ADDICTION

    Senator Harkin. Following up on that, it would seem that 
stress does play a high part, a big part, in people getting 
addicted to drugs, to relieve stress or they get stressed out. 
They want to smoke or they want to drink or they want to----
    Dr. Volkow. Take marijuana.
    Senator Harkin [continuing]. Take marijuana or more serious 
drugs.
    Dr. Volkow. Yes, and we are very much interested, and we 
have from the perspective of basic science, we have known for 
many years with the epidemiological data that environmental 
stressors, and in particular social stressors are some of the 
most profound in human subjects. We are very, very sensitive to 
social stressors. We have known that they affect our 
vulnerability to addiction. It is clear when people are in war, 
for example, which is very stressful, drug abuse can go up in a 
way to cope with the stress. Or if you come up with an 
environment where you have been physically abused or sexually 
abused, more likely to take drugs.
    What we did not know is why and what is the social stressor 
doing to your brain that makes you more vulnerable. For 
example, there have been studies now both in rodents and in 
primates that show that social hierarchical structure and 
pending on the level, if you are dominant versus subordinate, 
can modify specific proteins that regulate, modulate your 
vulnerability to take drugs.
    So if you are in an environment and very subordinate in a 
system that is very stressful to be a subordinate, then those 
proteins go down and that leads you to a facilitation of taking 
drugs. That is what I was highlighting. Of course, the 
challenge now is how can we buffer. If someone is born into 
that environment, if we learn how does that stress produce 
those changes, how can we buffer an intervention to be able to 
rehabilitate, to go back to recover some of those changes that 
is the basic perspective.
    We are also very interested in the mean time to do 
interventions and to evaluate the extent to which specific 
prevention interventions are useful. For example, we take for 
granted social skills. A child that has poor social skills 
predicts higher likelihood that they will take drugs. So 
something that makes a lot of sense, intuitive sense. Why do we 
not as a prevention strategy identify those kids that are 
unable to negotiate interactions with their peers as a 
prevention effort? It will be beneficial not just for drug use, 
but also for mental illness.
    So that is the sort of thing that we are also encouraging 
from the prevention behavioral intervention.

                               HEAD START

    Senator Harkin. That is what the Head Start program is for. 
Yet Head Start I think gets about half of the eligible 
preschoolers now. By the way, Head Start is not an educational 
program; it is a social skills program with education added in. 
A lot of people think Head Start is education. It is not that. 
That is why it is in the Department of Health and Human 
Services, not in the Department of Education. I do not know why 
I am telling you all this, but anyway.
    But the idea was to give these kids that kind of social 
interaction and that type of thing. But the problem is that we 
do not pay Head Start teachers well enough. We do not get 
qualified, a lot of qualified people in there with Head Start.
    So anyway, it just goes back to what you say about getting 
those early interventions.
    Dr. Volkow. Correct.
    Senator Harkin. Which we know are predictors for drug abuse 
and for mental health problems and for drug abuse.
    Dr. Volkow. Also can, for example, prevent criminal 
behavior, which is something that of course we just hinted at.

                             NIH BLUEPRINT

    Senator Harkin. Well, that is for a different thing.
    One last question and this is for all of you. All the 
Institutes here today have been involved in a collaborative 
effort called the NIH Blueprint for Neuroscience Research. Dr. 
Landis, I will start with you and we will just go down. What is 
this effort? What has been achieved? What are you doing, and 
what are the plans for next year, and how do you all 
participate and kick into this? So just tell me about the NIH 
Blueprint for Neuroscience Research so I can better understand 
it.
    Dr. Landis. A number of years ago we recognized that 
Institutes which funded research in the neurosciences had 
common interests, common goals, and common needs, and set out 
to actually create a collaborative environment. Once a month 
all the Institute Directors or Center Directors participate in 
this meet to discuss important initiatives, fund workshops and 
requests for applications and share best practices.
    We have a modest budget. Each of us chips in money to a 
central pot that represents a fraction, a very small fraction, 
of the amount of money from our budget that funds neuroscience. 
We discuss as a group what are the most important and the most 
interesting ways we can spend that money. We have funded 
training programs that benefit all the institutes. We have 
funded the generation of mutant mice which benefit all the 
Institutes.
    Several years ago we thought, instead of just investing in 
tools, that we might want to invest in some science. We picked 
three themes, neural degeneration, neural development, and 
plasticity, and have been working through those themes once a 
year. I have to say, you know, it is pretty amazing that we can 
get each of the Institute Directors to show up once a month to 
talk about science and initiatives, but we have done it. I 
think all the institutes in the neurosciences are a lot 
stronger for having done this.
    I am sure this is a little like an elephant, where I have 
just given you the trunk, someone else might give you a leg.
    Senator Harkin. Are you a leg, or what are you?
    Dr. Landis. He is the ear.
    Senator Harkin. Oh, he is the ear, of course.
    Dr. Battey. There is not a lot I can add to Story's 
beautiful description of the blueprint, other than to maybe 
make two observations. We were talking earlier about Math-1 and 
the mouse knockout that led us to the discovery that it was 
essential for hair cell development. That was not my grantee. 
That was her grantee [indicating], Louis Ogbee in Texas, did 
that.
    Dr. Landis. He actually was picking up on a gene discovered 
in drosophila that is required for the development of a 
particular kind of external sensory neurons, and he said, gee, 
why do we not figure out what it does in mammals.
    Dr. Battey. So my point is that the neuroscience Institutes 
have remarkable overlap in the experiments that need to be done 
to move this forward. We also have remarkable overlap in the 
needs. For example, Story has mentioned many times neuronal 
degeneration and I have told about hair cell degeneration. It 
is almost certain that many of the mechanisms that underlie 
degeneration of neurons are going to be the same ones that are 
going to be involved in degeneration of hair cells.
    So by pooling our resources and generating common reagents 
and resources, we leverage each other's science and advance the 
science of my relatively modest sized Institute is advanced 
enormously by the discoveries made in mental health, neurology, 
and the other neuroscience Institutes.
    So in particular for the smaller Institutes, the blueprint 
has been a really wonderful thing.
    Senator Harkin. Anybody else? Dr. Volkow, Dr. Li?
    Dr. Li. I would echo what Dr. Battey said. The NIAAA being 
a small Institute, we benefit tremendously from this 
collaboration, especially when it comes to not only just 
providing resources, but in having projects that are of joint 
interest, such as neural degeneration, neural development, and 
neural plasticity. This is the value of it.
    Dr. Volkow. I think I want to commend the notion that the 
big frontier after the genome is to understand how the human 
brain works, which is extraordinarily complex. We now have 
extraordinary tools to actually look inside the human brain, 
and not just look at its morphology but how it functions. So 
this has given us an opportunity, all of us together, to invest 
resources to understand how, for example, the brain changes as 
a function of development, something that would have been 
extraordinarily costly for one single institute. By putting our 
funding together, we can start to get the standardized data set 
that any investigator outside can go in to query, and that 
gives us the perspective to start with, for example how does 
the brain change as we grow from childhood to adolescence to 
adulthood. This is just an example about how powerful it is to 
integrate our efforts.
    Dr. Insel. I know we are going to be having to stop in a 
moment, so I would say that in terms of both the Neuroscience 
Blueprint and everything else that you have heard for the last 
almost 2 hours, we could not have done any of this without your 
support and the support of Senator Specter when he served as 
chair. I think I speak for all of us to say how grateful we are 
for all that you have done on our behalf.
    We are entirely committed to making a difference for the 
American people, but we only do it because you are there to 
help us along. We are delighted to have a chance to tell you a 
little bit about, and this is really a very little bit, about 
what all of us have been involved with. But most of all, we 
want to say thank you for being such a leader for us in this 
regard.
    Senator Harkin. You are very kind, Dr. Insel, but I will 
not let you have the last word on that.
    I want to thank all of you. It has been very enlightening. 
I enjoy this kind of a setting. I just learn things. I think it 
is very helpful to have this kind of a discussion among the 
institutes over at least a couple hour period of time. We will 
be continuing this process with other institutes.
    But in that regard of what you were just saying, Dr. Insel, 
let me return the favor and the compliment by thanking each one 
of you, each one of you, for a lifetime of dedication to 
research, to science, to doing the things that help to try to 
improve our quality of life and the way people live, to cure 
illnesses and diseases, to help people who may be at rope's 
end, and especially in mental health. They just have nowhere to 
go and they do not know what to do. You have been making great 
progress in these areas, all these areas. There is great hope 
out there for all of the things we have done, the genetics and 
stem cells, with new interventions coming on, some of the 
things that you talked about, Dr. Landis. Of course, you know 
of my intense interest in deafness and communications 
disorders. We are making significant progress in areas, 
although I want to move faster, as you can imagine.
    Dr. Battey. So do I.
    Senator Harkin. I know you do, Dr. Battey.
    Alcoholism, drug abuse, again all these areas.
    I just close by saying thank you. I thank each of you. I 
just hope that young people today will look upon each one of 
you as role models, as something to aspire to, to get involved 
in research, to get involved in science, to take it up as life 
work, and to think about the good that they can do during a 
lifetime of service.
    What we do at NIH, what each of you do, leaves a legacy 
that just cannot be expressed in monetary terms. It can only be 
expressed in terms of people's lives and how much better kids 
are today and how much better their lives are. To me it is just 
the best work that I can imagine anyone doing. I hope that we 
have another generation of Dr. Insel's and Volkow's and Li's 
and Battey's and Landis's coming along.
    That is my way of saying thank you very much, and I look 
forward to continuing our discussions and information that you 
would have for the subcommittee at any time. We will be doing 
our budget, getting our things worked out. But I think you have 
a lot of support here and I know that Senator Specter and I 
have worked together on this now for, we are going on almost 20 
years together on this committee. We have a great partnership. 
I could not ask for a better friend and partner. Whether he is 
chairman or I am chairman, it has not made a lick of 
difference. I just hope that we will have the finances and the 
budget and the money in order to help you do your work and to 
encourage these younger scientists coming along to know that 
this is something that they can dedicate their lives to and 
that they will be able to get the funding that will enable them 
to do their research and to do their work.
    It is going to be very tough. It is going to be very tough. 
I remember when I was a kid watching--it is funny I would think 
of this right now, but we used to watch GE Theater on 
television and the host was Ronald Reagan. I remember GE's 
theme at that time was ``At General Electric Research Is Our 
Most Important Product.'' I think that is what we have got to 
be about here. Research is our most important product, and you 
do it well.

                     ADDITIONAL COMMITTEE QUESTIONS

    There will be some additional questions which will be 
submitted for your response in the record.
    [The following questions we not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

               Questions Submitted by Senator Tom Harkin

                    CLINICAL TRIALS NETWORK AND NIMH

    Question. Dr. Insel, I understand that the large clinical trials 
that NIMH has undertaken in recent years (CATIE on schizophrenia, STEP-
BD on bipolar disorder, STAR-D on treatment resistant depression, TADS 
for child and adolescent depression) are now coming to an end. Each of 
these studies involved development of multi-site clinical trial 
networks that served a large number of subjects in real world treatment 
settings. What efforts are underway at NIMH to ensure that the 
important clinical research infrastructure that has been developed 
continues to help answer important questions about new treatments for 
mental illness?
    Answer. The National Institute of Mental Health (NIMH) is providing 
infrastructure support to maintain three large networks of 
investigative clinical teams that have evolved from the practical 
clinical trials on major depressive disorder (Sequenced Treatment 
Alternatives to Relieve Depression--STAR*D); schizophrenia (Clinical 
Antipsychotic Trials of Intervention Effectiveness--CATIE); and bipolar 
disorder (Systematic Treatment Enhancement Program for Bipolar 
Disorder--STEP-BD). At the same time, NIMH has been funding a child and 
adolescent clinical practice network. The networks comprise over 60 
sites throughout the United States with continual outreach and 
engagement to diverse groups of patients and families with mental 
illnesses. Therefore, the networks are ideally suited for addressing 
the kinds of real-world ``effectiveness'' questions that require large 
and diverse samples and aim to have an impact on clinical practice.
    The overarching principle guiding the networks is to conduct 
research designed to improve the mental health of the public and help 
better inform clinicians. To accomplish this, research must be informed 
by broad scientific and public input. In December 2006, NIMH issued a 
Request for Information (RFI) to solicit suggestions for the most 
important research directions and projects for the networks. The RFI 
sought input from investigators, stakeholders, and individuals living 
with mental illnesses, as well as additional expert advice and guidance 
from the National Advisory Mental Health Council. Advice was also 
sought from the NIMH Alliance for Research Progress--a group of patient 
and family advocates representing national voluntary organizations 
devoted to public mental health. Feedback from these efforts is being 
used to develop a list of key research questions and topics. The 
Institute is currently reviewing this input and will give high priority 
to those that have the greatest potential for using resources of the 
networks to improve the effective use of existing treatments and 
further development of new interventions.

                       BIPOLAR DISORDER RESEARCH

    Question. Dr. Insel, several years ago, Congress requested NIMH to 
undertake a national research plan on bipolar disorder. This request 
resulted in the current research plan on mood disorders at NIMH. Please 
update the subcommittee on the mood disorders research plan and what 
NIMH is learning about the causes and new treatments for bipolar 
disorder.
    Answer. NIMH continues to make strides in elucidating the causes of 
and determining new treatments for mood disorders, including bipolar 
disorder (BD). Much of this work is guided by goals laid out in 
``Breaking Ground, Breaking Through: The Strategic Plan for Mood 
Disorders Research.'' In addition, yearly progress in research on 
depression is reported through the Government Performance and Results 
Act as one of the stated goals for GPRA is to demonstrate through 
research, reductions in the burdens associated with depression. As one 
example, in fiscal year 2006 NIMH and its NIH collaborators were able 
to report significant progress as a result of the Sequenced Treatment 
Alternatives to Relieve Depression (STAR*D) study of nearly 2000 
depressed patients treated at 41 sites across the nation, including 
several primary care sites. This landmark study showed that up to 70 
percent of those with persistent depression can be successfully 
treated, yet may need to try several different treatment strategies. By 
analyzing specific individual patient characteristics, including genes, 
NIMH funded scientists are now discovering the keys to personalizing 
and optimizing treatments for depression.
    As outlined in the mood disorders strategic plan, NIMH undertakes 
numerous approaches toward the determination of the underlying causes 
of BD. While BD has long been known to be heritable, scientists have 
been unable to identify the key genes involved. Recently, BD has been 
the focus of a large international effort using whole genome 
association, a powerful, new approach that permits a screen for 
variations across the entire genome. Results from 7,000 BP patients and 
controls should be available later this year, providing the first 
large-scale, comprehensive scan of genes which contribute risk for BD. 
Even with these genes, we know that bipolar disorder is not easily 
diagnosed, especially in children. A recent NIMH-supported study found 
that BD could be distinguished from another similar childhood syndrome, 
severe mood dysregulation, through the measurement of the brain's 
electrical signals. This finding could significantly inform future 
efforts in diagnosing BD as early as possible.
    In terms of improving treatment, in 1998, NIMH undertook a large, 
national research program to determine best treatment practices for BD. 
Concluded in 2005, the Systematic Treatment Enhancement Program for 
Bipolar Disorder continues to inform the field. Recent publications 
addressed predictors of recurrence for those that had achieved recovery 
and the effectiveness of different medications in treating those 
patients who had not shown improvement despite several treatment 
attempts. According to another recent report, for depressed people with 
bipolar disorder who are taking a mood stabilizer, adding an 
antidepressant medication is no more effective than a placebo. These 
results indicate that careful management of mood stabilizer medications 
is a reasonable alternative to adding an antidepressant medication for 
treating bipolar depression. In addition, patients taking medications 
to treat bipolar disorder are more likely to get well faster and stay 
well if they receive intensive psychotherapy.

                     OBSESSIVE-COMPULSIVE DISORDER

    Question. Dr. Insel, what recent advances have been made in the 
area of obsessive-compulsive disorder?
    Answer. Obsessive-Compulsive Disorder is an anxiety disorder that 
is characterized by recurrent, unwanted thoughts (obsessions) and/or 
repetitive behaviors (compulsions). NIMH has funded several areas of 
research to understand the causes of and potential treatments for OCD. 
By studying families with members affected by OCD, NIMH-funded 
scientists have discovered regions of several chromosomes that may 
contain OCD susceptibility genes. Previous studies have suggested that 
the brain chemical serotonin may mediate the compulsive behaviors 
associated with OCD. Recent work has shown that mice with deletion of 
certain serotonin receptor genes exhibit impulsive and compulsive 
behaviors (e.g. burying marbles), suggesting that these mice could be 
used as models of OCD, and further studies of the serotonin system may 
provide clues to the etiology of OCD.
    Using magnetic resonance imaging, NIMH-funded researchers found 
that the pituitary glands of children with OCD were smaller than those 
of healthy children. The investigators speculate that the smaller 
volume in patients with OCD might be an effect of abnormal regulation 
of endocrine function. Further studies might lead to methods for early 
detection of the disorder.
    OCD in adults is known to be a disorder of many different symptoms, 
but studies have shown that certain symptoms tend to cluster together. 
Recent NIMH-funded research has revealed several types of symptom 
clusters--or symptom dimensions--in children and adolescents (e.g. 
hoarding obsessions and compulsions; symmetry, ordering, and 
repeating). These symptom dimensions closely mirror those reported in 
adults with OCD, suggesting relative stability across the course of 
development. Understanding how these symptoms cluster may help 
researchers identify the underlying causes of OCD.
    Other NIMH-funded studies have suggested a possible link between 
psychosocial stress and exacerbation of OCD symptoms. In a recent study 
of children who had OCD, Tourette syndrome (TS), or both OCD and TS, 
psychosocial stress significantly predicted whether OCD symptoms would 
worsen in the future. The results suggest that monitoring parental 
reports of stress, and intervening as appropriate, may help to prevent 
symptom exacerbations.
    Several NIMH-funded studies have focused on treatments for OCD. A 
recently completed study led to the development of a manual for 
psychosocial treatment of young children with OCD, with encouraging 
results on the efficacy of its use. A newly funded study is testing a 
treatment approach that incorporates self-administered, exposure-based 
behavior therapy as a low-cost option before implementing therapist-
administered exposure. Another study has yielded encouraging pilot 
results on the efficacy of deep brain stimulation for severe treatment-
refractory OCD. Finally, NIMH intramural researchers have evaluated 
azithromycin and penicillin as a prophylactic treatment for a subtype 
of OCD; both treatments appeared to reduce exacerbations of OCD 
symptoms.

                                 STROKE

    Question. Dr. Landis, the NINDS made a great advance against stroke 
with the advent of tPA, the clot-busting drug that can reduce 
devastating disabilities if given within three hours of the onset of 
stroke symptoms. Please highlight any recent advances that will help 
alleviate the burden of this disease.
    Answer. Researchers funded by the National Institute of 
Neurological Disorders and Stroke (NINDS) are making considerable 
headway into alleviating the burden of stroke, both in preventing new 
strokes and in treating strokes acutely and chronically. With respect 
to stroke prevention, NINDS-funded researchers have recently 
demonstrated that individuals at risk for stroke may benefit from 
taking multiple preventative therapies, including antiplatelet 
inhibitors like aspirin, angiotensin-converting enzyme (ACE) 
inhibitors, and/or statins. These agents exhibit a variety of effects 
that may lower the risk for future strokes, including reducing cellular 
stress and inflammation and improving blood flow in the brain. To test 
the impact of these therapies in combination, investigators conducted a 
retrospective study of more than 200 patients who presented within 24 
hours of stroke onset. Results indicated that individuals taking all 
three drugs exhibited less severe strokes than did people on a two-drug 
combination, antiplatelet inhibitors alone, or no stroke prevention 
therapy. Imaging data also suggested that patients on triple therapy 
had less at-risk tissue surrounding the damaged regions of their brains 
and that triple therapy appeared to be linked to shorter hospital stays 
and better function at hospital discharge. Although these data are 
preliminary, they provide support for the further exploration of the 
impact of this combination regimen on the prevention of severe strokes.
    With respect to acute stroke treatment, many potential new 
therapies are in the pipeline. Research teams in the NINDS-funded 
Specialized Programs of Translational Research in Acute Stroke 
(SPOTRIAS) are exploring many different options to treat acute stroke, 
including a combination of ethanol, caffeine and hypothermia for 
neuroprotection; the efficacy of using a clot-removal device to improve 
post-stroke outcomes; adding extra drugs to the clot-buster tissue 
plasminogen activator (tPA) that may increase the potency of tPA in 
disrupting a clot, so that less tPA is needed; and the delivery of the 
potential neuroprotectant magnesium sulfate by emergency responders, to 
try to prevent cell loss by intervening as early as possible for acute 
ischemic stroke.
    Rehabilitation following stroke has also entered a new era, since 
National Institute of Child Health and Human Development (NICHD) and 
NINDS-funded research demonstrated in 2006 that constraint-induced 
movement therapy--a rehabilitative technique that involves forced use 
of a partially paralyzed arm--could promote a 34 percent faster 
recovery in the affected arm than could standard therapy if applied 3-9 
months after stroke, and could contribute to an increased ability to 
perform tasks of daily living with the impaired arm and hand. These 
results provide evidence of significant intervention efficacy from one 
of the first major large-scale randomized trials of stroke 
rehabilitation and investigators are now hoping to test this therapy in 
a phase III trial at even earlier time points after stroke.

                          PARKINSON'S DISEASE

    Question. Dr. Landis, despite the constraints presented by a flat 
proposed budget, there are agreed-upon, high-priority research areas 
for Parkinson's disease. Please describe what the NINDS is doing to 
ensure that those high-priority areas are getting treated as high 
priorities and are being funded, and in a timely manner. Do you have a 
strategic plan for Parkinson's disease research that includes a budget? 
Are you following it? Does it include funding for those high-priority 
research areas?
    Answer. The National Institute of Neurological Disorders and Stroke 
(NINDS) leads the implementation of PD research efforts at the National 
Institutes of Health (NIH), in large part by following the priorities 
outlined in its 2006 PD Research Plan (http://www.ninds.nih.gov/
funding/research/parkinsonsweb/PD_Plan_2006.htm). The Institute 
considers these needs, along with those in many other disease areas, 
each time it assesses potential grant solicitations and other programs 
for future implementation. While NINDS does take priorities from its PD 
planning efforts very seriously, it does not develop specific budgets 
for any of its disease plans prior to their implementation, since 
appropriations and other emergent public health needs and opportunities 
are not known in advance. In the past, the absence of specific budgets 
for disease priorities has not hindered progress. In the first five 
years of the implementation of the PD Research Agenda, NIH and NINDS-
funded researchers made tremendous progress on several fronts, 
including advances in understanding the genes involved in inherited PD 
and the unexpected contributions made by screening large numbers of 
genes for clues regarding the role that genetic variability may play in 
sporadic PD. Researchers also made substantial progress in 
understanding how PD occurs at a cellular level and how treatments like 
gene therapy may be able to protect against further brain 
deterioration. NINDS is poised to continue this progress, and the 
Institute has already provided funding to address a number of 
priorities identified in the 2006 PD Research Plan. Examples of two of 
these programs are provided below.
    First, the 2006 PD Plan highlighted further exploration of the non-
motor aspects of PD--which can include sleep abnormalities, fatigue, 
behavioral and cognitive impairments, anxiety, and depression--as a 
major research priority. As just one example of possible implementation 
of this priority, the external scientists and members of the PD patient 
community who developed the Plan's recommendations strongly suggested 
that non-motor manifestations of PD be assessed in more clinical 
trials. The NIH Exploratory Trials in Parkinson's Disease (NET-PD) 
phase III trial--a large, randomized clinical trial of the potential 
neuroprotective agent creatine--will address this need directly, by 
exploring the ability of creatine to improve some of the non-motor 
features of PD in addition to its ability to slow the progression of 
the motor symptoms.
    Second, the 2006 PD plan also identifies PD biomarkers, which 
enable clinicians and researchers to track disease risk, activity, 
progression and response to treatment, as a very high priority for the 
field. In October 2006, the NINDS and the other NIH Institutes and 
Centers participating in the NIH Blueprint for Neuroscience Research 
program addressed this recommendation by issuing a grant solicitation 
to encourage research on biomarkers for neurodegenerative diseases, 
including PD. This solicitation elicited a vigorous response from the 
research community and the grant applications are currently under 
review.

                     OUTREACH ON ADDICTION RESEARCH

    Question. Dr. Volkow and Dr. Li, what are your institutes doing to 
infuse your research on addiction into local treatment centers--where 
the rubber meets the road? How does NIDA and NIAAA work with States, 
and the directors of State substance abuse systems, to ensure that the 
research done by NIDA and NIAAA reaches into our local clinics and 
treatment systems to make a difference?
    Answer. NIAAA is engaged in considerable outreach to increase use 
of research-proven treatments in community treatment centers. First, 
NIAAA has produced a variety of research summaries and practical tools 
to assist in dissemination and implementation of research findings. The 
2005 Edition of the NIAAA Clinicians Guide (updated in 2007) has been 
very popular for health care professionals. NIAAA staff are currently 
working on training programs for health care professionals centered 
around the Guide, a version of the Guide for non-prescribing 
professionals, and a Self-change Guide (called ``Rethinking Drinking'') 
aimed at consumers and concerned others. Second, NIAAA staff work 
closely with SAMHSA staff, providing research summaries, advice, 
participation in various work groups, and written and computerized 
tools to assist SAMHSA staff in their interactions with States systems 
and directors. Third, NIAAA works with other federal agencies such as 
VA, AHRQ, DOD, CDC and CMS to facilitate implementation of new research 
on treatment.
    NIDA is taking a collaborative approach aimed at proactively 
involving all entities invested in changing the system and making it 
work better--so that research results do not linger the customary 15-20 
years before they are implemented as part of routine patient care. One 
way this occurs is through the testing of drug abuse treatment 
approaches directly in the community settings where they will be used 
with real-world populations by counselors trained to implement them. 
This is the work of NIDA's National Drug Abuse Treatment Clinical 
Trials Network (CTN), which not only involves practitioners from 
community treatment programs (CTPs) in formulating research protocols, 
but also in providing real-world feedback on their success and 
feasibility.
    NIDA is taking a similar approach to enhance treatment for drug-
addicted individuals involved with the criminal justice system through 
our CJ-DATS (Criminal Justice-Drug Abuse Treatment Studies) initiative. 
Research supported through CJ-DATS is designed to effect change by 
bringing new treatment models into the criminal justice system and 
thereby improve outcomes for offenders with substance use disorders. It 
seeks to achieve better integration of drug abuse treatment with other 
public health and public safety forums, and represents a collaboration 
of NIDA, the Substance Abuse and Mental Health Services Administration 
(SAMHSA), the Centers for Disease Control and Prevention, Department of 
Justice agencies, and a host of drug treatment, criminal justice, and 
health and social service professionals.
    In addition to testing and evaluating protocols in the settings in 
which they will be used, NIDA works with our colleagues to create 
change at multiple levels and bridge the divide between scientific 
findings and their implementation. Our Blending Initiative exemplifies 
this approach and involves regular stakeholder conferences, a 
partnership with SAMHSA to support the work of Addiction Technology 
Transfer Centers (ATTCs) in training and disseminating research-based 
practices to community practitioners, and our ongoing relationship with 
State representatives and substance abuse directors. The Blending 
Initiative is helping to catalyze change by ``seeding'' the field with 
research-based practices and innovative products to facilitate their 
use. Specifically, Blending Teams made up of practitioners and 
researchers develop training modules and other dissemination products 
based on NIDA research, and thereby help implement and sustain 
effective drug abuse treatments in myriad settings.
    On way in which NIDA continues to build and enhance our productive 
partnership with state directors of substance abuse agencies is through 
annual meetings with their national association--the National 
Association of State Alcohol and Drug Abuse Directors (NASADAD)--to 
identify strategies for accelerating the adoption of evidence-based 
practices into State drug abuse prevention and treatment programs. We 
are gratified that State directors now consistently look to NIDA for 
credible information about selecting, implementing, and sustaining 
science-based and cost-effective treatment and prevention 
interventions.
    For example, NASADAD has embraced the promise of buprenorphine as 
an opioid abuse treatment option, developing a State Issue Brief on the 
topic and probing States for their specific needs. In response, States 
have identified technical assistance needs and areas where their 
Addiction Technology Transfer Centers (ATTCs) could provide support 
(e.g., training, best practice guidelines, dissemination packets, and 
strategies to further partnerships with physicians). Their feedback 
suggests new and expanded roles for existing treatment program medical 
directors of State Alcohol and Drug Abuse agencies. Moreover, most 
States have already begun aggressive outreach programs to approved 
physicians to provide them with expanded training and educational 
opportunities, both directly and in partnership with other entities.
    NIDA views the translational process as comprising systems-level 
factors aimed at continuous improvement. In that vein, a collaborative 
initiative--the NIDA-SAMHSA RFA, ``Enhancing State Capacity to Foster 
Adoption of Science-Based Practices''--encourages state agencies to 
team with research organizations to optimize their research 
infrastructure for evaluating delivery of publicly supported drug abuse 
treatment or prevention services. Several grants received initial 
funding in fiscal year 2006 to facilitate adoption of meritorious 
science-based policies and practices, including developing ways to 
measure and track program fidelity, promote adoption of research-based 
practices in addiction treatment, and streamline data collection and 
reporting requirements.
    Enhancing the adoption of research-based practices by state-based 
systems is a strong NIDA commitment and will continue to be a top 
priority since it ensures that new scientific discoveries are 
translated into prevention and treatment interventions that are adopted 
by the community.

                         ADDICTION AND OBESITY

    Question. Dr. Volkow, how are findings from your research linked to 
obesity?
    Answer. Animal studies and brain imaging studies in humans reveal 
similarities in the way circuits and neurotransmitter systems act in 
the rewarding effects of both food and drugs of abuse (e.g., opioids 
and other peptides, dopamine, cannabinoids). When imaged, the brains of 
both obese and drug-addicted people show a surge in dopamine when 
presented with food- or drug-related stimuli, respectively, and both 
show similar reductions in availability of dopamine receptors, 
suggestive of a less responsive reward system. Further, both obesity 
and drug addiction can be characterized by excessive, repetitive 
behaviors often marked by the inability to change or stop in the face 
of severe negative health consequences.
    Given these parallels, few fields offer as much potential for 
cross-fertilization as addiction and obesity research. In the treatment 
arena, it is noteworthy that some of the behavioral interventions 
beneficial for treating drug addiction (e.g., incentive motivation, 
cognitive--behavioral therapy) may also be helpful in treating obesity, 
and several potential candidates for the pharmacological control of 
food intake (e.g., the cannabinoid receptor antagonist Rimonabant and 
the appetitive molecule orexin) also show promise for drug addiction.

                           UNDERAGE DRINKING

    Question. Dr. Li, on March 6, the U.S. Surgeon General issued a 
``Call to Action on Underage Drinking'', which underscored that alcohol 
``remains the most heavily abused substance by America's youth.'' It 
also calls for changing public attitudes toward youth alcohol use. That 
includes making it harder for young people to have access to alcohol. 
Are you doing any research on the most effective ways to reduce the 
availability of alcohol to underage youth?
    Answer. NIAAA's comprehensive research portfolio on reducing 
underage drinking addresses both the demand for alcohol by youth as 
well as their access to it. Both components include approaches that 
target individuals, families, schools, communities and the overall 
environment. To reduce the appeal of alcohol to youth, NIAAA supports 
research on positive youth development including the ability to resist 
alcohol and other drugs. To address the supply of alcohol to youth, 
NIAAA supports a number of studies on the most effective ways to reduce 
the availability of alcohol to underage youth from late childhood 
through age 21. For example, some studies are testing the effectiveness 
of campus-community coalitions in reducing underage alcohol use by 
students in America's colleges and universities. These include 
promising studies comparing campuses that adopt comprehensive community 
interventions with control campuses that are doing business as usual. 
Other research studies are addressing neighborhood and community level 
interventions. For example, a recent study showed that an intervention 
for 15-29 year olds incorporating community mobilization, community 
awareness, responsible beverage service, underage alcohol access law 
enforcement and intoxicated patron-law enforcement was effective in 
reducing sales to minors as well as adverse outcomes related to alcohol 
in the targeted age group. At the community and state level NIAAA is 
funding studies evaluating the effects of policy changes on underage 
drinking. In addition, NIAAA is evaluating two separate community based 
OJJDP initiatives both of which include components aimed at reducing 
the availability of alcohol to youth. One is focused on rural 
communities in seven states and the other is focused on four Air Force 
bases and their surrounding communities.



    Question. We all know that young people are exposed to a wide range 
of messages in the media about alcohol--both positive and negative. Are 
you doing any research on how their exposure to these messages affects 
whether they will become dependent on alcohol?
    Answer. Given that early initiation of alcohol use, and especially 
early binge drinking, is associated with an increased risk of future 
alcohol dependence, it is important to identify factors that influence 
a young person's decisions about drinking. With respect to media 
influences, NIAAA funds research addressing the relationship between 
underage drinking and exposure to messages about alcohol, including 
advertising. However, assessing the effect of advertisements on the 
drinking behavior of individuals or populations is complicated. It is 
often difficult to ascertain the specific effects of advertising since 
they must be measured against a background dense in alcohol messages 
and images. Nevertheless some interesting findings have emerged. For 
example, in a widely-cited recent study, investigators interviewed a 
sample of youth aged 15 to 26, from 24 Nielsen media markets, on four 
occasions over a period of 21 months about their drinking. Advertising 
exposure in the study was measured both subjectively in terms of 
reported exposure and objectively in terms of advertising expenditures. 
It was concluded that each additional advertisement seen increased the 
number of drinks consumed in the past month by 1 percent. Further, 
youth in markets with greater advertising expenditures drank more: for 
each additional dollar spent per capita, the number of drinks consumed 
per month increased by 3 percent. More longitudinal studies such as 
this are needed.
    In addition, who sees/hears alcohol advertising and who is affected 
by it is an important issue. While almost all persons are exposed to 
significant amounts of alcohol advertising, youth may be at risk for 
overexposure. Others such as dependent drinkers, or those in recovery, 
for whom alcohol ads may provide drinking cues or triggers, may be 
especially vulnerable to advertising. A recent study comparing teens 
with and without alcohol use disorders (AUD) found that teens with AUD 
showed substantially more brain activation to pictures of alcoholic 
beverages than controls (Tapert et al. 2003).
    Additional research on adolescent decision-making will provide 
greater understanding of the factors that influence underage drinking 
behavior including initiation and escalation of alcohol use and binge 
drinking. This includes but is not limited to studies on media 
influence.
    Question. This question is about treatment, and why some people 
improve their behavior. I was interested to read in your testimony that 
there's a debate whether the treatment itself is responsible, or 
whether it results from the positive motivation in seeking treatment. 
You also write that a wide array of approaches yield similar results, 
suggesting that it's not the particular technique that's responsible 
for change but other common underlying factors. Tell me more about 
this--are most forms of treatment being used today generally equally 
effective? Is the most important thing simply getting the person into 
treatment?
    Answer. Research has established that several forms of behavioral 
treatment (cognitive-behavioral treatment (CBT), motivational 
enhancement therapy (MET), and twelve-step facilitation (TSF), yield 
roughly equivalent outcomes. In the year following treatment with one 
of these therapies, drinking is reduced by about 85 percent compared to 
the period immediately prior to treatment. Overall, about one-third of 
alcohol dependent persons undergoing treatment will either be abstinent 
or not engaging in any high-risk drinking, about one-forth will not 
respond to that episode of treatment (although they may respond to 
future treatment), and the remainder have markedly reduced drinking and 
alcohol-related consequences, but are not entirely well. Over time, 
many of this latter group eventually become abstinent. Naltrexone, a 
medication for reducing relapse, yields similar results when combined 
with brief counseling by a doctor or nurse. Since there is no single 
type of treatment that is generally more effective than others, 
``simply getting the person into treatment'' does seem to be more 
important than which treatment the engage in. However, on a practical 
level, people have clear preferences about what kind of treatment they 
would like, so offering a menu of currently supported approaches is 
likely to maximize the likelihood that one of them will be appealing 
enough to engage the affected individual.
    How well treatment provided in the community compares with the 
treatments used in the studies undoubtedly varies. Although a precise 
estimate of the effect of this deviation is not available, there is 
evidence that some practices that are not helpful still persist in some 
community programs. Additionally, most treatment programs fail to make 
patients aware of various treatment options available, including 
medications. One study found that 93 percent of programs offer only 
twelve-step oriented behavioral treatment. Although this type of 
program may be as effective as others, it means that most people do not 
have a meaningful choice if they wish to receive treatment.
    Although treatment appears to improve outcomes, the most 
significant are those commonly seen among all treatment-seekers. Common 
examples include a driving while intoxicated charge, an employer 
referral, or an ultimatum from a spouse. This process is the focus of 
an innovative new research program called the Mechanisms of Behavior 
Change Research Initiative.
                                 ______
                                 
            Questions Submitted by Senator Daniel K. Inouye

                                SUICIDE

    Question. Dr. Insel, suicide is a major, preventable public health 
problem. In 2004, suicide was the 11th leading cause of death in the 
United States, accounting for 32,439 deaths. In Hawaii, for young 
people age 15-34 years, suicide is the second leading cause of death--
second only to accidents. What type of research is NIH conducting with 
respect to the causes of and the best practices for the prevention of 
suicide?
    Answer. NIMH has a long-standing commitment to supporting research 
on suicide risk and prevention. In response to the 2002 Institute of 
Medicine Report, ``Reducing Suicide: A National Imperative,'' NIMH, 
NIDA, and NIAAA issued a request for applications and funded three 
centers focused on intervention and prevention of suicide. Now in their 
third year of support, the centers have conducted pilot intervention 
studies with patients suffering from mental and substance use 
disorders.
    These centers have also engaged in a number of collaborative 
efforts. Federal staff (NIH, CDC, VA, SAMHSA, IHS) and investigators 
from the centers have interacted via workgroups focused on 
methodological challenges in suicide research, such as developing 
common measures of suicidality as well as understanding the role of 
impulsivity in suicide risk. The American Foundation for Suicide 
Prevention funded a pilot project with the centers to create a registry 
of suicide attempters. This registry will facilitate understanding of 
the quality of care across services settings, as well as the longer-
term outcomes of acute treatment of adolescent suicide attempters. One 
of these centers also played a key role in re-reviewing suicidal events 
for the FDA's 2005 review of potential suicidal side effects of 
antidepressants. As a follow-up to the FDA review, in 2006, NIMH funded 
five research projects to examine the association between 
antidepressant medications, notably selective serotonin reuptake 
inhibitors (SSRIs), and suicidal thoughts and actions. These projects 
will help determine why and how SSRIs may trigger suicidal thinking and 
behavior in some people but not others, potentially leading to new 
tools that can be used to screen individuals who are most vulnerable.
    Suicide patterns in the United States vary significantly in terms 
of demographics and cultures. For example, older white males have the 
highest suicide rate; are likely to have had a late onset of major 
depression; and are likely to have been seen in a primary care setting 
within the month of their death, without being diagnosed or treated for 
depression. To address this issue, NIMH funded a study called the 
Prevention of Suicide in Primary Care Elderly: Collaborative Trial 
(PROSPECT) to test approaches to improve identification and treatment 
of older adults with depression in primary care settings. Results from 
PROSPECT indicated that a collaborative care approach to treating 
depression in primary care more effectively reduced suicide ideation as 
well as depressive symptoms, compared to treatment as usual.
    American Indian, Native Alaskans, Native Hawaiians, and other 
indigenous peoples in the United States. Territories have the highest 
suicide rates among youth. To address the problem, NIMH, in 
collaboration with other NIH offices and Institutes, worked with the 
Indian Health Service, Health Canada, and the Canadian Institutes of 
Health to convene a bi-national conference in 2006 entitled 
``Indigenous Suicide Prevention Research and Programs in Canada and the 
United States: Setting a Collaborative Agenda.'' Community members and 
research partners discussed the importance of cultural knowledge in 
developing interventions and considered best practices that could be 
shared in developing partnerships and infrastructure.
    NIMH-supported research has demonstrated that several promising 
treatments significantly reduce the risk for suicide re-attempts; these 
treatments include cognitive behavioral interventions provided to 
individuals who have made a recent suicide attempt, as identified 
through emergency room departments, as well as dialectical behavior 
therapy provided to individuals with borderline personality disorder. 
NIMH is also using knowledge gained from previous research studies to 
guide the conduct of clinical trials involving individuals at high risk 
for suicide. The Institute recently completed a series of practical 
clinical trials focused on treatments for schizophrenia, depression, 
and bipolar disorder. The individuals enrolled in these trials were 
closely monitored for suicidal behavior and were provided appropriate 
crisis treatment when necessary.

                              ALZHEIMER'S

    Question. Dr. Insel, less than two weeks ago a new report was 
released indicating that there are now 5 million Americans with 
Alzheimer's disease and that this number is projected to increase by 50 
percent to 7.7 million by 2030. Given that advancing age is the 
greatest risk factor for Alzheimer's disease and that the number of 
Americans surviving into their 80's and 90's is expected to grow, what 
specific studies are underway at NIMH to address the challenges posed 
by Alzheimer's disease?
    Answer. NIMH supports research on a broad range of topics 
pertaining to older adults with Alzheimer's disease, ranging from basic 
research on the disorder to clinical interventions and services 
research that may assist affected individuals with their symptoms and 
problems in day-to-day living. A primary concern in NIMH research is to 
improve our understanding of, and techniques for managing, the 
psychiatric disorders and behavioral disturbances that often accompany 
Alzheimer's disease and related dementias.
    Recently published results from NIMH's large scale Clinical 
Antipsychotic Trials for Intervention Effectiveness in Alzheimer's 
Disease (CATIE-AD) study highlight the challenge of managing agitation 
and behavioral problems in Alzheimer patients. Although some patients 
with these problems may benefit from treatment with atypical 
antipsychotic medications, the evidence from this study suggests that 
these medications hold limited value for the majority of patients and 
that the benefits are often offset by intolerability of medication side 
effects. These results indicate the need for research on alternative 
treatment approaches, including nonpharmacological interventions. 
Additional analyses of the data from the CATIE-AD trial are ongoing.
    Earlier work supported by NIMH established criteria for assessing a 
specific syndrome of depression that is commonly manifested in 
Alzheimer's disease and making this a target for treatment. The 
Institute is now in the fifth year of supporting a multi-site clinical 
trial studying pharmacologic treatment of Depression in Alzheimer's 
Disease (DIADS-2) and its impact on functional capacities in Alzheimer 
patients.
    NIMH supports various basic and intervention studies designed to 
improve clinical management of other psychiatric and behavioral 
disturbances associated with Alzheimer's disease, such as the common 
pattern of sleep disturbance and nocturnal agitation. For example, one 
current NIMH study investigates sleep disorder in people who have mild 
cognitive impairment, a precursor to Alzheimer's disease, and an 
intervention trial is evaluating alternative treatments for insomnia 
among older patients with dementia.
    Numerous NIMH studies examine potential risk factors for developing 
Alzheimer's disease in the hope that understanding these factors may 
inform efforts to develop preventive interventions. Research areas 
include genetics, brain structure, cognitive performance, and various 
other risk factors in young and middle-aged adults to determine whether 
it is possible to identify elements of risk prior to the appearance of 
clinical manifestations of illness. One study has been examining the 
deleterious effects that depression may have over time, potentially 
leading to central nervous system damage, cognitive decline, and the 
development of states of Mild Cognitive Impairment and dementia.
    NIMH also supports basic neuroscience research on etiological and 
athophysiological actors in Alzheimer's disease, including numerous 
studies investigating key cognitive processes and how these are related 
to normal and abnormal brain functioning.
                                 ______
                                 
            Questions Submitted by Senator Richard J. Durbin

                             FABRY DISEASE

    Question. There are a number of individuals currently participating 
in efforts conducted by the Developmental and Metabolic Neurology 
Branch at NINDS. There is concern that when the Branch closes, as it 
will due to the retiring of Principal Investigator (PI) Roscoe Brady, 
the efforts that are benefiting the lives of so many, in particular 
those that are living with Fabry Disease, Gaucher Disease, Tay-Sachs 
and others, will also cease. Can you explain the rationale behind the 
NINDS' decision to close the Branch indefinitely and not continue these 
efforts under the leadership of another PI?
    Answer. Following Dr. Brady's retirement, NINDS made the decision 
to close the Developmental and Metabolic Neurology Branch (DMNB), which 
is part of NINDS' intramural program (the component of the NINDS that 
is located on the NIH campus in Bethesda, MD). However, the closing of 
this branch certainly does not mean that NINDS efforts in lysosomal 
storage disorders (LSDs), including Fabry and Gaucher disease, will 
cease. Groundbreaking research on lysosomal storage disorders conducted 
by this Branch has provided a strong foundation for research in these 
areas to continue through the NINDS extramural program (research funded 
by NINDS that is carried out at universities, medical centers, and 
small businesses throughout the United States). In fact, the extramural 
program accounts for approximately 90 percent of NINDS' annual budget 
and NINDS already funds a large portfolio of extramural grants focused 
on understanding and treating these disorders. In addition to NINDS, a 
number of other Institutes and Centers at NIH also support research 
through their extramural programs on lyososmal storage disorders, 
including Fabry disease. These grants aim to better understand and 
treat these disorders, with a number of projects focused specifically 
on developing gene therapy approaches to treatment. Furthermore, based 
on the successes from forty years of research in the DMNB led by Dr. 
Roscoe Brady, companies have developed and marketed enzyme replacement 
therapy for several of these diseases and are conducting additional 
clinical trials to improve treatment using other therapeutic 
strategies. In terms of clinical care, there are currently over 100 
medical centers across the country with experience in diagnosing, 
treating, and managing care of patients with lysosomal storage 
disorders.
    NINDS' decision to close the DMNB was reached after much 
deliberation and after receiving input from the NINDS Board of 
Scientific Counselors, an external advisory group that reviews and 
evaluates the NINDS intramural program. NINDS and the Board of 
Scientific Counselors determined that the research and clinical care 
efforts that used to be unique to the Branch are now well represented 
at medical schools, research institutes, and tertiary care centers 
throughout the country. They recommended that the NINDS intramural 
program identify other rare neurological disorders that have lagged 
significantly behind Gaucher and Fabry disease and could benefit as 
they have from an intramural effort.
    Question. Can you provide additional information regarding the 
efforts of the branch on solving the problems that still exist with 
enzyme replacement therapy? How will the progress that has been made on 
these issues continue if the efforts of this Branch are stifled due to 
its closing?
    Answer. The DMNB was instrumental in developing enzyme replacement 
therapy, which is used to treat a number of the LSDs, including Fabry, 
Gaucher, and Pompe disease. While enzyme replacement therapy 
significantly improves the quality of life for patients with these 
disorders, the treatment is not sufficient to address all the symptoms, 
particularly those resulting from deficits in the central nervous 
system. This is due in part to the incomplete access of the enzyme 
replacement to the central nervous system (CNS) because of the blood-
brain barrier (a semi-permeable barrier that prevents materials in the 
blood from entering the CNS). NINDS, through its extramural program, 
funds a number of grants focused on facilitating the access of enzyme 
replacement to the CNS by protein reengineering, increased dosing 
regimen, and alternative delivery routes. NINDS also funds extramural 
research focused on developing other therapeutic approaches including 
substrate reduction (decreasing the production of the molecule that is 
accumulating in the disease), and pharmacological chaperones (small 
drugs that can specifically target and stabilize the defective enzyme, 
enhancing any residual activity). Longer-term therapeutic strategies 
such as stem cell transplantation and gene therapy are also being 
funded by NINDS.
    One of the goals of the NINDS intramural program is that research 
conducted there lay the groundwork for a broader based research effort 
in the extramural community. Historically, closure of other NINDS 
programs has proven the intramural program's success and shown that the 
research initiated by these branches can be effectively graduated into 
the extramural research community. For example, research carried out in 
a branch that focused on therapeutics for Parkinson's disease set the 
stage for a rigorous therapeutics development program on Parkinson's 
disease through the NINDS extramural program. Similarly, work carried 
out by an NINDS lab that demonstrated the transmissibility of 
Creutzfeldt-Jakob disease (CJD) helped stimulate research in the 
extramural community to better understand this and other disorders in 
the class of transmissible spongiform encephalopathies. It is our 
expectation that ongoing and future research through NINDS's extramural 
program will continue to improve the lives of individuals with LSDs.
    Question. What other work are you planning to do to improve both 
the quality and quantity of life of those living with Fabry disease?
    Answer. As I have just described, NINDS, through its extramural 
research program, funds research projects focused on developing new and 
more effective treatment strategies to improve the quality and quantity 
of life for those individuals with Fabry and other disorders. A number 
of these grants have been submitted through an ongoing NINDS Program 
Announcement with Set-aside funds (PAS), entitled ``CNS Therapy 
Development for Lysosomal Storage Disorders.'' This funding opportunity 
announcement was started in 2004 and since then many new promising 
therapeutic approaches are being investigated.
    Partnering with patient voluntary groups is another way that NINDS 
hopes to advance research and improve the lives of patients with these 
disorders. The PAS mentioned above is co-sponsored by the Lysosomal 
Storage Disease Research Consortium (LSDRC), a collaborative research-
funding group comprising LSD patient support groups and private family 
research foundations. In addition, the NINDS organizes a number of 
workshops in order to identify scientific gaps and opportunities 
related to various LSDs, and to foster collaboration between the 
researchers. Several of these workshops have been organized in 
conjunction with some of the patient voluntary groups. To promote the 
exchange of ideas on research across the many LSDs, the NINDS helped 
form the Lysosomal Disease Network. This consortium of scientists, 
healthcare professionals and clinics work to improve basic knowledge 
and understanding of LSDs, improve diagnosis, and advance therapeutic 
options for individuals affected by these disorders. The NINDS has 
supported the first two annual meetings of the Lysosomal Disease 
Network.

                                EPILEPSY

    Question. I understand that last week, NINDS hosted the second 
Conference on the Cure for Epilepsy. What new information did this 
conference yield about epilepsy and are we any closer to finding a 
cure?
    Answer. In March 2007, the NINDS co-sponsored a large conference, 
entitled: ``Curing Epilepsy 2007: Translating Discoveries into 
Therapies.'' The Conference was well-attended by the basic and clinical 
research communities, and specific sessions at the Conference focused 
on research conducted by junior investigators; the translation of 
advances in the genetics of epilepsy and our understanding of how 
epilepsy arises (epileptogenic mechanisms) into therapies; cognitive 
and psychological issues in epilepsy; and emerging technologies in 
diagnostics and cellular and molecular therapeutics. The meeting also 
involved presentations from several patients and patient 
representatives on their personal experiences with epilepsy.
    Several very exciting trends in epilepsy research were emphasized 
at the meeting. First, the ideal way to treat (and cure) epilepsy would 
be to prevent the development of seizures in the brain, not just to 
stop them from progressing or diminish their behavioral effects (e.g., 
seizures). A growing appreciation in the scientific community as to why 
neuronal circuits in the brain develop abnormal patterns of 
overexcitation is now enabling investigators to identify tangible 
therapeutic targets that may interfere with the earliest molecular 
events in the development of seizures. This shift heralds the 
availability of substantially more effective therapies for epilepsy. 
Second, advances in imaging are also making a dramatic impact on a 
number of disciplines in epilepsy research, including the development 
of biomarkers of seizure-prone brain regions, the characterization of 
the effects of epilepsy on brain development, and the cognitive impact 
of the disorder. The use of these techniques will facilitate epilepsy 
diagnostics as well as treatment. Third, completely new therapeutic 
approaches are emerging in epilepsy research, including the possibility 
that cell-based therapies may be able to restore normal patterns of 
activity in seizure-prone brain circuits and advancements in 
nanotechnology may improve devices that sense impending seizures with 
greater accuracy than ever before.
    Question. Are we putting adequate resources toward epilepsy 
research at NINDS to find a cure for epilepsy? In addition, I 
understand that new cases of epilepsy are most prominent in seniors 
(those aged 65 and older). What are we doing to better understand the 
cause of seniors having seizures and will NIH partner with other 
entities to study this emerging area?
    Answer. The National Institute of Neurological Disorders and Stroke 
(NINDS) has invested considerable funding to identify and test 
potential therapies for epilepsy. Currently, the NINDS is funding nine 
clinical trials in epilepsy, including phase III trials of drug therapy 
for childhood absence epilepsy and the use of progesterone therapy to 
reduce intractable seizures in women whose seizure severity is linked 
to their menstrual cycle. In addition to these and other ongoing 
trials, the NINDS also continues to support its Anticonvulsant 
Screening Program (ASP), a public-private partnership program designed 
to evaluate the potential efficacy and toxicity of pre-clinical 
candidate compounds in validated epilepsy model systems. In 2006, the 
ASP screened several hundred molecules for potential activity against 
epilepsy and related disorders. The Program has participated in the 
evaluation and development of eight currently marketed antiepileptic 
drugs, and nine new ASP compounds are currently in clinical testing.
    In addition to these efforts, the NINDS has also funded a number of 
epilepsy grants as part of its broad translational research program, 
which is designed to accelerate therapeutics research towards early 
clinical testing. Topics of these awards range from a study of specific 
chemical pores on neurons and their role in neonatal seizures to the 
preclinical development of the anticonvulsant chlorokynurenic acid--
which effectively accesses the brain when administered systemically--as 
a therapeutic agent for both adults and children with epilepsy.
    With respect to the study of epilepsy and the elderly, the NINDS 
has provided funding to several grants including a large multi-
investigator award focused on patterns of use of antiepileptic drugs in 
the elderly and the differences in breakdown of antiepileptic 
medications in older versus younger individuals. Understanding these 
patterns and differences is critical to their proper treatment 
(including dosing and avoidance of toxicity). In addition, stroke is a 
primary cause of epilepsy in the elderly, and NINDS-funded basic 
science researchers are developing a model of this form of epilepsy for 
subsequent use in understanding how seizures develop after stroke and 
how therapies might prevent and/or treat these events. The NINDS also 
meets regularly with a number of other National Institutes of Health 
(NIH) Institutes as part of the NIH Interagency Epilepsy Coordinating 
Committee meeting and would welcome potential collaborations in the 
area of aging and epilepsy as they emerge.
    Question. In 2002 NINDS conducted research on TBI and epilepsy. 
Given the increased number of cases of TBI due to the war in Iraq, will 
NINDS be studying the relationship between TBI and epilepsy for updated 
statistics and data?
    Answer. The primary role of the National Institute of Neurological 
Disorders and Stroke (NINDS) with respect to all types of epilepsy 
research--including that induced by traumatic brain injury (TBI)--is to 
provide support for research on the prevention, diagnosis, underlying 
causes, and treatment of this condition. The NINDS is currently 
supporting several studies that may reveal links between TBI and 
epilepsy, including an exploration of early post-injury changes in 
brain activity and its impact on affected neurons; the effects of 
structural changes in neuronal circuitry on the development of 
posttraumatic epilepsy--particularly in those circuits that help to 
prevent overexcitability in the brain--and the impact of head injuries 
on abnormal sprouting of undamaged neurons and the tendency of these 
new nerve pathways to become overly active. In addition to these basic 
studies, the NINDS is also funding a pilot clinical trial to test 
whether very early administration of the anticonvulsant drug 
levetiracetam can prevent posttraumatic epilepsy in adults as well as 
children. In this early-phase trial, researchers will explore the 
safety and tolerability of the drug in individuals with TBI and the 
feasibility of initiating treatment within eight hours of injury. If 
the pilot data are promising, the research team will utilize the 
results to build a larger-phase clinical trial.
    The mechanisms that underlie the development of epilepsy were also 
a focus of the March 2007 Curing Epilepsy Conference; specifically, the 
meeting included an entire session on the development of epilepsy, 
including TBI as a major environmental contributor. Discussions in this 
part of the meeting and during a session on the NINDS Epilepsy 
Benchmarks--a series of specific scientific goals for the epilepsy 
research community--confirmed that understanding how epilepsy develops 
is a very high research priority and should be a focus for the epilepsy 
community in the coming years.
    Although these and other studies funded by the NINDS are likely to 
inform researchers and ultimately clinicians on the best way to prevent 
and/or treat posttraumatic epilepsy, it is the Centers for Disease 
Control and Prevention (CDC) that typically collect statistics and 
study trends on medical conditions. Because of the increasing number of 
war injuries that involve TBI and the urgency in addressing the medical 
needs of these soldiers, the NINDS staff has established a working 
group with relevant government partners, including the Department of 
Defense, the Department of Veterans Affairs, the CDC, and others to 
discuss scientific topics of mutual interest and develop collaborations 
in these areas. Following the first meeting of the group last 
September, NINDS set up a listserv for timely dissemination of 
information on TBI research across these multiple agencies. The NINDS 
staff is planning another meeting for the summer of 2007.

               FUNDING RESEARCH ON SEVERE MENTAL ILLNESS

    Question. What is NIMH doing to fund more research on severe mental 
illness, as called for by national organizations such as the National 
Alliance for Mental Illness and Mental Health America?
    Answer. NIMH supports innovative research that promises to 
profoundly transform the diagnosis, treatment, and prevention of mental 
disorders, paving the way for a cure. Mental disorders are the leading 
cause of disability in the United States and Canada for ages 15-44,\1\ 
and each year, roughly 12 million people report symptoms of mental 
illness so severe as to cause significant disability and interference 
with everyday living.\2\ To address these critical health needs, the 
Institute supports, conducts, and promotes research that spans the 
continuum from basic research on brain and behavioral processes that 
provides the foundation for understanding mental disorders, to 
investigations of improved pathways for the rapid dissemination of 
evidence-based practices into mental health care and service efforts.
---------------------------------------------------------------------------
    \1\ The World Health Organization. The World Health Report 2004: 
Changing History, Annex Table 3: Burden of disease in DALYs by cause, 
sex, and mortality stratum in WHO regions, estimates for 2002. Geneva: 
WHO, 2004.
    \2\ Kessler RC, Chiu WT, Demler, O, Merikangas, KR, Walters, EE. 
Prevalence, Severity, and Comorbidity of 12-Month DSM-IV Disorders in 
the NCS-R. Arch Gen Psychiatry. 2005 Jun; 62: 617-627.
---------------------------------------------------------------------------
    Along this continuum, the Institute is supporting several key areas 
to ensure that each step along the pathway from scientific discovery to 
the implementation of improved interventions is fully supported. For 
example, NIMH is providing infrastructure support to maintain three 
large networks of investigative clinical teams that have evolved from 
the recent NIMH practical clinical trials on major depressive disorder, 
schizophrenia, and bipolar disorder. These practical trials were 
``effectiveness studies'' designed to examine not only changes in 
symptoms but changes in ``real world'' functioning. The networks 
comprise over 60 sites throughout the United States with continual 
outreach to, and engagement of, diverse groups of patients and families 
with mental illnesses. The overarching principle guiding the networks 
is to conduct research designed to improve the mental health of the 
public and to help better inform clinicians, families, and policy 
makers--efforts that require participation from the diversity of people 
and settings involved in health care.
    NIMH continues its strong commitment to investment in research to 
elucidate the causes of and best treatments for schizophrenia. Although 
current medications are reasonably effective in treating symptoms such 
as hallucinations and delusions, these treatments provide little relief 
for the cognitive problems (e.g., memory, attention) responsible for 
much of the long term disability associated with schizophrenia. To 
address this issue, NIMH funded the Measurement and Treatment Research 
to Improve Cognition in Schizophrenia (MATRICS) program. MATRICS 
brought together representatives from academia, industry, and 
government in a consensus process to address obstacles that are likely 
to interfere with the development of pharmacological agents for 
treating cognitive deficits associated with schizophrenia. As a result 
of MATRICS, researchers developed several comprehensive assessment 
tools to measure cognitive functioning abilities in patients with 
schizophrenia. To build upon the work from MATRICS, NIMH has also 
supported a network of Treatment Units for Research on Neurocognition 
and Schizophrenia (TURNS). The network is about to begin testing the 
safety and efficacy of new therapeutic compounds for treating the 
cognitive deficits of schizophrenia.
    In fiscal year 2008, through a Requests for Applications, NIMH will 
invite research grant proposals focused on early detection, prevention, 
and treatment of schizophrenia. These initiatives will foster research 
to define critical moments in the disease course, such as a first 
psychotic episode, and will promote the development of unique early 
interventions to pre-empt the serious disability caused by 
schizophrenia.

              SERVICES RESEARCH FOR SEVERE MENTAL ILLNESS

    Question. How is NIMH working to promote more research on what 
services lead to recovery for people with severe mental illness, as 
called for by the President's Mental Health Commission?
    Answer. NIMH supports research to establish an evidence-base for 
interventions and service systems that will provide citizens with the 
best possible care. Within this context, NIMH funds a program of 
research on disability and community reintegration, which focuses on 
ways to reduce the disability of people with mental illness through 
connective services within their communities. For example, an NIMH-
funded study is identifying the most effective strategies for building 
a partnership between university-based clinical services researchers 
and practitioners and consumers from a psychosocial rehabilitation 
service agency. This research aims to improve the effectiveness of 
community-based psychosocial rehabilitation interventions for 
functional disability in schizophrenia.
    NIMH supports a program of dissemination and implementation 
research, with the goal of building the knowledge base on how best to 
integrate effective mental health interventions into service systems. 
This research portfolio includes over thirty ongoing studies to better 
identify the means by which people with mental illness can receive the 
evidence-based services most likely to alleviate the burden of mental 
illness and lead to recovery. One recently funded project provided 
funding to the state of Illinois to determine the best way to implement 
supportive employment services for people with mental illness returning 
to the community. Another project is examining factors that improve the 
statewide implementation of an evidence-based treatment intervention 
for children in foster care across the state of California, using 
community development teams to optimize the use of the intervention for 
children and adolescents in the foster care system. Another study is 
determining the impact of consumer-run organizations to improve 
outcomes for individuals with mental illness in communities.
    NIMH supports a program of systems research, which focuses on ways 
in which systems (e.g. criminal justice, schools, welfare) can improve 
the access to care of persons with mental illness. One NIMH-funded 
researcher is studying a service system that helps people with mental 
illness transition from the justice system into a community with 
services to support their recovery. Another investigator is studying 
how a nurse manager intervention might improve the health and reduce 
disability of homeless people with schizophrenia.

            COLLABORATIONS WITH SAMHSA ON SERVICES RESEARCH

    Question. How is NIMH working with SAMHSA to develop a research 
agenda focused as much on services research as on clinical trials 
research?
    Answer. NIMH collaborates with SAMHSA on a number of activities to 
identify key priorities for services research. NIMH continues to 
collaborate with SAMHSA on research related to the transformation of 
mental health services in America. The Center for Mental Health 
Services, (CMHS) within SAMHSA, provides infrastructure support for 
nine states to collaborate across state agencies to determine how best 
to transform the delivery of services for people with mental illness. 
NIMH is supporting the cross-site evaluation of this program--an effort 
that will facilitate the augmentation of research to the state 
transformation efforts. In addition, SAMHSA established five 
interagency priority workgroups to address recommendations from the 
Commission Report.\3\ NIMH and the Agency for Healthcare Research and 
Quality are working with each of these workgroups to better connect 
services research to priorities in the areas of emergency response, 
suicide prevention, employment, financing, and the integration of 
mental health care and primary care.
---------------------------------------------------------------------------
    \3\ New Freedom Commission on Mental Health, Achieving the Promise: 
Transforming Mental Health Care in America. Final Report. DHHS Pub. No. 
SMA-03-3832. Rockville, MD: 2003.
---------------------------------------------------------------------------
    NIMH is actively engaged with SAMHSA to generate research based on 
SAMHSA's major services agendas. An example of this is the research 
program on ``Effectiveness, Practice, And Implementation in CMHS' 
Comprehensive Community Mental Health Services Program for Children and 
their Families Service Sites.'' This three year research effort funds 
researchers who specifically work within CMHS funded service systems.
    NIMH and CMHS have organized a series of Regional meetings for 
researchers, consumers, policymakers, clinicians, and other key 
stakeholders to identify research and services needs for state systems. 
NIMH is also working with CMHS on several meetings to identify the 
state of the science in specific services areas. The first, on shared 
decision-making, will bring together expert researchers, consumers, and 
service providers to discuss the current knowledge base regarding 
shared decision-making and to develop research priorities. A similar 
meeting on health promotion for people with mental illness is being 
planned.

                      RESEARCH ON SELF MANAGEMENT

    Question. In light of the Institute of Medicine's endorsement of 
the importance of patient-centered mental health care, what is NIMH 
doing to promote research on models such as illness self-management, 
patient education, and self-help?
    Answer. NIMH has a growing portfolio of research on approaches to 
improve patient education, self-help, and self-management of mental 
disorders. NIMH supports a Program Announcement titled ``Information 
Technologies and the Internet in Health Services and Intervention 
Delivery'' to test models of education and self-management for mental 
disorders.
    Current medications used to treat those with chronic and severe 
schizophrenia often lead to significant metabolic side effects, so a 
number of NIMH studies are testing models of self-management to promote 
healthy lifestyles and to reduce diabetes and weight gain in this 
population. Obtaining evidenced-based care remains a challenge for many 
individuals with schizophrenia. One study tests an interactive web-
based system that allows the individual consumer or family member to 
compare current treatment to evidence-based standards and to discuss 
treatment approaches with his or her clinician.
    Peer- and community-based programs to support families of adults 
with serious mental illness typically incorporate elements of self-
help, empowerment, trauma recovery, stress and coping theories, as well 
as mutual assistance for family members. NIMH currently supports 
several studies to provide scientific evidence that these programs 
effectively achieve their goals, including for example, the National 
Alliance for the Mentally Ill's Family-to-Family Education Program--a 
12-week class with a highly-structured standardized curriculum 
developed and conducted by trained family members.
    The collaborative care model, developed initially for diabetes 
medication management, has been successfully applied to depression 
treatments in primary care. Collaborative care combines patient 
education about the disorder and its treatment approaches with a 
depression specialist to assist in case management and treatment 
adherence. Collaborative care has been shown to be effective in 
reducing depression and suicidality in older depressed primary care 
patients, and is currently being studied among women with post-partum 
depression in two health care plans.
    One aspect of patient-centered care is psychoeducation, providing 
information about mental illness and its long-term care to families and 
patients. Psychoeducational models originally used with adult patients 
and their families have been adapted and are currently being tested for 
use with youth with various mental disorders to strengthen the person's 
understanding of the illness, to improve treatment adherence, and to 
facilitate overall illness management. Family-focused treatment as an 
adjunctive treatment to medication management is being tested with 
adolescents with bipolar disorder in a three-site clinical trial. An 
adapted version of this same approach is also being pilot tested with 
younger youth with mood disorders who are at risk for development of 
bipolar disorder. A similar approach involved multi-family 
psychoeducation groups designed as adjunct to medication management was 
tested for use with families of 8-11 year old youth with mood disorders 
(depressive disorders or bipolar disorder).

              RESEARCH ON FAMILY-BASED TREATMENT PROGRAMS

    Question. In light of the disproportional impact of meth on mothers 
with children, and the continued impact of crack among our poor and 
urban families, please discuss what research initiatives are being 
undertaken to recognize and expand the best practices of family-based 
treatment programs for substance abusing mothers and their children.
    Answer. NIDA recognizes the importance of family support as part of 
drug abuse treatment, particularly for drug-abusing mothers with 
custody of children. Family therapy that addresses the needs of mothers 
and that involves their children and other pivotal family members in 
the treatment program can strengthen and extend program benefits. 
Findings from research on Brief Strategic Family Therapy (BSFT)--a 
treatment intervention aimed at adolescents--einforce the benefits of a 
family-based paradigm to change problem-sustaining family patterns and 
increase treatment engagement and retention, even in patients with 
multiple comorbidities.
    NIDA supports a variety of research approaches to address the needs 
of substance-abusing mothers and their children. These include 
interventions that actively reach out to disadvantaged women at the 
community level, longitudinal studies that follow children prenatally 
exposed to drugs, services research to bring evidence-based treatments 
to the criminal justice system, and clinical research on medications 
and behavioral treatments in pregnant women and females of childbearing 
age.
    Recognizing the need for culturally-appropriate and gender-
sensitive interventions, NIDA-supported researchers are adapting 
behavioral treatments for substance-abusing female populations, 
including African American women who abuse crack cocaine, pregnant 
women in treatment, women with or at risk for HIV, and low-income women 
in community treatment programs. One study is adapting an empirically 
based behavioral therapy for drug abuse to a church-based system to 
intervene with cocaine-addicted African American women, while another 
is modifying an integrated family behavioral therapy for adolescents to 
intervene with pregnant women at risk for HIV. Other studies are 
looking at the quality of maternal-child feeding interactions (during 
the child's first year) among mothers who used cocaine during their 
pregnancy, as well as examining the serious risks faced by children 
exposed to methamphetamine use and manufacture. Results of such studies 
will help determine how to strategically intervene with mothers and 
their children.

       BETTER TREATMENTS FOR WOMEN IN THE CRIMINAL JUSTICE SYSTEM

    Question. Presently, the fastest growing prison population is women 
convicted of non-violent drug felonies. Most of these women are mothers 
and most of them are untreated addicts. At the same time, upwards to 
eighty percent of the families who come to the attention of child 
welfare are substance abusing. How can we work, or what is NIDA doing 
specifically, to stop this downward cycle of mothers being displaced 
into the prison system and children being placed in foster care while 
the underlying issue of parental addiction remains unaddressed.
    Answer. As reflected in the answer to the previous question, NIDA 
supports research aimed at treating women and mothers with children in 
the community to prevent their entering the criminal justice system in 
the first place. These efforts involve a variety of approaches--from 
adapting evidence-based interventions for use in multiple settings to 
conducting trials of family-based therapies to using a combination of 
medications and behavioral approaches to treat drug abusers in the 
community and help them achieve a healthier lifestyle.
    Unfortunately, far too often, drug abuse and addiction remain 
untreated and escalate to the point of criminal justice involvement, a 
problem intensifying for females. Indeed, the population of 
incarcerated women has more than doubled in this country from 1995 to 
2005, the problem of female criminal justice involvement characterized 
by gender-specific factors related to the pathways to substance abuse 
and recovery, socio-cultural roles and responsibilities, and certain 
co-occurring mental illnesses. A primary concern for women, which this 
question addresses, is the greater likelihood of parenting and 
childcare responsibilities.
    NIDA has addressed many of these differences in our recently 
released landmark publication--principles of Drug Abuse Treatment for 
Criminal Justice Populations--which conveys effective principles of 
substance abuse treatment to the criminal justice community and the 
treatment professionals working with drug-abusing offenders, including 
women with children. In addition to childcare services, female 
offenders are more likely than men to need medical and mental health 
services (given high rates of depression, anxiety, and trauma) and 
assistance in finding housing and employment. It is important to 
examine these special needs, for while treatment programs serving both 
genders can be effective for females, gender-specific programs may be 
more effective, particularly for women with histories of trauma and 
sexual or physical abuse. For female offenders with children, parental 
responsibilities can conflict with their ability to participate in drug 
treatment--and yet regaining or retaining custody of their children can 
also motivate mothers to participate in treatment. Treatment programs 
may therefore improve retention by offering childcare services and 
parenting classes.
    NIDA is examining these and other methods to make treatments more 
effective for women, including supporting development of a gender-
specific re-entry model to help women reintegrate into the community 
once released. In addition, a drug court study is looking specifically 
at ways to improve treatment engagement for women and children. NIDA is 
also supporting studies of adolescents involved with foster care, 
identifying the prevalence and heightened risk of substance use 
disorders among this population. It is worth noting that involvement 
with foster care is often a marker of prior adversities, including 
parental addiction, and an antecedent of negative adult outcomes, most 
of which stem from childhood adversities rather than from foster care 
per se. In fact, research has shown that therapeutic foster care can be 
beneficial, particularly to adolescent girls.

               VIOLENCE, TRAUMA AND FEMALE DRUG ADDICTION

    Question. Please talk about the interrelationship between physical 
and sexual iolence, trauma, and addiction among women, and what 
research is being done to excavate that interrelationship, especially 
as it relates to the experience of maternal addiction.
    Answer. It is well-established that childhood maltreatment (in the 
form of sexual abuse, physical abuse, or neglect) leads to enhanced 
risk for substance abuse, including earlier incidence of alcohol and 
drug abuse in adolescents. One study has shown that up to 65 percent of 
the variability in addiction risk is linked to childhood stress; with 
children who have been subjected to five or more ``insults'' (i.e., 
incidents of trauma) being ten times more likely to develop an 
addiction than those without such exposure. Many of the biological 
responses to stress have been implicated in the pathophysiology of both 
substance use disorders and Posttraumatic Stress Disorder (PTSD).
    The relationship of substance abuse and addiction to female 
victimization by sexual violence or other traumatic abuse presents a 
vicious cycle that can turn both ways, sustained in part by long-
lasting negative emotions and behaviors that elicit drug craving and 
use. Indeed, PTSD and depression are common results of sexual and/or 
physical abuse and primary risk factors for subsequent drug abuse in 
females. A multitude of factors influences these events, including age 
of exposure to physical or sexual abuse, family history, criminal 
justice involvement, race, co-occurring mental disorders, and other 
genetic and environmental variables--a tangle of risk factors that 
NIDA-supported research is investigating to help devise more effective 
interventions.
    Prior research has revealed, disturbingly, that most rape victims 
(62 percent) are girls under the age of 18, with 28 percent of victims 
under age 11. This finding reflects the early age at which violence 
often occurs, and the importance of understanding a person's history in 
determining how best to provide treatment. For women, violence more 
often precedes substance use than the other way around, although both 
patterns can occur. Thus, treatment that evaluates family history and 
exposure to violence at various ages might yield important information 
about chronology of critical variables and relative contributions of 
environmental and biological factors to comorbid mental and substance 
abuse disorders.
    The effects of trauma are complex and can be manifested in diverse 
ways. For example, longitudinal and developmental research suggests 
that girls' involvement in the juvenile justice system often follows 
from exposure to trauma and physical or sexual abuse and often co-
occurs with anxiety and mood problems. In a recent longitudinal 
analysis of women who lived in shelters or experienced major violence, 
study participants had a two-fold increase in their risk of depression 
over a 6-month follow-up period. And because substance abuse and 
addiction also significantly increase the risk of subsequent 
victimization that could lead to PTSD (the reverse direction of the 
vicious cycle), NIDA also supports studies seeking to add a violence 
prevention component to substance abuse treatment, particularly for 
male perpetrators of intimate partner violence. Research on 
cohabitating substance-abusing patients is offering options to 
treatment providers who deal with intimate partner violence--40 to 60 
percent of couples reporting episodes of partner aggression in the year 
preceding treatment entry.
    Finally, NIDA research has revealed encouraging results for a 
trauma-focused cognitive behavioral therapy (CBT) known as ``Seeking 
Safety,'' designed specifically for women with trauma histories. 
Compared to standard substance abuse treatment, the therapy improved 
both substance abuse and PTSD symptoms in female patients who 
identified the trauma's effects on their lives and practiced techniques 
to ease emotional pain, stop self-blame, and cope with difficult 
interpersonal and potential relapse situations. NIDA is now testing 
``Seeking Safety'' in its National Drug Abuse Clinical Trials Network, 
which uses ``real-world'' community treatment programs to validate 
treatment practicality and effectiveness. This therapy has also shown 
promising results in adolescent girls, suggesting the need for dual-
diagnosis treatment that more directly targets trauma-related symptoms 
and areas of individual difficulty. Such findings with adolescents are 
encouraging, as they suggest that comorbid PTSD and substance abuse may 
be amenable to change early to counter its typical persistence into 
adult
                                 ______
                                 
              Questions Submitted by Senator Arlen Specter

                     EFFECTS OF PRESIDENT'S BUDGET
        NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKES

    Question. If the President's budget were to be adopted by Congress 
and research funding were frozen or cut below existing levels, what 
specific research priorities at your institutes would be delayed or 
have to be set aside?
    Answer. The first priority of NINDS at any funding level is to 
maintain our existing research commitments, and the President's budget 
allows us to do that. However, progress against neurological disorders 
depends on maintaining robust investigator initiated basic, 
translational, and clinical research programs, and, as you heard in 
testimony from academic scientists, new and established investigators 
are struggling. They are spending more time writing and rewriting grant 
applications than doing research, and too often are forced to drop 
innovative work, lay off highly trained staff, or close down labs 
entirely. Under this budget scenario, we would have to reduce or 
eliminate programs and pass up promising opportunities in order to 
sustain our core research and ensure that we have a scientific 
workforce for the future. NINDS would, for example, move fewer 
promising early phase clinical trials from our SPOTRIAS stroke centers 
to large phase III trials, move more slowly in developing the Clinical 
Research Collaboration and Neurological Emergency Treatment clinical 
trials networks, and not undertake new initiatives, such as applying 
the model of therapeutics development from the SMA Project to other 
disorders.

    NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

    Question. If the President's budget were to be adopted by Congress 
and research funding were frozen or cut below existing levels, what 
specific research priorities at your institutes would be delayed or 
have to be set aside?
    Answer. With the resources requested in the fiscal year 2008 
President's Budget, NIDCD will be able to support its highest priority 
research. This includes support for a research contract for a multi-
center study entitled the ``CMV and Hearing Multicenter Screening 
(CHIMES) Study,'' on the role of congenital CMV in the development of 
hearing loss in children. The CHIMES study is one of the largest 
studies of its kind with approximately 100,000 children to be screened 
at birth for CMV infection. A major focus of this study is to identify 
asymptomatic children and follow their progress to determine if hearing 
loss develops. Those who test positive for CMV will undergo follow-up 
hearing screening to determine the onset, severity, and progression of 
hearing loss. If additional funds were to become available to NIDCD 
beyond these priorities, NIDCD would likely seek to increase the number 
of children who will be screened for CMV infection.

                  NATIONAL INSTITUTE OF MENTAL HEALTH

    Question. If the President's budget were to be adopted by Congress 
and research funding were frozen or cut below existing levels, what 
specific research priorities at your institutes would be delayed or 
have to be set aside?
    Answer. With the resources requested in the fiscal year 2008 
President's Budget, NIMH will be able to support its highest priority 
research. While the President's request did not propose to decrease 
NIMH's budget, if additional resources became available for NIMH to 
support research beyond these priorities, NIMH would likely seek to 
expand its support for in-depth analyses of data collected from whole 
genome association (WGA) studies for major mental disorders. WGA 
studies evaluate the subtle differences between the genomes of healthy 
people and those suffering from disease in order to determine how 
genetic variability may contribute to disease susceptibility. In 
addition to the WGA analyses, NIMH might invest in research to develop 
new compounds as fast-acting treatments for depression, with the 
ultimate goal of expanding treatment options so that physicians may 
offer more personalized care.

           NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM

    Question. If the President's budget were to be adopted by Congress 
and research funding were frozen or cut below existing levels, what 
specific research priorities at your institutes would be delayed or 
have to be set aside?
    Answer. The first priority of NIAAA at any funding level is to 
maintain our existing research commitments, and the President's budget 
allows us to do that. In addition, in the fiscal year 2008 
Congressional Justification, NIAAA has highlighted a number of 
promising areas for future research activity. For example, $3 million 
have been committed in fiscal year 2008 for research to investigate the 
short- and long-term effects of alcohol use on the developing 
adolescent human brain. This funding amount will allow us to conduct 
pilot studies to determine the best methodology for answering this 
critical question through future larger longitudinal studies. A second 
example relates to our funding of medications development. The fiscal 
year 2008 budget request provides for $2 million of additional funds 
for testing compounds and increasing the efficiency of the medications 
development infrastructure. Whereas it is cost effective to 
concurrently test multiple compounds, the fiscal year 2008 budget 
permits sequential testing of a few promising new compounds.

                    NATIONAL INSTITUTE ON DRUG ABUSE

    Question. If the President's budget were to be adopted by Congress 
and research funding were frozen or cut below existing levels, what 
specific research priorities at your institutes would be delayed or 
have to be set aside?
    Answer. With the resources requested in the fiscal year 2008 
President's Budget, NIDA will be able to support its highest priority 
research. While the President's request did not propose to decrease 
NIDA's budget, if additional resources became available to NIDA beyond 
these priorities, NIDA would likely seek to pursue additional clinical 
trials and development of new addiction medications; develop a 
specialized NeuroChip for substance abuse to put in place a single 
standardized platform for researchers to rapidly screen thousands of an 
individual's relevant gene variants; support a Genes, Environment, and 
Development Initiative (GEDI)--a cross-disciplinary initiative designed 
to increase knowledge of the interactions between genes, environment, 
and developmental stage in relation to drug abuse risk; and expand 
NIDA's services research programs operating at the community level, 
such as its large research collaborations to improve drug abuse 
treatment for criminal justice populations.

                  ECONOMIC BENEFITS OF NINDS RESEARCH

    Question. Dr. Landis, I am particularly interested cost-savings 
resulting from NIH research. I understand that NINDS has analyzed the 
economic benefit of NINDS-supported clinical trials. Could you 
highlight the results of this study for the Committee?
    Answer. At the request of the National Advisory Neurological 
Disorders and Stroke Council, the institute contracted for an 
independent evaluation of the costs and benefits of all NINDS phase III 
clinical trials conducted from 1977 to 2000. The total cost of the 
clinical trials in the study was $335 million (adjusted to 2004 
dollars). Over 10 years, the benefits from these trials exceeded $15 
billion and added 470,000 healthy years of life to people in the United 
States. For the entire period of the study, the benefits surpassed $50 
billion, which was greater than the total NINDS budget over that period 
($29.5 billion).
    Advances in neuroscience are yielding more clinical trial 
opportunities than ever before, but trials are expensive and can take 
years to complete. So, NINDS is now developing computer models to do 
this kind of analysis prospectively, that is to estimate in advance 
which trials would have the most impact on public health.

                      DUCHENNE MUSCULAR DYSTROPHY

    Question. Dr. Landis, I understand that NINDS recently funded a 
large-scale project in translational research for Duchenne muscular 
dystrophy. Can you tell me about this project, and how it fits into the 
bigger picture of finding cures for this disease?
    Answer. NINDS will soon fund a large-scale project to an 
investigator at the University of Pennsylvania to develop new small 
molecule drugs for the treatment of Duchenne muscular dystrophy (DMD) 
and potentially other forms of muscular dystrophy as well. DMD is a 
disease caused by mutations in the dystrophin gene, resulting in a lack 
of the dystrophin protein. Dystrophin is part of a complex structure 
involving several other protein components that is required for 
maintaining proper skeletal muscle structure and function. In the 
absence of the dystrophin protein, muscle weakening and wasting, and 
ultimately death, occurs.
    The project will pursue a number of strategies for therapy 
development, including stimulating muscle growth by modulating growth 
factor pathways, and upregulating proteins that may structurally and 
functionally substitute for dystrophin or that contribute to the 
dystrophin protein complex in normal muscle cells. The researchers have 
already completed a high-throughput screening process on each of these 
strategies in order to identify small molecules that are candidate 
therapies. The project will focus on improving the properties of these 
small molecules as drug candidates and carry out research that will 
help support further clinical studies using these compounds. One 
exciting aspect of this project is the fact that a patient voluntary 
organization (Parent Project MD) as well as a company (PTC 
Therapeutics) are contributing funds to this project, thereby creating 
a public-private partnership to leverage funds for this project.
    This project is one important component of the larger NIH effort to 
find cures for DMD and other forms of muscular dystrophy. The Senator 
Paul D. Wellstone Muscular Dystrophy Cooperative Research Centers also 
fund translational research aimed at developing therapies for muscular 
dystrophy. In addition, a few years ago, NIH released a number of 
initiatives to stimulate translational research in muscular dystrophy, 
and grants are being funded through these initiatives, as well as 
through other mechanisms at NIH. A number of strategies for therapy 
development are being pursued in these studies including gene therapy, 
cell replacement therapy, enhancing muscle regeneration, and genetic 
modification strategies. In addition to these translational projects, 
it is important to note that the mechanistic knowledge obtained through 
NIH-funded basic research studies has yielded a range of therapeutic 
targets that NIH-funded research is now pursuing.

                        SPINAL MUSCULAR ATROPHY

    Question. Dr. Landis, can you tell us if any progress has been made 
toward a treatment for spinal muscular trophy? What continuing efforts 
is your institute making in this area? Also please describe the SMA 
Project, explain what makes it different than the traditional way of 
doing translational research at NIH, and comment on how it might serve 
as a model for research on other diseases.
    Answer. The goal of the SMA Project is to bring at least one new 
drug for SMA to readiness for clinical testing as quickly as possible. 
The project uses a performance-based contract. It is quite different 
from the usual way we do research because of the central direction and 
the way it is organized. A project steering committee, with extensive 
expertise in drug development from industry and the FDA, as well as 
from the NIH, put together a detailed drug development plan and is 
heavily engaged in guiding progress. The project is implementing the 
plan via a ``virtual pharma organization'' that develops and brings 
together all of the necessary resources through subcontracts to 
companies that serve the drug development industry.
    The Project has put more than 800 compounds through repeated cycles 
of modification and evaluation in laboratory tests and is making 
encouraging progress. Some of these potential drugs show dramatically 
improved potency and efficacy in simple laboratory tests, and NINDS 
gathered sufficient data to file a patent application in March 2007. In 
2007 and 2008, the most promising compounds will advance through more 
definitive tests of effectiveness in mice that have been genetically 
engineered to mimic human SMA. By June of 2007, the project intends to 
select a clinical candidate and begin the preclinical safety studies 
that will support clinical testing. We are already applying lessons 
from the SMA Project for other disorders through a similar contract 
mechanism planned for this year that will address a major barrier to 
drug development by providing access to medicinal chemistry services.
    We are also continuing other lines of SMA research in both the 
extramural and intramural programs. This year, for example, intramural 
researchers collaborating with Italian scientists showed for the first 
time that a drug treatment could be effective in an animal model of SMA 
when treatment is begun after the symptoms of disease have already 
appeared, which is an encouraging finding.

                               STEM CELLS

    Question. Dr. Landis, you serve as the Chair of the NIH Stem Cell 
Task Force. What steps would NIH take to implement S. 5, the Stem Cell 
Research Enhancement Act of 2007?
    Answer. If the bill were to be passed, a panel of experts would 
need to be immediately convened to develop and issue guidelines for 
implementation. NIH's experience in implementing human embryonic stem 
cell (hESC) research the past years would be vital in developing these 
new guidelines. In addition, NIH would develop a format for reporting 
requirements mandated within sections 2 and 3 of the act.

                            CLINICAL TRIALS

    Question. Dr. Insel, when Dr. Zerhouni was here last week, he noted 
that to continue to support ongoing research projects and allow for new 
investigators to successfully apply for support, it has been necessary 
to reduce support for clinical trials research. Has this also affected 
your institute? Will you be able to continue important clinical trials?
    Answer. NIMH is providing infrastructure support to maintain three 
large networks of investigative clinical teams that have evolved from 
the recent NIMH practical clinical trials on major depressive disorder, 
schizophrenia, and bipolar disorder. The networks comprise over 60 
sites throughout the United States with continual outreach and 
engagement to diverse groups of patients and families with mental 
illnesses. NIMH plans to support research studies that utilize the 
resources established by these networks; these studies must be of 
significant public mental health importance, provide value to 
individuals living with mental illnesses and to practitioners, and 
incorporate input from broad scientific and public domains. Under the 
President's Budget request, NIMH would be able to support a few studies 
on these clinical trial networks.
    Other recent NIMH-funded research has led to several promising new 
pharmacological treatment approaches for mental disorders. For example, 
a recent study uncovered a new mechanism of action to target for the 
fast relief of depression. In addition, NIMH has supported a large 
research effort focused on identifying novel compounds for treating the 
cognitive deficits associated with schizophrenia. NIMH hopes to build 
on these research findings to develop new compounds as fast-acting 
treatments for depression and as cognitive enhancers for those 
diagnosed with schizophrenia. Under the President's Budget request, 
NIMH would support a limited number of trials to test the efficacy of 
these promising new compounds.

              ECONOMIC BENEFITS OF MENTAL HEALTH RESEARCH

    Question. Dr. Insel, can you tell us about the economic benefits 
that have resulted from investment in mental health research?
    Answer. Mental disorders are associated with enormous economic 
burdens. The President's New Freedom Commission on Mental Health 
estimated that these economic costs are on the order of $150 billion 
each year in the United States alone.\4\  Much of this cost is due to 
the lost work productivity that results from mental illness. A large 
body of NIMH-supported research indicates that much of this economic 
cost, including that derived from impaired work performance, could be 
alleviated by standard treatments for mental disorders. Yet, the cost 
of mental illness persists in part because of widespread underuse and 
the poor quality of implementation of treatments that have been shown 
to be efficacious and tolerable. Recent effectiveness trials supported 
by NIMH have shown that a variety of models that enhance the care of 
mental disorders through aggressive outreach and improved quality of 
treatments are highly effective at improving clinical outcomes, and in 
some cases, on work performance outcomes as well. Economic analyses 
accompanying these effectiveness trials have also shown that these 
quality improvement interventions are cost-efficient. Unfortunately, 
widespread uptake of these enhanced mental health treatment programs 
has not occurred due to barriers at the level of providers, health care 
systems, and purchasers of health care. Additional ongoing research 
supported by NIMH is examining how to most effectively overcome these 
barriers to high-quality mental health care and to ultimately reduce 
the enormous adverse economic impact from mental disorders.
---------------------------------------------------------------------------
    \4\ New Freedom Commission on Mental Health, Achieving the Promise: 
Transforming Mental Health Care in America. Final Report. DHHS Pub. No. 
SMA-03-3832. Rockville, MD: 2003.
---------------------------------------------------------------------------
                              HEARING LOSS

    Question. What recent progress has been made toward better 
treatments for partial and full hearing loss? Has there been any 
specific progress in better hearing aid technology?
    Answer. Approximately 28 million Americans have a hearing 
impairment. Hearing loss is one of the most prevalent chronic health 
conditions in the United States, affecting people of all ages, in all 
segments of the population, and across all socioeconomic levels. It 
affects approximately 17 in 1,000 children under age 18. Incidence 
increases with age: approximately 314 in 1,000 people over age 65 have 
hearing loss. Because of the immense public health need, for over 30 
years, the NIH has played a significant and important role in 
sponsoring the development of cochlear implant technology. The cochlear 
implant is the only sensory neural prosthesis in widespread clinical 
use and according to the Food and Drug Administration's 2005 data; 
nearly 100,000 people worldwide have received implants. In the United 
States approximately 22,000 adults and nearly 15,000 children have 
received them. Continued research on ways to assess how well current 
users benefit from their cochlear implants will enable scientists to 
design implants that will be more effective for all future implant 
users. Some individuals with severe to profound hearing loss are 
receiving a cochlear implant for each ear. Research is demonstrating 
that these dual implant users are significantly better at localizing 
sounds and hearing speech in a noisy room, when compared to individuals 
with a single implant. Scientists also are developing a new cochlear 
implant electrode designed to provide electrical stimulation of the 
auditory nerve for high-frequency sounds while preserving useful, 
residual hearing at low frequencies. Scientists can now study the large 
groups of newborns who are identified for hearing loss and use this 
knowledge to document how cochlear implants can lead to improved speech 
acquisition, academic performance, and economic outcomes for these 
children.
    While cochlear implants bypass damaged portions of the inner ear 
and directly stimulate the auditory nerve, hearing aids amplify sounds. 
Scientists are determining which individuals can most benefit from 
hearing aids and the best ways to select and fit hearing aids in 
children and other people whose hearing ability is difficult to test. 
One of the most exciting advancements in hearing aid technology 
resulted from NIH-supported research. The discovered technology is 
based on the ears of a parasitic fly, Ormia ochracea. Despite their 
small size and the short distance between them, Ormia's ears are able 
to rapidly pinpoint the location from which the sound of a potential 
host--a cricket--is coming, even in a noisy environment. The intriguing 
mechanism that enables Ormia to accomplish this feat has provided a 
model for scientists and engineers to use in developing miniature 
directional microphones for hearing aids that can better focus on 
speech in a single conversation, even when surrounded by other voices. 
This finding has revolutionized the technology used for directional 
microphones and will improve the quality of life for the million of 
individuals with hearing impairment.
    Scientists are continuing to develop treatments for hearing loss 
that can be tailored to individuals' unique needs. The combined use of 
a hearing aid and a variation of the cochlear implant is another 
treatment being explored. A hearing aid in one ear combined with a 
shortened electrode array inserted into a portion of the cochlea of the 
other ear have proven to be effective in allowing individuals with 
hearing loss in the high frequencies to improve hearing. More research 
needs to be done to determine which individuals should receive these 
combined devices and which devices yield the most benefit. Researchers 
continue to conduct studies to determine the age at which hearing aids 
provide maximum success in early language development.

                       BASIC RESEARCH AND HEARING

    Question. Please give us an example of how basic research into the 
mechanics of hearing has led to better patient outcomes. Why is basic 
research important in the areas covered by your institute?
    Answer. Hearing aid users want devices that enable them to better 
understand speech. Two recent surveys demonstrate this desire. Poor 
benefit in noisy situations was listed among the top 20 reasons why 
hearing aid owners don't use their hearing aids. Another survey of 
2,428 hearing aid owners found that improved understanding of speech in 
noise was among the top 10 desired changes. Of all the available 
technologies, directional microphones for hearing aids have shown the 
most promise for addressing this problem, as demonstrated by clinical 
studies of individuals with hearing loss.
    Because of basic research, NIH-supported scientists successfully 
completed a fabrication process to miniaturize the prototype of a low-
power, highly directional hearing aid microphone so that it will fit 
into a hearing aid. This directional microphone mimics the auditory 
system of the parasitic fly, Ormia ochracea. The fly's system is an 
excellent model to imitate because its mechanically coupled ears enable 
it to detect the direction of sound and because it suggested a way to 
miniaturize a microphone for use in hearing aids. The scientists used 
silicon microfabrication technology to make a directional microphone 
that is small enough to be incorporated into a hearing aid. The 
directional microphone developed in fiscal year 2006 will ultimately 
help hearing aid users to better understand speech in a noisy 
background, such as in a crowded room. The microphone is able to do 
this by giving more weight to sound originating closest to the ear.
    This is an excellent example of why basic research is so important. 
Basic research often relies on studies in ``model organisms,'' such as 
mice, fruit flies, or bacteria. Because human cells contain the same 
molecular building blocks and pathways as those of most other living 
things, researchers can learn much about the way our cells work by 
studying these simpler organisms. These models allow scientists to 
design and control their experiments tightly and to select the type of 
organism best suited for examining a specific problem or process. The 
ability to conduct basic research on the ears of Ormia, has 
revolutionized the technology used for directional microphones and will 
improve the quality of life for millions of individuals with hearing 
impairment. This is one of the many examples of advances that grew out 
of basic research. In conclusion, while basic research studies do not 
always have an immediate impact on our health, such research often 
leads to new medicines, technologies, and research tools.

                          DRUG ABUSE TREATMENT

    Question. Dr. Volkow, I understand that your Institute has released 
principles of drug abuse treatment for criminal justice populations. 
Could you please summarize for us how you recommend dealing with drug 
abuse treatment for criminal populations?
    Answer. NIDA's recently released booklet, Principles of Drug Abuse 
Treatment for Criminal Justice Populations: A Research Based Guide, 
reflects NIDA-supported research aimed at improving outcomes for 
offenders with substance abuse problems. The principles emphasize the 
need for customized strategies, which can include behavioral therapies, 
medication, and consideration of other mental and physical illnesses. 
The key message is that drug abuse treatment works, especially with 
community involvement and support, and brings about reduced drug abuse, 
criminal recidivism, and relapse to addiction.


    For that reason, treatment is cost-effective: for every dollar 
spent on drug abuse treatment an estimated $4-$7 in benefits ensues 
from avoided criminal justice costs--benefits that grow as addiction 
treatment continues over time. Data also show that treatment can work 
even when it is entered involuntarily. NIDA therefore recommends that 
treatment for criminal justice offenders be part of a continuum of care 
that begins in prison and continues throughout the difficult periods 
during and following re-entry into the community.
    To help ensure better outcomes for offender populations, NIDA 
recommends an integrated approach that cuts across multiple public 
health and public safety systems. In this vein, NIDA launched a 
Criminal Justice-Drug Abuse Treatment Studies (CJ-DATS) Initiative, a 
multisite and multiagency research initiative to focus on implementing 
new research-based drug abuse treatment models in the criminal justice 
system. And because effective interventions may include 
pharmacotherapies, or medicines for drug abuse and addiction, NIDA 
recommends their use in criminal justice settings as part of a 
comprehensive treatment regimen--which will necessitate a culture 
change.
    Another tenet of effective drug abuse treatment is a proper balance 
of rewards and sanctions to encourage prosocial behavior and treatment 
participation. It is important to reinforce positive behavior for those 
participating in drug abuse treatment, with sanctions applied 
gradually, in line with degree or persistence of noncompliance.
    To effect needed changes, NIDA will continue to reach out to judges 
and others in the criminal justice system to educate them about the 
behavioral and biological aspects of addiction through intensive 
training workshops. We will also continue to support studies examining 
ways to make quality treatment options available through drug courts 
and other alternatives to incarceration for substance abusers.

                      ADDICTION AS A BRAIN DISEASE

    Question. Dr. Volkow, I understand that many in the field of drug 
abuse research strongly argue that addiction is a brain disease. Do you 
agree with this assessment, and if so, why?
    Answer. Yes, I wholeheartedly agree that addiction is a brain 
disease. Decades of scientific research by NIDA and others have 
affirmed drug addiction as a disease that alters the brain in ways that 
affect behavior. The compulsive craving, seeking, and use of drugs, 
even in the face of dire life consequences, happens because addiction 
affects the same brain circuits that are also involved in reward, 
motivation, memory, and control over behavior. And when these are 
usurped by drugs, so is a person's capacity to freely choose not to use 
drugs, even when it means losing everything they used to value. In 
fact, the inability to stop is the essence of addiction.
    Brain imaging and basic neuroscience research have helped us to 
understand how drugs of abuse alter brain function. We depend on our 
brain's ability to release dopamine in order to experience pleasure and 
to motivate responses to the natural rewards of everyday life, such as 
the sight or smell of food. Drugs of abuse produce very large and rapid 
dopamine surges and over time the brain responds by reducing normal 
dopamine activity. Eventually, the disrupted dopamine system renders 
the addict much less sensitive to pleasure--even to the drugs they seek 
to feed their addiction. Drugs of abuse also affect the regions of the 
brain that help people control desires and emotions, as evidenced by 
brain imaging research in humans revealing changes in the functions of 
these circuits. Thus, drug addiction affects the very brain areas that 
people need to ``think straight,'' apply good judgment, and make good 
decisions for their lives. The resulting lack of control leads addicted 
people to compulsively pursue drugs, even after the drugs have lost 
their effectiveness in producing pleasure; for now even the memories 
that are linked to the drug motivate behaviors to seek the drug. 
Behavior becomes reflexive and much less amenable to cognitive 
interference. Just as the damaged heart can no longer propel the blood 
to our bodies, the damaged brain can no longer propel the nerve 
impulses to control desires and emotions.
    Like any other medical disorder that impairs the function of vital 
organs, repair and recovery of the addicted brain depends upon targeted 
and effective treatments that address the complexity of the disease. 
Brain imaging shows recovery as well. Research is proving new insights 
on how this can be done. NIDA is engaged in studying new scenarios for 
what constitutes effective treatment: pharmacological treatments to 
mitigate stress and prevent relapse, cognitive treatments that 
strengthen the frontal (thinking) part of the brain, and strategies 
that diminish conditioned responses, promote new learning, inhibit 
stress-induced relapse, and restore the rewarding experiences from 
natural reinforcers.

                           UNDERAGE DRINKING

    Question. Dr. Li, how is your institute addressing the growing 
problem of underage drinking? Is progress being made?
    Answer. Although the problem of underage drinking persists progress 
is being made:
    (1) Based on converging evidence from multiple fields we now know 
that underage drinking is best addressed and understood within a 
developmental framework because this behavior is directly related to 
processes that occur during adolescence. Using such a framework will 
make us more effective in preventing and reducing underage alcohol use 
and its associated problems.
    (2) This paradigm shift along with recent advances in the fields of 
epidemiology, developmental psychopathology, human brain development, 
and behavioral genetics provided the scientific foundation for the 
Surgeon General's recently released Call to Action to Prevent and 
Reduce Underage Drinking, the work of the Interagency Coordinating 
Committee on the Prevention of Underage Drinking (ICCPUD) and the work 
of its member federal agencies and departments.
    (3) The release of the first ever Surgeon General's Call to Action 
on underage drinking is a landmark event which will heighten awareness 
of the problem in all sectors of society.
    (4) Federal surveys indicate some modest declines on certain 
measures of underage drinking. While this progress is encouraging, the 
prevalence of underage drinking, and especially binge drinking, remain 
high.
    (5) In order to better characterize trends in underage drinking in 
America, information beyond that previously available from national 
surveys is needed. Based on NIAAA's recommendations, new questions on 
patterns of drinking (e.g. very high level consumption, sources of 
alcohol, and drinking venues) are now being included in national 
surveys.
    (6) A key research question is the extent to which adolescent 
drinking impacts the developing human brain. Research with rodents and 
studies with alcohol dependent youth suggest that alcohol use during 
adolescence, particularly heavy use can have deleterious short- and 
long-term effects on the developing brain. To further address this 
central scientific question, NIAAA has released a Funding Opportunity 
Announcement for two-year pilot studies in this area entitled The 
Impact of Adolescent Drinking on the Developing Brain. Successful 
applications in response to this announcement will be funded in fiscal 
year 2007. These studies are expected to inform a larger longitudinal 
initiative.

                           ALCOHOL AND CANCER

    Question. Dr. Li, I understand that drinking alcoholic beverages 
has been linked to an increased risk of several types of cancer. Could 
you please tell us if this link has been confirmed, and if so do we 
know what the mechanism for the link might be?
    Answer. Chronic alcohol consumption is a well-established risk 
factor for cancer of the oral cavity, pharynx, esophagus, and larynx. 
For example, for those individuals who average 100 grams of alcohol 
consumed per day (about 7 standard drinks) the relative risk for cancer 
of the oral cavity and pharynx increases 6.5 times compared to non-
drinkers. Consuming this same level of alcohol increases the relative 
risk for cancers of the larynx, esophagus, breast and liver 3.9, 3.6, 
2.4, 1.8 fold respectively. While not as high, there are also 
significant elevated risks for each of these cancers associated with 
consumption of 25 grams of alcohol per day (about 2 standard drinks). 
Concurrent smoking and drinking, which is common, synergistically 
increases the risk of cancer. For example, one study reported an 18-
fold increase in the relative risk for esophageal cancer due to the 
consumption of more than 6 drinks/day, a 5-fold increase due to smoking 
more than 20 cigarettes/day, and 44-fold greater risk for combined 
heavy alcohol consumption and cigarette smoking.
    Alcohol is metabolized primarily by alcohol dehydrogenase in the 
liver to form acetaldehyde, a highly reactive and carcinogenic compound 
which is further metabolized by aldehyde dehydrogenase (ALDH2) to 
acetate. A variant of this enzyme (ALDH2*2) is virtually inactive 
(leading to higher concentrations of acetaldehyde) and occurs in 28-45 
percent of Asian populations. As a result of the accumulation of 
acetaldehyde, homozygous carriers of this allele (ALDH2*2/*2) 
experience aversive reactions to alcohol including strong facial 
flushing and toxic reactions. Therefore most homozygous individuals 
either abstain or drink infrequently. In contrast, heterozygous 
carriers (ALDH2*1/*2, which has about 10 percent residual ALDH2 
activity) who consume alcohol are at a high risk for developing 
esophageal cancer. Thus, acetaldehyde is implicated as a carcinogen, 
and is included in the list of ``IARC Group 2B Carcinogens.'' Several 
mechanisms have been implicated in alcohol-induced cancer, including: 
(1) formation of acetaldehyde which forms adducts with DNA; (2) 
production of reactive oxygen species (ROS) and lipid peroxidation 
products; (3) changes in folate and methionine metabolism; (4) alcohol-
induced increase in estrogen formation in breast cancer; (5) suppressed 
immune function; and (6) alcohol's solvent action enhancing the 
bioavailability of carcinogens from tobacco and other sources. The 
induction of microsomal cytochrome P450 enzymes by alcohol increases 
the metabolism of procarcinogens, such as nitrosamines, present in 
tobacco smoke, and likely plays an important role in the greater risk 
for cancer due to heavy alcohol consumption and smoking.

                          SUBCOMMITTEE RECESS

    Senator Harkin. So with that, thank you very much.
    The subcommittee will stand in recess to reconvene at 9:30 
a.m., Wednesday, March 28, in room SD-124. At that time we will 
hear testimony from the Honorable Elaine L. Chao, Secretary, 
Department of Labor.
    [Whereupon, at 5:24 p.m., Monday, March 26, the 
subcommittee was recessed, to reconvene at 9:30 a.m., 
Wednesday, March 28.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              


                       WEDNESDAY, MARCH 28, 2007

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:46 a.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin and Specter.

                          DEPARTMENT OF LABOR

                        Office of the Secretary

STATEMENT OF HON. ELAINE L. CHAO, SECRETARY

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. This Appropriations Subcommittee on Labor, 
Health and Human Services and Education will come to order for 
this hearing on the funding for the Department of Labor.

                          JIM SOURWINE TRIBUTE

    But before we begin, I would like to have us take a moment 
here to pay tribute to someone who has meant a great deal to 
me, to this committee, the Senate, and the mission of the 
Department of Labor. That is Jim Sourwine.
    Jim has been an essential part of the committee's work 
since 1972, when he was detailed to this committee from the 
Department of Labor. So this morning I want to recognize him on 
his retirement from the committee staff.
    For more than 30 years, Jim did his best to keep a low 
profile and stay out of the limelight. But I am sorry, Jim. It 
is time you get the public credit you deserve.
    Jim's outstanding service has made a real difference for 
the American people. When Jim started working at the Department 
of Labor in 1967, the Job Corps program was in its infancy--
just 3-years-old. Today it is a $1.6 billion enterprise, widely 
touted for its performance standards and student outcomes, 
helping more than 60,000 youths each year. Well, it was Jim's 
skill, and expertise, and doggedness that helped make that 
happen.
    He has organized and staffed countless hearings on 
important topics, such as ergonomics and overtime. And whenever 
this subcommittee has faced some sticky legislative problems, 
he has always known just how to solve them. You might say he is 
our default guy. He is our go-to person.
    For example, Jim is the one who figured out how to create a 
stable funding system to handle the fluctuating workloads of 
unemployment insurance claims. So Jim will be missed not just 
for his outstanding work for the committee, we will also miss 
him for how he has treated each of us. Senators and staffers 
alike. Always courteous. Always helpful. He is an 
appropriator's appropriator.
    He has worked for Republicans and he has worked for 
Democrats, back and forth for all these years. He has done it 
with equal diligence and faithfulness to both.
    Now he deserves a chance in retirement to do all the things 
he had less time to do while he slaved here late into the night 
and on weekends, and everything else for all those years. I 
suspect and hope that many of the things he will be doing 
involve golf clubs.
    So, Jim, the committee thanks you for your service, as do I 
personally. We wish you all the best in your retirement.
    I would yield to my esteemed colleague, Senator Specter.

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Well, thank you, Mr. Chairman. Thank you 
for scheduling this well-deserved tribute to Jim Sourwine. When 
you go back to 1972, when Senator Warren Magnuson was the 
chairman of this subcommittee, that establishes Jim Sourwine 
with a lot of seniority. More seniority than either the 
chairman or the ranking member have at the present time.
    The staff work that Jim has undertaken has been really 
very, very difficult. Our staffs on the Appropriation Committee 
are called upon to draft, and redraft, and amend, and 
supplement legislation. It is a job which requires a lot of 
overnights, when they have to read out the bill. A lot of 
weekends, when we are into that stage in September, October. It 
is very, very intense work. I think unusually so. Jim has 
undertaken a wide share, focusing on the very difficult issues, 
which the Department of Labor has had.
    I suspect that the golf courses will be seeing a lot more 
of Jim Sourwine in the future than they have in the past. But 
this will give him an opportunity to spend more time with his 
wife, Annette, children, Molly, Matt, and Billy. We will miss 
you, Jim, but we wish you the very best.
    Mr. Sourwine. Thank you.
    Senator Harkin. That is great.
    Madam Secretary.
    Secretary Chao. Yes. Please.
    Senator Harkin. No. Wait, Jim. We are not done, yet.
    Secretary Chao. No. We are not finished yet.

                          JIM SOURWINE TRIBUTE

    On behalf of the Department of Labor, let me also thank Jim 
Sourwine for his 40 years of service to America's workers. As 
the chairman and Senator Specter mentioned, Jim began his 
career at the Job Corps, at the Department of Labor. In 1972, 
he was detailed on a temporary basis. What a detail it has 
been.
    While he may have moved up to the Hill 35 years ago, before 
even the Department's Francis Perkins Building opened in 1974, 
he has dedicated his entire career to the Senate, to working on 
some of the most difficult and significant budgets, 
appropriations issues, facing several very significant 
departments. That is a tremendous accomplishment.
    I have been told that today is the thirty-fifth Labor 
Appropriations hearing that Jim has attended. As you know, 
Chairman Harkin and Senator Specter, Jim has been the Senate's 
institutional knowledge, not only for the Senate, but also for 
the Department of Labor as well.
    He understands these issues. He has always been an honest 
broker. We have valued his judgment, and also, many times, his 
advice. He knows how much this committee has spent on the 
Department's programs and which states they operate. All these 
kinds of details.
    Most of all, I think we all know that at the Department, he 
really appreciates the staff at the Department of Labor, the 
tremendous work that the Department does to advance the 
interest and the concerns of working men and women. So thank 
you, Jim, so much.
    You obviously have had a wonderful time up here. We want to 
wish you the best. We hope that you will take it easy, really 
enjoy yourself, and also get the time that your family so 
richly deserves, and your loved ones as well. Thank you.
    Mr. Sourwine. Thank you all so much.
    I will have to get a copy of the transcript now.
    Senator Harkin. Thank you, Jim. It will never be the same 
without you.
    Well, Madam Secretary, thank you very much. We will now 
turn to our hearing, as soon as I find my right page here.

                           OPENING STATEMENT

    First of all, Madam Chairman, I would like to welcome you 
again to the committee, and return to the subject of today's 
hearing, the budget of the Department of Labor. First and 
foremost, I would be remiss if I did not thank you for the 
great work you did on the Job Corps Center in Ottumwa, Iowa. 
Also in Wyoming and New Hampshire.
    As we just said about the Job Corps, it is interesting that 
this was Jim's deal when he first started. To this day, and 
today, we are still opening new Job Corps centers around the 
country. These three, I think, will be a welcome addition to 
all the other Job Corps centers around the country. So I thank 
you for that. We will see what we do to work together to make 
sure we move these along as rapidly as possible. Whatever else 
we need to do up here.
    Madam Secretary, your Department has several critical 
responsibilities. One is administering Federal labor laws that 
guarantee workers' rights to safe and healthful working 
conditions. Another is helping workers find and prepare for 
work, such as a worker displaced by an employer that is 
relocating overseas and other things.

                    MINE COMMUNICATIONS TECHNOLOGIES

    Now, Madam Secretary, I am a little disturbed by some of 
the progress, or I should say lack of progress being made on 
some of these objectives. Now we had hearings here last month 
on MSHA; the assistant secretary of Mine and Safety Health 
Administration was here. I expressed my disappointment with the 
small number of communications technologies approved by MSHA to 
date.
    We had had that hearing a year ago or so. That was under 
Chairman Specter's reign at that time. We had those hearings. 
We were talking to MSHA about moving ahead on some of these 
technologies. But it does not seem like we are making much 
progress on that.
    Earlier this month, United Mine Workers Association 
reporting on the Sago Mine disaster, found significant 
shortcomings in MSHA's actions that could have prevented the 
deaths of the 12 miners who perished in that tragedy.

                   OIL REFINING INDUSTRY INSPECTIONS

    Last week, the Chemical, Safety, and Hazard Investigation 
Board released a report on the BP Texas City Refinery explosion 
in 2005 that resulted in the deaths of 15 workers and more than 
100 injuries. The Board found that on your watch the 
Occupational Safety and Health Administration has not conducted 
one planned comprehensive inspection in the oil refining 
industry.

                       INTERNATIONAL CHILD LABOR

    I am also concerned, as you might guess, Madam Secretary, 
about the proposed--once again, the fight against international 
child labor. Now this is something that this committee has 
focused on, oh, for 12, 13, 14, years. Something like that. 
Last year, the International Labor Organization's global 
report, ``The End of Child Labor Within Reach,'' stated that 
for the first time, child labor, especially in its worst forms, 
is in decline across the globe.
    Between the years 2000 and 2004, the number of child 
laborers worldwide fell by 11 percent. So we are making real 
progress that could be reversed by the proposed cuts in this 
budget on that.
    So I do not think this is the time to rest on our laurels. 
We are making headway. This Department has been a partner with 
us, as I said, going back a dozen years maybe or so in the 
efforts on child labor. I hope we are not going to be backing 
off on that now.

                           DOL BUDGET REQUEST

    We may get into talking about ergonomic standards, 
enforcing the requirements for protective equipment. Effective 
enforcement under the Family Medical Leave Act. But it is not 
just worker protection program. Your budget proposes a cut of 
$1 billion in job training programs.
    Earlier this month, Bill Gates testified before the HELP 
Committee, on which I also sit, the authorizing committee, and 
he said, and I quote, ``Workforce enhancement should be treated 
as a matter of national competitive survival.'' He went on to 
say, ``It is a down payment on our future. An extremely vital 
step to secure American competitiveness for future generations 
and to honor the American ideal that every single one of us 
deserves the opportunity to participate in America's success.'' 
So I wonder what kind of a future can we expect if we are going 
to be cutting our budget by $1 billion.
    So Madam Secretary, that is what we are here to talk about, 
is the budget. Obviously, we are going to have some 
disagreements in that budget, because these values and 
policies, I think, this committee has supported strongly in the 
past under both Democratic and Republican chairmen.
    We just cannot turn a blind eye towards employers who are 
denying their workers a safe place to work. Our continued 
success, I believe, in this country depends on investments that 
we make in workforce. Workforce training.
    So again, we will get into more of that later and talk 
about these proposed cuts and stuff. But first, I would 
recognize my ranking member, Senator Specter, for any comments.
    Senator Specter. Thank you. Thank you, Mr. Chairman. Madam 
Secretary, I join the chairman in welcoming you to this 
hearing. I compliment you, on your seventh year of service to 
the administration of President Bush. If you are not the 
longest serving secretary, you are certainly tied, because you 
have been here for the entire tenure of the President.
    At the outset, I want to thank you for the Department's 
prompt response and your prompt response to the inclusion of 
$25 million in the continuing resolution--directed at at-risk 
youth and tremendous problems in juvenile crime across this 
country.
    It takes very prompt action to get those funds moving, so 
that they will be available for the start of the school year, 
and perhaps even sooner.
    I share the concern about the budget. I know we live in an 
era of severe budget constraints. I know we made a large--or we 
are in the process of making a large appropriation on an 
emergency basis for the administration's programs, including 
the funding in Iraq.
    But it seems to me that with the very heavy 
responsibilities which your Department has, that a decrease in 
the budget of $1.1 billion, almost 10 percent from the fiscal 
year 2007 level, is hard to sustain.
    If there is going to be this kind of a cut, there are going 
to have to be some very important programs affected. The $1 
billion decrease in job training and employment services, is a 
real problem. It impacts directly upon juvenile crime. As does 
the $55 million cut in the Job Corps.
    You have the prisoner reentry initiative and the 
reintegration of ex-offenders, with a decrease of $25.4 
million. These cuts will be very, very difficult to sustain, 
given the issues which that funding addresses.
    We will, obviously, be taking a very, very close look at 
these recommendations. On our constitutional responsibility to 
appropriate, we will be putting our own imprint on the budget, 
as we always do. But we thank you for your hard work and your 
diligence, and look forward to your testimony.
    Senator Harkin. Thank you very much. Secretary Elaine Chao 
was sworn in as the twenty-fourth Secretary of Labor on January 
31, 2001. She is the first Asian-American woman appointed to 
the President's cabinet in U.S. history.
    Secretary Chao was president and CEO of the United Way 
Foundation from 1992 to 1996, and served as Director of the 
Peace Corps and Deputy Secretary of the Department of 
Transportation under former President Bush.
    Most recently, she was a distinguished fellow at the 
Heritage Foundation. Secretary Chao received her MBA from 
Harvard Business School and her undergraduate degree from Mount 
Holyoke College. She also studied at M.I.T., Dartmouth, and 
Columbia University.
    Madam Secretary, my first question for you--are you the 
longest-serving Labor secretary?
    Secretary Chao. No. I am not.
    Senator Harkin. Oh.
    Secretary Chao. Frances Perkins was Secretary of Labor for 
12 years, under Franklin Delano Roosevelt. There was also Mr. 
Wilson.
    Senator Harkin. Has anyone served longer as a secretary in 
the administration of George W. Bush?
    Secretary Chao. I am probably the longest serving. Since 
the 1960s, I am probably the longest-serving Secretary of 
Labor.
    Senator Harkin. Very good. Welcome, Madam Secretary. And 
please proceed.

                SUMMARY STATEMENT OF HON. ELAINE L. CHAO

    Secretary Chao. Thank you. Mr. Chairman, I have got a 
longer statement, which I will leave for the record. And then I 
have a shorter statement. I will go through it very quickly.
    Senator Harkin. That will be great.
    Secretary Chao. I will just go through some of the numbers, 
which we know already. But just also emphasize some of the 
priorities.
    Chairman Harkin, Senator Specter, thank you for the 
opportunity to present the administration's fiscal year 2008 
budget for the Department of Labor. The total budget for the 
Department is $50.4 billion, of which $10.6 billion is for 
discretionary spending. The Department's fiscal year 2008 
budget focuses on four overall priorities: Protecting workers' 
health and safety; protecting workers' pay, benefits, pensions, 
and union dues; securing the employment rights of America's 
veterans; and increasing the competitiveness of America's 
workforce.
    In fiscal year 2008, $1.5 billion is requested for the 
Department's worker protection programs. The fiscal year 2008 
budget request for MSHA is $313.5 million, and 2,306 FTEs. The 
request will allow MSHA to continue implementing the historic 
MINER Act. This request also includes $16.6 million 
specifically targeted to retain the 170 mine and safety 
enforcement personnel that were added in 2006 and 2007.
    The budget would support MSHA's efforts to provide for the 
following: approval of emergency response plans; strengthening 
compliance for increased civil penalties; improving the safety 
of abandoned areas of mines and increasing the effectiveness of 
mine rescue teams.
    This request will also enable MSHA to continue testing and 
evaluating promising new technologies that could be deployed in 
support of mine rescue operations.
    The fiscal year 2008 request also includes $490.3 million 
and 2,186 FTEs for OSHA. This request will enable OSHA to focus 
its enforcement efforts on high hazard industries that 
typically employ disproportionate numbers of low-wage, 
vulnerable workers.
    The fiscal year 2008 budget request before this committee 
for the Employment Standards Administration is $699.6 million 
and an FTE of 4,082. The request for ESA includes $182.4 
million, and 1,336 FTEs for the wage and hour division. The 
request for wage and hour includes funding for additional 
inspectors, enhanced enforcement in low waging industries, and 
a legislative proposal to increase civil monetary policies 
associated with the violation of child labor laws.
    The ESA request also includes $84.2 million and 625 FTEs 
for the Office of Federal and Contract Compliance Programs, 
OFCCP, to protect workers from discrimination by, obviously, 
Federal contractors. Another $106.6 million and 867 FTEs are 
requested for the Office of Workers' Compensation Programs. ESA 
also requests an additional $56.9 million and 369 FTEs for the 
Office of Labor-Management Standards.
    For the Employee Benefits Security Administration, EBSA, 
which protects the health and retirement benefits of 150 
million workers, the fiscal year 2008 budget request is $147.4 
million, and 855 FTE.
    This request will enable EBSA to implement important 
regulations required under the Pension Protection Act, 
including making it easy for Americans to save for retirement, 
ensuring that the pension promises made to workers are kept, 
and that retirement security for workers is, indeed, 
maintained.
    Then on your point, Mr. Chairman, as we all know, the 
United States is transitioning to a knowledge-based economy, 
closely intertwined with the worldwide economy. Our country's 
worker training programs need to keep pace with these 
developments. We need to equip workers with the skills needed 
to succeed in this new economic environment.
    The fiscal year 2008 budget request includes $8.3 billion 
and 1,196 FTEs for the Department's Employment and Training 
Administration, ETA. This request includes proposals for 
innovative reforms that will increase the quality of the 
training offered, as well as the number of workers trained.
    The next priority is this Nation's commitment to our 
veterans must be honored. The Department is committed to 
providing returning veterans with the support needed to make 
the transition back to the non-military workforce a smooth and 
successful one.
    So for the Department's Veterans' Employment and Training 
Service, the fiscal year 2008 budget request is $228.1 million 
and 244 FTEs. This will enable VETS to maximize employment 
opportunities for veterans and protect their employment and re-
employment rights.

                           PREPARED STATEMENT

    So, Mr. Chairman, the Department's fiscal year 2008 budget 
request will enable us to meet our key priorities. That is 
protecting workers, preparing workers for the 21st century 
workforce and economy, ensuring veterans' employment and re-
employment rights, and maintaining fiscal discipline.
    I will be happy to answer any questions.
    Senator Harkin. Yes, your statement, full statement will be 
made part of the record in its entirety.
    Secretary Chao. Thank you.
    [The statement follows:]
               Prepared Statement of Hon. Elaine L. Chao
    Good morning Mr. Chairman, Ranking Member Specter, distinguished 
Members of the Subcommittee, ladies and gentlemen. Thank you for the 
opportunity to appear before you today to present the fiscal year 2008 
budget for the Department of Labor.
    The total request for the Department in fiscal year 2008 is $50.4 
billion and 16,869 FTE, of which $15.4 billion is before the Committee. 
Of that amount, $10.6 billion is requested for discretionary budget 
authority. Our budget request will allow us to build on the 
accomplishments achieved in recent years and enable the Department to 
meet its critical priorities for fiscal year 2008, while helping to 
achieve the President's deficit reduction goals by reforming programs 
and reducing or eliminating ineffective or duplicative activities.
    As the President has noted, our country's economy is strong and 
growing. We have seen:
  --42 months of uninterrupted job growth;
  --7.6 million new jobs created since August 2003;
  --An unemployment rate that has fallen to 4.5 percent since June 
        2003;
  --An increase in average hourly earnings of 4.1 percent over the past 
        12 months (before adjustment for inflation); and
  --GDP growth of 3.1 percent in 2006.
    These achievements are a tribute to the flexibility of our 
workforce and the dynamism of our economy. The Department's fiscal year 
2008 budget will promote continued economic growth by strengthening the 
health, safety, and competitiveness of our Nation's vibrant workforce.

                         RECENT ACCOMPLISHMENTS

    As an introduction to the fiscal year 2008 budget, I would like to 
highlight some of the Department's recent accomplishments, which 
reflect the strong enforcement of worker protection laws and efforts to 
assist American workers. For example:
  --In 2006, the Employee Benefits Security Administration achieved 
        monetary results in the protection of workers' pension and 
        health benefits that were 94 percent higher than in 2001.
  --Since 2001, there has been a nearly 7 percent reduction in the 
        fatality rate, an achievement that can be partially attributed 
        to the Occupational Safety and Health Administration's 
        enforcement and cooperative programs. The fatality rate among 
        Hispanic workers has fallen by 18 percent during the same 
        period. There has been a more than 13 percent reduction in the 
        overall injury and illness rate since 2002.
  --In 2006, as a result of the Wage and Hour Division's enforcement, 
        more than 246,000 workers received $172 million in back wages, 
        including overtime. This is a 30 percent increase over the 
        amount of back wages recovered in 2001.
  --The Office of Federal Contract Compliance Programs has posted 
        record results in enforcing equal opportunity rights for 
        employees of Federal contractors, with an increase in financial 
        recoveries of nearly 80 percent between 2001 and 2006. In 2006, 
        OFCCP recovered $52 million in back pay, salaries, and benefits 
        for over 15,000 employees.
  --The Employment and Training Administration has enhanced its 
        services to American workers through innovative initiatives 
        designed to link economic development, education and workforce 
        development.

                      FISCAL YEAR 2008 PRIORITIES

    The Department's fiscal year 2008 budget seeks to build on the 
success of previous years. The budget features three overall 
priorities: protecting workers' safety and health; protecting workers' 
pay, benefits, pensions, and union dues; and increasing the 
competitiveness of America's workforce.

                 PROTECTING WORKERS' SAFETY AND HEALTH

    The 2008 budget includes $1.5 billion in discretionary funds for 
DOL's worker protection activities. This funding level will enable the 
Department to continue its record-setting protection of workers' 
health, safety, pay, benefits and union dues.
Mine Safety and Health Administration (MSHA)
    The fiscal year 2008 budget request for MSHA is $313.5 million and 
2,306 FTE. The request will allow MSHA to continue implementing the 
historic Mine Improvement and New Emergency Response (MINER) Act, the 
most sweeping mine safety legislation in 30 years.
    Since the President signed the MINER Act of 2006, the Department 
has taken aggressive action to implement and enforce the Act. For 
example, we have:
  --Established new policies regarding the approval of Emergency 
        Response Plans and the creation of a Family Liaison program;
  --Proposed regulations to increase the Civil Penalties for violations 
        of safety and health standards;
  --Issued information bulletins regarding the provision of post-
        accident breathable air to trapped miners and guidance for 
        sealing abandoned areas of mines;
  --Initiated rulemaking to develop new standards for Mine Rescue 
        Teams;
  --Coordinated the first meeting of the Belt Air and Conveyor Belt 
        Materials technical study panel to review the use of belt air 
        to ventilate the mine production area;
  --Begun to aggressively hire and train 170 new mine safety 
        enforcement personnel; and
  --Issued an Emergency Mine Evacuation Final Rule (ETS).
    The fiscal year 2008 budget will allow the Department to continue 
these efforts and improve the health and safety of all miners. The 
request includes $16.6 million specifically targeted to retain the 170 
coal enforcement personnel that were added in 2006 and 2007 in response 
to the increase in coal mine fatalities. The budget will support MSHA's 
efforts to provide for approval of Emergency Response Plans; strengthen 
compliance through increased civil penalties; improve the safety of 
abandoned areas of mines; and increase the effectiveness of mine rescue 
teams. The request allows MSHA to continue testing and evaluating 
promising new technologies that could be deployed in support of mine 
rescue operations.
Occupational Safety and Health Administration (OSHA)
    The fiscal year 2008 budget request for OSHA is $490.3 million and 
2,186 FTE. The request provides resources to support 89,700 Federal and 
State safety and health inspections.
    With an emphasis on enforcement, complemented by compliance 
assistance, OSHA will focus on those high-hazard industries where we 
typically find large numbers of non-English speaking workers. In fiscal 
year 2008, all elements of OSHA's intervention strategies--enforcement, 
training, compliance assistance, outreach, cooperative programs and 
guidelines--will be brought to bear to protect this vulnerable 
population. The request for OSHA includes $4.6 million and 13 FTE to 
expand OSHA's Voluntary Protection Programs (VPP), a cooperative health 
and safety recognition program that has been very effective in reducing 
illness and injury rates. Employers participating in VPP achieve lost-
time injury and illness rates that are 50 percent lower than their 
industry average.

           PROTECTING WORKERS' PAY, BENEFITS, AND UNION DUES

    The Department will also continue its high priority programs to 
protect workers' pay, benefits, and union dues.
Employment Standards Administration
    The Department's Employment Standards Administration (ESA) 
administers and enforces a variety of laws designed to enhance the 
welfare and protect the rights of American workers. The fiscal year 
2008 budget request for administrative expenses for ESA is $699.6 
million and 4,082 FTE.
Wage and Hour Division
    The Wage and Hour Division is responsible for the administration 
and enforcement of a wide range of worker protection laws, including 
the Fair Labor Standards Act, Family and Medical Leave Act, Migrant and 
Seasonal Agricultural Worker Protection Act, worker protections 
provided in several temporary non-immigrant visa programs, and 
prevailing wage requirements of the Davis-Bacon Act and the Service 
Contract Act. These laws collectively cover virtually all private 
sector workers, as well as State and local government employees.
    The fiscal year 2008 budget also includes resources to hire 
additional Wage and Hour investigators to strengthen enforcement 
resources for industries and workplaces that employ low-wage, immigrant 
workers. The budget also re-proposes legislation to increase civil 
monetary penalties associated with violation of child labor laws, 
raising the penalties from $11,000 to $50,000 for violations that 
result in the death or serious injury of youth in the workplace, and 
increasing the penalty to $100,000 for willful or repeat violations 
that result in death or serious injury. The administration expects to 
transmit legislation to the 110th Congress shortly, and urges Congress 
to act swiftly to pass it.
    The fiscal year 2008 budget request for the Wage and Hour Division 
totals $182.4 million and 1,336 FTE, which excludes $31.0 million in 
estimated fee revenue from DOL's portion of the H-1B visa fraud 
prevention fee authorized by the 2004 H-1B Visa Reform Act. Given 
strict statutory limits on the use of these funds DOL has been unable 
to spend more than $5 million in any single year and entered 2007 with 
more than $60 million in unspent balances. The fiscal year 2008 budget 
cancels $50 million of these balances and amends the Immigration and 
Nationality Act to permit a more effective use of the fraud prevention 
fees collected under this provision going forward.
Office of Federal Contract Compliance
    The fiscal year 2008 budget request for the Office of Federal 
Contract Compliance Programs (OFCCP) totals $84.2 million and 625 FTE. 
OFCCP is responsible for ensuring equal employment opportunity and non-
discrimination in employment for businesses contracting with the 
Federal Government. OFCCP carries out this mandate by conducting 
compliance evaluations to identify instances of systemic discrimination 
in the workplace, taking appropriate enforcement action, and providing 
relevant and effective compliance assistance programs. During fiscal 
year 2008, OFCCP will use its Active Case Management and Functional 
Affirmative Action Programs to target non-compliant contractors and 
continue to improve the effectiveness of OFCCP's enforcement 
activities, meaning more workers will be protected.
Office of Workers' Compensation Programs
    The fiscal year 2008 discretionary budget request for 
administration of the Office of Workers' Compensation Programs (OWCP) 
totals $106.6 million and 867 FTE to support the Federal Employees' 
Compensation Act (FECA) ($93.4 million) and the Longshore and Harbor 
Workers' Compensation program ($13.2 million).
    The OWCP budget also includes mandatory funding totaling $104.7 
million (including $55.4 million for HHS/NIOSH) and 275 FTE to 
administer Part B of the Energy Employees Occupational Illness 
Compensation Program Act (EEOICPA), and $56.9 million and 189 FTE for 
Part E of the act. EEOICPA provides compensation and medical benefits 
to employees or survivors of employees of the Department of Energy and 
certain of its contractors and subcontractors, who suffer from a 
radiation-related cancer, beryllium-related disease, chronic silicosis 
or other covered illness as a result of work at covered Department of 
Energy or DOE contractor facilities.
    Lastly, OWCP's fiscal year 2008 budget includes $37.6 million in 
mandatory funding and 201 FTE for its administration of Parts B and C 
of the Black Lung Benefits Act, and $52.3 million and 127 FTE in FECA 
Fair Share administrative funding.
    The 2008 budget includes two legislative proposals affecting OWCP 
programs that play a critical role in protecting workers' economic 
security, by providing monetary and medical benefits to Federal 
employees and coal miners whose ability to work has been diminished by 
an occupational injury or illness. The first re-proposes reforms to the 
Federal Employees Compensation Act to update its benefit structure, 
adopt best practices of State workers' compensation systems, and 
strengthen return-to-work incentives. This proposal is expected to 
generate Government-wide savings of $608 million over 10 years. The 
second is a proposal to restructure, and eventually retire, the 
mounting debt of the Black Lung Disability Trust Fund--a debt that now 
approaches $10 billion.
Office of Labor-Management Standards
    The fiscal year 2008 budget request for the Office of Labor-
Management Standards (OLMS) totals $56.9 million and 369 FTE. OLMS 
enforces provisions of Federal law that establish standards for union 
democracy and financial integrity. OLMS conducts investigative audits 
and criminal investigations for embezzlement and other financial 
mismanagement; conducts civil investigations of union officer elections 
and supervises remedial elections where required; administers statutory 
union financial reporting requirements; and provides for public 
disclosure of filed reports. OLMS also administers employee protective 
provisions created under Federal transit legislation.
    The resources requested will allow OLMS to continue to further the 
goals of financial integrity, union democracy, and transparency. The 
budget also supports legislation that would authorize OLMS to impose 
civil money penalties on unions and others that fail to file required 
financial reports on a timely basis.
Employee Benefits Security Administration
    The Department's Employee Benefits Security Administration (EBSA) 
protects the integrity of pensions, health plans, and other employee 
benefits for more than 150 million workers. The fiscal year 2008 budget 
request for EBSA is $147.4 million and 855 FTE. The request includes a 
$5.5 million increase to be supplemented with $2.5 million of agency-
absorbed costs to complete the replacement of EBSA's outdated, paper-
based ERISA Filing and Acceptance System, known as EFAST. I note that 
the amount of the fiscal year 2008 EFAST2 funding request may be 
reduced pending the final resolution of EFAST2 funding in fiscal year 
2007, and we appreciate the opportunity to continue working with the 
committee on this important project. The new electronic filing system 
for Form 5500 reports will strengthen the protection of employee 
benefits by greatly reducing processing times for Form 5500 filings and 
improving the reliability of Form 5500 data. By making data on the 
funding of pension and other benefit plans more transparent and 
accessible, this new system will support the President's efforts to 
strengthen retirement security for the Nation's workers and retirees.
Pension Benefit Guaranty Corporation
    The Pension Protection Act of 2006 made important structural 
reforms to the defined benefit pension system, but further premium 
changes are needed to restore long-term solvency to the pension 
insurance program. The President's fiscal year 2008 budget proposes to 
adjust insurance premiums paid by underfunded pension plans to address 
the nearly $19 billion gap between the liabilities and assets of the 
Pension Benefit Guaranty Corporation (PBGC). Although PBGC will be able 
to pay benefits for some years to come, it is projected to be unable to 
meet its long-term obligations under current law. The proposed reforms 
would improve PBGC's financial condition and safeguard the future 
benefits of workers and retirees.

                PREPARING WORKERS FOR NEW OPPORTUNITIES

Reforming the Workforce Investment System
    The fiscal year 2008 budget request for the Department's Employment 
and Training Administration (ETA) is $8.3 billion in discretionary 
funds and 1,196 FTE, not including the 120 FTE associated with the PERM 
fee legislative proposal. Through innovative reforms, the budget 
request for ETA will allow the Department to increase the 
competitiveness of the American workforce in a knowledge-based economy.
    The United States competes in a global economy that is far 
different from the international markets of the past. As our Nation's 
economy and businesses transform to meet the challenges of the 21st 
century, so too must the government systems and structures that support 
our economic growth and job creation.
    The President has sought to transform worker training programs into 
a demand-driven system that prepares workers for jobs in growth sectors 
of the economy. The workforce investment system should recognize and 
strengthen workers' ownership of their careers, and provide more 
flexible resources and services designed to meet their changing needs.
    American workers will need higher levels of education and skills 
than at any time in our history, as evidenced by the fact that almost 
90 percent of new jobs in high-growth, high-wage occupations are 
expected to be filled by workers with at least some post-secondary 
education. However, the current workforce investment system does not 
provide the necessary educational and training opportunities for 
workers. Too much money is spent on competing bureaucracies, overhead 
costs, and unnecessary infrastructure, and not enough on meaningful 
skills training that leads to employment opportunities and advancement 
for workers.
    To increase the quality of training offered, as well as the number 
of workers trained, the Department proposes legislative reforms to 
consolidate funds for the following programs into a single funding 
stream:
  --Workforce Investment Act (WIA) Adult Program;
  --WIA Dislocated Worker Program;
  --WIA Youth Program; and
  --Employment Service programs (including Employment Service formula 
        grants, labor market information grants, and grants for 
        administration of the Work Opportunity Tax Credit and the 
        Welfare-to-Work Tax Credit).
    States would use these funds primarily to provide Career 
Advancement Accounts (CAAs) to individuals who need employment 
assistance. CAAs are self-directed accounts of up to $3,000, an amount 
sufficient to finance approximately 1 year's study at a community 
college. The accounts could be renewed for one additional year, for a 
total 2-year account amount of up to $6,000 per worker. CAAs would be 
used to pay for expenses directly related to education and training. 
The accounts would be available to both adults and out-of-school youth 
entering the workforce or transitioning between jobs, and incumbent 
workers in need of new skills to remain employed. The funds would also 
be used by States to provide basic employment services such as career 
assessment, workforce information, and job search assistance to job 
seekers. By removing bureaucratic restrictions that can prevent workers 
from being trained, increasing the flexibility of State and local 
officials to shift funding to where it is most needed, and requiring 
the majority of dollars in the system to be spent on training instead 
of infrastructure, these reforms will significantly increase the number 
of individuals who receive job training and attain new and higher-level 
job skills.
Community-Based Job Training Initiative
    The fiscal year 2008 budget provides $150 million for the fourth 
year of grants under the President's Community-Based Job Training 
Initiative. This competitive grant program leverages the expertise of 
America's community colleges and takes advantage of the strong natural 
links between community colleges, local labor markets and employers to 
train workers for jobs in high-demand industries. In October 2005, the 
Department awarded the first grants totaling $125 million to 70 
community colleges in 40 States. A second competition for Community-
Based Job Training Grants was held in the summer of 2006, and in 
December 2006, the Department awarded $125 million in grants to 72 
entities in 34 States. These grants will be used to increase the 
capacity of community colleges to provide training in local high 
growth, high demand industries and train new and experienced workers 
for jobs in these industries. The Department plans to hold the 
competition for the fiscal year 2007 Community-Based Job Training 
Grants in the summer of 2007.
YouthBuild
    In the summer of 2006, Congress unanimously passed the YouthBuild 
Transfer Act to transfer the YouthBuild program from the Department of 
Housing and Urban Development to the Department of Labor, as 
recommended by the White House Task Force on Disadvantaged Youth. The 
fiscal year 2008 budget includes $50 million for YouthBuild to provide 
competitive grants to local organizations for the education and 
training of disadvantaged youth age 16-24. Under these grants, youth 
will participate in classroom training as well as learn construction 
skills by helping to build affordable housing. Within DOL, YouthBuild 
will take advantage of better connections to the workforce investment 
system, closer association with occupational safety and health and 
youth employment protection programs, stronger ties to Job Corps and 
apprenticeship programs, new links to the President's High Growth Job 
Training Initiative, improved access to the postsecondary and community 
college system, and stronger connections to employers and local labor 
markets.
Reintegration of Ex-Offenders
    The fiscal year 2008 budget requests $39.6 million for a program 
that brings together the President's Prisoner Re-entry Initiative (PRI) 
and the Responsible Reintegration of Youthful Offenders (RRYO) program. 
This new consolidated program would avoid the duplication of efforts 
that currently exists between PRI and RRYO and adopt the practices of 
these two efforts that have shown great promise in boosting employment 
and reducing recidivism among ex-offenders. Through competitively 
awarded, employment-centered grants that holistically address the 
multiple challenges facing offenders upon their release, the 
Reintegration of Ex-Offenders program would tap the unique strength, 
networks, and relationships of faith-based and community organizations 
to reach out to ex-offenders to help them find jobs and build new 
lives.
Strengthening Unemployment Insurance Integrity and Promoting Re-
        Employment
    The fiscal year 2008 budget continues the administration's efforts 
to ensure the financial integrity of the Unemployment Insurance (UI) 
system, and help unemployed workers return to work promptly. Our three-
pronged approach includes:
  --A package of legislative changes that would prevent, identify, and 
        collect UI overpayments and delinquent employer taxes. These 
        changes include: allowing States to use a small amount of 
        recovered overpayments and collected delinquent taxes to 
        support additional integrity efforts; authorizing the U.S. 
        Treasury to recover UI benefit overpayments and certain 
        delinquent employer taxes from Federal income tax refunds; 
        requiring States to impose a penalty on UI benefits that 
        individuals obtain through fraud and using those funds for 
        integrity activities; and requiring employers to include a 
        ``start work'' date on New Hire reports to help identify 
        persons who have returned to work but continue to receive UI 
        benefits. We estimate that these legislative proposals would 
        reduce overpayments and increase recoveries and delinquent tax 
        collections by a total of $2.3 billion over 5 years.
  --A $40 million discretionary funding increase to expand Reemployment 
        and Eligibility Assessments (REAs), which review UI 
        beneficiaries' need for reemployment services and their 
        continuing eligibility for benefits through in-person 
        interviews in One-Stop Career Centers. This initiative already 
        has yielded quicker returns to work for UI beneficiaries. We 
        estimate that annual benefit savings of $205 million could 
        result from this investment.
  --A legislative proposal to permit waivers of certain Federal 
        requirements to allow States to experiment with innovative 
        projects aimed at improving administration of the UI program, 
        and speeding the reemployment of UI beneficiaries.
    We urge the Congress to act on these important proposals to 
strengthen the financial integrity of the UI system and help unemployed 
workers return to work.
Senior Community Service Employment Program
    The fiscal year 2008 budget requests $350 million for the Senior 
Community Service Employment Program (SCSEP). The Department is pleased 
that the recently reauthorized Older Americans Act includes many of the 
administration's reform proposals to streamline SCSEP and increase the 
number of persons who may enjoy the benefits of unsubsidized 
employment. The Department expects that legislative reforms will 
improve program efficiency and reduce costs compared to the previous 
program design. We are optimistic that the important reforms included 
in SCSEP reauthorization--including the elimination of inappropriate 
fringe benefits, caps on the duration of program participation, 
additional flexibility to provide training, and increased emphasis on 
placement in unsubsidized employment--will allow SCSEP to use funds 
more efficiently, serve more participants per dollar, and allow 
participants to achieve greater economic self-sufficiency than ever 
before.
Job Corps Transfer
    The budget includes $1.5 billion to operate a nationwide network of 
123 Job Corps centers in fiscal year 2008. Job Corps provides training 
to address the individual needs of at-risk youth and ultimately equip 
them to become qualified candidates for the world of work. In the 
fiscal year 2006 appropriation act, the Congress directed the 
Department to transfer the Job Corps program out of the Employment and 
Training Administration (ETA) into the Office of the Secretary. The 
2008 budget proposes to return the program to ETA, where it had been 
administered for more than 30 years, to ensure close coordination with 
the other job training and employment programs administered by ETA, 
including the YouthBuild program. Moving the program back to ETA will 
ensure these young people have access to the principal experts on labor 
markets as well as other youth employment programs.

                             OTHER PROGRAMS

Veterans' Employment and Training Service
    This Nation's commitment to our veterans must be honored. No 
veteran should return home without the support that is needed to make 
the transition back to private life a smooth and successful one. For 
the Department's Veterans' Employment and Training Service (VETS), the 
fiscal year 2008 budget request is $228.1 million and 244 FTE. This 
will enable VETS to maximize employment opportunities for veterans and 
protect their employment and reemployment rights.
    The $161.9 million requested for State grants will help over 
approximately 700,000 veterans seeking reemployment services. The 
fiscal year 2008 budget includes $23.6 million for the Homeless 
Veterans Reintegration Program (HVRP), allowing the program to provide 
employment and training assistance to an estimated 15,100 homeless 
veterans. In addition, the budget requests an additional $2.5 million 
to meet the increased demand for Transition Assistance Program (TAP) 
services. It is projected that the number of departing service members 
receiving TAP Employment Workshops will increase from 160,000 in fiscal 
year 2007 to 170,000 in fiscal year 2008. TAP Workshops play a key role 
in reducing jobless spells and helping service members transition 
successfully to civilian employment. The fiscal year 2008 request will 
also enable VETS staff to carefully monitor our performance in 
administering the Uniformed Services Employment and Reemployment Rights 
Act (USERRA) to protect the civilian job rights and benefits of 
veterans and members of the armed forces, including members of the 
Guard and Reserve and others.
Bureau of Labor Statistics
    In order to maintain the development of timely and accurate 
statistics on major labor market indicators, the fiscal year 2008 
budget provides the Bureau of Labor Statistics (BLS) with $574.4 
million and 2,431 FTE. This funding level provides BLS with the 
necessary resources to continue producing sensitive and critical 
economic data, including the Consumer Price Index (CPI) and the monthly 
Employment Situation report. The CPI is a key measure of the Nation's 
economic well-being that directly affects the income of millions of 
Americans. To ensure that the CPI is accurate and up-to-date, the 
budget includes funding of $10.4 million to continually update the 
housing and geographic samples that underlie the index to ensure that 
these samples fully incorporate the most recent demographic and 
geographic trends and changes. The current sample was derived from the 
1990 Census and has not been updated since the late 1990s.
Office of Disability Employment Policy
    The fiscal year 2008 budget request provides the Office of 
Disability Employment Policy (ODEP) with a total of $18.6 million and 
40 FTE. The fiscal year 2008 budget reflects a decrease in ODEP's 
grantmaking function, which duplicates those of other Federal agencies 
like the Department of Education. The fiscal year 2008 budget focuses 
ODEP on its core and critical mission of providing national leadership 
in developing disability employment policy and influencing its 
implementation to increase employment opportunities and the 
recruitment, retention and promotion of people with disabilities.
Bureau of International Labor Affairs
    The request for the Bureau of International Labor Affairs (ILAB) in 
fiscal year 2008 is $14.1 million and 58 FTE. In recent years, ILAB has 
had a very large grantmaking function, duplicating activities that are 
carried out by State, USAID, and other agencies with a larger role in 
international affairs. The budget returns ILAB to its core mission of 
developing international labor policy and performing research, 
analysis, and advocacy. It also includes $1.5 million to allow ILAB to 
monitor the use of forced labor and child labor in violation of 
international standards, as required in the Trafficking Victims 
Protection Reauthorization Act (TVPRA) of 2005.
    The requested funding levels would allow ILAB to implement the 
labor supplementary agreement to NAFTA and the labor provisions of 
trade agreements negotiated under the Trade Act of 2002, participate in 
the formulation of U.S. trade policy and negotiation of trade 
agreements, conduct research and report on global working conditions, 
assess the impact on U.S. employment of trade agreements, and represent 
the U.S. Government before international labor organizations, including 
the International Labor Organization.
    ILAB will continue to implement ongoing efforts in more than 70 
countries funded in previous years to eliminate the worst forms of 
child labor and promote the application of core labor standards.
Office of the Solicitor
    The fiscal year 2008 budget includes $103.1 million and 643 FTE for 
the Office of the Solicitor (SOL). This amount includes $95.5 million 
in discretionary resources and $7.7 million in mandatory funding. The 
Solicitor's Office provides the legal services that support the 
Department, including the Department's enforcement programs. This 
appropriation level will allow SOL to provide legal services for the 
nearly 200 laws the Department must enforce, including new legislation 
that Congress recently passed to strengthen mine safety and retirement 
security. The fiscal year 2008 budget includes $3.5 million and 23 FTE 
to provide additional legal support for DOL client agencies, and $4.4 
million to support 30 FTE who are currently providing certain auxiliary 
administrative services to client agencies that are closely related to 
legal services provided by SOL. The requested appropriation level is 
essential to allow SOL to fulfill its primary mission of ensuring that 
the Nation's labor laws are forcefully and fairly applied.
Women's Bureau
    The fiscal year 2008 budget includes $9.8 million and 60 FTE for 
the Women's Bureau. This budget will allow the Women's Bureau to 
continue its mission of designing innovative projects addressing issues 
of importance to working women and providing information about programs 
and polices that help women succeed in the 21st century workplace.
President's Management Agenda and Department-wide Management 
        Initiatives
    Before I close today, Mr. Chairman, I also want to highlight the 
Department's ongoing efforts to implement the President's Management 
Agenda. In August 2001, President Bush sent to Congress his President's 
Management Agenda (PMA), a strategy for improving the management and 
performance of the Federal government. The agenda called for focused 
efforts in the following five government-wide initiatives aimed at 
improving results for citizens: Strategic Management of Human Capital; 
Competitive Sourcing, Improved Financial Performance; Expanded 
Electronic Government; and budget and Performance Integration. DOL is 
also responsible for three of the PMA initiatives that are found only 
in selected departments: Faith-Based and Community Initiatives; Real 
Property Asset Management; and Eliminating Improper Payments.
    I am proud to say that the Department was the first Cabinet agency 
to earn ``green'' ratings in all five government-wide PMA scorecards. 
By the close of fiscal year 2006, the Department had achieved two 
additional ``green'' ratings, for its efforts to Eliminate Improper 
Payments and support the President's Faith-Based and Community 
Initiative. In December 2006, DOL was honored with the President's 
Quality Award for excellence in Expanded Electronic Government, in 
addition to previous presidential honors received for management 
excellence.
    The Program Assessment Rating Tool, or PART, is central to our 
efforts at the Department of Labor to improve the performance of our 
programs. To date, 32 DOL programs have been assessed through the PART. 
The PART assessments have not only been useful to informing the public 
and policy makers of our programs' strengths and weaknesses, but they 
have provided our programs and their managers a systematic method of 
self-assessment. A PART review helps inform both funding and management 
decisions aimed at making programs more effective. The Department is 
actively implementing program improvements identified through PART 
assessments and its 5-year plan to conduct re-assessments of programs 
that have previously undergone a PART review.

                               CONCLUSION

    With the resources we have requested for fiscal year 2008, the 
Department will continue its strong enforcement of worker protection 
laws, provide innovative programs to increase the competitiveness of 
our Nation's workers, secure the employment rights of veterans, and 
maintain fiscal discipline.
    Mr. Chairman, this is an overview of the programs we have planned 
at the Department of Labor for fiscal year 2008.
    I am happy to respond to any questions that you may have.
    Thank you.

                        OTTUMWA JOB CORPS CENTER

    Senator Harkin. We will start with a round of questions.
    First of all, Madam Secretary, I started out by 
congratulating you and thanking you for your work on getting 
these three Job Corps things designated in New Hampshire, 
Wyoming, and in Iowa; Ottumwa, Iowa. But we hear things from 
different sources, and just the other day I heard from a source 
that said that maybe the Ottumwa Job Corps center is going to 
be delayed.
    Secretary Chao. Oh, we hope not.
    Senator Harkin. Oh, okay. I just want reassurance. I hear 
it might be delayed perhaps up to 8 years.
    Secretary Chao. Oh. I hope not. That is not our intent. We 
are going ahead with the design and construction.
    Senator Harkin. Okay.
    Secretary Chao. Each Job Corps center costs about $40 
million.
    Senator Harkin. Right.
    Secretary Chao. There are different phases. So I do not see 
any delays in that.
    Senator Harkin. In all three of them?
    Secretary Chao. We do not anticipate delays. Unless there 
are funding issues. But it is never the practice to fund 100 
percent up front anyway.
    Senator Harkin. Okay. But when are you going to----
    Secretary Chao. I think that----
    Senator Harkin. When are you going to finalize the Ottumwa 
center? I do not know about the other two, but----
    Secretary Chao. There are design--there are planning, 
feasibility studies, design, construction. So it is a multi-
year project. We do not anticipate delaying it. It is on 
target, as far as I know.
    Senator Harkin. Okay.
    Secretary Chao. We are proceeding with planning----
    Senator Harkin. Yes.
    Secretary Chao [continuing]. The satellite facility in 
Iowa. We know, also, the priorities of this committee on these 
issues.
    Senator Harkin. Yes. Well, I appreciate that. I was told, 
correct me if I am wrong, that the Ottumwa is to be looking at 
opening sometime by 2010. Is that----
    Secretary Chao. That might be possible. It takes about 4 
years to go through the planning. Because there is--you have to 
go--it takes about a year for the planning. It takes another 
year for the design. It takes a couple of years for 
construction. But those are usual planning----
    Senator Harkin. Okay. But there is nothing----
    Secretary Chao [continuing]. Time lines, so----
    Senator Harkin [continuing]. That you know of that is going 
to be delaying this at all.
    Secretary Chao. No, Mr. Chairman. I would also assure you 
that, again, we know how important this----
    Senator Harkin. Okay. Thank you.
    Secretary Chao [continuing]. Issue is.

                            FMLA ENFORCEMENT

    Senator Harkin. Thank you very much. There was one--oh, 
yes. I have been contacted by a number of Iowans who have told 
me that Wage and Hour in Iowa is telling them that if they 
belong to a union, they cannot ask Wage and Hour to intervene 
on their behalf in resolving Family Medical Leave Act 
enforcement. Rather, it is up to them to go through the labor 
management grievance process instead. Then even if they cannot 
resolve the situation satisfactorily, they still cannot even 
appeal that decision to Wage and Hour.
    My question is: Is this action by Wage and Hour in Iowa 
coming from some DOL directive that I do not know about, and 
that we have not seen?
    Secretary Chao. I am not aware of that complaint. I will be 
more than glad to look into it.
    Senator Harkin. Would you, please?
    Secretary Chao. There is a lot of--Family Medical Leave 
was, obviously, passed in 1993. Regulations are promulgated. 
There have been a number of court challenges. It has been very 
confusing. But I have not heard that one. So I will be more 
than glad to take a look at that.
    Senator Harkin. I wish you would. I would like to resolve 
this. Do you feel that DOL is doing what it can to proactively 
improve overall FMLA compliance and employee understanding of 
their rights?
    Secretary Chao. Enforcement of the law is always our 
priority. So we are always very concerned when there are any 
lapses or any non-compliance. We enforce the law.
    Senator Harkin. Well, let us look at that one in Iowa and 
see what is happening there.
    Secretary Chao. I will do so.

                 FUNDING FOR INTERNATIONAL CHILD LABOR

    Senator Harkin. I would appreciate that. International 
child labor. One of my priorities as you know. Has been for a 
long time. The fiscal year 2008 budget requests $14 million for 
international labor affairs. A decrease of $58.4 million from 
last year. An 80 percent cut.
    Well, that is just like tearing it out. This would cause 
reduction of 27 FTEs, and significant reduction in grants for 
technical assistance on ending international child labor. Madam 
Secretary, could you, again, just tell us why you are proposing 
to cut funds for fighting international child labor? What is 
the reasoning behind this?
    Secretary Chao. We care about this issue. Mr. Chairman, I 
think we have talked about this before. We are just going to 
have to respectfully disagree.
    ILAB was an organization that was fairly small. I know that 
in 1996, this committee gave ILAB about $76 million, $74 
million. In 2000, it increased the budget further to about $147 
million.
    Senator Harkin. That was under his chairmanship.
    Secretary Chao. We know this is a priority, but the 
administration respectfully disagrees with the mission of this 
organization. We believe that it should be pared back to its 
original mission of providing technical assistance, providing 
participation at the ILO, working on advocacy and increasing 
core labor standards. That grant making is not really a 
function that was the original intent of this organization. But 
we care about this issue. Obviously, when given the money, we 
have used it wisely.
    Senator Harkin. But it is all right to care about it.
    Secretary Chao. Yes.
    Senator Harkin. We all care about it. But we are trying to 
do something about it. Quite frankly, the Department of Labor 
has done some really good things in the past, both before you 
and in your earlier time--I mean in your first few years. But 
lately, it seems like we are just totally backing off of this. 
At a time when the ILO and others, they are making--they are 
saying, ``Things are--you know, things are happening. These 
things take time.''
    Once we started on this back in the 1990s, and we kept at 
it, as I said, we have actually seen some discernible progress. 
Also, in the past couple of years, the Department of State has 
come to the Department of Labor to carry out projects and 
workers' rights, in relation to CAFTA, the Central American 
Free Trade Agreement.
    So when I see something like that, obviously, the 
Department of State is saying, ``You have the expertise. You 
know how to do it.'' They come to you to ask you to handle it. 
So it is not that somebody else is going to pick this up 
someplace. It is the Department of Labor. I just do not think 
that it is befitting a great Nation like ours, that has put so 
much stock in human rights and the value of children, to make 
sure that children are not abused, and make sure that they get 
a decent education, and that they are not exploited.
    I think it is one of the best faces that America can give 
the rest of the world. That is to help try to end this 
exploitative labor of children in other countries. I visited 
some of these things around the world. The reverberations are 
great.
    When we work on that and--and I am just telling you, it has 
been one of the best, I think, reflections of America anywhere 
in the world. We may respectfully disagree on it, but this is 
something that this committee has charged the Department of 
Labor to do, and we will again.
    Secretary Chao. Yes, I understand.
    Senator Harkin. I am just sorry to see that we are having 
this conflict on it. Because I just do not think we want to 
back down on that one and back off of what we have been doing 
around the world.

                             CAFTA FUNDING

    Secretary Chao. We agree with you on the goals. I think the 
disagreement, perhaps, may be that we are just not quite sure 
this is the right agency or the organization with which to 
channel these funds.
    On the State Department, the CAFTA, we got additional 
funding for that. The money was----
    Senator Harkin. They transferred money over.
    Secretary Chao. Yes. It was given to us. Yes.
    Senator Harkin. They gave you money----
    Secretary Chao. Right.
    Senator Harkin [continuing]. To do it.
    Secretary Chao. But it was given to State. No. I agree with 
you. So the State Department gave it to us.
    Senator Harkin. Yes.
    Secretary Chao. We will do the same thing.
    Senator Harkin. You seem to indicate----
    Secretary Chao. We will do the same thing. We were given 
the money. We will do the same thing.
    Senator Harkin. We are going to give you money, and we are 
going to ask you to enforce it.
    Secretary Chao. We will do so.
    Senator Harkin. All right, Madam Secretary. Well, you know 
that we are going to be tough on it. Well, my time has run out. 
I am going to yield this round and I will yield to Senator 
Specter.
    Senator Specter. Thank you, Mr. Chairman.
    Secretary Chao, at the outset, I would associate myself 
with the remarks that Senator Harkin made about the 
international child labor issue. He has emphasized it 
sufficiently. But I just want you to know that he has my 
concurrence.

                          JOB TRAINING FUNDING

    On the issue of the cuts which are made for job training 
and Job Corps, and the prisoner reentry initiative, and 
reintegration of ex-offenders, Madam Secretary, I would 
emphasize that the increase in crime across the country, and 
especially juvenile crime, really underscores the need for 
those programs.
    I think that our budget recommendations will reflect that, 
but I want you to know how deeply at least I feel about it. As 
you know, I have had a lot of experience in the field of being 
a district attorney of a city like Philadelphia, and seeing the 
kind of crime problems. It is characteristic of cities across 
the country.
    When you have job training, you are trying to provide the 
background to take these at-risk youth off the streets. When 
you are talking about reentry, it has been a problem that I 
have been intimately concerned with for decades. The recidivism 
rates are extremely high because of the lack of job training, 
and releasing functional illiterates from jail without a trade 
or skill--so they go back to a life of crime. It would be 
surprising if they did not. So these reentry programs and the 
legislation that is pending now on second chance, these, I 
think, are of the highest priority.

                              PANDEMIC FLU

    Let me ask you now about the issue of pandemic flu. It 
could be a catastrophe of phenomenal proportions. We have had a 
series of hearings on the subject and, to date, this 
subcommittee has included $5.4 billion for pandemic flu.
    There was a petition filed in December 2005 for the 
Department of Labor to issue standards for public health care 
workers in the event of such a pandemic. On February 26, your 
Department denied the petition on the grounds that no human 
influenza virus exists at this time.
    Shouldn't there be protections in place to protect workers, 
in case there is a pandemic? Shouldn't we be prepared. Every 
day you see an article on the H5N1 virus, though regrettably, 
they are in the back pages of the papers. I believe yesterday 
Pakistan was going to submit information on the virus, but in a 
limited extent. I would ask you to take another look at this 
regulation.
    Secretary Chao. I will do so. There is a government-wide 
task force on pandemic flu. So we, through, OSHA, have 
participated in this government-wide interagency workforce, and 
have been a very active participant. We have issued five 
significant guidance documents. I will take a look at that.
    Senator Specter. Well, it looks to me as if the rejection 
of that petition may have been decided by someone at a lesser 
level than the Secretary.
    Secretary Chao. The emergency--I did not quite understand 
the question.

               EMERGENCY STANDARD FOR HEALTH CARE WORKERS

    Senator Specter. The petition was for an emergency standard 
to protect health care workers in the event of a pandemic. So 
take another look at it.
    Secretary Chao. I will take another look, but I think the 
original premise was that it was not--there are very strict 
guidelines as to what constitutes an emergency standard. Based 
on our review of the situation, it was not deemed to fit those 
quite--I mean it has to be a--well, I am not being very 
eloquent. But it has to be--there are emergency standards, 
there are rules and criteria to when that should be issued. It 
has to be like a pandemic.
    I do not want to defend that without looking----
    Senator Specter. Do we have to be in the middle of the 
pandemic before the rules are issued?
    Secretary Chao. Pretty near it. But as ridiculous as that 
sounds, I do not want to talk any further. I will take a look 
at----
    Senator Specter. Now we have finally found something we 
agree upon. That is as ridiculous as it sounds.
    Secretary Chao. Yes. I will take another look at that.

                      OSHA'S SUSAN HARWOOD GRANTS

    Senator Specter. Okay. Speaking of OSHA, why is the 
administration proposing to eliminate the $10 million OSHA 
program for worker training and education? Have these programs 
been unsuccessful?
    Secretary Chao. I suppose you mean the Susan Harwood 
grants. That was a very narrow, a very--a targeted--it was a 
very narrow set of grants given out to a very narrow 
constituency. We are concerned about worker training. We 
thought that with a wider approach through more--a web-based 
educational approach, more outreach, and efforts to other 
groups, to a larger array of groups, would be a more effective 
way to use those education grants.
    Senator Specter. Well, we may have a disagreement there, 
too.
    Mr. Chairman, I know my red light is on, but I have two 
more questions, and that will eliminate the need for a second 
round. If I may?
    Senator Harkin. I have some that I want to follow-up on, 
but go ahead.

                    FUNDING FOR MIGRANT JOB TRAINING

    Senator Specter. Okay. Well, I will proceed here. The 
funding for the migrant and seasonal farm workers program has 
been eliminated. Almost $80 million. We are right in the middle 
of our new immigration bill, which is a very high priority for 
the President. Migrant job training is a big part of that. We 
are dealing with gigantic costs on employer verification and 
border patrol.
    Why the repeated effort to eliminate that program when 
every time you do, both the House and Senate come back and 
insist on it?
    Secretary Chao. The whole issue of trying to integrate 
migrant workers into the work force is one that we both share. 
The question is how best to do that. This administration's 
philosophy has always been to take specific programs that are 
segregating workers into separate funding streams and finding 
that that is not a very effective way of helping workers, when 
there is a whole nationwide publicly funded network of one-stop 
career centers, with all its full array of services that will 
be much better to help workers access the professionals that 
are in this system as well as the full array of funding 
programs. So the intent is to integrate more fully the migrant 
workers into the workforce development system.
    Senator Specter. Well, do not the migrant farm workers have 
very unique needs, contrasted with the rest of the work force?
    Secretary Chao. Well, the program--we understand how 
important this is to members of this committee and to others on 
this committee. But there does seem to be some disagreement as 
well. We have found that this program, aside from the reason 
that I just gave previously, has been very often used as an 
income support program. We want to be able to use these funds 
to help migrant workers find better jobs, be able to transition 
into other opportunities on a seasonal basis, if they--if that 
were to occur.
    Senator Specter. Well, I do not think it should be an 
income support program. But I think you could eliminate that 
and still have the training.

                        H-2B LABOR CERTIFICATION

    The final question I have for you, Madam Secretary, relates 
to the H-2B labor certification. We are in the middle of a 
great human cry from some of the leading entrepreneurs of the 
world. Bill Gates is leading the charge on this.
    The current regulations permit employers to file 
applications only 120 days in advance of their seasonal needs. 
Your Department's regulations call for an adjudication, a 
decision, within 30 days. Now the processing takes more than 
100 days.
    Two questions. Can you reduce or eliminate that delay in 
applications? Should we allow employers to file their 
applications more than 120 days in advance of their seasonal 
needs, in light of the delays in your Department's decisions on 
the applications?
    Secretary Chao. You are referring to the H-2A, H-2B program 
or to the H-1----
    Senator Specter. To the H-2B labor certification----
    Secretary Chao. Okay. The H-2B.
    Senator Specter [continuing]. Program.
    Secretary Chao. Right. Unfortunately, we have had an 
increase in backlog in the H-2B program this year. As 
background, let me say that when we first came into this 
Department, we had tremendous backlogs in the PERM and in other 
visa programs.
    We have worked diligently to work down the backlog. This 
particular year, there has been a 40 percent increase in the 
number of H-2B visas. We do have a backlog in Georgia, in that 
processing center.
    We have diverted additional personnel and additional 
resources to that region in an effort to work down the backlog. 
But the real problem is the cap that occurs on this visa and 
the time line that is involved, of which we are not in control. 
We play a very small part in this whole visa/immigration issue. 
Most of it is over at the Department of Homeland Security.
    Where it is possible, where we have control, we have been 
able to decrease the backlog from over 100 days to process to--
to be a little bit under 30.
    Senator Specter. Well, Madam Secretary, I can understand 
the problem of the backlog, especially when the funding for 
your Department is cut.
    Secretary Chao. Well, this comes out of a different fund. 
That is not--it does not come out of--in fact, we have 
requested funding every year for the last 5 years, and the 
Congress has not given us additional funding. We have been 
underfunded for about $8 million.
    Senator Specter. It does not come out of your overall 
budget?
    Secretary Chao. Some of that is--we have asked for, like, 
$37 million and $46 million, and we have been given about $37 
million.
    Senator Specter. Well, is it not a part of your $10 
billion-plus appropriations?
    Secretary Chao. Yes. It is.
    Senator Specter. Well, if you would submit a bigger budget 
request to OMB, or if you could get OMB to give you more money, 
you would have more money.
    Secretary Chao. It is the President's request. The 
President has traditionally asked for about $46 million. We 
have gotten about $37 million for the last 5 years.
    Senator Specter. Well, you make the request, but it is a 
question of how we slice up the pie. If the pie were a little 
bigger, we would be able to give more to your requests. That 
means you have to come in here and bang the table. Before that, 
you have to have practice at OMB banging the table.
    Secretary Chao. Well, we went over there----
    Senator Specter. You might even go from banging the table 
to banging heads. You are a strong secretary.
    Secretary Chao. Well, we have succeeded at OMB. We have 
requested about $45 million, $47 million for the last 3 years. 
The enacted was about $37 million.
    Senator Specter. Well, we will continue to work with you, 
Madam Secretary. We have been for a long time. These are big, 
big problems. We want to do our best to try to solve them.
    Secretary Chao. Thank you very much.
    Senator Specter. Thank you very much. Thank you, Mr. 
Chairman.
    Senator Harkin. Thank you, Senator Specter. Madam 
Secretary, I just have a few areas I would like to also go 
through with you. You just mentioned something I wrote down 
about narrow grants to narrow constituencies. I want to get 
into an area----
    Secretary Chao. I did not----

                         CONGRESSIONAL EARMARKS

    Senator Harkin [continuing]. That has gotten a lot of 
publicity lately, as it concerns Congress. I am not going to 
single you out, Madam Secretary. I am going to bring this up 
with every secretary that appears here. Secretary of Health and 
Human Services. Secretary of Education. Those are the three 
under our jurisdiction. That has to do with earmarks. Earmarks.
    In President Bush's State of the Union address this year, 
he stated, and I quote, ``Next, there is the matter of 
earmarks. These special-interest items are often slipped into 
bills at the last hour, when not even C-SPAN is watching. The 
time has come to end the practice.''
    Now for the record, I do not think that more than 1 
percent--almost all the earmarks are less than 1 percent. One-
third to two-thirds of 1 percent of all that we appropriate 
here, but they have really gotten hit by the President.

                    HIGH-GROWTH JOB TRAINING GRANTS

    On the other hand, a recent Congressional Research Service 
report found that 90 percent of the funds under DOL's high-
growth job training initiative were awarded non-competitively. 
Ninety percent. In other words, over the past 5 years, DOL 
earmarked more than $250 million without any competition and 
without any transparency.
    Now I understand that Federal regulations allow for the 
awarding of sole-source contracts in certain situations. 
However, earmarking 90 percent of these funds raises some very 
serious questions.
    Now I just drafted a letter for the inspector general, Mr. 
Heddell, of the Department of Labor. I said, ``Dear Mr. 
Heddell, I am writing today to request that you look into the 
Department's practices of awarding non-competitive awards under 
its high-growth job training initiative.'' As I said, ``As you 
may know, the Congressional Research Service recently analyzed 
the Department's funding practices under this initiative, and 
found that 90 percent of the funds were awarded through non-
competitive awards. These actions resulted in more than $250 
million in funding being awarded without full and open 
competition.''
    ``I understand''--and this is my letter--``I understand it 
is sometimes maybe in the public's best interest to award funds 
on a non-competitive basis. For example, if the services are 
available from only one responsible source and no substitute 
will suffice.''
    ``The Federal Grant and Cooperative Agreement Act 
identifies other exceptions to the general rule of competition. 
However, I believe such extensive use of non-competitive grant 
making raises serious questions.''
    ``I encourage you to look into these matters on an 
expedited basis. I ask that you audit a sufficient number of 
non-competitive awards to understand whether relevant statutes 
and regulations were adhered to, and to evaluate the extent to 
which these awards are meeting their specific performance 
objectives and contributing to the Department's missions.''
    So Madam Secretary, that is a lot of money. Ninety percent 
raises a lot of questions. Could you explain the criteria that 
you used when making the decision to earmark a quarter-of-a-
billion dollars under this initiative?
    What are the specific performance measures, the evaluation 
criteria, and operational requirements of grantees? I would 
like to know what the results of these grants are thus far. So, 
again, help me understand, what is your criteria in sole 
sourcing 90 percent of this money?

            COMPETITION FOR HIGH-GROWTH JOB TRAINING GRANTS

    Secretary Chao. First of all, let me say that it is a 
philosophy--it is, in fact, the tendency of the Department to 
engage in competitive bidding. All high-growth grants are now 
competitive. The initial grants in the sectors were--in the 
high-growth job training program were initially directly 
responsive to worker shortage sectors. So that was just the 
first round.
    All single-source contracts have to go through what is 
called a procurement review board. They were all approved by 
the procurement review board.
    Having said that, our preference is always to competitively 
bid. So I think the particular instance that you mention--I 
wonder about the 90 percent. Because it depends on what you use 
as a base. But it is our preference to always competitively 
bid.
    There are single-source contracts that do have to go 
through the procurement review board. As for the specific 
criteria, it is done by a group of--by the Employment Training 
Administration, which was trying, again, to meet the tremendous 
deficits in worker shortages in some of the high-growth 
industries.
    Senator Harkin. Madam Secretary, you said they are all 
competitive now. Not because of what you did. But because 
Congress required it.
    Secretary Chao. I do not think so. I think it was always 
the intent to competitively bid these.
    Senator Harkin. Intent? When 90 percent went 
uncompetitively?
    Secretary Chao. That was the only first round, to my 
understanding. That was to get the program off to a rapid 
start, because we were receiving a great deal of concerns.
    Senator Harkin. So you are saying that that did not happen 
over 5 years. It just happened in 1 year?
    Secretary Chao. I do not--I do not believe that is true. I 
do not believe that is the case. Whether it was 5 years or 1 
year, it was--it was the first round. I will look more into it, 
but it was never our--our preference always is to competitively 
bid. And it was part of an overall effort to get--you know, we 
also--you asked about the performance measures, and----

             RECIPIENTS OF HIGH-GROWTH JOB TRAINING GRANTS

    Senator Harkin. Okay. Well, I am looking at some of these, 
and I asked the IG to look at them. One went to the National 
Retail Federation Foundation. $2.25 million.
    Secretary Chao. I was not involved in that. But I would 
suspect that that, again, was to address the tremendous need 
for retail workers. We were trying to match workers' skill sets 
with high-growth industries that needed particular workers. 
There are many others as well. Construction workers are at a 
premium. Skilled trade workers are at a premium. We needed 
workers in financial and professional services.
    I mean these were dire requirements in our economy. We 
actually can have a larger discussion about how training occurs 
through the Employment Training Administration and the 
workforce development system. I think it is actually quite 
valuable to have a discussion like that. Because right now 
there is a disconnect between the workers--between the skill 
sets that are needed, and what workers are being trained in. 
How many workers are being trained.
    Senator Harkin. Well, some of these--I do not know. There 
is one in 2004 to the Manufacturing Institute of the National 
Association of Manufacturers.
    Secretary Chao. Again, I was not involved in that. But that 
is probably involving advanced manufacturing workers. 
Traditional manufacturing is declining as we all know. It has 
been declining worldwide for the last 40 years. Yet, 
manufacturing is evolving.
    There is a new phenomenon now called advanced 
manufacturing, in which workers with higher technological and 
information technology skills are desperately needed. So what 
we are seeing, and this is precisely what the issue is facing 
our workforce, it is a skills gap. We have--at any one time, 
about 4 million jobs are vacant. We have high-growth industries 
that are desperately seeking workers. Yet, we do not have 
workers with the right skills.
    So we have to train workers, help to train workers for 
relevant skills, so that they can get a job when they graduate.
    Senator Harkin. Madam Secretary, you are right.
    Secretary Chao. Okay.
    Senator Harkin. So then why is your budget cutting a 
billion dollars out of workforce training and all of that?

                      WORKFORCE INVESTMENT SYSTEM

    Secretary Chao. Well, it is an excellent question. I am 
pleased to answer it. It is, primarily, because--and I am 
grateful for this dialogue, because it is so important.
    I agree with Bill Gates. We need to prepare our workforce. 
But what is happening is that of the workforce--I love the 
system. We all support and treasure the system. But even people 
who work in the system are frustrated by the bureaucracy, the 
overlaying, duplicative infrastructure.
    Most of the funding goes to salaries and infrastructure. We 
are training 200,000 people at a budget of $6.8 billion. We 
have employment services offices that reside right next to one-
stop career systems. They do the same thing. Yet they cannot 
talk to one another or they do not coordinate.
    We have $1.1 billion to $1.7 billion in excess carryover 
funds every year. So in terms of just good cash management, 
that is not a very good practice. Over $3.4 billion goes to 
infrastructure.
    We need to--all of us who work in the system need to 
challenge ourselves more to do more to ensure that workers are 
being trained for the relevant skills. We have this wonderful 
system. Yet we also have high-growth industries, where they 
cannot find enough workers. So something is wrong. Again, we 
need to challenge ourselves to do more and take a look at the 
system.
    How can we use this money better? How can we train more 
workers? That is an issue----
    Senator Harkin. So you are saying you do not need any 
more--you can use--you can do all of this with a lot less 
money. That is what you are saying.
    Secretary Chao. We need to carry out reforms. We need to 
carry out reforms that will enable----
    Senator Harkin. Have you suggested any reforms to this 
committee and to the Congress?
    Secretary Chao. We have. That is part of the overall debate 
and discussion that we need to have.
    Senator Harkin. All right.
    Secretary Chao. It takes 10 years--7 to 10 years for the 
whole system and for these national debates to occur. It 
happened with----
    Senator Harkin. Well, we have been there----
    Secretary Chao [continuing]. JPTA and, you know, in 1998 
with WIA. So we are in the process of discussing further 
enhancements and reforms to this workforce investment program.

                         WIA CARRYOVER BALANCES

    But the reality is, there is $1.1 billion in carryover 
funds that are not used. Every State has excess funds.
    Senator Harkin. Well, I am going to have to look at that, 
too. But I wanted to follow up on just one thing. You mentioned 
that there were 200,000 being trained annually. GAO has 
consistently refuted the data that you have presented to us. 
GAO found that your Department's calculation of carryover, what 
you just mentioned, has created a mistaken impression of excess 
unspent balances. Now this is GAO.
    GAO found in their June 2005 report that GAO's estimates 
represent a more complete and accurate picture than Department 
of Labor's. Because they are based on information obtained 
directly from the local workforce areas. Include all funds 
spent or obligated for training. Count all adults who received 
training in program year 2003, not just those who exited the 
program.
    So your Department's justification for a $335 million 
cancellation of job training funds rests on your claim of 
excess unspent carryover, which you just mentioned. 
Overestimates, according to the GAO. The GAO found that most 
unspent balances in states had already been obligated or 
committed.
    So I hear you. I hear what you are saying. But GAO does not 
agree with you and we rely on GAO. That is our investigative 
arm. So we have to rely on GAO to give us accurate information. 
So are you telling me that GAO is not giving us accurate 
information?
    Secretary Chao. Unfortunately, we respectfully disagree 
with GAO's findings. We are also disturbed--and just from that 
passage that you just read--we are very results oriented. If we 
ask--if we help a person go through training, we owe it to that 
person to ensure that they get relevant training, so they can 
access a real job when they graduate.
    So we have performance measurements. So graduation rates do 
make a difference. Placement rates do make a difference. We are 
looking at employment upon graduation, retention, and also 
earnings. We want to know how long that person stays on the job 
after they graduate. After they get a job. Also what the 
earnings are.
    So we are concerned about, again, the outcome. The 
graduation rate is important.
    Senator Harkin. I never said it was not.
    Secretary Chao. I thought that GAO said that they were 
looking at not only those who exit the program.
    Senator Harkin. That is right. But GAO--but they are 
looking--what they are talking about is the actual picture. 
Because they said their information is obtained directly from 
local workforce areas, directly. They include all the funds 
spent or obligated for training. Count all adults who receive 
training in program year 2003. Not just those who graduated.
    Secretary Chao. Yes.
    Senator Harkin. So to get a whole picture of what is 
happening, obviously, graduation rates are important. But you 
have to look at the whole pool that is out there.
    Secretary Chao. Absolutely. But we do--we do not--I want to 
just--I want to be respectful. So we disagree with that.
    If you look at the unspent balances in each of the states, 
there are unspent balances. Every year, there are carryovers. 
Every year. They range from $1.7 million to $1.1 billion.
    Senator Harkin. Let me put it this way. Let us say that I 
have a contract in 2006 to do certain things in 2007, to meet 
certain obligations. I have a contract to do that. That 
contract is $1,000.
    Let us say in December 2006, I have $1,000 in my pocket. 
Well, you can say in December 2006, I have $1,000 of unspent 
money. But if you really calculate it on a balance sheet, like 
GAO would look at it, they would say, ``Well, no, because that 
is obligated.'' You really do not have any unspent --you have 
not spent it yet, but you are obligated to it.
    That is what they are looking at here. So I respectfully 
also say, are we playing some word games here? I am looking at 
obligated--what they have. You say unspent. GAO says obligated 
to spend. When you look at it that way, you do not have that 
much carryover money.
    Secretary Chao. Well, that brings us, unfortunately, to 
another area of discussion. Related, of course. That is the 
whole issue of when you--if you have $1,000, and let us say 
someone buys 3 years of training slots, because, first of all, 
WIA does not train. We purchase the training slots from a 
training provider.
    Senator Harkin. Right.
    Secretary Chao. So whether the training slots are actually 
used or not is another story. So you can obligate it for 3 
years or 330 slots, or 2 years, and then 334, for another. But 
whether workers are actually filling those slots is another 
question.
    So there are a lot of--not only is there the issue of 
excess balances, or in your words, obligated funds, but there 
is also the tremendous need for reforms in this program. When 
we talk about the money, that is just part of it. We need to 
reform this program so that it is relevant.

                              WIA REFORMS

    Senator Harkin. What is the most significant reform that 
comes to your mind that we need to do?
    Secretary Chao. I think we need to give the States more 
flexibility. Right now, I keep--the Federal Government keeps 5 
percent. The rest of the money goes down to the State. 
Depending on the 17 different revenue funding streams, the 
State keeps about 15 to 35 percent, and the remainder goes into 
the municipalities.
    What we have sometimes are adjoining districts. When they 
have a surplus, when they have a deficit. Yet, the State will 
not have any flexibility in shifting those funds around. We do 
not want to shift those funds around. We are not proposing that 
we be given the authority. But we think that these funds, at 
least, should be more flexible. So that at the State level, 
they can shift them around. Right now, that cannot be done. 
Also, we have----
    Senator Harkin. But you can.
    Secretary Chao. Not really. It is very strict. It is very 
strict.
    Senator Harkin. Well, I will have to look into that. I 
mean, obviously, I do not know it as well as you do. But it has 
been my information that DOL can do that, if you have----
    Secretary Chao. Not really. If you have employment 
services. Adult. Youth. Dislocated. These are very strict 
funding----
    Senator Harkin. You are saying your hands are tied. If you 
have a deficit area right next to a surplus area, you cannot 
take it from the surplus area and put it in the deficit area if 
that is needed?
    Secretary Chao. No. Because it is their money. It has 
already been given out, by statute.
    Senator Harkin. Okay.
    Secretary Chao. So what we are asking for is just more 
flexibility. Again, we are not asking for the authority 
ourselves. We are just asking that the State level be given 
more flexibility.
    Senator Harkin. Why will you not ask for the authority? Why 
not give it to the DOL? Why give it to the States?
    Secretary Chao. Because I think probably----
    Senator Harkin. You have a better handle on the national 
picture.
    Secretary Chao. Well, number one, it is by statute. So 
there has to be a statutory change. And number two, probably 
the States would----
    Senator Harkin. Well, there would have to be a statute 
change for the States to do it, too.
    Secretary Chao. Yes.
    Senator Harkin. Well, I am just saying, I do not know--I 
mean it would seem to me that if you are talking about 
flexibility to do that--and I will look at that and consider 
that.
    Secretary Chao. There are workforce investment boards. I 
think that the thought was that probably the States know 
better. They are more direct to the grassroots and to the 
ground. They would know at a faster rate--they would know 
faster what the needs are.
    Then another thing is incumbent workers. I will give you 
another example. Right now, we have major companies in our 
country that have said that in 2 or 3 years they are going to 
close a plant. With all the money that we have in this fund, we 
do not have any money for incumbent workers. So we have to wait 
until the workers are laid off before we can offer them 
transition employment services assistance.
    These days, companies are getting further and further in 
advance notice of when they plan to shift facilities around. 
Yet, we cannot do anything to help these incumbent workers 
while they are waiting for this transitional period. So we--and 
so this is a big issue, too.
    There are reforms such as this that we believe that would 
really make the system better, more responsive.
    Senator Harkin. That is interesting.
    Secretary Chao. More helpful to workers. Because we support 
the system. But there has got to be a better way to do all 
this.
    Senator Harkin. Well, I will look at that, too. I mean if 
you have some suggestions on changes in that, we will look at 
that. Let me just consult with my staff on that.
    Well, now I am getting different information.
    Secretary Chao. Okay.
    Senator Harkin. I am told for the last 5 years we have 
given you the authority for flexibility to train incumbent 
workers. I have just been told that for the last 5 years we 
have given you that authority. So----
    Secretary Chao. Okay. I hate to give you piecemeal answers. 
So I apologize. I have been told that it is only at the State 
level, but not at the local level.
    Senator Harkin. What? The State level?
    Secretary Chao. Because all the funds, if you recall, go 
directly to the local--most of the funds go directly to the 
local WIB boards.

                        WIA FUNDING FLEXIBILITY

    Senator Harkin. My brains over here just told me that we 
have provided for an authority for 30 percent to shift between 
the adult block grant and the other block grant. So you have a 
30 percent authority there. Is that right?
    Second, you say it is at the State level, not the local 
level. But I am also told that when the State takes the block 
grant and gives it to the local level, they can provide the 
flexibility to the local level. States can do that.
    So you are saying they do not have the flexibility at the 
local level. That has more to do with the State than us. If you 
want to give more money to the States, then--but they are not 
providing the flexibility at the local area. Not us. The States 
are not doing it.
    Secretary Chao. I guess what we are saying is that we need 
flexibility, not only at the State level, but at the local 
level as well. The whole system is very important.
    Senator Harkin. Well then we are going to have to tell the 
States that--obviously, we are going to have to tell the States 
they have to do certain things. So it is not just a block 
grant. We are going to have to tie some strings to it, to tell 
the States that they have to give the flexibility at the local 
level.
    Secretary Chao. We would agree with that as well. Because a 
lot of times the funding goes directly to the local, and it is 
used for deficit reduction purposes as well sometimes.
    I would really welcome a discussion with your staff about 
this. We would welcome that.
    Senator Harkin. Well, because--and the reason I am caught 
up in this is because we really have a difference here between 
what GAO is telling us and what you are telling us. We have a 
real difference here.
    Secretary Chao. Inflexibility in the system and the 
different silos, in terms of funding streams, makes it very 
difficult to shift money around. We are not trying to decrease 
the money. We are just trying to shift it around, so that it is 
more responsive to local conditions.
    Senator Harkin. But is it 30--as I have just been told by 
counsel, you have 30--up to 30 percent to shift around.
    Secretary Chao. I was told it was an insignificant amount, 
not as large an amount as that. Is it 30 percent?
    Let me correct it. It is 30 percent. But apparently the 
local boards do not think that that is significant or large 
enough.
    Senator Harkin. Well, are they even utilizing the 30 
percent?
    Secretary Chao. It is on--I believe so. We get a lot of 
waivers. We get a lot of requests. That is very burdensome. It 
is very--it is done only under extraordinary circumstances.
    Senator Harkin. Well, we will get to the bottom of it. We 
will, and I will have my staff get a hold of your staff and 
start working some of this stuff out here.
    Secretary Chao. Thank you.

                    HIGH-GROWTH JOB TRAINING GRANTS

    Senator Harkin. I still just repeat for emphasis sake, and 
I am going to have the IG look at this earmarking, the 90 
percent. We changed it. We stopped it, in law. Did I just read 
to you the public law that we just passed, that said you cannot 
do that any more. That is why, because----
    Again, Madam Secretary, I do not think anyone would have 
minded if it were 10 percent or 4 percent. I mean we, in 
Congress, our congressionally directed funding is less than 1 
percent.
    Secretary Chao. Yes.
    Senator Harkin. All the newspapers and all the press are 
out there going after Congress. It is less then 1 percent.
    Secretary Chao. It is a bigger budget, too.
    Senator Harkin. I agree that sometimes you have--what?
    Secretary Chao. It is a bigger budget, too.
    Senator Harkin. But it is still less than 1 percent. If you 
look at it percentage wise.
    Secretary Chao. I do not want to dispute on the 90 percent. 
We have to take a look at that, because that is a surprising 
number to me. I think, again, it depends on what you--it was 
that one particular year, when it was starting up. That was an 
effort to jumpstart some worker training programs in high-
growth industries that were desperately seeking workers. But I 
will take a look at that.
    Senator Harkin. Well, like I said, I think there is a need 
for you as a secretary, me as a senator, Senator Specter as a 
Senator, and others, to respond to certain needs that may not 
be applicable on a competitive basis. But we have guidelines 
for that.
    Secretary Chao. Absolutely.
    Senator Harkin. We have guidelines for that. But when it 
comes out to 90 percent, that sort of--is pretty startling. I 
think that is one of the reasons we put that in the law this 
year. Just this year. Well, last year. Pertaining to this year.

                      WORKFORCE INVESTMENT SYSTEM

    Secretary Chao. Mr. Chairman, may I also suggest--request 
one other thing. As we talk about some of these issues with the 
overhang and the excess balance, may we also talk about some of 
the--may our staffs also discuss some of the need for how to 
handle the duplicative structure? Because right now----
    Senator Harkin. Duplicative----
    Secretary Chao [continuing]. We have dual structures within 
the workforce investment system. Again, I believe that everyone 
wants to do the right thing. The issue is: How do we break down 
some of these silos that are preventing a full focus on the 
worker?
    All of these services should be arrayed with the worker in 
the center. Nowadays, the workforce investment system is so 
complicated that a worker almost needs an advanced degree to be 
able to access the various different types of programs. It is 
very confusing, so----
    Senator Harkin. Back in the nineties, then Secretary of 
Labor--I do not remember who, which one it was. We started 
these--I remember they had a big deal about this one-stop shop. 
This one-stop thing. What has happened to all that?
    Secretary Chao. Well, it was an improvement over the 
previous years. But the idea is not complete. So more needs to 
be done to bring that about.
    Senator Harkin. Legislatively? Or administratively? You are 
the administrator.
    Secretary Chao. I think we--we have tried to do as much as 
we can, administratively. Then some of it has to be 
legislatively done as well.
    Senator Harkin. Have you----
    Secretary Chao. We would hope that----
    Senator Harkin. Have you suggested legislative language to 
us?
    Secretary Chao. We have.
    Senator Harkin. I mean, if you have, I am sorry.
    Secretary Chao. I----
    Senator Harkin. In fact, that is the other committee, but I 
am on that committee, also.
    Secretary Chao. Right. Again, we have. It is part of the 
national discussion that we need to be having.
    Senator Harkin. Because, obviously, my concern here is 
budget-wise, money-wise, but that has to do with the issues, 
and how the programs are carried out. Then, of course--then the 
other committee I serve on the--the HELP Committee, in terms of 
the----
    Secretary Chao. So you are ideally positioned, Mr. 
Chairman.
    Senator Harkin. Say what?
    Secretary Chao. You are ideally positioned, Mr. Chairman.
    Senator Harkin. Well, maybe if I was chairman of that other 
committee, too, maybe.
    Let me--a couple of other things, Madam Secretary. I do not 
mean to drag it out too--but there are some issues here that I 
want to cover with you.

                               ERGONOMICS

    One of your four stated goals is protecting worker safety. 
I am going to get into an issue that has sort of been a sore 
point between us for a long time. Not between you and me, but 
just between the Department and Congress. Ergonomics.
    Secretary Chao. Yes.
    Senator Harkin. Approximately one-third of all injuries and 
illnesses with days away from work are musculoskeletal 
disorders that result from exposure to ergonomic hazards on the 
job. In 2005, the last year we have data for, there were 
375,540 serious ergonomic injuries, resulting in time off the 
job, reported by employers.
    In 2002, after the repeal of OSHA ergonomics standard, you, 
Madam Secretary, announced a comprehensive plan to address 
ergonomic injuries, including, and I quote, ``Industry-targeted 
guidelines and tough enforcement measures.'' You stated, ``Our 
goal is to help workers by reducing ergonomic injuries in the 
shortest possible timeframe.''
    Well, let us look at the tough enforcement measures. OSHA 
has only issued 17 ergonomic citations since 2001. Twelve were 
issued in 2003. Four in 2004. One in 2005. None in 2006. So 
Madam Secretary, when are you going to practice this tough 
enforcement that you have committed to?
    One citation, I think, over the past 2 years does not sound 
like tough enforcement, when we see there were 375,000-plus 
serious injuries reported by employers, resulting in time off.
    So I want to ask you about, where is the tough--where is 
this tough enforcement?

                         ERGONOMIC ENFORCEMENT

    Secretary Chao. Well, as you mentioned, the approach that 
we have taken is strong enforcement, outreach, research based 
on sound science, and, of course, industry-specific guidelines. 
So we have issued the final ergonomic guidelines for nursing 
homes, retail grocery stores, poultry processing. They are 
obviously all industries of high rates of MSDs.
    Then a fourth guideline on shipyards was delayed, because 
of some information quality challenges. OSHA is in the process 
of updating that, and we hope to have a draft for public 
comment shortly, soon.
    We have conducted over--OSHA has conducted over 850 
ergonomic inspections per year and sent out about 408 hazard 
alert letters.
    Senator Harkin. Well, why one citation in the last 2 years, 
when you have all these injuries? Why only one citation? How 
come it has gone from 17--or 12 in 2003, down to none? I mean 
that is just----
    Secretary Chao. I will take a look at that.
    Senator Harkin. That just does not sound right, you know, 
when no citations are being issued. So someone at OSHA is just 
not--I do not know--I am trying to figure this out. Why? What 
is happening at OSHA?
    I hope that you will provide us with some plans to step up 
these enforcement efforts. Now that is enforcement of the 
guidelines. You mentioned the guidelines.

                          ERGONOMIC GUIDELINES

    You appointed members to a national advisory committee on 
ergonomics, which recommended 16 industries--you mentioned some 
of them there--for the development of guidelines. But only 
three guidelines have been issued, and none since 2004. So when 
are the other 13 guidelines going to be provided or completed?
    Secretary Chao. If you--I will just bring this up. If you 
recall, we did not have an OSHA Administrator for almost 18 
months. So it does--leadership does count. When we do not have 
leadership at the agency level, it does make a difference.
    We now have a new Administrator. He is committed to 
ensuring the worker's safety and health of our workforce. I 
will take a look at that.
    Senator Harkin. Well, please take a look at it, because 
these guidelines are just dead. Nothing is happening. Can you 
provide us with a specific time--not today. But can you provide 
us with a specific time line for the number of guidelines 
issued this fiscal year and next? Looking at those 13.
    Secretary Chao. Yes. May I also just mention that we take, 
of course, these issues seriously. But the musculoskeletal 
disorders involving days away from work declined 13.7 percent. 
So they have been declining.
    Now the total number of cases evolving and days away from 
work declined both in 2003 to 2005. So the decline in the MSD 
is twice that of other cases. But your point is well taken. I 
will take a look at it.
    [The information follows:]

    OSHA has carefully considered the recommendations offered by the 
National Advisory Committee on Ergonomics (NACE) which was established 
to advise the Secretary of Labor on ergonomics guidelines, research, 
and outreach and assistance. We have updated the NACE analysis using 
more recent injury statistics. The agency is using the results of this 
updated analysis as one source of information as it considers 
candidates for future ergonomics guidelines. It should be noted that 
NACE recommended that OSHA consider ``Other Criteria'' (e.g., injury 
trends, absence of available guidelines) established by the Guidelines 
Workgroup when making specific industry selections from the NACE list.
    Our past experience with guideline development is the best 
indicator of future timelines. The Guidelines for Nursing Homes were 
completed in about a year. The Guidelines for Poultry Processing and 
the Guidelines for Retail Grocery Stores were completed simultaneously 
in a 2-year period. We plan to publish draft Guidelines for Shipyards 
in fiscal year 2007, and anticipate finalizing them in late fiscal year 
2007 or early fiscal year 2008.

    Senator Harkin. All right. Thank you. One last question 
about this.
    Secretary Chao. Sure.

                MUSCULOSKELETAL DISORDER REPORTING FORM

    Senator Harkin. You talk about decreases. I have been told 
that you changed the reporting form and eliminated the column 
that had been used to report musculoskeletal disorders. Is that 
so?
    Secretary Chao. I seem to recall----
    Senator Harkin. I was told that you changed the reporting 
form and eliminated the column that had been used to report 
musculoskeletal disorders. So then it would make it look like 
there is less.
    Secretary Chao. I do not think that was the intent. I do 
remember something to that effect, but I do not have the answer 
at hand.
    Senator Harkin. Can you provide the committee----
    Secretary Chao. I will look into--sure.
    Senator Harkin [continuing]. With that information, too, on 
this? Also, any analysis that you have done concerning the 
effect that the elimination of this column may have had on the 
accuracy of reporting. I am not here saying it has or it has 
not.
    Secretary Chao. Okay.
    Senator Harkin. I am just asking if you had done any 
looking at getting rid of that column--I do not know why it was 
gotten rid of. I am not an expert in that area. But why it was 
gotten rid of. Analyzing if it has had any effect on the 
accuracy of reporting.
    Secretary Chao. We will do so.
    Senator Harkin. If you can provide that to us, I would 
appreciate that.
    [The information follows:]

    Each year, the Bureau of Labor Statistics (BLS) produces statistics 
of Musculoskeletal Disorders (MSDs) as part of its annual survey of 
occupational injuries and illnesses. The BLS is able to calculate and 
publish both the number and rate of MSDs involving days away from work, 
using individual case data collected from the detailed OSHA injury and 
illness 301 form. MSD statistics are available by industry and 
occupation, along with various estimates of MSD characteristics (such 
as median days away from work), and demographics (such as the age and 
sex of the injured employee). The BLS statistics on MSDs are generated 
by including cases with a defined combination of nature of the injury 
or illness and event or exposure, and a specific MSD column on the OSHA 
form is not needed to generate them. The BLS MSD statistics enable OSHA 
and the general public to accurately evaluate the scope and trend of 
MSDs in America's workplaces.
    OSHA has never implemented a specific column for recording MSDs on 
its injury and illness forms. OSHA's old 200 Log contained a column for 
``repeated trauma'' cases, which captured some, but not all MSDs, but 
also included other conditions, such as occupational hearing loss. 
Since the column did not provide an accurate tally of all MSDs, it 
caused confusion regarding MSD statistics and was removed in 2001 as 
part of a comprehensive injury and illness recordkeeping revision.
    An MSD case is recorded on the OSHA Log 300 using the same process 
as for any other type of injury or illness. If an MSD is work-related, 
and is a new case, and meets one or more of the general recording 
criteria, the case must be recorded on the OSHA forms. Inclusion of a 
specific MSD column would have no bearing on the recordability of an 
MSD case. However, requirements for entering MSD cases in a specified 
MSD column would have relied on the same MSD definition used in the 
ergonomics standard repealed by the Congress. The requirements for the 
MSD column were delayed while the agency reconsidered the issue, and in 
2003, following public comment and extensive deliberation, OSHA decided 
not to include an MSD column on the form. The agency decision was based 
on several factors, including: (1) the column would not impact 
employer, employee and OSHA MSD analyses at the establishment level; 
(2) the column had no impact on OSHA's ability to carry out ergonomics 
enforcement under Section 5(a)(1) of the OSH Act; (3) different 
definitions of MSD may be appropriate depending upon the context in 
which they are used; and (4) accurate MSD statistics were already 
available from BLS.


    Senator Harkin. I do not know why we are having so much 
trouble with ergonomics. I just do not know why. You know. We 
know it is happening. We see people every day. We hear the 
reports. We see the data. Yet nothing ever seems to get done 
about it. It is--it is a health problem in America.
    I mean if we had workers exposed to asbestos or dangerous 
substances, we would be taking action. Yet, they are exposed to 
repetitive motion injuries that many times will plague them for 
the rest of their lives. Yet we just seem to just do nothing 
about it.
    Secretary Chao. I do want to correct one perception. When 
we inspect workplaces, it is not that we do not inspect for 
ergonomic infractions. When we talk about some of this, this is 
specifically ergonomics--specific ergonomics investigations or 
inspections. When our inspectors go into a workplace, they will 
take a look at the whole array of non-compliance activities and 
behaviors, which include many times, but it is not specifically 
targeted out as ergonomics.

                    MSHA'S REVIEW OF MINE ACCIDENTS

    Senator Harkin. Senator Byrd cannot be here today, and 
wanted me to just ask a couple of questions on MSHA. It has 
been more than 16 months since the mining tragedies at Sago and 
Alma. The United Mineworkers Association, as I said in my 
opening statement, issued a report recently stating that if 
MSHA had followed their legislative mandates, all 12 Sago 
miners would have survived. That was according to the United 
Mineworkers Association.
    MSHA's internal reviews of these accidents will be released 
shortly. I do not know when. Sometime soon. Could you provide 
for the record: One, a plan and time line for taking the 
corrective actions necessary to prevent tragedies, like those 
that occurred last year. Number two, the specific steps MSHA 
will take to get better communication and tracking technology 
into mines as soon as possible, until wireless systems are 
available. Third, provide for the record quarterly reports on 
MSHA funds being used to and outcomes achieved related to the 
specific requirements of the MINER Act.
    So if you could provide that to the committee. I will have 
these----
    Secretary Chao. I will do so.
    [The information follows:]

    MSHA is currently conducting exhaustive internal reviews of its own 
enforcement activities at the Aracoma, Darby, and Sago mines. These 
will evaluate the actions of MSHA prior to the accidents and provide 
appropriate recommendations to improve the quality and effectiveness of 
MSHA's enforcement program at the field offices, district offices and 
the headquarters levels of MSHA. MSHA will assess any deficiencies in 
its enforcement program and take corrective actions as soon as possible 
to address all identified shortcomings and issues.
    MSHA Technical Support has conducted an exhaustive review of 
communication and tracking technologies available in other industries 
globally and solicited interest from providers of this technology. We 
have received suggested technology improvements from more than 138 
interested parties, met with 52 of these parties and witnessed 20 
underground demonstrations of these improved technologies. MSHA's focus 
has shifted from evaluating and encouraging new technology 
manufacturers into the mining industry (as was done last year) to 
testing and evaluating for MSHA approval of this new technology. MSHA 
has received a total of 51 applications for approval of new 
communications and/or tracking technology since January 2006, and 25 of 
these were received in 2007. This represents a very significant 
increase from the typical number of communications systems approval 
applications. MSHA's Approval and Certification Center has prioritized 
all communications and tracking approval applications and has shifted 
internal resources towards evaluation of these applications. Six new 
communications or tracking products and 15 revised products have 
already been approved as of May 24, 2007, and it is anticipated that a 
significant number of improved technology products will be approved in 
the near future. Under the MINER Act, MSHA is ensuring that each mine's 
accident response plan provides for a redundant means of communication 
with the surface, such as secondary telephone or equivalent 2-way 
communication, and provides for pre-accident tracking as an interim 
step to wireless 2-way communication and electronic tracking systems.
    MSHA does not directly track expenditures of funds to the MINER 
Act. However, MSHA has implemented, or is in the process of 
implementing, all mandated MINER Act provisions. The following table 
summarizes MSHA's actions to date to implement the MINER Act:

               MINER ACT--IMPLEMENTATION DATES AND STATUS
------------------------------------------------------------------------
            Description of task                        Status
------------------------------------------------------------------------
        SEC. 2. EMERGENCY RESPONSE
 
Develop and adopt an Emergency Response         MSHA issued Program
 Plan (ERP) that contains provisions for     Policy Letters P06-V-8 on
 post-accident communications and            07/21/06; P06-V-9 on 08/04/
 tracking; post-accident breathable air;     06; P06-V-10 on 10/24/06
 lifelines; training; and local              implementing the Emergency
 coordination.                               Response Plan (ERP)
                                             provisions in section 2 of
                                             the MINER Act.
Update plans periodically.................      MSHA issued breathable
                                             air guidance on 2/8/07 in
                                             Program Information
                                             Bulletin (PIB) No. P07-03.
                                                ERPs submitted to MSHA
                                             by 08/14/06 or citations
                                             were issued to operators.
                                                MSHA has partially
                                             approved 100 percent of
                                             ERPs and fully approved 66
                                             percent of ERPs for active,
                                             producing underground coal
                                             mines. Once the breathable
                                             air provisions and other
                                             deficiencies are addressed,
                                             ERPs can be fully approved.
Post-accident communications and tracking.      MSHA issued a Request
                                             for Information (RFI) on 01/
                                             25/06 soliciting proposals
                                             for new communication and
                                             tracking technology. MSHA
                                             is sharing results of
                                             evaluations and testing
                                             with NIOSH. MSHA is
                                             evaluating submitted
                                             proposals, assisting in
                                             arranging demonstrations,
                                             observing testing at
                                             various mine sites, meeting
                                             with communication and
                                             tracking system company
                                             representatives, and
                                             communicating with parties
                                             interested in developing a
                                             mine communication and/or
                                             tracking system.
                                                MSHA approved four
                                             communication systems in
                                             2006 that are commercially
                                             available now.
                                                MSHA issued PIB P07-01
                                             on 01/18/07 addressing the
                                             use of Global Positioning
                                             Systems during storms.
Post-accident breathable air for                MSHA published an RFI on
 maintenance of individuals trapped          8/30/06; comments received
 underground.                                10/16/06.
                                                MSHA issued PIB P07-03
                                             and associated compliance
                                             materials containing
                                             options for providing post-
                                             accident breathable air to
                                             underground coal miners on
                                             02/08/07.
                                                Mine operators were
                                             required to submit a
                                             portion of the ERP
                                             addressing breathable air
                                             by 3/12/07. Mine operators
                                             have resubmitted ERPs with
                                             provisions for breathable
                                             air. As of May 31, 2007,
                                             306 of these ERPs have been
                                             fully approved while the
                                             remaining are currently
                                             being reviewed by the
                                             districts for breathable
                                             air and other deficiencies.
                                             The National Mining
                                             Association has challenged
                                             MSHA's breathable air
                                             guidance in the Court of
                                             Appeals for the District of
                                             Columbia.
                                                Mine operators must
                                             implement breathable air
                                             provisions 60 days after
                                             MSHA approval of ERP.
Post-accident, flame resistant,                 Emergency mine
 directional lifelines.                      evacuation final rule was
                                             published 12/08/06. The
                                             final rule requires that
                                             lifelines be made of flame-
                                             resistant material upon
                                             replacement, and that all
                                             lifelines be flame-
                                             resistant no later than
                                             June 15, 2009
Training program for emergency procedures.      Required in emergency
                                             mine evacuation final rule
                                             published 12/08/06.
Local coordination and communication            Required in ERPs
 between the operators, mine rescue teams,
 and local emergency response personnel.
Emergency Response Plan approval and            Required to be submitted
 review.                                     to MSHA by 8/14/06 and
                                             every 6 months thereafter
 
         SEC. 4. MINE RESCUE TEAMS
 
Provides certification, composition, and        MSHA drafting proposed
 training requirements for underground       rule expected. The final
 coal mine rescue teams.                     rule is due under the MINER
                                             Act on 12/14/07.
 
   SEC. 5. PROMPT INCIDENT NOTIFICATION
 
Requires operator to notify MSHA within 15      Included in Emergency
 minutes of a death or an injury or          Mine Evacuation final rule
 entrapment, which has a reasonable          (published on 12/08/06).
 potential to cause death.
                                                Minimum civil penalties
                                             under the MINER Act are in
                                             effect (see penalties,
                                             below).
 
   SEC. 7. REQUIREMENT CONCERNING FAMILY
                 LIAISONS
 
MSHA to be liaison and primary                  Assistant Secretary for
 communicator with families of victims and   MSHA was assigned
 primary communicator with mine operators,   responsibility for
 the press, and the public.                  developing Family Liaison
                                             Program on 11/02/06.
                                                MSHA issued PPL P06-V-11
                                             on family liaison and
                                             primary communicator on 12/
                                             22/06.
                                                MSHA is developing
                                             policy to be implemented as
                                             a part of accident
                                             investigation handbook.
                                                Training completed for
                                             14 designated MSHA
                                             personnel.
 
             SEC. 8. PENALTIES
 
Revise existing rule to increase minimum        MSHA immediately
 penalties for unwarrantable failure         implemented new minimum
 citations and orders; and ``flagrant''      civil penalties after
 violations.                                 passage of the MINER Act
                                             for unwarrantable failure
                                             and failure to notify
                                             violations. MSHA
                                             established procedures for
                                             evaluating ``flagrant''
                                             violations in October 2006.
                                                MSHA's final rule on
                                             civil penalties was
                                             published on 03/22/07 and
                                             is now in effect.
 
    SEC. 10. SEALING OF ABANDONED AREAS
 
Requires increase of 20 psi standard for        MSHA issued PIBs
 sealing of abandoned areas in underground   establishing a temporary
 coal mines.                                 moratorium on new seal
                                             construction until the
                                             agency issued subsequent
                                             guidance for addressing
                                             alternative seals: PIB-06-
                                             11 issued 06/01/06; PIB-06-
                                             12 issued 06/12/06; PIB-06-
                                             14 issued 06/21/06; PIB-06-
                                             16 issued 07/19/06. Seal
                                             strength for alternative
                                             seals was increased to 50
                                             psi under this PIB.
                                                MSHA issued Procedure
                                             Instruction Letter (PIL)
                                             I06-V-09 on 08/21/06
                                             establishing procedures for
                                             agency approval of
                                             ventilation plans that
                                             include alternative seals.
                                             MSHA has approved one plan
                                             that included alternative
                                             seals and has approved a
                                             number of others
                                             provisionally.
                                                MSHA will continue to
                                             work with NIOSH on research
                                             and testing of seals, pa
                                             articularly full-scale
                                             testing of seals at higher
                                             explosion pressures.
                                                NIOSH draft report
                                             issued 02/09/07.
                                                Emergency Temporary
                                             Standard (ETS) issued on
                                             May 22, 2007. The ETS,
                                             effective May 22, 2007,
                                             addresses the design,
                                             construction, maintenance
                                             and repair of seals, as
                                             well as requirements for
                                             sampling and controlling
                                             atmospheres behind seals.
                                             It requires training for
                                             persons who conduct
                                             sampling, and who construct
                                             and repair seals. Mine
                                             operators must submit
                                             design and installation
                                             applications for MSHA
                                             approval. In accordance
                                             with the Mine Act, the ETS
                                             must be finalized by
                                             February 22, 2008.
 
      SEC. 11. TECHNICAL STUDY PANEL
 
Establish Belt Air Technical Study Panel        Belt Air Technical Study
 to provide review and recommendations on    Panel established 12/20/06.
 the use of belt air and the composition
 and fire retardant properties of belt
 materials in underground coal mining.
                                                1st meeting held on
                                             January 9-10, 2007.
                                                2nd meeting held on
                                             March 28-30, 2007.
                                                3rd meeting held on May
                                             16-18, 2007.
                                                Procedures and timetable
                                             established. Relevant
                                             documents posted on MSHA's
                                             website.
                                                4th meeting will be June
                                             20-22, 2007 in Birmingham,
                                             AL.
                                                5th meeting will be
                                             scheduled to summarize all
                                             the Panel's activities.
Submit a report to the Secretaries of           Panel report due 12/20/
 Labor and HHS and to the Congress.          07.
Provide a response to Congress describing       Secretary of Labor's
 the actions that the Secretary intends to   response due 6/20/08.
 take based on the report and the reasons
 for such actions.
 
    SEC. 13. RESEARCH CONCERNING REFUGE
               ALTERNATIVES
 
Conduct research, including field tests,        MSHA will share with
 on the utility, practicality,               NIOSH data collected as a
 survivability, and cost of refuge           result of MSH's Request for
 alternatives in an underground coal mine    Information (RFI),
 environment.                                published 01/25/06, and
                                             other MSHA/NIOSH public
                                             meetings, including 03/13/
                                             06 meeting on mine rescue
                                             communication and tracking
                                             technology and 4/18/06
                                             meeting on Mine Escape
                                             Planning and Emergency
                                             Shelters.
Issue report to Congress concerning its         NIOSH report due 12/15/
 research re-  sults.                        07.
Provide response to Congress describing         MSHA response due 6/15/
 the actions that the Secretary intends to   07.
 take based on the report, including
 proposing regulatory changes.
 
      EMERGENCY MINE EVACUATION RULE
 
MSHA issued final rule, effective               National Mining
 immediately, on 12/08/06 finalizing         Association has challenged
 emergency temporary standard providing      the final rule in the Court
 improved protections for emergency mine     of Appeals for the District
 evacuation.                                 of Columbia.
                                                On 03/30/07, MSHA issued
                                             notice on availability of
                                             SCSR training units which
                                             must be used within 60 days
                                             after receipt of the units.
------------------------------------------------------------------------

    Senator Harkin [continuing]. Submitted----
    Secretary Chao. Did you want me to answer some of that or--
--
    Senator Harkin. What?
    Secretary Chao. Did you want me to answer some of that?
    Senator Harkin. Do you want to answer that? I just----
    Secretary Chao. We will provide more for the record as 
well. Obviously, we have been very, very focused----
    Senator Harkin. Okay.
    Secretary Chao [continuing]. On all of this in the 
aftermath of the tragedy of 2006.
    Senator Harkin. Do you know when this review is going to be 
issued? Do you have any idea on MSHA's review?
    Secretary Chao. Yes.
    Senator Harkin. Shortly?

                       MSHA'S ARACOMA MINE REPORT

    Secretary Chao. Yes. In fact, the Aracoma Mine report will 
be coming out tomorrow. I respectfully ask that we debrief--we 
brief the family members first before doing so to the 
committee.
    Senator Harkin. Okay.
    Secretary Chao. That has always been the procedure. But we 
are--it takes a long time to file these reports. Please know 
that we are diligently working away to find out the causes. We 
do not want to prejudge. There is an internal review process 
that occurs. Then that report is usually released about a month 
after the accident report.

                     PERSONAL PROTECTIVE EQUIPMENT

    Senator Harkin. One last thing and then we will, I think--
one or two last things here. Personal protective equipment.
    Secretary Chao. Yes.
    Senator Harkin. OSHA's own estimates indicate that 
requiring employers to pay for basic personal protective 
equipment such as safety goggles and earplugs could prevent 
workers from suffering nearly 50,000 workplace injuries per 
year. These are OSHA's estimates.
    It has now been 8 years since a standard was first 
proposed. Despite repeated assurances, OSHA has let this 
fundamental worker safety requirement languish. In response to 
a recent lawsuit, OSHA, again, is promising to issue a 
standard. This time by November. OSHA has offered no assurances 
about what kind of standard it will issue.
    So my question, Madam Secretary, is: When will you issue 
the standard that OSHA first proposed in 1999? Given the 
opposition to this proposal by special industry interests, what 
assurances can you give us that you will not weaken the final 
standard in comparison to the 1999 proposal?
    Secretary Chao. We have been, actually, working on this 
issue for quite a while. The issue as to who should pay for 
personal protective equipment, you know, appears pretty 
straightforward on the surface. But, in fact, it is a very 
complicated issue. It requires careful deliberation to address 
a lot of the complex issues that have been raised in the 
rulemaking record.
    We are currently considering the issues raised in the 
rulemaking. We reopened it for comment in 2004. We do--we know 
that this is important. So the Department does intend to issue 
a final rule, absent, again, unforseen circumstances, by 
November of this year. We think that we can probably do it. It 
is our intent to do it by that time.
    Now regardless as to who pays for PPEs, our standards 
require employers to determine and ensure that workers use PPEs 
appropriately, so they can be protected. That is very firm.
    Senator Harkin. All right. Thank you very much.
    Let me loop back to something that I talked about earlier. 
Because in between time, I talked about these earmarks and 
stuff. These special non-competitive awards.

                    INTERNATIONAL LABOR ORGANIZATION

    Again, back to international child labor. Which has been an 
interest of this Subcommittee--mine, but also Senator Specter's 
too, when he was chair.
    We--you, the Department of Labor, had a relationship with 
the International Labor Organization for a long time. What I am 
hearing--what I am hearing is that you are now thinking of 
putting that out for other recipients.
    As I said earlier, a small amount of non-competitive grants 
is reasonable. We have guidelines for that. Considering certain 
factors, such as the unique qualifications of a grant 
recipient. The continuance of an existing relationship that has 
allowed for the maintenance of services are of particular 
significance to the agency on a long-term basis.
    So I am concerned that you are undergoing efforts to 
discontinue the relationship that Labor has had with the 
International Labor Organization. I am wondering what that is 
all about.
    Secretary Chao. Well, that certainly is not true. I mean I, 
myself, have gone to every single International Labor 
Organization's annual meeting. I think I have gone more 
frequently than any other secretary. I think that is pretty 
accurate.
    As I mentioned, the stance of the Department is that we try 
to competitively bid these grants. Because we want to ensure 
that the best services are available to the recipients and 
beneficiaries of these grants.
    The 90 percent that you mentioned, I will look at that.
    Senator Harkin. Okay. Well, we do not need to go over ----
    Secretary Chao. I do not think that is quite correct.
    Senator Harkin [continuing]. That ground any more.

                        PERFORMANCE REVIEW BOARD

    Secretary Chao. Then where there are instances for sole-
source, which, again, we try not to do, it has to go through a 
performance review board. As you mentioned, there has to be 
some pretty extraordinary circumstances.
    Senator Harkin. Who makes up that performance review board 
anyway? How are they appointed? How are they picked? Who picks? 
How many are there?
    Secretary Chao. I think I--I think I choose them, but I 
think I sign off on the candidates who are nominated for this 
board, and it goes--you know, goes through clearance. It is 
primarily----
    Senator Harkin. Could you find out for me?
    Secretary Chao [continuing]. Professionals----
    Senator Harkin. I want to find out who this performance 
review board is, and how they are picked, and how many. I do 
not have any idea whatsoever.
    Secretary Chao. They are primarily career people.
    Senator Harkin. Yes.
    Secretary Chao. It has been there before we--you know, it 
has been there for a very long time.
    Senator Harkin. I think so. I just do not know anything 
about it.

                        ILO FUNDING THROUGH ILAB

    Secretary Chao. We hope that the ILO will compete in this 
grant-making process. ILO is very competent. They should be 
able to do very well in the grant competition.
    We have over 30 other organizations, however, that do work 
in child labor. We have AED. Catholic Relief Services. 
International Rescue Committee. Save the Children. Winrock 
International. International Youth Foundation. UNICEF, even.
    So absent, again, a hard earmark within the legislation, 
there are many other organizations that have this capability to 
provide the services. So--
    Senator Harkin. Well, I would respectfully disagree with 
you on that. In terms of this--I mean they do good stuff. Do 
not get me wrong. But this is something I have tracked down for 
a long time. The ILO has been involved in this. They have the 
structures. They work with these other agencies. They 
coordinate with these other agencies to do certain things in 
the field on child labor.
    Secretary Chao. Then if they fund----
    Senator Harkin. Gathering data, for example. That type of 
thing. Pardon?
    Secretary Chao. If they fund these other organizations 
then, they of course, take a fee, you know, for the management. 
There is an overhead--excess overhead charge. Again, we are not 
against ILO for doing this. We just say--we are just saying 
that in the current situation--as you well know, throughout the 
administration, there is this emphasis on earmarks. Unless--in 
the language of the bill, which, of course, could not happen in 
this last go-around. But nevertheless, anything short of that, 
we basically are opening it up for competitive bidding.
    So we hope the ILO will compete.
    Senator Harkin. Well----
    Secretary Chao. I mean with their particular expertise, 
they should do very well.
    Senator Harkin. Again, as I said, there is a--there is an 
exception made for unique qualifications, continuance of an 
existing relationship for maintenance and services, on a long-
term basis, that allow for non-competitive grants.
    The problem I see with this is that--obviously, everybody 
wants some money. So if you throw it out there, sure, you may--
I do not want to see this parceled out. I do not want to see a 
little bit going to Catholic Relief Services, and a little 
bit--Lutheran Relief Services. A little bit to Red Cross, or 
whoever, out there. They are all good organizations. They do 
great work in a lot of ways.
    We have had a focus on international child labor from this 
Department through ILO, for about, if I am not mistaken, 12 
years now. I think that has been about right. Maybe a little 
bit longer.
    As I said, we are making great progress. It is something 
that I monitor closely personally, and my staff. I am concerned 
about parceling things out and sort of taking the focus off. 
You have just got to--you have a good focus on it. I think ILO 
has been uniquely qualified to do that. Only because they--
well, they have been doing it for a long time.
    All of the things I have seen in the field indicates that 
they are doing a good job. If you have other information other 
than that, I would be more than happy to see it. But I am 
concerned about that aspect of it. So we will leave it at that, 
I guess.
    Secretary Chao. I take your advice on not fragmenting or 
parceling out----
    Senator Harkin. Yes.
    Secretary Chao [continuing]. These----
    Senator Harkin. Because it is not that much money anyway.
    Secretary Chao. It is a lot of money.
    Senator Harkin. Well, you are trying to cut it. You are 
trying to cut it. I know that. But I am not trying to cut it.
    Secretary Chao. I understand your point about not parceling 
it out. But I think that is still separate from competitive 
bidding. So----
    Senator Harkin. I do not know about that.
    Secretary Chao. Okay.
    Senator Harkin. We will have to take a look at it----
    Secretary Chao. I will.
    Senator Harkin [continuing]. And see. See who else--see if 
there is anyone else out there qualified. Only because I said 
that we have--unless you have information and data that can 
show me that ILO is not doing its job, and that it has been 
falling down on it, and that, then that is different. That is 
quite different.
    Secretary Chao. Yes. I do not think that is the case 
either. I think it has always been--we just try to--more and 
more we are just trying to competitively bid these contracts, 
again, with----
    Senator Harkin. I do not have anything wrong with 
competitive bidding, unless that would lead to a derogation----
    Secretary Chao. I understand.
    Senator Harkin [continuing]. Of the efforts that we have 
ongoing. Well, Madam Secretary, first, before I--this is really 
all I wanted to cover, that I had. The only other thing I would 
just say is that a 9.4 percent cut in this budget is--it is not 
good. Especially, just the whole area of Job Corps cut, $55 
million. A 3.5 percent cut.

                 OFFICE OF DISABILITY EMPLOYMENT POLICY

    The other one--oh. Yes. There is one other area I just want 
to bring to your attention. There is a proposed cut in funds 
for the Office of Disability Employment Policy by $9 million. 
That is a 32 percent cut.
    Madam Secretary, we passed the American Disabilities Act in 
1990. President Bush, the first Bush, signed it into law. It 
was bipartisan. We have had 17--and my name is on that, by the 
way. We have had 17 years of experience under ADA. One of the 
goals of ADA was self-sufficiency, that people with 
disabilities would become self-sufficient.
    Yet, 17 years later, the unemployment rate among people 
with disabilities is over 60 percent.
    Secretary Chao. Right.
    Senator Harkin. It is over 60 percent.
    Secretary Chao. I agree with you, yes.
    Senator Harkin. So, you know, this is one where we just 
have to start focusing more attention. Now that is why, and 
this is not in your area, but--I am making sure we have 
reasonable accommodations for people with disabilities. 
Transportation. All those other things. But that is outside of 
your bailiwick.
    But one thing that is in there is this disability 
employment policy. I do not know why--what is the reason for a 
32 percent cut when we have over 60 percent unemployment among 
people with disabilities.
    Secretary Chao. We share your concern about the high rate 
of unemployment among Americans with disabilities. But I think 
we disagree on what ODEP should be doing. By having ODEP give 
out grants, we do not feel it is the best way to tackle this 
problem either. ODEP should be a catalyst. It should be a 
facilitator. It should be a--you know, a convener. It should be 
sharing best practices. It should be doing the kind of--
advocacy. Promotion work. Rather than give out grants. We are 
very limited on----

                              ODEP GRANTS

    Senator Harkin. What do those grants do?
    Secretary Chao [continuing]. What people----
    Senator Harkin. What do those grants do, Madam Secretary?
    Secretary Chao. With not very much results, I am afraid.
    Senator Harkin. But what do they do? What do those grants 
do?
    Secretary Chao. They give them out--sometimes they are 
direct grants to increase employment. A very small amount. $20 
million, basically.
    Senator Harkin. Is that $20 million just given out in 
grants?
    Secretary Chao. Actually, the budget is about $40 million. 
So we have asked for $20 million. So there is a difference of 
about $20 million. But we do not think that, again, ODEP should 
be involved in grant making.
    Senator Harkin. Well, can your staff give us some idea of 
what those grants are?
    Secretary Chao. Sure.
    Senator Harkin. I have been told that some of those grants 
actually go out to show employers how they can employ people 
with disabilities by making modest, small accommodations that 
do not cost a lot of money.
    I have heard all kinds of stories of these grants going out 
and showing an employer that by just a small amount of 
investment, they can hire people with disabilities, and have 
good workers who are very productive.
    But a lot of times, they do not think about things. It is 
not that they are bad. The employers do not think about things 
like that. They have businesses to run, and they are trying to 
move ahead and stuff. But sometimes these grants go out to 
really show what can be done. Then others can see it.
    So if I am wrong in that, let me know. I would like to know 
what some of these----
    Secretary Chao. I will take a look.
    Senator Harkin [continuing]. Grants look like.
    Secretary Chao. I will do so.
    Senator Harkin. I am not sure if I agree with you that we 
should not be giving grants. It depends on what the grants are 
for. If the grants are just busy work and studying something to 
death, well, you are right. I would agree with you that that 
would not be--but if it is actually going out to provide 
information and support to employers, especially small 
employers, to show what they can do to enhance the workplace 
for people with disabilities, well, I would not think those 
would be bad things to do. But if you would just give me some 
information on it, I would sure appreciate it.
    Well, actually, I have kept you long enough, Madam 
Secretary. There are some others, but--well, we may have some 
questions for the record we will submit to you.
    One last thing. Madam Secretary, I am concerned that the 
Department is not responding to requests from the subcommittee. 
We are still waiting for responses to questions for the mine 
and safety hearing record, which were due last week, and the 
State tables on the impact of your proposed $335 million 
cancellation of Job Training funds.
    Again, will you assure me that your Department will provide 
this subcommittee, our staffs, both sides, with timely and 
accurate responses to requests for information?
    Secretary Chao. I am sorry that that has been delayed. I 
thought they were--I am sorry that you have to bring it up. It 
will not happen again.
    Senator Harkin. I appreciate that very much. Then we also 
have some questions for the record.
    Secretary Chao. I would be more than glad----
    Senator Harkin. Anything else?
    Secretary Chao [continuing]. To answer them.
    Senator Harkin. All right. Anything else, Madam Secretary, 
you would like to request of us, or bring our attention to, or 
anything? I mean----
    Secretary Chao. I think we are okay. We have a good 
relationship with your staff. We look forward to working with 
them on some of these----
    Senator Harkin. Very good. Yes.
    Secretary Chao [continuing]. Tough issues.
    Senator Harkin. Okay. Well, thank you very much. You have 
been generous--oh, wait. Just a moment.
    Secretary Chao. I will submit a document on the balances 
per the State. I thought you might be interested in this.
    Senator Harkin. Oh. Yes. Yes. Yes. We would like to see 
that.
    Secretary Chao. All right.
    Senator Harkin. I will get my staff to take a little bit 
more look at that. On the balances. This is the carryovers that 
we were talking about earlier.
    Secretary Chao. Right.
    Senator Harkin. Yes.
    Secretary Chao. Because this comes up every year.
    Senator Harkin. I know. I would like to get a handle on it.
    Secretary Chao. Yes.
    Senator Harkin. I have one kind of view, or something, or 
one way that I think about it. I do not know if that is the 
right way or not, because--well, I mentioned about the 
contractual obligations. That type of thing.
    You had a different way of looking at it, as to whether or 
not that money is actually spent or not. Well, I do not know 
the answer to that question.
    Secretary Chao. We look forward to working with you on 
this.
    Senator Harkin. I appreciate it very much.
    Secretary Chao. Thank you.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Harkin. Well, you have been very generous with your 
time, and your answers and responses.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

               Questions Submitted by Senator Tom Harkin

            NUMBER TRAINED UNDER CAREER ADVANCEMENT ACCOUNTS

    Question. Please provide a chart displaying for the past 5 program 
years, the number of individuals trained under the proposed 
consolidated programs versus the number trained under the proposed 
Career Advancement Accounts. Please provide a quantitative analysis of 
how this proposal, which reduces funding sources for consolidated 
programs by more than $600 million, or 16 percent, can result in an 
increase of the number of trained individuals from 200,000 under 
current law to 600,000 under your proposal.
    Answer. The Career Advancement Account proposal for Workforce 
Investment Act (WIA) reauthorization proposes the consolidation of four 
programs--the WIA Adult, Dislocated Worker, and Youth programs and the 
Employment Service. The following table shows the number of individuals 
trained in each of the past 5 years in the WIA Adult and Dislocated 
Worker programs. A minimal number of youth receive training under the 
WIA Youth program, and training is not provided under the Employment 
Service.

----------------------------------------------------------------------------------------------------------------
                                                                       Number of Individuals Trained
                                                          ------------------------------------------------------
                         Program                                                Program year
                                                          ------------------------------------------------------
                                                              2001       2002       2003       2004       2005
----------------------------------------------------------------------------------------------------------------
WIA Adult................................................     75,963    107,671    102,950    109,492    105,457
WIA Dislocated Worker....................................     66,192     98,540    102,415     95,113     83,669
----------------------------------------------------------------------------------------------------------------
Source: Workforce Investment Act Standardized Record Data file.

    The President's proposal for WIA Reauthorization would result in 
over 600,000 individuals trained through Career Advancement Accounts 
each year. Under the proposal, the amount of WIA funding dedicated to 
training would be substantially increased. This would be accomplished 
by (1) eliminating the current inefficient ``silo'' business model 
whereby programs are duplicative and create inefficient and parallel 
service delivery structures and (2) implementing a customer-focused 
model that enhances access to postsecondary education and training.
    At the President's request level in the fiscal year 2008 budget, 
local areas would be required to spend a total of $1,899,000,000 on 
training. A Career Advancement Account would provide up to $3,000 each 
year for a worker to obtain training, resulting in an estimated 633,000 
individuals trained each year. Additional funds are provided to States 
for Employment Services, to be used by local areas for the provision of 
intensive services and discretionary One-Stop Career Center services in 
addition to the provision of core services. More detail on the proposed 
funding structure is provided in the following table.

 WIA REAUTHORIZATION PROPOSAL FUNDING STRUCTURE PRESIDENT'S FISCAL YEAR
                           2008 BUDGET REQUEST
------------------------------------------------------------------------
                                                             Amount
------------------------------------------------------------------------
      Total Appropriation............................     $3,413,000,000
National Reserve (7.5 percent of Total Appropriation)        255,975,000
                                                      ==================
      Total Funding to States........................      3,157,025,000
Set Aside for Outlying Areas (.025 percent)..........          7,892,563
State Administration (5 percent of Total Funding to          157,456,622
 States).............................................
                                                      ------------------
33 percent to State Level............................      1,039,213,704
    State Administration (5 percent of the Total             157,456,622
     Funding to States)..............................
Employment Services (67 percent of State Level funds)        696,273,182
    State-wide Activities (Remaining State Level             185,483,901
     funds)..........................................
                                                      ==================
67 percent to Local Areas............................      2,109,918,733
    Local Administration (10 percent of Local Area           210,991,873
     funds)..........................................
    Career Advancement Accounts (90 percent of Local       1,898,926,860
     Area funds).....................................
                                                      ==================
Average Account......................................              3,000
Number of Accounts...................................            632,976
------------------------------------------------------------------------

                     FUNDS SPENT ON ADMINISTRATION

    Question. The budget justification States that ``too many resources 
are being used to pay for administrative functions, overhead costs, and 
multiple layers of staff.'' What is the specific evidence for these 
conclusions? Please provide more detailed information about the amounts 
of resources that DOL believes is spent inappropriately on 
administrative functions.
    Answer. The Department's belief that too much workforce investment 
funding is used for administration and overhead costs comes from a 
number of sources. First, while the Employment Service is intended to 
be a cornerstone of the One-Stop Career Center system under the 
Workforce Investment Act (WIA), many States continue to have separate 
Employment Service offices offering the same core services that are 
available in the same communities at the One-Stop Career Centers under 
WIA. The lack of integration in the delivery of core services by 
different programs has continued duplicative bureaucracies that divert 
funds that could be spent on services, including education and 
training.
    Second, the current WIA regulation at 20 CFR 667.220(b) enumerates 
the specific functions defined as administrative costs. As required by 
WIA, this definition of administrative costs was developed in 
consultation with Governors and other stakeholder groups in 1999, and 
was more narrow than the definition in use before 1999. However, 
instead of reducing the level of administrative activity when the caps 
were lowered, some States and local areas charge some activities 
considered administrative costs under earlier programs as program 
costs. Activities such as performing oversight and monitoring of the 
program, the costs of facilities used for programmatic activities, the 
provision of technical assistance, the activities of State and local 
boards, professional organization membership dues, and the evaluation 
of program results, which have traditionally been classified as 
administrative costs, are currently classified as programmatic costs. 
As a result, there is no effective administrative cost ceiling.
    Finally, based on expenditure data submitted by the States, the 
Department estimates that the proportion of WIA and Employment Service 
funding that has been spent on infrastructure is about one-quarter for 
the last 4 program years. For this estimate, the Department looks at 
the costs of infrastructure, including both physical and organizational 
costs, at the State and local levels that support the delivery of 
services to participants by the One-Stop system such as local 
administration and other infrastructure costs. While the Department 
does not question whether some of these costs are necessary or 
appropriate, taken in total, too large a proportion of WIA funds is 
spent on infrastructure and overhead rather than direct services.

                  COMMUNITY-BASED JOB TRAINING GRANTS

    Question. The budget request proposes to continue a fourth year of 
investments in two related initiatives that according to the Department 
are critical to the ``transformation of the workforce system and talent 
development''--the High Growth Job Training Initiative and the 
Community-Based Job Training Initiative, better known as the Community 
College Initiative.
    To improve the training capacity in many communities, the budget 
request also includes the Community College Initiative. How does the 
Department plan to evaluate the impact of this investment--$250 million 
in the first two rounds alone--on increased community college capacity, 
better skilled workers, and community economic growth? How does the 
Department plan to identify and share promising practices with the 
education, workforce and economic development networks to further 
advance these improvements? How will the Department determine what is a 
``promising or best'' practice?
    Answer. The Department of Labor's Employment and Training 
Administration (ETA) is launching a full evaluation of the Community-
Based Job Training Grant (CBJTG) program, also known as the Community-
College Initiative, in Program Year (PY) 2007. It is focused on all 
grants awarded under the first two competitive Solicitations for Grant 
Applications. The evaluation will be composed of two parts. The first 
part is an implementation study that explores the effectiveness of 
capacity building efforts. The second part of the CBJTG evaluation is a 
net-impact study. This study, using non-experimental matching 
methodologies, will assess the net impacts of CBJTG training against a 
comparison group of like individuals. Additionally, grantees report 
their progress towards meeting their capacity building goals and the 
impact of their capacity building activities to ETA on a quarterly 
basis. ETA is in the process of compiling and validating the impact 
data reported to date.
    Grantees are taking a variety of approaches to help bridge the gap 
between the workforce needs of industry, and the training and education 
provided to individuals who need jobs. As a result of these new 
approaches, grantees are producing a variety of products including best 
practice case studies, curriculum, competency models, distance learning 
tools, career awareness and outreach materials, research, career 
lattices, creation of industry skill centers, and Web sites.
    CBJTGs were funded because they met an identified high growth or 
high demand industry need by implementing a capacity building and 
training strategy. Therefore, ETA believes all products developed under 
these grants may provide useful resources to the workforce system and 
many are potential promising or best practices. ETA is currently 
implementing a comprehensive dissemination plan to distribute the 
approaches, products, models, and tools from both the CBJTG and High 
Growth Job Training Initiative grantees to the public workforce 
investment system and educators from across the country. To do this, 
ETA utilizes a network of national, regional, State, and local 
stakeholders including industry, education, and the workforce 
investment system. ETA makes all of these grantee tools, models, and 
products available through the Workforce3One Web site 
(www.workforce3one.org), a site designed for sharing innovative 
resources, tools and learning events with workforce and education 
professionals. ETA routinely features products and promising practices 
through Webinars and monthly electronic newsletters distributed through 
Workforce\3\One. In addition, ETA is developing a series of industry 
product CDs in order to share all Workforce\3\One materials with 1,900 
community colleges, 3,200 local One-Stop Career Centers, State and 
Local Workforce Investment Boards, Governors, and a wide variety of 
industry associations.

                    WIA REALLOCATION AND RESCISSION

    Question. The budget proposes to cancel $335,000,000 of unexpended 
balances from various State formula grant programs authorized under the 
Workforce Investment Act. Since this proposal will cancel unexpended 
balances in State WIA funds, how will the Department know whether these 
funds are obligated already for authorized activities, including 
training?
    Answer. States submit quarterly financial status reports to the 
Department which include data on Workforce Investment Act (WIA) title I 
formula fund obligations as well as expenditures. By using data 
reported at the end of Program Year (PY) 2005 (the most recent 
completed program year) as a guideline, approximately $555 million in 
WIA formula funds not obligated by the State and local areas were 
carried over into PY 2006. Since these unobligated funds greatly exceed 
the proposed $335 million cancellation, and make up only part of the 
total unexpended carryover balance that reaches over $1.1 billion, the 
Department does not expect obligated balances to be impacted 
significantly. Furthermore, the proposal would provide flexibility for 
the Secretary, at the request of the State, to allow a portion of the 
cancellation to be applied to a State's current-year funds, which are 
less likely to be fully obligated.
    Question. The budget proposes to allow the Secretary to reallocate 
among the States for program year 2007 any amount that a State had 
unexpended for certain WIA program in excess of 30 percent and provide 
those funds to any State that did not have a balance greater than this 
amount. In addition, bill language is proposed that would allow 
Governors to reallocate funds in the same manner at the local level.
    For each of the last 3 program years, please provide information on 
the extent to which reallocations at the local level take place 
currently, by State. Is there good enough data available to the 
Secretary and governors for making the reallocations, under the 
authority requested in the fiscal year 2008 budget?
    Answer. The fiscal year 2008 budget proposes that the Secretary for 
States, and the Governor for local areas, have the authority to 
recapture and reallocate unexpended funds in excess of 30 percent of 
available funds. This would expand the current law recapture and 
reallocation authority that only applies to unobligated funds. The 
Department currently receives certified reports on expenditures from 
States providing the information needed to calculate which States would 
be affected by the proposed recapture and reallocation. Because of 
early concerns about the quality of accounting and financial reporting, 
the Department has conducted extensive financial training sessions with 
State and local staff to ensure that financial data is accurately 
gathered, recorded and reported. For instance, the Department developed 
and offered across the Nation a course on accrual accounting.
    Individual local area financial data is reported to the State, but 
only aggregate local information is reported by the State to the 
Department of Labor. The State determines the recapture and 
reallocation of local funds and the Department does not collect 
reallocation data from the States; therefore, the Department cannot 
provide that information.

                      FINANCIAL REPORTING GUIDANCE

    Question. Has DOL provided more financial reporting guidance, 
technical assistance and promising practices, as recommended by the 
Government Accountability Report, GAO-03-239? Please describe the 
actions taken and/or planned (including a timeline) to address the 
recommendations in this report.
    Answer. Yes, the Department has provided financial reporting 
guidance and technical assistance. Between fiscal year 2004 and fiscal 
year 2006, the Department provided a number of States considerable 
technical assistance through Accrual Accounting and Financial Reporting 
training sessions. During these sessions, the Department provided 23 
States with guidance and technical assistance on accrual accounting and 
financial reporting requirements, such as in-depth training on the 
reporting requirements for WIA funds as well how to account for, 
define, and report consistently on obligations, unliquidated 
obligations, and accrued expenditures.
    The Department conducted Accrual Accounting and Financial Reporting 
training sessions for State and local employees on the following dates:
  --January 23-27, 2006--Two sessions in Washington
  --April 11-12, 2006--One session in Maryland
  --April 18-19, 2006--One session each in Wisconsin and Arkansas
  --April 25-26, 2006--One session each in Minnesota and Oklahoma
  --May 9-10, 2006--One session in New Mexico
  --May 17-18, 2006--One session in Michigan
  --May 23-24, 2006--One session in Oregon
  --June 27-28, 2006--One session in Ohio
  --June 20-21, 2006--One session in Pennsylvania
  --July 17-18, 2006--One session in Nebraska
    Additionally, the Department has held three major national 
conferences around the country during the most recent year to train 
State, local and other financial and administrative staff on WIA and 
other Federal requirements that must be followed, including those 
relating to financial reporting.

                MIGRANT AND SEASONAL FARMWORKER PROGRAM

    Question. The budget proposes to eliminate funding for this 
program, inpart, because the Department believes the program does not 
focus enough on providing employment and training services. Over the 
last 5 years, about 5 percent of grant funds have been spent on related 
assistance, of which some is for gas and car repairs and some for 
emergency food, housing and medical care. Over 80 percent of the funds 
have been spent on job training and placement activities. About 90 
percent of the jobs farmworkers were placed into were outside of 
agriculture and came with benefits and significant wage gains. Are 
these figures consistent with Department of Labor records? If not, why 
not? If the data is accurate, what's wrong with spending patterns and 
outcomes achieved by grantees under this program?
    Answer. The Department does not collect data on whether jobs into 
which farmworkers are placed are outside of the agricultural industry. 
However, the goal of the program, and of all job placements, is 
economic self-sufficiency.
    The expenditure rates cited are largely consistent with what 
grantees have reported to us. The Department of Labor's Employment and 
Training Administration (ETA) has been concerned that, historically, a 
majority of participants have been receiving only low cost related 
assistance services, which are available through other Federal programs 
and do not promote self-sufficiency, compared to those receiving 
employment and training services. This concern led ETA to implement 
three new approaches during the 2005 Program Year (PY):
    (1) refocusing the Solicitation for Grant Applications by 
highlighting that the National Farmworkers Jobs Program (NFJP) is a job 
training program;
    (2) establishing a cap on the number of participants who could 
receive related assistance services only; and
    (3) changing the reporting system so that, for the first time, ETA 
could collect both participant and financial data on related assistance 
services only. Therefore, the PY 2005 expenditures for related 
assistance, accounting for 5.4 percent of the total, reflect, for the 
first time, the expenditures for those participants receiving these 
services and no others.
    Currently, the NFJP provides services to about 20,250 of an 
estimated 2 million farmworkers, which demonstrates the need for a 
wider system approach. The One-Stop Career Center system can provide a 
full array of employment and training services, as well as supportive 
services and other related assistance, available from 17 Federal 
programs. Those being served by the NFJP have similar types of barriers 
to full-time employment that other workers do, and the relatively small 
NFJP does not provide its participants with the full array of benefits 
they would derive from the workforce investment system.

            COMMUNITY SERVICE EMPLOYMENT FOR OLDER AMERICANS

    Question. The budget proposes a reduction of $133.6 million for the 
Community Service Employment for Older Americans program, based in part 
by efficiencies that could be realized under the reauthorization of the 
program. Specifically, what are the efficiencies that DOL believes will 
be achieved for administration of this program? What factors and 
assumptions did DOL use to calculate the proposed reduction of $133.6 
million?
    Answer. Improvements to the program as a result of the changes made 
by the 2006 amendments to title V of the Older Americans Act (OAA), 
which authorizes the program, allow the Department to more efficiently 
use funds to serve workers than is possible under current law. Reforms 
that will contribute to increased efficiency in the program include the 
following:
  --A new time limit on participation of eligible individuals in the 
        program is a key reform of the program. This ensures that more 
        people can access the program by rotating individuals more 
        promptly through available slots, and helps grantees focus on 
        the end goal of the program--helping seniors find unsubsidized 
        employment.
  --Performance measures have been streamlined and strengthened, 
        holding grantees accountable for results, and promoting 
        efficient and effective use of program funds.
  --The newly reauthorized program provides more training options for 
        participants. While community service can provide valuable work 
        experience, many seniors need additional education and training 
        in order for their skills to be viable in regional labor 
        markets.
  --The reauthorized OAA requires that an open competition for national 
        grants be conducted every 4 years, ensuring that the best 
        grantees operate the program and provide a stimulus for new 
        ideas, innovation, and high-quality service.
    The Department examined a number of factors in determining its 
fiscal year 2008 request. These include excessive recaptured funds, 
which have steadily increased over the past few years and topped $13 
million in PY 2004. The Department also considered the high number of 
unfilled slots among program grantees, which totaled over 1,500 in 
Program Year 2005. These factors indicate that program improvements are 
still needed in order to provide the most efficient and responsive 
services to low income seniors.
    Question. What is the cost of maintaining the participant level at 
the 2007 program year level as adjusted by the higher minimum wage 
provided by H.R. 2, which was passed by the Senate on February 1, 2007?
    Answer. Program Year (PY) 2007 has not yet begun, but will begin on 
July 1, 2007. In PY 2006 (July 1, 2006-June 30, 2007), the Department 
allocated 60,438 SCSEP authorized positions. The higher minimum wage 
provided by H.R. 2 would increase the unit cost. The unit cost 
represents how much each authorized position costs, and its calculation 
is set by the Older Americans Act section 506(g). The current unit cost 
is $7,153. The minimum wage increase was signed into law May 25, and 
will become effective 60 days later on July 24, 1 month into PY 2007. 
The new unit cost for PY 2007 will be $7,949. To support 60,438 
positions at the PY 2007 unit cost of $7,949 requires $480,421,662 
($7,949 unit cost times 60,438 authorized positions). To support 60,438 
positions at the $6.55 minimum wage and a unit cost of $8,850 requires 
$534,876,300 ($8,850 unit cost times 60,438 authorized positions). The 
actual unit cost of SCSEP authorized positions will depend on whether a 
minimum wage bill is passed by the Congress, and the effective date of 
the minimum wage increase.
    Question. How does the Department analyze and interpret the data 
that it has collected from all SCSEP grantees since July 2004 as well 
as the SCSEP evaluation completed by DAH Consulting for DOL in 2006? 
Both provide a very positive report on SCSEP's effectiveness. For 
example, SCSEP is given a higher customer satisfaction score than WIA 
by participating seniors and employers, according to a national survey 
published by the Charter Oak Group, a DOL contractor.
    Answer. The Department regularly analyzes Senior Community Service 
Employment Program (SCSEP) data using the following sources: (1) 
grantee data in the SCSEP Performance and Results Quarterly Progress 
Report (SPARQ) system and (2) customer satisfaction surveys returned by 
SCSEP participants, host agencies, and employers. Although the customer 
satisfaction scores from participants, host agencies and employers are 
quite high, an analysis of performance data and financial data raises 
concerns about program effectiveness and indicates that some grantees 
have not provided services at the full level for which they receive 
funds, resulting in a significant amount of funds being recaptured and 
a significant number of authorized training positions or ``slots'' 
being unfilled. Improvements to the SPARQ system will result in 
increasingly accurate data and will allow the Department to provide 
better guidance and technical assistance to grantees in efforts to 
perform more efficiently.
    The Department also has analyzed results from a draft of the SCSEP 
evaluation by DAH Consulting. Although the DAH evaluation was positive 
overall, it also pointed to some areas where the SCSEP needs 
improvement. Specifically, the program could be more effective at 
moving participants into unsubsidized employment. As the report points 
out, this involves improving collaboration between SCSEP and the One-
Stop Career Center system and improving access to training for good 
jobs. Two specific aspects of the newly reauthorized SCSEP--providing 
more training options for participants and placing a time limit on 
participation--should begin to address this challenge, ultimately 
enabling more individuals to secure unsubsidized employment. Finally, 
although the evaluation included some analysis of outcomes, it did not 
look at a critical aspect of the program's effectiveness: its impact on 
the longer-term self-sufficiency of its participants. The Department 
will begin a study of that aspect of SCSEP this summer.

                            JOB CORPS OFFICE

    Question. The fiscal year 2008 budget proposes to transfer the Job 
Corps office back to ETA on the basis of better integration of Job 
Corps within the workforce system and greater efficiencies. Please 
provide a more detailed justification for this proposal.
    Answer. We continue to believe that the unique services of the Job 
Corps program are maximized when leveraged with the other job training 
and employment programs administered by ETA. The transfer back to ETA 
will maximize coordination and strategic planning efforts, and achieve 
efficiencies in overhead and administrative costs.
    ETA already has an accountability structure in place. The Office of 
the Secretary, by contrast, is not structured to directly administer 
over $1 billion in contracts. Doing so would require creating new 
bureaucracy in the Office of the Secretary to coordinate many 
functions, including:
    1. National contracting support from the Office of Administration 
and Management.
    2. Policy guidance from the Office of Policy.
    3. Approval of media campaigns by the Office of Public Affairs.
    4. Technology support from the Office of Administration and 
Management.
    5. Administrative support for human resources, payroll, staff 
training, etc. from Administration and Management.

                       TEACHER SALARY INITIATIVE

    Question. How will funds be allocated for the teacher salary 
initiative identified in the fiscal year 2008 budget? Which occupations 
will be covered and will it apply to all individuals in those 
occupations? How many individuals will receive an increase under the 
proposal and by how much?
    Answer. Funding will be provided to each center operating 
contractor based upon the differential between their existing salary 
structure at that time and the salaries indicated by the comparability 
study for the positions in their area. The occupations covered are the 
Academic and Vocational Instructors (teachers). There are 2,051 
teachers eligible to receive a pay increase under this proposal. 
However, the actual salary increase will be based on their salary 
comparability at that time, as indicated in the study, and by the 
center operator's determination of qualifications (certifications 
received, experience).

                  EFFICIENCIES IN JOB CORPS OPERATIONS

    Question. What are the efficiencies identified in the budget that 
will be achieved in Job Corps operations? How did the Department 
calculate the $57 million in savings that could be achieved without any 
programmatic impact?
    Answer. By identifying the number and location of student training 
slots that have remained consistently unfilled, we are able to reduce 
the slot levels at centers at the beginning of their contract or option 
year and thus reduce the fixed costs associated with providing services 
for more students than are on the center. Currently, we recover cost 
underruns from the contractors at approximately 15 percent of the per 
student cost because they must maintain fixed costs in anticipation 
that those training slots might be filled. It is far more efficient to 
price the contract at what is actually needed based upon consistent 
trends in on board strength. The services to those students who are at 
the center are retained and thus, there is no impact on the program.
    The savings were calculated by determining the per student training 
slot cost multiplied by the number of training slots identified for 
reduction. Some of the savings were offset by increases for pay and 
FECA, rent, inflation for all other categories resulting in an overall 
savings of approximately $57 million.

                      JOB CORPS MARKETING CAMPAIGN

    Question. DOL has announced a ``major national marketing campaign 
to try to attract and to get more young people interested in attending 
the Job Corps program.'' Can you describe this campaign, including the 
amounts budgeted in fiscal year 2007 and fiscal year 2008 for related 
activities?
    Answer. On a national level, Job Corps' National Recruitment and 
Outreach Campaign consists of program recruitment on television, radio, 
and specific print publications. Television spots remain the largest 
component of the campaign and are the most successful referral source 
in driving calls to Job Corps' National Call Center, the first step of 
the admissions process. For Program Year 2006, we funded the campaign 
at $5 million; for Program Years 2007 and 2008, Job Corps intends to 
fund it at $6 million (which is the same level of funding from PY 1999 
thru PY 2005).
    Additionally, in October 2006, we launched Job Corps' Consolidated 
Outreach Plan, which combined the program recruitment efforts of the 
National Office and its six Regional Offices into a single recruitment 
contract, which allows Job Corps to take advantage of economies of 
scale and ensures that a single message and unified brand is 
communicated to our target audience. With this consolidated plan, we 
are rolling out new Job Corps recruitment materials and television 
spots beginning May 1, 2007. All OA contractors, Regional Offices, and 
the Job Corps National Call Center will be provided with these national 
materials.

                         JOB CORPS RECRUITMENT

    Question. Historically, Job Corps' student enrollment levels have 
been cyclical and dependent on various factors including the economy, 
retention and recruitment. In the past, Job Corps has quickly devised 
plans to increase enrollment on Job Corps centers across the country. 
What is your national recruitment plan? What amounts are planned to be 
spent in fiscal year 2007 and fiscal year 2008 to implement the plan? 
When do you expect to see results?
    Answer. Recruitment is a priority at all levels of the program and 
is independent from the decision to reallocate student slots. We do not 
believe that it makes economic sense to funnel additional recruitment 
funds to centers that have historically not been able to maintain full 
capacity. Instead, we would prefer to set more realistic slot levels at 
these centers and move the unfilled slots to other centers where they 
can be filled.
    It is important to note that the number of students enrolled in the 
program is not solely a function of recruitment and admissions. In 
addition to student arrivals, the number of student separations and 
students' average length of stay also factor into the OBS count. Even 
if student arrivals increase, students' length of stay must not 
decrease (just as the student separation rate must not increase) if 
centers are to be filled. A vital component of increasing Job Corps' 
OBS is student commitment, or the willingness and readiness of a 
student to remain in the program through graduation. To improve 
performance in this area, Job Corps has implemented the Speakers, 
Tutors, Achievement, Retention, and Success program (STARS), offering 
structured tutoring and mentoring to provide those students at risk of 
leaving early the encouragement and support necessary to remain longer 
in the program, thereby increasing the number of program graduates. 
Furthermore, we have implemented Career Success Skills (CSS) which 
permeates employability and social skills development into all aspects 
of the program, leading to a more personalized relationship between 
staff and students, improving center culture, and students' willingness 
to remain in Job Corps. Additionally, we are piloting a drug screening 
program in which applicants are tested for drug use prior to admissions 
to further ensure that we are enrolling students who are committed to 
their education and ready for the rigor and demands of the program.
    Job Corps monitors the programs' arrivals, separations, weekly 
termination rates, average length of stays, and reasons for separation, 
at the center, regional and national levels, to ensure that any 
unexpected fluctuations in these areas are identified and reviewed, and 
to evaluate the effect new programs and programmatic changes may have 
on the OBS.
    On a national level, Job Corps' National Recruitment and Outreach 
Campaign consists of program recruitment on television, radio, and 
specific print publications. Television spots remain the largest 
component of the campaign and are the most successful referral source 
in driving calls to Job Corps' National Call Center, the first step of 
the admissions process. For PY 2006, we funded the campaign at $5 
million; for PYs 2007 and 2008, Job Corps intends to fund it at $6 
million (which is the same level of funding from PY 1999 thru PY 2005).
    Thus, Job Corps is addressing challenges with recruitment and 
retention throughout the program in order to implement a more holistic 
solution.

                           WIA ADULT PROGRAM

    Question. ETA is developing and disseminating policy guidance and 
practical technical assistance to assist the WF system to increase 
education opportunities for adults and eliminate duplicative 
administrative and service delivery structures. What specifically has 
been provided in fiscal year 2006 and fiscal year 2007?
    Answer. The Department of Labor's Employment and Training 
Administration (ETA) has issued a number of policy guidance documents 
designed to support the State and local workforce investment system in 
increasing adults' access to education opportunities and to ensure that 
the majority of workforce investment system resources are invested 
strategically in training and education, rather than in administrative 
expenditures and duplicative infrastructure. Examples of such policy 
guidance include the following:
  --In March 2006, ETA issued policy guidance entitled, ``Using 
        Workforce Investment Act Funds to Serve Incumbent Workers and 
        Employed Workers'' (Training and Employment Guidance Letter 
        (TEGL) No. 18-05). This guidance encourages the workforce 
        investment system to take advantage of existing flexibilities 
        under the Workforce Investment Act (WIA) to provide education 
        and training to employed workers in order to support their 
        career advancement and mobility.
  --In November 2006, ETA issued Training and Employment Notice (TEN) 
        No. 17-06, ``Vision for 21st Century Apprenticeship.'' The TEN 
        encourages the workforce investment system to adopt innovative 
        apprenticeship models as a critical post-secondary education 
        and training approach for adults.
  --In January 2007, ETA issued policy guidance on the development and 
        submission of States' strategic State Plans (TEGL No. 13-06, 
        ``Instructions for Workforce Investment Act and Wagner-Peyser 
        Act State Planning and Waiver Requests for Years Three and Four 
        of the Strategic Five-Year State Plan (Program Years 2007 and 
        2008)''). The TEGL explicitly requires that States discuss in 
        detail their strategies for reducing duplicative administrative 
        expenditures and structures, in support of increasing adults' 
        access to education and training.
    In addition to these policy issuances, ETA is currently developing 
guidance documents that, when published, will support the workforce 
system in increasing access to education for adults, while eliminating 
duplicative spending and service delivery structures. ETA expects to 
publish all of these draft policy guidance documents this year. 
Examples of policy currently in development include:
  --Policy guidance on enhancing the integration of reemployment 
        services for unemployed workers identified as most likely to 
        exhaust their unemployment insurance benefits, within the 
        broader continuum of education and training services provided 
        through the public workforce investment system.
  --Policy guidance that builds off of TEN No. 17-06 and provides the 
        workforce investment system and the Registered Apprenticeship 
        system with additional guidance on strategies for using the 
        apprenticeship model as an innovative competency-building and 
        education approach for adults, which could result in greater 
        access for women in this program, as recommended by the PART 
        assessment.
  --Policy guidance that encourages the workforce investment system to 
        implement innovative approaches to providing adults with access 
        to entrepreneurship training and education.
  --A TEN that communicates to the workforce investment system ETA's 
        vision for the critical role of talent development and 
        education as the key drivers of competitiveness and growth in 
        regional economies.
  --Policy guidance that provides the workforce investment system with 
        guidance on accessing supportive service resources and support 
        for adults through programs other than those funded under WIA, 
        to ensure that the maximum amount of WIA resources are devoted 
        to education and training, rather than to duplicative 
        supportive service expenditures.
  --Policy guidance encouraging the use of technology-based learning to 
        increase access to learning opportunities for workforce 
        investment system customers within existing statutory and 
        regulatory flexibilities.
    In addition to policy guidance currently in development, ETA is 
pursuing a number of cross-cutting initiatives and approaches aimed at 
enhancing adults' access to education and lifelong learning 
opportunities and improving the provision of training for adults under 
WIA. Examples of these efforts follow.
  --The Workforce Innovation in Regional Economic Development (WIRED) 
        initiative is focused on developing and replicating innovative 
        talent development strategies that create high skill, high wage 
        jobs for workers. Increasing education and training 
        opportunities is a strong component of the WIRED initiative. In 
        each region, the workforce investment system is collaborating 
        with the continuum of education, industry, and economic 
        development partners to ensure that workers are becoming 
        educated and trained for high growth occupations and sectors. 
        Promising practices from the WIRED Initiative will be 
        highlighted at Workforce Innovations 2007 and shared widely on 
        Workforce\3\One, a knowledge network for the workforce system, 
        industry, and economic development stakeholders.
  --Both ETA's High Growth Job Training Initiative and Community-Based 
        Job Training Grants seek to develop, implement, and support the 
        dissemination and replication of innovative models for 
        providing adults with education and training in high growth, 
        high demand, and emerging industries and sectors.
  --Through the Technology-Based Learning (TBL) Initiative, ETA seeks 
        to increase the number of people trained in high growth jobs 
        through the broadening of opportunities for skill and 
        competency development made available timely and conveniently 
        through the use of technology-based learning methodologies.
  --Our Performance Enhancement Project (PEP), a dynamic technical 
        assistance contractual resource that assists ETA in improving 
        the performance of WIA program operators, has provided a varied 
        array of customized technical assistance to under-performing 
        State and local areas over the past 4 years. One topic PEP 
        addresses for the benefit of the workforce investment system as 
        a whole is service integration. Through PEP, ETA is providing 
        States and local areas with promising practice examples and 
        simple training tools to help them better integrate programs.
  --Workforce\3\One is an interactive learning tool designed to build 
        the capacity of the workforce investment system to develop 
        strategies that enable individuals to be successful in the 21st 
        century economy by fully understanding the skills and 
        competencies needed of business and industry and working 
        collaboratively with a wide range of strategic partners to 
        develop innovative workforce solutions. Workforce3One carries 
        out this mission through a variety of strategies:
    --Allowing the workforce system, educators, business and industry, 
            and others to share their innovative approaches, products, 
            and tools;
    --Hosting online learning events as Webinars that highlight 
            promising practices and provide a forum for policy 
            discussions;
    --Providing a vehicle for ETA to share information and products 
            developed at the national level;
    --Serving as a key point of dissemination for the approaches, 
            products, and tools of the High Growth Job Training 
            Initiative, Community-Based Job Training Grants, and WIRED; 
            and
    --Offering a searchable database of over 3,500 learning objects, 
            including tools, data, Webinars, and self-paced learning 
            events.
    Question. What guidance and tools have been disseminated to assist 
in working with veterans?
    Answer. It is the Employment and Training Administration's (ETA) 
specific mission to ensure that the public workforce investment system 
is positioned to provide priority of service to veterans and to help 
veterans maximize their employment opportunities in civilian life by 
providing them access to education and training opportunities they need 
to obtain good jobs with career pathways. This requires understanding 
the full array of services and resources that are available to veterans 
and collaborating across organizations and programs to ensure 
leveraging of those resources for the benefit of veterans.
    In response to the unique career and job placement assistance needs 
of transitioning military personnel and veterans, ETA has collaborated 
with the Department of Defense (DOD) and the Department of Labor's 
Veterans Employment and Training Service (VETS) on multiple efforts to 
create integrated and substantive employment, training, and support 
services. These efforts include providing guidance to the workforce 
investment system, including State workforce agencies, grantees, and 
One-Stop system leads, on priority of service for veterans; promoting 
awareness among veterans of One-Stop Career Center assistance; and 
exploring ways to ease the transition into civilian employment.
    ETA has focused efforts on ensuring that veterans are provided with 
priority of service at One-Stop Career Centers. Training and Employment 
Guidance Letter (TEGL) No. 5-03, ``Implementing the Veterans Priority 
Provisions of the Jobs for Veterans Act (Public Law 107-288)'' was 
issued on September 16, 2003. This guidance was followed with the 
development of the Jobs for Veterans Act Web site, www.doleta.gov/
programs/vets, and the posting of a series of questions and answers on 
this site for 15 programs administered by ETA.
    With a policy of priority of service to veterans and an extensive 
array of programs and services in place, the Department has turned its 
focus to increasing veterans' awareness of, access to, and use of these 
employment and training services. The Key to Career Success campaign is 
designed to connect veterans and separating military personnel to 
services and resources available from One-Stop Career Centers 
nationwide. Announced by Secretary Elaine L. Chao on November 10, 2005, 
the centerpiece of the Key to Career Success campaign is a special 
wallet card issued worldwide to military personnel and others 
transitioning to civilian life. Information on the card guides veterans 
to their nearest One-Stop Career Center. To date, over 300,000 Key to 
Career Success cards and brochures have been distributed to over 300 
DOD and DOL-VETS locations in the United States and abroad, mainly 
through Transition Assistance Program (TAP) workshops worldwide. The 
TAP is a partnership among the Departments of Defense, Veterans 
Affairs, Transportation and the Department of Labor's Veterans' 
Employment and Training Service (VETS) to give employment and training 
information to armed forces members within 180 days of separation or 
retirement through comprehensive 3-day workshops at selected military 
installations nationwide.
    In November 2006, a Key to Career Success Military Transition 
Portal was launched at www.careeronestop.org/militarytransition. The 
portal provides career information and links to services that help 
veterans and military service members successfully transition to 
civilian careers and functions as a landing page for accessing the 
resources that are currently available on the suite of CareerOneStop 
Web sites. The Key to Career Success portal will continue to be 
upgraded and will provide key components to the DOD TurboTAP Web site 
under development by the DOD in cooperation with DOL-VETS and ETA. The 
TurboTAP Web site provides information for service members on 
transitioning from military service and is a supplement to the services 
offered by the Transition Assistance Offices and other groups. The site 
is supported by DOL-VETS and ETA.
    ETA will work with One-Stop Career Center staff to further 
implement the Key to Career Success campaign by documenting best 
practices and success stories at local One-Stop Career Centers. During 
the next few months, a 60-minute Web conference will be available 
through ETA's Workforce3One Website targeted at service providers with 
the goal of sharing best practices. Also, at Workforce Innovations, 
ETA's annual workforce conference, a workshop will focus on developing 
and connecting a local HireVetsFirst campaign to the Key to Career 
Success campaign.
    In addition to connecting veterans with One-Stop Career Centers 
through the Key to Career Success campaign, ETA is examining ways to 
ease the transition into civilian employment for returning veterans. 
DOD and ETA have established a ``Credentialing Working Group'' to help 
remove credentialing barriers that some veterans and transitioning 
service members face. Translation of qualifications from the context of 
the military mission to the civilian setting still presents challenges 
for individual transitioning military members. In many cases, this is 
due to the range of civilian occupational licensing and certification 
requirements, which vary from State to State. The group will target 
high-value occupations that are both significant to the military and 
are sought by civilian employers. In those areas, the group will 
sponsor work to: (1) map career pathways between military occupations 
and civilian occupational employment, (2) promote uniformity/
reciprocity across States with regard to occupational licensing, and 
(3) promote efforts to maximize the transferability of military 
education and training for purposes of credit toward licensure and 
certification requirements. To support this effort, ETA has established 
the Workforce Credentials Information Center, on the Careeronestop.org 
Web site. The Center provides information on licenses, certifications, 
apprenticeship programs, educational degrees, and training, and 
includes information on matching military experience with civilian 
opportunities.

                      ADULT TRAINING OPPORTUNITIES

    Question. The budget proposal would result in more than 50,000 
fewer training opportunities under the Adult program. What's the impact 
of this proposal?
    Answer. The budget proposal would not result in more than 50,000 
fewer training opportunities under the Adult program. Under the 
President's Career Advancement Account proposal for Workforce 
Investment Act (WIA) reauthorization that is part of the fiscal year 
2008 budget, the WIA Adult, Dislocated Worker, and Youth programs and 
the Employment Service would be integrated into a single funding stream 
and, thus, a separate Adult program would no longer exist. The 
integrated funds would be used for Career Advancement Accounts and 
employment services for job seekers and employers. This proposal would 
result in significantly more individuals being trained in comparison 
with the number who now receive training under the current system. The 
Department estimates that over 600,000 individuals would receive Career 
Advancement Accounts at our fiscal year 2008 budget request level 
versus the roughly 189,000 adults who exit training under the current 
system. Under the Department's proposal, these individuals would 
include adults and out-of-school youth entering or re-entering the 
workforce or transitioning between jobs, and incumbent workers in need 
of new skills to remain employed or move up the career ladder.

            MONEY SPENT ON BUREAUCRACIES AND OVERHEAD COSTS

    Question. The budget claims that too much money is spent on 
competing bureaucracies, overhead costs, and unnecessary 
infrastructure. Please cite specifically the evidence for this 
conclusion.
    Answer. The Department's belief that too much workforce investment 
funding is used for administration and overhead costs comes from a 
number of sources. First, while the Employment Service is intended to 
be a cornerstone of the One-Stop Career Center system under the 
Workforce Investment Act (WIA), many States continue to have separate 
Employment Service offices offering the same core services that are 
available in the same communities at One-Stop Career Centers under WIA. 
The lack of integration in the delivery of core services by different 
programs has continued duplicative bureaucracies that divert funds that 
could be spent on services, including education and training.
    Second, the current WIA regulation, at 20 CFR 667.220(b) enumerates 
the specific functions defined as administrative costs. As required by 
WIA, this definition of administrative costs was developed in 
consultation with Governors and other stakeholder groups in 1999, and 
was more narrow than the definition in use before 1999. However, 
instead of reducing the level of administrative activity when the caps 
were lowered, some States and local areas charge some activities 
considered administrative costs under earlier programs as program 
costs. Activities such as performing oversight and monitoring of the 
program, the costs of facilities used for programmatic activities, the 
provision of technical assistance, the activities of State and local 
boards, professional organization membership dues, and the evaluation 
of program results, which have traditionally been classified as 
administrative costs, are currently classified as programmatic costs. 
As a result, there is no effective administrative cost ceiling.
    Finally, based on expenditure data submitted by the States, the 
Department estimates that the proportion of WIA and Employment Service 
funding that has been spent on infrastructure is about one-quarter for 
the last 4 program years. For this estimate, the Department looks at 
the costs of infrastructure, including both physical and organizational 
costs, at the State and local levels that support the delivery of 
services to participants by the One-Stop system, such as local 
administration and other infrastructure costs. While the Department 
does not question whether some of these costs are necessary or 
appropriate, taken in total, too large a proportion of WIA funds is 
spent on infrastructure and overhead rather than direct services.

                    REFOCUSING THE WORKFORCE SYSTEM

    Question. According to the budget justification, ETA is increasing 
its focus on postsecondary and training resources to help the workforce 
system be more responsive to changing labor market needs and regional 
economies. Please provide examples of what is being done and how the 
fiscal year 2008 budget supports this focus.
    Answer. There are two ways the Department is helping the workforce 
investment system be more responsive to regional economic needs: (1) by 
implementing initiatives designed to promote regional competitiveness 
and greater access to education and training, and (2) by working with 
the Congress to substantially reform the workforce investment system.
    Through the President's High Growth Job Training Initiative, ETA 
has invested over $285 million in 150 partnerships among employers, 
education programs, and the workforce investment system. Each project 
targets the skill and talent needs of high-growth, high-demand and 
transformational industries in our Nation's economy and provides the 
resources necessary to train workers in the skills demanded by the 21st 
century economy.
    Community-Based Job Training Grants, also known as the Community 
College Initiative, seek to address a critical shortcoming in the 
workforce development capacity of many regions by supporting community 
colleges to train workers for jobs in high-growth, high-demand 
industries. Due to their close connection to local labor markets, 
community colleges are well positioned to understand the intricacies of 
local economies and better prepare workers for occupations in these 
industries. The Department has provided $250 million to 142 community 
colleges and other entities under this initiative.
    The Department launched the Workforce Innovation in Regional 
Economic Development (WIRED) Initiative in February 2006 to emphasize 
the critical linkage between workforce development and economic 
development in regional economies. WIRED focuses on the role of talent 
development in driving regional economic competitiveness, job growth 
and prosperity for workers. Under the WIRED Initiative, the Department 
has invested $260 million and provided expert assistance to 26 regions 
across the Nation to implement strategies that will create high-skill 
and high-wage opportunities for American workers.
    The administration has also recently submitted to Congress 
legislation that will improve the ability of the workforce investment 
system to support our Nation's competitiveness by providing States and 
local communities more flexibility to design streamlined workforce 
systems that best fit the unique needs of their economies. Our proposal 
would also better serve the needs of American workers and employers by 
making more money directly available for education and training. Under 
the proposal, four separate funding streams would be consolidated and 
allocated to States--and through States to local areas--to provide 
Career Advancement Accounts and employment services to job seekers and 
employers. Most of these funds would be spent on education and 
training.
    Career Advancement Accounts would enable current and future workers 
to gain the skills needed to successfully enter, navigate, and advance 
in the 21st century labor market. Accounts would be available to both 
adults and out-of-school youth entering or re-entering the workforce or 
transitioning between jobs, and to incumbent workers in need of new 
skills to remain employed or move up the career ladder.

                       DISLOCATED WORKER PROGRAM

    Question. Under DWAC pilot programs--for career advancement 
accounts and other automotive industry layoffs--will help inform 
broader efforts for dislocated workers for fiscal year 2007 and beyond. 
What are these activities and specifically what is being learned that 
will shape future activities? What is proposed in the fiscal year 2008 
budget under pilot programs and based on lessons learned?
    Answer. Five States impacted by the announced General Motors and 
Ford plant closures (Georgia, Michigan, Minnesota, Missouri, and Ohio) 
have volunteered to pilot Career Advancement Accounts (CAAs) to serve 
the dislocated workers impacted by the closures as well as those 
workers who are displaced as a result of impacts on supplier companies 
and the community. This demonstration will focus on the use of CAAs for 
transitioning workers in need of tuition assistance for education, 
enabling them to either build on transferable skills or gain skills for 
new careers. Each State has received $1.5 million from the Department 
and is expected to leverage a like amount in Federal, State, and local 
resources.
    The CAA automotive demonstration is being evaluated to establish 
empirical knowledge and understanding of the provision of customer-
driven training vouchers to dislocated workers impacted by the Ford and 
GM plant closures, as well as impacted employees of supplier companies 
and in communities. The evaluation involves four steps--technical 
assistance, data collection, an implementation study, and a net-impact 
evaluation, which together will lead to evaluation results that will 
inform future proposals and activities.
  --Technical Assistance.--Technical assistance is currently being 
        provided to the five automotive States. The overall objective 
        of the technical assistance strategy is to support the CAA 
        demonstration States with information and training that will 
        help them to successfully implement their CAA projects.
  --Data Collection.--To evaluate the overall effectiveness of the CAA 
        demonstration, a standardized participant reporting system to 
        collect data on services received through the CAA demonstration 
        will be established and maintained.
  --Implementation Study.--An implementation study of the CAA 
        demonstration will examine the extent to which both individual 
        project objectives and the overall grant program objectives 
        were achieved; document project activities undertaken for 
        possible replication in other States; and measure changes in 
        outcomes relative to a baseline period prior to the funding of 
        the grantees projects. Work on the implementation evaluation 
        will begin in June 2007.
  --Net-Impact Evaluation.--A net-impact evaluation will provide 
        statistically valid and reliable estimates of the effects of 
        CAAs on key outcomes. A non-experimental net-impact evaluation 
        of the five automotive States using either comparison group or 
        comparison site methodologies will be conducted. The purpose of 
        the net-impact evaluation is to determine the effects of the 
        CAA training model on the employment and earnings of the 
        dislocated workers participating in the demonstration. The CAA 
        evaluation will also include two types of cost analyses--an 
        administrative cost analysis and a benefit-cost analysis. The 
        administrative cost study examines the extent to which the 
        workforce investment system realized savings in bureaucratic 
        and administrative costs from conducting the CAA model. The 
        benefit-cost analysis looks at the overall CAA model to 
        determine the cost effectiveness of the initiative to the 
        government, the taxpayers, and society.

                 YOUTH ACTIVITIES: YOUTH PILOT PROJECT

    Question. Youth Pilot Project--Have any States submitted the 
required reports to DOL? What is known about the changes and 
performance that have been achieved under the Pilot Projects? If DOL 
has yet to receive information, what is the timeline for the receipt of 
such reports? Please provide information about the amount of funds 
currently being spent on technical assistance to States related to 
furthering collaborative approaches for youth activities.
    Answer. In February 2007, the Department of Labor issued the 
``Shared Youth Vision Pilot Project'' application to the 16 State Teams 
that attended the 2006 Shared Youth Vision Forums. The State Teams 
submitted their completed applications to the Department on or before 
April 6, 2007. Funds will be awarded to the State Teams in two phases 
between now and June 30, 2007, based on the States' readiness as 
demonstrated by their proposals. The Shared Youth Vision Federal 
Partnership is currently reviewing these proposals to determine how 
well the State Teams responded to the criteria in the pilot application 
that States demonstrate how their collaborative strategy will support 
integrated systems development and collaboration at the local service 
delivery level.
    Because the pilot projects will not begin implementation until July 
1, 2007, it is too early to assess changes and performance that have 
been achieved under the projects. States will operate the pilot 
projects over the course of Program Year 2007 (July 1, 2007-June 30, 
2008), reporting quarterly on their progress. Also, the Department is 
funding a Shared Youth Vision Pilot Project Study to document the 
success of the shared youth vision collaborative efforts at the 
Federal, State, and local levels. This study will be completed by the 
fall of 2008. As part of this study, the Department will conduct the 
following analysis of the Shared Youth Vision Federal Partnership and 
the State Teams:
  --Documenting the work of the Federal Partnership from 2004 to 2007 
        in support of system transformation, as recommended by the 
        White House Task Force for Disadvantaged Youth.
  --Documenting the work of the State Teams in a usable and 
        transferable fashion in the following areas: (1) coordination 
        and integration of services for the targeted populations; (2) 
        multiple partner agencies working together at the service 
        delivery level to serve targeted youth population(s) that 
        reflects the State's overall shared youth vision; (3) policies 
        and practices identified and implemented based on gap analysis; 
        (4) challenges associated with higher-level strategic planning 
        and implementation among the State Teams; (5) interagency State 
        Teams definition, collection and validation of measurable 
        outcomes for neediest youth; (6) methods for engaging business 
        and industry; and (7) implementation of replication and 
        sustainability strategies.
  --Developing a ``Blueprint'' model that can be used by States and 
        local levels to assist them in their collaborative efforts 
        around a shared youth vision.
    The total amount of funding to be provided to the State Teams 
through the Shared Youth Vision Pilot Projects is $1,720,000. In 
addition, the Department is funding $100,000 of technical assistance 
for the pilot projects.

                YOUTH ACTIVITIES: ALTERNATIVE EDUCATION

    Question. In working with the Department of Education on 
identifying and bringing to scale systemic alternative education 
approaches for creating multiple pathways to graduations, how did DOL 
and the Department of Education factor in evidence of effectiveness? 
What was the standard adopted and what role did the Education's 
Institute of Education Sciences play in this collaboration? How will 
this focus on the alternative education be continued under the current 
law budget request?
    Answer. The Departments of Labor and Education promote alternative 
education through unique yet complementary initiatives, and collaborate 
in sharing evidence of effective practices and productive strategies. 
Through its implementation of the No Child Left Behind Act, the 
Department of Education is focusing its efforts on reducing the number 
of drop-outs and holding school districts accountable for low 
graduation rates. In the Department of Labor, the Employment and 
Training Administration's (ETA's) Youth Vision, developed over 2 years 
ago, augments this work by addressing the large number of youth leaving 
high school without a diploma and unprepared for the demands of the 
21st century workplace. Through the Youth Vision, ETA uses the 
Workforce Investment Act (WIA) Youth program as a catalyst for 
increasing both the quality and quantity of alternative learning 
environments and re-connecting out-of-school youth with secondary and 
post-secondary educational opportunities and high growth employment.
    ETA studied different alternative education interventions for 
evidence of effectiveness. In a report funded by ETA on alternative 
education programs that re-engage out-of-school youth with learning, 
the Urban Institute found that there are few scientifically-based 
rigorous evaluations on the effectiveness of alternative education 
approaches. However, the study points to programs that have a clear 
focus on academic learning and address the education and career 
interests of students as promising interventions.
    In an effort to build upon that research, ETA gathers evidence of 
effective practices not only from its own research and demonstrations, 
but also from the Department of Education's efforts, such as the Office 
of Vocational and Adult Education's (OVAE's) Disconnected Youth project 
and related research. Further, in an effort to comprehensively factor 
evidence of effectiveness into program planning and to learn more about 
the factors that contribute to strong, vibrant academic alternative 
learning environments, ETA has held three Alternative Education 
Listening Sessions. These sessions were attended by experts from around 
the country well-versed in alternative education including Department 
of Education representatives who shared expertise from all of 
Department of Education's sub-agencies, practitioners, policy makers, 
and individuals from various educational think tanks and affinity 
groups.
    The Listening Sessions provided invaluable input from a range of 
experts on the effectiveness of different alternative education models. 
The consensus of experts revealed an urgent need to take existing 
models that have been proven successful to scale, as well as a need to 
support the development of new models that address the rapidly changing 
skill sets needed for the workplace and post-secondary education. 
Listening Session experts concluded that in order to be effective, new 
models should:
  --Align with the No Child Left Behind legislation;
  --Focus on helping participants meet State standards in the core 
        subjects;
  --Include alternative learning strategies such as applied and/or 
        contextual learning;
  --Acknowledge the need for interdisciplinary learning;
  --Support portable credentialing;
  --Provide extensive career exploration, guidance, and planning; and
  --Provide multiple pathways for both learning and career growth.
    ETA integrated these elements in several grant competitions 
recently launched which provide support for alternative education, 
including:
  --A $47 million YouthBuild competition that will fund approximately 
        95 programs that provide an integrated academic and 
        occupational skill training model for at-risk youth;
  --A $3 million competition which will support towns with populations 
        between 75,000 and 300,000 to develop blueprints for multiple 
        education system pathways; and
  --A $6 million competition to improve alternative educational 
        pathways for youth recently released from juvenile corrections 
        or on probation.
    The Department's fiscal year 2008 current law budget request 
continues to support ETA's focus on alternative education through the 
YouthBuild program, pilot and demonstration funding, the proposed 
Reintegration of Ex-Offenders program which will serve both adults and 
youth, and the WIA Youth program which will continue its focus on out-
of-school youth by addressing alternative education. The Department 
will also address alternative education in fiscal year 2008 through the 
Workforce Innovation in Regional Economic Development (WIRED) 
initiative, through which several regions are using WIRED grant funds 
to examine their existing education infrastructure. In all of these 
efforts, the Department will continue to collaborate not only with the 
Department of Education but also with other private foundations and 
organizations that are addressing the Nation's drop-out crisis.

                     DISABILITY PROGRAM NAVIGATORS

    Question. The Disability Program Navigators have been a major 
benefit to improved services and service delivery coordination with the 
One-Stops for job seekers with disabilities. Why are you recommending 
no funding for this activity? Does DOL have a plan for serving 
individuals with disabilities and others with multiple barriers to 
employment through the Workforce Development System in the future? What 
is the plan?
    Answer. The Disability Program Navigator (DPN) program has been 
successful. However, from the outset, it has been the Department's 
intent for States to ultimately assume responsibility for this 
activity. The Department has been actively working with grantees on 
developing sustainability plans. These plans provided strategies by 
which the States could continue to provide these services through 
integration within the One-Stop Career Centers. The Department is also 
working with the Social Security Administration on the pending 
regulatory revisions to the Ticket to Work program which will make it 
much easier for One-Stop Career Centers to become Employment Networks, 
providing an additional funding source to sustain these activities.
    The DPN grants have provided effective strategies to improve the 
accessibility of One-Stop Career Center services for job seekers with 
disabilities. Effective State practices are being shared broadly 
through a variety of mediums--such as the Employment and Training 
Administration's interactive knowledge Web site, Workforce\3\One, 
grantee meetings, and conferences--in order to expand the capacity of 
the One-Stop system to serve people with disabilities and increase 
service levels to this population.

                      PRISONER REENTRY INITIATIVE

    Question. Please provide a copy of the evaluation of this 
initiative, which is expected by the end of program year 2007. Also, 
please provide information on the number of grants awarded under the 
beneficiary choice model. What is the evidence base for funding this 
model of service delivery?
    Answer. The Prisoner Reentry Initiative (PRI) evaluation will be 
completed in November 2008, with a final report submitted at that time. 
An interim report presenting early observations and findings is in 
development, a copy of which will be provided following DOL/ETA review, 
which is anticipated to be completed by November 2007.
    With regard to the Beneficiary Choice Initiative (BCI), a 
substantial body of research on ex-offenders has documented high levels 
of unemployment, substance abuse and mental illness following release 
from incarceration, in conjunction with low levels of educational 
attainment, engagement with family members, and healthy ties to the 
community. These factors contribute to renewed criminal behavior, 
reduced public safety, and a host of poor outcomes for future 
generations, all of which contributed to development of the BCI.
    Faith-based and community institutions are among the most trusted 
institutions in the urban neighborhoods to which the majority of 
released inmates will return. They have a rich tradition of outreach 
and service to those most in need of assistance and a proven ability to 
work collaboratively with other service providers and justice agencies 
for the delivery of social services. In addition, research has shown 
that ex-offenders with strong family and community ties have greater 
success in reintegrating into the community and avoiding future 
incarceration.
    Consistent with the administration's emphasis on individual choice 
and personal responsibility, the PRI provides flexibility and freedom 
to both participants and providers in developing a strategy that best 
fits the unique needs of each individual for developing his or her own 
talents. Assisting ex-offenders to develop their own service strategy 
will increase their personal investment in their training decisions 
with a resultant increase in engagement and, it is hoped, completion of 
program services.

 PRISONER REENTRY INITIATIVE AND RESPONSIBLE REINTEGRATION OF YOUTHFUL 
                               OFFENDERS

    Question. According to the fiscal year 2008 budget justification, 
this proposed initiative is based on the lessons learned from the 
Responsible Reintegration of Youthful Offender Community College 
Initiative: To date, what outcome data provided by grantees has been 
used to assess whether this program is meeting stated objectives? What 
changes, if any?
    Answer. The proposed Reintegration of Ex-Offenders initiative would 
capitalize on lessons learned from both the Prisoner Reentry Initiative 
(PRI) and the Responsible Reintegration of Youthful Offenders (RRYO). 
Outcome data on both efforts are provided below.
    The PRI performance measures include enrollment, entered 
employment, employment retention, employment earnings, and recidivism. 
During the first year of the project, the Department of Labor collected 
baseline information on which to base the goals for these performance 
measures.
    As of the first year of data, with four full reporting quarters, 
the enrollment rate exceeded the first year goal of 6,250 participants 
across all 30 sites. The entered employment rate was 47 percent; 
however, this measure is based on program ``exiters'' of which there 
are few in the program's first year. The initiative achieved 3,420 
initial job placements, indicating success placing participants into 
employment. The recidivism rate was at 11 percent. It is too early to 
report data on earnings and retention given that these are also ``exit-
based'' outcomes.
    For RRYO, outcome data provides information on: enrollment, 
placement (including job, military, post-secondary education, or long-
term occupational training placements), diploma/GED attainment, 
participation, career pathways, high growth employer engagement, 
retention, community service, and service-centered mentoring.
    The Ready4Work demonstration, which was funded through the RRYO 
appropriation and which piloted the PRI program, enrolled 4,482 former 
prisoners over a 3-year period, placed 2,543 of these persons into 
employment, and showed a recidivism rate of 6.9 percent over 1 year and 
a participant cost of $4,500.
    Other grants provided under the RRYO appropriation are serving 
large numbers of youth each year in high-crime communities. Over 9,000 
youth and young adults are served by these grants each year, with 
participants experiencing a recidivism rate of roughly 10 percent.

                      EBSA FTE AND FUNDING LEVELS

    Question. For the past 5 years (including fiscal year 2007, based 
on the enacted appropriation), please provide a table identifying FTEs 
and dollars allocated by budget activity.
    Answer. The following table depicts enacted funding and FTE levels 
by budget activity from fiscal year 2003 through fiscal year 2007.

                                    EMPLOYEE BENEFITS SECURITY ADMINISTRATION
                                             [Dollars in thousands]
----------------------------------------------------------------------------------------------------------------
                                                                    Fiscal year
                                 -------------------------------------------------------------------------------
         Budget activity               2003            2004            2005            2006            2007
                                 -------------------------------------------------------------------------------
                                   Funding   FTE   Funding   FTE   Funding   FTE   Funding   FTE   Funding   FTE
----------------------------------------------------------------------------------------------------------------
Enforcement & Participant           $91,526  696   $102,730  800   $109,374  764   $111,239  753   $118,718  738
 Assistance.....................
Policy & Compliance Assistance..     20,441  143     16,907  108     17,357  101    $17,283   96    $17,585   92
Executive Leadership & Program        4,316   22      4,403   22      4,482   22      5,029   26      5,270   25
 Oversight......................
                                 -------------------------------------------------------------------------------
      Totals....................    116,283  861    124,040  930    131,213  887    133,551  875    141,573  855
----------------------------------------------------------------------------------------------------------------
Note.--The fiscal year 2004 FTE level for the Policy and Compliance Assistance budget activity reflects a
  comparative transfer of 40 FTE for the EBSA participant assistance function into the Enforcement and
  Participant Assistance budget activity.

                     pension protection act of 2006
    Question. Please provide a timeline for the issuance of regulations 
required by the Pension Protection Act of 2006.
    Answer.

            PENSION PROTECTION ACT OF 2006 (PPA) REGULATIONS
------------------------------------------------------------------------
             PROJECT                  PAST ACTION         NEXT ACTION
------------------------------------------------------------------------
PPA Annual Report Form Changes    Supplemental        Final Forms and
 (including simple report for      Proposal 71 FR      Related Rule
 under 25 participant plans,       71562 (Dec. 11,     changes--Summer
 pension funding info & e-file     2006) related to    2007
 for actuarial schedule).          larger proposed
                                   Forms Revisions
                                   71 FR 41359;
                                   41392; 41616
                                   (July 21, 2006).
Default Investments--Safe Harbor  Proposed Rule 71    Final Rule--Summer
                                   FR 56806 (Sept.     2007
                                   27,  2006).
Cross Trading Exemption.........  Interim Final Rule  Final Rule--Fall
                                   72 FR 6473 (Feb.    2007
                                   12, 2007).
Revocation of Election Re:        Model Notice 71 FR  Completed
 Multiemployer Plan Status.        69594 (Dec. 1,
                                   2006).
Investment Advice--plans........  Issued              Proposed Rule--
                                   interpretive        Fall 2007
                                   guidance--Field
                                   Assistance
                                   Bulletin 2007-01
                                   (February 2,
                                   2007) RFI 71 FR
                                   70429 (Dec. 4,
                                   2006).
Investment Advice--IRAs           RFI 71 FR 70427     Report to Congress
 Feasibility Determination.        (Dec. 4, 2006).     by December 31,
                                                       2007
Plan Assets Regulation..........  ..................  Proposed Rule--
                                                       Fall 2007
Rollovers for Non-spouse          Interim Final Rule  Final Rule--Fall
 Beneficiaries--Amendment to       72 FR 7516 (Feb.    2007
 Abandoned Plan Regulation.        15, 2007).
DB Plan Annual Funding Notice...  ..................  Interim Final Rule
                                                       and Model--Fall
                                                       2007
Periodic Benefit Statements.....  Issued              Proposed Rule and
                                   interpretive        Model--Fall 2007
                                   guidance to
                                   facilitate
                                   administration in
                                   the absence of
                                   regulations--Fiel
                                   d Assistance
                                   Bulletin 2006-03
                                   (December 20,
                                   2006).
Access to Multiemployer Pension   ..................  Interim Final
 Plan Information.                                     Rule--Summer 2007
Civil Penalty 502(c)(7)--Failure  ..................  Final Rule--Summer
 to Provide Notice of Freedom to                       2007
 Divest ERISA 101(m) (Treasury
 Model 180 days).
QDRO Timing.....................  Interim Final 72    Final Rule--Early
                                   FR 10070 (March     2008
                                   7, 2007).
Notification of Endangered or     Requires            Model--Early 2008
 Critical  Status.                 coordination with
                                   Treasury.
Civil Penalty 502(c)(4):
    (1) Failure to Respond to
     101(k) Request.
    (2) Failure to Provide
     514(e) Notice of Auto
     Contributions.
    (3) Failure to Provide
     101(l) Notice of Withdrawal
     Liability.
    (4) Failure to Provide        ..................  Proposed Rule--
     101(j) Notice of Funding-                         Early 2008
     Based Limitation.
Summary Report of Multiemployer   ..................  Interim Final Rule
 Plan Information to Employers                         and Model--Early
 and Unions.                                           2008
Notice of Funding-Based           Requires            Proposed Rule--
 Limitation.                       coordination with   2008
                                   Treasury.
Notice of Potential Withdrawal    Requires            Proposed Rule--
 Liability.                        coordination with   2008
                                   Treasury and PBGC.
Notice of Reduction to            ..................  Proposed Rule and
 Adjustable Benefits.                                  Model -2008
Civil Penalty 502(c)(8)--Failure  ..................  Proposed Rule--
 to Adopt Funding Improvement                          2008
 Plan.
Civil Penalty 502(c)(2)--Failure  ..................  Proposed Rule--
 to Provide Notice of Election                         2008
 of Multiemployer Status.
Civil Penalty 502(c)(2)--Failure  ..................  Proposed Rule--
 of Multiemployer Plan to Secure                       2008
 Timely Actuarial Certification.
------------------------------------------------------------------------

    Question. What level of resources and FTEs will be devoted to this 
activity in fiscal year 2007 and under the budget request for fiscal 
year 2008?
    Answer. EBSA's Policy and Compliance Assistance budget activity has 
primary responsibility for the development and issuance of the 
regulations required by the Pension Protection Act of 2006 (PPA). 
Within this activity, approximately 19 FTE and $3.6 million will be 
devoted to PPA regulatory activity during fiscal year 2007. In fiscal 
year 2008, EBSA estimates approximately 19 FTE and $3.8 million will be 
needed for PPA implementation. In addition, the Plan Benefits Security 
Division of the Office of the Solicitor estimates that it will devote 
approximately 2.5 FTE and $412,500 in both fiscal year 2007 and fiscal 
year 2008. These estimates exclude the resources expended by other 
organizations outside EBSA such as Departmental Management, and other 
oversight/clearance activities.

                  EMPLOYMENT STANDARDS ADMINISTRAITON

    Question. For the past 5 years (including fiscal year 2007, based 
on the enacted appropriation), please provide a table identifying FTEs 
and dollars allocated by budget activity.
    Answer. The requested information is included in chart Employment 
Standards Administration, Budget Activity by fiscal year.
    [The information follows:]

                                           EMPLOYMENT STANDARDS ADMINISTRATION BUDGET ACTIVITY BY FISCAL YEAR
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                        Fiscal year
                                 -----------------------------------------------------------------------------------------------------------------------
             Program                       2003                    2004                    2005                    2006                  2007 \1\
                                 -----------------------------------------------------------------------------------------------------------------------
                                    FTE       Funding       FTE       Funding       FTE       Funding       FTE       Funding       FTE       Funding
--------------------------------------------------------------------------------------------------------------------------------------------------------
Wage and Hour Division..........   1,392    $155,626,000   1,442    $160,095,829   1,346    $164,494,758   1,300    $165,685,410   1,200    $170,219,521
Federal Contractor and EEO           742      78,033,000     749      79,441,000     691      80,059,000     670      81,285,000     625      82,441,456
 Standards Enforcement..........
Office of Workers' Compensation
 Programs:
    Federal Employees'               839      86,392,000     839      86,260,000     801      86,819,000     801      88,446,000     760      90,137,213
     Compensation...............
    Longhsore and Harbor              96      10,232,000      96      10,490,000      93      10,511,000      93      10,682,000      90      10,752,158
     Workers' Compensation--
     General....................
    Longhsore and Harbor              11       1,958,000      11       2,016,000      11       2,012,000      11       2,028,000       9       2,041,885
     Workers' Compensation--
     Trust Fund.................
    Division of Coal Mine            214      31,632,000     214      31,628,000     214      32,232,000     205      32,659,000     191      33,171,000
     Workers' Compensation......
Office of Labor-Management           297      34,279,000     347      38,580,000     336      41,681,000     384      45,737,000     313      47,753,357
 Standards......................
Program Direction and Support...     107      14,591,000     107      15,499,000     103      15,635,000      93      17,592,000      93      17,933,000
Federal Employees Compensation    ......     160,000,000  ......     160,000,000  ......     230,000,000  ......     237,000,000  ......     227,000,000
 Act Benefits...................
Federal Employees Compensation       133      37,657,000     133      39,261,000     128      39,668,000     127      53,695,000     127      51,034,000
 Act--Fair Share................
Disabled Coal Miners............      17       5,564,000      17       6,143,000      17       5,191,000      17       5,250,000      17       5,373,000
Energy Employees Occupational        380     104,867,000     300      51,651,000     275      40,321,000     275      96,081,000     275     102,307,000
 Illness Compensation Program
 Act, Part B....................
Energy Employees Occupational     ......  ..............  ......  ..............     105      49,975,000     189      59,950,000     189      59,531,000
 Illness Compensation Program
 Act, Part E....................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Fiscal year 2007 reflects full-year continuing resolution apportionment approved by OMB.

                         WAGE AND HOUR DIVISION

    Question. For the past 5 years (including fiscal year 2007, based 
on the enacted appropriation), please provide a table identifying FTEs 
and dollars allocated by budget activity.
    Answer.

------------------------------------------------------------------------
                                                             Actual
               Fiscal year                  FTE used      obligations
------------------------------------------------------------------------
2003....................................        1,396       $155,673,000
2004....................................        1,333        160,084,000
2005....................................        1,266        164,616,000
2006....................................        1,238        165,706,000
2007....................................    \1\ 1,212   \2\ 101,253,000
------------------------------------------------------------------------
\1\ Estimated.
\2\ Through May 9, 2007.

    Question. According to the February 26, 2007 Daily Labor Report, 
Wage and Hour Administrator said that ``he understands the concerns of 
attorneys who believe opinion letters were being used as a tool in 
ongoing litigation and that it is an issue that needs to be reviewed 
inside DOL.'' What is the status of the review of this alleged 
practice? Have you reached any conclusions, and, if necessary, 
identified steps for corrective action?
    Answer. That portion of the Daily Labor Report article is an 
imprecise and potentially confusing paraphrasing of the Administrator's 
remarks. The Wage and Hour Division (WHD) has long had a policy of not 
issuing an opinion letter to a party to either an ongoing WHD 
investigation or private litigation involving the issue or issues 
raised in the request for an opinion letter. During a presentation that 
the Administrator made to a section of the American Bar Association, 
some audience members suggested that this policy is unfair to workers. 
Their concern was that WHD's policy would not preclude DOL from issuing 
an opinion letter to a trade association or other entity that was not a 
party to a WHD investigation or private litigation, who in turn would 
provide that opinion letter to a member of the organization that was 
involved in an investigation or ongoing litigation. They argued that 
workers who might like to obtain an opinion letter lack a similar 
option. The Administrator acknowledged that concern and stated that it 
merited further consideration. This matter is currently under review.

                      FAMILY AND MEDICAL LEAVE ACT

    Question. In response to questions for the record for the fiscal 
year 2007 Department of Labor budget, the Department indicated that the 
possibility of revisions to the Family and Medical Leave Act remains an 
item on the Department's regulatory agenda. It has been more than 2 
years since that statement. Please provide details on the types of 
changes the Department is considering and a timeline? Will the 
Department commit to not take any action that would lessen the rights 
of workers to leave under the Act?
    Answer. WHD invited interested parties having knowledge of, or 
experience with, the Family and Medical Leave Act to submit comments 
and pertinent information related to the effectiveness of the current 
implementing regulations and the Department's administration of the 
statute. WHD received more than 15,500 submissions from a broad cross-
section of commenters including employer associations, unions, interest 
groups, and individuals. These comments are currently being reviewed, 
and no final decisions have yet been reached as to what, if any, 
changes might actually be proposed.
    Question. Misclassification of employees as independent contractors 
is a growing problem. Studies have found that up to 30 percent of 
companies misclassify workers. In all of these industries low-wage 
workers predominate, and misclassification is often a particular 
problem for immigrant workers. Please provide an analysis of the 
expenditures you make and FTEs you devote to enforcing FLSA 
requirements against misclassification of workers.
    Answer. All WHD investigators examine the employment relationship 
during the conduct of an investigation. Employees who are misclassified 
as ``independent contractors'' are identified during the course of 
investigations that cover many provisions enforced by WHD, and it is 
not possible to segregate expenditures or FTE used to enforce FLSA 
minimum wage and overtime requirements on behalf of misclassified 
workers. However, in its 2006 audit on the contingent workforce, the 
Government Accountability Office suggests that misclassified employees 
are more prevalent in low-wage industries, and WHD spends approximately 
60 percent of its enforcement hours in industries that employ low-wage 
workers.
    Question. Please provide a detailed description of your enforcement 
efforts and results in this area.
    Answer. As the Government Accountability Office notes in its 2006 
audit, WHD addresses the misclassification of employees as independent 
contractors through its investigations, primarily those involving the 
FLSA. All WHD investigators first establish the employment relationship 
between the worker and the company during the conduct of investigations 
to determine whether workers are covered under the FLSA.
    In its 2006 audit on the contingent workforce, the Government 
Accountability Office suggests that misclassified employee are more 
prevalent in low-wage industries, and WHD spends approximately 60 
percent of its enforcement hours in industries that employ low-wage 
workers. Moreover, WHD devotes 20 percent to 25 percent of its 
resources to directed enforcement in low-wage industries--including 
construction, agriculture, and landscaping.
    In addition to enforcement, WHD has been increasing its appearances 
on Spanish-language radio and television programs, reaching out to 
Spanish-language press, distributing worker rights cards, and 
participating in community events, in an effort to inform workers of 
their rights and prevent misclassification from happening in the first 
place. WHD is also in the process of revising its workplace poster to 
add the agency's toll-free number and web site address, which can be 
used to report alleged violations of the laws that WHD enforces, 
including those that may be related to employee misclassification 
issues.
    Question. Please provide a breakdown of what percentage of all 
cases (e.g., all overtime cases, all janitorial services 
investigations, etc.) and outcomes involve misclassification of 
employees as independent contractors by the company.
    Answer. The requested information is not available. Misclassified 
workers are identified during the course of investigations that cover 
many provisions enforced by WHD, and it is not possible to segregate 
cases that involve misclassification of employees as independent 
contractors.

             OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION

    Question. For the past 5 years (including fiscal year 2007, based 
on the enacted appropriation), please provide a table identifying FTEs 
and dollars allocated by budget activity.
    Answer. The information on budgeted resources follows.

                                                                 [Dollars in thousands]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                    Fiscal year
                                                          ----------------------------------------------------------------------------------------------
                                                                  2003               2004               2005               2006               2007
                                                          ----------------------------------------------------------------------------------------------
                                                            Approp.     FTE    Approp.     FTE     pprop.     FTE    Approp.     FTE    Approp.     FTE
--------------------------------------------------------------------------------------------------------------------------------------------------------
Safety & Health Standards................................    $16,014      95    $15,920      85    $16,003      84    $16,462      83    $16,893      83
Enforcement Programs.....................................    162,973   1,612    166,015   1,581    169,651   1,570    172,575   1,542    176,973   1,542
State Programs...........................................     90,547  ......     91,959  ......     91,013  ......     91,093  ......     91,093  ......
Technical Support........................................     20,102     107     21,593     109     20,742     107     21,435     105     22,392     105
Compliance Assistance....................................     61,321     357     67,049     356     70,859     352     72,545     348     72,658     348
Consultation.............................................     53,204  ......     52,211  ......     53,362  ......     53,357  ......     53,357  ......
Training Grants..........................................     11,102  ......     10,509  ......     10,217  ......     10,116  ......     10,116  ......
Safety & Health Statistics...............................     25,894      39     22,237      39     22,203      38     24,253      38     32,274      38
Executive Direction......................................      9,153      50     10,047      50     10,106      49     10,591      49     11,169      49
                                                          ----------------------------------------------------------------------------------------------
      Totals.............................................    450,310   2,260    457,540   2,220    464,156   2,200    472,427   2,165    486,925   2,165
--------------------------------------------------------------------------------------------------------------------------------------------------------

                          TARGETED INSPECTIONS

    Question. OSHA announced in March 2007 that approximately 14,000 
employers have been notified that injury and illness rates at their 
worksites are higher than average. Approximately 4,500 of these will be 
initially targeted for inspection under OSHA's Site Specific Targeting 
program. What is the rationale for identifying 4,500 for inspection of 
these 14,000? What level of resources in FTEs and dollars would be 
required to inspect adequately all of these worksites in fiscal year 
2008?
    Answer. OSHA collects occupational injury and illness data from 
employers each year through the OSHA Data Initiative. Approximately 
14,000 employers each year report a Days Away, Restricted, or 
Transferred (DART) rate that is more than twice the national private 
sector DART rate. These employers are contacted by letter in an 
outreach initiative, and are encouraged to take advantage of OSHA's 
Consultation Program, a free and confidential service in each State 
that assists employers in reducing injuries and illnesses.
    Federal OSHA conducts about 37,700 inspections each year. Slightly 
less than half of these are ``unprogrammed'' inspections: responses to 
fatalities and catastrophes, reports of imminent danger situations, 
employee complaints, and referrals. The other half are ``programmed'' 
or targeted inspections, which do not include inspections in the 
construction industry. The Site-Specific Targeting (SST) program is 
OSHA's primary national targeting system for inspecting the specific 
general industry workplaces that have reported the highest injury and 
illness rates.
    Out of the 14,000 employers with a high DART rate, OSHA then 
selects approximately 4,500 worksites with the highest self-reported 
injury/illness rates--approximately four times the national private 
sector DART rate--to be included for inspection under OSHA's SST. In 
order to verify generally the reliability of claims by establishments 
that they have achieved low DART rates, analysts in OSHA's Office of 
Statistical Analysis in Washington, DC, will select--by applying a 
random number table to all establishments that have reported a low 
rate--approximately 100 low-rate establishments in high-rate 
industries. Some employers who did not respond to the mandatory data 
collection are also included for inspection. This data effectively 
targets OSHA's inspection resources towards establishments that are 
experiencing the highest rates of injuries and illnesses under our 
jurisdiction.
    OSHA believes it is prudent to continue to include those worksites 
with approximately four times the national private sector DART rate in 
its inspections, and to use other inspection resources for other SST 
program sites and to respond to fatalities and catastrophes, reports of 
imminent danger situations, employee complaints, and referrals.
    The rest of OSHA's targeted inspections currently fall under 
National Emphasis Programs (such as refineries, lead exposure, 
amputations, and trenching fatalities), construction inspections, and a 
wide variety of Local Emphasis Programs designed to address hazards and 
industries of concern, depending on local needs.

                NATIONAL EMPHASIS PROGRAM FOR REFINERIES

    Question. In response to the Chemical Safety and Hazard 
Investigation Board's report into the BP Texas City refinery explosion 
recommendation, OSHA announced a new National Emphasis Program (NEP) to 
ensure that every refinery under OSHA's jurisdiction is inspected. What 
is the timeline for carrying out all of the inspections under this new 
National Emphasis program? Will these planned inspections be Program 
Quality Verification (PQV) inspections or of a lesser standard? If the 
inspections will be of a lower standard, please explain why.
    Answer. OSHA began developing the National Emphasis Program for 
refineries prior to the CSB report and includes the agency's plans to 
inspect every refinery under Federal jurisdiction by the end of 2008.
    The planned NEP inspections will not be program-quality-
verification (PQV) inspections as described in OSHA's 1992 directive 
outlining compliance guidelines for the Process Safety Management (PSM) 
standard. The PQV approach employs a broad, open-ended inspection 
strategy and uses a more global approach to identify compliance 
deficiencies. The new refinery NEP provides a more focused and 
effective protocol for evaluating compliance with the PSM standard by 
directing OSHA compliance officers (CSHOs) to review documents, 
interview employees, and verify implementation for specific processes, 
equipment and procedures.
    This NEP is designed to facilitate inspections at all refineries 
within its scope. In contrast to the PQV approach, this NEP addresses a 
number of priority items which CSHOs are to evaluate for compliance. 
OSHA's compliance officers, using the list of inspection priority 
items, will focus on the conditions most likely to be catastrophic 
fire/explosion and toxic release hazards to workers in the facility. We 
believe the NEP's new inspection strategy will yield more effective 
results than the current approach to enforcing PSM.

                       PROCESS SAFETY MANAGEMENT

    Question. The Board's report also recommended that OSHA hire or 
develop new, specialized inspectors and expand the PSM training 
curriculum at its National Training Institute. What level of resources 
will be spent in fiscal year 2007 or is planned to be spent in fiscal 
year 2008 on these activities? How do these spending levels compare to 
fiscal year 2005 and fiscal year 2006?
    Answer. OSHA began the process of expanding the number of 
Compliance Officers trained in PSM prior to CSB's report. PSM training 
has been offered annually by the OSHA Training Institute for the past 
several years. The OSHA Training Institute conducts a sequence of three 
different courses that qualifies OSHA personnel to participate in 
inspections conducted in accordance with the NEP on the process safety 
management standard for petroleum refineries.
    OSHA personnel with experience in the chemical processing or 
refinery industries qualify as Level 1 Refinery NEP Inspection Team 
Members by completing the required OSHA Training Institute course or by 
completing other equivalent specialized seminars in process safety 
management. Employees who have at least 2 years of OSHA inspection 
experience qualify as Level 2 refinery NEP inspection team members by 
completing two OSHA Training Institute PSM courses.
    Between fiscal year 2000 and fiscal year 2006 the OSHA Training 
Institute trained 194 OSHA staff on PSM. The Institute is projecting 
that approximately 250 OSHA staff will attend PSM training courses in 
fiscal year 2007.

                     VOLUNTARY PROTECTION PROGRAMS

    Question. According to OSHA data provided for a Gallup study of 
this program, injury rates remain unchanged before and after 
participation in the VPP. Why does the budget propose additional 
resources for an activity that, according to OSHA's own data, does not 
improve workplace safety and health?
    Answer. To the contrary, the data collected and analyzed by the 
Gallup Organization clearly indicates that injury and illness rates 
dramatically improve for Voluntary Protection Programs (VPP) 
participants in the years prior to and working toward VPP acceptance. 
Additionally, once a worksite is accepted into VPP, injury and illness 
rates remain fairly constant with further improvement in rates for most 
sites over time
    VPP provides a systematic approach for improving workplace safety 
and health performance. The VPP program allows employers, employees, 
and OSHA to work together to implement an effective workplace safety 
and health management system that ensures safety is efficiently 
integrated into the management of day-to-day workplace operations. In 
November 2003, Gallup was contracted by the Department of Labor to 
design and conduct an independent evaluation of the VPP. Gallup 
collected data from approximately 300 worksites for the 5 years prior 
to acceptance into VPP. Gallup also looked at how these same worksites 
performed once they were accepted into the VPP. As the chart below 
shows, VPP participants achieved dramatic reductions in worker injury 
and illness rates with the most dramatic change in all 5 years occurs 
between year 4 and year 3.
  tcir and dart rates for the five years prior to acceptance into vpp



    The Gallup study found that VPP participants not only enhance 
safety and health at their worksites, but also conduct mentoring and 
outreach to other worksites within and outside of their company. For 
example, Gallup found that in 2004, VPP participants mentored over 
1,500 other worksites. This impacted over 500,000 employees. It is this 
very beneficial impact on workplace safety and health that support the 
agency's proposal to increase resources for VPP.

                               ERGONOMICS

    Question. DOL has issued 408 hazard alert letters on ergonomics. 
Please provide for the record an example of the hazard alert letter 
issued by OSHA to an individual company.
    Answer. Example is Northwest Airlines, Tampa facility, baggage 
handling, attached.





                               ERGONOMICS

    Question. Please provide for the record a detailed explanation of 
the types of follow-up actions OSHA undertakes after the issuance of a 
hazard alert letter to determine if ergonomic hazards have been 
addressed.
    Answer. Follow-ups of ergonomic hazard alert letters are generally 
conducted under OSHA Instruction CPL 02-00-144--Ergonomic Hazard Alert 
Letter Follow-up Policy (copy included). This policy is similar to OSHA 
Instruction CPL 02-00-140--Complaint Policies and Procedures, in that 
an employer is first contacted by telephone and then faxed a copy of 
the original ergonomic hazard alert letter. The employer is given 20 
working days to respond as to what steps have been taken to address the 
hazards identified in the original letter. The response is then 
evaluated and a determination made as to what progress the employer has 
made. The outcome of the evaluation can range from the case being 
closed to scheduling the employer for a second inspection.
    The directive CPL 02-00-144 Ergonomic Hazard Alert Letter Follow-up 
Policy, is attached.

                           OSHA INSTRUCTIONS

                          DEPARTMENT OF LABOR

              Occupational Safety & Health Administration

  directive number: cpl 02-00-144      effective date: april 11, 2007

        subject: ergonomic hazard alert letter follow-up policy

                                ABSTRACT

    Purpose.--The purpose of this directive is to outline a process for 
contacting employers who received an ergonomic hazard alert letter 
(EHAL).

    Scope.--This directive applies to any inspection coded N-03, or 
other IMIS code for ergonomic inspections, for which an ergonomic 
hazard alert letter has been issued. This directive is intended to 
apply only to ergonomic hazard alert letters (EHALs).

    References.--Ergonomics Enforcement Policy, found on the web at: 
(http://www.osha.gov/SLTC/ergonomics/enforcement_plan.html); Field 
Inspection Reference Manual, OSHA Instruction CPL 02-00-103.

    Cancellations.--None.

    State Impact.--State adoption not required.

    Action Offices.--Regional Offices, Area Offices

    Originating Office.--Directorate of Enforcement Programs

    Contacts.--Office of Health Enforcement, 200 Constitution Avenue 
NW, Room N-3119, Washington, DC 20210

            By and Under the Authority of
                                      Edwin G. Foulke, Jr.,
                                               Assistant Secretary.

                           Executive Summary

    Employers who have received ergonomic hazard alert letters (EHALs) 
will be asked to provide information on progress in addressing the 
hazards outlined in the EHAL. This Notice outlines a process for 
contacting employers to determine whether hazards and deficiencies 
identified in the letter have been addressed. This directive applies to 
any inspection coded N-03 for which an ergonomic hazard alert letter 
has been issued, regardless of whether the inspection was initiated 
under an emphasis program, the Site Specific Targeting (SST) program, 
or was unprogrammed. This directive is intended to apply only to EHALs.

                          Significant Changes

    No significant changes to previous policy.

I. Purpose.--The purpose of this directive is to outline a process for 
contacting employers who have received an ergonomic hazard alert letter 
(EHAL) since April 2002. This contact is a continuation of the 
inspection that led to the EHAL, and is intended to determine whether 
hazards and deficiencies identified in the letter have been addressed.

II. Scope.--This directive applies to any inspection coded N-03, or 
other Integrated Management Information System (IMIS) code for 
ergonomic inspections, for which an ergonomic hazard alert letter has 
been issued, regardless of whether the inspection was initiated under 
an emphasis program, the SST program, or was unprogrammed. This 
directive is intended to apply only to EHALs.

III. References.
    A. Ergonomics Enforcement Policy, found on the web at: (http://
            www.osha.gov/SLTC/ergonomics/enforcement_plan.html);
    B. Field Inspection Reference Manual, OSHA Instruction CPL 02-00-
            103.

IV. Cancellations.--None.

V. Action Offices.
    A. Responsible Office.--Directorate of Enforcement Programs, Office 
            of Health Enforcement.
    B. Action Offices.--Regional Offices. Each Region will be 
            responsible for ensuring that this process is implemented.
    C. Information Offices.--The Region may determine who will 
            implement this directive (e.g., the Compliance Safety & 
            Health Officer [CSHO], the Regional Ergonomic Coordinator 
            [REC], etc.) based upon the most effective use of 
            resources.

VI. Federal Program Change.--This Notice describes a Federal program 
change which does not require State adoption or response.

VII. Significant Changes.--Not applicable.

VIII. Initial Contact with Employer.
    A. Using the current phone/fax process, contact will be made with 
            all employers who received an EHAL issued on or after April 
            1, 2002 and have been in receipt of an EHAL for at least 
            one year (this will allow employers time to implement 
            changes). Employers who voluntarily supplied a progress 
            report to the Area Office (AO) need not be contacted again, 
            unless the AO determines that the response was inadequate.
    B. During the initial phone/fax contact, OSHA staff will explain 
            that the employer is being contacted as a follow-up to the 
            original inspection. OSHA staff is to determine what 
            specific measures were taken by the employer in response to 
            the EHAL. It is suggested that in order to maintain 
            consistency, OSHA staff should ask to speak, if possible, 
            with the management contact(s) at the establishment who was 
            (were) originally involved in the inspection.
    C. Following the initial phone/fax-type telephone call, the 
            employer will be faxed a copy of the original EHAL and a 
            letter (OSHA staff are to use the template provided in 
            Appendix A) requesting: (1) the employer's response 
            regarding measures taken to address the hazard(s) noted in 
            the EHAL; (2) copies of the employer's Log of Work-Related 
            Injuries and Illnesses (OSHA Form 300) since the close of 
            the original inspection; and (3) the estimated number of 
            full-time employees (FTE) or work hours for the exposed 
            employees for the time period corresponding to the injury 
            and illness reports. The employer should be asked about all 
            ergonomic control measures implemented, including those 
            recommended in the EHAL.
    D. A response from the employer is due within twenty (20) working 
            days of the initial phone/fax-type telephone call. The 
            employer may provide the response via fax, e-mail or U.S. 
            Postal Service mail, or common carrier (i.e., FedEx, UPS, 
            etc.).
    E. An evaluation of the employer's response will be made and the 
            employer's efforts will be categorized, as indicated below. 
            The RECs will be available to assist in reviewing the 
            response, if necessary. The response categories are:
        1. No response (NR).--The employer did not provide any e-mail, 
            fax or mail response to the EHAL or telephone/fax inquiry.
        2. Inadequate response (IR).--The employer's response did not 
            establish that it had taken useful steps, such as those 
            identified in the EHAL, to reduce the hazard identified in 
            the EHAL.
        3. On-the-right-track response (RT).--The employer has 
            undertaken measures to address the hazards identified in 
            the EHAL, but the efforts may have either stalled or have 
            not been sufficient to address the hazards. Injury and/or 
            severity rates are not improving.
        4. Successful response (SR).--The employer has implemented 
            measures which address the hazards in the EHAL.

IX. Second Contact with the Employer.
    A. No response (NR) or Inadequate response (IR)
        1. If no response is received from the employer within the 
            allotted twenty (20) working days, or if an inadequate 
            response is received, additional contact with the employer 
            should be made to obtain the desired information. The AO 
            may determine whether this second contact should be made by 
            phone, letter, or inspection (see section X. for inspection 
            procedures).
        2. If the second contact with the employer is by phone call or 
            letter, the response shall be evaluated. The AO will have 
            discretion regarding whether additional follow-up phone 
            calls or additional letters are still warranted. This 
            judgment will be based on the extent to which the employer 
            implemented measures to address the hazard.
        3. Upon completion of any additional contact(s) if the employer 
            still has not responded or has responded inadequately, an 
            inspection shall be scheduled to determine if the ergonomic 
            hazards are being addressed (see section X. for inspection 
            procedures)
    B. On-the-right-track response
      For all responses deemed to be ``on-the-right-track,'' the AO 
            will have discretion regarding whether a follow-up phone 
            call, an additional letter, or an on-site inspection is 
            warranted (see section X. for inspection procedures). This 
            judgment will be based on the extent to which the employer 
            implemented measures to address the hazard.
    C. Successful response
        No further action is required.

X. Inspection Procedures.
    A. All inspections shall be unannounced. The scope of the 
            inspection will be limited to the ergonomic hazards 
            identified in the original EHAL, any conditions cited in 
            the original inspection, and any hazards in plain view.
    B. Inspection findings shall be handled in accordance with the FIRM 
            and any other enforcement guidelines. Conditions which are 
            re-inspected may be considered as apparent potential 
            violations, and citations may be issued based on the 
            findings of the reinspection.
    C. Where ergonomic hazards remain and citations are not issued, the 
            employer should be sent a letter (additional EHAL) 
            suggesting relevant hazard abatement measures (Appendix B).

XI. Data.
    A. A spreadsheet listing ergonomic hazard alert letters will be 
            provided to the Area Offices by the RECs. The results of 
            the follow-up contact with each employer shall be entered 
            into the spreadsheet and be forward the RECs twice a year 
            (June and December) or as otherwise requested by the RECs. 
            The information submitted by the AO will be limited to the 
            date of the initial contact under section VIII., the date 
            the follow-up is finalized and the final outcome for each 
            employer. Possible results are given below and the outcome 
            for each employer may have more than one result. For 
            example, if an employer is contacted and provides an 
            inadequate response resulting in an inspection which leads 
            to a second EHAL, the spreadsheet would contain codes IR, 
            FI and LT in addition to the appropriate dates. The EHAL 
            follow-up will be considered final if the site is no longer 
            in business, when a successful response is received, when 
            an on-the-right-track response has been received and the AO 
            determines no further action is required, or when an 
            inspection is initiated.

      NR No response
      IR Inadequate response
      RT On-the-right-track
      SR Successful response
      OB Out of Business
      FI Follow-up inspection
      LT Second Letter
      CI Citation

    B. The RECs will be responsible for submitting the results to the 
            NO. The NO will summarize the results.

XII. IMIS.
    A. When a second inspection is not conducted:

      The time spent on the evaluation is to be recorded on the CSHO's 
            OSHA 31 under Activity Details. Mark line 5a I 
            (Inspection), then enter the inspection number of the 
            original case on line 6 along with the time spent on the 
            contact.

    B. When a second inspection is conducted:

      This will be considered a new inspection, and normal coding 
            procedures are to be used.

XIII. Expiration.--This directive will be effective for three (3) years 
from the date signed.

             APPENDIX A--TEMPLATE LETTER FOR EHAL FOLLOW-UP

    Dear Employer:
    On ____ (date) ____, the ______ Area Office of the Occupational 
Safety and Health Administration (OSHA) conducted an inspection of your 
workplace, including an evaluation of risk factors which may contribute 
to injuries of the musculoskeletal system. As a result of this 
inspection, a letter addressing these hazards (copy enclosed) was 
forwarded to you on ____ (date) ____.
    To evaluate your progress in addressing the hazards identified, we 
are seeking the following information:
  --Any controls you may have implemented to address these hazards, 
        including adding mechanical devices, redesigning workstations, 
        modifications to employee workloads, changes to the way 
        injuries are addressed, or any other changes which you feel may 
        have impacted the hazard identified in OSHA's letter. This 
        includes any controls recommended by OSHA or other controls 
        implemented.
  --A list of the types of training provided to your employees to 
        address these hazards.
  --Copies of OSHA's Form 300, Log of Work-Related Injuries and 
        Illnesses, beginning with the year of the original inspection.
  --An estimate of the number of hours worked or full-time employees 
        for each employee whose job title(s) is (are) ____ or are in 
        at-risk job(s) ____, by year beginning with the year of the 
        original inspection.
    Please provide your response to the ______ Area Office within 
twenty days of receipt of this request by fax, e-mail, regular mail, or 
common carrier. A brief evaluation of the effectiveness of the controls 
may be included if you believe this will help OSHA in evaluating your 
efforts. The lack of a response to this letter will result in further 
action by OSHA, possibly including another inspection of your facility.
            Sincerely,
                                                     Area Director.
            Enclosure.

             APPENDIX B--TEMPLATE LETTER FOR SECOND CONTACT

    Dear Employer:
    An evaluation of your efforts to address ergonomic hazards related 
to an Occupational Safety and Health Administration (OSHA) inspection 
has been conducted. As you know, the original inspection took place on 
______. We initiated a second contact with your organization to 
determine your success in addressing the hazards in your workplace.
    OSHA has determined that your efforts in addressing ergonomic risk 
factors are (unlikely to address the hazard/on-the-right-track) and 
that further measures, as detailed below, would contribute to 
resolution of the hazard:
  --List relevant Engineering Controls
  --Administrative/Work Practice Controls
  --Training Needed
    OSHA offers various forms of cooperative assistance to employers, 
some focused on specific hazards, others aimed at helping employers 
develop and implement safety and health management systems that provide 
more comprehensive protection for workers. These include:
  --The OSHA Consultation Program, administered by the States and 
        funded largely by OSHA, which offers free consultation services 
        to qualifying small businesses, primarily in high hazard 
        industries. Consultants help employers identify and correct 
        workplace hazards and develop more comprehensive safety and 
        health management systems.
  --The Voluntary Protection Programs (VPP), which recognize companies 
        where managers and employees are working together to establish 
        comprehensive safety and health management systems. The VPP 
        Mentoring Program, offered by the independent VPP Participants' 
        Association, offers mentoring to any employer seeking 
        assistance.
  --OSHA Strategic Partnerships, which often address specific safety 
        and health issues such as ergonomics.
  --OSHA Alliances with trade or professional organizations, employers, 
        labor organizations, and educational institutions, which 
        provide training and other services to help employers reduce 
        injuries and illnesses. Many OSHA Alliances focus on ergonomic 
        issues.
    You can find information about these programs, plus an array of 
electronic tools (e-tools), publications, and other information at 
www.osha.gov. Any further assistance needed in this matter may be 
obtained by contacting our offices.
            Sincerely,
                                                      AREA DIRECTOR
                               ERGONOMICS

    Question. Please provide for the record a list of follow-up 
inspections conducted after the issuance of an ergonomic hazard alert 
letter.
    Answer. Because the Ergonomic Hazard Alert Letter Follow-up Policy 
was recently signed (April 11, 2007), only three sites have received 
follow-up inspections thus far. All three of those inspection sites 
were Transportation Security Administration locations (Anchorage and 
Fairbanks Alaska, and Portland Oregon). The original and the follow-up 
inspections were conducted under a Federal agency targeting program in 
effect for OSHA's Seattle Region.
    Question. Please provide for the record the number of ergonomic 
hazard alert letters issued by year for the years 2001 to 2006.
    Answer. The information follows.

----------------------------------------------------------------------------------------------------------------
                                                                                    Year
                                                           -----------------------------------------------------
                                                              2001     2002     2003     2004     2005     2006
----------------------------------------------------------------------------------------------------------------
Letters...................................................       NA       30      224      109       52       31
----------------------------------------------------------------------------------------------------------------
Note.--OSHA did not begin tracking ergonomic hazard alert letters until after the announcement of Secretary's
  Four-Pronged Approach to Ergonomics in April 2002.

    Question. Please provide for the record the number of follow-up 
inspections conducted after the issuance of an ergonomic hazard alert 
letter by year for the years 2001 to 2006.
    Answer. Because the Ergonomic Hazard Alert Letter Follow-up Policy 
was recently signed (April 11, 2007), only three Transportation 
Security Administration sites have received follow-up inspections, one 
each in 2004, 2006, and 2007.
    Question. In 2004, the National Advisory Committee on Ergonomics 
(NACE) recommended 16 industries for developing ergonomic guidelines. 
To date, only 3 industry ergonomic guidelines have been developed--for 
nursing homes, poultry processing and retail grocery. What other 
ergonomic guidelines is OSHA working on? Which ergonomic guidelines 
will OSHA finalize in fiscal year 2007 and in fiscal year 2008?
    Answer. OSHA has completed work on guidelines for three industries 
(nursing homes, retail grocery and poultry). The approaches to 
addressing ergonomics in these guidelines are also applicable to 
hospitals and department stores, two industries that NACE recommended 
for future guidelines.
    Since 2004, OSHA has updated the NACE analysis with more recent 
injury and illness statistics and is considering industries for future 
ergonomics guidelines. OSHA is working on the ergonomics Guidelines for 
Shipyards. Once completed we anticipate a 60-day comment period and, if 
requested by interested parties, a stakeholder meeting shortly 
following the end of the comment period. We anticipate publishing the 
final Guidelines for Shipyards late in fiscal year 2007 or early fiscal 
year 2008.
    Question. Overall, how long will it take for OSHA to issue 
guidelines on the 16 industries recommended by your National Advisory 
Committee?
    Answer. OSHA has carefully considered the recommendations offered 
by NACE, which was established to advise the Secretary of Labor on 
ergonomics guidelines, research, and outreach and assistance. We have 
updated the NACE analysis using more recent injury statistics. The 
agency is using the results of this updated analysis as one source of 
information as it considers candidates for future ergonomics 
guidelines. It should be noted that NACE recommended that OSHA also 
consider the ``Other Criteria'' (e.g., injury trends, absence of 
available guidelines) established by the Guidelines Workgroup when 
making specific industry selections from the NACE list.
    Our past experience with guidelines development is the best 
indicator of future timelines. The Guidelines for Nursing Homes were 
completed in about a year. The Guidelines for Poultry processing and 
the Guidelines for Retail Grocery Stores were completed simultaneously 
in a 2-year period. We plan to publish draft Guidelines for Shipyards 
in fiscal year 2007, and anticipate finalizing them in late fiscal year 
2007 or early fiscal year 2008.

                     PERSONAL PROTECTIVE EQUIPMENT

    Question. In litigation regarding the OSHA Employer Payment for 
Personal Protective Equipment standard, DOL informed the U.S. Court of 
Appeals for the District of Columbia that it will issue a final 
standard by the end of November 2007, barring unforeseen circumstances. 
Please provide the committee with a written timetable indicating the 
remaining steps in the process for issuing the final rule and the 
timetable for completing those steps and bi-monthly reports on the 
progress that has been made in meeting that timetable.
    Answer. As you note, OSHA is moving forward with the PPE payment 
rulemaking. The regulatory team assigned to work on the project is 
currently developing the regulatory text and preamble discussion 
explaining the rule, as well as the legal discussions and economic 
analyses required by the various laws and executive orders that affect 
the rulemaking process. We have agreed to provide the court with 
updates on the rule's progress every 60 days, with the first report to 
be made on June 4, 2007.
    When the team has completed its work and I have approved the 
rulemaking documents, we will submit them to OMB for review. When that 
process is completed, we will publish the final rule in the Federal 
Register and submit it to Congress per the Congressional Review Act. 
Barring unforeseen circumstances, we expect to complete that process in 
November 2007.

                    PANDEMIC INFLUENZA PREPAREDNESS

    Question. On February 26, 2007, the Department of Labor denied a 
petition from AFSCME and other labor organizations to issue an OSHA 
emergency temporary standard (ETS) to protect health care workers and 
other emergency responders. During the hearing on March 28, Secretary 
Chao indicated that the Department did not believe that OSHA had the 
legal authority to issue an ETS for pandemic flu under the Occupational 
Safety and Health Act because a pandemic had not yet occurred. Has the 
Department re-evaluated its authority on this issue? If so, does the 
Department still believe that the United States needs to be in the 
middle of a flu pandemic to be able to issue an emergency standard?
    Answer. After careful consideration of the provisions of the 
Occupational Safety and Health Act of 1970, OSHA determined that it had 
to deny the petition because it could not legally support an ETS for a 
hazard that does not technically exist at this point. The rulemaking 
process can be complex, but has evolved in such a manner as to ensure, 
as much as possible, that a final rule is not only effective, but can 
also stand up to legal challenges.
    We clearly recognize and agree with the petitioner's concerns about 
the need to be prepared for the possibility of an influenza pandemic. 
To this end, OSHA recently issued guidance to assist employers and 
employees in preparing for a pandemic, entitled ``Guidance on Preparing 
Workplaces for an Influenza Pandemic.'' This guidance outlines steps 
employers and employees can take to prepare for and respond to an 
influenza pandemic. On May 21, 2007, OSHA also issued guidance for 
hospital-based health care providers, entitled ``Pandemic Influenza 
Preparedness and Response Guidance for Healthcare Workers and 
Healthcare Employers.''
    Question. When will the Department of Labor issue guidelines for 
protecting health care workers and emergency responders in the event of 
a pandemic?
    Answer. In addition to its recently published general guidance for 
workplace preparations for an influenza pandemic, OSHA, in close 
consultation with the Centers for Disease Control and NIOSH, has just 
issued a detailed guidance document for healthcare facilities entitled 
``Pandemic Influenza Preparedness and Response Guidance for Healthcare 
Workers and Healthcare Employers.'' OSHA also ensured that this 
critical subject was addressed at a conference co-sponsored with the 
Joint Commission for the Accreditation of Healthcare Organizations in 
the fall of 2006. Now that the healthcare guidance has been issued, 
OSHA plans to seek opportunities for outreach in the healthcare 
industry.
    Question. Does the Department intend to enforce these guidelines 
under the general duty clause (section 5(a)(1)) of the Occupational 
Safety and Health Act?
    Answer. No. As a matter of policy, OSHA does not issue general duty 
clause citations based on guidelines that the agency has issued.
    Question. Please provide information or data on the percentage of 
hospitals that have implemented the infection control procedures and 
respiratory protection measures for health care settings recommended by 
the Department of Health and Human Services in order to prepare for a 
pandemic.
    Answer. OSHA has no information on the percentage of hospitals/
healthcare facilities that have implemented infection control 
procedures and respiratory protection measures. We are not aware of a 
source for this information.

                                PERM FEE

    Question. The fiscal year 2008 budget proposes legislation to 
authorize a cost-based user fee on new applications for the Permanent 
Labor Certification (PERM) program. What is the fee structure for the 
PERM proposal?
    Answer. The Department's proposal sets an initial filing fee of 
$650 per application. This fee amount was calculated based on the 
Department's analysis of the funds necessary to recover the processing 
costs of administering this service, which helps employers to lawfully 
hire non-immigrant workers to fill labor shortages. Employers, not 
alien beneficiaries, would pay the fee. Under the Department's 
proposal, the Department would review and adjust the fee amount 
annually to ensure it remains a cost-based fee.

                  A-76 CIRCULAR, COMPETITIVE SOURCING

    Question. From fiscal year 2004 through fiscal year 2006, please 
indicate at DOL how many standard OMB Circular A-76 competitions have 
been completed and how many of those standard competitions were won by 
in-house workforce? For the same period at DoL, please indicate how 
many streamlined OMB Circular A-76 competitions have been completed and 
how many of those streamlined competitions were won by the in-house 
workforce?
    Answer. DOL completed 3 standard competitions that were all won by 
the in-house workforce. DOL completed 18 streamlined competitions that 
resulted in 2 converting to contract performance and 16 being won by 
the in-house workforce.
    Question. From fiscal year 2004 through fiscal year 2006, please 
indicate at DOL how many times in-house workforces have been allowed to 
compete to perform new work? For the same time period, please indicate 
how many times in-house workforces have been allowed to compete to 
perform outsourced work. Please indicate whether OMB has ever directed 
or encouraged the Department of Labor to allow in-house workforces to 
compete to perform new work or outsourced work. Please identify those 
instances as well as the numbers of FTEs involved.
    Answer. New work is typically staffed by Federal employees using 
OPM and DOL personnel rules and procedures. Where appropriate, 
contractor support may be procured using the Federal Acquisition 
Regulation procedures to perform work that is commercial in nature.
    OMB has neither encouraged nor discouraged the use of the A-76 
competition process by in-house workforces to perform new work or work 
currently performed by contractors. The opportunity to recompete work 
previously competed under the A-76 process has not presented itself 
because contracts awarded for previous competitions have not yet 
expired.
    Question. From fiscal year 2004 through fiscal year 2006, please 
indicate whether DoL has ever sought to use alternatives (e.g., high 
performing organization, business process reengineering, etc.) to OMB 
Circular A-76 to reach its competitive sourcing goals. Has OMB 
encouraged or allowed for the use of alternatives to achieve the goals? 
Please identify those instances as well as the numbers of FTEs 
involved.
    Answer. Between the years fiscal year 2004 through fiscal year 
2006, DOL focused its attention on a relatively narrow set of 
activities (less than 5 percent of its commercial workforce and less 
than 3 percent of its entire workforce) that were good candidates for 
competitive sourcing--e.g., common recurring support services, 
performed competently and cost-effectively in the marketplace, suitable 
for performance by either a contractor or an in-house team. DOL also 
identified commercial activities for which competitive sourcing is not 
the best management tool and will not be considered for competition, 
largely because the activities are core to the agency's mission and 
best performed with Federal employees. Of the 26 competitions completed 
to date, Federal staff have been successful retaining the work in-house 
in 23 cases. However, none of the competitions have reached the 
conclusion of their full performance period--generally 3 to 5 years 
following the competition. Therefore, DOL has not yet had an 
opportunity to consider the high performing organization (HPO) 
alternative. In general, OMB has indicated that they are receptive to 
allowing agencies to use HPO as an alternative to conducting A-76 
competitions.
    Question. How many OMB Circular A-76 privatization reviews has DOL 
scheduled for fiscal year 2010, fiscal year 2011, fiscal year 2012, and 
fiscal year 2013, and how many FTEs would be involved during each of 
those years?
    Answer. DOL's current fiscal year 2010 Competition Plan identifies 
approximately 1,500 FTEs for possible competition. However, the final 
management decision to pursue competition and the size and scope of a 
competition will be contingent on the results of a feasibility study. 
DOL has not yet developed a competition plan for fiscal years 2011-
2013.

  OFFICE OF DISABILITY EMPLOYMENT POLICY (ODEP) WORKING TO ELIMINATE 
                         BARRIERS TO EMPLOYMENT

    Question. Based on findings and results of ODEP's grants, what 
policy to reduce barriers to employment for people with disabilities 
has ODEP developed and seen implemented?
    Answer. ODEP has developed policy in several disability-related 
employment policy areas for implementation at the national, State and 
local levels. Examples include:
  --Disability-related Amendments to the Workforce Investment Act 
        (WIA).--Based on issues identified through ODEP's pilot project 
        and technical assistance grants, ODEP developed a set of policy 
        recommendations for and proposed amendments to the WIA. These 
        recommendations and proposed amendments targeted the needs of 
        persons with disabilities, and included a description of 
        problems with current law, justification for change, the 
        proposed amendment, and an explanation of its intent. As a 
        result of ODEP's efforts, the State plan requirements for WIA 
        implementation were amended in several ways; first, to ensure 
        that the description of how the State will meet the needs of 
        persons with disabilities is tied to WIA section 188 (which 
        ensures non-discrimination and equal opportunity) and Executive 
        Order 13217 (relating to community-based alternatives for 
        individuals with disabilities); and second, that the State 
        should be required to specifically describe how it will ensure 
        physical and programmatic accessibility for persons with 
        disabilities. ODEP also recommended that the WIA youth program 
        elements be expanded to include instruction in basic economic 
        literacy, which while necessary for all youth, is particularly 
        important for youth with disabilities in planning for a solid 
        financial future and working toward self-sufficiency. The 
        administration's bill for reauthorization of the WIA contained 
        many additional recommendations from ODEP's, and a number of 
        ODEP's recommendations are in the House and Senate bills for 
        reauthorization of WIA.
  --Improving Transition Results for Youth with Disabilities.--Special 
        education students are more than twice as likely to drop out of 
        high school as their peers in general education, are half as 
        likely to participate in post secondary education, and are much 
        more likely to be unemployed and live in poverty as adults than 
        their non-disabled peers. To help steer families, institutions, 
        and youth themselves through the difficult transition form 
        youth to adulthood, ODEP developed Guideposts for Success, 
        reflecting what research has identified as key educational and 
        career development interventions that can make a positive 
        difference in the lives of all youth, including youth with 
        disabilities.
    The dissemination of Guideposts for Success has increased access to 
coordinated, comprehensive transition services that youth with 
disabilities need to successfully enter employment and/or post-
secondary education. Examples of how the Guideposts have been 
implemented at the State and local levels include:
  --In Iowa, a State team of nonprofit and State government agencies 
        working to strengthen employment services for Iowans with 
        disabilities, is developing a State Report Card looking at 
        indicators specific to youth with disabilities and transition 
        from secondary school to employment and/or postsecondary 
        education based on the Guideposts. The State Report Card will 
        be used to measure how Iowan youth with disabilities are 
        transitioning to adulthood compared to their peers. A draft 
        report card can be found at http://
        www.iowaemploymentpartners.com/tools/draft_report_card92205.xls
  --To date, South Carolina, Indiana, Wisconsin, and Texas are at 
        various stages of implementing High School/High Tech projects 
        using the Guideposts for Success model. Oklahoma's HS/HT 
        program has received a $300,000 grant from the National Science 
        Foundation to develop a new program using the HS/HT model for 
        middle school students with disabilities.
  --In Maryland, the State Superintendent for the Maryland Department 
        of Education signed a Statewide Transitioning Cooperative 
        Agreement, which provides for statewide implementation of the 
        Guideposts framework and is finalizing agreements with 24 local 
        school districts to provide for incorporation of the Guideposts 
        at the local level. Five of those agreements also include a 
        voluntary addendum for provision of assistive technology before 
        students leave high school. These agreements will ensure that 
        all students with disabilities, not just those participating in 
        the High School/High Tech program, have access to the type of 
        comprehensive transition programming that research indicates 
        leads to transition success.
  --ODEP worked with the National Alliance for Secondary Education and 
        Transition to develop a framework identifying what schools need 
        to do to ensure that youth have access to the services and 
        supports articulated in the Guideposts. Forty-six States are 
        now using the framework to develop their transition improvement 
        plans, helping students in thousands of school districts 
        prepare to enter employment and/or post-secondary education.
    Question. What ODEP grants have lead to what policy, and where is 
it implemented?
    Answer. ODEP pilot project, research, and technical assistance 
grants have lead to policy developed and implemented on the Federal, 
State, and local level. These grant efforts have supported ODEP's 
development of disability employment policy in the areas of:
  --Universal access and design to improve the workforce development 
        system's operational practices, services, and physical 
        environments so they benefit the greatest number of people, 
        including people with disabilities, and enhance the workforce 
        development system's overall cost-effectiveness and quality;
  --Youth in transition to ensure that the transition-related needs of 
        youth with disabilities between the ages of 14 to 24 are viewed 
        holistically with their non-disabled peers and are effectively 
        prepared for entering employment or post-secondary education;
  --Employment strategies and incentives to expand the implementation 
        of creative strategies such as customized employment, telework, 
        and utilization of tax and work incentives to maximize 
        employment opportunities for people with disabilities; and
  --State and local infrastructure leadership to increase leadership, 
        collaboration and foster the development of needed 
        infrastructure at the State and local levels where policy 
        implementation ultimately occurs.
    Forty-six States--including Alaska, Florida, Wisconsin, Georgia, 
New York, and California--have adopted evidence-based policies and 
practices that ODEP has developed based on the findings of the grants 
that the agency has funded.
    We have included a chart for the record that provides specific 
examples of policy developed by ODEP that the agency has since seen 
implemented. None of these examples of policy adaptation, adoption, and 
implementation would have happened without ODEP's ongoing efforts to 
improve employment opportunities for people with disabilities.
    Question. Has ODEP developed and implemented policy that ODEP 
developed from efforts other than grants? If so, what policy and where 
has it been implemented?
    Answer. While awarding pilot project, research, and technical 
assistance grants is one strategy that ODEP has successfully used to 
develop policy and foster its implementation, ODEP also employs other 
critical non-grant strategies, each of which relies on its staff of 
disability experts and their policy analysis and development and 
research skills. ODEP's mandate--to eliminate barriers to employment 
for people with disabilities--requires an approach that utilizes 
multiple strategies. Policies that ODEP has developed from efforts 
other than grants include:
  --Expanding Employment-related Transportation Options.--Since 
        research supports the lack of available and accessible 
        transportation as the most often cited barrier to employment, 
        ODEP's policy staff established new working relationships with 
        the Department of Transportation (DOT) and other Federal 
        partner agencies that provide transportation supports and 
        services. The policy staff also worked with DOT on the creation 
        of DOT's technical assistance and grant programs that assist 
        States in their efforts to better coordinate their employment-
        related transportation activities. This initiative eventually 
        resulted in the following:
    --ODEP's co-sponsorship with DOT of a National Summit on Employment 
            and Transportation for People with Disabilities.
    --ODEP's draft of Executive Order13330, Human Service 
            Transportation Coordination (EO), was signed and announced 
            by the White House at a second, larger conference that 
            included the Departments of Education and Health and Human 
            Services. The EO established the Coordinating Council on 
            Access and Mobility, which implemented the United We Ride 
            initiative. The United We Ride initiative, led by DOT, 
            includes the participation of ten Federal agencies working 
            together to simplify, coordinate, and enhance customer 
            access to transportation, and to reduce duplicative laws, 
            ensure comprehensive planning, standardize cost allocation 
            processes, and document successful strategies for human 
            service transportation.
    --ODEP's work with DOT ensured that the reauthorization of SAFETEA-
            LU included $80 million in new funding for employment-
            related transportation for people with disabilities. These 
            funds will be provided to each State to be used to 
            establish new transportation options for people with 
            disabilities to gain or maintain employment.
  --Documenting the Unemployment Rate of People with Disabilities.--A 
        credible unemployment rate is fundamental to research and 
        policy development across government and the private sector to 
        increase workforce participation for people with disabilities. 
        A multi-year collaborative effort between ODEP research staff 
        and the Bureau of Labor Statistics (BLS) is ongoing to develop 
        a valid and reliable method of measuring the unemployment rate 
        of people with disabilities.
    Seven disability questions are being tested and validated for use 
in the Current Population Survey (CPS), which is jointly conducted by 
BLS and the Bureau of the Census. BLS is working to launch these 
questions in the monthly CPS in June of 2008, and for the first time, 
the Department of Labor will be able to publish an official 
unemployment rate for people with disabilities.
    In addition to the examples given here, we have included a chart 
for the record that provides more examples of policy developed by ODEP 
that the agency has since seen implemented. None of these examples of 
policy adaptation, adoption, and implementation would have happened 
without ODEP's ongoing efforts to improve employment opportunities for 
people with disabilities.

----------------------------------------------------------------------------------------------------------------
      Strategy /Activity         Issue Addressed               Policy Implemented               Location /System
----------------------------------------------------------------------------------------------------------------
                                            Workforce Systems Policy
 
Pilot Project Grants.--         Promoting Self-    One-Stop Career Centers--Self-Employment    States and State
 Customized Employment.          Employment as a    Training for Workforce Investment Act       workforce
                                 Valid Employment   Clients TEGL#16-04 http://wdr.doleta.gov/   agencies
                                 Outcome for        directives/corr_doc.cfm?DOCN=1684.
                                 People with
                                 Disabilities.
Technical Assistance and Pilot  Ensuring Access    WIA section 188 Disability Checklist http:/ One-Stop Career
 Project Grants.--National       to One-Stop        /www.dol.gov/oasam/programs/crc/            Centers
 Center on Workforce and         Career Centers     WIASection188DisabilityChecklist.htm;
 Disability for Adults (NCWD-    for People with    Strategies and Practices for Effectively
 A); Working for Freedom,        Disabilities.      Serving all One-Stop Customers--A
 Opportunity and Real Choice                        Framework for Systems Change.
 Through Community Employment
 (WorkFORCE) Action; and
 Customized Employment.
Technical Assistance and Pilot  Increasing Access  Youth Vision Training and Employment        Workforce
 Project Grants.--National       to Youth           Guidance Letter No. 28-05 (TEGL) http://    Investment Act
 Collaborative on Workforce      Services for       wdr.doleta.gov/directives/                  (WIA)-funded
 and Disability for Youth        Youth with         corr_doc.cfm?DOCN=2224.                     programs
 (NCWD-Y) and Innovative State   Disabilities.
 Alignment Grants for
 Improving Transition Outcomes
 for Youth with Disabilities
 through the Use of
 Intermediaries
 (Intermediaries).
Pilot Project Grants            Increasing         ODEP recommendations in the                 Federal WIA
 Activity.--Customized           Participation in   administration's bill for reauthorization   legislation
 Employment grant and            WIA Programs for   of the WIA; ODEP recommendations in the
 (Intermediaries)                People with        House and Senate bills for
                                 Disabilities       reauthorization of WIA..
                                 through
                                 Reauthorization
                                 of the WIA.
Grant Activity.--High School/   Improving          Guideposts for Success http://www.dol.gov/  46 State
 High Tech (HS/HT) State         Transition         odep/categories/youth/.                     education
 Development and                 Results for                                                    systems
 Implementation Grants and       Youth with
 NCWD-Y.                         Disabilities.
Pilot Project Grant.--          Improving the      Customized employment policy for the WIA    Workforce
 Customized Employment.          Workforce          system.                                     Investment
                                 Investment                                                     system
                                 System's
                                 Effectiveness
                                 with ``hard to
                                 serve''
                                 Customers.
Research Project Grant.--       Validating         Telework strategies that promote            Employers; One-
 Telework/Telecommuting Pilot    Telework as a      employment, impact employer policies, and   Stop Career
 Research.                       Strategy to        integrate telework into the services of     Centers
                                 Reduce             the Nation's One-Stop Career Centers.
                                 Employment         www.teleworkusa.net.
                                 Barriers for
                                 People with
                                 Disabilities.
 
                                       Employers and the Workplace Policy
 
Technical Assistance and Pilot  Improving          Knowledge, Skills, and Abilities of Youth   National
 Project Grants.--NCWD-Y and     Professional       Service Practitioners: The Centerpiece of   Association of
 Innovative State Alignment      Development of     a Successful Workforce Development System   Workforce
 Grants for Improving            Youth Service      http://www.ncwd-youth.info/assets/          Development
 Transition Outcomes for Youth   Practitioners.     background/ksa.doc; National Association    Professionals:
 with Disabilities through the                      of Workforce Development Professionals      4,500 members;
 Use of Intermediaries.                             use: http://www.nawdp.org/                  National
                                                    certification.htm; National Partnership     Partnership for
                                                    for Juvenile Services use: http://          Juvenile
                                                    www.npjs.org/Training/default1.html.        Services: 900
                                                                                                member
                                                                                                organizations
Non-Grant Activity.--ODEP       Promoting          Preparing the Workplace for Everyone:       National,
 Staff work.                     Workplace Safety   Accounting for the Needs of People with     regional, and
                                 and Security for   Disabilities--A Framework of Emergency      field levels in
                                 Federal            Preparedness Guidelines for Federal         GSA; HR and
                                 Employees with     Agencies (Framework): http://www.dol.gov/   disability
                                 Disabilities.      odep/pubs/ep/preparing2.htm.                program managers
                                                                                                in OPM; Federal
                                                                                                safety and
                                                                                                health officials
                                                                                                in OSHA
Non-Grant Activity.--ODEP       Influencing        Valid, credible workplace accommodations    Society for Human
 Staff work.                     Employer           information: http://www.jan.wvu.edu/        Resource
                                 Policies and       Society for Human Resource Management       Management
                                 Practices.         (SHRM)/ODEP Alliance Agreement: http://     (SHRM): 217,000
                                                    www.dol.gov/odep/alliances/directive.htm.   members;
                                                                                                Employers
Non-Grant Activity.--ODEP       Increasing         Secretary of Labor's New Freedom            Employers
 Staff work.                     Awareness about    Initiative Award (NFI): http://
                                 Persons with       www.whitehouse.gov/news/freedominitiative/
                                 Disabilities and   freedominitiative.html.
                                 Employment.
 
                                       Employment-Related Supports Policy
 
Non-Grant Activity.--ODEP       Employment and     Customized employment and Guideposts        Department of
 Staff work.                     Mental Health.     influencing the design of service           Labor /VETS &
                                                    delivery methods of OASVETS training        ETA
                                                    curriculum and REALifelines; Draft
                                                    guidance by ETA for front-line staff in
                                                    the One-Stop Career Centers nationwide.
Non-Grant Activity.--ODEP       Expanding          Executive Order (13330): Human Service      Department of
 Staff work.                     Employment-        Transportation Coordination; The            Transportation
                                 related            reauthorization of SAFETEA-LU included
                                 Transportation     $80 million in new funding for employment-
                                 Options.           related transportation for people with
                                                    disabilities: http://www.unitedweride.gov/
                                                    .
Non-Grant Activity.--ODEP       Documenting the    In June 2008, BLS will launch seven (7)     DOL/Bureau of
 Staff.                          Unemployment       disability questions in the Current         Labor
                                 Rate of People     Population Survey (CPS), which is jointly   Statistics;
                                 with               conducted by BLS and the Bureau of the      Department of
                                 Disabilities.      Census; The results will, for the first     Commerce
                                                    time, document the actual unemployment
                                                    rate of people with disabilities: http://
                                                    www.dol.gov/odep/categories/research/
                                                    rate.htm.
----------------------------------------------------------------------------------------------------------------

            Questions Submitted by Senator Daniel K. Inouye

                     TECHNOLOGY TRAINING FOR WOMEN

    Question. In your testimony, you discussed the preparation of 
workers for jobs in growth sectors of the economy. The Maui Economic 
Development Board introduced the Women in Technology program in Hawaii 
to encourage young women and underrepresented minorities to pursue 
educational opportunities in fields such as science, technology, 
engineering, and math. Madame Secretary, would you comment on programs 
to provide technology training for women, such as the Women in 
Technology Program introduced by the Maui Economic Board?
    Answer. The Department of Labor applauds State and local efforts to 
promote opportunities for women in the fields of science, technology, 
engineering and math (STEM). The national STEM workforce agenda of the 
Department's Employment and Training Administration (ETA) ensures that 
all workers, including women, can take advantage of the opportunities 
presented in the STEM fields and can develop the skills that employers 
demand. ETA's national STEM workforce agenda is focused on (1) building 
an educated and prepared STEM workforce in the context of regional 
economies; (2) developing national, State, and regional strategies for 
talent development in support of economic growth; and (3) implementing 
STEM workforce education strategies across the continuum of education 
with a focus on post secondary opportunities for workers. In the Fall 
of 2007, ETA anticipates a grant competition for approximately $10 
million for STEM talent development strategies that attract and prepare 
workers for STEM careers, including creating an alternative pathway for 
out-of-school youth.
    ETA's national STEM initiative is underpinned by the flagship 
initiatives of the agency. The President's High Growth Job Training 
Initiative builds partnerships among employers, education programs, and 
the workforce investment system to balance the skills of America's 
workers with the demands of employers in high growth, high demand 
industries that include STEM fields, such as Aerospace, Biotechnology, 
Health Care, and Information Technology. In order to build the pipeline 
of STEM workers to meet the current and future demand for their 
talents, the Community-Based Job Training Grants strengthen the 
capacity of community colleges and increase the training opportunities 
in the STEM fields.
    Within the Workforce Innovation in Regional Economic Development 
(WIRED) initiative, regions are bringing together the workforce 
investment system, the continuum of education, industry, economic 
development, and other regional partners to ensure that workers are 
becoming educated and trained for high growth occupations and sectors 
in their regional economy. Many of these regions are targeting high-
tech industries that require strong foundational skills in STEM 
education. The WIRED regions are pursuing strategies to open the door 
to STEM fields for a broader range of individuals, including developing 
2+2+2 and accelerated math/science programs, supporting teacher 
development through summer camps and internships, and establishing 
apprenticeship programs.
    Building on WIRED, Community-Based Job Training Grants, and the 
High Growth Job Training Initiative, ETA is committed to working 
collaboratively with community colleges, agencies across the Federal 
government, the State and local workforce investment system, and a wide 
array of strategic partners in the public and private sectors to help 
coordinate regional assets and to drive a national workforce agenda for 
promoting STEM education and workforce preparation.

           MAUI COMMUNITY COLLEGE NURSING DISTANCE EDUCATION

    Question. The nursing shortage in the United States is particularly 
problematic in rural communities. I appreciate your interest in 
pursuing proper labor support to train health professionals for rural 
Hawaii. In particular, distance education seems to be an effective 
strategy to train nurses in rural areas. The Department of Labor 
recently funded a streamed video delivery of the nursing curriculum at 
the Maui Community College. I am interested in your impressions of this 
nurse training program at the Maui Community College.
    Answer. The distance education program at Maui Community College 
significantly increases the geographical reach of the nursing program 
while expanding health care training capacity in Hawaii by making 
training offered at the campus available statewide through streamed 
video technology. For instance, in the spring semester pharmacology 
class, only 20 of the 130 registered students live on Maui. The 
remaining students live elsewhere in the State and accessed the course 
content remotely. This type of training delivery offers a low-cost 
means of expanding training capacity in that only one instructor is 
needed rather than a separate instructor at each campus. This is a 
promising practice in addressing the nationwide health care faculty 
shortage. Further, the fact that the training can be accessed around 
the clock from any location helps to attract more individuals to the 
profession by providing more flexible training options.

              Questions Submitted by Senator Arlen Specter

                OFFICE OF WORKERS' COMPENSATION PROGRAMS

    Question. It has taken DOL 2.5 years to post the site exposure 
matrices, which lists the toxins present at some facilities, to your 
website. Over 14,000 claims were denied under Part E before the 
claimants had access to this information. It appears that these 
claimants did not have the necessary evidence to develop their claim. 
Does DOL plan to reopen these denied claims and if so, can you 
elaborate on how long it will take and how much money will need to be 
expended?
    Answer. There are a number reasons why Part E claims have been 
denied, including the submission of claims by ineligible survivors, 
claims for non-covered employment, claims for the death of an employee 
that is not related to a covered condition, insufficient medical 
evidence to support a claimed condition, and no relationship between 
toxic exposures and the claimed conditions.
    Although the public Site Exposure Matrices (SEM) website was just 
recently launched, a SEM database has been available for claim 
adjudication purposes by claims examiners and the Final Adjudication 
Branch since April 2006. Moreover, the SEM is one of many tools 
available to DOL in making decisions on causation. Claims staff 
routinely obtains exposure information from the Department of Energy 
and former worker programs, and resource center staff conduct an 
occupational health survey with the claimant. In addition, claims staff 
may request a review of the case by an industrial hygienist or a 
physician. Utilizing the SEM database in conjunction with other 
causation development methods afforded equitable decision-making on 
claims adjudicated prior to the deployment of the public SEM website.
    As a matter of policy, the SEM is not used as the sole basis for a 
decision. Additional tools are used by the Division of Energy Employees 
Occupational Illness Compensation (DEEOIC) in causation evaluation and 
every effort is made to assist the claimant in meeting his or her 
burden of proof, regardless of what information is available in SEM.
    Further, although the SEM database is a valuable tool, it does not 
represent 100 percent of the toxic substances potentially present at a 
given facility and it is updated as new information becomes available. 
Interested stakeholders are encouraged to submit evidence to the SEM 
project team for evaluation and possible inclusion into the SEM. The 
status of site-specific comments will be available for viewing on the 
public site.
    If an individual whose claim was previously denied now finds 
information in the public SEM website concerning the toxic substances 
that are linked to his or her particular illness, and believes that 
this information is relevant to the claim and was not previously 
considered, then he or she may submit this information with a written 
request to reopen the claim to the DEEOIC.
    DEEOIC also engages in an ongoing review of the quality of 
decisions throughout the decision-making process. Recommended decisions 
are written by claims examiners and reviewed and signed by senior 
claims examiners. The claimant has the opportunity to object to the 
recommended decision through a review of the record or hearing, and the 
Final Adjudication Branch reviews and issues the final decision. Even 
after the final decision, a claimant may request a reconsideration 
within 30 days. In addition, the program conducts accountability 
reviews of a sample of cases. During these reviews, all aspects of the 
case are reviewed by a National Office team. Any errors discovered in 
the decision would result in reopening the claim.

               REQUEST FOR PHILADELPHIA SHIPYARD FUNDING

    Question. On September 7, 2006, Senator Santorum and I sent you a 
letter that identified the core concept of a project to revitalize the 
Philadelphia Shipyard. The concept is that in a global economy, 
companies focus their efforts on a limited set of core competencies and 
procure all other necessary goods and services through a highly 
competitive global sourcing process. If the procurement requirements of 
major companies are intensely analyzed, business that can potentially 
be done locally at competitive prices can be identified and 
strategically targeted.
    It is my understanding that on October 26, Assistant Secretary 
Emily DeRocco subsequently met with Philadelphia Shipyard Development 
Corporations (PSDC). PSDC explained that its goal was to have small and 
medium sized companies in the Philadelphia region reclaim supplier jobs 
now being done by foreign workers for the Aker Philadelphia Shipyard 
and to start a pilot program to prove it could be done. At that point, 
the Department of Labor was very excited about the project. The WIRED 
Region in Philadelphia was mentioned as a possibility for funding. At 
that meeting, the Department also recommended that PSDC apply for the 
WIRED 3rd Generation funding. However, as you know, the Governor is 
able to only submit two applications in this round and the Commonwealth 
has already endorsed projects for WIRED Generation 3 for Central PA and 
Western PA.
    It is more than 5 months later and the PSDC is still looking for 
funding through the Department of Labor. My constituents in Southeast 
Pennsylvania are very frustrated with this process and the progress 
with possible funding opportunities within the DoL. The innovative 
supplier network training program would return jobs to the tri-State 
region. The cost of the project is $1.6 million over 18 months. It will 
immediately result in $16 million in sales for deckhouses to be built 
here with an increasing number of local workers. It includes both 
classroom and on the job training. It will create 60 jobs which will 
pay about $55,000, including benefits, vacation and holidays.
    Once PSDC provides this turnkey process, they would like to move on 
to other supplier contracts involved in Aker's contract for 13 tankers, 
with options for more that now goes overseas.
    Where does the Department suggest PSDC go to secure the Department 
of Labor funding for this important project? This has been ongoing 
since early September 2006.
    Answer. The U.S. Government, specifically the Department of Labor 
and the Department of Defense, has devoted significant funding during 
the past 9 years to the employees of the Philadelphia Shipyard. In 
particular, the Department of Labor's Employment and Training 
Administration (ETA) has provided approximately $35,205,600 since 1997 
in the following grants:
  --A dislocated worker demonstration grant of $11,880,000 between 1999 
        and 2003;
  --A Defense Conversion Adjustment grant of $5,505,600 between 2001 
        and 2002; and
  --National Emergency Grant funds totaling $17,820,000 between 1997 
        and 2005 to serve employees of the shipyard.
    The Commonwealth of Pennsylvania has also provided considerable 
funding to support the shipyard and its employees in the form of State 
and local Workforce Investment Act funds since 1998, and previously, 
under the Job Training Partnership Act.
    ETA has worked with the Philadelphia Shipyard Development 
Corporation (PSDC) to assess the economic development opportunities for 
the shipyard and the surrounding community. Recently, Assistant 
Secretary Emily S. DeRocco convened a meeting of Federal, State, and 
local government, workforce development, economic development, and 
business leaders to examine the opportunities and challenges in 
developing the region's comprehensive economic strategy, and to 
strategically align and leverage the Federal, State, and local public 
and private resources available to transform the local economy. ETA has 
also supported collaboration between PSDC and the Mid-Atlantic 
Innovation Network and Innovation Philadelphia, which has received an 
ETA WIRED Initiative grant.
    ETA aims to award its grants through competitive processes as 
requested by Congress. ETA is facilitating a connection between Aker 
Philadelphia Shipyard and a broader audience of stakeholders and fund 
sources to determine the best methods of support for the supplier 
development proposal. ETA is hopeful that the PSDC proposal can be 
supported and that the shipyard can become self-sustaining, providing 
meaningful jobs to the many workers in the Philadelphia area.

              Questions Submitted by Senator Thad Cochran

               PROPOSALS TO STREAMLINE AND STRENGTHEN WIA

    Question. Secretary Chao, I understand that the Department of Labor 
has recently proposed policy changes to the Workforce Investment Act to 
streamline and strengthen the Nation's workforce development system. 
Can you comment on how these changes will affect States and their 
ability to meet the needs being met by the current framework?
    Answer. The administration's most recent legislative proposal for 
Workforce Investment Act (WIA) reauthorization, which was transmitted 
to the Congress in April, would improve the ability of the workforce 
investment system to support our Nation's competitiveness by providing 
States and local communities more flexibility to design streamlined 
workforce systems that best fit the unique needs of their economies. 
The proposal would also better serve the needs of American workers and 
employers by making more money directly available for education and 
training.
    Under the proposal, four separate funding streams through which 
funds are currently allotted to States to support the workforce 
investment system--the WIA Adult, Dislocated Worker, and Youth programs 
and the Employment Service--would be integrated into a single funding 
stream. This consolidated funding would be allocated to States--and 
through States to local areas--to provide Career Advancement Accounts 
and employment services to job seekers and employers. Career 
Advancement Accounts would be available to both adults and out-of-
school youth entering or re-entering the workforce or transitioning 
between jobs, and to incumbent workers in need of new skills to remain 
employed or move up the career ladder.
    The proposal would further enhance the workforce investment system 
by strengthening One-Stop Career Centers, providing for more effective 
governance arrangements, promoting access to a more comprehensive array 
of employment and training services, and improving performance 
accountability. We believe our proposal will give States the tools they 
need to enable current and future workers to gain the skills needed to 
successfully enter, navigate and advance in the 21st century labor 
market.

        HIGHER EDUCATION AND ADVANCED SKILL TRAINING INITIATIVES

    Question. Secretary Chao, as we prepare workers for the new 
challenges of competing in a global economy, can you comment on 
specific initiatives that will provide opportunities for higher 
education and advanced skill training?
    Answer. Today's globally competitive economy has heightened the 
demand for a skilled workforce. Aligning the workforce system with the 
new economic realities of the 21st century is critical to ensuring that 
American workers and businesses are competitive in the global 
marketplace. The Department of Labor has strived to transform the 
workforce investment system into a demand-driven system that catalyzes 
and leverages all available resources to respond to regional 
businesses' need for a skilled workforce and create employment and 
advancement opportunities for workers. The Department has undertaken 
three key initiatives to create a demand-driven workforce investment 
system and increase opportunities for education and skills training:
  --Through the President's High Growth Job Training Initiative, ETA 
        has invested over $285 million in 150 partnerships among 
        employers, education programs, and the workforce investment 
        system. Each project targets the skill and talent needs of 
        high-growth, high-demand and transformational industries in our 
        Nation's economy and provides the resources necessary to train 
        workers in the skills demanded by the 21st century economy.
  --Community-Based Job Training Grants, also known as the Community 
        College Initiative, seek to address a critical shortcoming in 
        the workforce development capacity of many regions by 
        supporting community colleges to train workers for jobs in 
        high-growth, high-demand industries. Due to their close 
        connection to local labor markets, community colleges are well 
        positioned to understand the intricacies of local economies and 
        better prepare workers for occupations in these industries. The 
        Department has provided $250 million to 142 community colleges 
        and other entities under this initiative.
  --The Department launched the Workforce Innovation in Regional 
        Economic Development (WIRED) Initiative in February 2006 to 
        emphasize the critical linkage between workforce development 
        and economic development in regional economies. WIRED focuses 
        on the role of talent development in driving regional economic 
        competitiveness, job growth and prosperity for workers. Under 
        the WIRED Initiative, the Department has invested $260 million 
        and provided expert assistance to 26 regions across the Nation 
        to implement strategies that will create high-skill and high-
        wage opportunities for American workers.
    In addition, the administration has recently submitted Workforce 
Investment Act (WIA) reauthorization legislation to Congress that would 
improve the ability of the workforce investment system to support our 
Nation's competitiveness. The proposal would provide State and local 
communities with more flexibility to design streamlined workforce 
systems that best fit the unique needs of their economies. The WIA 
reauthorization proposal would also better serve the needs of American 
workers and employers by making more money directly available for 
education and training.

          Questions Submitted by Senator Kay Bailey Hutchison

  ADMINISTRATIVE FUNDING FOR STATE UNEMPLOYMENT COMPENSATION PROGRAMS

    Question. It is my understanding that the Resource Justification 
Model, currently being utilized to allot funds to the States to 
administer the State unemployment compensation program, is under review 
by DOL.
  --Could you explain how DOL is planning to comply with the current 
        Federal statutory requirements (i.e., to properly allocate 
        funding to States based on(1) determinations necessary for the 
        proper and efficient administration of the UI program, (2) the 
        population of the States, and (3) the estimated number of 
        persons covered by each State's law)?; or
  --Does DOL currently allocate State administration grants according 
        to these certain enumerated Federal requirements and 
        appropriately account for State populations and their 
        administrative efficiencies?
  --If you believe that DOL is properly allocating the UI 
        administrative grants, then could you explain how DOL, and its 
        current methodology, is in compliance with Federal law in its 
        administration of the grants to the States equitably?
    Answer. The Department of Labor has completed its review of the 
long-standing method by which the Department of Labor allocates funds 
to States to administer the unemployment compensation program. The 
Department determined that the method takes into account the statutory 
requirements of section 302(a) of the Social Security Act (SSA).
    Section 302(a) requires the Secretary to grant each State ``such 
amounts as the Secretary of Labor determines to be necessary for the 
proper and efficient administration . . .'' of the State's unemployment 
compensation law. In making this determination, the Department collects 
data through the Resource Justification Model (RJM) reflecting actual 
expenditures by States each year in administering their unemployment 
compensation laws. The Department uses these data along with its 
projections of the level of claims and employers in each State for the 
upcoming budget year to determine the amount allocated to each State. 
These allocations in total are constrained by the total amount 
appropriated for State Unemployment Insurance administration.
    The Department believes that all of the enumerated Federal 
requirements cited in section 302(a), including population, are 
appropriately accounted for in the allocation methodology. The statute 
does not assign weights to the various factors cited, thereby allowing 
the Secretary broad discretion. A key component of the allocation 
methodology is a State's claims workload level which is influenced by 
factors including the population of the State, its economic situation, 
and its unemployment compensation laws. In addition, a State's 
population is reflected in the number of wage records reported 
quarterly by employers and processed by States as a workload item 
funded in the allocation methodology. Wage records are also an 
excellent ``estimate of the number of persons covered by the State 
law'' cited in section 302(a).
    ``The cost of proper and efficient administration'' upon which the 
Secretary is to determine the allocation begins with the actual cost 
data collected by RJM. However, the allocation process takes into 
consideration each State's operating costs vis-a-vis other States, and 
adjusts downward (through an iterative mathematical process) the 
subsequent year allocations of States whose costs are comparatively 
higher, thus encouraging efficiency in program administration. Finally, 
the statute allows the Secretary to use other relevant factors which, 
for example, include the cost of space rental and maintenance, 
utilities costs, and personnel salaries and benefits.
    Each State's administrative funding allocation is based on State 
submitted data and a methodology which treats each State equally using 
the factors cited in section 302(a). Hence, the Department believes 
administrative funding for the unemployment compensation program is 
allocated equitably among States and in compliance with Federal 
requirements.

                          SUBCOMMITTEE RECESS

    Senator Harkin. Thank you very much, Madam Secretary. I 
hope that our subcommittee here will do you a favor and give 
you more money than what you requested.
    The subcommittee will stand in recess to reconvene at 2 
p.m. on Tuesday, April 17, in room SD-124. At that time we will 
hear from Dr. Julie Gerberding, Director, Centers for Disease 
Control and Prevention and Dr. Thomas R. Insel, Director, 
National Institute of Mental Health.
    [Whereupon, at 11:28 a.m., Wednesday, March 28, the 
subcommittee was recessed, to reconvene at 2 p.m. Tuesday, 
April 17.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              


                        TUESDAY, APRIL 17, 2007

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 2:05 p.m., in room SD-124, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin, Durbin, Reed, and Specter.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

               Centers for Disease Control and Prevention

STATEMENT OF DR. JULIE GERBERDING, DIRECTOR

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. Good afternoon, the Subcommittee on Labor, 
Health, Human Services, Education, and Related Agencies of the 
Appropriations Committee will come to order.
    The subcommittee has invited a number of distinguished 
witnesses to appear before this hearing and this subcommittee, 
to tell us more about a very important issue, autism.
    The Centers for Disease Control and Prevention estimates 
that 1 of every 157 children born this year will be diagnosed 
with autism. Millions of families across the country are facing 
the very real difficulties in coping with this disease.
    It's tough on parents who would do anything to help their 
children at home, while at the same time, fighting to find the 
supportive services that their children so badly need. We hear 
the heartbreaking stories, day after day, about families just 
trying to get the best treatments for the children, and 
wondering why it's their family that faces this ordeal.
    I know we have heard from several families and groups, and 
I want to thank them for sharing their stories.
    This hearing will address a number of questions. First, is 
the prevalence of autism on the rise, both in the United States 
and other countries? If so, why is that? Is there really an 
increase in children of autism, or is the disease being better 
diagnosed? I keep hearing both sides of that debate.
    Second, of course, what causes autism? Is it environmental, 
is it genetic? Is it a combination of both? Imagine my 
surprise, when I read the last issue of Discover magazine. It 
had a big story in there about understanding autism, and the 
subtitle is, The Answer May Lie in the Gut, Not in the Head, 
saying that there may be a direct link between physical 
illness--physical illness--and the onset of autism. So, again, 
I'll be asking questions about that article. [Discover 
magazine, April 2007, ``Autism: Its Not Just in the Head,'' by 
Jill Neimark.]
    Third, what therapies work best for children with autism? 
Are parents able to find the services they need for their kids, 
and at what cost?
    As Dr. Favell will point out, and also Marguerite Colston 
in her testimony, that in looking for a cure and putting more 
research dollars out there, and trying to find how we have a 
cure, or a good intervention, we can't forget the families need 
help now. Now--not 10 years from now, they need help right 
now--in finding the best possible support for their children.
    So, we have two panels of witnesses today. The first panel 
will be, of course, Dr. Julie Gerberding, the Director of the 
Centers for Disease Control and Prevention, who will talk about 
the incidents, and prevalence, of autism. Dr. Thomas Insel, the 
Director of the National Institute of Mental Health, will bring 
us up to date on some of the science.

                           PREPARED STATEMENT

    Our second panel will include Dr. Judy Favell, who has done 
great work with young children with autism; Marguerite Colston, 
a parent of a child with autism who can speak to the issue from 
the perspective of a parent; Mr. Bob Wright, the Co-Founder of 
Autism Speaks; and, Bradley Whitford, actor; as well as, former 
Deputy Chief of Staff to President Jed Bartlett (on TV, of 
course) and foremost an advocate for children with autism.
    [The statement follows:]

                Prepared Statement of Senator Tom Harkin

    Good Afternoon. The subcommittee has invited a number of 
distinguished witnesses, this afternoon, to bring us up to date on a 
very important topic: the status of autism, and of autism research, in 
the United States. The Centers for Disease Control and Prevention 
estimates that one of every 157 children born in the United States this 
year will be diagnosed with autism. Millions of families are grappling 
with the profound difficulties of understanding and coping with this 
disease. My heart goes out, in particular, to parents who go to heroic 
lengths to assist their autistic children at home, and who fight the 
daily fight to secure the support services that their children so badly 
need.
    This hearing will look at several key questions:
    First, the number of diagnosed cases of autism is on rise, both in 
the U.S. and in other countries. Why is this? Are we simply doing a 
better job of diagnosing autism, or has there been a real increase in 
the incidence of this disease?
    Second, what causes autism? Are the causes environmental? Are they 
genetic? My guess is that it is a combination of the two, but I am 
eager to hear the views of our witnesses.
    Third, which therapies work best for children with autism? And are 
parents able to find the services they need for their children, and at 
what cost? As Dr. Favell points out in her testimony: while doing 
research on causes and cures is important, people need help now to 
overcome or lessen the effects of autism.
    Last, what is the outlook for finding a cure for autism? And what 
more can the federal government do to help?
    We will have two panels of witnesses today. The first panel 
includes Dr. Julie Gerberding, the Director of the Centers for Disease 
Control and Prevention, who will talk about the incidence of autism; 
and Dr. Thomas Insel, Director of the National Institute of Mental 
Health, who will bring us up-to-date on the science and research.
    Our second panel includes Dr. Judy Favell, who has done great work 
with young children with autism; Marquerite Colston, a parent of a 
child with autism, who will speak to this issue from the perspective of 
a parent; Bob Wright, the co-founder of Autism Speaks; and Bradley 
Whitford, former deputy chief of staff to President Jed Bartlett--
actually, a very accomplished actor--and an outspoken advocate for 
children with autism.

    Senator Harkin. With that, I will turn to my colleague, 
Senator Specter.

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Thank you, Senator Harkin, for convening 
this very important hearing on this very debilitating disorder. 
We have seen a significant increase in the funding by the 
National Institute of Health for autism research from $27 
million in 1998, to the current funding of $108 million. CDC 
funding for autism has grown from $281,000 in 1998, to $15.1 
million today.
    My view is that the funding through the NIH is 
insufficient. As is generally known, Senator Harkin and I have 
taken the lead on increasing the funding for the National 
Institutes of Health from $12 billion to $29 billion. During 
the course of the past decade, we have re-allocated priorities 
within this subcommittee--as we frequently say, the gavel has 
changed seamlessly between the two of us over the course of the 
past decade and a half--and in some years, have increased NIH's 
funding by as much as $3.5 billion.
    This year, with a lot of pressure, the budget resolution 
came forward with an additional $1.5 billion, and Senator 
Harkin and I added an amendment to add $2.2 billion more to the 
National Institutes for Health.
    Candidly, a budget resolution is only Confederate money, it 
doesn't really count until there is an allocation. Senator 
Harkin and I are working our way up the seniority route, and 
we're getting to be closer to the coveted status of chairman of 
the Appropriations Committee. Only Senator Cochran is ahead of 
me on the Republican side, and it's a great position to have to 
be able to deal in real dollars when those allocations are 
made.
    But, we hear parents across the country tell us about their 
children with autism, and it's an ailment, a malady, which I 
think could be, could be solved if we had sufficient research 
intensity.
    For a moment, on a purely personal note, one of the leading 
national advocates on this subject is John Shestack, who is the 
son of a very prominent lawyer, Jerome Shestack in 
Philadelphia--longstanding friend of mine--and, his mother 
Marcia Rose is a noted television personality. John and his 
wife, Portia, have established a foundation, one of the largest 
non-governmental funding resources for autism, and they have 
recently joined with Bob and Suzanne Wright for the February 
merger of their two leading autism organizations.
    So, it is very heartening to see this in the private 
sector, and Senator Harkin and I, and this committee--and I 
think, really, the whole Congress--are determined to increase 
funding so we can find an answer to autism.
    Regrettably, I'm not going to be able to stay for the 
entire hearing today, we are very deeply involved in the issue 
with the Department of Justice and the resignation of the U.S. 
Attorneys which is taking a great deal of time, and I'm going 
to have to excuse myself partway through this hearing to attend 
there, but I will stay for as long as I can.
    Thank you, Mr. Chairman.
    Senator Harkin. Thank you very much, Senator Specter. 
Again, thank you for our close working relationship over all 
these years, and for your continued commitment to bio-medical 
research and especially to this very important issue of autism.
    I had dinner Sunday night with a couple whose child is 
autistic, and all I can say is that we've got to get the 
families some help. People are looking to us for answers and 
some help. Hopefully this hearing today will point us in the 
right direction.
    So, let's get started, and I'll just make it clear that all 
of your statements will be made part of the record in their 
entirety. I'm going to ask each of our witnesses to try to sum 
it up in about 5 minutes. But if you get around 7 minutes or 
so, I might start motioning for you to quit.
    So, if you could just sum it up for us, and then I'm going 
to ask both you, Dr. Gerberding and Dr. Insel, at the end of 
your presentations, to maybe take a seat on either end, and 
we'll bring up the other witnesses. It's not my intent to 
question you at that time--but to question everyone all at 
once.
    Okay? So, we'll kick it off first with Dr. Julie 
Gerberding, the Director of the Centers for Disease Control and 
Prevention. Dr. Gerberding, welcome back.

              SUMMARY STATEMENT OF DR. JULIE L. GERBERDING

    Dr. Gerberding. Thank you, it's good to be back. We really 
appreciate the committee's interest in this topic. Is my 
microphone on, can you hear me okay?
    Senator Harkin. Yes.
    Dr. Gerberding. We are very grateful for all of the support 
that the committee has given us, and particularly for our 
ability to expand our autism activities significantly.
    Senator Harkin, I also know that you walk your talk on this 
issue, having had a chance to be with you at the summer 
Olympics--the Special Olympics last summer--and knowing your 
commitment to developmental disabilities, and disabilities of 
all nature. So we really appreciate your championing this 
issue.
    I'd like to share with you the CDC perspective on autism 
and the work that we're doing. It's important to appreciate 
that we recognize that we're talking about a spectrum of 
diseases here, not a single disease. We're talking about 
autism, per se, about pervasive developmental disorders, and 
some other conditions that have characteristics in common with 
autism--Asperger's disorder and some other conditions--and 
these are diseases that are not diagnosed by a test. They're 
diseases that are diagnosed by observing behaviors, and 
watching behaviors change and develop over time. So, there's a 
lot of difficulty in making a distinction between who has what, 
and where one of these conditions leaves off and the other one 
begins.
    We know that autism has a tremendous impact on children who 
are affected as well as their families and the people who care 
for them. The diseases are characterized primarily by 
difficulties in forming relationships, and engaging in the kind 
of social interactions and communications that enrich life, and 
allow people to effectively communicate with one another.
    Many of these children also have differences in the way 
they respond to stimuli in the environment; the way they learn, 
the way they play, and the way they experience their life 
overall.
    The bottom line is, there is no cure for autism now, and 
these effects can last a lifetime. We also know that the sooner 
we make the diagnosis of autism spectrum disorders, the more 
likely children are to benefit from interventions, and so it's 
imperative that we not wait until the full-blown syndrome has 
evolved, but that we have early detection and characterization.
    Under the Combating Autism Act, CDC has three main 
responsibilities. One is, to answer your first question, what 
is the prevalence of autism in our communities, and is it 
changing over time, and who is at risk, why and when?
    Our second priority is research. We are engaged in several 
kinds of epidemiologic research that will help us look at a 
variety of the hypotheses about causality, and try to make some 
determinations about which are the most promising associations, 
and what can we learn about cause that could help us lead to 
intervention, or even treatment.
    Last, and importantly, is our responsibility for awareness. 
We need to be able to inform parents and caregivers, as well as 
teachers and clinicians about the full spectrum of these 
conditions so that earlier diagnosis is possible. We also need 
to improve community awareness so that children can live more 
comfortably in their communities, and overall public awareness 
so that we have the kind of support we need to solve these 
problems.
    Just recently, CDC published information about the rate of 
autism in communities around our country. I'm going to focus on 
the communities that were reporting data in 2002, we also have 
a report from 2000, and there will be an upcoming report on 
information from 2004. But the information from 2002, probably 
is the largest sample, and so I'm going to focus on that--this 
represents about 10 percent of 8-year-old children in our 
country, so it's not everyone, it's not every community, but 
it's a significant proportion.
    What was found in this study is that about 1 in 150 
children have autism. Boys, in general, were more likely than 
girls, and at least some of the sites showed that white 
children were more likely to have autism than non-white 
children. So, this is a healthy--a helpful--perspective, but we 
can't yet say anything about trends over time, until these 
studies go on for a longer period of time.
    We also have initiated a set of studies in a group of sites 
called CADRE, Centers for Autism and Development Disabilities 
Research and Epidemiology. And this is a study that will allow 
us to look at causes. We're going to compare children who have 
these disorders, with children who have other disabilities, and 
children who are normal, and look for the frequency of a 
variety of factors, including infections, as you mentioned in 
the Discover magazine, their parents' health status, their 
family health status, their genes and so on and so forth. We 
will be able to tease out of that leading hypothesis about why 
are children with autism different from children who have other 
conditions, or who don't have a developmental disability. This 
is a project we're starting this spring, and we will probably 
have information from the study over the next couple of years.
    The last point I wanted to make very quickly, was the 
importance of awareness. We know that at least half of children 
with autism have obvious symptoms and signs before they're age 
three, but most children with autism are not diagnosed until 
they are 4 or 5 years old, so there's a gap between when it 
should be completely clear what is going on, and the gap when 
they come to attention.
    So, we initiated this ``Learn the Signs, Act Early'' 
campaign to target parents, health professionals and caregivers 
in pre-school and daycare to be able to recognize the child who 
is at risk, or who may have early signs. Of course, we're doing 
this with a number of our partners.
    This has been an incredibly effective campaign already. 
Pediatricians now indicate that they have the tools to be able 
to diagnose autism at least two-thirds of the time, parents 
understand that this disease can be detected through 
developmental screening, and an increasing proportion of 
doctors recognize that you can diagnose autism as early as 18 
months, and that you need to initiate the screening much 
earlier than when the child enters school, which is often when 
these conditions are initially detected.

                           PREPARED STATEMENT

    So, we're going to continue this awareness campaign, we 
hope that will create a platform so that the work that we're 
doing on research, on causality and interventions will have a 
better chance to really make a difference.
    So, I--again, I thank you for your attention, and I look 
forward to being able to answer some specific questions that 
you mentioned at the beginning of this hearing.
    [The statement follows:]
             Prepared Statement of Dr. Julie L. Gerberding
    Good afternoon, Senator Harkin and distinguished members of the 
subcommittee. Thank you for the opportunity to appear before you on 
behalf of the Centers for Disease Control and Prevention (CDC), an 
agency of the Department of Health and Human Services, to discuss our 
agency's research and prevention activities addressing autism spectrum 
disorders. Thank you also for your continued support of CDC's goals in 
support of healthy people throughout all stages of their lives and 
facets of living. Good health is essential to a good life, and the 
health and well-being of a Nation's people are essential for its 
continued strength and growth.
    Today, our Nation and the world are focused on urgent threats such 
as pandemic influenza, natural disasters, and terrorism. While these 
threats require and deserve our immediate attention, we cannot lose 
sight of the pressing realities of public health issues that we face 
every day, such as autism and other developmental disabilities. Autism 
spectrum disorders include autistic disorder, pervasive developmental 
disorder--not otherwise specified (PDD-NOS, including atypical autism), 
and Asperger's syndrome.
    Autism spectrum disorders cause considerable impairments in social 
interaction and communication that show up early in a child's life--
before the family celebrates the child's third birthday--and can 
dramatically affect a child's ability to participate in activities with 
loved ones, caregivers, and peers. It is often difficult for a child 
with an autism spectrum disorder to communicate and interact with 
others, and they can retreat from group activities. An affected child 
may also have unusual ways of learning, paying attention, or reacting 
to different sensations, and can show unusual behaviors and interests. 
There's no cure at this time, and the effects of these disorders can 
last a lifetime. The profound lifelong impact of autism spectrum 
disorders, tremendous costs to the affected individuals and their 
families, the lack of known causes or cures, and concerns about the 
increased rates of diagnosis all make autism spectrum disorders one of 
our urgent realities, and a top concern for many families, health 
professionals, educators, and local and national organizations.
    CDC's efforts on autism spectrum disorders are led largely by our 
National Center on Birth Defects and Developmental Disabilities 
(NCBDDD), which was created following the Children's Health Act of 
2000. The Center takes a life-span approach by working to identify and 
prevent birth defects and developmental disabilities--including autism 
spectrum disorders--and by promoting the health of children and adults 
with disabling or potentially disabling conditions. The Center's top 
priorities are improving health and wellness for people with 
disabilities, preventing birth defects, and addressing autism and 
related conditions.
    As reauthorized by the Combating Autism Act of 2006 (Public Law 
109-416), NCBDDD's work in autism spectrum disorders focuses on three 
broad areas--understanding rates and trends, advancing public health 
research in the search for causes or a possible cure, and improving 
early detection and diagnosis so that affected children can begin 
receiving intervention as soon as possible. Early intervention that 
provides structure, direction, and organization can often help a child 
with an autism spectrum disorder. Today, I will provide an update on 
the prevalence of autism spectrum disorders, discuss the launch of 
CDC's epidemiologic study of potential causes and correlates, and share 
with you some of our successes in promoting early identification of 
autism spectrum disorders and other developmental disabilities.

           CDC'S WORK IN AUTISM SPECTRUM DISORDERS PREVALENCE

    Parents, policy makers, and the public want to better understand 
how many people are affected by autism spectrum disorders--and whether 
the higher rates are due to better identification or a true increase in 
the occurrence. In order to address these questions about rates and 
trends, we have focused our efforts on developing prevalence estimates 
of autism spectrum disorders in multiple communities over time. 
``Prevalence'' is the number of existing disease cases in a defined 
group of people during a specific time period, and it should be 
differentiated from ``incidence,'' which is the number of new cases for 
a given period of time.
    Previous efforts to understand the prevalence of these conditions 
have varied widely in their methods and findings--making it difficult 
to accurately answer critical questions about trends. For example, 
studies published before 1985 indicated that the prevalence of autism 
and related conditions was 0.4--0.5 per 1,000 children. However, later 
studies using updated diagnostic criteria and differing methods from 
multiple countries have identified rates ranging from 2.0 to 12.0 per 
1,000 children with ``best estimate'' rates ranging from 2.0 to 6.0 per 
1,000 children. Two previous CDC studies specific to U.S. communities 
from the mid-1990s found rates of 3.4 and 6.7 per 1,000 children 3-10 
years of age and have identified the urgent need for population-based 
autism spectrum disorder prevalence monitoring in the United States.
    CDC has been monitoring the prevalence of developmental 
disabilities since the 1980s and autism spectrum disorders specifically 
since 1996. Since 1999, CDC and its partners in 14 States have been 
building the Autism and Developmental Disabilities Monitoring (ADDM) 
Network to better understand the size and characteristics of the 
population of children with autism spectrum disorders, and to provide 
consistent and reliable estimates over time. This network, the only one 
of its kind, provides multiple-site, multiple-source, population-based 
prevalence data on the number of children with an autism spectrum 
disorder. CDC began with six sites (Arizona, Georgia, Maryland, New 
Jersey, South Carolina, and West Virginia) in 2000 and in 2002 expanded 
to include eight additional sites (Alabama, Arkansas, Colorado, 
Missouri, North Carolina, Pennsylvania, Utah, and Wisconsin). Today, we 
are continuing our surveillance efforts in 10 of these sites. While 
this method does not provide a nationally representative sample, the 
network represents the largest effort to monitor prevalence to date, 
capturing up to 10 percent of the U.S. population of 8-year-old 
children. The network aims to provide accurate information and a strong 
basis for bringing autism and developmental disabilities surveillance 
to scale, similar to our national efforts in monitoring other urgent 
realities.

                      RECENT PREVALENCE ESTIMATES

    Together with our partners in the ADDM network, CDC is beginning to 
answer one of the critical concerns that I discussed earlier--are rates 
of autism spectrum disorders truly increasing? In February of this 
year, the CDC released the largest summary of prevalence data from 
multiple U.S. communities ever reported. The results showed an average 
of 6.7 children out of 1,000 with an autism spectrum disorder in the 
six communities assessed in 2000, and an average of 6.6 children out of 
1,000 with an autism spectrum disorder in the 14 communities included 
in the 2002 study. The average finding of 6.6 and 6.7 per 1,000 eight-
year-olds translates to approximately 1 in 150 children in these 
communities. This estimate is consistent with the upper end of 
prevalence estimates from previously published studies, with some of 
the communities having an estimate higher than those previously 
reported in U.S. studies. Reported rates ranged from about 1 in 100 to 
1 in 300 children in the 2002 study year.
    Six of the participating sites (Arizona, Georgia, Maryland, New 
Jersey, South Carolina, and West Virginia) reported data in both 2000 
and 2002. Autism spectrum disorder prevalence was similar across the 2 
years in four of the six sites. New Jersey's prevalence estimates are 
higher than all other sites in both years, but did not increase 
significantly between 2000 and 2002. In West Virginia, the prevalence 
estimate is significantly higher in 2002 than in 2000; the prevalence 
in Georgia appears to have increased, but not significantly. While the 
stability of autism spectrum disorders in four of the six sites is 
fairly consistent, the increase in two sites is a concern.
    As anticipated, the findings from both study years confirmed a 
higher prevalence for boys than girls; this finding is consistent with 
past studies. Also, the data show some differences in rates among 
children by race or ethnicity. Similar to past reports, prevalence 
rates in most sites were similar for white and black children; however, 
five of the 14 sites found a higher prevalence among white children 
compared to estimates for black children.
    In addition to measuring prevalence and demographic differences, 
the studies looked at when parents and others first noted signs of 
developmental concerns in their children. We know that autism and 
related conditions can be diagnosed as early as 18 months. However, 
these studies showed that up to 88 percent of children with an autism 
spectrum disorder had documented developmental concerns before the age 
of three, but half of these were diagnosed between 4\1/2\ and 5\1/2\ 
years. It is of critical importance to diagnose the child as early as 
possible, as early intervention services hold the most promise to 
improve the quality of life for these children and their families.
    The 2000 and 2002 data points do not constitute a trend, but they 
do provide important baseline information on the prevalence of autism 
spectrum disorders in multiple areas of the United States. As I 
mentioned earlier, we are continuing to work with our network partners 
on prevalence estimates for 10 of these same sites for 2004 and 2006. 
Since the system has now been established, I expect information for 
these new data points will come more quickly, hopefully by the end of 
2008.
    I want to stress that CDC and many of our public and private 
partners see these numbers as an important step in understanding autism 
spectrum disorders, but more importantly, we recognize that ``1 in 150 
children'' represents the lives of the hundreds of thousands of 
children and parents touched by autism and related conditions. Because 
of this, we are committed to the search for answers. We are also 
working to ensure that parents, health care and child care 
professionals, and everyone who cares for children, are able to 
recognize the early signs of autism spectrum disorders. In the absence 
of a cure, early identification and action hold the most promise for 
affected children and families.

                         EPIDEMIOLOGIC RESEARCH

    We all want to know the causes of autism and related conditions. In 
addition to building a public health surveillance network for 
developmental disabilities, CDC has also been researching potential 
causes. Following the passage of the Children's Health Act of 2000, CDC 
has been working closely with partners in five sites to develop the 
Centers for Autism and Developmental Disabilities Research and 
Epidemiology, or CADDRE. This multi-state collaborative study will help 
to identify factors that may put children at risk for autism spectrum 
disorders and other developmental disabilities.
    CADDRE is a collaborative effort from which we expect to build a 
large pooled data set that will be used to examine priority research 
questions. As the largest epidemiologic study of its kind, it holds the 
potential to be an important complement to the array of other work 
occurring at the National Institutes of Health and in academia. It is 
important to note that what CDC brings to autism spectrum disorder 
research is a unique perspective of studying health issues in large 
populations--not just among individuals or families who self-refer for 
intervention or study. To date, CADDRE sites have studied conditions 
that often occur with autism spectrum disorders, screening and 
management, and associations with immune system and genetic and 
environmental factors.
    Later this spring, CADDRE will begin data collection to study a 
number of factors for their potential association with autism spectrum 
disorders. Known as the Study to Explore Early Development (SEED), the 
factors include: infections or abnormal responses to infections in the 
child, mother, or father; genetic factors in the child, mother and 
father; mother's reproductive history; abnormal hormone function in the 
child, mother or father; gastrointestinal problems in the child; family 
history of medical and developmental problems; select environmental 
exposures; behaviors during pregnancy; and parents' occupations and 
other socio-demographic factors. The information will be obtained by 
conducting interviews and exams, reviewing medical records, and by 
collecting cheek swabs and blood and hair samples.
    Several steps in the development of SEED have already been 
completed. The protocol has been written, and Institutional Review 
Board approval has been obtained. In addition, site-specific advisory 
boards have been established to review the study materials and the 
study design. Focus groups with parents of children--with and without 
developmental disabilities--were conducted to obtain additional 
feedback on the study design and feasibility of the study. The 
implementation and quality control protocols for all aspects of SEED 
field work have been developed and ``train-the-trainer'' sessions for 
field implementation procedures have been completed. Data sharing 
protocols and general analysis plans have been developed, and the 
CADDRE Information System (web-based subject tracking and data 
collection application) has been established. We expect data collection 
to take 3 to 4 years, and preliminary results would be available 
shortly thereafter.
    Study participants will include approximately 3,000 children ages 
2-5 years and their parents. All study children will be drawn from the 
cohort of children born and currently residing in the study areas of 
each CADDRE site in select birth years. Three groups of children will 
be selected: children identified with autism spectrum disorders, 
children identified with other developmental problems, and a random 
sample of all children in each area born in the selected birth years 
(most of them typically developing).

                       LEARN THE SIGNS. ACT EARLY

    Recent studies have shown that developmental disabilities such as 
autism spectrum disorders can be diagnosed as early as 18 months; 
however, we know that about half of all children are not diagnosed 
until much later. Early intervention is a child's best hope for 
learning to communicate and connect with his or her parents and friends 
and to be able to learn in a classroom with his or her peers.
    CDC, in collaboration with a number of national partners--the 
American Academy of Pediatrics (AAP), Autism Speaks (Cure Autism Now 
and the National Alliance for Autism Research, which have both recently 
merged with Autism Speaks), the Autism Society of America (ASA), First 
Signs, the Interagency Autism Coordinating Committee (IACC), and the 
Organization for Autism Research (OAR)--launched a national public 
awareness campaign in 2004 called Learn the Signs. Act Early. The 
campaign aims to educate parents, health care professionals, and child 
care providers about child development, including the early signs of 
autism spectrum disorders and other developmental disabilities, and to 
encourage developmental screening and intervention. Learn the Signs. 
Act Early. builds on familiar experiences of parents, such as 
monitoring their children's physical growth, and expands to social and 
emotional milestones such as how children speak, learn, act, and play. 
Just as taking a first step is a developmental milestone, so are 
smiling, pointing, and waving goodbye.
    We know that when developmental delays are not recognized early, 
children cannot get the help they need. By increasing the awareness of 
autism spectrum disorders and other developmental disabilities and 
their signs and symptoms, we can increase early developmental 
screening, diagnosis and intervention. This means affected children can 
receive the help they need to enhance their development and improve the 
quality of life for them and their families.
    To date, the campaign has reached more than 11 million health care 
professionals, parents, partners, campaign champions, and it is 
achieving its first goal--to encourage target audiences to ``Learn the 
Signs'' of autism spectrum disorders and other developmental 
disabilities. Outcome data show significant improvements in the 
percentage of parents who are aware of early warning signs of 
developmental delays, as well as increases in the number of 
pediatricians who agree that a child with an autism spectrum disorder 
can be diagnosed as early as the age of 18 months. Since the launch of 
the campaign, more pediatricians report that they regularly screen 
pediatric patients for developmental delays.
    In November 2006, Learn the Signs. Act Early launched the childcare 
provider segment, targeting the more than 407,000 childcare facilities 
in the United States. This new phase will provide free materials to 
help childcare providers and preschool teachers educate parents about 
child development and autism spectrum disorders.

                          FUTURE OPPORTUNITIES

    CDC recognizes that parents want answers. If a child has an autism 
spectrum disorder, his or her parents want to know what caused it, the 
most effective intervention, and how they can lower their risks if they 
plan to have other children. We share their frustration at not having 
more answers about the causes and possible cure for the debilitating 
symptoms of autism and related conditions. That is why CDC continues to 
track the rates of autism spectrum disorders, research possible causes, 
and provide accurate information about identifying developmental 
concerns and seeking help during a child's early years of development.
    CDC is positioned to bring surveillance, research, awareness and 
intervention activities to scale. Building on the encouraging success 
in these areas, CDC can continue answering important questions about 
prevalence and trends and can bring to bear population-based research 
tools in the effort to find answers about potential causes of autism 
spectrum disorders. The CDC can encourage the best known timely 
interventions for children and their families. Enhancing our programs 
would allow us to maintain surveillance in key sites and evaluate 
prevalence for different age groups, research potential causes more 
aggressively, and answer prevalence and trend questions faster. We can 
build on successes in educating the public about early intervention and 
education in our Learn the Signs campaign by continuing to develop and 
implement strategies to support parents, healthcare professionals and 
childcare providers in their efforts to Act Early when concerns are 
raised about autism spectrum disorders and other developmental 
disabilities.
    Thank you for the opportunity to appear here today to discuss this 
important public health issue. Thank you also for your continued 
interest in, and support of, our activities on autism spectrum 
disorders. Together we hope to find answers for this very complex 
disorder.
    I appreciate your longstanding support for our vision of healthy 
people throughout all stages of their lives and all facets of living. I 
will be happy to answer any questions you may have.

    Senator Harkin. Thank you, Dr. Gerberding, and I just 
mentioned, I am going to change the format since Senator 
Specter has to leave, I will go with Dr. Insel, then we will 
have some questions for the two of you before we bring the 
other people up.
    Dr. Gerberding. Thank you.
    Senator Harkin. Now, we turn to Dr. Thomas Insel, Director 
of the National Institute of Mental Health since September 
2002. Dr. Insel received his B.A. and M.D. degrees from Boston 
University. Dr. Insel, welcome back to the committee.

                     National Institutes of Health


                  National Institute of Mental Health

STATEMENT OF DR. THOMAS R. INSEL DIRECTOR
    Dr. Insel. Thank you, Senator Harkin and Senator Specter.
    It's a real pleasure to be here, and I too would like to 
express my gratitude for the support that we've gotten from 
both of you, and your leadership positions over the years.
    As you mentioned, the NIH budget has increased very 
significantly, in the case of autism, it's gone up, actually, 
almost five-fold since 1997, and that's only possible with your 
leadership and with your advocacy for bio-medical research.
    I think in view of the time and the number of the things 
that we want to cover, you already have my written testimony, I 
think I will make my comments rather brief.
    What I thought I would do is speak to what we actually 
know, that we're confident about at this point in time, and 
unfortunately, I can do that in less than 5 minutes, because 
it's a fairly short list.
    So, what you have before you are what, I think, are the 
four most important points that we can use as a baseline for 
the knowledge-base. We can talk more about some of the 
specifics and some of the actual research, as we get further 
into the hearing.
    The first point to make, and it may seem obvious, but it's 
actually a fairly complicated point, is that autism is a 
developmental brain disorder. Yes, it involves other organs of 
the body, and the gut is one that has been implicated, as you 
mentioned Senator Harkin, but it's important for us to focus on 
this as a brain disorder that evolves through development.
    The reason I stress that is, because when you think about 
developmental brain disorders, it's not simply what happened, 
or where it happened, it's when it happened that may be really 
critical. So, much of what we need to understand is when the 
train goes off the tracks in brain development to result in the 
kinds of deficits that Dr. Gerberding mentioned--the 
difficulties in social reciprocity, the difficulties in 
language, the abnormal behaviors that are really key to autism.
    It changes the way we think about this a little bit because 
it suggests also that there could be multiple causes that if 
they occur at the same point in time--and many of us think that 
that point may be prenatal--it sets up a trajectory that's 
abnormal, that leads to this very, as you mentioned, 
devastating disorder.
    Point number two, you'll hear from constituents and you'll 
read in the press--is this really genetic? Is this really 
environmental? The answer is, it's both. That, with this 
disorder, as with so many of these developmental disorders that 
we study now, we've--in the scientific world--have gotten 
beyond the point of arguing between genes and environment, it's 
like the old nature/nurture debate. The debate now is about how 
genes and the environment interact to result in this disorder.
    We do know there's an important genetic component, no 
question about that, from what we have from twin studies, but 
we also know that that doesn't explain the entire disorder. And 
it certainly wouldn't explain any potential increase in the 
prevalence--or increase, even, in the incidents--over the last 
decade.
    So, lots of interest in what the environmental factors 
might be. But, to understand those, we will need to drill down, 
and get a very good understanding of who has the genetic risk 
to be responsive to that environmental factor. So, much 
interest now, in trying to understand the complicated 
interaction of those two factors.
    Third, this is--as Dr. Gerberding mentioned--important to 
have early detection, early interventions. There are treatments 
that work--they don't work for all children. Perhaps 25 to 30 
percent of children respond beautifully to behavioral 
interventions, but they respond best with early detection and 
early intervention, particularly before age 3. As Dr. 
Gerberding mentioned, many of these children aren't even 
diagnosed until sometime thereafter.

                           PREPARED STATEMENT

    Finally, current science more and more is telling us that 
this is not one illness. This is a group of disorders--much the 
way we think about hypertension, much the way we think about 
other classes of disorders in medicine. This is one--in the way 
that we perhaps once talked about mental retardation--it's 
likely we're going to find many, many disorders within this 
overall rubric. Increasingly, at NIH, we talk about ``autisms'' 
instead of ``autism.'' That is probably an important 
perspective to remember, as we begin to think about causes, and 
also about treatments.
    Thank you, I look forward to your questions, and I look 
forward to the discussion, as well.
    [The statement follows:]

               Prepared Statement of Dr. Thomas R. Insel

    Good afternoon, Senator Harkin and members of the subcommittee, I 
am pleased to present a brief review of the research activities and 
accomplishments in autism research of the National Institutes of Health 
(NIH), an agency of the Department of Health and Human Services (HHS). 
I deeply appreciate your continued support for our mission: making 
medical discoveries to improve health and save lives. In focusing 
today's hearing on autism we will be discussing an urgent, critical 
public health challenge affecting many families.
                            what is autism?
    Autism is a developmental brain disorder, with onset by 3 years of 
age. We now believe that autism includes a large number of disorders 
that share deficits in social behavior, abnormal communication, and 
repetitive behaviors. Autism in turn is part of a broader continuum of 
syndromes called pervasive developmental disorders, now more commonly 
known as autism spectrum disorders (ASDs). ASDs range in severity, with 
``classic'' autism being the most disabling, while others, such as 
Asperger's syndrome, produce milder symptoms. Among children at the 
more severe end of this spectrum, mental retardation, seizures, and 
self-injurious behaviors are common.
    Current Centers for Disease Control and Prevention (CDC) estimates 
of the prevalence of ASDs are as high as 6.7 children per 1,000.\1\ 
``Prevalence'' refers to the number of affected individuals at a given 
point in time, essentially a snapshot. While prevalence estimates have 
increased many-fold since the early 1990s, it is unclear if there also 
exists an increase in ``incidence'', which measures the number of new 
cases across time in the same population. It is unclear whether the 
rise in prevalence is due to a rise in incidence, better identification 
and awareness of the disorder, or both. A similar increase in 
prevalence has been observed in many countries outside of the United 
States, and in virtually every study, boys are three to four times as 
likely to have ASDs compared to girls.\2\
---------------------------------------------------------------------------
    \1\ Centers for Disease Control and Prevention. Prevalence of 
Autism Spectrum Disorders' Autism and Developmental Disabilities 
Monitoring Network, 14 Sites, United States, 2002. Surveillance 
Summaries, February 9. MMWR 2007;56 (No. SS-1).
    \2\ Fombonne E. Epidemiology of autistic disorder and other 
pervasive developmental disorders. J Clin Psychiatry. 2005;66 Suppl 
10:3-8.
---------------------------------------------------------------------------
                          WHAT CAUSES AUTISM?

    There is much that remains unknown about the causes of autism. 
Scientific research has demonstrated that autism is highly heritable, 
as measured by concordance rates in twins. If one identical twin has 
autism, there is a 60-91 percent chance the other will also have it. 
For fraternal twins, the concordance for autism drops significantly, to 
0-10 percent.\3\ While higher concordance in identical twins is not 
proof of a genetic cause, approximately 10 percent of autism cases with 
a family history of ASDs are associated with genetic mutations.\4\ 
Recently, a study of people with autism who did not have another family 
member also affected found approximately 10 percent associated with 
spontaneous genetic mutations.\5\ In addition, autism is frequent in 
children with several known genetic neurodevelopmental disorders, such 
as Fragile X, Rett Syndrome, or Tuberous Sclerosis Complex.
---------------------------------------------------------------------------
    \3\ Veenstra-VanderWeele, J, Christian, SL, Cook, EH (2004) Autism 
as a paradigmatic complex genetic disorder. Annu. Rev. Genomics Hum. 
Genet. 5:379-405.
    \4\ Barton M, Volkmar F, J Autism Dev Disord., 1998, 28(4):273-8.
    \5\ Sebat et al, Strong Association of De Novo Copy Number 
Mutations with Autism. Science. 2007 Mar 15; [Epub ahead of print].
---------------------------------------------------------------------------
    Identifying both the environmental and the genetic underpinnings of 
autism are critical first steps in bringing the full scientific power 
of modern neuroscience to bear on this complex set of disorders. We now 
have the genetic sequencing and neuroimaging tools that will permit a 
more thorough understanding of the neural substrates of autism. Indeed, 
what these scientific tools may tell us is that ASDs are illnesses with 
multiple causes and, much like hypertension or cancer, may be treated 
and possibly prevented through interventions on multiple fronts. 
Importantly, these new scientific approaches will enable us to develop 
new diagnostic tests and rational therapies based on the biology of the 
illness that will permit us to detect and treat ASDs in much the same 
way was as other medical conditions.

                   HOW IS RESEARCH COMBATING AUTISM?

    Combating autism is a collaborative effort, involving several NIH 
Institutes, the CDC, and public-private partnerships with advocacy 
organizations. NIH has increased funding for autism nearly five-fold 
since 1997, to support broad research efforts across genetic, 
neuroscience, environmental, and treatment studies. Already, this 
investment is bearing important results for better understanding the 
brain abnormalities in autism, improved methods for early detection, 
and refining interventions for optimizing daily functioning. NIH 
continues to fuel this research momentum, most recently with program 
announcements encouraging research on the characterization, genetics, 
pathophysiology, and treatment of autism and related neurodevelopmental 
disorders, as well as requests for applications to collect data and 
biomaterials from autistic individuals and their relatives for use in 
genomic, basic, translational neuroscience research, and clinical 
trials. Here I will note just a few of the recent developments that 
offer hope for families struggling with autism.
    The recently established NIH National Database for Autism Research 
(NDAR) for the first time provides an open-access platform to 
facilitate sharing of raw research materials, foster collaborations and 
public-private partnerships, and enhance rapid dissemination of 
research findings into clinical practice. It is envisioned as a 
dynamic, federated system, with improvements and updates being added 
routinely to meet the most critical and valuable needs of the research 
community.
    Early detection is important for improving outcomes. The National 
Institute of Child Health and Human Development (NICHD) and the 
National Institute on Deafness and Other Communication Disorders 
(NIIDCD) continue to partner with Autism Speaks to support the High 
Risk/Baby Sibling Research Consortium, an effort to improve early 
detection and diagnosis. The Consortium?s primary project is to 
identify factors that may influence recurrence rates of ASDs and 
broader developmental outcomes in infant siblings of individuals with 
ASD. Recruitment of sibling and comparison groups is on target and 
database development and data analysis have begun.
    Responding to the urgent need for an amplified autism effort, the 
National Institute of Mental Health (NIMH) created a new, integrated 
autism research program in its intramural laboratories in Bethesda. 
Several new clinical trials were launched in 2006 that provide 
opportunities for rapid progress in defining the biological and 
behavioral characteristics of different subtypes of ASDs and examining 
effects of innovative treatments for autism. Intramural researchers are 
also collaborating with M.I.N.D. (Medical Investigation of 
Neurodevelopmental Disorders) Institute and University of California at 
Davis scientists in a pilot of the first large-scale effort to provide 
a comprehensive biomedical and behavioral characterization of 1,500 
individuals with autism spectrum disorders. The goal of this Autism 
Phenome Project is to identify the many subtypes of autism, providing 
guides for personalized approaches to treatment.
    In addition to these efforts, NIH is striving to identify and 
understand environmental influences as potential causes of ASDs. The 
National Institute of Environmental Health Sciences (NIEHS), in 
partnership with the Environmental Protection Agency (EPA), supports 
research through Centers that focus on this important question. One of 
the centers, at the University of California at Davis, is conducting 
the first large population-based, epidemiologic case-control study of 
children with autism. In addition, the National Institute of 
Neurological Disorders and Stroke (NINDS) is providing support for a 
five-year prospective epidemiological study of a large Norwegian birth 
cohort of 75,000 women and their babies. The study, which we expect to 
include up to 500 children with ASDs, will examine the contribution of 
genetic and environmental factors to the development of autism and 
other neurodevelopmental disorders; these factors include infection 
history, low birth weight, dietary and environmental exposure to 
methyl-mercury, and vaccination history.
    Solving the mysteries of autism will require scientists from many 
disciplines working together on common problems. To launch a broad, 
multidisciplinary attack on autism, NIH recently created an ambitious, 
integrated program in order to maximize coordination and cohesion of 
NIH-sponsored efforts--the Autism Centers of Excellence (ACE), for 
which the first grants will soon be issued. Research projects will 
focus on identifying biological and environmental causes and preventive 
interventions for autism, as well as improved pharmacological and 
behavioral treatments. These Centers will be coordinated through NDAR 
and will represent the first integrated, national research effort for 
this disorder, with an estimated funding level of $25 million per year.

                        HOW CAN WE CURE AUTISM?

    While there is not a proven biological treatment for the core 
symptoms of autism, it is generally agreed that early identification 
and behavioral intervention is beneficial. Thirty years of study have 
shown the value of employing behavioral methods to enhance social 
skills, language acquisition, and nonverbal communication. Such gains 
may be evident in individual responses to particular behavioral 
techniques in the short term ? in as little as a matter of months.
    Yet even in studies where children have received the largest gains, 
outcomes are variable, with some making significant progress and others 
advancing quite slowly or not at all. A multi-study analysis of the 
effect of treatment indicates that behavioral treatments are most 
successful when they begin early, are intensive, and highly structured. 
Current NIH-funded research includes studies for toddlers that involve 
parents in the delivery of interventions at home, immediately after 
diagnosis, as opposed to waiting for community or other services to 
begin.
    While medications are useful for some of the accessory symptoms of 
autism, such as self-injurious behaviors, we lack medical treatments 
for many of the core symptoms, such as social deficits. As we discover 
more about the causes and the mechanisms of autism, we expect to 
develop a new generation of medications to help children and adults 
affected with ASDs. Ultimately, our goal is prevention, based on early 
detection of risk, understanding environmental factors that increase or 
decrease symptoms, and development of effective interventions before 
behavioral and cognitive deficits appear.

                               THE FUTURE

    The Combating Autism Act of 2006 (Public Law 109-416) was signed 
into law on December 19, 2006. Plans are underway to implement the 
provisions of this law, which calls for the establishment of a new 
Interagency Autism Coordinating Committee (IACC) to coordinate all 
efforts within HHS concerning autism spectrum disorders, including the 
development of a strategic plan that sets research funding priorities. 
Thus, broad collaborative partnerships involving government, private 
industry, public and educational institutions, and families of those 
with autism will continue to fuel the vital research endeavors that 
will reveal the mysteries of this disabling disorder and lead to 
prevention and effective treatments.
    Autism is a serious, disabling developmental illness that affects 
many families in this country. Research is our best hope for making a 
difference for these families. Given the complexity of the disorder, 
answers will not be as simple or as quick as we wish, but NIH is 
committed to bringing the best minds and the best tools to ensure that 
we get the correct answers that will lead to the best treatments. I 
therefore appreciate the interest of the members of this Subcommittee 
on autism research. I look forward to answering your questions.

    Senator Harkin. Thank you very much, Dr. Insel, and Dr. 
Gerberding.
    I'll yield to Senator Specter.

                           BUDGET ALLOCATIONS

    Senator Specter. Well, thank you very much, Mr. Chairman 
for accommodating my schedule.
    Dr. Insel, the funding for autism has risen, as I noted, 
from $27 million in 1998, to a projected budget in 2008 of 
$107,870,000--that's actually about a $400,000 decrease from 
last year.
    The allocation for autism is substantially less than the 
allocation for other major research activities, of the National 
Institutes of Health. It is obviously a very serious disorder, 
striking 1 children out of 150. With the New Jersey statistics, 
which are said to be more representative of the national 
average, being 1 child out of 97.
    There is total discretion left within the National 
Institutes of Health to make the allocation of the $29 billion 
which is appropriated by Congress, and that is so we do not, 
so-called ``politicize'' it--we don't make political decisions, 
but leave it up to the scientists. But, I think within the 
range of following that very important principle, it is not 
inappropriate to raise a question. When you take a look at the 
budgets for cancer--and I'm all for cancer research--or the 
budgets for heart disease, they range into, close to $5 billion 
for cancer. How are the allocations made, to have the $107 
million, roughly, which is a very, very small part of the NIH 
budget, compared with other research budgets?
    Dr. Insel. Well, as you mentioned, much of this is driven 
by the science, it's investigator-initiated for the largest 
part of what we're currently doing.
    In the area of autism, unlike many of the other areas that 
you mentioned, and many areas in medicine, in general, we do 
have an organization in place to begin to think about how best 
to deploy the funds that we have. That's this Inter-agency 
Autism Coordinating Committee, that meets twice a year, 
includes public members as well as members of several Federal--
--
    Senator Specter. How about the basic decision as to how 
much goes to the National Cancer Institute, for heart research, 
contrasted with $107 million for autism?
    Dr. Insel. So, how is the decision for the envelope, the 
overall envelope, made for autism, versus other priorities at 
NIH?
    Senator Specter. Start there.
    Dr. Insel. Right. So, I would have to again, give you the 
answer that Dr. Zerhouni has given when you've asked him a 
similar question, that it's a combination of public health 
needs and scientific priorities. This case, the public health--
--
    Senator Specter. Public health, what?
    Dr. Insel. Public health needs. There, and as you 
mentioned, the public health urgency here is obvious, to all of 
us. This is a problem which is increasing in everyone's radar 
screen, this is, without question, a much bigger issue for us 
than it was 5 years ago----
    Senator Specter. I've got to move on to some other 
questions because of limited time, but you will be here for the 
entire proceeding today, and maybe when you hear some of the 
parents, you'll have a little different view of the urgency of 
a greater allocation. That is a judgment which NIH is going to 
have to make.
    Autism is characterized--as the experts have written--by 
three distinctive behavior difficulties, with social 
interaction, display problems with verbal and non-verbal 
communications, and the exhibition of repetitive behavior, or 
narrow obsessive interests.
    It is well-known, Dr. Gerberding, and you've noted it, that 
the early detection of these behavioral disorders can produce 
improvements. What should parents do as soon as they observe 
some of these behavioral disorders? Your comments here will get 
some substantial coverage on C-Span--what advice would you give 
to parents who--well, let's start with something more concrete 
than the definition I've just given you, which is pretty high-
falluting. What should parents look for, specifically, in lay 
terms?
    Dr. Gerberding. You know, when you have a child, you're 
used to thinking about, what is its weight, what is his or her 
height, what is their head circumference--we're used to 
measuring those physical development milestones. But, there are 
behavioral milestones just like that.
    By early age, a child ought to be able to make eye contact, 
if you play peek-a-boo with a child, they should engage your 
attention, they can repeat after you----
    Senator Specter. Okay, eye contact--eye contact is not 
made. Give us another easy-to-understand symptom.
    Dr. Gerberding. If a child is unable to repeat simple 
motions, in other words, if you clap your hands, a young child 
ought to be able to repeat your pattern--we have these laid out 
by age, just like you would lay out weight by age----
    Senator Specter. Laid out where, are they on a website?
    Dr. Gerberding. They are, absolutely, on the CDC website, 
www.cdc.gov, they are posted prominently in pediatricians' 
offices around the country----
    Senator Specter. Can you give us a couple of other simple 
illustrations?
    Dr. Gerberding. I would be happy to give you a whole little 
chart, because I have here----
    Senator Specter. Why don't you repeat them, so people can 
hear you on C-Span?
    Dr. Gerberding. Okay, I'd be happy to.
    I'm quoting from Newsweek magazine, because I thought they 
did a terrific job in one of the articles here of laying them 
out.
    By 7 months, a normal child ought to be able to turn its 
head when its name is called and smile at another person. If 
your children is a year old, usually they can wave ``bye-bye'' 
and they can make sounds like ``mom'' and ``dad'' or ``ma'' and 
``da'' and they can clap when you clap.
    At 18 months, a child ought to be able to pretend, like 
pretend to talk on a telephone, or to look at objects when you 
point to them. By 2 years, a child ought to be able to make 
simple sentences with several words in a phrase, and follow 
simple instructions, and, I think most importantly, engage 
socially with other children, they'll play----
    Senator Specter. Let me interrupt you, at that point--to 
ask you what should a parent do to try to deal with the issue 
of the behavioral disorder as soon as it noted?
    Dr. Gerberding. If a child is--if a parent is concerned 
about their child's development, the pediatrician or the family 
doctor is absolutely the first place to go, and we have really 
been pushing information--about 85,000 kits have gone out to 
pediatricians around the country. So, parents go in, express 
their concern when they're bringing the child in for well-baby 
care, or for the immunization clinic visit, and the most 
important thing to the parent is, don't give up. If the doctor 
says, ``Oh, no, maybe your child is just a little slower to 
catch on,'' ask for the doctor to do a screen, and if there's 
any worry, make sure that you get a second opinion, or ask the 
child to be seen by someone with more expertise.
    Senator Specter. But, what kind of a screening?
    Dr. Gerberding. It's a developmental screening, and 
typically the doctor will ask the child to go through some of 
the same activities that I just mentioned to you, they'll 
conduct a developmental assessment.

                      NEW DIRECTIONS FOR RESEARCH

    Senator Specter. One final question, because I don't want 
to go too long, and out of sequence.
    Dr. Insel, if more funds were available, suppose we're able 
to increase NIH funding so all the boats would rise, where 
would those additional research funds be directed to the kinds 
of problems that Dr. Gerberding has described?
    Dr. Insel. Well, there are at least three very urgent 
problems that we would like to do more of, and do them faster. 
One would be very similar to what Dr. Gerberding is describing, 
looking at the tools for early detection or early diagnosis, 
early intervention--much of that's going through what we call 
our ``baby sibs'' project, looking at children at risk, and 
studying them in a very comprehensive way.
    Second area, very important, is to lay out what we call the 
``autism phenome'' project, the idea of being, the phenome is 
like phenomenology, understanding the full spectrum of this 
disorder, and all of the components, so that we can get a sense 
of, what are the sub-groups? That this is many disorders, if 
it's 10 disorders, what are they? How do we diagnose them? How 
do we treat them?
    Third area that's very important, it doesn't sound so sexy, 
perhaps, but is developing a database, which we call the 
National Database for Autism Research--we have such a database 
that brings the entire research community, as well as, 
potentially, families together. It's a federated database, 
which means it will take other databases that are out there and 
bring them in for imaging, genetics, and clinical information.
    What we'd like to do--we have this now, it went live on 
April 2, but it's still very restricted--we need to grow that, 
and we need to make this a sort of electronic meeting place for 
both families and scientists from across the country, to try to 
get the best information possible about autism.
    Senator Specter. Well, in conclusion, let me just make an 
observation or two.
    Dr. Gerberding, I think the website is fine. If people 
write to you, not having access to the website, or not 
understanding the website, is CDC in a position to respond to 
parents by providing this kind of a graphic illustration of 
symptoms and signs to look for, perhaps even a copy of what 
appears in Newsweek, under the caption, Babies and Autism?
    Dr. Gerberding. We would be happy to get information to 
parents and to their doctors, and we can do that by a variety 
of means, absolutely.
    Senator Specter. Dr. Insel, when you take a look at your 
priorities, I know you'll pay attention to all of them, and I 
know you'll listen carefully to what you hear today.
    Senator Harkin and I, and some of the others on the 
committee are magnets for a lot of comments from parents, 
because they see what the committee has done. It is accurate to 
say that I hear a disproportionate comment from parents whose 
children have the autism disorder. I hear a lot of people--and 
a lot of my friends are dying of cancer--and I know a lot of 
people with heart conditions. I've seen a fair amount of that 
in the mirror. But, on a numerical basis, I hear, just a lot 
about autism, and maybe that comes because we advertise on this 
Subcommittee with what we do for NIH, but I'd like to see it 
get a little more attention.
    Senator Harkin, thank you for your courtesy.
    Senator Harkin. Thank you, Senator Specter.
    Again, just another little change because the clock is 
ticking, and I want to hear the testimony of others. I would 
ask if you two could maybe, give us some bookends here, Dr. 
Insel on one side, Dr. Gerberding, because I have questions for 
you, I'm sure other Senators do. But I'd like to ask our second 
panel to come up, if I could, at this time.
    Marguerite Colston, Dr. Judith Favell, Mr. Bob Wright, and 
Mr. Bradley Whitford.
    Again, welcome to the committee, and as I said at the 
beginning, all of your statements will be made a part of the 
record in their entirety, and I'd appreciate it if you'd just 
sort of sum up for us, the essence of your statements, and I'll 
go in the order in which I had called people up.
    First, we'll recognize, Marguerite Colston, Communications 
Director for the Autism Society of America. More importantly, 
she's a parent of a child with autism, her 6-year old son, 
Camden. Welcome to the committee, and please proceed.

STATEMENT OF MARGUERITE COLSTON, DIRECTOR OF 
            COMMUNICATIONS, AUTISM SOCIETY OF AMERICA, 
            BETHESDA, MARYLAND
    Mrs. Colston. Thank you. I'd like to thank Chairman Harkin, 
and Senator Specter and the members of the subcommittee for 
giving me the opportunity today to share my experience of 
living with a child on the autism spectrum. I also wanted to 
say thank you very much to you and Senator Specter for those 
very important questions you asked.
    It is truly an honor to be asked to speak to you today, and 
I hope I can convey some of the needs, hopes and dreams of the 
more than 1 million families in America who are affected today.
    As you mentioned, I am the Director of Communications for 
the Autism Society of America, and I am the mother of two 
children, including a 6\1/2\ years old son with autism. My son, 
pictured here, is Camden, this is Camden.
    My son has a disorder with no known cause, and no known 
cure. You have, at your disposal today, the best experts on 
researching causes and cures. But I am here today to tell you 
about the very important space between causation and cure, the 
space that Camden and I occupy, that is, how we live with 
autism.
    Because that important space is occupied today by 500,000 
children, and at least as many adults, families desperately 
need Federal leadership and funding for autism today.
    Camden is on the severely affected end of the spectrum. He 
cannot talk, has some cognitive delays, major attention 
deficits, and suffers significant social and behavioral 
challenges. As you can see, though, he's also adorable, and he 
has a much larger capacity to learn than any of us imagined.
    Like many parents, I was told that autism was not 
treatable, and that the best thing I could do for Camden was to 
prepare myself and my family for the idea that he would never 
be independent. Experts told me that information when he was 
only 2\1/2\ years old.
    Today, my little boy, who for years did not turn to his 
name or react to games, now grabs my hand after dinner, and 
takes me to the refrigerator for his nightly ice cream. When 
the school bus comes every morning, he walks on with a grin and 
he finds his seat. Camden does not make these developments 
naturally, but through intensive therapy, Individualized 
Education Plans, high medical costs, and a sizable team of 
dedicated professionals.
    In many respects, my story is typical. Camden was diagnosed 
with autism when he was 2\1/2\. However, I was lucky that 
Camden was born with other medical ailments, and very low 
muscle tone, because unlike most children with autism, Camden 
began receiving Early Intervention services from our county 
when he was just 6 weeks old. Even though we only received 4 
hours per week of Early Intervention, that program was the 
reason Camden can chew, sit up, and walk onto a school bus 
today.
    Like most families, I had to wait 12 long months to get an 
appointment with a developmental pediatrician, when my 
pediatrician expressed concerns about Camden. My wait times for 
his specialists continue to be 12 to 18 months, so we rely 
heavily on the public educational services we receive, thanks 
to the IDEA Act, and thank you for your support of that.
    As I think about it, however, I am still very concerned 
about what would happen to Camden, once the school bus stops 
coming. Camden, and most children and adults with autism, is 
going to need a lifetime of supports and services. Even if he 
is able to speak someday, he will need training to prepare him 
to enter the workforce, assistance with transportation and 
housing, access to health care, and a range of other services 
to allow him to live as independently as he is able.
    Unlike most parents, I consider myself to be a very 
privileged American. I received a great education, I have a 
good job, I own my own house, and I have a wonderful and 
supportive family, and several of them are here today. I can 
afford a small amount of respite care and private therapy. So, 
I have to wonder, if I couldn't get my son diagnosed before 
2\1/2\, and if it takes me 18 months to see a doctor, and if I 
can't afford truly comprehensive services, than what is 
happening to the average American with a child on the autism 
spectrum today?
    If I accepted that autism was not treatable, and Camden had 
no hope, what do others do? What happens after Camden turns 22, 
and the federally-mandated disability services end? What are we 
going to do about this?
    One of the things we can do for Americans living with 
autism is fund the Combating Autism Act, and encourage the 
resulting research to be treatment-guided, not just causation 
specific. Funding the CAA also means funding the Inter-Agency 
Autism Coordinating Committee, and they have a wonderful 
roadmap for services. We can also pass and then fund the Autism 
Services bill put forth by Senators Clinton and Allard last 
month, and which the House introduced today.
    As a parent, I strongly support those bills. As a staff 
member for the Autism Society, I can assure you that we, our 
chapters and our members will work tirelessly to advance 
legislation that includes research services and supports for 
individuals with autism.
    I love my son, Camden, with every bone in my body. I know 
there are a million Camden's out there whose needs are not 
being met, and whose families are in crisis. Regardless of the 
cost, we need to support coordinated Federal autism solutions 
today. Only then will we be able to optimize the potential of 
each child with autism, and provide them opportunities for 
success in their communities.

                           PREPARED STATEMENT

    Being here today and being heard by the U.S. Senate gives 
me an enormous sense of hope that I never dared to have. With 
your help and your leadership, I may start to hope for Camden, 
the same hopes I have found I have for my neuro-typical 
daughter, Theresa--that he will be provided the opportunity to 
be a happy, productive member of his community.
    I'd like to thank the committee again, for hearing me, and 
for support of this legislation.
    [The statement follows:]

             Prepared Statement of Marguerite Kirst Colston

    I would like to thank Senator Harkin and the members of this 
subcommittee for giving me the opportunity today to share my experience 
of living with a child with autism. It is truly an honor to be asked to 
speak to you today, and I hope I can convey some of the needs, hopes 
and dreams of the more than 1 million families in America today who are 
affected by autism.
    My name is Marguerite Kirst Colston. I am the Director of 
Communications with the Autism Society of America and I am the mother 
of two children, including a 6-year-old son with an autism spectrum 
disorder. My son, pictured here, is named Camden.
    As you have heard today from the panelists, my son has a disorder 
with no known cause and, as I have been told by many doctors, no cure. 
You have at your disposal the best experts on researching causes and 
cures, but I am here today to tell you about the very important space 
between causation and cure--the space Camden and I occupy--that is: how 
we live with autism. Because that important space is occupied today by 
500,000 children, and at least as many adults, families desperately 
need federal leadership and funding for autism.
    Camden is on the more severely affected end of the autism spectrum, 
by which I mean he cannot talk, has some cognitive delays, major 
attention deficits and suffers significant social and behavioral 
challenges. As you can see, he is also adorable and, as I am finding, 
has a much larger capacity to learn than any of us imagined.
    Like many parents, I was told that autism was not treatable, and 
that the best thing I could do for Camden was to prepare myself and my 
family for the idea that he would never be independent. Experts told me 
that when Camden was 2\1/2\. Today, my little boy, who for years did 
not turn to his name or react to games, now grabs my hand after dinner 
and takes me to the refrigerator for his nightly ice cream. When the 
sun sets, he runs to take a bath. When the school bus comes every 
morning, he walks on with a grin and finds his seat. Camden does not 
make these developments naturally, but through intensive therapy, 
individualized education plans, high medical costs, and a sizeable team 
of dedicated professionals helping us along.
    In many respects, my story is typical. Camden was diagnosed with an 
autism spectrum disorder when he was 2\1/2\. This diagnosis came after 
2\1/2\ years of emerging symptoms, disappearing interaction, specialist 
referrals, hundreds of doctor's visits, several hospitalizations--and 
many missed clues. I was ``lucky'' that Camden was born with other 
medical ailments and very low muscle tone, because unlike most children 
with autism, Camden began receiving Early Intervention services from 
our county when he was just 6 weeks old. Even though we only received 4 
hours per week of Early Intervention, that program was the reason 
Camden can chew, sit up, and walk onto his school bus today.
    Like many parents with children with autism, I had to wait 12 long 
months to get an appointment with a developmental pediatrician when my 
pediatrician expressed concerns about Camden. My wait times for his 
specialists continue to be 12 to 18 months in duration, so we rely 
heavily on the educational services with receive in our public school 
system thanks to IDEA Act. I want to say a heartfelt thank you to you, 
Senator Harkin, for your strong support of legislation like this.
    As I think about it, however, I am still very concerned about what 
will happen to Camden once the school bus stops coming. Camden--and 
most children and adults with autism--is going to need a lifetime of 
services and supports. Even if he is able to speak one day, he will 
need training to prepare him to enter the workforce, supports in his 
job, assistance with transportation and housing, access to health care, 
and a range of other services to allow him to live as independently as 
he is able.
    Unlike most parents, I consider myself a very privileged American. 
Like the rest of the panelists here today, I received a great 
education, have a good job, own my own house, and have a wonderful and 
supportive network of family. I can afford a small amount of respite 
care and private therapy. I stand up for my rights and have the 
confidence to ask questions of the medical and educational communities. 
But I have to wonder: if I couldn't get my son diagnosed before 2\1/2\, 
and if it takes me 18 months to get into a doctor, and I can't afford 
truly comprehensive services, then what is happening to the average 
American with a child with autism today? If I accepted, in a desperate 
moment, that autism was not treatable and Camden had no hope, what do 
others do in their sorrow? What happens after he transitions away from 
the education system? And, what are we going to do about this?
    One of the things we can do for Americans living with autism is 
fund the CAA and encourage the research done here to be treatment-
guided, not just causation-specific. Funding the CAA also means funding 
the Inter-Agency Autism Committee, which could serve parents 
tremendously by coordinating Federal autism services and research along 
a road map that will help us now. This is why the Autism Society of 
America encouraged tens of thousands of members to support CAA and why 
we also support legislation like the reauthorization of the IDEA act, 
the Lifespan Respite Act, and S-CHIP funding.
    Last month, Senators Clinton and Allard took a historic step toward 
empowering families and individuals with autism by introducing 
legislation to build and support a services infrastructure for autism 
spectrum disorders. Unfortunately, our current system for assisting 
adults with disabilities is stretched way too thin. Providers do not 
have the capacity to meet the ever increasing number of individuals 
with autism. We must do more to identify best practices for serving 
people with autism spectrum disorders. The House companion bill will be 
introduced today.
    As a parent I strongly support this legislation. As a staff member 
for the Autism Society of America, I can assure you that we will work 
tirelessly to advance this bill, and other measures that improve 
services and supports for individuals with autism. I love my son Camden 
with every bone in my body, and I know there are a million Camdens out 
there whose needs are not being met and whose families are in crisis. 
Regardless of the cost, we need to support coordinated federal autism 
solutions today. We will then be able to optimize the potential of each 
child with autism and provide them opportunities to for success in 
their communities.
    Being here today and being heard by the U.S. Senate, gives me an 
enormous sense of hope that I never dared to have. With your help and 
your leadership, I may start to hope for Camden the same hopes that I 
have for my ``neurotypical'' daughter Theresa--that he will be a happy, 
productive member of his community in his way, some day. Thank you.

    Senator Harkin. Thank you very much. That is very poignant 
and heartfelt testimony.
    Next, we turn to Dr. Judith Favell, CEO of AdvoServ, a 
multi-State network of treatment programs for children and 
adults with developmental challenges. Dr. Favell received her 
Bachelor's Degree in Psychology from Western University, and 
her Ph.D. from the University of Kansas, out my way. Dr. 
Favell, welcome to the committee, please proceed.

STATEMENT OF DR. JUDITH E. FAVELL, CHIEF EXECUTIVE 
            OFFICER, ADVOSERV, EXECUTIVE DIRECTOR, THE 
            CELESTE FOUNDATION, MOUNT DORA, FLORIDA
    Dr. Favell. Thank you, Mr. Chairman.
    I'm also executive director of the Celeste Foundation, and 
a member of the Professional Advisory Board for the Autism 
Society of America.
    During my nearly 40-years' career as a behavior analyst and 
as a psychologist, I have devoted myself to the field of 
autism, and developmental disabilities.
    Now, during this period, I've specialized in the treatment 
of behavior problems such as self-injury and aggression that 
sometimes associated with these disorders. It is on the 
delivery of such treatment services that I'm focusing my 
comments today.
    While research on the cause and course of autism continues, 
while the incidents and prevalence is tracked, while basic 
research on the underlying mechanisms of the disorder is 
conducted, we cannot lose sight, as just has been said, of the 
1.5 million children and adults today living with autism who 
need help today. Today they are seeking services that will 
allow them to gain the skills and resolve the behavioral 
challenges that will enable them to live and enjoy the fullest 
life possible.
    Fortunately, across the last years, major advancements have 
been made in the development of educational and behavioral 
strategies to teach these skills and to treat these problems. 
These methods have been tested across, literally, decades of 
scientific research, and confirm that children and adults with 
autism can indeed be helped in meaningful and substantial ways.
    They can learn to communicate, they can learn to care for 
themselves. They can achieve academic and job goals. They can 
reciprocate love with friends and family. Likewise, people 
experiencing autism can engage in behavioral problems that hurt 
themselves, or harm others. In short, effective treatment and 
teaching methods designed to help people with autism, notably 
those based on learning theory, and applied behavior analysis 
are available today, and each day are becoming more effective 
with continued research.
    So, this picture is a decidedly optimistic one. However, 
effective methods of instruction and behavioral treatment are 
clearly not enough. To impact the lives of people with autism, 
an equally important issue must be addressed, and that is, how 
to actually make these services available to people who need 
them. There exists not just a gap, but a chasm, between what we 
know, and what consumers actually receive.
    For example, we know as has been said, that to be optimally 
effective, services should begin as early in a child's life as 
possible, and be intensive, that is, encompass as many hours as 
possible. Yet, as we hear, families lose precious months--
years--waiting for services, and then too often must settle for 
a fraction of what their child needs.
    Too often, then, those very services are not available when 
and where they are actually needed--at bedtime, during meals, 
or in the midst of the meltdown during the weekend. Needs of 
people with autism do not conveniently conform to professional 
appointments or clinic hours. Support may be needed any time, 
day or night.
    Further, we know that to be effective, and to produce 
positive outcomes, services need to be provided by qualified 
caregivers, and yet, despite widespread training of families 
and service personnel, despite extensive recruitment of 
professionals to the field of autism, there remains a serious 
shortfall of qualified professionals to guide the treatment 
process.
    Thus, though we know a great deal about how to help, we 
must increase the accessibility and availability of these 
services, to ensure that people with autism actually receive 
that help.
    If we're truly to ensure that services are available early, 
in sufficient amounts, and targeted when and where needed, 
traditional solutions, for example, increasing training of 
professionals--though important--is simply not sufficient. To 
meet the challenge, new service models must be developed.
    Our own work at the Celeste Foundation provides an example 
of possible new approaches to improving services, both their 
availability, and potentially their cost-effectiveness. From 
support from the Department of Education and the States within 
which we conducted this project, we recently completed a 
demonstration project, investigating the use of tele-health 
systems to provide professional services directly into homes.
    Now, in this model, after a brief period of on-site 
training, families were linked to professionals via an 
interactive video system that enabled live, real-time teaching, 
consultation and support directly into the home when and where 
it was needed. Through this tele-health model, families 
received help teaching their child, coping with their 
challenges, from professionals who might be located hundreds, 
even thousands of miles away, ensuring rapid and responsive 
assistance, regardless of the distance involved.
    This demonstration, utilizing technology developed by the 
CNOW Organization, proved to be an extremely effective and 
reliable vehicle for aiding families and children with autism.
    Children learned and maintained a wide array of skills from 
communication, to toilet training to eating green beans. 
Parents reported relief from stress, and an improvement of 
quality of life as a function of having support available to 
them on an ongoing basis, and families and professionals alike 
affirmed the effectiveness of this method of facilitating 
services, and its ease of use.
    The following brief news feature provides a graphic picture 
of the benefits of the model involved, of using tele-health 
systems for service delivery, and it features Josh Cobbs and 
his family, who is with us today.
    Work such as this by the Celeste Foundation, demonstrating 
the efficiency and effectiveness of utilizing tele-health to 
facilitate services exemplifies the type of innovative approach 
that we must pursue, if we are truly going to meet the ever-
increasing needs of children, and adults, and their families 
with autism, bridging that chasm between knowledge and 
practice, moving services from the paper to the people.

                           PREPARED STATEMENT

    I ask all in a position of influence, certainly including 
the distinguished members of this committee, to support efforts 
to find innovative methods of service delivery for all of those 
on the spectrum, including my grandson, Alex, so that they may 
receive the very best we have to offer, and lead the brightest 
future possible.
    Thank you.
    [The statement follows:]

               Prepared Statement of Dr. Judith E. Favell

              ``SEEKING INNOVATIONS IN SERVICE DELIVERY''

    Good afternoon, Mr. Chairman and members of this distinguished 
committee. My name is Dr. Judith Favell. I am CEO of AdvoServ, 
Executive Director of the Celeste Foundation, and a member of the 
Professional Advisory Board of the Autism Society of America. I have 
devoted my nearly 40-year career as a behavior analyst and psychologist 
to the field of autism and developmental disabilities. During this 
period I have specialized in the treatment of problem behaviors such as 
self-injury and aggression which can be associated with autism. And it 
is on the delivery of such treatment that I focus my comments this 
afternoon.
    While research on the cause and course of autism continues, while 
its incidence and prevalence is tracked, while basic research on the 
underlying mechanisms of the disorder is conducted, we cannot lose site 
of the one and a half million children and adults who are now living 
with autism, and who need help now. Today they are seeking services 
that will help them gain the skills and resolve the behavioral 
challenges that will enable them to enjoy the fullest life possible.
    Fortunately, across the last years, major advancements have been 
made in developing educational and behavioral methods to teach these 
skills and treat these problems. These methods, tested through decades 
of scientific research, confirm that children and adults with autism 
can be helped in meaningful and substantial ways. They can learn to 
communicate, to care for themselves, to achieve academic and job goals, 
to reciprocate love with friends and family. Likewise, people 
experiencing autism need not engage in behavior problems that hurt 
themselves or harm other people. In short, the treatment and teaching 
methods designed to help people with autism, notably those based on 
learning theory and applied behavior analysis, are available today, and 
each day are becoming more effective as a result of ongoing research. 
This picture is an optimistic one. However, improving these methods of 
instruction and treatment is not enough. To impact the lives of people 
with autism, an equally important issue must be addressed: how to 
actually make these services available to people who need them.
    There exists not just a gap, but a chasm between what we know and 
what consumers receive. For example, we know that in order to be 
optimally effective, services should begin as early in the child's life 
as possible and be intensive, encompassing as many waking hours as 
possible. Yet families lose precious months or years waiting for 
services, and then must settle for a fraction of the help that their 
child really needs. Too often, these supports are also not available 
when and where they are needed, for example at bedtime, during meals or 
in the midst of a weekend meltdown. The needs of people with autism do 
not conveniently conform to clinic hours or professional appointments. 
Support may be needed at any time, day or night.
    Further, we know that effective services and positive outcomes for 
people with autism depend on qualified caregivers, and yet despite 
widespread training of families and service personnel and extensive 
recruitment of professionals to the field of autism, there remains a 
serious shortage of qualified professionals to guide the treatment 
process.
    Thus, though we know a great deal about how to help, we must now 
increase the accessibility and availability of these services, to 
insure people with autism actually receive that help. If we are to 
truly meet this ever expanding need, if we are to insure that services 
are available early, in sufficient amounts, and targeted when and where 
they are most needed, traditional solutions such as increased training 
of professionals are simply not enough. To meet the challenge, new 
service delivery models must be explored.
    Our own work at the Celeste Foundation serves as an example of 
possible new approaches to improving the scope and cost-effectiveness 
of delivering services to people with autism and their families. With 
support from the Department of Education we have recently completed a 
demonstration project investigating the use of telehealth systems to 
provide professional services directly into homes. In this model, after 
a brief phase of on-site training, families were linked to 
professionals by an interactive video system that enabled live 
training, consultation and support directly into the home when and 
where it was needed.
    Through this telehealth model, families received help in teaching 
their children and coping with their challenges from professionals 
located hundreds of miles away, insuring rapid and responsive 
assistance. This demonstration, utilizing technology developed by the 
Cnow organization proved to be an extremely reliable and effective 
vehicle for helping families and their children. Children learned and 
maintained skills ranging from communication to toilet training, 
parents reported relief from stress due to the availability of support, 
and families and professionals alike affirmed the effectiveness and 
ease of using the system. This very brief news feature provides a more 
graphic picture of the model and benefit of using telehealth to 
facilitate services.
    Work such as this by the Celeste Foundation, demonstrating the 
efficiency and effectiveness of utilizing telehealth technology in 
service delivery, exemplifies the type of innovative approach we must 
pursue if we are to truly meet the ever increasing needs of children 
and adults with autism, bridging the current chasm between knowledge 
and actual practice, moving services from the paper to the people. I 
ask all those in a position of influence, including members of this 
distinguished committee, to support efforts to find innovative 
solutions to service delivery, so that those living with autism now 
will receive the best we have to offer, leading to the brightest 
futures possible.

    Senator Harkin. Well, thank you very much, as I said in my 
opening statement, I hear two pleas from families with autistic 
children. One, find a cure, but help us now. So many people 
that, they just don't have the ability to have someone come 
visit them every day to tell them what to do. I'll have more 
questions about that later, but I just thought--that's really 
the first time I've seen that clip, I'd heard about it, since 
it did take place in Iowa, I'd heard about it.
    So I'll have more to ask you about that when we get into 
our formal questioning period.
    Dr. Favell. Certainly.
    Senator Harkin. Mr. Bob Wright, Chairman of the Board of 
NBC Universal, the Vice Chairman of the Board and the Executive 
Officer of the General Electric Company. Mr. Wright, along with 
his wife, Suzanne, co-founded Autism Speaks.
    Mr. Wright is a graduate of the College of the Holy Cross, 
received his law degree from the University of Virginia School 
of Law.
    Mr. Wright, again, I thank you for your leadership in this 
area, and for co-founding Autism Speaks, and again, your 
statement will be made a part of the record in its entirety, 
and please proceed as you desire.

STATEMENT OF ROBERT C. WRIGHT, CO-FOUNDER, AUTISM 
            SPEAKS, FAIRFIELD, CONNECTICUT
    Mr. Wright. Mr. Chairman, thank you very much for having us 
here.
    Our grandson was diagnosed in 2004, at just 2 years and 3 
months, and we were helpless. He was potty-trained, he spoke, 
he was very active, he was apparently a very normally-
developing child, and everything slipped away from him. We were 
helpless as we watched him slip away into this cruel embrace of 
a disorder. My wife, Suzanne, likes to call it kidnapping, as 
if someone had taken Christian who was meant to live, yet he 
was taken away, and we got nothing back, and there's no way to 
restore him back to his family--he's a little prisoner.
    Since that diagnosis, we embarked on a mission to learn as 
much as we could about autism. We received, Christian received 
the best therapies and treatments that were available, but we 
discovered, however, that there are scarce resources for 
parents dealing with autism, and how thin the knowledge base is 
on the whole issue.
    We had so many questions, and instead of answers, we were 
confronted with a bewildering array of theories and guesses.
    Here's what we do know about autism. The numbers that Dr. 
Gerberding talked about, 1 in 150 children in the United 
States, 1 in 94 boys, that's the ratio. A decade ago, the 
experts estimated the prevalence in autism to be 1 in 2,500.
    This year, more children will be diagnosed with autism than 
with AIDS, diabetes, and cancer combined. Autism costs the 
society, American society, approximately $35 billion in direct 
and indirect expenses each year, according to a Harvard School 
of Public Health study. Caring for a child with autism can cost 
over $3 million over a person's lifetime, those are the 
estimates.
    Frankly, Mr. Chairman, we were shocked that a disorder this 
prevalent commands so little in terms of resources devoted to 
research and treatment when compared to other, less common, 
disorders.
    For example, leukemia affects 1 in 25,000 people, children, 
but receives $300-plus million a year of support from the NIH. 
Pediatric AIDS affects 1 in 8,000, and it's about $400 million 
a year. And autism affects 1 in 150, and the funding level is 
approximately $100 million.
    To help close this gap, we launched Autism Speaks in 
February of 2005 to help raise the funds that would quicken the 
pace of research. We worked--and together we worked with 
literally thousands of families affected by autism, to 
introduce, and pass, and have the President sign the Combating 
Autism Act.
    This is an historic act, it is considered by some to be the 
most comprehensive piece of single-disease legislation ever 
passed in the U.S. Congress. It authorizes $920 million over 5 
years for research and autism surveillance, awareness, early 
identification, and authorizes a 50 percent increase in the 
Department of Health and Human Services spending on autism.
    For fiscal year 2008, the Combating Autism Act authorizes a 
spending level of a total of $168,000, to the Health and Human 
Services Secretary for autism activities, and within that 
total, provides for three, distinct, autism-specific items. 
Sixteen and a half million dollars to the Centers for Disease 
Control and Prevention, to conduct the developmental disability 
surveillance and research program, which Dr. Gerberding 
outlined, the $37 million for Health Resources and Services 
Administration to carry out an autism education, early 
detection, intervention program; and $144 million for NIH-
funded research.
    Mr. Chairman, let me elaborate quickly on each of these. 
First, for the NIH, the funding increases are incremental, in 
total. Most important, the act directs the NIH to spend those 
dollars more wisely, according to a strategic research plan, 
devised by an Inter-Agency Autism Coordinating Committee with 
consumers and advocates comprising a third of its membership. 
The act also directs the NIH to ramp up its investment in 
research, and potential environmental causes of autism.
    With these new funds, CDC can expand its awareness and 
intervention activities, to reach more parents, health 
professionals, et cetera. Previous investment in the CDC has 
produced the largest-ever surveillance study, which established 
a baseline to measure autism prevalence trends in the United 
States.
    These studied need to continue so that we can measure the 
true changes in autism prevalence over time. They probably 
aren't enough, by a long shot, but you know, that's the best we 
have right now.
    It is also critical that funds be appropriated to the CDC 
to fund the Seed Study, which is the first epidemiological 
study to search for environmental exposure, and exposure gene 
immune interactions.
    The Combating Autism Act also creates new and innovative 
State-based programs in autism education, detection, and early 
intervention. Early intervention, as we've heard here, can lead 
to improvements in speech relating to learning.
    One of the things I would offer as a comment here, that--
this is something we do know, that a child that does early 
intervention, is diagnosed before 3 years old, and is fortunate 
enough to have active therapy such as behavioral, occupational, 
or speech therapy, has a 50 percent chance of being able to 
matriculate to a public school. If you don't do that, you have 
almost no chance.
    What we also know, is that children in the minority 
community, the average age of diagnosis is 7 years old. So, if 
you put those two together, there's almost no chance those 
children are going to be able to matriculate through a public 
school system. The two largest minorities are African-Americans 
and Hispanics, which total almost 80 million, in total. A third 
of our population is in the minority community. So, I mean, 
this whole thing, the cost involved, the issues involved, it's 
critically important.
    Mr. Chairman, the funding increases recommended by the 
Combating Autism Act are relatively modest, at only $25 million 
more than the Congressional Budget Office's baseline estimates 
for HHS's autism activities. But the impact this subcommittee 
would have by not just matching those increases, but by 
dictating how those funds would be spent, would be a start.
    By doing so, Mr. Chairman, this subcommittee would take a 
giant step toward fulfilling the promise offered to hundreds of 
thousands of children and their families when Congress passed 
the Combating Autism Act. The public health crisis posed by 
autism requires an extraordinary response. With every new child 
diagnosed with autism, we're looking at another $3 million bill 
over their lifetime--it isn't business-as-usual. I know you 
understand that, I know everybody sees this.
    But we see a response needed that is akin to what happened 
with AIDS--a crisis in the 1990's. With line-item 
appropriations for autism intervention, surveillance and 
research tied to a strategic plan. This is a leg-up, it's late-
coming to recognize the prevalence, if we don't do something 
special, the funding won't rise at a fast enough level to deal 
with that.
    I'm fully aware that the autism community is asking this 
subcommittee to do something which many claim to oppose, in 
principle, namely to appropriate by disease. In fact, Congress 
already took that extraordinary step when it passed the 
Combating Autism Act. The act--by authorizing the creation of 
autism-specific line-item appropriations--recognized that 
autism deserves, no, requires, this approach, because of the 
combination of autisms high prevalence, coupled with the 
historical neglect exemplified by the numbers you heard today 
on NIH and the inability to prioritize autism within its 
portfolio, at least at this juncture.

                           PREPARED STATEMENT

    Last year, the House and the Senate unanimously passed the 
Combating Autism Act and we urge you to make the funding part 
of the implementation of the act, as it's written, equally 
bipartisan, and universally a supported effort.
    Thank you very much, Mr. Chairman.
    [The statement follows:]

                 Prepared Statement of Robert C. Wright

    Good afternoon, Mr. Chairman. I am Bob Wright, chairman of the 
board of NBC/Universal and vice chairman of the board of the General 
Electric Company. But I appear before you today in another capacity, as 
co-founder of Autism Speaks and as a grandfather of child with autism.
    Our grandson, Christian, was diagnosed with autism in 2004. 
Helpless, we watched him slip away into the cruel embrace of this 
disorder. My wife, Suzanne, likens it to a kidnapping, as if someone 
had taken away the life Christian was meant to live. We all want 
nothing more than to have him back where he belongs, restored to his 
family.
    Since the diagnosis, our family has been on a mission to learn all 
we could about autism, and to help ensure our grandchild received the 
best therapy and treatments available. What we discovered, however, was 
just how scarce the resources are for parents dealing with autism, and 
how thin the knowledge. We had so many questions, and instead of 
answers, we confronted a bewildering array of theories and guesses.
    Here's what we do know about autism.
  --According to a recent CDC report, autism is now diagnosed in 1 in 
        150 children in the United States, and a shocking 1 in 94 boys.
  --A decade ago, experts estimated the prevalence of autism to be 1 in 
        2,500.
  --This year more children will be diagnosed with autism than with 
        AIDS, diabetes and cancer combined.
  --Autism costs society the American economy more than $35 billion in 
        direct and indirect expenses each year, according to a Harvard 
        School of Public Health study. And caring for a child with 
        autism can cost over $3 million over the person's lifetime.
    Frankly, Mr. Chairman, we were shocked that a disorder as prevalent 
as autism commands so little in terms of resources devoted to research 
and treatment, when compared to other, less common disorders.
  --For example, leukemia affects 1 in 25,000 people but receives 
        research funding of $310 million per year;
  --Pediatric AIDS affects 1 in 8,000 children; its funding, $394 
        million per year; and
  --Then there's autism, which affects 1 in 150 children and yet NIH 
        research funding is a paltry $108 million.
    To help close this gap, we launched Autism Speaks in February 2005 
to help raise the funds that will quicken the pace of research. Mr. 
Chairman, we also worked together with thousands of families affected 
by autism to introduce, pass and have the President sign the Combating 
Autism Act. This historic act is considered by some to be the most 
comprehensive piece of single-disease legislation ever passed by the 
U.S. Congress. It authorizes appropriations of $920 million over 5 
years for autism research, surveillance, awareness and early 
identification, authorizing a 50 percent increase in the Department of 
Health and Human Service's spending on autism.
    For fiscal 2008, the Combating Autism Act authorizes a total of 
$168 million to the HHS Secretary for autism activities and within that 
total provides for three distinct autism-specific line items--
  --$16.5 million for the Centers for Disease Control and Prevention to 
        conduct its Developmental Disabilities Surveillance and 
        Research program;
  --$37 million for Health Resources and Services Administration to 
        carry out an Autism Education, Early Detection, and 
        Intervention program; and
  --$114.5 million for NIH-funded autism research.
    Mr. Chairman, let me elaborate on each of these items.
    For the NIH, the funding increases are incremental. Most important, 
the Act directs NIH to spend those dollars more wisely, according to a 
Strategic Research Plan devised by an Interagency Autism Coordinating 
Committee, with consumers and advocates comprising a third of its 
membership. The act also directs NIH to ramp up its investment in 
research into potential environmental causes of autism.
    With these new funds CDC can expand its awareness and intervention 
activities, to reach new parents, health care professionals and health 
care providers. Previous investment in CDC has produced the largest-
ever surveillance study which established a baseline to measure autism 
prevalence trends in the United States. These studies need to continue 
so that we can measure the true changes in autism prevalence over time. 
It is also critical that funds be appropriated to CDC to fully fund the 
SEED study, which is the first epidemiological study to search for 
environmental exposures and exposure-gene-immune interactions.
    The Combating Autism Act also creates new and innovative state-
based programs in autism education, detection and early intervention. 
Early intervention can lead to profound improvements in speech, 
relating and learning. Right now, we consider getting a diagnosis and 
intervention for a 3-year-old child a success. But we can do better. 
Through new diagnostic instruments we can reduce the age of diagnosis 
to within the first year of life. Service provision must keep pace.
    Mr. Chairman, the funding increases recommended by the Combating 
Autism Act are relatively modest at only $25 million more than the 
Congressional Budget Office's baseline estimates for HHS's autism 
activities. But the impact this subcommittee would have by not just 
matching those increases but dictating how those funds would be spent 
would be historic. And by doing so, Mr. Chairman, this subcommittee 
would take a giant step toward fulfilling the promise offered to 
hundreds of thousands of children and their families when Congress 
passed the Combating Autism Act.
    The public health crisis posed by autism requires an extraordinary 
response. With every new child diagnosed with autism costing an 
estimated $3 million over his or her lifetime, we cannot afford to rely 
on standard, ``business as usual'' practices. The autism crisis demands 
a focused, coordinated, and accountable response by our public health 
agencies, similar to the Federal response to the AIDS crisis in the 
1990s, with line-item appropriations for autism intervention, 
surveillance and research tied to a strategic plan.
    I am fully aware that the autism community is asking this 
subcommittee to do something which many claim to oppose in principal--
namely, to appropriate by disease. In fact, Congress already took that 
extraordinary step when it passed the Combating Autism Act. That act, 
by authorizing the creation of autism-specific line-item 
appropriations, recognized that autism deserves, no, requires, this 
approach because of the combination of autism's high prevalence, 
coupled with historical neglect exemplified by the failure of the NIH 
to appropriately prioritize autism within its portfolio.
    Last year, the House and the Senate unanimously passed the 
Combating Autism Act. We urge you to make funding the implementation of 
the CAA an equally bipartisan and universally supported effort.
    Thank you, Mr. Chairman.

    Senator Harkin. Thank you very much for your statement, and 
thank you for taking your time to be here today, and for all of 
your involvement in this issue.
    Next, we'll turn to Mr. Bradley Whitford, well-known 
Broadway and TV actor, who is probably best-known for his role, 
of course, on ``West Wing''.
    Mr. Whitford studied theater and English literature at 
Wesleyan University. Dr. Favell went to that school.
    Dr. Favell. Illinois.
    Mr. Whitford. Oh no, Connecticut.
    Dr. Favell. He went to the other one.
    Senator Harkin. Different Wesleyan.
    Dr. Favell. Yes.
    Mr. Whitford. Different one.
    Senator Harkin. Oh. Where was yours?
    Mr. Whitford. Connecticut.
    Senator Harkin. Oh, okay. Then earned a Master's Degree in 
Theater from the Julliard Theater Center, and again, Mr. 
Whitford, thank you very much for being here, and for your 
testimony, and please proceed.

STATEMENT OF BRADLEY WHITFORD, VOLUNTEER SPOKESPERSON, 
            AUTISM SPEAKS
    Mr. Whitford. Well, thank you, Senator Harkin, on behalf of 
the acting President of Autism Speaks, I want to thank you for 
your support on this issue.
    Autism is not a disease that any beloved celebrity is going 
to come down with, and I know sometimes it seems as if 
celebrity has no place in discussions of priorities, but I hope 
you will forgive it, because these children have no voice, and 
it seems an appropriate use of the attention that actors get, 
to bring voice to them.
    I came to this cause when my college roommate, movie 
producer John Shestack, and his wife, Portia Iverson, had their 
son, Dov, diagnosed with autism, and founded the amazing 
advocacy group, Cure Autism Now, which is known, lovingly, as 
CAN.
    CAN recently merged with Autism Speaks, founded as you 
know, by Bob and Suzanne Wright, and I just want to take a 
moment to say, I know you're aware of the urgency here, but I 
want you to express to your colleagues the incredibly proactive 
nature of the autism community. It's the most heroic response 
to personal devastation that I have seen in John's family, to 
not only take of their family, but to reach out and help 
others. I know there is a great return on whatever investment 
is made in autism research and treatment.
    Autism Speaks is going to make sure that all Americans, and 
certainly all of our elected officials understand the urgency 
of this problem.
    As my friend, John, has said many times, it's as if 1 in 
150 American children was being kidnapped. What would this 
Congress do if that was the case? What must it do to deal with 
these sad facts as they truly are?
    I know the enormous burden of your high office means you 
must bear a certain stoicism. I also know that most Senators 
are parents, and grandparents.
    Portia has written a book about Dov called Strange Son. 
Here's how she describes the kidnapping, ``It was his mind they 
came for. They came to steal his mind. Before anyone gave it a 
name, even before I knew what it was, I knew it was in our 
house. They were very, very dark things, and there was no way 
to get rid of them. When I closed my eyes, I felt their shadows 
passing over me. I didn't like to think about where they came 
from, or where they were going. It was too frightening.
    Dov was only a baby, and something was trying to steal him 
away. I knew that that was what they did whenever I 
accidentally fell asleep. Night after night, I sat beside his 
crib. I knew he was slipping away from us, away from our world, 
and there was nothing I could do to stop it from happening, and 
there was nothing anybody could do, they told me. So, I did the 
only things I could--I guarded him. Although I knew it would do 
no good, because I could not guard his mind. Then, one day, it 
happened. He was gone.''
    It is even more than just a tragedy for these kids, many of 
whom, like Dov, we now know to be of extraordinary 
intelligence, but trapped in bodies which do not allow them to 
effectively communicate or interact with the rest of us. It's 
also a tragedy for our families and for our country.
    A mother of an autistic child recently told me, through her 
tears, that she had been forced to abandon her beloved life's 
work as a nurse, not mainly to give her more time with her 
autistic child, but rather to purposely make her family poor 
enough to qualify for the payment of some of the services her 
child so desperately needs. She said, ``The one thing I won't 
do, even though I have friends who have, is get divorced just 
to qualify for additional benefits.''
    Then there are the cases which don't make national news, 
but which echo loudly among people in the autistic community. 
About once a month, somewhere in America, the father of an 
autistic child kills the child, and himself, to end the 
despair.
    Yet, despite all of this, there is some genuinely good 
news. The unanimous passage at the end of last year of the 
Combating Autism Act by both Houses of Congress can be an 
historic turning point. The act contains, for the first time, 
specific authorizations of appropriations to combat a single 
disease, including bio-medical research, public awareness, and 
consolidation and coordination of Federal efforts to ensure the 
early diagnosis of kids with autism, so they can get--when it 
matters most--the interventions that can give them the best 
possible quality of life.

                           PREPARED STATEMENT

    Now the burden falls on you. I know you have many important 
matters before you. I also know that none is more important 
than this. In no other case do you have the opportunity and 
responsibility to fulfill the commitment made by this historic 
piece of legislation. These are our most vulnerable citizens. 
It is our obligation to make them realize their potential, and 
to make their voices heard.
    Thank you.
    [The statement follows:]

                 Prepared Statement of Bradley Whitford

    Chairman Harkin, ranking member Specter, members of the 
subcommittee--it's my great honor to be here today in the hope that my 
years of training as an actor and stomaching countless audition 
rejections have led me to some degree of celebrity which I can put to 
use, helping you garner the support you need to fully fund the 
appropriations authorized in the Combating Autism Act.
    One in 10,000 kids will have autism. That's what top scientists 
would have told you little more than a decade ago. Then, it became 
clear that number was ridiculous. And the CDC--with the support of this 
subcommittee--started to really look at the prevalence of autism. 1 in 
2,500, then 1 in 500. By the time the Children's Health Act of 2000 
became law, the estimate had become 1 in 250. A few short years ago, 
the CDC said 1 in 166.
    Now, just a couple of months ago, the best data ever collected 
produced the scariest number yet--1 in 150--1 out of 94 American boys.
    I came to this cause when my college roommate, movie producer Jon 
Shestack and his wife, Portia Iverson, had their son, Dov, diagnosed 
with autism and founded the amazing advocacy group, Cure Autism Now, 
known lovingly as ``CAN''.
    CAN recently merged with Autism Speaks, founded, as you know, by 
Bob and Suzanne Wright--on behalf of their grandson. Now this strong 
national organization is going to make sure that all Americans--and 
certainly all of our elected officials--understand the urgency of this 
problem.
    As my friend Jon Shestack has said many times--it's as if 1 in 150 
American children was being kidnapped. What would this Congress do if 
that was the case? What must it do to deal with these sad facts, as 
they truly are?
    I know the enormous burden of your high offices means you must 
bring to bear a certain stoicism. I also know that most Senators are 
parents and grandparents. Portia has written a book about Dov--Strange 
Son. Here's how she describes the kidnapping.
    ``It was his mind they came for. They came to steal his mind.
    Before anyone gave it a name. Even before I knew what it was, I 
knew it was in our house . . . They were very, very dark things. And 
there was no way to get rid of them . . . When I closed my eyes, I felt 
their shadows passing over me . . . I didn't like to think about where 
they came from or where they were going. It was too frightening. Dov 
was only a baby and something was trying to steal him away. I knew that 
was what they did whenever I accidentally fell asleep . . . Night after 
night, I sat beside his crib. I knew he was slipping away from us, away 
from our world. And there was nothing I could do to stop it from 
happening. And there was nothing anybody could do, they told me. So I 
did the only thing I could. I guarded him, although I knew it would do 
no good, because I could not guard his mind.
    And then one day, it had happened. He was gone.''
    And it is even more than just a tragedy for these kids--many of 
whom, like Dov, we now know to be of extraordinary intelligence, but 
trapped in bodies which do not allow them to effectively communicate or 
interact with the rest of us. It's also a tragedy for families, and for 
our country.
    I recently spoke to one mom who told me--through her tears--that 
she had been forced to abandon her beloved life's work as a nurse--not 
mainly to give her more time with her autistic child, but rather to 
purposely make her family poor enough to qualify for the payment of 
some of the services her child so desperately needs. She told me: ``The 
one thing I just won't do--even though I have friends who have--is get 
divorced just to qualify for additional benefits.''
    Then there are the cases, which don't make national news but which 
echo loudly among people who ``get it''--probably about once a month, 
somewhere in America--the father of an autistic child kills the child 
and himself, to end the despair.
    Yet, despite all of this, there is some genuinely good news. The 
unanimous passage, at the end of last year, of the Combating Autism 
Act, by both Houses of Congress can be a historic turning point. The 
act contains, for the first time, specific authorizations of 
appropriations to combat a single disease--including biomedical 
research, public awareness and the consolidation and coordination of 
federal efforts to ensure the early diagnosis of kids with autism (so 
they can get, when it matters most, the interventions which can give 
them the best possible quality of life).
    Now the burden falls on you, on this subcommittee, to turn 
Congress' promise on autism into reality.
    I know how many important matters come before you. I also know none 
is more important that this. And in no other case, do you have the 
opportunity and responsibility to fulfill the commitment made in a 
historic piece of legislation.
    I know you will do the right thing.
    Thank you.

                       AUTISM AND THE ENVIRONMENT

    Senator Harkin. Mr. Whitford, thank you very much. You give 
a very powerful statement.
    I thank you all very much, for taking the time to be here--
as I said earlier--but also for your day in and day out 
efforts, on behalf of our families and our kids with autism.
    I'll begin this round of questions now, and then yield to 
my friend from Illinois.
    I want to start with our first panel, Dr. Insel, and I 
don't know if you're aware of this magazine article, the 
Discover magazine article that came out--maybe you are, maybe 
not--but I wrote down what you said in your testimony, you said 
that we must focus on this as a brain disorder. At least that's 
what I wrote down. I hope I can challenge you on that, and see 
what your response is.
    This Discover magazine article had a map of Texas, and the 
top map was the autism rates per 10,000 from 1990 to 1993, up 
on top, you can't see it, but the bottom two are what's 
important. It was the autism rates per 10,000 of the last few 
years of the last decade, and then it had the pounds of 
environmental toxic release. When you overlay one over the 
other, it is frighteningly the same.
    So, is there something in the environment? Why should we 
just focus on it as a brain disorder, but maybe it's, maybe 
there's something environmental out there, that we also ought 
to focus on, which is one question, and it leads to the second 
part of it--how much of the money, of the $108 million that you 
invest in autism research, is on environmental aspects, looking 
at some of the environmental aspects of this?
    Dr. Insel. These are important questions, Senator Harkin, 
and the way that we think of this is that there is an 
environmental component, but it interacts with some genetic 
component. The reason we believe in the genetic piece of this, 
which is driving the brain pathology, is that there is such a 
high concordance in identical twins, it's difficult to explain 
that based on just an environmental factor, because in non-
identical twins, the rate goes way, way down.
    Senator Harkin. Fraternal twins.
    Dr. Insel. Right. So, there's some effect--it's not 100 
percent concordance, so there's something beyond genetics--so 
we're talking about both environment and the genes.
    What are we doing about the environment? As you know, the 
2007 budget that was approved by this committee involved an 
appropriation for the Gene Environment Initiative, GEI, that 
was a particular request from, in this case, the Secretary--not 
simply through NIH, but it was part of the Secretary's budget. 
This, you know, our Secretary Levitt came from EPA, and he came 
to Health and Human Services with a tremendous interest in 
environmental issues.
    What he was recommending here was that we bring the very 
best genetics and the very best abilities on the environmental 
side together in this new initiative, and the $40 million will 
be spent each year for 4 years. The first grants in that arena 
are just being funded in the next few months----
    Senator Harkin. Did you say $40 million?
    Dr. Insel. Per year, for the next 4 years.
    Senator Harkin. On the environmental aspects?
    Dr. Insel. Not specifically for autism, but generally, if 
we're looking at gene-environment interactions--part of what's 
hung us up here----
    Senator Harkin. Through your Institute?
    Dr. Insel. This is the National Human Genome Research 
Institute doing the genetics part, and the National Institute 
of Environmental Health Sciences, which is developing the 
technology.
    We have great precision on genetic sequencing, not such 
good precision on environmental exposure. So part of this will 
be to develop the tools, so that we'll have sensors, and other 
ways of looking at environmental exposures, often well after 
the fact.
    Senator Harkin. I still need to know, and if you don't have 
it right now, if you'd provide it for the record, about how 
much of that $108 million goes in for environmental.
    Dr. Insel. We can provide that for the record.
    [The information follows:]

                 Environmental Role of Autism Research

    Of the $108 million invested in autism research in fiscal year 
2006, $14 million was invested in environmental aspects of autism 
research by the following Institutes and Centers: NINDS, NICHD, NIEHS, 
NIMH, NCRR, and OD.

    Senator Harkin. Second, if we were to provide the increase 
that the groups have asked for, how would that money, that 
extra money be utilized in the next fiscal year? I'd like to 
have some handle on that.
    Dr. Gerberding, I was shocked when my daughter and her 
husband showed me the schedule of vaccinations for my first 
grandchild in the first 2 years of his life. I was shocked. 
Evidently this is what is required; and they have good 
pediatricians, they go to great doctors out on the west coast, 
but I guess I just never realized that. I think, when my kids 
were born we had a couple, maybe three shots, but we didn't 
have this long list. I think 12 or 15, is that correct?
    Mr. Wright. Thirty-one.
    Senator Harkin. Thirty-one, thank you, Bob. Thirty-one.
    Mr. Wright. Zero to 18 months.
    Senator Harkin. Please, go ahead, what did you say?
    Mr. Wright. Between zero and 18 months, there are 31, 
including influenza.
    Senator Harkin. Okay. That's the list I looked up. They 
were upset, they were asking me, I said, ``Well, I'm not a 
doctor, how do I know?'' So, they wanted me to ask you.
    I mean, I'm serious, they wanted me to ask. They're really 
concerned about this. About all of those vaccinations in the 
early ages. When you have a small child that's not an adult, I 
would be concerned if I had that many shots in 18 months. There 
has been, and there have been some, at least, allegations, some 
thought that perhaps, many of these, at least with the use of 
thimerosal, which was a mercury additive for preservatives, 
might have had some influence in that, although thimerosal has 
now been taken out.
    Mr. Wright. Not entirely.
    Senator Harkin. Except in the influenza, the influenza shot 
still has thimerosal, am I right?
    Mr. Wright. That's right.
    Senator Harkin. I think that's right.
    Could you address yourself to that? Just the number of 
vaccinations, the fact that we still put thimerosal in the 
influenza shot, but it's been taken out of the measles, mumps 
and rubella, I understand.
    Dr. Gerberding. It's important, first of all, to recognize 
how many children are alive today because of those shots, and 
how little vaccine-preventable disease we see in this country 
as a consequence of the enormously successful immunization 
program.
    Keep in mind that an immunization is really just a way to 
expose a child to a specific protein or antigen that causes it 
to develop an immune response, and that happens to children all 
of the time, naturally. They're exposed in their food, they're 
exposed to things they come in contact with their friends and 
with day care, so while they may receive intentional exposures 
to protect their health, they're naturally doing the same thing 
to themselves, just as part of being a child, and being exposed 
to the environment.
    The concern about the safety of vaccine is something that 
we take very seriously at CDC, and we recognize that we're 
having our own challenges in keeping up monitoring the safety 
of vaccines when so many more are out there, and we haven't 
been able to scale our safety efforts the way we would like to.
    But, we do know--and I think the scientists at the 
Institute of Medicine have provided great leadership in this, 
is that when all of the information that is available has been 
looked at by external scientists, not only has the Institute of 
Medicine said that vaccines are not associated with autism, but 
they have said that there is not an association, that there is 
no evidence for an association.
    What we say to that is, that's good, and that's what we 
expected to see, but we have still a lot of work ahead of us to 
identify what are the safety aspects of vaccines, in general, 
but also what are the causes of autism? We need to continue the 
studies that we have in progress, including the study underway 
to look at the potential association of environmental toxins 
and autism, and the SEED study that's going on, and not be 
dogmatic.
    I was really struck by Mr. Wright's statement about the 
similarity between autism and AIDS, because I lived through the 
very first phases of AIDS, and if you go back to 1981, the 
situation we were in with that urgent reality for many, many 
people in our country, is we had no idea what caused it, there 
was no cure, the people who were affected were driving the 
agenda because it was so powerfully affecting their lives and 
their health status, and the people that they loved and cared 
about. Government was slow to get on board, Government was slow 
to scale and provide the kind of scientific leadership, the 
door was open for junk science, and for all kinds of theories 
to come and go, and ultimately, it was the Congress of the 
United States that stepped in and provided the leadership and 
the investment to get that whole picture turned around.
    Domestically, back in the eighties, and more recently, 
internationally with the PEPFAR fund. We don't want to go 
through that cycle again, and I think we really recognize that 
this is an urgent threat. While we're sitting here today in 
these 2 hours, at least six children will be diagnosed with 
autism in our country, 25,000 children this year. We really do 
need to regard this as an urgent threat. So, I just wanted to 
put that perspective in the context of your question.

                       AUTISM IN OTHER COUNTRIES

    Senator Harkin. Well, Dr. Gerberding, obviously, CDC during 
your epidemiological studies also, I'm wondering, are they also 
looking at some of these environmental factors?
    Second, has CDC looked at autism rates in other countries? 
Has any research been done to see if countries in Europe and 
Asia have different autism prevalence rates? If so, can this 
tell us about possible environmental factors that can, or may 
contribute to autism?
    Dr. Gerberding. The SEED study that I mentioned that's 
going on in six sites initiated this summer is designed to look 
for a variety of potential associations and causes of autism, 
including exposure to mercury in the environment, in Rhogam, 
which is sometimes used to treat mothers with Rh factor 
incompatibilities, and a variety of other sources. So, it's 
looking at genes, it's looking at environment, it's looking at 
the social-behavioral context of the family.
    Also looking at occupational exposures in parents that 
could potentially create a hazard of exposure in the home for 
children. So, a comprehensive look, as a first study.
    You might know about the NIH study that will be starting in 
Europe in the cohort of Norwegian children--children in The 
Netherlands, excuse me----
    Dr. Insel. It's Norway.
    Dr. Gerberding. Norway--to follow a cohort of children 
longitudinally to look for prospective evidence of causality, 
and then there are studies, for example, in the United Kingdom. 
that have been tracking children over time, and looking at 
changes in rates.
    Finally, a very important study that we don't have data 
from, going on in Italy, where just by coincidence, some 
children were enrolled in a study of a whooping cough vaccine, 
some of the vaccine was made with thimerosal as a preservative, 
and some of it was made without thimerosal as a preservative, 
so the study was designed to compare the efficacy of the two 
vaccines, we will indirectly be able to determine whether 
there's any difference in autism among the children who did or 
did not receive the vaccine that contained the preservative.
    So, we have more information coming, but I think we're 
beginning to work in the international context of a community 
of investigators all looking for the same kinds of information. 
This is a global health issue, not just an American health 
issue.
    Senator Harkin. Well that's, that is comforting to know, 
that you--CDC is looking at other countries, you are 
coordinating with other countries to find out about the 
prevalence rates, and you're also looking at the Norway study, 
I know.
    Are you also coordinating with Dr. Insel, and his Institute 
on this?
    Dr. Gerberding. The Norwegian study is an NIH study.
    Dr. Insel. But this is an area where there's a lot of 
coordination between all of these Federal agencies, we're 
actually organized around this. This is, very much, an 
integrated effort.
    The Norwegian study, if I can just take a moment, because I 
think it's going to help us over the next couple of years. It 
makes no presumption about the cause, it says, ``We don't know 
enough, to even have a hypothesis,'' but it takes 100,000 
children, following them, their moms, from the second trimester 
to birth cohort, waits 5 years to see, 400 or so children with 
autism, and then it goes back, because samples are collected 
all the way from the very first prenatal visit. So, we have 
biological samples, we have a tremendous amount of clinical 
information. It goes back to ask, what is it, then, that might 
have been an exposure for the children who ultimately had 
autism, versus those who didn't?
    Senator Harkin. I'm going to yield to my colleague for some 
questions now, I have a couple more for Dr. Gerberding and Dr. 
Insel.
    But really, in my next round of questions, I want to focus 
on you, Dr. Favell, and I want to talk about this intervention 
program which holds so much promise, and again, involve you and 
Ms. Colston in that, and also Mr. Wright, in terms of your 
experiences with your grandson, with Dov, and see how we start 
getting to families early on, and providing that kind of help 
and support, if we don't really have an infrastructure for it, 
and we don't--what's the most cost-effective way of doing it? I 
am intrigued by this idea of a tele-health distance-type thing 
where you could support someone in a family 24 hours a day, so 
I want to focus on that in my next round.
    But, with that I would yield to my colleague from Illinois, 
Senator Durbin.

                         ALLOCATION FOR AUTISM

    Senator Durbin. Thank you, Mr. Chairman, and thank you to 
all of the witnesses. This is the first hearing I've attended 
on this issue. It isn't for lack of interest. There are many 
things pulling at us, in the position I have in the Senate, and 
the work that we have to do in so many other places, but I 
wanted to make a point of being here today. Not because we have 
any situation in my immediate family, that relates to autism 
spectrum disorder, but because of the number of friends that 
have been touched by this, and what appears to be the alarming 
increase in the diagnosis of autism across America.
    My wife and I, fortunately, raised three children, and have 
a grandchild without a problem in that regard, but we 
frequently speak of this, the incidence of this, and why it 
appears to grow as it has, I know there's a serious question as 
to whether this is an indication of incidents or just 
identification now, better identification, but I think that 
begs the question. I think, the fact is, this is a significant 
challenge.
    I thank all of you for testifying, Dr. Gerberding, again we 
really appreciate your public service, Dr. Insel, I'll have a 
question for you in a moment, thank you for what you do at NIH, 
and for all of you on the panel, starting with Ms. Colston and 
Dr. Favell.
    Mr. Wright, you raised a question which comes to the office 
of a Congressman and Senator more frequently than you can 
imagine. People visit us from my State of Illinois or other 
places, and say to you, ``Senator, can you possibly explain why 
they're spending ``x'' amount of dollars at the NIH on this 
issue?'' There are people who represent children with juvenile 
diabetes, there are people with parents who have Alzheimer's, 
there are victims of Parkinson's--you name it. They all come 
with the same basic question--how can they possibly rationalize 
this amount of money for this issue of such gravity, why isn't 
more money being spent when it comes to research--and you 
raised that question. You compare the amount of money being 
spent on autism to other significant diseases and disorders, 
and I'd like to ask Dr. Insel the question.
    Because, as I see the numbers here, in the past 10 years 
there's been a dramatic increase at NIH in terms of research 
funding for autism spectrum disorders. In 1998, in the range of 
$27 million, by the year 2008, about $108 million, and I'd like 
to ask you, if you could, give me some indication of whether or 
not this amount is adequate to the task. Do you believe that 
you are able to fund the promising research proposals that come 
before NIH in the field of autism with this amount of money, 
$108 million each year?
    Dr. Insel. Overall, what we call our success rate, that is 
the possibility that anyone in any area will get funded when 
they come to NIH is roughly 20 percent. There's a 1 in 5 chance 
that you're going to get funded.
    Senator Harkin. That's a peer-reviewed.
    Dr. Insel. Peer-reviewed grant, that's right. But, 
virtually all of our, other than contracts, virtually 
everything that we fund is through peer review. That's a system 
that provides the quality control that we need.
    Is autism--how does that stack up against other areas? 
Well, obviously, we're doing better there, because it's growing 
faster. Overall, the budget's grown, a little more than double 
since 1997, this area has grown almost by five-fold, but 
remember, we were starting at a very, very low baseline. So, we 
still have a ways to go in this area.
    I'm not proud to tell you that I can give you the full sum 
of our knowledge in less than 4 minutes, when we talk about 
autism. This is an area where we have many more questions than 
answers. We have a long way to go to fill in those answers. The 
good news is we have some of the tools now, that were not 
available 5 years ago. So, we should be able to make progress 
faster, going forward, than we have in this past period.
    Senator Durbin. So, does your response suggest that 4 out 
of 5 of these peer-reviewed clinical trials that you think are 
worthy of investment each year, have to be denied?
    Dr. Insel. Well, this isn't to say that all of the other 
four would be worthy of investment. We would like to be able to 
fund, always, more than we can do, that's the reality, it's the 
same reality we all experience with our pocketbooks, we can't 
go as far as we'd like.
    However, in the area of autism, we've made that a priority, 
and we've tried to reach as far as we can.
    The problem isn't only that we may not have enough funding 
to do everything we'd like to do, but here also, we haven't 
until recently, had the capacity, we haven't had the population 
of outstanding scientists out there really pushing this agenda. 
That's taken time to build. I think it's there now, and I think 
part of it has been through the help that we've gotten from 
this subcommittee, that's really helped us to grow overall, and 
it's also helped us to stay focused on areas of public health 
need, but there has to be the people out there asking the right 
questions for us to spend the money on.
    Senator Durbin. In order for those people to commit their 
lives and careers to that research, they have to feel that 
funding for research is somewhat reliable, and predictable in 
the years to come, is that not true?
    Dr. Insel. That is absolutely the case, and that is, of 
course, right now a particularly sensitive question. Because 
there are many people who are asking whether they can have a 
career in science, because they find that funding at this 20 
percent success rate is a high-risk game.
    Senator Durbin. I think we made some dramatic progress, and 
I want to thank my colleague from Iowa and Senator Specter from 
Pennsylvania for all their leadership in that regard, but I'm 
afraid that we have reached a part where we're flat-lining 
stagnant here, in terms of the growth in medical research at 
NIH, and I hope we can change that. We are spending a lot of 
money in other places in the world, but I think most families 
would agree that this is a high priority for us to spend.
    Mr. Whitford, you talk about, and I thank you, and Mr. 
Wright for being here, in your public capacities to engage in 
this issue--but you talk about the frustration of your friends, 
that you know, who find it difficult to qualify for help in 
Government programs without making some radical personal 
decisions about their finances and their marital status and 
things of that nature.
    I think that is the part that Ms. Colston was raising 
earlier, too, is how do we sustain the families that are doing 
their level best to help their child, suffering from autism? I 
really believe that that is something that we overlook. 
Research is the first place to turn, but beyond that, it's 
support for these families with children in this circumstance.
    One of the things that I've thought about is to view the 
role of caregivers in America as a special group that receive 
special consideration. Whether we're talking about daycare 
centers or personal attendants for the disabled, there is at 
least one State that gives all caregivers automatic health 
insurance, provided by the State. It's the State of Rhode 
Island, provides Medicaid for caregivers. It strikes me that in 
many instances, families with children with autism would be 
able better to afford the services of caregivers if they could 
offer health insurance as part of the bargain, and we can help 
them do that.
    So, I'm hoping we can find some innovative ways to expand 
the spectrum of services for children who are going to need 
much more, but I thank you for raising that.
    Mr. Whitford. I don't think it's possible to overstate the 
impact that I--actually my, I, subsequent to my involvement 
with CAN, my godson was diagnosed, and it was a different 
situation, they live in a one-bedroom apartment, they do not 
have the funds that they need, and it is absolutely devastating 
to a family, it is--depending on where you are in the spectrum, 
you know, these kids, it's 24 hours. There is a tremendous 
amount of anxiety wondering, where on the spectrum the kid will 
end up. There is, it's an absolutely full-time job, the career 
goes out the window, the marriage goes out the window, and 
you're juggling therapies in a desperate race to see if your 
kid can live an independent life. So, it sounds like a great 
idea.
    Senator Durbin. I hope we can interest some people in it.
    Ms. Colston, I'll ask you the last question I have, and 
turn it back to the chairman on this, but your son, Camden is 
in public schools now?
    Mrs. Colston. He is, he's in Montgomery County, Maryland.
    Senator Durbin. How is that working out?
    Mrs. Colston. It's great. I live--I'm lucky, again, I live 
in Montgomery County, Maryland which is the top 10 counties in 
the Nation in the way they handle disabilities, and the IDEA 
Act. It's great--he gets picked up at my door on the school 
bus, he goes to school, he gets 10 hours a week of intensive 
therapy, he is mainstreamed, or included if you will--not 
mainstreamed, he's included with his typical peers for a third 
of the day, and in a contained classroom for two-thirds of the 
day. I've seen just remarkable improvement in his socialization 
and cognition. So, I'm very grateful for that.
    Senator Durbin. Very fortunate to be in Montgomery County, 
Maryland.
    Mrs. Colston. That's right, I'd say to people, ``I love 
D.C., I'd love to move there, but I can't.''
    Senator Durbin. That just tells the story.
    Mrs. Colston. Yeah, right.

                           PREPARED STATEMENT

    Senator Durbin. A few miles away from you live----
    Mrs. Colston. I can't move there.
    Senator Durbin [continuing]. The schools cannot provide the 
basic care that these children need. I think, I want to salute 
again my chairman, it sounds like I'm doing my best to get on 
his good side, but he had been a national leader on IDEA from 
the start----
    Mrs. Colston. He has been, thank you.
    Senator Durbin. We're lucky to have him.
    Thanks, Mr. Chairman.
    [The statement follows:]

            Prepared Statement of Senator Richard J. Durbin

    As a United States Senator, I hear from thousands of people in my 
State of Illinois. But no stories are as powerful as those of a parent 
who is worried about their child. Whether the worry is because of the 
fear of having to pay for their child's upcoming educational debt, the 
angst of having their child abroad in a war that seems to have no end, 
or the uneasiness of having a child with autism and not knowing what 
the future holds for him or her.
    As we have heard today, autism is a severe neurological disorder 
that affects language, cognition, emotional development, and the 
ability to relate and interact with others. Current estimates suggest 
that over 1 million Americans suffer from some form of autism, 
including more than 24,000 children in my State of Illinois. For 
unknown reasons, the number of children diagnosed with autism has 
skyrocketed in recent years, from one in 10,000 children born 10 years 
ago to approximately 1 in 150 children born today--making autism the 
fastest-growing developmental disability in our Nation.
    Last year, I heard from a woman named Ellen whose story represents 
so well the similar sense of constant worry that I hear from so many 
others. Ellen wrote to let me know that her son's autism was a constant 
source of worry for her. She is a mother that loves her son. At the 
same time, she worries that her son's siblings carry a genetic tendency 
and that their own hopes for marriage and children are tainted with 
concerns about how these genetic tendencies will manifest themselves in 
the lives of their own children. She worries that her other son one day 
will have to bear the strain of raising a child who is affected by 
autism. Ellen writes, ``As much as we love our son, we would give 
anything to have him be `typical'. He will always require supervision 
and assistance. He is the great passion of my life and also a very 
great burden.''
    My State of Illinois has seen a dramatic increase in the number of 
autism cases in the past 10 years. The number of children in Illinois 
receiving special education with autism as a primary diagnosis has 
grown from 1,960 to 9,455--more than a 450 percent increase. As more 
and more families become aware of the disorder and the impact on their 
lives, it is imperative that we all--federal, state, and local levels--
make the most of our ability to promote research, advocacy, and policy 
for autism-related disorders.
    The State of Illinois is very involved. Our communities are 
strongly committed. In 2003, the Illinois General Assembly passed a law 
to develop an innovative model of service delivery called the Autism 
Program to help these children and their families. Through a 
partnership with the CDC, this program offers evidence-based diagnoses, 
treatments, trainings, resources and referrals. Last year, the program 
provided more than 4,700 clinical contacts and trained more than 9,400 
parents and providers. This year, there is hope to expand the 
initiative.
    Late last year, the President signed into law the Combating Autism 
Act. The new law says we have authority to provide dramatic increases 
in federal funding for autism, specifically for medical research, 
screening tools, therapy interventions and education about the 
disorder. But the new law says something else, too.
    Coupled with State based efforts like those in Illinois, the new 
law reflects the dawning awareness in Congress and throughout this 
country that far too many people are affected by autism spectrum 
disorder. It is my hope that this new law proves to be a significant 
step toward a better understanding of how to prevent autism, of 
effective treatments for people living with autism, and maybe even, one 
day, a cure.
    The efforts conducted at the State and now at the Federal level 
will bring much needed action to address the growing prevalence of this 
disorder. More importantly, however, these efforts can bring hope to 
the thousands of families impacted by autism. We may have a long way to 
go but I look forward to today's discussion and learning what the CDC 
is doing and will do to help these families and keep such hope alive.

    Senator Harkin. Thank you very much, Senator Durbin. Thanks 
for your strong support.
    Senator Harkin. As I said, I wanted to get back to 
questions, I wanted to talk about interventions now, and how we 
handle, how to handle those now.
    Now, Ms. Colston, tell me again, how old was Camden when he 
was first diagnosed?
    Mrs. Colston. He was 2\1/2\ when he was diagnosed with 
autism.
    Senator Harkin. Two and a half, and you said that he'd made 
progress through intensive therapy, Individualized Education 
Plans, a sizable team of dedicated professionals. I mean, did 
that start right at 2\1/2\ when he was diagnosed?
    Mrs. Colston. My experience was slightly different, as I 
mentioned. In addition to having autism, he's got medical 
ailments that he was born with, so when he was born, he was 
small for his age, he had horrible acid reflux--you've read the 
Discover article, so you're going to see a lot of parallels 
there.
    Senator Harkin. You read this too, then?
    Mrs. Colston. In full disclosure, I not only read it, but I 
helped place it with Dr. Herbert, so----
    Senator Harkin. Bob Wright says he individually kept the 
magazine afloat for a month by buying up all the magazines.
    Mrs. Colston. Thank you so much, Bob Wright.
    Senator Harkin. Sending them out.
    Mr. Wright. Largest single purchaser.
    Mrs. Colston. It's a great thing. So, he was undiagnosed, 
but we had horrible acid reflux, we were hospitalized, we had 
these allergies, and they thought he had something called 
Noonan Syndrome, the diagnosis changed--all that being said, in 
the NICU these problems presented, and so therefore, the 
Georgetown University Hospital made me sign up for Early 
Intervention. I didn't even know what it was. So he, because he 
had low muscle tone and these other medical problems, at 6 
weeks of age, the team came to my house. I know for a fact that 
he is where he is because they came to my house, and gave only 
4 hours of therapy, but that, I mean, with them, he turned his 
neck, he sat up, he--they were the ones that actually--the 
therapists there are amazing, because they encouraged me to 
really look at the autism before the doctor saw it.
    Senator Harkin. Yeah, I guess what I'm wondering, and I--as 
I said I had dinner Sunday night, no secret, I had dinner with 
the former Lieutenant Governor of the State of Iowa, Sally 
Peterson, who's been very much involved in this issue. Their 
son, Ron is now, I think 20, 21, doing very well.
    Mrs. Colston. Oh, good.
    Senator Harkin. But, again, they had early intervention, 
they could afford it, they had all of the accoutrements, 
everything that they needed. They asked the question--what 
happens to families that don't have the monetary resources that 
we do? How did you happen to--I don't mean to pry, but how is 
this--this costs money----
    Mrs. Colston. Oh, oh yeah. I mean, my out-of-pocket 
annually--and I have good insurance, keep in mind.
    Senator Harkin. Yes.
    Mrs. Colston. Is between $9,000 and $15,000 a year. That's 
not easy. At Autism Society of America, we have a 1-800-3AUTISM 
number, and it's a great resource, but we learned so much from 
that. Because the calls we get are about desperation 
financially.
    Senator Harkin. Sure.
    Mrs. Colston. People--so, I'm lucky to be able to swing 
that, in good years and bad, but these people mortgage their 
homes--especially when their children become adults--that's 
where the rubber hits the road, financially.
    Senator Harkin. Now, this is where I'm going to focus on 
Dr. Favell. I am so intrigued by what you're doing. As many 
families tell me, or people I've talked to with autistic 
children, you know, when they go to the doctor's office, or 
when they see a behaviorist or a psychologist, maybe the child 
is not exhibiting anything at that time.
    Dr. Favell. Right.
    Senator Harkin. When they need help is at home when things, 
go all to heck, all right? There's no one there. That's why I'm 
intrigued by what you're doing.
    How, tell me, enlighten me a little bit more about how, how 
many families could a trained psychologist, behaviorist, 
someone who is trained and knows how to deal with children with 
autism, how many could they handle on some kind of a system 
like this? I mean, on a 24-hour a day basis, I'm trying to 
figure, could one handle three families? Or two, or five? I 
just don't know.
    Dr. Favell. Mr. Chairman, it's an excellent question, and 
the answer is just evolving, but for example, we did as part of 
our work with the Celeste Foundation, one demonstration that 
calculated that, if a professional, like a behavior specialist, 
was to provide in-home services, they might be able to visit 
two families a day, given travel distances, given missed 
appointments, given inclement weather, all of the vagaries of 
the logistics of supplying services, perhaps they could see two 
to three families a day. Of course, again, in more rural areas, 
that number decreases.
    On the other hand, if you have a behavior specialist, or a 
behavior analyst, who is working with this interactive video 
kind of capacity, you could see potentially 20 families a day. 
Now, this kind of remote, this tele-health, does not replace 
face-to-face intervention and support, but it can augment it, 
and expand, exponentially, the number of families that can be 
touched a day.
    Senator Harkin. As I understand it, in the beginning you do 
have face-to-face involvement with the families, is that 
correct?
    Dr. Favell. Yes, in the model that we tested in our 
demonstration project, they spent--the families such as Josh 
Cobbs' family--spend a week on-site, developing priorities and 
learning basic strategies of intervention and teaching. Then 
they went home with their interactive video system, and then 
that began the process of the interactive consultation, support 
and training.
    It started with about 10 to 14 hours a week of interactive 
video support--it's a couple of hours a day. We think, 
actually, and the families tell us, it might be able to be 
somewhat less, it all is individualized, depending on the needs 
of the child. Then, it was after three weeks reduced to about 5 
to 7 hours a week, and then 3 to 6 hours a week.
    Senator Harkin. I see.
    Dr. Favell. So, there's yet to be worked out the formula 
for exactly the parameters for what is needed, and it will 
always be individualized, just as the IEP and the IHP requires, 
but the intuitive reasoning behind having one professional who 
now is able to touch lives through this remote medium is quite 
clear.
    Senator Harkin. What more do we need to do to test this 
out?
    Dr. Favell. Well, I think we need to bring it, as we say, 
to scale. We need to test fully the economics of it, we need to 
test it across broader bands, including some other 
disabilities, and may I say, also, this kind of innovation 
should not be restricted to children alone. We can't forget the 
many, many thousands of people who are adolescents and adults 
who are adolescents and adults who are also living with autism. 
So, we have further to test there. But, I think probably the 
single most important element in bringing this to scale, as I 
say, is to develop the policies behind reimbursement 
strategies. If I, as a psychologist and a behavior analyst, can 
be reimbursed for providing services face-to-face in a home, 
than I should presumably, also be allowed to be reimbursed for 
providing comparable services, now, over remote interactive 
video. Yet, easily half of the States do not allow for that 
kind of reimbursement through Medicaid.
    So, and then those States that do allow it, there's wide 
discrepancy in what they reimburse. Yes, sir.
    Senator Harkin. Let me ask you, Mrs. Colston. If you had 
had something like this available to you, would that have 
helped you?
    Mrs. Colston. Yes, it would have helped me a lot. Not only 
because, most parents of children with autism work full time, 
and are probably hourly wage workers, and so getting off to run 
home for the times you can do an early intervention is tough.
    But also, because then the therapist could see, as Dr. 
Favell says, the bad time of night.
    Senator Harkin. Yes.
    Mrs. Colston. Where, when the behaviors of autism, it just 
gets harder to be a kid with autism.
    Senator Harkin. I'm, I have a note here, I'm holding in my 
hand that says Josh Cobbs is here, the father of Noah Cobbs who 
is in that news clip, is that right?
    Mr. Cobbs. Yeah.
    Senator Harkin. Oh, well Josh, welcome to the committee, I 
should have pulled up a chair for you and asked you a question. 
Yeah, come up here, come up here, sit down.
    I didn't even know you were here. Now, the recorder is 
going to want to know your name.
STATEMENT OF JOSH COBBS
    Mr. Cobbs. It's Josh, last name is Cobbs, C-O-B-B-S. I am 
not prepared, but I'll do my best.
    Senator Harkin. I wasn't prepared to have you here, either.
    But, I just want to know--now. We saw that little clip, 
obviously, you know, TV wants to get in the gane, with all due 
respect to Mr. Wright, television tries to get it in a very 
short clip, tell me what this has meant for you and your wife 
and your son, on this, again, the availability of it, that you 
can do this during the day, right? On weekends, too, I don't 
know, can you, weekends?
    Mr. Cobbs. Sure, we actually had services, initially, 7 
days a week, two calls, one in the morning, one in the evening, 
and we structured them around when we were struggling, such as 
sitting at the dinner table, or breakfast table, which was very 
helpful.
    The doctors got to see Noah in his true element, so he 
wasn't acting up because there was a worker in the class, or in 
his, in our home, and he wasn't putting on, on-stage, if you 
will, so he was in his natural surroundings, which was very 
helpful for us, because that's where the behavior was 
happening. So, that was very important.
    One thing I'd like to clarify, it's not just important for 
our immediate family, but also our, his grandparents, and aunts 
and uncles who are affected by autism as well, they were able 
to come in and help and once Tina and I were trained adequately 
through the Celeste Foundation and our immediate family, we 
then had the tools to go out and help others, so----
    Senator Harkin. Now, I'm told, I'll just throw this 
question out. I'm told that many times, what might be the 
normal reaction of a parent to a behavioral problem of a child, 
that if that child is autistic, it may in fact, exacerbate the 
problem, and make it worse, and so you have to have other 
approaches.
    Mr. Cobbs. Absolutely.
    Senator Harkin. I'm not a behavioral scientist, or anything 
like that, I've just been told that. So the answer is yes.
    Mrs. Colston. We like to say that children with autism 
don't have osmosis, as many of us do. So, a lot of speech 
therapies and other therapies are talk, and so when you talk at 
a child, or even soothe them with your voice, you're changing 
the environment, and that may make them, there's a term called 
sensory violation--it may sort of freak them out a little bit.
    For example, I was trying to comfort Camden, and I would 
stroke him--well that, that just makes him feel completely out 
of his element. So, there are things that a mother does 
naturally, that sometimes we have to alter, because children 
with autism like deep pressure, and that grounds them. Or 
vestibular inputs.
    Senator Harkin. So, something like a tele-health thing 
could be instructive in that, where you could actually talk to 
someone and say, don't do this, or do this?
    Mrs. Colston. Right.
    Mr. Cobbs. Absolutely.
    Senator Harkin. Has that happened to you?
    Mr. Cobbs. Excuse me, absolutely. I do want to point out, 
the actual day that the TV station was there was Noah's worst 
day. Everything that could wrong, went wrong. He went outside, 
he was crying, he was kicking, it was--I was thinking to 
myself, ``We are failing right now, as parents,'' with TV 
reporters there, and a few other people, and through the 
project from Celeste, they actually, right there, coached us 
through the moment, and it, it took about 40 minutes, to get 
Noah reeled back in, to get him back into the house, and to get 
him calmed down, but, wow, what a great feeling. That was a 
true test for us, is we can make that happen with the right 
help and coaching.
    Senator Harkin. Bob Wright, your grandson, how old is he 
now?
    Mr. Wright. He'll be 6 in August.
    Senator Harkin. Six. He was diagnosed early on?
    Mr. Wright. He was diagnosed at 2 years and 3 months.
    Senator Harkin. Now, his parents think about what we were 
just talking about, this is a new thing, here, about having 
that kind of tele-health, where someone could come into your 
home, so to speak, at any time of the day or night, would that 
have been of help to them?
    Mr. Wright. It's hard to say, I can't imagine it wouldn't 
have been helpful. My grandson has auto-immune problems, and he 
had gastro-intestinal issues which were not diagnosed at the 
time. So, they weren't diagnosed until 2 years later, almost 2 
years. Which meant that he was suffering during that period of 
time, and we--nobody understood why. So, it was a very 
difficult situation with him. I think you made the comment, 
you're--in some respects a parent is better off, in some 
respects, if the autistic child has treatable, or at least has 
traditional medical problems. Because then you get access to 
doctors and hospitals and insurance. At least for some of it.
    If you have no medical problems whatsoever, you don't get 
access to hospitals, doctors or insurance, really.
    Senator Harkin. Yes.
    Mr. Wright. So, if you, if you're awfully serious, on the 
other hand, and it's not diagnosed, you really are in a pickle. 
That's what my daughter found.
    However, having said all of that, the kind of--anything 
that would allow a third party to be of help at the time, at 
the worst time of the day is going to be of benefit to an 
autistic family. There's no question about it--whether it's on 
the phone or whether it's in person, or--that is so important. 
Because the mothers just--I mean, you know, I worry as much 
about my daughter as I worry about my grandson. I worry about 
my daughter being on the edge all of the time.
    Senator Harkin. Yes.
    Mr. Wright. Because he has these serious problems, and he 
can't just--he can go from looking and acting very normal to 
get 104 degree temperature in like, it seems like, 3 hours 
later. You have to rush him right to the hospital. Of course, 
they look at him like, you know, ``How could this happen?'' 
They don't have a clue what he's, what's happening.
    Turns out he has severe colitis, bordering on Crohn's 
disease, that's an adult, that's an adult condition, not a 
children's condition. You also find, though, in the case of a 
lot of these children, when they have medical problems, the 
medical protocols don't exist for children for some of these 
conditions. The medical protocols generally require the 
cooperation of the patient for diagnosis of certain kinds of 
things, like gastro. Where you can't talk to a child who can't 
talk. A child who won't express and react to--you point to your 
stomach, you don't point to his, he looks at you like, you 
know, you're from another land. So you, they don't, they can't 
be diagnosed in many cases, either, which makes it 
extraordinarily frustrating.
    So, I would say that--I wrote down the Celeste Foundation, 
I thought that was an excellent concept, I'm not aware of it, 
and I think anything--I think one of the issues is how do 
organizations like that get funding? Do they, they have a 
foundation that gets them started, how do they get enough 
funding, so that they can begin to develop data, you know, that 
won't be sharply criticized by the first skeptical person that 
comes along.
    Senator Harkin. Yes.
    Mr. Wright. So that it can get, you know, it can get enough 
attention, it is very difficult to get insurance, it's very 
difficult to get State or Federal funds to support this, 
because the burden, the burden of proof is so substantial. So, 
that's a real challenge--how do you take this experiment and 
build it up and, you know, at some point, you run out of money 
to do that, and I think that's part of what Autism Speaks--
we're trying to figure out how we can help groups like that 
when they get to a point, to get to the next stage.
    Senator Harkin. Because that's again, what I'm looking at, 
you said it was costing you $9,000 to $15,000 year, out of 
pocket.
    Mrs. Colston. Yes, that's above and beyond--I mean, 
Camden's non-verbal, so of course, I've had 6.5 years of speech 
therapy--and it's always declined. So, that adds up, and 
medical issues and that. So, that's above and beyond co-pays.
    Senator Harkin. So, we do know. I'm going to make a 
statement, I don't know if it's scientifically sound or not, 
but everyone I've ever talked to says that it is factual that, 
the earlier you get to a kid with autism, and you provide 
interventions and analysis, intervention, support, training, 
the proper kind of activities--that it can lead, later on, to 
them being more self-sufficient, more independent.
    My friend Sally Peterson, and Jim Autry whose son Ron is 
now 21, lives by himself, has a job, takes the bus back and 
forth to work. They say, if it hadn't been for those early 
interventions it never would have happened. Because they know 
other people that didn't have that. Their kids, after 4 or 5 or 
6, they just level out, and that's the end of it.
    Mr. Wright. Mr. Chairman, my grandson's costs are well over 
$100,000 a year, out of pocket.
    Senator Harkin. Wow.
    Mr. Wright. Now, I can afford to help on that.
    Senator Harkin. Yes.
    Mr. Wright. But how many people could do that? That's why 
we're here.
    Senator Harkin. Well, this is what I'm trying to see, I'm 
trying to think of two things, here. How do we do more and 
better research, and I've got a couple of more questions I've 
got to ask you, too, and I know Dr. Gerberding has to leave. 
But then, how do we also do the most cost-effective, best 
methodologies to get the families that have kids now, so that 
we have that early intervention? I'm thinking that so many 
people out there can't get it, they may be isolated, they don't 
have the financial resources that some of us do, and if they 
don't have an attendant illness, they may not have anything.
    So, if we can use something like a tele-health, a thing 
like that, where one trained person can interact with a number 
of families, and where families can get help when things go all 
to heck in the family, it seems to me that that just begs, begs 
for more expansion, to see how it would work, and to see if we 
can adapt this, adopt it, adapt it, adapt it to the, to a 
larger segment of our population. It seems to cry out for that 
kind of support.
    Mrs. Colston. It seems to me, as a parent, that there's a 
natural fit. If you could take this technology, or your 
funding, and put it towards early intervention, which I think 
is IDEA Part C?
    Senator Harkin. Yes.
    Mrs. Colston. You know, there are so many great models in 
place in this country, that are cost-effective, and that's one 
of them. And I wonder if you could marry those two through Part 
C, and see how it worked, or pilot it. Because I know that the 
early intervention therapists who helped me, they had a 
tremendously huge caseload. I think they got caught up in 
overall education funding as well.
    Senator Harkin. Yes.
    Mrs. Colston. So.

                           TREATMENT RESEARCH

    Senator Harkin. I wanted to ask you a question, and I'm 
glad my panels are still here for Dr. Gerberding, Dr. Insel. In 
this party, in Discover magazine, there's some interesting, 
interesting language about different approaches to treating 
kids, people with autism. There's some indication that using 
chelation therapy, chelation therapy, which I'm not all that 
familiar with, I just kind of halfway know what it is, after 
reading this, I looked it up some more, but that it quotes at 
least one or two families in here whose, I think they had more 
than one child that was autistic that went through this, and 
they just, improved immensely. I'm wondering, have you looked 
at that? Is there something there?
    This, the doctor they quote in this is a Dr. Asco, she's a 
microbiologist, she has a Doctorate in Microbiology and other 
things. Now, I'm intrigued by this. Is this part of looking at, 
you know, of treating people with autism?
    Dr. Insel. One of the ways that, at NIH, we've tried to 
increase our effort in this whole area is to develop an 
intramural program, the first such program for focusing on 
autism. It started about a year ago, there are five protocols 
that have been rolled out there, and this is to have a kind of 
rapid response team that can pick up an idea and run with it 
quickly, where we don't have to go through a very long process 
of peer-review.
    They have, as one of their protocols, they do have a 
chelation protocol, that was approved by our Science Committee 
in September. It's actually been held by the Institutional 
Review Board, whose members have some additional questions, 
they're going to address it again on May 1. So there have been 
no subjects actually entered into the protocol. But the hope is 
that will be approved and we can use this intramural program as 
the first place to do a controlled trial, a real, randomized 
controlled trial to find out whether there's, a, value in this 
approach, and b, what the risk is.
    Senator Harkin. Is NCCAM involved in that?
    Dr. Insel. I'm sorry.
    Senator Harkin. NCCAM?
    Dr. Insel. NCCAM is not involved. This is one that NIMH is 
taking the lead on.
    Senator Harkin. But, you say on May first, you're going 
to----
    Dr. Insel. May first the IRB, the Institutional Review 
Board, will be reviewing this particular protocol, and we are 
hopeful that once it's approved, we can begin to run with it. 
But I must say, they have has some considerable reservations, 
the Review Board itself, about the safety of chelation, they've 
brought in some outside experts who have made them even more 
concerned about the potential risks involved, based on some 
very recent animal research.
    Senator Harkin. Dana Halburtson, from Iowa, told me that 
chelation therapy made a big difference with her 8-year old 
daughter, Robin. So, again, this is something I don't 
understand completely, but if things are happening out there, 
that people are having success with, I would think that NIH 
would want to look at it.
    Dr. Insel. That's exactly why we have this intramural group 
put together for just that purpose, and it's not only on this, 
but on a number of other ideas that have come up, we're trying 
to move quickly to be able to test them out, but we want to 
bring the best science to those questions, and we want to make 
sure that we're doing it in a way that's safe as well as 
informative.
    Senator Harkin. I know, Dr. Gerberding, you have to go, and 
I'm respectful of your time, but again, I just, I want to be 
reassured that you're coordinating with NIH in your, in your 
epidemiological studies, that you are coordinating with them, 
and that you're looking at, in your studies, the different 
aspects of these vaccinations that we talked about, I mean, 
look--I agree that, you know, the vaccinations obviously have 
saved a lot of lives. But, one has to begin to wonder, are 
there some other side effects that are happening out there that 
we don't know about? Maybe they need to be modified, or 
something, I don't know.
    But, I'm just, I want to be reassured that CDC is 
coordinating with NIH, in looking at the possible causes, and 
maybe environmental factors that might, that might spur on the 
genetic predisposition to have autism.
    Dr. Gerberding. First of all, we are collaborating across 
the Department, in particular with NIH in two lanes that are 
relevant to your question. The first has to do with the autism 
agenda, and we have the inter-agency approach to doing that.
    Separate from that, we have collaborative work going on, on 
vaccine safety, that includes NIH, CDC, FDA and the National 
Vaccine Program Office, and those are two separate but related 
issues, and we are fully engaged. I love to spend NIH's money. 
So, I have a very strong incentive to collaborate with NIH on 
the development and research agendas and so forth. I'm 
concerned, Senator, because I've been long aware of the worries 
about the safety of vaccine with respect to autism, but we 
really need to get past that, and I think one of the downsides 
of focusing on that association is that it's closed us off to 
really looking, broader, at some of the more biologically 
tenable hypotheses.
    So, I want to reassure your daughter that she's doing the 
right thing for your grandchildren, but we also know that no 
vaccine is ever going to be 100 percent safe, and we have a 
responsibility to investigate safety, not just from this lane, 
but from the whole spectrum.
    Senator Harkin. I don't want to continue on this, we can 
discuss this at further hearings that we'll have, Dr. 
Gerberding. My point is not that these vaccines aren't safe. 
That's not my point. My point is, that you add them all up, and 
do we really know that 31 of those, given in the first 18 
months--within that short span of time--each one of them may be 
individually fine, but do we know what the outcomes, what the 
impact is, say, on someone who may be genetically predisposed, 
to have autism. Then you hit them with 31 of these vaccines, 
all combated in a short period of time. What may be--how could 
that, perhaps, trigger that genetic predisposition? I don't 
know that you can answer that question.
    Dr. Gerberding. Well, I can tell you that it's not related 
to thimerosal. Because the childhood vaccines that your child, 
your children are getting do not contain thimerosal as a 
preservative, so----
    Senator Harkin. Except that one.
    Dr. Gerberding. If they, some of the flu shot vaccines 
still contain thimerosal, they're trying to take it out, but it 
hasn't happened----
    Senator Harkin. Yes.
    Dr. Gerberding [continuing]. Across the board, yet.
    Senator Harkin. Yes.
    Dr. Gerberding. But, it's a very small amount of 
thimerosal, and you know, we've been talking about, is the 
prevalence of autism increasing in our country? It's continuing 
to either stay the same, or increase, even though we have 
removed the thimerosal as a preservative of vaccine for several 
years now, so----
    Senator Harkin. But I'm not talking about thimerosal. I'm 
just talking about the combined effects of all those vaccines 
on a small body that may be genetically predisposed anyway? 
That's what I'm talking about. I'm not talking about 
thimerosal.
    Dr. Gerberding. It's one of the hypotheses that, I think, 
needs to be evaluated in the studies that are going on. I don't 
think it's the most likely hypothesis, but it certainly should 
be included in the risk profile.
    Dr. Insel. I think the message that we'd like to convey is 
it's too early to reach premature closure on any of this--we 
simply don't know--I think all of us agree that there must be 
something beyond the genetics.
    Senator Harkin. There's got to be, because, Dr. Insel--and 
that's why I asked the question at the beginning--do we know 
what's happening in other countries? Now, there are other 
countries that have a pretty decent standard of living in which 
they do not give all of these vaccinations in the first year or 
two of life. Do we know what the incidents of autism is in 
those societies?
    Dr. Insel. We have good prevalence estimates for most of 
Western Europe and for Japan. So, we have some comparisons, and 
in fact, the United Kingdom is a good example where, in this 
case, the thimerosal came out in the early nineties----
    Senator Harkin. I'm not talking about, I'm just talking 
about all of those vaccines----
    Dr. Insel [continuing]. But in terms of the early child, 
and vaccines----
    Senator Harkin. Does every child in Great Britain get 31 
vaccinations before they're 18 months?
    Dr. Insel. Julie would have a better idea of that.
    Dr. Gerberding. No, and their rate of prevalence of autism, 
if anything, is higher than it is here.
    Senator Harkin. Well, then I'd, that's what we'd like to 
look at. Other countries, too, to see what's happening. Now, 
that would be an interesting epidemiological study. To compare 
what we're doing here to other countries, and to see if there's 
any correlation. Now, you say they have a higher incidence in 
Great Britain than we have here.
    Dr. Gerberding. When we talk about the incidence or 
prevalence of autism, there's been an issue that hasn't come up 
in this hearing, and I just want to lay a marker down, so we 
can talk about it. In order to know how many children have this 
disease, we have to have access to their health records, as 
well as their education records. As you know, we are stymied in 
getting that information. So, in order to compare across 
countries, we have to be able to get similar information from 
all of the other countries that are in play here, and that's 
really touch--that's a tough challenge to make those direct 
comparisons.
    Senator Harkin. You had, earlier, a memorandum of 
understanding with the Department of Education.
    Dr. Gerberding. That's right.
    Senator Harkin. I understand that they stopped that because 
of privacy concerns.
    Dr. Gerberding. Well, smart people have looked at the law, 
the Family Education Responsibility Privacy Act, and the 
Department of Education attorneys have interpreted that law, to 
say that our means of having access to children's educational 
records is inconsistent with FERPA, that act.
    We think, our responsibility is toward the HIPPA Act, the 
Privacy Act, and under the Privacy Act, public health 
utilization of data is allowed, so there's a stalemate here, 
and the Department of Health and the Department of Education 
are trying to work this out, but right now, it's really 
jeopardizing our ability to understand the true prevalence of 
autism in our children, and that's a big concern to me.
    Mr. Wright. We've looked at this at Autism Speaks, this is 
a very serious issue, because it, obviously so much work has 
been done at Government expense at CDC to put in the system of 
developing the data that the CDC is publishing, and this whole 
system relies upon getting information from school records. If 
you lose that, the system--which has taken several years to 
build--will collapse, and it would be a lost, you know, tons 
of--years will be lost.
    My personal conclusion is, that having looked at this, 
hard, that it probably is going to take, it is going to take 
some congressional action to clarify this. Because it, after 
all, it is going to end up being the reading of legislation and 
when you have disagreements, you're going to have different 
kinds of positions, and at some point or other, I think, that's 
going to require a congressional, a few lines, in a few bills, 
to say that this is the interpretation we intended. Because 
this all comes from congressional legislation over prior years. 
It probably is absolutely necessary.
    Senator Harkin. Well, I would welcome any suggestions you 
have that your, or your organization has on legislative 
changes, legislation that we need to do to change the language 
so that we can get that kind of information from the Department 
of Education.
    Mr. Wright. We would be happy to help you in any way we 
can.
    Senator Harkin. I would apreciate that--that could be very, 
very helpful. Or you, or anybody else. I don't know if I could 
call on Federal Government people to do that, or not, I don't 
know if I can ask you to do that.
    Well, listen, this has been a very helpful hearing. Again, 
I feel good that through NIH that we're doing more research.
    Now, we have ramped it up, but I do want to say this. I 
hear every time, I hear people tell me, ``Well, you know, the 
percentage increase has been so great here or there.'' I always 
remind people that from zero to one is infinite increase.
    Now, I've got to know where you start before you tell me 
what the percentage increase is. I want to look at the total 
dollars, and what is needed and what can be used. That's why I 
ask, Dr. Insel, if we had this increase, could it be used, what 
it would be used for, and whether or not.
    Now, I do believe that your answer to the questions of 
Senator Durbin, I think informs me that, yes, if only 20 
percent of the peer-reviewed are being funded, well, that 
indicates that, obviously, there are more out there that can be 
funded, that are peer-reviewed, obviously. So, that we can 
provide that kind of, if we provide that funding for you.
    But, I also thank the other panelists for being here. I, 
we've just got to do something about getting to these kids 
earlier. Darn it, we just always patch and fix and then later 
on it costs us a thousand times more. If we can get these kids 
earlier with the kinds of interventions that we know works. I 
mean, we've seen what's happened with families that had the 
wherewithal to do that and we've seen what's happened to their 
kids and how much better they perform. So, what's most cost 
effective? How do we reach out?
    I am anxious to see how the Celeste Foundation will expand 
this and we'd like to be helpful in any way we can. But, I 
just, my senses tell me that this could really be very helpful 
to a lot of families around the country who are somewhat 
isolated. I'm thinking of rural areas, obviously in small towns 
and communities where they just don't have the ability to get 
that kind of intervention.
    So, I'm hopeful that we can take a further look at that. I 
would, I would invite any from you, Dr. Favell, any suggestions 
that you have for how we might expand the scope of this. You 
suggested that in your testimony in response to a question.
    Mr. Whitford, I just want to say that, that you mentioned 
something about celebrity status. I wrote it down here, about 
celebrity. You know, people pay attention to people like you 
and, you know, if you're one of those celebrities that are 
dancing with the stars, or running off to the Riviera and all 
that, well, people read this, they pay attention. But, if 
you're a celebrity and you're using your status, and the fact 
that you reach a lot of people and you're using that to focus 
people's attention on good things that they can do to help our 
society, to help people live better, to help us do our job 
here--I think that's commendable. I just want to commend you 
for that, for doing that, and being out in front on this issue. 
It helps a great deal that you would use your status to do that 
and I appreciate it very much.
    Do we have anything else that any of you want to say for 
the record or, anything before I call this to a close, at all?
    Dr. Insel?
    Dr. Insel. I think all of us would like to thank you for 
your interest in this problem. This is the first such hearing 
we've had on this topic and for everyone here at the panel, 
even for somebody who's not at the panel, but right behind us. 
This is a mission, and we really appreciate your interest and 
your willingness to support it.
    Senator Harkin. Well, I appreciate all of you, and the 
organizations that you started or that you've been involved in. 
Dr. Gerberding, I thank you for your great leadership and Dr. 
Insel.
    Mr. Whitford, no Ms. Favell.
    Dr. Favell. Yes.
    Senator Harkin. Dr. Favell, and all of you.
    So, this, I think, this is the first hearing of this 
nature, but there will be more. I'm hoping that our budget, 
again to echo what Senator Specter said at the very beginning, 
I just hope that within our budget confines that we can move 
ahead more aggressively on this whole area of autism than we 
ever have before. It, it almost is like that AIDS epidemic. 
We've just got to get to it.
    Mr. Wright. Mr. Chairman, this reminds me, almost a little 
bit, of the early 1980s. There were two things going on. It was 
the AIDS issue was going on and, if you also remember at that 
point in time, there was this enormous outcry for cancer 
treatment, effective cancer treatments. People were running off 
to South America and Mexico and France. It was not like one or 
two people. It was, that they were just going down there for 
treatments, they were all considered to be too risky----
    Senator Harkin. Yes.
    Mr. Wright [continuing]. For the United States. That 
brought on a tremendous surge in, in cancer study. Some of it 
had to do with AIDS, some of it didn't. You had, Herceptin came 
out of all of that and you had the AIDS vaccine and the AIDS 
treatment. You know, it took a period of time, but it was an 
enormous upswing.
    I get, I have a sense that this is the same, we're in the 
same timeframe here with the same kinds of issues.
    You know, even though Dr. Insel is, I understand exactly 
the concerns of safety, but there are thousands of children 
that are undergoing that Kelation, one or more of those 
Kelation processes today. The parents are all told, they all 
know there are risks involved. They're saying, ``Look at the 
risks I have at home. I have to make a judgment. Look at the 
state of my child. If this has a possibility of making him 
better, much better, I'm going to have to take the chance. 
Because I just don't, I don't believe I can't.''
    So, there is, there is a, it isn't going to Mexico for 
cancer treatment, but it is going, this Kelation activity, you 
know, rightly or wrongly, is a little bit like that migration 
that took place, you know, years and years ago.

                  ADDITIONAL STATEMENTS FOR THE RECORD

    Senator Harkin. Well, I hope and trust that we'll be 
looking at that and that NIH will be examining that. I hope 
this May 1 IRB will come through and it will be moving ahead on 
that, in that area of research.
    [The statements follow:]

               Prepared Statement of Senator Thad Cochran

    Mr. Chairman, thank you for scheduling this hearing to discuss 
autism and the spectrum of disorders related to autism. Since the month 
of April has been designated by the Senate as ``National Autism 
Awareness Month,'' it is fitting that we have a discussion on this 
important issue during this time. We welcome Dr. Gerberding and Dr. 
Insel as members of the panel today. As leaders of Federal agencies 
tasked with autism surveillance, research, and treatment, your insight 
into current programs and your vision of future efforts to combat this 
disorder is important. We appreciate other distinguished panel members 
joining us today to provide their unique perspectives of the impact of 
autism disorders. We look forward to your comments and your direction 
on how this committee can be helpful in addressing your concerns as we 
move through the appropriations process.
    Autism Spectrum Disorders are developmental disorders which affect 
a child's social interaction, behavior, and basic ability to 
communicate with others. The prevalence of autism-related disorders 
continues to increase, with recent Centers for Disease Control and 
Prevention reports estimating that 1 in 150 children in our country is 
affected, referring to this increase as a national public health 
crisis. Despite the increased attention to autism in recent years, the 
cause remains unknown and a cure is not available.
    Congress has been responsive to this heightened public awareness 
and focus on autism from the medical community. The Combating Autism 
Act of 2006, which I cosponsored in the last Congress, was signed into 
law in December. This comprehensive legislation authorizes 
approximately $800 million over the next 5 years for research, early 
detection and intervention of autism. For the upcoming fiscal year, the 
President's budget contains no new funding for the Combating Autism Act 
and recommends level funding, approximately $115 million, for existing 
autism programs at the CDC and the NIH. Autism advocates have requested 
an increase in this funding to $168 million to expand autism efforts.
    I look forward to your comments on the status of the current 
programs and on how an increase in autism funding would be used.
                                 ______
                                 
                 Prepared Statement of Allison Chapman

    To Whom It May Concern: I am a parent of a child who regressed into 
Autism after his vaccinations. I have several areas I would like 
addressed at these hearings and I hope that an A-CHAMP representative 
will be there to represent my son and the hundreds of thousands of 
others with the same story. The following are a list of my questions,
  --Will there be money for double blind studies using the DAN! (defeat 
        autism now) protocal?
  --Is there an understanding that Autism is a Whole Body Illness which 
        can be treated?
  --Will there be a vaccinated vs. non-vaccinated study?
  --Will there be monies for studies on the dangers and implications of 
        thimerosal (49.6 percent ethyl mercury) like the Burbaker 
        study?
  --Will there be an extension to these genetic studies to find out if 
        it is Mercury (a known mutagen) that is causing deletions and 
        mutations in the DNA?
  --WILL THERE BE BIOLOGICAL TESTS TO FIND OUT WHAT'S GOING ON IN THESE 
        KIDS BODIES THAT MIGHT BE CAUSING THE BRAIN DIFFERENCES?
  --Will there be monies to teach Drs and pediatricians that Autism can 
        have many medical issues that need treatment and to refer them 
        to professionals who understand this like DAN!s, Toxicologists, 
        GIs, etc.
  --Will you separate vaccine safety into a separate, independent 
        organization other than the CDC which is the org that mandates 
        them (A tremendous conflict of interest)?
    I my mind there are 4 areas of Autism that need attention. 
Diagnosis, Educational intervention, whole body medical treatments that 
are already helping these children and research broken into BOTH 
environmental and genetic pieces. I've seen much in the areas of 
diagnosis, education, and genetics but by concentrating on those only 
leaves the biggest areas untouched. This is about the children and 
making them better or else the windfall of financial assistance it will 
take to support these kids who don't get treatment for the rest of 
their life, will most likely bankrupt this country. Thank you so much 
for your time. I truly do look forward to what happens in this Senate 
hearing, I am hoping you side with the children no matter what.
                                 ______
                                 
                   Prepared Statement of Anna W. Wolk

    I am the very proud mother of a young man diagnosed with PDD/NOS-
high functioning Autism at the age of 3. Adam is now 14--nearly 15--and 
as puberty has set in, so have many new behaviors. He has become 
frustrated with an inability to express his anxiety over the many 
changes occurring within his body, and as a result has become 
aggressive with us, his parents. What has become increasingly clear to 
me as we travel our journey that is autism is three things:
    (1) We all (as parents of any child) have the same destination in 
mind--we are simply traveling different routes to get there,
    (2) There are many books and tons of advice for the parents and 
families of newly diagnosed children, but nothing of substance for 
those of us who have made it to the teen years,
    (3) The State of Illinois is not servicing our children as well as 
the rest of the Nation. Why is it that, when my son turns 20 years 364 
days old, he is cut loose from the system. Is it the State of Illinois' 
opinion that, on my son's 21st birthday he is magically cured? If only 
it were true!
    It is a disgrace that we are ranked 48th out of the 50 States in 
services for our Special Needs children and their families--and we must 
include the families, as Autism affects the entire family unit.
    Luckily, my husband and I have not become one of the many couple 
who have divorced due to the pressures of raising a child with autism, 
but I can tell you the toll--both emotional as well as financial--is a 
huge burden. And the effect on the siblings is enormous as well, as 
they don't get ot have a normal childhood either. Simple things like 
birthday parties, sleep overs or even extra-curricular sports require 
enormous analyzing before undertaking them. Many times, the siblings 
just have to forego many of the usual rites of childhood because of 
their siblings needs.
    When it is time to plan for the disabled child's future, there is 
no central ``clearinghouse'' of information regarding residential 
settings, day programs, vocational training, etc. It's purely luck of 
the draw and word of mouth. Many times, it comes down to who you know.
    Well, I don't know anyone. I don't have any idea where to begin 
this new phase of my son's life, and there' s no direction from the 
school system. I feel lost to my son, and I feel lost as to how to help 
him.
    ANYTHING you can do to help centralize information for parent's and 
families would be an enormous help.
    Current statistics reveal that 1 in every 150 children is diagnosed 
with Autism--one of them is my son.
    Help create a miracle--support Autism Research and Awareness.
    Thank you for your time.
                                 ______
                                 
         Prepared Statement of the National Autism Association

    On behalf of the Board of Directors and membership of the National 
Autism Association and SafeMinds, we thank Senator Harkin and all the 
committee members for holding these hearings to ensure funding the 
Combating Autism Act. Once fully funded, this landmark legislation will 
help answer questions of vital concern to the autism community: what 
causes this disorder, now at epidemic levels, affecting 1 in 150 
children, and how can it be most effectively treated and prevented.
    Several dozen recently published peer-reviewed scientific papers 
point to environmental triggers, including vaccines and their 
components, as a cause of autism. Most recently, a study by the Autism 
Genome Consortium Project of 1,500 families with multiple affected 
children failed to identify an autism gene and failed to replicate most 
highly touted finding from recent genome scans. The negative AGPC 
findings provide strong evidence that heritability claims are 
exaggerated, if not false. Provided with massive resource support and 
under the most favorable study conditions, the AGPC found no evidence 
of heritability. These powerful findings suggest that the search for 
the actual cause of autism must focus on the environment to which the 
mother, fetus, and infant are exposed.
    In the report language accompanying the CAA, Congressman Joe Barton 
stated, ``. . . the legislation rightfully calls for renewed efforts to 
study all possible causes of autism--including vaccines and other 
environmental causes.'' Representative Barton also said, ``. . . these 
provisions will insure continuation and intensification of crucial 
research at NIEHS so that it is able to conduct all necessary research 
to determine the environmental factors in autism.''
    Senator Chris Dodd stated in the Senate colloquy, ``In our search 
for the cause of this growing developmental disability, we should close 
no doors on promising avenues of research. Through the Combating Autism 
Act, all biomedical research opportunities on ASD can be pursued, and 
they include environmental research examining potential links between 
vaccines, vaccine components and ASD.''
    With acknowledgement from our Federal Government that environmental 
factors such as mercury from vaccines may play a role in the 
development of autism, and a clear directive that this will be 
investigated by the National Institutes of Environmental Health 
Sciences (NIEHS), the National Institute of Mental Health, and other 
Institutes, we must now ensure that this area receives the necessary 
funding to establish a solid program of goal-driven research.
    Rather than merely counting the children diagnosed with autism, we 
now have government confirmation that autism is a national health 
emergency that must be addressed with all deliberate speed. The 
government can move quickly and decisively when it wants to. Recent 
examples include the coordinated responses to E. Coli outbreaks in 
spinach, SARS, and threats from bird flu and mad cow.
    Autistic children deserve and must have this same level of 
commitment and response. Imagine how quickly the government, indeed 
every institution of society, would react if 1 in 150 children were 
suddenly kidnapped. This is the stark reality faced every day by 
families with autistic children. Autism imposes massive costs to 
families and society, totaling $3.2 million in lifetime care per 
individual, according to a recent study from Harvard University.
    Epidemiology studies performed by the CDC must now test a clear 
environmental hypothesis rather than simply count affected children. 
Also, since it is scientifically impossible to have a genetic epidemic, 
the funds spent on finding an ``autism gene'' should more appropriately 
be devoted to finding the environmental triggers. NIEHS must play a 
leading role as such research is within its area of specialization, 
while NIMH and other Institutes are best equipped to fund research 
within their areas of expertise.
    Placing the major focus of government research on the environmental 
factors triggering autism and on biomedical treatments reaffirms the 
National Autism Association's long-standing position that there is hope 
for all families affected by autism. An environmentally triggered 
disorder is both treatable and preventable; therefore, there is hope--
hope both for families that already suffer with autism and hope that 
this disorder can quickly be relegated from an epidemic to the annals 
of history.
    To that end, we urge this committee to fully appropriate the 
Combating Autism Act. In the area of environmental research including 
vaccines and their components, we ask the committee to include a line 
item amount of $45 million over 5 years, as was authorized in the 
Senate-passed version of the bill. These funds should be specifically 
designated to the NIEHS so that this under-funded area of research can 
finally receive the attention it deserves. Hundreds of thousands of 
children suffering with autism spectrum disorders, that we now know is 
caused by one or more environmental factors, are depending on the 
wisdom of this committee to fully fund this critical research 
directive.
                                 ______
                                 
    Prepared Statement of Robert J. Krakow, Esq. President, A-CHAMP

    My name is Robert J. Krakow. Thank you for this opportunity to 
submit written testimony regarding the epidemic of autism and 
neurodevelopmental disorders that exists among our children. The autism 
epidemic is the most urgent public health issue facing our Nation.
    This testimony is submitted on behalf of A-CHAMP, a political 
action organization that is comprised of thousands of parents 
nationwide. We have supporters in every state and District Leaders in 
more than 200 Congressional Districts. Most of our members have 
evidence showing that their children, labeled with autism, are vaccine 
injured, heavy metal toxic, with proof that their children are mercury-
toxic. Notwithstanding this focus we advocate for all children with 
autism, irrespective of the possible causes of their disorders. We are 
a 100 percent volunteer organization that is organized on a grassroots 
and ``netroots'' basis. We are all parents or grandparents trying to 
improve the welfare of our children.
    We appreciate the opportunity to submit written testimony and to 
have an A-CHAMP representative make a statement in person before the 
committee. As you know, we learned of this hearing only two business 
days prior to the hearing. We have had many members of A-CHAMP 
contacting their Senators and the committee to impress upon you our 
right and desire as stakeholders on this issue to voice our concerns 
about the autism epidemic and about our children. As a preliminary 
matter we wish to express our concern that only one organization 
appears to have participated in the planning of this hearing and to 
have been invited to testify before the committee, other than 
representatives of the Centers for Disease Control and the National 
Institute of Mental Health. We do recognize that once you heard our 
concerns about this hearing the subcommittee was responsive to our 
concerns and offered the opportunity to submit our concerns in writing.
    It was A-CHAMP that alerted the larger autism community about this 
hearing and urged other organizations that are concerned with autism to 
attend, participate and submit testimony. This reflects a core 
principle of A-CHAMP that our government must recognize that there are 
many stakeholders that have claim to a voice on the issues affecting 
children with autism and that, notwithstanding the claims of one 
organization, it is not the case that a particular organization speaks 
for all of us. I think you have learned from our telephone calls and 
other communications over the last several days that no one but A-CHAMP 
speaks for us or our children.
    I also wish to emphasize that our organization represents many 
constituents of the honorable members of this subcommittee. I have 
conferred with residents of Iowa, the home of this committee's 
Honorable Chairman, Tom Harkin, and they have authorized me 
specifically to state that this submitted statement reflects their 
views and concerns. These individuals include among others Dana 
Halvorson, Lin Wessels, John Olsen, Ruby Olsen, Meg Oberreuter, Barb 
Romkema and many others. Similarly, in Pennslyvania, home of the 
ranking minority member of this committee, Senator Arlen Specter, Holly 
Bortfeld, and Colleen Strom, among many others have authorized us 
specifically to represent their views to the committee. This is but a 
tiny portion of the parents we represent in every State of the Union.
    The issue of which persons or what organization is the authentic 
voice of our children is one that is not easily answered, despite the 
claims that you may hear. We appreciate the responsiveness of this 
committee to our concerns in this regard.
    I am the father of a 7 year-old boy named Alexander who became sick 
in 2001 at the age of 2 years old, after receiving flu shots that were 
recommended by the Centers for Disease Control. An immunologist and 
pediatrician first diagnosed him with heavy metal toxicity, immune 
dysfunction, colitis, hypotonia, endocrine dysfunction, multiple 
additional autoimmune symptoms and a list of other physiological 
disorders too long to state here. My wife and I were told to 
immediately see a neurologist. We later brought our son to a world-
renowned neurologist who observed a child who was very ill, in great 
pain but who had nothing to offer but the label of autism.
    My son is unable to speak but is an extremely intelligent and 
loving child who is very related to his parents and sister. My daughter 
is 13 years old and is in Middle School and loves her brother dearly.
    I am an attorney. I spent the first decade of my career as a 
prosecutor in Manhattan serving for 5 years as a Bureau Chief with the 
Office of the Special Narcotics Prosecutor for the City of New York. I 
have been engaged in the private practice of law for 18 years.
    I became involved in working for individuals with developmental 
disabilities before my son became ill. I have served as chairman of the 
board of Lifespire, Inc. for 5 years. As you will read in separately 
submitted testimony, Lifespire is a large 55 year-old not-for profit 
with 1,500 employees that serves 6,000 developmentally disabled persons 
every day--in group homes, day centers, supported work, medical 
clinics, after-school programs, transition counseling and many other 
areas. Lifespire, formerly Association for Children with Retarded 
Development (``ACRMD'') has always served individuals with autism. In 
the last 5 years we have devoted a great deal of time and resources to 
developing programs for children and adults with autism. Lifespire was 
founded by parents and its Board consists today primarily of parents or 
relatives of individuals with developmental disabilities. We are a 
homegrown, local, community-based organization, even if we have grown 
large over the years. The reason we grown large is because we and 
others have advocated long and hard over the past half-century to 
improve services for the developmentally disabled. In our State of New 
York the response has been good in some areas. In other parts of the 
nation the response has been uneven. Lifespire's concern is not 
research or etiology. Our concern is client-centered individually 
tailored community-based services and supports.
    Now we need to confront a new emerging challenge--a very real 
increase in the numbers of individuals, mostly children aged 4-17 who 
are diagnosed with autism.
    At Lifespire we knew very well in 2002 that there was an 
unacceptably high number of cases of autism among children, that rates 
of autism were 1 in 150 or higher and that there existed then, in 2002, 
a looming crisis for our State. We also knew that the prevalence of 
autism was something new, because for 50 years we were in the business 
of serving individuals with disabilities. While autism was always 
present in some of the population who we serve, it was not nearly as 
prevalent among our adult population as what we were observing among 
children.
    In 2002 we knew that we needed to act immediately to address the 
crisis in services that would result as the leading edge of children 
with autism--the cohort of increased prevalence born around the year 
1990--moved forward in age. Sadly, little has been done in the last 5 
years by government to address these concerns.
    Lifespire provides services and does it well for a long time. The 
tradition of Lifespire was born in a crucible of parent activism that 
became necessary because the schools and government were not responding 
the needs of families. 50 years ago parents joined together to provide 
for their children, by pressuring government to do what was necessary. 
30 years ago ACRMD /Lifespire parents blew whistles outside 
legislators' windows to call attention to problems with our care for 
those who area least able to care for and speak for themselves--then 
they were whistleblowing about infamous Willowbrook and the 
institutional abuse of disabled children.
    As I stated, Lifespire's CEO will be submitting testimony 
separately.
    Sadly, today, things are better but children and adults with 
developmental disabilities still suffer abuse and often do not get the 
care that they need.
    It is evident from the overwhelming response to this hearing today 
that parents are once again active. Two years ago, along with some 
dedicated parents we founded a national political advocacy group called 
A-CHAMP, and I am honored to serve as its President. We have 10,000 
supporters and we are growing. Our volunteer parent-advocates 
throughout the country have already persuaded legislators in many 
States to enact provisions to make vaccines safer, thus protecting 
children, and to make insurance coverage fairer for individuals with 
autism.
    I have a message for you as legislators. Parents are mobilized. We 
do not need nor do we use professional lobbyists. We find our 
children's interests are best served by direct parent-citizen 
communication with legislators. We find that professional lobbyists who 
may be employed by some large organizations do not necessarily 
understand what our children need. Parents understand what our children 
need and we are sufficiently sophisticated, motivated and organized to 
make sure that our children's voices are heard loud and clear, so that 
our children's needs may be heard, even though many cannot speak.
    We urge you to get it right on this--get it right on the autism 
issue. The parents know what's right and they will be heard.
    I call for what we describe as ``A Culture of Advocacy for a 
Lifetime of Care.'' Around the State and the country parents are 
learning to advocate for their children. This echoes the story of 
Lifespire. My uncle and cofounder of Lifespire was a postal worker who, 
60 years ago, had a child with special needs. He was also a labor 
organizer. In those days there was nothing for children like my cousin, 
Eugene. He and a few other parents created an organization and changed 
the laws of New York State by direct parent advocacy, not through 
professional lobbying. His campaign was called ``A Children's 
Mandate.'' My uncle is gone now for some 10 years but his son has a 
home and an extended family to watch over him at Lifespire--for LIFE. 
My uncle gave him the greatest legacy--a lifetime of care by people who 
care. His mandate for his son and many other children was realized.
    Nothing will stop the advocacy of a parent who fights for his or 
her child. At A-CHAMP we have worked hard to empower parents around the 
country by instilling them with the will and desire to advocate for 
their children so that they will be taken care of with love and 
generosity. When a parent fights for his own child he or she fights for 
every child.
    I say to you as legislators that this is the problem confronting 
you--how to use limited resources to create a lifetime of care for our 
children. Parents expect a lot from our government--you--and our 
children deserve it. These hundreds of thousands of children will be 
the responsibility of our government. We need to come to grips with the 
problem and we need to do that NOW.
    We are years too late and we are playing catch-up--we are playing 
with the lives of children.
    I would like to address a few specific areas that are of great 
concern to me and many parents that address the subject of today's 
hearing.

              COMMUNITY CONTROL OF SERVICES AND RESOURCES

    We have developed detailed information on the daunting costs of 
caring for an individual with autism through his or her lifetime. We 
know that for a an autistic adult the cost of care from age 23 through 
66 will be approximately $17 million for an individual who is severely 
disabled and at least $10 million for an individual who is less 
severely disabled. These numbers are based on actual experience and are 
explained in testimony given by Mark Van Voorst, CEO of Lifespire at a 
March 8, 2007 hearing conducted by the New York legislature. I have 
attached a copy of Mr. Van Voorst's testimony. Given the Centers for 
Disease Control's recent estimate that there are exist 560,000 children 
under age 21 with autism, and probably many more given the reports of 1 
in 94 children in New Jersey having some form of autistic spectrum 
disorder the costs of caring for our children will be staggering. We 
know from hard and concrete experience that the costs will be in the 
trillions.
    We are already many years late in addressing the demands that this 
crisis will make on our resources. We will need innovative ideas in 
housing, in creating bridges to our communities for our developmentally 
disabled adults, and in providing therapeutic and loving environments 
for our children. Most importantly, we must create an environment in 
which parents will feel confident that as they grow old their children 
will be provided and cared for--``A culture of advocacy for a lifetime 
of care.''
    What does this mean? It means that when we develop a ``coordinated 
response'' to addressing the autism epidemic we must understand that we 
are dealing with individuals and not numbers. This means that we must 
direct our resources to solutions that are community-based. We see in 
legislation pending before this committee and laws already enacted that 
one approach to the autism epidemic is to create large centralized 
institutions that will address needs on a mass scale. While a massive 
response to the autism epidemic is required that response must not be 
overly centralized and it cannot favor one or a few gatekeeper 
organizations that aim to control the autism industry. We must invest 
in local and regional institutions so that we may build a community of 
care. We must involve parents in homegrown organizations because only 
then will our precious children receive the care and concern that they 
deserve. I fear that the solutions to services and support issues that 
have been promoted before Congress, including the Combating Autism Act, 
do not reflect these values. I have observed that moneyed power 
organizations driven by a corporate model have gained access to 
Congress by professional lobbyists and have begun to dominate the 
public forum on autism. For the sake of our children this trend must 
stop.
    I have spoken with many parents around the county, including those 
in Iowa and Pennsylvania, among many others. They have told me that 
what works for their children are integrated community-based programs 
that address their needs and provide supports where they live. This 
builds community and provides service. They require a combination of 
behavioral approaches applied locally in community centers or at home 
by qualified therapists, in combination with approaches that address 
the fundamental physiological disorders that have cause our children to 
become ill. I will address the issue of using effective non-
pharmaceutical biomedical interventions for our children later in this 
statement, but the important point here is to provide services and 
supports through community-based parent-driven regional and local 
organizations. Our experience is that these organizations are usually 
most effective if they are structured on a not-for-profit rather than a 
for-profit basis. Profit making ventures certainly may have a role in 
providing services but they should not be the gatekeepers or primary 
caregivers of our children.
    I would like to address another point that has arisen in the 
context of this hearing. One witness invited to this hearing will 
address a strict behavioral approach to therapy for children with 
autism that focuses on delivery of service by interactive video--a 
method dubbed ``telehealth'' that involves, in part, installing a video 
camera in one's home and engaging in therapeutic sessions by video. It 
appears that the Department of Education and the NIMH have devoted 
substantial funds to research in this area. I have studied this area 
over the last few days and consulted with many parents about it. The 
universal response to this approach to service delivery is surprise and 
rejection. Children with autism are often characterized by their 
inability to develop proper socialization. They cannot speak--they need 
social reinforcement. It is incongruous to think that therapists in 
remote locations who essentially ``phone it in'' can address these 
problems and others.
    We urge you to invest in our communities and not some technological 
fix that can lay claim to addressing children with needs when in 
reality it presents a method of providing services on the cheap. While 
I welcome learning more about telehealth I have serious concerns about 
this approach toward providing therapy for our dear children.

                                Research

    Autism is not genetic. A recent genetic research study that cost 
more than $10 million found almost no clear indication of a genetic 
association with autism. At most, the researchers found genes that 
might create susceptibility to environmental toxins, but their great 
breakthrough was finding a gene association in 1 out of 1,168 families. 
The researchers will dispute what I have said here, but quietly other 
researchers will tell you I am correct. There is no ``autism gene.'' We 
can produce well-respected researchers to support our position.
    Epidemics cannot be genetic because gene mutations occur very 
slowly. The unavoidable evidence points to an environmental factor or 
trigger that has caused the upsurge in the numbers of cases of autism. 
Yet, little government or private research money is devoted to the 
study of environmental factors.
    For reasons that are not valid, research in autism has been 
disproportionately devoted to genetic research. Notwithstanding the 
bias by private organizations and government to fund genetic research a 
great deal of peer-reviewed replicated research has shown that autism 
is a physiological disorder. The emerging research research strongly 
implicates environmental toxins and toxins from vaccines, including 
mercury, in creating impairment leading to physiological disease.
    We must have honest research that inquires into every area of 
autism etiology regardless of who may find the results of such research 
inconvenient.
    Parents supporting A-CHAMP almost universally believe that vaccines 
have injured their children, either alone or in combination with other 
external toxins to which their children have been exposed. We have also 
found that treatment focused on addressing these problems have worked 
to improve the health of many children and even recovered some children 
fully from autism. Our children's physiological disorders are not 
comorbid or unrelated to their autism. Their physiological disorders 
collectively are what autism is--and result in the observable 
behavioral symptoms that we define as autism. We need research into 
these treatments--research that has shamefully been ignored or set 
aside because it is too controversial. Backing off from controversy 
will not help our children.
    Some valiant practitioners from the Autism Research Institute, 
DAN!, Thoughtful House in Texas and others have developed effective 
treatments and undertaken vital research that is directly helping our 
children today. Why is this research ignored or actively suppressed by 
our government agencies? How can ``evidence-based'' treatments such as 
these be validated if there exists no funding for the supporting 
research? The answer, of course, is that it cannot be validated. A 
highly manipulated scenario has developed that has resulted in a self-
fulfilling prophecy: condemn treatments as ``anecdotal'' and not 
sufficiently evidence-based while simultaneously blocking funds 
necessary for research that will validate the same treatments. We 
regard this process as a cruel and unacceptable joke that has deprived 
our children of the chance for recovery. The scenario is not acceptable 
and our parents will work tirelessly to change it.
    Recently, we were pleased to learn that the NIMH had initiated a 
chelation study. Without going into detail we were concerned about the 
study protocol used for this study because we knew that the protocol 
did not reflect the methods many of us have used successfully in 
chelating our children, safely and effectively. We have also heard 
rumors that this study has been suspended. We urge the committee to 
investigate why research like the chelation study is not proceeding and 
further, make sure that practitioners who have used chelation 
successfully are consulted in constructing meaningful research 
protocols.
    There are some questions raised by some about whether there is a 
true increase in the incidence of autism among our children. We have 
observed some so-called experts in the field revise past estimates of 
prevalence of 1 in 2,000 children affected in the 1980's as being 
incorrect because current research shows a rate of 1 in 150 or higher. 
We hear claims that current methods result in better counting and that 
autism at current rates have always been with us but that individuals 
with autism were ``hiding in plain sight.'' We reject such claims as 
the product of an agenda promoted by those who need to deny the 
existence of an epidemic to protect the vaccine program or avoid 
potential liability for vaccine related injuries.
    So that we may know with certainty how many children and adults are 
affected we need epidemiological studies conducted by independent 
researchers outside the CDC or the government. We also need a study 
comparing individuals who are vaccinated versus those who are 
unvaccinated to determine which group has more disease. Legislation 
calling for such as study was introduced last session and will be 
introduced again. We support it.
    Finally, the CDC has placed barriers to access to by independent 
researchers to the Vaccine Safety Datalink (``VSD''). This database can 
help answer questions about the cause or causes of the autism epidemic. 
The Institute of Medicine has severely criticized the CDC's handling of 
the VSD. A panel of public and private experts has found that 
productive research can be conducted using the VSD to answer the 
question of whether vaccines or their components cause autism, a 
question not yet fully answered using the VSD. Yet to shield the VSD 
from outside researchers the CDC has paid a private company millions of 
dollars to house the data--data developed by the investment of millions 
of dollars of taxpayer funds. We respectfully request the Senate to 
conduct an investigation of this issue.
    An addendum is attached to this statement that contains a non-
exhaustive list of areas of research that we believe have been ignored 
and require attention.

                               TREATMENT

    There is great controversy over treatment for autism, as discussed 
earlier in a different context. While Applied Behavioral Analysis 
(``ABA'') has helped some children it is not the panacea that some 
originally thought it would be. Yet, at every turn the only treatment 
option offered by medical professionals and schools is ABA. The use in 
legislation of the words ``evidence-based'' to validate treatments will 
surely result in the only approved treatment covered by insurance to be 
ABA.
    I can tell you that my son has made tremendous progress not because 
of some strict regimen of ABA--the technique has been used to some 
extent with him--but through the use of various non-pharmaceutical 
biomedical interventions. My son's so-called ``tantrums'' were the 
result of one thing: severe gastrointestinal inflammation. He was in 
pain.
    Once this was treated my son was able to become the happy--very 
related to his family--child he was meant to be. It is a myth that 
children with autism are all in their own world and cannot relate to 
others. It is also a myth that little can be done to improve their 
condition and welfare. Much can be done; we have done it. I know other 
parents are submitting to the subcommittee information about biomedical 
intervention that can effectively treat autism--a physiological, 
neurobiological disorder. I have met many children who have completely 
recovered by children through non-pharmaceutical biomedical 
intervention. Yet, few research dollars are devoted to this area. Those 
who criticize biomedical interventions in autism decry the lack of 
``peer-reviewed'' research supporting ``evidence-based'' research. This 
criticism is a self-fulfilling prophecy made by those who block the 
very research that could support diets such as the specific 
carbohydrate diet, supplements such as methyl B12, hyperbaric oxygen 
therapy, safe methods of chelation therapy and many more.
    At the same time pharmaceutical treatments such as Prozac, Ritalin, 
Concerta, Adderall, Zyprexa, Seroquel, Geodon and others are used even 
though they are untested and unapproved for children, and have serious 
side effects. While Risperdal has been approved for treatment of 
irritability in autism it gained approval only through the expenditure 
of large sums of research dollars, and it is most definitely not a 
treatment for autism. It too has serious side effects that its 
manufacturer failed to disclose until the manufacturers were pressured 
to do so.
    While there may be place for pharmaceuticals in some cases focus on 
these non-treatments have sucked the life out of any effort to produce 
research that will satisfy those who seek peer-reviewed research. 
Notwithstanding this, the research has been produced, often privately. 
More needs to be done.

          INTERAGENCY AUTISM COORDINATING COMMITTEE (``IACC'')

    The Combating Autism Act did expand the Interagency Autism 
Coordinating Committee. But the IACC was not given sufficient authority 
to conduct oversight over the NIH research agenda. In addition, for too 
long the community participants in the IACC have been limited to the 
same individuals from the same organizations. The IACC has been 
ineffective. The key to making government responsive to the autism 
crisis is to listen to the parents. They know what their children need. 
Give parents a central role in fashioning government's response to the 
autism crisis. Broaden the participation in the IACC to voices outside 
the ones that bureaucrats may find safe. The IACC and other government/
private committees should not be window-dressing that allows government 
to make empty claims that the community participated in their decision-
making on policy. Community and stakeholder participation must be 
genuine so that members of our community can say that their voices are 
being heard. Many in our community believe that they are excluded from 
the process and that the IACC and other committees are not functioning, 
as they should in a democratic society.
    Returning to the theme that introduced by testimony I want to 
emphasize that our government must give all parents, not just those 
from one or two self-selected groups, a central role in solving the 
autism epidemic. If government fails in this area the consequence will 
be a public health, political and social problem even greater than the 
one we face today. A-CHAMP's slogan is ``We Are Everywhere, and We're 
Not Going Away.'' We are watching our government's response to the 
autism epidemic with great attention because our responsibility to our 
children's welfare and future mandates such scrutiny.
    Parents are mobilized, engaged, empowered. We are sophisticated and 
smart. We are also beleaguered and our resources are strained to the 
breaking point. We urgently need help now for our kids. We are ready 
for government to become our partners in addressing the autism crisis--
but that means true partners in our communities, not public-private 
partnerships with special interest group organizations.
    On behalf of all the supporters of A-CHAMP I thank you for 
convening this hearing today to listen to our concerns. We appreciate 
the opportunity to be heard. Given that this testimony was prepared on 
extremely short notice I will be happy to answer any questions from the 
Committee to clarify or amplify the points I have made in this 
statement.

                                Addendum

            SUGGESTIONS FOR SOME AREAS OF RESEARCH ON AUTISM

    With respect to research we recommend the inclusion of the 
following areas into a research agenda on autism and environmental 
factors:
  --Research related to treatment of autism as a ``treatable'' or 
        ``reversible'' condition. Specifically, the focus must be 
        placed on autism as a chronic impairment, resulting from 
        oxidative stress. For example, there exists evidence showing 
        that autism is characterized by the presence of ``sick'' 
        neurons rather than ``dead'' ones or even impaired development 
        processes (e.g., GABAergic neuron migration). This type of 
        research highlights the inherent reversibility of the disorder 
        and must be pursued with urgency in order to develop and 
        validate treatment of the disorder.
  --Research on large cohorts of children to determine their status 
        based on testing for urinary porphyrins, urinary toxic metals, 
        urinary amino acids, organic acid tests, immune panels, 
        cytokine testing, chemokine testing, etc.
  --Research of the use in treatment of autism of anti-inflammatory 
        medications such as Actos, Celebrex or Singulaire in quelling 
        inflammation in the gut and brain and in reducing levels or 
        pro-inflammatory cytokines and chemokines;
  --Genetic research should be focused on single nucleotide 
        polymorphisms and their relationship to metabolic and other 
        mechanisms that create vulnerability to environmental toxins 
        (including vaccines) rather than the latest genetic research 
        focusing on genetic anomalies or CNV's that have not been tied 
        to a biological mechanism affecting more than a tiny number of 
        children;
  --Research evaluating the mitochondrial status of children diagnosed 
        with autism. Mitochondrial impairment plays such a strong role 
        in MS;
  --Full investigation of the role of heavy metals, including mercury, 
        aluminum, lead and arsenic, from any source, in any form 
        (including thimerosal), specifically including vaccine 
        exposures in the etiology of autism;
  --Complete access to the Vaccine Safety Datalink data by independent 
        researchers outside the government;
  --A recognition in developing a research agenda that vaccine sourced 
        exposures may be a contributing factor in many cases of autism 
        alone or in conjunction with other environmental exposures;
  --Funding of research of the biological mechanisms that may 
        contribute to autism;
  --Full investigation of the role of viruses, bacteria and other 
        infectious agents independently or in conjunction with other 
        environmental exposures in the etiology of autism;
  --Research of environmental factors, including the MMR vaccine, as 
        they relate to gastrointestinal symptoms and histopathological 
        findings'' and treatment of these underlying bowel problems;
  --Investigation of the effect of various metals, viruses, toxins with 
        each other and other environmental agents--also known as 
        synergistic toxicity--in the etiology of autism;
  --Research of the role urinary porphyrin profile analysis can play in 
        measuring heavy metal toxicity;
  --Research of the role of mercury and other toxicants in ambient air 
        pollution, including toxicants emitted from coal burning power 
        plants, in the etiology of autism;
  --A thorough analysis of the role of thimerosal, heavy metals, and 
        other toxins play as mutagens and how this mutagenicity may 
        play a role in autism;
  --The role of the hypothalamus-pituitary-adrenal axis in the etiology 
        and trealuient of autism.
                                 ______
                                 
   Prepared Statement of Mark van Voorst, CEO/President of Lifespire

    Good morning/good afternoon. My name is Mark van Voorst. I am not a 
physician, scientist, geneticist, statistician, nor even a practicing 
clinician so my comments will not address the issue of the rise in the 
numbers of individuals diagnosed with autism, nor will I attempt to 
offer any insights regarding the cause of this phenomenon.
    However, for the past 29 years I have worked as an administrator in 
organizations that provide an array of services to individuals 
diagnosed with Mental Retardation or other forms of Developmental 
Disability. I am presently the CEO of a large not-for-profit 
organization in New York City which provides services to roughly 5,000 
individuals per day and my comments are intended to enlighten the 
Committees on the enormous challenges that every New York State 
voluntary agency will face in the coming years as we struggle to ensure 
that all children and adults who are diagnosed with an Autism Spectrum 
Disorder receive the supports and services they will need.
    In February 2007, the Center for Disease Control and Prevention 
released a new finding that concluded that the rate of autism in the 
United States is now 1 per 150 births. The National Census for 2004 
shows that there were 4,115,590 births in 2004. Using CDCs figures, 
this means that of all of the children born in 2004, roughly 27,437 
will be diagnosed with some level of autism. Current national estimates 
suggest that there are already between 560,000 and 800,000 individuals 
who are diagnosed with some level of autism.
    In 2003 the New York State Office of Mental Retardation and 
Developmental Disabilities estimated that there were 52,991 individuals 
with autism.
    In 2004 the National Census figures for New York indicated that 
there were 250,894 births. Using the newly released CDC figures, this 
means that roughly 1,673 of all new births in 2004 will at some point 
be diagnosed with autism. Current literature suggests that roughly 50 
percent (45 percent--60 percent) of these 1,673 individuals will also 
be diagnosed with an IQ of 70 or less, which means that in addition to 
being autistic, they will carry a diagnosis of Mental Retardation. It 
is safe to say that of the 1,673 children born in 2004 who will be 
diagnosed with autism, approximately 837 will require some level of 
support and assistance throughout their entire lives.
    As I am not an educator, I do not know the cost of providing 
supports and services to these individuals from birth to 21. However, I 
can give you some idea of what it will cost to provide support and 
services to these individuals once they become adults. The figures I am 
presenting are based on real, current annual costs for providing day 
and residential services at Lifespire Inc.
Individual with a high level of need
    Day Services--$44,174
    Residential Services--$154,764
    Combined Annual Costs--$198,983
Individual with a lower level of need
    Day Services--$26,686
    Residential Services--$109,489
    Combined Annual Costs--$136,175
    If we now project these figures over the lifetime of an individual 
who needs ongoing supports and services (between the ages of 23 and 66 
= 43 years) and build in an annual increase of costs of 3 percent the 
total costs rise dramatically.
Individual with a high level of need between 23-66
    Day Services--$3,933,615
    Residential Services-$13,790,753
    Cost over 43 Years--$17,724,368
Individual with a lower level of need between 23-66
    Day Services--$2,376,328
    Residential Services--$9,756,402
    Cost over 43 Years--$12,132,730
    Looking only at the 837 children born in 2004 who may well need 
lifelong supports and services, it will cost between $10,155,095,010 
(low side) and $14,835,296,016 (high side) to provide services once 
they leave the school system.
    In 2003 the Office of Mental Retardation and Developmental 
Disabilities estimates that there are 52,911 individuals with autism 
currently in New York. Until we have an actual breakdown of the ages of 
these individuals we have no way of knowing how many are currently 
being served and how many are about to enter the adult service world. 
However, I think it is fair to say that the need for increased funding 
will be staggering.
     crisis number two: who will provide the supports and services?
    In January 2006 the U.S. Department of Health and Human Services 
released a report entitled ``The Supply of Direct Support 
Professionals'' (DSP). HSS estimated that, in 2003, approximately 
874,000 individuals worked full time providing care for roughly 4.3 
million Americans of all ages. Most importantly the report noted ``DSPs 
are essential to the quality of life, health and safety of more than 
one million Americans who are in need of long term services and 
supports''.
    By 2020 the demand for DSPs will grow to 1.2 million. This 
represents an increase of 37 percent. However, during this same time 
period the available pool of labor will increase by only 7 percent.
    HHS also estimates that on a national level there is a 10-11 
percent vacancy rate in all Direct Support Professional positions. The 
situation is so severe that many existing service providers are 
refusing to expand services to meet the growing demand because they 
cannot recruit and retain the work force necessary to do so. 
Additionally, the turnover rate of DSPs is estimated to be 50 percent 
nationally.
    While perhaps not as severe as the ``national problem'', Lifespire 
Inc. is experiencing both crises identified in the 2006 HHS report. At 
any given time we have between 80-100 positions that are not filled and 
our turnover rate for those individuals providing direct support to our 
consumers in 2006 was 39 percent. While I have not seen any figures for 
all of New York State, I suspect that my experience at Lifespire is 
shared by most, if not all not-for-profit organizations in the State.
    The legislature and OMRDD have done a wonderful job providing 
resources that enable organizations like Lifespire to serve New Yorkers 
with developmental disabilities. Unfortunately, the funds allocated by 
the legislature are still not enough to allow us to attract and retain 
a skilled work force. Unless we are in a position to both attract new 
staff while at the same time are given the dollars to retain our 
existing staff, the wave of individuals diagnosed with autism which 
will begin to spill over into the supports and services within the 
``adult world'' will simply overwhelm the provider system and will have 
disastrous consequences for an entire generation of children and their 
families.
    During one of his campaign speeches, Governor Spitzer stated that 
it was important that we ``take care of those who cannot take care of 
themselves'', and that ``everyone who has special needs will get the 
care they need for as long as they need it''.
    Mr. Chairman, I believe that we have a moral obligation to ensure 
that all New Yorkers who have been or will be diagnosed with autism 
have access to a service system that is both sufficient in size and 
sufficiently well trained to provide the services and supports that 
they will need. While I certainly hope that there is funding for 
ongoing research to determine a cause for autism, I also implore the 
Committees to take this message back to the full Senate and Assembly so 
that increased dollars flow to the voluntary provider community or to 
parents so that they can directly purchase the services they feel their 
children need. If we do not do something soon the provider community 
will simply not be equipped to deal with the numbers of individuals 
diagnosed with autism who will need adult services.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Harkin. There will be some additional questions 
which will be submitted for your response in the record.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]
             Questions Submited by Senator Daniel K. Inouye

                        AUTISM SPECTRUM DISORDER

    Question. I would like to thank the Centers for Disease Control and 
Prevention (CDC) for their attention to accurate reporting of autism 
spectrum disorders by each State. The startling rise in the prevalence 
of autism spectrum disorders presents many challenges to society. The 
uniqueness of Hawaii raises even further challenges when one considers 
the remoteness and relative lack of resources available to support 
individuals affected by autism spectrum disorders. How can the Centers 
for Disease Control and Prevention (CDC) work with States such as 
Hawaii with rural areas and other unique needs to contribute to a 
better understanding of autism spectrum disorders?
    Answer. Early identification and intervention hold the most promise 
for children and families affected by autism spectrum disorders (ASD) 
and other developmental disabilities. CDC is working with partners on a 
campaign reaching parents, health professionals, and childcare 
providers with information on developmental milestones and the early 
signs of autism. The campaign--Learn the Signs. Act Early.--is helping 
to change perceptions about the importance of identifying developmental 
concerns early.
    Recent ASD surveillance data show concerns had been raised for more 
than half of the children with autism or related disorders prior to 
their third birthday, yet children were not diagnosed until well into 
their fourth or fifth years. Encouraging early intervention will help 
children reach their full potential during the critical window of early 
development.
    Since the launch of the campaign in October 2004, information about 
Learn the Signs. Act Early. has been made available to more than 11 
million health care professionals, parents, partners, campaign 
champions, and child care providers. CDC and its partners have 
distributed more than 83,000 resource kits targeting the three major 
audiences.
    CDC continues to work with campaign partners on new ways to reach 
parents, child care professionals, and health care providers with the 
most up to date information about developmental disabilities--including 
ASD. Also, CDC has been working with partners to reach underserved 
populations--including minorities and both urban and rural/remote 
populations. For example, campaign staff recently worked with the 
Autism Society of America (ASA) on a project to increase dissemination 
of campaign materials in underserved communities (including rural 
populations) through ASA chapters throughout the country.
    The campaign is also in the process of piloting multi-disciplinary 
teams of medical professionals, educators, policymakers, and parents to 
develop action plans to address obstacles in early identification and 
intervention at the State and local level. If this model proves to be 
successful, it could be replicated in additional States.

                          COMBATING AUTISM ACT

    Question. A recent study by the Centers for Disease Control and 
Prevention (CDC) found that autism spectrum disorders now affect 1 in 
150 children in the United States, up more than tenfold from a decade 
ago. The Congress responded to this growing public health crisis when 
it passed the Combating Autism Act, which authorized more than $900 
million over 5 years for the Department of Health and Human Services' 
autism activities. How does the NIH and the National Institute of 
Mental Health intend to implement the Combating Autism Act's 
recommendations with the budget recommendations that have been sent to 
us?
    Answer. The NIH has made considerable progress in implementing 
provisions of the Combating Autism Act (CAA) of 2006 (Public Law 109-
416). A noteworthy accomplishment was the creation of the Autism 
Centers of Excellence (ACE) program, which received $25.5 million in 
fiscal year 2007. The ACE program represents a consolidation of two 
existing programs, the Studies to Advance Autism Research and Treatment 
(STAART) and the Collaborative Programs of Excellence in Autism (CPEA), 
to maximize coordination and cohesion of NIH-sponsored ASD research 
efforts. The ACE program encompasses research centers and networks 
focusing on a broad range of autism-related research, including topics 
such as neuroimaging, biomarkers and susceptibility genes, 
pharmacotherapy, early intervention, and personal and environmental 
risk and protective factors.

               INTERAGENCY AUTISM COORDINATING COMMITTEE

    Question. How does the National Institute of Mental Health intend 
to implement the recommendations of the Combating Autism Act with 
respect to the Interagency Autism Coordinating Committee (IACC) 
strategic plan?
    Answer. The Combating Autism Act (CAA) of 2006 (Public Law 109-416) 
requires the Secretary of the Department of Health and Human Services 
(HHS) to establish a new Interagency Autism Coordinating Committee 
(IACC) with the following responsibilities regarding autism spectrum 
disorders (ASD):
  --Develop and annually update a summary of advances in ASD research
  --Monitor Federal activities with respect to ASD
  --Make recommendations to the Secretary regarding any appropriate 
        changes to Federal activities and public participation in 
        decisions relating to ASD
  --Develop, annually update, and submit to Congress a strategic plan 
        for the conduct of, and support for, ASD research, including 
        proposed budgetary requirements
    The IACC was chartered under the Federal Advisory Committee Act 
(FACA) with the National Institute of Mental Health designated as the 
lead for this activity. With a sense of urgency and a spirit of 
collaboration, the IACC is developing a strategic plan for ASD research 
that focuses on the unique needs of individuals with ASD and their 
families. The plan will encourage public and private partners to work 
together to rapidly advance our scientific understanding of ASD, 
improve health and well-being across the lifespan, and help individuals 
with an ASD lead fulfilling lives. In developing the strategic plan, 
the IACC assembled expert workgroups to tackle challenging tasks, 
identified recent investments and accomplishments in ASD research, 
gathered ideas for research priorities from many stakeholders, and 
convened four scientific workshops with broad stakeholder 
participation. Furthermore, the IACC has decided to amplify its efforts 
and accelerate progress by meeting four times a year (a minimum of two 
meetings per year are required by the CAA).
    The IACC strategic planning workgroup will consider the research 
initiatives proposed by the scientific workshops. The IACC strategic 
planning workgroup will review public comment and current ASD research 
funding to offer recommendations for structuring the strategic plan and 
estimating budgetary requirements for components of the plan. The IACC 
will consider the recommendations of the strategic planning workgroup 
and define the next steps in the strategic planning process, which may 
include additional opportunities for stakeholder input through Web-
based town hall meetings or other innovative approaches for outreach. 
Once approved by the IACC, a draft strategic plan will be posted on the 
IACC website for public comment. Upon completion, the IACC will submit 
the strategic plan to the Secretary of HHS.

             CARE OF INDIVIDUALS WITH ASD LIVING IN HAWAII

    Question. Realizing that the care of individuals with autism 
spectrum disorders requires an interagency approach, what suggestions 
do you have for those living in Hawaii faced with the unique challenges 
of remoteness caring for individuals with autism spectrum disorders?
    Answer. NIH does not provide direct patient services, but several 
agencies that belong to the IACC address issues concerning care for 
individuals with ASD in remote or rural locations, and these agencies 
have provided information to NIH on their efforts. For example, 
according to the Centers for Medicare & Medicaid Services (CMS), adults 
with ASD enrolled in Medicaid receive many home and community-based 
services through Hawaii's section 1915(c) waiver for children and 
adults with developmental disabilities and/or mental retardation. The 
CMS renewed the waiver in June 2006 for 5 years. The waiver provides 
numerous services to about 3,000 people throughout the islands, 
including people with ASD, who choose to live in community, rather than 
institutional, settings. The operating agency for this waiver is the 
State's Department of Health, supervised by its Department of Human 
Services, the State Medicaid Agency. These two entities are charged 
with working together to assure that eligible individuals are aware of 
and can access waiver services.
    The CMS also indicates that the State of Hawaii has included a 
``self-directed'' option in the waiver that permits individuals to 
hire, fire, supervise, and train direct support workers. This option 
greatly expands the universe of potential providers, particularly in 
rural areas, and may include family members and spouses as providers. 
In February 2008, CMS approved an extension of the State's section 1115 
demonstration, which will provide mandatory managed health care 
starting in November 2008 to aged, blind, and disabled beneficiaries in 
Hawaii. The expansion of the demonstration to include this group, which 
likely also includes individuals with ASD, will permit the State to 
streamline and better coordinate care and expand provider networks in 
remote areas.
    In addition to these efforts from CMS, successful models for 
providing interagency services within remote and rural settings may be 
found among the Systems of Care Sites (including programs in Idaho, 
Wyoming, Alaska, Hawaii, Montana, and other States) funded by Substance 
Abuse and Mental Health Services Administration (SAMHSA), another 
member of the IACC. These programs emphasize the core principles and 
practices of the Systems of Care, focusing on designing services that 
are child-centered, family-driven, community-based, and culturally 
competent. Some interagency groups have used technology to employ tele-
health, tele-psychiatry, clinical supervision, case consultations, and 
interactive videoconferencing. Training of local leaders is another 
important element. Some programs employ culturally-specific approaches 
developed with community elders that respect native traditions--e.g., 
oral traditions and storytelling, a holistic ``heart centered'' 
approach or understanding that the family is the central unit, rather 
than the individual. Cross-agency training has been used in several 
locations. Hawaii is conducting innovative work linking communities of 
practice at the local and State levels.
    Furthermore, SAMHSA's Children's Mental Health Program has a grant 
in the Kalihi-Palama area in Oahu (urban area) that is focusing on 
transition-age youth with emotional or behavioral challenges. This 
cross-agency approach uses combined funding to surround the individual 
with formal and informal services and supports. The approach is 
appropriate in rural areas where there are often shortages of trained 
professional providers.
                                 ______
                                 
              Questions Submitted by Senator Thad Cochran

               AUTISM DEVELOPMENTAL DISABILITIES PROGRAM

    Question. The CDC supports autism surveillance through a 
collaborative program, the Autism Developmental Disabilities Program 
(ADDP). It is my understanding that the program now has monitoring 
sites in 17 States. Could you comment on the CDC's plan for expanding 
this program and project a timeline when all States will benefit from 
the data collected through this program?
    Answer. The dramatic increase in the number of children diagnosed 
and receiving services for autism spectrum disorders (ASD) suggests 
that the disorder is more common than was once believed. Understanding 
the prevalence of a disorder like autism depends on collecting and 
analyzing data from multiple sources. In addition, it is important to 
use this method of data collection in multiple locations across the 
nation at different points in time. Doing so gives us the best 
understanding of ASD rates and trend in different communities in the 
United States
    In order to do this, CDC currently supports the Autism and 
Developmental Disabilities Monitoring (ADDM) Network at 11 sites 
(including CDC). Together with the ADDM partners, CDC provides critical 
data needed to answer questions about how common ASD are, whether we 
are identifying more children with ASD over time, and whether ASD 
affect certain groups more than others (i.e. boys are affected more 
often than girls). Also, it provides clues into potential causes that 
can be investigated further through research.
    The goal of the ADDM Network is to provide comparable, population-
based estimates of the prevalence rates of autism and related disorders 
in different sites over time. The program has made significant strides 
in attaining this goal. During the first phase of the project, as many 
as 16 sites (including CDC) have participated in the ADDM Network to 
determine the prevalence and characteristics of children with ASDs in 
their study areas.
    In 2006, CDC awarded funds to 10 ADDM Network sites to allow the 
network to develop ASD prevalence estimates for 2006 and 2008. The 
sites are currently working on a report from 2004 and another report to 
look at changes in ASD prevalence across 3 time periods in 4 sites.
    Establishing a national surveillance system for ASD is complex. CDC 
will continue to support in-depth, ongoing prevalence tracking in the 
current ADDM sites. Opportunities to enhance autism surveillance 
efforts in the United States include:
    1. Developing and implementing projects that continue to link 
prevalence studies with screening and early identification efforts,
    2. Supplementing national surveys, and
    3. Conducting investigations of ASD occurrence in adults. Doing so 
will enhance our understanding of the population characteristics of 
ASDs and how they have changed over time.

    CENTERS FOR AUTISM AND DEVELOPMENTAL DISABILITIES RESEARCH AND 
                              EPIDEMIOLOGY

    Question. The Children's Health Act of 2000 directed the CDC to 
create regional centers of excellence to study autism spectrum 
disorders and other developmental disabilities. The Centers for Autism 
and Developmental Disabilities Research and Epidemiology (CADDRE) 
Network was created in response to this direction. Can you comment on 
the most recent research developments resulting from implementation of 
this network?
    Answer. The search for the causes of autism spectrum disorders 
(ASD) is a top priority at CDC. CDC has engaged with partners in the 
Centers for Autism and Developmental Disabilities and Research 
Epidemiology (CADDRE) network to develop and implement public health 
research tools to identify potential causes.
    Last year, CDC and CADDRE partners launched the Study to Explore 
Early Development (SEED). Through this effort, study partners expect to 
collect information on 2,700 children with ASD and their parents that 
will help answer questions about the characteristics of affected 
individuals as well as potential ASD causes. Researchers will explore a 
number of priority hypotheses such as the role of infections, genetic, 
reproductive and hormonal factors as well as select exposures.
    As the largest epidemiologic study of its kind, SEED holds the 
potential to be an important complement to the array of other work 
occurring at the National Institutes of Health and in academia. CDC 
brings a unique public health perspective of studying health issues in 
large populations--not just among individuals or families who self-
refer for intervention or study.

           LEADING RESEARCH HYPOTHESES ON THE CAUSE OF AUTISM

    Question. In recent years, certain vaccines have been suggested as 
being linked to autism. Scientific evidence and the most recent 
Institute of Medicine report do not support this theory. What are the 
other leading hypotheses among the research community of the cause of 
autism? How much of current autism funding is being focused on research 
to determine the cause of autism-related disorders?
    Answer. Most scientists believe that there are multiple causes of 
autism spectrum disorders (ASD), resulting in various manifestations of 
the core symptoms. Twin studies provide strong evidence that ASD is 
highly heritable, but that the disorder involves the interaction of 
many genes. NIH-funded research has begun to reveal clues about how 
genetic variations affect the risk of developing ASDs. Although some 
studies have shown that mutations in individual genes are linked to 
only a small percentage of autism cases, new reports suggest that part 
of the explanation for ASDs may be due to deletions and duplications of 
genetic material. Many of these are spontaneous de novo mutations not 
present in the parents. The study indicates that different cases of 
autism could be traceable to any of 100 or more genes, alone or in 
combination.
    Environmental modifiers may also interact with genes to cause ASD 
or modify its expression, although such environmental mechanisms have 
not yet been identified. The delicate interplay between genetic 
susceptibility and immunological and environmental triggers may lead to 
differences in the healthy development of brain circuits and brain 
function. NIH is committed to meeting this complex challenge, 
determining the potential causes of ASDs.
    In fiscal year 2007, the NIH spending for autism-related research 
totaled approximately $127 million. About 22 percent of the funding 
supports grants addressing specific risk factors, including genetics, 
environmental mechanisms, and gene-by-environment interactions. An 
additional 29 percent supports grants aimed at better understanding the 
underlying neurobiology of the disorder, which is critical knowledge in 
order to identify hypotheses about additional risk factors for 
investigation. Several large initiatives to uncover the underlying 
causes of ASD involve joint initiatives and activities sponsored by the 
NIH Autism Coordinating Committee (NIH/ACC). The NIH/ACC functions to 
synchronize autism research activities funded and conducted by the 
various NIH Institutes (NIMH, NICHD, NINDS, NIDCD, and NIEHS).

                           SUBCOMMITEE RECESS

    Senator Harkin. Well, thank you all again very much. It's 
been a very informative and constructive hearing.
    The committee will stand in recess to reconvene at 9:30 
a.m., Friday, April 20, in room SD-116. At that time we will 
hear testimony from the Honorable Richard J. Hodes, M.D., 
Director, National Institute on Aging.
    [Whereupon, at 4:16 p.m., Tuesday, April 17, the 
subcommittee was recessed, to reconvene at 9:30 a.m., Friday, 
April 20.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              


                         FRIDAY, APRIL 20, 2007

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:30 a.m., in room SD-116, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin, Specter, Cochran, and Craig.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENT OF DR. RICHARD J. HODES, DIRECTOR, NATIONAL 
            INSTITUTE ON AGING

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. Good morning. The Senate Subcommittee on 
Labor, Health and Human Services, Education and Related 
Agencies will come to order. This is the subcommittee's third 
hearing on the National Institutes of Health this year.
    On March 19 we heard from NIH Director Elias Zerhouni and 
several topics from real scientists and the following week we 
heard from Directors of four Institutes that oversee brain and 
behavior research.
    Today we turn our attention to four more Institutes: The 
National Institute on Aging, the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases, National 
Heart, Lung and Blood Institute, and the National Institute of 
Diabetes, Digestive and Kidney Diseases.
    As I explained at the last hearing, the subcommittee 
intends to meet with the Director of every Institute in the 
Center at NIH this spring. Senator Specter and I have already 
pledged to reject the President's proposed cuts to NIH for 
fiscal year 2008 and hearings like this will help us make our 
case.
    It is important that we understand how NIH is spending its 
money and how additional funding will be used and again we're 
going to continue to do this sort of in blocks of two, or three 
or four. Try to get them organized in a certain fashion.
    We asked this particular group of four Directors to appear 
together because they all deal in one way or another with 
chronic diseases but again I don't want you to feel constrained 
that that's all you have to talk about. Anything that goes on 
in your Institute is pretty fair game. What we want to know is 
what you want to say and what you want to get across to us.
    I'll ask each Director to speak for 5 to 7 minutes, 
summarize what you have overseen over the past year or so, give 
us a look ahead at the initiatives that are planned for fiscal 
year 2008 and beyond. We'll go through the witnesses and then 
we'll open it up for just general discussion and questions so 
there will be interplay among all of us here.
    At the onset I want to thank each of the Directors for what 
you are doing to improve people's health. Yours is a noble 
profession. We're grateful for your dedication and your skill 
and I would ask if Senator Specter had an opening statement.

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Thank you, Mr. Chairman for convening this 
important hearing and thank you, Dr. Hodes, Dr. Katz, Dr. 
Nabel, and Dr. Rodgers for joining us this morning to explore 
the needs of your various Institutes and the impact of the 
budget cuts proposed by the administration.
    As I think it is fairly well known, Senator Harkin and I, 
over the course of the past two decades, have taken the lead on 
increasing funding for the National Institutes of Health so 
that we have taken it from about $12 billion to about $29 
billion. At some point we were able by rearrangement of 
priorities within our subcommittee to add as much as $3, $3.5 
billion a year for a number of years in a row. This puts 
enormous impetus behind medical research. Our joint view which 
we have persuaded much of the Congress to believe is that this 
is the secret to finding the cures to the maladies which affect 
this country and the world.
    The administration has come forward with a cut this year, 
again. The proposal is to cut NIH by $327 million.
    The budget resolution does contain an increase this year of 
$1.3 billion and Senator Harkin and I added an amendment to 
increase the budget resolution for $2.2 billion more. We have 
to be candid about it. The budget resolution is confederate 
money. Until it gets into an appropriation it doesn't count.
    I'm looking forward to the day when either Senator Harkin 
or I will be chairman of appropriations. I have a preference.
    But there really ought to be a greater allocation here 
beyond any question and I never miss an opportunity to 
emphasize the importance of some political muscle which needs 
to come from the experts which you four are and others, and 
those in the research field, and those who come to this town, 
to pressure the Congress, breast cancer and prostate cancer and 
juvenile diabetes and Alzheimer's and Parkinson's, they fill 
our largest hearing rooms, but somehow the political pressure 
stops there.
    Senator Harkin and I have talked about a million person 
march on the Mall when we finish the stem cell bill which we'll 
pass again and where there is a veto threat but if the 110 
million Americans who suffer personally from these ailments or 
their families directly would put political pressure on, 
there's nothing we couldn't do. We could make it all happen. 
There's enough political pressure to do that.
    So that is my message, Mr. Chairman. I'm not going to be 
able to stay too late today because I have commitments in 
Philadelphia. We have a lot of State responsibilities which you 
all know and Friday's the day when we have to tend to some of 
that, but I will stay as long as I can and of course, I will 
follow the hearings.
    Senator Harkin. I appreciate that very much, Senator 
Specter.
    We'll just go down the line and we'll start first with Dr. 
Hodes. Dr. Hodes has served as Director of the National 
Institute on Aging since 1993. A graduate of Yale University 
received his M.D. from Harvard Medical School. A leading 
immunologist, Dr. Hodes has appeared before the subcommittee 
several times and we welcome him back and again if you would 
just take five, seven minutes or whatever to just sort of 
summarize your testimony. By the way all, for the record, all 
of your statements will be made a part of the record in their 
entirety.
    So, Dr. Hodes, welcome, and please proceed.

               SUMMARY STATEMENT OF DR. RICHARD J. HODES

    Dr. Hodes. Thank you, Mr. Chairman and Senator Specter, for 
the opportunity to participate in this hearing on the burden of 
chronic disease. In past years, advances made through hygiene, 
public health, and as a result of biomedical research have 
addressed many of the causes of acute illness so that 
progressively chronic disease has become a prominent cause of 
disease, disability, and morbidity. Consequently NIH, 
particularly the four Institutes who are here, have directed 
increasing attention to chronic diseases.

                         DISABILITY AND OLD AGE

    As you know, the National Institute on Aging has as its 
mission to understand the aging process and those disorders 
that are age related. Chronic diseases are in fact a prominent 
cause of disability of old age and the constant loss of 
independence, quality of life and productivity.
    The studies of trends in disability with old age are both 
promising and equally a cause of concern and I would point to 
the first graph as a handout which illustrates three studies 
(National Health Interview Survey, National Long-Term Care 
Survey, and the Medicare Current Beneficiary Survey) over the 
past 20 years studying individuals aged 65 and older to 
determine the trends and disability rates over this period.
    So from 1982 to the present these studies are rather 
unanimous, indicating the very encouraging trend towards a 
decrease in disability equivalent to approximately a 20 percent 
decrease in disability for older men and women aged 65 and 
older over this period, evidence that disability is not an 
inevitable consequence of aging.
    Studies carried out concurrently over a spectrum of ages, 
however, have shown that individuals in their 30s, 40s and 50s, 
younger adults, over the same period of time have actually seen 
an increase in disability, pointing out the urgency of our 
addressing the causes of chronic disease disability.
    Senator Harkin. What do those different letters mean?
    Dr. Hodes. I apologize. These are the abbreviations which 
are in the footnotes that illustrate each of the individual 
studies, which converge, as you can see. Each of these lines is 
downward trending, showing that in each of the studies there is 
agreement that the levels of disability in the populations 
studies are decreasing over time.
    Senator Harkin. What kind of disabilities are you talking 
about, physical, mental, the whole thing?
    Dr. Hodes. Yes, the disability definitions have largely to 
do with the ability to carry out the activities of daily life 
to function independently.
    The major causes of disability are illustrated in the 
second handout. These are the leading five, and I point out 
that arthritis, heart disease, and diabetes are topics that are 
going to be addressed in more detail by my colleagues this 
morning.
    I should add these are grounds for intensive collaboration 
between the Aging Institute and among all the Institutes at NIH 
over these common interests.

                           RESEARCH ADVANCES

    The National Institute on Aging supports research to 
understand the basic mechanisms of aging and of aging-related 
disorders and to translate them into clinical interventions. 
The findings of genes and intervention such as caloric 
restriction which affect life span and longevity in model 
organisms are now being studied for their translatability to 
humans.
    In the case of specific diseases there are some important 
advances that have already been made. For example, clinical 
trials have been successful in decreasing rates of falls and 
consequent fractures; we pursue this area of research in common 
with NIAMS.
    Studies have shown that treating the most common cause of 
the most common category of hypertension in older Americans can 
result in dramatic decreases in stroke and congestive heart 
failure; we are pursuing this research in collaboration with 
NHLBI.
    Studies show the possibility of using drug as well as 
behavioral interventions to decrease the incidence of diabetes; 
we pursue these studies in collaboration with NIDDK.
    The studies that I'd like to emphasize in my remaining 
comments deal with yet a fourth major cause of disability, 
dementia. In older men and women the most common cause of 
dementia is Alzheimer's disease.

                          ALZHEIMER'S DISEASE

    We've learned a great deal in past years about three genes 
which are responsible for causing early onset familial 
Alzheimer's disease as well as identifying genetic risk factors 
for more common old age variants, including the demonstration 
just this past year of a new gene, SORL1, which is associated 
with higher risk of Alzheimer's disease.
    We've also succeeded in translating the leads which come 
from this understanding of underlying biology and epidemiology 
into clinical studies, and we have some 25 different prevention 
and treatment trials ongoing.
    Among them, I point to one recently reported which is 
really the first success in prevention of Alzheimer's disease 
in a population of high risk. As is shown on this figure which 
illustrates the effect of the drug donepezil, patients 
receiving that drug who developed Alzheimer's disease at a 
slower rate at a lower frequency than those in the other 
control groups. Of interest, this effect was made demonstrable 
by targeting individuals with the APO E4 gene, a risk factor 
for Alzheimer's disease, which underscores the importance of 
using genetic and other risk factors to identify targets and to 
monitor success of interventions.
    This is a very modest beginning but it is an encouraging 
illustration of the ability to intervene and in fact to prevent 
this devastating disease.
    Progress has also been substantial in the area of neuro-
imaging, important in both early diagnosis and as a means for 
monitoring more efficiently the success of interventions to 
treat or prevent disease; it is potentially more efficient, for 
example, than monitoring the clinical symptoms alone.
    The understanding of the lesions that cause Alzheimer's 
disease, the plaques and tangles which are characteristic of 
the brain in Alzheimer's, have led to the development of 
compounds which bind specifically to these plaques and tangles 
and the use of these compounds to image in patients and study 
subjects the deposits of Alzheimer's lesions in the brain. This 
is illustrated quite dramatically in this slide, which shows 
the result of a compound called Pittsburgh Compound B that 
binds specifically to amyloid. You can see the contrast in the 
AD, which is the Alzheimer's disease patient.
    The reds and yellows show a high intensity of amyloid 
plaques in those individuals in comparison to the control, the 
individual at similar age but without those lesions.
    This study is now a part of a larger Alzheimer's disease 
neuro-imaging initiative with the remarkable partnership of 
Institutes at NIH, the FDA, the foundations as well as 
pharmaceutical and biotech industry aimed at identifying 
markers, including new imaging markers which will again serve 
as vehicles for early diagnosis and to allow better and more 
efficient monitoring of interventions for their effectiveness.

                           PREPARED STATEMENT

    The challenge posed by chronic illness is indeed a daunting 
one but one which the Institutes at NIH are addressing with 
full vigor and with all resources. I again appreciate the 
opportunity to be here before you and look forward to 
discussions with you.
    [The statement follows:]

               Prepared Statement of Dr. Richard J. Hodes

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2008 President's budget request for the National 
Institute on Aging (NIA). The fiscal year 2008 request provides 
$1,047,148,000 for the NIA.
    Thank you for this opportunity to provide testimony for today's 
hearing. I am Dr. Richard Hodes, Director of the National Institute on 
Aging (NIA). The NIA leads a broad scientific effort to understand the 
nature of aging and to extend the healthy, active years of life. I 
appreciate the opportunity to discuss the burden of chronic disease, a 
critical issue for our older citizens.
    The face of aging in the United States is changing dramatically--
and rapidly, according to a recent U.S. Census Bureau report 
commissioned by the NIA. Today, older Americans are very different from 
their predecessors, living longer, having lower rates of disability, 
achieving higher levels of education, and less often living in poverty. 
The baby boomers, the first of whom celebrated their 60th birthdays in 
2006, promise to further redefine what it means to grow older in 
America.
    While many of our seniors are enjoying their later years in good 
health, a number of chronic conditions remain common among older 
Americans. For example, more than half of all Americans over age 65 
show evidence of osteoarthritis in at least one joint.\1\  Over half of 
Americans older than 50 have osteoporosis or low bone mass,\2\ and 
cardiovascular disease, cancer, and diabetes remain common among older 
Americans. Through research, we are discovering new and better ways to 
diagnose, treat, and even prevent these and other diseases and 
conditions.
---------------------------------------------------------------------------
    \1\ See ``Handout on Health: Osteoarthritis,'' National Institute 
of Arthritis and Musculoskeletal and Skin Diseases, July 2002.
    \2\ See America's Bone Health: The State of Osteoporosis and Low 
Bone Mass in Our Nation. National Osteoporosis Foundation, February 
2002.
---------------------------------------------------------------------------
    The NIA provides leadership in aging research, training, health 
information dissemination, and other programs relevant to aging and 
older people. The Institute's robust research portfolio covers all 
aspects of aging, from the basic cellular and molecular changes that 
occur as we age, to the prevention and treatment of common age-related 
conditions, to the behavioral and social aspects of growing older, 
including the demographic and economic implications of an aging 
society. In addition, the NIA is the lead Federal agency for research 
related to the critically important effort to prevent and treat 
Alzheimer's disease. Finally, our education and outreach programs 
provide vital information to older people across the Nation on a wide 
variety of topics, including living with chronic conditions, 
maintaining optimal health, and caregiving.

           ALZHEIMER'S DISEASE AND THE NEUROSCIENCE OF AGING

    While it is true that our senior and elderly citizens are aging far 
better today than in previous decades, the specter of Alzheimer's 
disease (AD), one of the most devastating neurodegenerative diseases, 
is a source of enormous concern as we and our loved ones age because of 
its enormous impact on individuals, families, the health care system, 
and society as a whole. Approximately 4.5 million Americans are 
currently battling AD, with annual costs for the disease estimated to 
exceed $100 billion.\3\  Moreover, the rapid aging of the American 
population threatens to increase this burden significantly in the 
coming decades. By 2050, the number of Americans with AD could rise to 
some 13.2 million, an almost three-fold increase.\4\
---------------------------------------------------------------------------
    \3\ Data from the Alzheimer's Association. See also Ernst, RL; Hay, 
JW. ``The U.S. Economic and Social Costs of Alzheimer's Disease 
Revisited.'' American Journal of Public Health 1994; 84(8): 1261-1264. 
This study cites figures based on 1991 data, which were updated in the 
journal's press release to 1994 figures.
    \4\ Hebert, LE et al. ``Alzheimer Disease in the U.S. Population: 
Prevalence Estimates Using the 2000 Census.'' Archives of Neurology 
August 2003; 60 (8): 1119-1122.
---------------------------------------------------------------------------
    AD is a chronic condition that advances gradually but inexorably, 
from early, mild forgetfulness to a severe loss of mental function 
called dementia. Eventually, people with AD become dependent on others 
for every aspect of their care taking a tremendous toll on family 
members and other caregivers, often for several years. The NIA supports 
an extensive research program with the goal of facilitating early 
diagnosis of AD and developing more effective preventive strategies and 
therapeutic interventions. Moving forward in each of these areas 
requires the translation of findings from the laboratory through 
preclinical testing and into full-scale clinical trials. Recent 
advances have been made on several fronts.
    Neuroimaging.--The discovery of compounds such as Pittsburgh 
Compound B and, more recently, FDDNP that enable the visualization of 
AD's characteristic amyloid plaques and neurofibrillary tangles in the 
living brain--an impossibility until several years ago--will not only 
enable scientists to diagnose AD earlier, but may also help researchers 
and clinicians develop new treatments and monitor their effectiveness, 
as well as reduce the time and cost of clinical trials. Research in 
this area has been intense and productive, with the Alzheimer's Disease 
Neuroimaging Initiative (ADNI) continuing to be a major venue for 
facilitating neuroimaging research relevant to AD.
    Genetics.--Discovery of risk factor genes will help illuminate the 
underlying disease processes of AD, open up novel areas of research, 
and identify new targets for drug therapy. Researchers recently 
determined that variations in a gene known as SORL1 may be a risk 
factor for the development of late onset AD. This discovery provides a 
new genetic clue about the late onset forms of AD. Further research is 
needed to determine the role of SORL1 in AD pathogenesis.
    Research is continuing in this important area through the AD 
Genetics Initiative, which to date has recruited nearly 1,000 families 
to establish a data base for studies of familial inheritance of AD. In 
addition, the NIA has established a national genetics data repository 
to facilitate access by qualified investigators to genotypic data for 
the study of the genetics of late-onset AD. Investigators have already 
begun submitting data to this repository and requesting additional data 
for genetic studies.
    Pre-Clinical and Translational Research.--NIA plans to speed drug 
discovery and movement of promising new treatments and prevention 
strategies into clinical trials. The launch of a major new 
translational research effort to expand the range of novel compounds to 
be tested for their effect in preventing or slowing progression of 
cognitive decline, mild cognitive impairment, and AD, and to more 
quickly move research from the laboratory to clinical trials in humans, 
will further support our efforts in this regard.
    Clinical Research.--The NIA is currently supporting approximately 
25 AD-related clinical trials. NIA plans to use the knowledge gained 
through basic and mechanistic studies to select the most promising 
imaging and biological markers, as well as improved clinical and 
neuropsychological evaluation methods, to design and perform less 
expensive, shorter, and more efficient drug trials. Recent progress in 
understanding the basic genetic and molecular processes of AD has 
provided new mechanism-based approaches to designing interventions. 
NIA-supported researchers are also studying simple lifestyle changes 
that may confer protective benefits on cognition. For example, in one 
recent study, increased vegetable consumption was found to be 
associated with reduced risk of cognitive decline in women. In another, 
certain mental exercises were found to help older individuals maintain 
their cognitive abilities; the benefits may last as long as 5 years.

                             HEALTHY AGING

    Preservation of cognition in specific domains can be of particular 
importance to the safety and independence of aging adults. For example, 
NIA-supported researchers have provided the underlying research for and 
developed the Useful Field of View (UFOV) test to help predict the 
degree to which a person may safely perform activities such as driving. 
The measure is now a major component of assessments tested and about to 
be adopted by three State Departments of Motor Vehicles for use in 
screening older drivers. NIA-supported research will also provide the 
foundation for development of training to help older adults improve 
their visual attention and speed of processing based on UFOV testing, 
and for the translation of this training as part of driving safety 
programs for older adults.
    In addition to testing ways to maintain cognitive function, NIA-
supported investigators are actively seeking ways to maintain physical 
function into older age. For example, several studies suggest that 
physical exercise may prevent physical disability, including impaired 
mobility, in healthy and frail older adults. To develop definitive 
evidence regarding the effectiveness of such interventions, NIA and 
grantee researchers have designed the LIFE (Lifestyle Interventions and 
Independence in Elders) study, a clinical trial testing the effects of 
a physical activity program vs. a health education program among older 
Americans in preventing major disability. A successful pilot study 
(LIFE-P) completed in 2005 showed both feasibility and positive 
preliminary data, permitting design and consideration of this large-
scale clinical trial.
    A large body of research in animal models indicates that 
substantially reducing caloric intake while maintaining optimal 
nutrition results in significant increase in life span. The NIA-
supported Comprehensive Assessment of Long-Term Effects of Reducing 
Intake of Energy (CALERIE) will help to determine if these beneficial 
effects extend to humans. Results from pilot studies demonstrated that 
overweight people who cut their calories by 25 percent for 6 months 
have reduced fasting insulin levels and core body temperature, two 
markers that have been associated with increased longevity in animal 
models, and that may be similarly associated with human longevity. A 
two-year study will begin in early January 2007 to determine whether 
healthy non-obese men and women ages 25-45 who reduce their caloric 
intake by 25 percent maintain these metabolic changes, and will measure 
other long-term effects of sustaining lowered caloric intake on factors 
related to aging changes and risks for age-related diseases.
    Because an intensive regimen of restricted food intake may prove 
difficult for many people to follow over the long term, and may in fact 
have adverse consequences in some circumstances, investigators are also 
searching for compounds that mimic the effects of caloric restriction 
on the body. One compound currently under study is resveratrol, an 
activator of a family of enzymes called sirtuins, whose cell-protective 
activities are themselves the subject of intensive scientific inquiry. 
In a recent study, overweight, aged male mice given a high-fat diet 
supplemented with resveratrol had better health and survival than aged 
overweight mice who did not receive the compound. Resveratrol's safety 
and effectiveness to address aging and age- or obesity-related 
conditions in humans have not been demonstrated, and further research 
is needed on the short- and long-term effects of resveratrol in animals 
and humans.
    The NIA Intervention Testing Program supports the testing of 
compounds with the potential to extend the lifespan and delay disease 
and dysfunction in a mouse model. Plans are to renew this promising 
initiative in fiscal year 2007 for funding in fiscal year 2008. In 
addition, NIA is continuing to search for genes and biological pathways 
that influence longevity and aging through the Longevity Associated 
Gene initiative, which to date has identified over 100 new longevity-
associated genes, along with many conserved biological processes and 
pathways that regulate longevity in a host of divergent species, 
including humans.
    New research findings may one day translate into better ways to 
support the aging immune system. A new initiative on ``Membrane 
Associated Signaling Defects in Immune Cells with Aging'' seeks to shed 
light on the cellular processes that may lead to impaired immune 
function in older people. This research may ultimately lead to the 
development of interventions to bolster the immune system and reduce 
vulnerability to disease and disability in older people.
    Thank you for the opportunity to provide my testimony to this 
Subcommittee and to describe these examples of research targeted at 
improving the health and quality of life of aging and older adults. I 
would be happy to answer any questions you may have.






    Senator Harkin. Well thank you very much, Dr. Hodes for a 
very succinct and straightforward presentation. We appreciate 
it very much.
    Now we turn to Dr. Steven Katz, who has served as the 
Director of the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases since 1995. Dr. Katz received 
his B.A. from the University of Maryland, his M.D. from Tulane 
University School of Medicine and his Ph.D. from the University 
of London. His own particular research, I am told, focuses on 
skin diseases and immunology. Dr. Katz, welcome to the 
committee, please proceed.

STATEMENT OF DR. STEPHEN I. KATZ, DIRECTOR, NATIONAL 
            INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL 
            AND SKIN DISEASES
    Dr. Katz. Thank you very much, Mr. Chairman, Senator 
Specter, subcommittee members. It's indeed a privilege to be 
here this morning to present priorities and programs of the 
National Institute of Arthritis and Musculoskeletal and Skin 
Diseases that I will abbreviate by calling it NIAMS.
    Our support is of a broad range of research, training and 
health information activities related to diseases of the 
joints, bones, muscles and skin. Many of the conditions that we 
study are common, chronic and costly both in economic and 
societal terms. Collectively they have a major impact on 
quality of life and disability for affected patients and 
families.
    The slides that I've provided, these two blue slides really 
reinforce the point that Dr. Hodes made, that is, that not only 
is there significant disabilities measured by activity 
limitation in older individuals, but also younger individuals 
also suffer from a wide range of chronic conditions.
    This disability is related to diseases and injuries of the 
bones and joints which the NIAMS covers as well as other 
chronic conditions that are represented by my colleagues on 
this panel.
    I'd like to paint a picture of recent progresses at the 
Institute as well as areas of future progress by highlighting 
three specific conditions: osteoporosis, low back pain and 
osteoarthritis.
    I'll begin with osteoporosis. A thinning of the bones often 
associated with aging, it puts people at risk for fractures and 
related complications. That's the real problem, the fractures. 
Osteoporosis is a major chronic public health issue. Ten 
million Americans have osteoporosis. Thirty-four million other 
Americans are at risk for osteoporosis, almost 70 percent of 
those affected are women.
    More than 1.5 million fractures occur as a consequence of 
osteoporosis, including 300,000 hip fractures and 750,000 
vertebral fractures. We've gained many insights from our 
investments in osteoporosis research, many in collaboration 
with the Aging Institute. These investments have aided in the 
development of effective interventions, both in the treatment 
as well as the prevention of the disease.
    In a long-term study co-funded by the Aging Institute, 
scientists have found that increased age and low body weight 
are two of the most important risk factors, and that sedating 
drugs and failing visual acuity contribute to osteoporatic 
fractures by increasing falls. A family history of fracture 
also contributes to an individual's risk.
    More recently we've turned our attention to osteoporosis in 
men. Osteoporosis usually occurs a decade or decade and a half 
later in men than in women, and these new studies in the next 
years will tell us about factors that increase the risk in men 
for fracture occurrence.
    Many questions remain including how best to measure bone 
strength in a reliable way. How can we better predict who is 
susceptible to a fracture?
    Current methods that are used include DXA which is good, 
but not great in terms of predicting fracture. To fill this gap 
the NIAMS is putting together a collaborative initiative on 
bone strength. The public/private partnership will help us 
identify better markers of bone strength that can better 
predict fracture risk and can be used in clinical trials to 
assess new therapies.

                             LOW BACK PAIN

    Now I want to turn to low back pain. How common is low back 
pain? Approximately half of adults have low back pain in any 
given year. An estimated 32 million Americans have frequent low 
back pain. For the past several years, NIAMS has invested in a 
large multi-center clinical study comparing surgical versus 
non-surgical intervention for three different types of back 
pain.
    The one I'll talk about today is the first of these studies 
that has come out, on herniated discs, and this study is called 
the SPORT study. Scientists have worked on this effort for the 
past seven years and have recently reported results with 
important clinical implications.
    They found that patients with low back pain from herniated 
discs improve over time even without surgery. This new 
information, that non-operative therapies may offer similar 
benefits to those who forgo surgery, will guide future 
treatment decisions by patients and physicians. In other words, 
the rush to surgery is not so great because some of these 
people will actually get better without the surgery.
    Over the next few years we anticipate additional findings 
from this study, which is addressing other forms of low back 
pain; for example spinal stenosis where the bones in the 
vertebra become less patent and also a form of arthritis in the 
back that causes low back pain.

                             OSTEOARTHRITIS

    Now I'd like to turn to osteoarthritis or OA, a condition 
like osteoporosis that presents a growing public health problem 
as our population ages. A few quick statistics, an estimated 12 
percent of the U.S. population aged 25 and older have 
osteoarthritis, nearly 21 million Americans. A recent analysis 
shows that 5.3 percent of all U.S. adults ages 18 to 64 
reported work limitations due to arthritis in 2002, including 
absenteeism. This relates to the point in your discussion with 
Dr. Hodes about absenteeism, reduced productivity, work loss 
and lower income.
    Osteoarthritis is the most common form of arthritis as 
people age and is often called the wear and tear disease. It 
can also develop following injury to the joints. Now in going 
back to my elementary school experiences, I thought that a show 
and tell might be interesting because we hear a lot about 
osteoarthritis, the most common form of arthritis.
    This is a knee, this is a knee cap, and let's unfold the 
knee cap and just look at the knee. This is the part of the 
bone that is covered by the cartilage and it's the cartilage 
that's here in the knee. It's here and here and this cartilage 
on each side of the bone opposes each other. This really takes 
the wear and tear of walking, of injury, of running. If this 
little, thin layer is damaged in some way, then you get bone on 
bone. Bone on bone doesn't even sound good, does it?
    Basically that's what causes the disability and the 
limitation of motion, and that's really what we're trying to 
address.
    One of the areas that holds tremendous promise for people 
affected by osteoarthritis is regenerative medicine, and this 
emerging field includes tissue engineering and efforts that cut 
across the life, physical and engineering sciences.
    Recently scientists supported by the NIAMS developed an 
innovative three-dimensional fabric to aid in joint cartilage 
repair. In other words, the end of the line is a new joint, but 
what we're trying to do is prevent that. We're trying to 
identify risk factors, prevent those risk factors, but also 
develop methods that are not as invasive as putting in a new 
joint.
    So using a unique weaving machine, one tries to build a 
matrix on which cells will grow, and if you get cells to grow 
on that matrix, it will form this cushion. That's part of the 
goal before the endpoint of total knee or total hip 
replacement. These are very good forms of surgery, but still 
we'd like to avoid that for as long as we possibly can.

                           PREPARED STATEMENT

    So, as I hope I've illustrated this morning, the NIAMS has 
made significant strides in our efforts to improve the outlook 
of patients affected by a number of common chronic conditions, 
and we are poised to make further progress in the near future 
as well as in the long future and I'm delighted to be here and 
look forward to answering any questions that you may have.
    [The statement follows:]

               Prepared Statement of Dr. Stephen I. Katz

    Mr. Chairman and members of the Committee: I am pleased to present 
the fiscal year 2008 President's budget request for the National 
Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). 
The fiscal year 2008 budget includes $508,082,000.

                              INTRODUCTION

    The NIAMS supports a broad range of research, training, and health 
information activities related to arthritis, musculoskeletal, and skin 
diseases. These disorders are among the most common, chronic, and 
costly conditions affecting the U.S. population, and have a major 
impact on quality of life and disability for patients and families. In 
many ways, the mission of the Institute is defined by its diversity--
the disorders that are studied afflict adults and children, and affect 
individuals and families of all races, ethnicities, and economic 
strata. While it is critical to support investigations across the 
research spectrum--from basic, to translational, to clinical studies--
the NIAMS places a strong emphasis on work that has the potential to 
benefit patients directly.
    Recent results from two clinical studies supported by the Institute 
underscore this commitment: in the first, researchers showed that, 
while surgery may be an effective route to relief from low back pain 
for patients with herniated (slipped) discs, over the longer term, non-
operative therapies may offer similar benefits for those who cannot or 
elect not to have surgery. In the second, scientists in the NIAMS 
intramural research program discovered that the Food and Drug 
Administration (FDA)-approved arthritis medication anakinra brings 
marked improvement both in symptoms and the inflammation underlying a 
rare, debilitating, and often fatal disorder in children and young 
adults called neonatal-onset multisystem inflammatory disease (NOMID).
    Looking ahead, NIAMS is also investing in emerging areas of 
science, such as tissue engineering and regenerative medicine, which 
hold the promise of substantially reducing the disability and health 
care costs associated with many common conditions. For example, 
insights gained from examining the development of connective tissues in 
the laboratory could be translated into approaches for the repair and 
regeneration of tissues in clinical settings. Over time, patients 
affected by disabling disorders such as osteoarthritis could benefit 
from this multidisciplinary work.

                          PREVENTIVE MEDICINE

    The NIAMS continues to place a high-priority on studies to identify 
risk factors and biomarkers of disease, in an effort to facilitate the 
early identification of signs and symptoms, and to develop 
interventions that are more effective. To this end, scientists funded 
by the Institute are improving the understanding of the factors that 
affect bone mass in older men--to complement the considerable work that 
has been done in women--so that clinicians can better identify 
individuals potentially at high risk for fractures associated with 
osteoporosis, and help determine appropriate treatment and prevention 
approaches. To date, investigators have identified lifestyle, medical, 
and demographic traits that are associated with low bone mass and 
potential fracture risk. In other work, researchers have identified 
biomarkers for lupus-related kidney disease. These biomarkers can be 
used to indicate the type and severity of renal disease, as well as the 
extent of kidney damage. Ultimately, this discovery could form the 
basis for a test that would save patients with lupus the expense, 
discomfort, and potential complications of repeated kidney biopsies.
    In the coming year, NIAMS will continue its commitment to two novel 
public-private partnerships that are designed to improve prevention of 
osteoarthritis and osteoporosis--conditions that already affect 
millions of Americans, with many more at risk as the population ages. 
The first, the Osteoarthritis Initiative (OAI), is a long-term effort, 
developed with support from numerous NIH components, private sector 
sponsors, and with the participation of the FDA, to create a publicly-
available research resource to identify and evaluate biomarkers of OA 
for use in clinical research. The study has 4,800 participants who are 
at high risk for knee OA and, as of early fiscal year 2007, clinical 
data from approximately 2,000 of them were available for research 
projects. The second, the Collaborative Initiative on Bone Strength 
(CIBS), will enable researchers to identify markers of bone strength to 
be used as surrogate endpoints for fractures in clinical trials, and to 
find measurements that are more accurate than bone density to predict 
risk of fracture. Information collected through this partnership--which 
also involves several NIH components, the FDA, academic centers, and 
industry--will facilitate the development of new treatments to prevent 
fractures because it enables the design of clinical trials that are 
smaller, shorter, and less expensive than current studies.

                        COMPLEX GENETIC DISEASES

    The NIAMS is harnessing the explosion of information related to 
genomics and proteomics to better understand the causes of complex 
genetic diseases, and how best to treat and prevent them. This year, 
scientists supported by the Institute identified a gene that causes 
susceptibility to psoriasis, an autoimmune disease characterized by 
patches of thick, inflamed skin which are often itchy and sore. With 
this information, it may be possible to target the product of this 
particular gene in developing new treatments--rather than using current 
therapies which suppress the entire immune system, leaving patients 
vulnerable to infections. Progress has also been made in understanding 
the genetic underpinnings of rheumatoid arthritis (RA), due in part to 
a twin study which revealed three genes involved in the disease. Using 
a sophisticated technique called microarray analysis, the scientists 
discovered three genes that were consistently overexpressed in the RA-
affected twins--pointing to new potential mechanisms of disease that 
can guide future research activities.
    In fiscal year 2008, the NIAMS will enhance its efforts in this 
area, in part by pursuing genome-wide association studies for diseases 
of interest to the Institute. Such work--which will likely focus on 
analyses of phenotypes for autoimmune diseases and musculoskeletal 
disorders which collectively affect millions of Americans--would build 
on investments being made at the NIH level through the Genetic 
Association Information Network (GAIN). Over time, identification of 
the genetic bases of these conditions could lead to new predictive, 
preventive, diagnostic, and therapeutic approaches.

                  TRANSLATIONAL AND CLINICAL RESEARCH

    A hallmark of research success is translation: work to bring 
insights from the laboratory bench to the patient bedside, and back 
again, with the ultimate goal of improving patient care and public 
health. To this end, the NIAMS recently launched the new Centers of 
Research Translation (CORT) program, to bring together basic and 
clinical researchers in a way that helps translate fundamental 
discoveries into new diagnostics and treatments. This year, the 
Institute funded four new centers focused on the following areas: the 
biological basis of fracture healing and the efficacy of a potential 
new treatment for healing of fragility fractures in the elderly; the 
role of different cell types in lupus pathogenesis, the development of 
markers of disease activity and severity, and the identification of new 
targets for therapies; the molecular contributors to a genetic form of 
rickets, and the development of new treatments; and the molecular basis 
of scleroderma, by using functional genomics and gene networks to 
understand the underlying causes of the disease.
    In the coming year, the NIAMS will fund a second set of CORTs, in 
addition to supporting translational and clinical studies in a number 
of other promising areas. For example, together with the National 
Institute of Neurological Disorders and Stroke and the National 
Institute of Child Health and Human Development, the NIAMS is placing a 
high-priority on translational research for therapeutics development 
for the muscular dystrophies (MDs). Additional research in the MDs will 
be supported through the Senator Paul D. Wellstone Muscular Dystrophy 
Cooperative Research Centers, which promote side-by-side basic, 
translational, and clinical research. Further, within the Institute's 
intramural research program, work is being done to facilitate patient-
oriented studies with a particular emphasis on the genetic, 
inflammatory, and immune-mediated mechanisms of arthritis, 
musculoskeletal, and skin diseases.

                               CONCLUSION

    Since the Institute's inception 20 years ago, significant progress 
has been made to better understand the causes of many disorders of the 
bones, muscles, joints, and skin, as well as to develop treatment and 
prevention approaches for these diseases. In the coming year, NIAMS 
will place a particular emphasis on leveraging resources with public 
and private sector partners to support key initiatives. In this vein, 
the Institute plans to fund training fellowships in partnership with 
scientific organizations to support orthopaedic surgeons and 
dermatologists to pursue epidemiology, clinical trials, and health 
outcomes research across our mission areas. Within the intramural 
research program, a clinical scholars training program will be pursued 
to foster interactions among existing trainees with common scientific 
interests. As well, as part of efforts to enhance the research 
pipeline, the Institute will fund promising new investigators through 
the NIH Pathway to Independence program.
    In addition, the NIAMS will continue to be an active partner with 
other Institutes and Centers in implementing the NIH Roadmap for 
Medical Research. In particular, the Institute is helping to lead one 
of the Roadmap initiatives designed to reengineer the clinical research 
enterprise. The Patient Reported Outcomes Measurement Information 
System, or PROMIS, network is developing new ways to measure patient-
reported symptoms such as pain, fatigue, physical functioning, and 
emotional distress that have a major impact on quality of life across a 
wide variety of chronic diseases. Investigators funded through this 
initiative are creating a computerized adaptive test that, once 
validated, will be publicly available for use by the clinical research 
community. Over time, this tool will benefit patients who suffer from 
chronic conditions, as well as their health care providers.
    Finally, as part of other efforts to serve patients, providers, and 
the American public, the NIAMS remains committed to a robust program to 
disseminate research results and science-based health information. In 
the coming year, the Institute will place an increased emphasis on 
underserved populations. Work in this area will include expanding the 
development and distribution of patient publications in Spanish and 
selected Asian languages, as well as low-literacy materials. Outreach 
activities with a variety of minority communities will also be 
enhanced, to increase awareness about NIAMS clinical research studies 
and health information resources.

    Senator Harkin. Thank you again, Dr. Katz for again for a 
very straightforward presentation. I appreciate it and we'll 
get into a discussion on many of these things.
    Now we turn to Dr. Elizabeth Nabel, who has served as 
Director of the National Heart, Lung and Blood Institute since 
2005, received her M.D. from Cornell University Medical 
College. A cardiologist, Dr. Nabel focuses her current research 
on the genetics of blood vessel diseases. Dr. Nabel, welcome 
again to the committee.

STATEMENT OF DR. ELIZABETH G. NABEL, DIRECTOR, NATIONAL 
            HEART, LUNG AND BLOOD INSTITUTE
    Dr. Nabel. Thank you, Senator Harkin.
    Senator Harkin and members, it is my pleasure to come 
before you this morning to talk about the exciting research 
program that's part of the National Heart, Lung and Blood 
Institute, or NHLBI.
    As you know we have responsibility for heart, lung and 
blood research in this country and our responsibilities include 
three of four leading causes of death in this country: heart 
disease, chronic obstructive pulmonary disease or COPD, and 
stroke in collaboration with the Neurological Institute.
    I'd like to highlight briefly advances in each of the areas 
in heart, lung and blood and then I look forward to expanding 
on those conversations later this morning.

                         HEART DISEASE ADVANCES

    In the area of heart disease, we're learning more about the 
consequences of childhood obesity and its effect on heart 
disease. As you know, we do have an obesity epidemic in this 
country, but what's alarming is that many of our children are 
becoming overweight or obese at very early ages and as Dr. 
Rodgers will elaborate, many of those children are developing 
diabetes, type 2 diabetes, earlier and we're beginning to see 
risk factors for heart disease in our children, much earlier 
than we ever saw in our generation.
    This is obviously alarming to many of us but in the past 
year we've completed studies that show that girls who are 
overweight at age 9, are 10 times more likely than normal 
weight girls to have an elevated blood pressure and they're 
much more likely to develop risk factors for heart disease that 
can appear even as early as age 18.
    Senator Harkin. This is at age 10?
    Dr. Nabel. This is at age 10. You can begin to predict 
those individuals who are going to be at risk for heart disease 
and diabetes as early as elementary school and that quite 
honestly is frightening.
    We have other studies from our population cohorts that 
suggest that as young adults enter their 20s, the presence of 
risk factors for heart disease will predict those individuals 
who will develop heart disease by middle age. Individuals who 
enter middle age or who reach age 50 with reduced or no risk 
factors for heart disease have longer life span and improved 
quality of life and indeed individuals who enter older age, 
being overweight or obese, consume a large proportion of our 
Medicare dollars, no real surprise.
    So the picture that I'm trying to paint is really a 
continuum that begins very early in life and builds over the 
years. If one is in poor health early in life, overweight, 
developing risk factors, the more likely you are for developing 
heart disease and its complications later in life and consuming 
more health care dollars.
    Now that's the fairly sobering news. The good news is that 
we are learning that interventions early in life do make a 
difference. In other words, if we can focus and help our young 
children learn to make good, healthy lifestyle decisions early 
in life, we can begin to see reductions in blood pressure, 
begin to see weight loss and improve risk factors for heart 
disease.
    So what are those interventions? The introduction of 
physical activity, P.E. back into the schools, something simple 
that we grew up doing thinking not much about it, but as you 
know, P.E. is lost among many of the public schools now in this 
country.
    It's helping children to make healthy food choices. Helping 
children to understand that drinking the quantities of soda and 
eating the bags of chips is not healthy; they have to reach for 
an apple or a piece of fruit or vegetables as well.
    Encouraging kids to remain physically active rather than 
coming home from school and sitting in front of the video game 
or the TV. Get out there and ride your bike, do sports, et 
cetera.
    They sound very simple but studies do show that these types 
of interventions clearly make a difference.
    The other piece I'll share with you is through our 
Framingham Heart Study, for many years we understood that high 
blood pressure was the leading risk factor for heart disease in 
this country. That's improving with our treatments for 
hypertension, but the sobering news is that diabetes is now 
carrying a greater and greater weight in terms of risk factors 
for heart disease and we think that in the future diabetes will 
be the dominant risk factor for heart disease in this country. 
So clearly, obesity, diabetes, heart disease are all very 
tightly linked.

                GENETIC SUSCEPTIBILITY TO HEART DISEASE

    Some of the very exciting research that we're doing in the 
NHLBI is really surrounding trying to understand the genetic 
susceptibility to heart disease. As you know for many years we 
have sponsored wonderful population studies, the Framingham 
Heart Study, the Jackson Heart Study and others.
    We now are beginning to do what is known as genotyping, 
which is an analysis of a predisposition to various diseases 
and understanding the genetics of susceptibility of heart 
disease in these populations so we can then bring together the 
genetic understanding together with clinical characteristics 
that we have been determining, say in the Framingham since 1948 
and really understand which families and which individuals may 
be at risk.
    When an individual or family understands the risk, they 
then can be encouraged and empowered to take action to reduce 
that risk, and that might be through life-style interventions 
or it might be through medication or other approaches. So we 
believe that we will be able to understand risk for some of the 
chronic diseases at a much earlier age.

                 CHRONIC OBSTRUCTIVE PULMONARY DISEASE

    Let me move on quickly to the lung. Chronic obstructive 
pulmonary disease, it's a mouthful, but it's the fourth leading 
cause of death, COPD. It's on the rise. We don't understand it, 
but it's disconcerting to us.
    The face of COPD is changing. We used to think of COPD 
predominately in men, but more and more, older women are 
developing COPD, women who smoke, women who don't smoke.
    There are many more non-smokers who are developing COPD 
which suggest to us that's there's something in the environment 
or something genetic that we don't quite understand yet.
    We, this past year, in partnership with many of the 
respiratory associations across the United States developed a 
new public awareness campaign called, Learn More, Breathe 
Better, and it's really to help create a brand out of COPD, 
simply to raise awareness that if you're having symptoms of 
COPD, see your doctor, get a simple breathing test. There are 
direct things that you can do.
    We are very proud of a trial that we're funding in 
collaborating with CMS to look at the benefit of long-term 
oxygen treatment to improve morbidity mortality and the quality 
of life in COPD and that study is going very well.

                          SICKLE CELL DISEASE

    Finally in the area of blood, as always we are very, very 
committed to the area of sickle cell disease. We are continuing 
a very promising study looking at the potential benefit of a 
drug called hydroxyurea in treating sickle cell infants before 
nine months of age and we're hopeful that early treatment will 
prevent some of the devastating organ damage that these young 
children develop from sickle cell disease.
    We are very excited about the future as you can imagine. We 
have a tremendous number of wonderful research projects that we 
can fund going from basic science to clinical trials to 
population studies and particularly public awareness.

                           PREPARED STATEMENT

    In our Institute we're very proud of our public awareness 
programs: women and child heart disease, childhood obesity, 
asthma and now COPD and we believe very strongly that we have a 
responsibility to take our research advances and translate them 
into language and programs in an understanding that the public 
and the individual can incorporate to improve their own health. 
So Senator, thank you very much.
    [The statement follows:]

              Prepared Statement of Dr. Elizabeth G. Nabel

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2008 President's Budget request for the National Heart, 
Lung, and Blood Institute (NHLBI). The fiscal year 2008 budget includes 
$2,925,413,000. The NHLBI provides leadership for an outstanding, 
visionary, and highly productive research program in heart, lung, and 
blood diseases. I will briefly describe the Institute's strategic 
planning process, and then highlight advances in three important 
research areas.

                          NHLBI STRATEGIC PLAN

    With the extensive involvement of the scientific, professional, and 
patient-advocacy communities, the NHLBI has just completed development 
of a comprehensive Strategic Plan to guide its efforts in the near 
future. The Plan identifies a number of basic research areas of focus 
with the intent of delineating normal and pathological biological 
mechanisms and exploiting the emerging understanding of these 
mechanisms to identify biomarkers of disease. Such biomarkers--broadly 
defined as measurable indicators of genotype, biological or 
pathological processes, or responses to therapeutic intervention--will 
facilitate identification of disease subtypes and point the way toward 
new molecular targets for prevention, diagnosis, and treatment.
    The Plan's clinical and translational research goals emphasize 
transmission of knowledge between basic and clinical research so that 
findings in one arena rapidly inform and stimulate research in the 
other. More precise methods of risk-stratification and diagnosis are 
expected to arise from application of new approaches (e.g., noninvasive 
imaging, biomarkers) from basic science laboratories. A critical 
challenge will be to develop personalized preventive and therapeutic 
regimens based on one's genetic makeup in combination with 
developmental and environmental exposures. Insights are already 
emerging, but robust and efficient means of validating both 
individualized and population-based treatments will be needed to 
establish an evidence base to guide medical practice.
    The Institute is cognizant of the need to improve understanding of 
the processes involved in translating research into practice and to use 
that understanding to enable improvements in public health and 
stimulate further scientific discovery. Particular emphasis will be 
placed on conducting research in primary prevention and identifying 
interventions that work in the practice communities that will 
ultimately constitute the targets for translation and education. As 
well, the NHLBI will continue to investigate and evaluate new 
approaches to communicate research advances to the public, and will 
stress the importance of public involvement in the research process. 
These are ambitious tasks, but we are eager to take them on and 
optimistic about their ultimate success.
    Over the past year, the NHLBI has made significant progress on a 
number of research fronts, but we highlight major advances in three 
areas.

                            MARFAN SYNDROME

    Marfan syndrome is a genetic disorder of connective tissue--the 
framework that binds and supports the body. Although the syndrome has 
many manifestations, the most serious is a weakening (aneurysm) of the 
aorta that sets the stage for life-threatening ruptures. New research 
offers hope that losartan, a drug commonly prescribed to treat 
hypertension, might be effective in preventing this frequent and 
devastating complication.
    After the discovery that Marfan syndrome is associated with a 
mutation in the gene encoding a protein called fibrillin-1, researchers 
tried for many years, without success, to develop treatment strategies 
that involved repair or replacement of fibrillin-1. Recently, a major 
breakthrough occurred with the discovery that one of the functions of 
fibrillin-1 is to bind to another protein, TGF-beta, and regulate its 
effects. After careful analyses revealed aberrant TGF-beta activity in 
patients with Marfan syndrome, researchers began to concentrate on 
treating Marfan syndrome by normalizing the activity of TGF-beta. 
Losartan, which is known to affect TGF-beta activity, was tested in a 
mouse model of Marfan syndrome. The results, published only last April, 
showed that the drug was remarkably effective in blocking the 
development of aortic aneurysms, as well as lung defects associated 
with the syndrome.
    Based on this promising finding, the NHLBI Pediatric Heart Network 
is now undertaking a clinical trial of losartan in patients with Marfan 
syndrome. About 600 patients aged 6 months to 25 years will be enrolled 
and followed for 3 years. This development illustrates the outstanding 
value of basic science discoveries in identifying new directions for 
clinical applications. Moreover, the ability to organize and initiate a 
clinical trial within months of such a discovery is testimony to the 
effectiveness of the NHLBI Network in providing the infrastructure and 
expertise to capitalize on new findings as they emerge.

                          SICKLE CELL DISEASE

    Excellent progress is being made against sickle cell disease, 
another genetic disorder that affects about 70,000 persons within the 
United States, mostly of African ancestry. The underlying defect, which 
deforms red blood cells, wreaks havoc on nearly every organ in the 
body. Fortunately, NHLBI research has yielded vastly improved treatment 
for this disease and an increase in life expectancy from the mid-teens 
to about 50 years of age.
    Hydroxyurea, the first specific therapy, was shown in clinical 
trials to be safe and effective for adult patients and, subsequently, 
for children between the ages of 5 and 15 years. The treatment reduced 
anemia, the frequency of painful episodes, and the prevalence of acute 
chest syndrome--the main hallmarks of the disease--and also reduced 
mortality. Moreover, hydroxyurea did not adversely affect either normal 
growth or pubertal development in the children who received it. Two 
ongoing trials are now exploring other beneficial effects of 
hydroxyurea. Baby HUG is determining whether administering the drug to 
infants can prevent early damage to their spleens and kidneys. A second 
trial, SWITCH, is studying the possibility that children who have 
suffered a stroke and are now on chronic transfusion and iron chelation 
therapy can be switched to hydroxurea treatment to prevent another 
stroke. It would be of great benefit to these patients to have a 
treatment that could be taken orally without the side effect of iron 
overload.
    The NHLBI also has an active program exploring cord blood/bone 
marrow transplantation for sickle cell disease. Heretofore, transplant 
procedures have been curative but limited to the few patients who have 
a compatible donor. However, recent cord blood transplant research is 
showing that success can be achieved with a less-than-perfect tissue 
match and, consequently, many more patients may be eligible to receive 
this treatment and avoid the disease's grim consequences.
    Overall, it is expected that hydroxyurea therapy, future transplant 
protocols, and other therapeutic approaches will dramatically improve 
the lives of many patients with sickle cell disease and reduce the 
costs of recurrent hospitalizations and long-term care of 
complications. The NHLBI now has in place a pipeline for drug therapy, 
a drug screening program, and platforms for clinical trials for this 
orphan disease that will require multiple therapies for its many 
sequelae.

                                  COPD

    At long last, COPD is moving from obscurity to prominence. Now the 
4th most common cause of death in the United States, COPD claims more 
than 120,000 lives annually--5.1 percent of the death toll. Moreover, 
for every person who will die of COPD this year, an estimated 200 
others will suffer from impaired airway function, more than half of 
whom are undiagnosed. Once primarily an affliction of cigarette-smoking 
men, COPD now affects American women nearly equally and occurs 
surprisingly often among lifelong nonsmokers.
    Progress against COPD has been slow and difficult, in part because 
the illness is complex and often perceived as being self-inflicted. 
Unlike diseases defined by a particular molecular defect or infectious 
agent, COPD has no single risk factor, no diagnostic blood test, and no 
definitive treatment. However, we are now entering a period of rapid 
discovery and translation into clinically effective interventions for 
patients. Investigators are exploring mechanisms of injury and repair 
to the lungs, pathways involved in the regulation of airway mucous 
secretion, and genetic and environmental determinants of COPD. Applied 
studies are developing new methods of lung imaging and testing their 
ability to provide a better characterization of changes that occur in 
disease. The NHLBI-supported Lung Tissue Research Consortium is 
collecting lung tissues for preparation and distribution to researchers 
for innovative studies. Just this year, we embarked upon the Long-Term 
Oxygen Treatment Trial to test the efficacy of supplemental oxygen 
therapy in COPD patients with less-than-severe hypoxemia, and the COPD 
Clinical Research Network has been in place since 2003 to provide an 
infrastructure for rapid evaluation of emerging disease-management 
approaches.
    An important and immediate challenge is to narrow the gap between 
what is commonly being done for COPD patients today and what can, in 
fact, be done. Many approaches--including drugs, pulmonary 
rehabilitation, smoking cessation, oxygen therapy, and surgery--are 
available to improve longevity and quality of life for people with 
COPD, but they are by no means universally applied. To address this 
shortfall, the NHLBI has launched a new educational campaign, Learn 
More, Breathe Better. The campaign encourages men and women over age 45 
with respiratory symptoms, especially current or former smokers and 
people who have risks associated with genetics or environmental 
exposures, to seek spirometric testing and discuss treatment options 
with their doctors. Physicians are urged to be alert for indicators of 
COPD among their patients, to offer appropriate diagnostic testing, and 
to update their strategies for managing the disease. Our hope is that 
this educational campaign will yield an immediate public health benefit 
and also set the stage for translation and implementation of new 
discoveries that are on the horizon.
    Thank you for the opportunity to present this snapshot of NHLBI 
activities. I would be pleased to respond to any questions by committee 
members.

    Senator Harkin. Well, again, Dr. Nabel, thank you very 
much, again, for a great statement.
    Now we turn to our last witness. Dr. Griffin Rodgers has 
served as the Director of NIDDK, National Institute of Diabetes 
and Digestive and Kidney Diseases for about 3 weeks.
    Although I would hasten to add that he's been either the 
Deputy Director or the Acting Director since 2001. Dr. Rodgers 
received his undergraduate, graduate and medical degrees from 
Brown University. Dr. Rodgers, welcome and please proceed.

STATEMENT OF DR. GRIFFIN P. RODGERS, DIRECTOR, NATIONAL 
            INSTITUTE OF DIABETES AND DIGESTIVE AND 
            KIDNEY DISEASES
    Dr. Rodgers. Thank you, Mr. Chairman and members of the 
committee. I'm really pleased to be here as the newly appointed 
NIDDK Director and to thank you for your continuing support of 
NIDDK funded research to combat an array of chronic health 
problems.
    For millions of Americans, these diseases are common, 
costly and consequential. Our research mission is quite broad. 
It includes diabetes and other endocrine and metabolic 
diseases, digestive problems including liver and bowel 
diseases, kidney diseases including polycystic kidney disease, 
urologic conditions such as interstitial cystitis and prostate 
disorders, blood and nutritional disorders, and obesity.
    Today I will provide research highlights on just a few of 
these areas. As noted by Dr. Nabel, obesity is a major risk 
factor for other diseases, including heart disease and type 2 
diabetes. We are testing promising approaches to combat obesity 
and break these links.
    Of grave concern, as Dr. Nabel pointed out, is the 
increasing rate of overweight and type 2 diabetes in children, 
particularly in certain racial, ethnic, minority groups.
    One in 14 American children between the ages of 12 and 19 
has pre-diabetes. Many of them also have risk factors for 
cardiovascular disease. Therefore our HEALTHY study is testing 
whether interventions in a group of middle school kids, sixth 
graders through eighth graders, predominately minority 
students, can successfully reduce overweight and other diabetes 
risk factors.
    Another important effort is an evaluation of 
gastrointestinal surgery to promote weight loss, the so called 
Longitudinal Assessment of Bariatric Surgery; the acronym is 
LABS. This study doesn't provide for the surgery, but rather, 
collects and analyzes data in order to assess the safety and 
efficacy of these procedures for different groups of people 
with extreme obesity. We have also recently begun a parallel 
effort to examine the effects these procedures may have on 
severely overweight adolescents during development.
    For people who already have type 2 diabetes, NIDDK has 
contributed to recent developments and approval of powerful new 
medical treatments. These include the drugs exenatide and 
gliptin. The drugs work to improve the body's own capacity to 
produce insulin. At the same time new avenues of intervention 
are likely to emerge from our advanced understanding of basic 
biology of appetite control and energy balance. For example, 
NIDDK researchers have recently demonstrated the key role of a 
protein called mTOR in influencing eating behavior.
    We are also making strides in type 1 diabetes research. 
Type 1 diabetes in contrast to type 2 is not associated with 
being overweight or obese. It is an autoimmune destruction of 
the insulin producing cells of the pancreas. For example, NIDDK 
supported basic research contributed to the development and 
recent approval of continuous glucose monitors. These devices 
can make it much easier for patients to manage their blood 
sugar effectively, a vital means of preventing kidney, eye, 
nerve and heart damage, characteristic complications of both 
type 1 diabetes as well as type 2 diabetes.
    These new monitors are really a critical step towards the 
development of an artificial pancreas and such a device would 
both recognize and respond to the body's need for insulin as 
quickly as possible and thus greatly improve diabetes 
management.
    Just as obesity is a leading cause of type 2 diabetes, 
diabetes in turn is a leading cause of chronic kidney disease 
and irreversible kidney failure in the United States. When the 
kidneys fail, patients are dependent on costly kidney 
transplantation or dialysis for survival. New data has 
suggested that there is finally some cause for optimism now 
that the incidence of kidney failure has stabilized after a two 
decade increase of 5 to 10 percent annually.
    Very recently there seems to have been a plateau in this 
change. This may be partly attributable to better preventive 
care that implements findings from a number of NIH studies.
    These trials established the importance of proper glucose 
control, for example, in cases of diabetes, better blood 
pressure control and the use of medications that block the 
angiotensin II system to help prevent progression of kidney 
disease. Unfortunately, however, troubling racial disparities 
in kidney health persist. This is why our National Kidney 
Disease Education Program has developed materials specifically 
designed to ``get the word out'' about the importance of kidney 
health in African Americans, Latinos, and American Indian 
communities, and the health care workers who provide services 
to them.
    I'd also like to talk about some exciting work in the fight 
against chronic digestive diseases. One example of this is the 
recent discovery of a second major susceptibility gene for 
Crohn's disease, a form of inflammatory bowel disease. From 
such research springs hope of improved diagnosis and treatment.
    In hepatitis C research, scientists have now identified a 
gene that helps determine how patients respond to therapy with 
the anti-viral agent, interferon. This finding may enable a 
more personalized and effective medical approach for a subset 
of patients. I think a few weeks ago you heard, Dr. Zerhouni 
testify to you about his vision of more ``personalized 
medicine.'' This is just one example.
    The handouts that I have brought for you are two that 
simply illustrate the risk factors and complications of 
diabetes: retinopathy, neuropathy, nephropathy, and 
cardiovascular disease. Diabetes is the leading cause of non-
traumatic amputations in this country. The second slide just 
illustrates the stages of the natural history of type 2 
diabetes. There are roughly 54 million Americans in this 
country with pre-diabetes and roughly 21 million with type 2 
diabetes and I could discuss this later if you like.
    We've posted copies of these handouts on our website for 
the public to view as well.

                           PREPARED STATEMENT

    Thank you for the opportunity to present a few examples of 
chronic disease research that are within the mission of NIDDK. 
Again, thank you for inviting me and I would certainly be 
pleased to respond to any questions that the committee might 
have.
    [The statement follows:]

               Prepared Statement Dr. Griffin P. Rodgers

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2008 President's budget request for the National 
Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) a sum 
of $1,858,045,000, which includes $150,000,000 for the Special 
Appropriation for Research on Type 1 Diabetes through sec. 330B of the 
Public Health Service Act. The NIDDK transfers some of these funds to 
other Institutes of the NIH and to the Centers for Disease Control and 
Prevention (CDC).
    Our Institute supports research to combat a wide range of chronic 
health problems that affect many millions of Americans, and which can 
be debilitating, deadly, and expensive to treat. These include diabetes 
and other endocrine and metabolic diseases; digestive and liver 
diseases; kidney and urologic diseases; blood diseases; and obesity.

                      LEVERAGING PRIOR INVESTMENTS

    Through continued investment in research, NIDDK-funded scientists 
have valuable assets at their disposal as they strive to mitigate or 
prevent chronic disease. These assets include both accumulated 
knowledge of life processes and the highly valuable data and cohorts of 
patients assembled through long-term investment in clinical research. 
For example, the landmark Diabetes Control and Complications Trial 
proved that tight control of blood glucose greatly diminished risk of 
eye, kidney, and nerve complications of type 1 diabetes. Patients who 
volunteered for this effort are providing scientists an invaluable 
opportunity to study long-term benefits of such care by participating 
in the follow-up study, Epidemiology of Diabetes Interventions and 
Complications. This study has now demonstrated that intensive blood 
glucose control also greatly diminishes risk of heart attack and 
stroke, with remarkably long-lasting benefits. Important knowledge is 
also being gained through the long-term follow-up of participants in 
the Diabetes Prevention Program (DPP), which established that regular 
physical activity and modest weight loss can prevent or delay type 2 
diabetes in those at risk. In a recent advance, NIDDK-supported 
researchers capitalized on DPP data to study the effect of a gene in an 
Icelandic population identified by industry, confirming that variants 
in the gene predispose people in a diverse U.S. population to type 2 
diabetes. Importantly, this study showed that the intensive DPP 
lifestyle and metformin interventions successfully delayed or prevented 
type 2 diabetes in people with the genetic risk factor. Thus, building 
on prior investments in clinical trials is yielding profound new 
insights into diabetes treatment and prevention.
    Similarly, consortia for studying inflammatory bowel disease (IBD) 
and type 1 diabetes are leveraging years of careful, classical genetic 
analyses with findings of the Human Genome Project and HapMap to 
elucidate the complex genetic foundations of these diseases. Already, 
the IBD Genetics Consortium has identified a major genetic risk factor 
for the disease. The Beta Cell Biology Consortium is capitalizing on 
genomics with the PancChip, a tool that permits the study of genes in 
the pancreas. The NIDDK has created central repositories for saving and 
distributing data and biologic samples, and established its research 
consortia to synergize progress via these repositories, and trans-
disciplinary cooperation.
    More important than leveraging the opportunities for researchers 
are the direct benefits to patients that flow from these efforts. The 
Institute is committed to helping patients and health-care providers 
adopt research-driven innovations in disease treatment and management 
to improve lives. Crucial to NIDDK's approach are its education 
campaigns, including culturally-sensitive materials for 
disproportionately affected minority populations. These include the 
National Kidney Disease Education Program and the National Diabetes 
Education Program, which launched a new campaign to prevent diabetes in 
women who had gestational diabetes, and their offspring. The 
Interstitial Cystitis Awareness and Celiac Disease Awareness campaigns 
spotlight these often undiagnosed chronic illnesses. A key NIDDK goal 
is to derive the maximum benefit from prior investments, even as we 
continue to build for the future.

                        DEVELOPING PARTNERSHIPS

    The NIDDK has strong, productive relationships with other NIH 
Institutes and Centers due to the intersection of our Institute's 
research responsibilities with those of other NIH components. For 
example, diabetes can lead to heart disease, blindness, and nerve 
disease, so we frequently collaborate with the NHLBI, NEI, and NINDS. 
The NIDDK also recognizes the vital importance of collaborating with 
other Federal and State agencies and non-profit groups, as well as with 
external experts from the scientific, health care, and patient advocacy 
communities. For example, the Institute led the development, with broad 
stakeholder input, of strategic plans for type 1 diabetes research and 
for pediatric urology. The Institute is currently providing leadership 
to the development of a long-range research plan by the National 
Commission on Digestive Diseases. By engaging in highly collaborative 
strategic planning, the Institute endeavors to maximize use of its 
resources to best support future research advances.
    In addition, the Institute is positioned to capitalize on 
opportunities for public-private partnerships. The Foundation for the 
NIH recently announced the formation of a Biomarkers Consortium, which 
combines resources and expertise of the NIH, the Food and Drug 
Administration, and the Pharmaceutical Research and Manufacturers of 
America. Biomarkers are measurable molecular, biological, or physical 
characteristics that indicate a specific underlying physiologic state 
and can facilitate accurate diagnosis, assessment of risk for or 
severity of a disease, and/or gauging response to therapy. The 
Consortium is seeking to accelerate the development of these biomarkers 
to a degree beyond the capacity of an individual partner. The NIDDK 
proposed and the Consortium accepted the ``Diabetes and Pre-Diabetes 
Biomarkers Project.'' Building on an existing NIDDK study, the Project 
may make it possible to achieve significant health care savings and 
advantages by enabling more rapid and accurate detection of diabetes.
    The NIDDK also values its important partnerships with the research 
community and with the patients who participate in clinical trials. 
Critical to the continued development of this human-capital resource is 
our commitment to new investigators, through priority funding, small 
grant and career awards, and mentoring workshops.

                       GENES AND THE ENVIRONMENT

    New genomics technologies enable us to address scientific questions 
of enormous complexity and importance. For example, the Institute is 
very interested in the effect of genetics on liver health and response 
to therapeutics. NIDDK intramural scientists recently identified a gene 
that helps determine how people with hepatitis C respond to interferon 
therapy. Also, NIDDK's Drug Induced Liver Injury Network plans to look 
for genes that have an impact on whether various drugs cause liver 
damage.
    Genetic data is key to deciphering the equation of health. The 
other key term in that equation is the way the environment influences 
health. ``The Environmental Determinants of Diabetes in the Young'' 
study is designed to solve this equation for type 1 diabetes, in which 
a one or more as-yet unidentified environmental triggers spark 
autoimmune destruction of the body's insulin-producing cells. The hope 
is that a vaccine or change of diet, for example, could one day prevent 
the disease in those at risk. The project may also provide key insights 
on environmental causes of celiac disease, which has overlapping 
genetic susceptibility with type 1 diabetes. In celiac disease, 
gluten--a major protein in wheat, rye, and barley--triggers an immune 
response that damages the small intestine and interferes with the 
absorption of nutrients. Microbes that live in the human gut represent 
a key part of our environment. Recent NIDDK-supported research has 
established that there is bidirectional induction of genes between the 
host and intestinal bacteria, influenced by other environmental 
factors, such as nutrients. Future NIDDK efforts seek to expand 
understanding of the genomes of the gut bacteria (the microbiome) and 
detail the microbes' impact on human health.
    The NIDDK Metabolic Clinical Research Unit established at the NIH 
Clinical Research Center will permit intramural and extramural 
scientists an unprecedented opportunity to take environmental, dietary, 
and metabolic snapshots of normal, overweight, or obese patients. The 
facility will be an excellent resource for understanding the gene-
environment interaction as it affects metabolic health, as well as for 
answering other research questions pertinent to obesity and overweight. 
Another effort to tie environmental variables to metabolic health 
outcomes is an initiative on the obese and diabetic intrauterine 
environment, which seeks to shed light on long-term consequences for 
offspring that can arise during this developmental period.

                      FORGING NEW PATHWAYS TO CARE

    NIDDK-supported researchers continue to make dramatic strides in 
improving the health and well-being of people with chronic diseases. 
Institute and industry support combined to enable the development of 
continuous glucose monitors which can, in the short and medium term, 
reduce the number of painful, daily finger sticks for people with type 
1 diabetes. Through better blood glucose control, the monitors may 
reduce their chances of serious complications in the long term. The 
NIDDK is also forging a new path to prevention through approaches such 
as the HEALTHY trial. This study is testing a school-based intervention 
to reduce students' type 2 diabetes risk factors in middle schools with 
predominantly minority populations. More than half of the children in 
these schools are overweight, and 15 percent have two additional 
disease risk factors. The NIDDK is also seeking to enhance evidence-
based medicine through studies such as the ``Randomized Intervention 
for Children with Vesicoureteral Reflux,'' a disease of the bladder. 
The trial is testing whether long-term use of antibiotics could prevent 
urinary tract infections in affected children, as well as scarring of 
the kidneys. For people with end-stage renal disease, NIDDK is 
conducting a trial to determine if more frequent dialysis improves 
quality of life and reduces cardiovascular risk.
    Other new pathways to patient care may emerge from the ``Biliary 
Atresia Clinical Research Consortium.'' This network is shedding light 
on this rare, poorly understood, but extremely serious disease by 
conducting basic studies to identify its causes and by testing the 
ability of a drug regimen to improve outcomes following surgery to 
improve bile drainage. Improvements in patient care may also come from 
the NIDDK's Molecular Therapy Centers, which are working to realize the 
potential of gene therapy care for patients with cystic fibrosis and 
other devastating genetic disorders.
    The studies, trials, and initiatives I have highlighted represent 
just a few of the important elements in NIDDK's research agenda, made 
possible through a robust core of investigator-initiated studies, 
representing the solid foundation of NIDDK's research portfolio. Recent 
findings from this core research include: the discovery that the amount 
of a protein in blood correlates with insulin resistance in people at 
risk of type 2 diabetes; new technologies for imaging insulin-producing 
cells in the pancreas; and the identification of genes and proteins 
that regulate the absorption and utilization of iron and have key 
effects on development of red blood cells--discoveries that may have 
great importance in the treatment of common forms of anemia.
    Thank you, Mr. Chairman, and members of the Committee, for this 
opportunity to share with you just a few highlights of NIDDK's vigorous 
research program. I would be pleased to answer any questions you may 
have. 





            Stages in the History of Type 2 Diabetes--Legend

    The NIDDK and other ICs support a range of clinical studies related 
to diabetes, with interventions at different stages of the disease.
Primary Prevention--Preventing disease onset
  --HEALTHY--A school-based trial to prevent middle school children 
        from developing risk factors for type 2 diabetes by exercising 
        and improving their diets.
  --DPPOS--A follow-up study to test the long-term impact of 
        interventions used in the extremely successful Diabetes 
        Prevention Program (DPP). The initial, three-year DPP trial 
        showed that people at risk of developing type 2 diabetes could 
        markedly reduce their likelihood of developing the disease 
        through an intensive diet and exercise program or with the 
        generic drug metformin. http://www.bsc.gwu.edu/dpp/
        index.htmlvdoc
Secondary Prevention--Preventing those with a disease from developing 
        complications
  --TODAY--Treatment Options for type 2 Diabetes in Adolescents and 
        Youth is designed to compare three treatment strategies for 
        type 2 diabetes in the growing number of adolescents diagnosed 
        with the disease. (http://www.todaystudy.org/index.cgi)
  --ACCORD--Action to Control Cardiovascular Risk in Diabetes is a 
        trial initiated by the NHLBI in collaboration with the NIDDK 
        that focuses on preventing heart attack, stroke and other 
        cardiovascular problems in people with type 2 diabetes. 
        (www.accordtrial.org/public/index.cfm)
  --Look AHEAD--Action for Health in Diabetes is a trial initiated by 
        the NIDDK in collaboration with the NHLBI to examine a 
        lifestyle intervention designed to achieve and maintain weight 
        loss in people with type 2 diabetes over the long term through 
        decreased caloric intake and exercise, in order to prevent 
        cardiovascular disease. (http://www.lookaheadtrial.org)
Tertiary Prevention--Preventing disease complications from worsening or 
        causing death
  --Ban 2D--Bypass Angioplasty Revascularization Investigation 2 
        Diabetes is an NHLBI study, with additional support from NIDDK, 
        to compare surgical or angioplasty to medical treatments for 
        type 2 diabetes patients who have cardiovascular disease and 
        also to compare two strategies to control blood sugar in these 
        patients (http://www.bari2d.org/)

    Senator Harkin. Dr. Rodgers, thank you very much. Thank you 
all. I don't seem to have a clock here so I'll have to look at 
the one up there. I'll just take maybe 7 minutes and just go 
down the line here.
    Boy, I have a lot of questions from your testimony to look 
at here. Well, I'll start with Dr. Rodgers.
    Tell me about GERD. That falls within your jurisdiction and 
eating disorders and I was told a couple of years ago that the 
leading cause of young women dropping out of college was eating 
disorders, the largest single cause of women dropping out of 
college or interrupting their school was eating disorders and 
then a lot of this has to do with GERD. What does this stand 
for?
    Dr. Rodgers. Esophageal reflux disease.
    Senator Harkin. So, can you address yourself to that? What 
kind of research is being done into eating disorders that seem 
to be so prevalent in our country?
    Dr. Rodgers. Thank you, Senator. The NIDDK is involved in a 
number of studies related to GERD and other so called 
functional bowel diseases. These diseases range from GERD, or 
gas-
troesophageal reflux disease, gastroparesis, in which the 
stomach is unable to empty its contents, and then a number of 
motility disorders, particularly functional bowel disease or 
irritable bowel syndrome.
    The research at the NIDDK and other Institutes at NIH 
involves better understanding the brain, gut coordination of 
the function and motility of the gastrointestinal tract and the 
critical role that a number of neurotransmitters such as 
serotonin play in emptying the contents of the gastrointestinal 
tract.
    Very recently we have developed a National Commission on 
Digestive Diseases, Functional Bowel Disorders, which include 
GERD and IBS, or irritable bowel syndrome, are critical areas 
that have been identified by this group of outside experts who 
are currently developing a research plan, to guide efforts over 
the next 5 to 10 years.
    We've also been working on gastroparesis--the inability of 
the stomach to empty. A major risk factor for gastroparesis 
turns out to be diabetes and this is a very disabling problem 
for a number of Americans. A gastroparesis consortium of 
leading experts and centers throughout the country is really 
studying these patients very carefully to understand their 
natural history and develop a better treatment method for these 
patients.
    Senator Harkin. Let me see if I wrote this down right. One 
in four Americans aged 12 to 19 has a condition of pre-
diabetes.
    Dr. Rodgers. That was 1 in 14, Senator.
    Senator Harkin. That's still pretty high, not quite as bad 
as 1 in 4. Then you mentioned something about surgery for 
adolescents. What is this all about, surgery?
    Dr. Rodgers. They are bariatric surgical procedures.
    Senator Harkin. We usually think about that for people like 
my age who are obese and have a hard time getting rid of it but 
we don't think about in terms of teenagers.
    Dr. Rodgers. For a number of Americans who are morbidly 
obese, particularly adults, the surgery offers a great deal of 
promise. However, what has not been done is to carefully 
determine who are the optimal patients for this form of 
surgery.
    Surgery can be very corrective in many cases. Patients with 
pre-diabetes or even frank diabetes who undergo this surgery 
actually lose a substantial amount of weight and have a 
correction of their diabetes and other risk factors for 
cardiovascular disease. However, the surgery does have its 
complications and what we're trying to determine is for which 
individuals this is an optimal form of treatment.
    Now the Agency for Healthcare Research and Quality reported 
in January this year there were roughly 121,000 bariatric 
surgeries done in 2004. They also estimate that among kids 
between the ages of 12 to 17 there were roughly 350 or 400 of 
these surgeries that year.
    Senator Harkin. Well, I guess my mind rebels of something 
like that. Just thinking about the fact that is really sort of 
a catastrophic type of intervention and that there are other 
things that could be done. I'll have to think about that a 
little bit more. That kind of shocked my conscience when you 
talked about that.
    I wanted to know, getting back to my first question on 
eating disorders. So is your Institute working with NIMH for 
example, are you correlating and doing some combinations of 
studies of the neurotransmitters that maybe affect that? How 
the mind interacts with the eating disorders?
    Dr. Rodgers. Our Institute principally focuses upon the 
molecular basis of what controls hunger and satiety and eating.
    Senator Harkin. I'm sure you are. The answer is you are 
working with NIMH.
    Dr. Rodgers. Partially, but by and large the National 
Institute of Mental Health is really the lead Institute on 
eating disorders per se, not in terms of the understanding of 
the molecular biology of eating.
    Dr. Volkow, the NIDA Director I think testified.
    Senator Harkin. Yes, we did.
    Dr. Rodgers. Is really one of the leading experts in this 
area and has published a number of studies using imaging 
techniques of the brain to characterize patients with various 
eating problems.
    Senator Harkin. Well, I followed this very closely. It just 
seems you've got a couple of things. You've got what the mind 
is doing but you also have people that have what's called 
irritable bowel syndrome where they have something going on in 
their gut that tends to feed on that and tends to make it worse 
so one kind of feeds on the other and I've wondered for some 
time whether or not we're focusing too much on the brain and 
not enough on physical things that are going on.
    Dr. Rodgers. Absolutely, those are areas we are clearly 
beginning to address, particularly with this national 
commission.
    Senator Harkin. I've used up my time. I would yield to 
Senator Cochran. Thank you.
    Senator Cochran. Thank you very much, Mr. Chairman. It is a 
pleasure to join you for this important hearing this morning.
    I would ask each of you who chair or are representing the 
Institutes this morning to comment about the adequacy of the 
funding levels and what could be done if we were able to 
increase those above the President's level.
    I don't know if we would be able to but it would be good to 
know what the money would go for, how it would be used. Would 
there be other beneficial uses of additional funding if we were 
able to increase these appropriations levels. I guess Dr. 
Hodes; we should start with you and then have each Institute 
Director comment on the research in their areas of interest.
    Dr. Hodes. Well, it is an important question. Thank you for 
raising it. Let me try to respond at two levels. The first 
having to do with the limitations which current funding might 
place on research initiatives. What clearly each of us does 
with a level of budget we have is to make judgments that 
maximize the use of the funds and that generally means an 
appropriate balance between the basic research which a promise 
for the future and the translation of what we know in the more 
immediate outcomes.
    The ability now to fund research across this whole spectrum 
is certainly limited. It's reflected in numbers, such as 
success rates, the proportion of applications, outstanding 
applications that we are able to actually fund, but those 
numbers really have meaning in terms of the studies that cannot 
be done because we cannot fund them.
    In the case of the Aging Institute, I think representative 
of others this means, I think some of the studies understand 
basic underlying biology it also means the number of clinical 
trials, be it Alzheimer's disease, or to prevent frailty, to 
prevent diabetes, to prevent other age related outcomes are 
being limited. That is there are proposals by scientists which 
are judged by their peers to be highly meritorious but which 
cannot be funded, if they fall outside of our pay line.
    There's some particular areas of vulnerability that I think 
have been stressed by Dr. Zerhouni and across all of NIH in 
addition to these concerns about what's happening in immediate 
areas of research.
    We're very concerned about particular vulnerabilities 
having to do with the workforce, young investigators, 
vulnerable populations that concern that even if we were able 
to carry it through with some bridging funds in small amounts 
for a year or two that the duration period we have been going 
through is such that we have very real concerns that 
individuals are going to be discouraged from entering the 
workforce and this would truly be a long lasting adverse 
consequence.
    As a result with funds that we have and continue the high 
priority if we had additional funds we would attempt to make 
special efforts to provide incentives to continue entry of new 
investigators in the workforce and carry them through the 
vulnerable periods so this generation will be the one that can 
generate discoveries 10, 20, and 30 years from now.
    Senator Cochran. Dr. Katz.
    Dr. Katz. Well, I would reiterate Dr. Hodes' point with 
regard to the success rate. The success rate is the number of 
applications that are actually funded over the number that are 
applied for and in fact there are many outstanding applications 
that we just don't fund now so we would increase the success 
rate.
    We also have even in constrained times made a special 
effort for new investigators to keep them in the pipeline 
because even before they get to that new investigator stage, 
there's a tremendous investment before they get there. There's 
a tremendous investment in their training, not only their 
clinical training, in many cases, but also in their post 
clinical training to learn how to do science because you have a 
long lag period before when you actually apply for your grant 
so we're trying to address that this year. I think we need to 
address that in a bolder, more robust way in the future. 
Specifically in our Institute we have initiatives that I talked 
about in regenerative medicine. Will we continue those 
initiatives, yes. Will they be at a slower pace, yes.
    We have also clinical studies that we will continue to do. 
The doubling really enabled us to do many clinical studies, 
some of which I mentioned during my opening statement with 
regard to surgery verses non-surgery for low back pain, but 
they will be slowed down.
    Finally, we have a major initiative we embarked upon with 
the Aging Institute and other Institutes as well as private 
industry, the pharmaceutical companies, called the 
osteoarthritis initiative. The goal is to be able to identify 
biomarkers and predictors for progression of disease--to know 
who is at risk, number one and number two, to do clinical 
studies that don't take 10 years to get an answer. If you've 
got a biomarker, you can do it in a much shorter amount of 
time.
    Well this research resource, in which we have invested 
collectively about $60-$65 million over the last 7 years, is 
now coming to fruition. The data are coming out. It is publicly 
available. The data on 2,000 individuals who are being followed 
are coming out. We want to take advantage of that and stimulate 
the communities to be able to utilize this resource. We will do 
it, but we will do it at a slower pace.
    Senator Cochran. Dr. Nabel.

                           YOUNGER GENERATION

    Dr. Nabel. Thank you, Senator Cochran. I'm quite concerned 
about the effects of our current budget status on the young 
people in this country.
    I just got back from San Francisco where I had a chance to 
visit with medical students, residents and fellows at the 
University of California at San Francisco, many of whom are 
desperate to go into medicine. Their passion is to make 
discoveries and help their fellow humankind, but they're 
discouraged, they're fearful about job security. Will I be able 
to get a NIH grant, will I be able to support my family, and 
will I be able to find a job at the end of my training?
    This is a concern that we're hearing not just from one 
university in the country, but we're hearing from universities 
across this country and it really is something that we take 
quite seriously because we know the future of medicine, science 
and health care in this country relies in our younger 
generation.
    We have many, many bright people going into medicine now 
and we want to do everything we can to support their career 
development so training is a major issue that we're very 
concerned about. Like my colleagues, we have many grants that 
come from investigators at universities that are very, very 
worthy of funding that we're not funding right now.

                            CLINICAL TRIALS

    In addition we have clinical trials that we would love to 
go forward with. Two of them are programs to reduce heart risk 
in young adults by preventing weight gain. I told you about 
some of our studies previously in children. We now want to look 
at this in young adults.
    We have a new blood pressure intervention trial that we're 
eager to get going on. Looking into what level should we treat 
a lower blood pressure to reduce heart risk, but those studies 
are delayed as well.
    We have just begun a very large study of heart disease in 
four Hispanic communities in this country, but we had to cut 
back on that study and cut back on the number of indicators of 
disease that we could measure because we simply did not have 
enough money to fully fund it.
    Those are just some examples.
    Senator Cochran. Dr. Rodgers.
    Dr. Rodgers. Thank you, Senator Cochran. I really echo the 
sentiments expressed by my colleagues here at the table. If I 
would sort of put my finger on it, I think training is 
critically important. To get an investigator in biomedical 
research through college, through graduate or professional 
school, and through medical school or dental school represents 
a tremendous investment, and also for them to do the post-
doctoral training necessary to secure a career.
    If we allow them to have some additional funding but then 
the next time around they lose that funding, it's quite likely 
we could lose a generation of investigators.
    In addition to what's already been said, some of the things 
that we have not been able to do is for example to fund small 
innovative grants of new ideas at a low level. Many of these 
ideas end up accelerating into a larger grant. Support for 
these small innovative types of awards is one concern.
    Another issue is that we offer supplements to people to 
bring in new talent, such as physicists and people involved in 
nanomedicine, to supplement existing grants. We've had to scale 
back on that. It is important to bring in new ideas to the 
pipeline. Also, supplements can replenish equipment to keep the 
research ongoing. That has been an area that we have had to cut 
back on.
    Like my colleagues I have a number of very basic 
investigations and clinical studies that we really would like 
to fund. One example is to determine whether if you intervene 
early, right at the time the diagnosis for diabetes is made, 
you can forestall, prevent, delay, or reverse some of the 
morbidity and mortality associated with the disease. It seems 
intuitively obvious but until we actually do a study to examine 
this, we just won't know. This is something we would love to 
study.
    Senator Cochran. Thank you very much. Dr. Nabel, as you 
pointed out in Jackson, Mississippi is the Jackson Heart study 
and it's directed to give us answers to questions about why 
there's such a disproportionate high rate of death and disease 
from cardiovascular diseases in my State than in any other 
State. The age adjusted rate is highest. Is there money in the 
budget to continue this program and could you tell us what we 
need to do in terms of funding for your Institute or some way 
to be sure that study is continued at an aggressive level?
    Dr. Nabel. Thank you, Senator Cochran. As you know we're 
all extraordinarily proud of the Jackson Heart study. It's the 
largest longitudinal study of heart disease of African 
Americans in this country. We've had the pleasure of visiting 
Jackson and visiting the site of the study in the Cochran 
Medical Mall and it is an enormous, enormous contribution.
    This has been a wonderful collaboration between the Heart, 
Lung and Blood Institute and the National Center for Minority 
Health Disparities, which Dr. John Ruffin leads and so we 
partnered together and we co-fund the study. Dr. Ruffin and I 
are very committed to the continuation of the Jackson Heart 
study. We have ensured that we have budgeted monies in the out 
years for the study, but of course, we are always limited in 
what we can do.
    With the last contract period we had to scale back some of 
the analysis that we had intended to do because we just didn't 
have sufficient monies in the budget.
    Senator Cochran. Thank you very much for that report and 
the good work the National Institute is contributing to that 
effort.

                           PREPARED STATEMENT

    Mr. Chairman, I would like to have my full statement 
printed in the record at the beginning of the hearing if that 
is ok and I will be glad to yield whatever time I have left. 
I've probably gone way beyond what we agreed today, but thank 
you for your generosity.
    Senator Harkin. Without objection your statement will be 
made a part of the record and we kind of engage a little bit 
more in depth to look at all the different Institutes so I 
appreciate your being here if you can stay.
    Senator Cochran. I'll stay for a little while. Thank you 
very much.
    [The statement follows:]

               Prepared Statement of Senator Thad Cochran

    Mr. Chairman, thank you for giving us this opportunity to review 
the proposed budget for the National Institutes of Health for fiscal 
year 2008. I am pleased the Committee has four NIH Institute Directors 
with us today to discuss the budget and to provide their important 
perspectives on research priorities. We appreciate the participation of 
this distinguished panel and their sharing with us their vision for the 
future of their respective Institutes.
    Many people in our country suffer from a disease that decreases 
their quality of living or ends life prematurely. Whether it is a 
disease that occurs as part of the aging process, such as age-related 
dementia, or one affecting a child in the early stage of life, such as 
Type 1 diabetes. Many Americans are searching for improved therapies 
and cures for these debilitating diseases.
    The NIH is leading the research effort to identify these new and 
improved treatments. Dr. Zerhouni testified before this Committee in 
March about many of the medical advances that have resulted from NIH-
supported research. Each Institute has a special and significant role 
in helping improve the chance for a healthy life for all Americans.
    Cardiovascular disease affects nearly 80 million people in our 
country and continues to be the leading cause of death from disease. In 
2007, the cost associated with heart disease is estimated to be over 
$430 billion. This is of special interest to my constituents because 
Mississippi has more cardiovascular disease than any other State. We 
also have the highest death rate from heart disease, particularly among 
our African American population. The Jackson Heart Study, the first 
large-scale epidemiologic cardiovascular disease evaluation in African 
Americans, is currently underway at the University of Mississippi 
Medical Center to examine factors leading to heart disease in this 
population.
    This is only one example of the important work sponsored by the 
National Heart, Lung and Blood Institute. Dr. Nabel, I look forward to 
your comments on NHLBI's broader plan to reduce cardiovascular disease 
through NIH research efforts.
    Diabetes is another example of a chronic disease that continues to 
increase in prevalence throughout our Nation. What was once thought to 
be ``adult'' diabetes is occurring more often in children as we see the 
numbers of overweight and obese young people increase. Progress in this 
area is also very important in my state because we have higher 
occurrences of diabetes than any other State, especially the 
Mississippi Delta region. Diabetes leads to such problems as blindness, 
nerve damage, kidney failure, and heart disease. Scientific advances in 
this area would help a significant number of people who suffer from 
these painful outcomes.
    The contributions of each Institute at NIH are important to 
accomplishing our national goal. Translating basic science knowledge 
into improved and life-saving therapies for individuals is challenging, 
but it is the key to improving disease outcomes. I appreciate your hard 
work and your dedication to helping the NIH be successful in these most 
important efforts.

    Senator Harkin. If you have more questions or any follow 
ups, I'd be glad to turn to you at any time.
    Dr. Nabel, first of all let's go back to what you were 
saying about healthy lifestyles the Institute has been good at. 
I like to see NIH applying research and doing outreach to 
improve people's health.
    I remember the first person that chaired this committee 
that I'm now privileged to chair, when I first came here, was 
Lowell Weicker, Senator Weicker, and at hearings he always 
said, you know NIH does not stand for the National Institute of 
basic research. It's called the National Institute of Health 
for a reason, to try to make people healthy and to get outreach 
out. Now obviously one of the biggest factors in that is for 
NIH to fund basic research, but not to just end there, it's to 
take the findings and move it out and so I compliment you on 
that and other Institutes for doing that. Institutes should do 
more of that kind of work, of getting information out.
    Just the things you said, interventions early in life, 
reducing incidents of heart disease, physical activity in 
school, healthy food choices, we need to hear from you and from 
the science community more on this. We know that we're building 
elementary schools in America today without a playground.
    I had a frightening quote from a principal at an elementary 
school, I won't say where, but it was, he was quite profound. 
Someone said why are you building these schools without 
playgrounds? He said we're in the business of education, not 
building monkey bars. What a narrow view on education. When we 
were younger, I'll bet we were always kicked outside for 
recess.
    We had to go out and do things and run around and get 
physical activity and no longer is that happening. So again, we 
need your strong voice out there again promoting this and 
healthy food choices in schools.
    For some reason we allowed schools to put in more vending 
machines and soda pop and junk food and all that kind of stuff 
and kids eating that and not only getting obese but also 
leading to heart disease. So we need, again, to have more input 
from your Institute to do the studies that are necessary and 
also to just inform us what we need to do on these healthy food 
choices.
    There is one area I want to cover with you and that has to 
do with blood pressure. Now you made the point that blood 
pressure, high blood pressure is a dominant factor leading to 
heart disease. Is that a correct statement?
    Dr. Nabel. Yes.
    Senator Harkin. Well, now, is it also not true that high 
intakes of sodium will elevate your blood pressure? Am I being 
scientifically correct here?
    Dr. Nabel. Yes.
    Senator Harkin. Well I've always had good blood pressure 
until recently, a year or so ago, all of a sudden my blood 
pressure started going up, not dangerously high so I decided 
what I was going to do, I was going on a low sodium diet. Have 
you ever tried to go on a low sodium diet?
    Dr. Nabel. It is tough, isn't it?
    Senator Harkin. It is tough and how about all these kids 
out there? I mean, try to buy a prepared meal that is not just 
loaded with sodium. Try to buy a can of soup. We have a chef 
over in the cafeteria in this building, in the basement of this 
building and I like to have soup for lunch, so one day I sat at 
my desk and had soup brought up to me by staff. Staff got me 
some soup so I could eat and do some work. Suddenly it occurred 
to me that I was eating salt and so I got a hold of the Senate 
chef and I said this is loaded. How much sodium is in this?
    Well, it was just loaded with salt and so I said why can't 
you just get soup with low sodium. Well they do now. They have 
it on the menu. You get low sodium soup, very low, hardly any 
sodium at all. It tastes just great, but that's what you have 
to go through to get it done.
    Try to buy a frozen dinner, a frozen dinner, Healthy 
Choice, Healthy Choice it says. What's some of the other ones, 
I forget. So you go through and start looking at the Healthy 
Choice, yes it's low in fat, no trans fats and then you see the 
sodium, just packed with sodium. How can that be a healthy 
choice?
    Dr. Nabel. It is not, it's not.
    Senator Harkin. What are you doing about it?
    Dr. Nabel. I wish I had a magic wand.
    Senator Harkin. Seriously, are you working with, we've got 
to get the FDA to start looking at this too. We need your 
scientific background to buttress things.
    Dr. Nabel. Absolutely, we see our role as providing the 
scientific evidence that then helps make these directives and 
we're working very, very closely with the Food and Drug 
Administration and CMS and other Federal agencies, CDC on these 
areas.
    I do want to credit many of the professional groups, 
organizations in this country, for example, the American Heart 
Association has fantastic public awareness programs in public 
health, obesity, heart risk factor reduction and they have in 
particular developed a number of alliances with members of the 
food industry to begin to look at the quality of foods that are 
prepared, particularly those given to our young people.
    Senator Harkin. Do we need any more research into the 
effects of sodium or do we know all of that?
    Dr. Nabel. We know a fair amount. We know blood pressure is 
controlled by the kidneys which regulates water and sodium 
intake. It's controlled by the brain by a series of hormones, 
but blood vessels themselves also control blood pressure and 
the reality is we all get older, our blood vessels stiffen a 
little bit and that's probably a good reason why our blood 
pressure tends to get a little bit higher as we get older.
    In fact we've had conversations recently with Dr. Hodes and 
his superb scientists about potential ways to address this 
issue in individuals, but getting back to your earlier point, I 
think you're absolutely right, we have shifted in this society 
toward a dependency on prepared foods and that is really, I 
think that the shift that has occurred post World War II.
    We don't rely on using fresh ingredients to make home 
prepared meals like we did when many of us were growing up and 
I think we are seeing the untoward consequences. So much of 
what we tried to help young families with, is just learning how 
to eat fresh fruits, fresh vegetables, fresh food products and 
learning how to prepare very simple meals that are healthy and 
less dependent on prepared foods.
    We have got a long way to go, but there is a lot of energy 
and a lot of momentum that is building through a number of 
organizations around the country.

                       SCHOOL NUTRITION PROGRAMS

    Senator Harkin. Well, Senator Cochran and I are trying to 
do our part in the school nutrition programs in fruits and 
vegetables. We've worked together on that and tried to get more 
fruits and vegetables into the schools, that type of thing, but 
it's good to have the National Institutes of Health out there 
again promoting this, again the outreach, the information, the 
translation of your research into better public knowledge and 
awareness.
    The statements by the Director of the National Heart, Lung 
and Blood Institute carry a lot of weight, it has a big impact 
and so we encourage you to continue on this.
    Dr. Nabel. Thank you. We realize that and we know that we 
have a major role to play in helping to promote health, prevent 
untoward consequences.

                              COPD CAUSES

    Senator Harkin. I just have two other things I want to 
cover with you, Dr. Nabel.
    Chronic obstructive pulmonary disease, the fourth leading 
cause of death. Tell me again, in layman's terms, what is that?
    Dr. Nabel. So COPD is what we used to call emphysema. So 
it's shortness of breath. They can't breathe and you probably 
remember the picture of the individual and historically it's 
been caused by smoking and what the smoking does is it 
literally destroys the lung tissue. So you lose the air sacs.
    Senator Harkin. Is the biggest factor for COPD, smoking?
    Dr. Nabel. It continues to be smoking and what we're 
particularly concerned about is while there are fewer smokers 
in the older generation, there are more and more smokers in the 
younger generation, particularly young women and again, it's 
getting the message out that what may appear to be a simple act 
early in life leads to real problems.
    Senator Harkin. What does you research show other causes? 
You mentioned other factors that may be involved.
    Dr. Nabel. There are other causes. There are some 
environmental factors, pollutants, toxins that can lead to lung 
scarring. We know that there are certain infections that go on 
for a long period of time, if not adequately treated can 
produce this. We also have the sense that there may be some 
genetic susceptibility that we don't quite understand.
    I had a visit the other day from a woman from Honolulu, 
Hawaii, 45 years old. She came to my office and said, you know 
at 45, I've got COPD. I've never smoked. I don't understand 
this. It is those types of individuals that we really need to 
reach out and try to understand.
    So we have made a major investment in trying to understand 
the factors that contribute to COPD and it's going to take a 
major investment, a few years of study, but we will be looking 
at genetic causes, environmental causes, biochemical causes, et 
cetera.

                         LAM LONGITUDINAL STUDY

    Senator Harkin. One last thing and here I'm going to try to 
pronounce the word, Lymphangioleiomyomatosis.
    Dr. Nabel. Lymphangioleiomyomatosis.
    Senator Harkin. LAM, ok. A constituent of mine suffers from 
LAM. I understand there's been a lot of distress among LAM 
patients across the country about your decision, your 
Institute's decision to close the intramural program on this 
disease and end a longitudinal study that has collected LAM 
tissue samples for many years. These patients are concerned 
that one, the data collected through the longitudinal study 
will be wasted and two, they will no longer have access to 
dedicated care providers at NIH. Could you address those 
concerns?
    Dr. Nabel. Sure, if I could, Senator, I would like to 
correct some of that information.
    Senator Harkin. Absolutely.
    Dr. Nabel. We are very committed to LAM. This is really a 
very, very tragic lung disease that occurs predominately in 
young women. It probably has a very strong genetic etiology.
    Senator Harkin. How does it manifest itself?
    Dr. Nabel. Shortness of breath, all lung diseases manifest 
in shortness of breath, fatigue, inabilities to do activities 
that one once could and there are certain types of cells. We 
think that they might be like smooth muscle cells that grow 
within the lung tissue and slowly destroy the lung tissue.
    Now we're very proud of the fact that, for probably the 
past 5 to 10 years, our Institute constituted the first natural 
history study of LAM, through our intramural program and many, 
many young women with LAM throughout the country came and 
participated in that study.

                          LAM TREATMENT TRIAL

    That study is near completion and the next phase then will 
be a treatment trial. One always likes to go from understanding 
the disorder to a treatment trial so we have a very active 
treatment trial ongoing in the intramural program, so that is 
what I wanted to correct.
    Senator Harkin. So the longitudinal study is coming to an 
end, but the data collection will be used?
    Dr. Nabel. Absolutely and in addition, the data collection, 
we're embellishing and building upon that and now making that 
tissue available through a repository to many extramural 
investigators so our extramural program will be involved in the 
data collection in addition to the intramural program.
    Senator Harkin. Can you assure me the LAM research will not 
suffer as a result of this decision to end the longitudinal 
study and that every effort is made to place the patients with 
new, highly qualified care providers?
    Dr. Nabel. Absolutely and in fact, the ending of the 
longitudinal study was really a decision made by the 
investigators themselves, not by the Institute. They said look, 
we have collected all the data we need. We now need to begin 
the treatment trial and so we are clearly inviting the same 
group of women who participated in that natural history study 
to come now and join us in the treatment trial.
    As part of their coming to visit at the clinical center, we 
do visit with them about their care that they're receiving in 
other areas and as we have in the past, we are strongly 
committed to continuing that and helping them to receive the 
best care that they can, whether we can provide it at the NIH 
or we can refer them to physicians around the country.
    Our commitment to this program is extraordinarily strong.
    Senator Harkin. I thank you for that reassurance. I'm sure 
my constituent will be reassured also. Senator Cochran.
    Senator Cochran. Mr. Chairman, I want to thank you for the 
hearing. I think the witnesses have done an excellent job of 
putting information before us that we can use to have a better 
bill of appropriating money for these important activities.
    Our goal, of course, is to have a healthier America and 
make sure that the therapies and cures that are being 
discovered as a result of this research are translated into 
patient care and improving the health of individuals in our 
country. That is why we put some more emphasis in last years 
budget on cures and therapies and some of us are pushing that, 
Senator Harkin and I, and others to improve the way we get the 
information to physicians and other health care providers so 
that we make sure we are getting the best possible remedies out 
there available to the people who are sick and want to stay 
healthy.
    So, thank you all for the role that you play. It's 
enormously important and we appreciate what you do.

                              OSTEOPOROSIS

    Senator Harkin. Thank you, Senator Cochran. Dr. Katz, let's 
turn to you now.
    Osteoporosis, so all the research has been done on this. 
What's the best preventative measure that people can take now 
to prevent osteoporosis?
    Dr. Katz. Well, to start with they can pick their parents 
because there is a genetic factor. Obviously that's outlandish, 
but what they can do goes back to some of the points that you 
made with Dr. Nabel. Diet is important, and adequate dosages of 
vitamin D and calcium, as well as exercise, are particularly 
important. Going back to another point that you made earlier, 
exercise in young people becomes really important in building a 
bone bank, for both men and women, because the better your bone 
mass is early on, the more you can actually lose and get away 
with it.
    What we don't know is, we have a pretty good index of bone 
density using these DXA machines, but we don't really know much 
about the architecture of the bone in terms of what predisposes 
to fracture. So what we're trying to do is learn more about 
that, but in terms of addressing osteoporosis, exercise and 
certain medications can help. Also one must avoid certain 
medications that are being found to decrease your bone density.
    Senator Harkin. Such as?
    Dr. Katz. Such as certain types of sedatives. For example 
there's a drug, rosiglitazone, that is actually used for 
diabetes that we've had discussion with Dr. Rodgers about that 
suggest that, in addition to doing well with diabetes, it 
decreases bone mineral density. We're under discussion now 
about actually studying why that happens, not only for the 
patient and the physician, but to better understand what the 
balance is between taking such a drug for diabetes, while on 
the other hand decreasing bone mineral density.
    Senator Harkin. If you have one of these tests, these bone 
density tests they take and your caregiver, or doctor, or 
whoever does that says, yeah, it's not that good. We recommend 
you take some calcium and magnesium. Is that valid?
    Dr. Katz. Calcium clearly. Magnesium is thought by some to 
play an important role, but certainly you need vitamin D as 
well to help absorb the calcium, and so there has to be 
adequate intake of both as a start.
    Senator Harkin. Because this is, well, I can tell you, I 
don't know what the incidence of osteoporosis is, but I am 
hearing more and more and more people who have osteoporosis and 
I'm not certain what's causing it, whether it's just genetic, 
all genetic. People are just living longer, not having the 
proper diet or all of the above, I suppose.
    Dr. Katz. Lack of exercise.
    Senator Harkin. Lack of exercise, yes.
    Dr. Katz. Also for a long time people were using estrogens, 
for example, to build bone strength, particularly women at the 
time of menopause. But the long-term study the NIH supported 
over a 10-year period, the Women's Health Initiative, has shown 
that there are adverse effects of estrogens on the one hand, 
and number two, we now have alternatives to estrogens in terms 
of preserving bone strength.

                             OSTEOARTHRITIS

    Senator Harkin. Let's turn to the other osteo, 
osteoarthritis. You said 12 percent of the population?
    Dr. Katz. 12 percent of the population over the age of 25. 
That becomes really a tremendously large number when you figure 
that in the year 2030 we will have 70 million people who will 
be at risk for osteoarthritis.

                         REGENERATIVE MEDICINE

    Senator Harkin. Then you mentioned regenerative medicine. 
Could you explain that a little bit further?
    Dr. Katz. So, regenerative medicine is something that we're 
all concerned about in terms of support. It really means to try 
to re-grow certain tissues, and in our case, the major emphasis 
is on the re-growth of cartilage.
    Regenerative medicine is also being used to re-grow certain 
cells in the pancreas, which the Diabetes Institute is 
particularly interested in, but this isn't such an easy thing.
    First of all one needs either one's own stem cells that 
will replenish the tissue, or one needs other stem cells that 
will replenish the tissue. Regenerative medicine involves 
building some sort of matrix or material upon which cells will 
grow into the type of tissue that you want them to grow into, 
and stem cells have the ability to grow into cartilage cells, 
fat cells, muscle cells, etc, depending on what their 
environment is, so basically regenerative medicine in terms of 
cartilage repair requires a matrix on which cartilage cells 
will grow.
    Then when you put the matrix back into an individual the 
matrix dissolves. It's sort of like resorbable sutures. If you 
have sutures, the body absorbs them and you are left with the 
actual tissue so that is what regenerative medicine is about.
    Many, many organ systems are being looked at in terms of 
the potential for regenerative medicine.
    It's a form of tissue engineering. It's bringing biologists 
together with engineers to try to build a new organ system.
    Senator Harkin. What you're giving out in terms of research 
projects, how much of this is in the area of regenerative 
medicine? I mean, looking at stem cells for example, is this a 
big area of study that you're promoting perhaps, or looking for 
proposals for research grants?
    Dr. Katz. So we work with other Institutes on this. Our 
investment in regenerative medicine is about $42 million.
    Senator Harkin. What's your budget?
    Dr. Katz. It's about $507 million.
    Senator Harkin. $507 million, and about $42 million.
    Dr. Katz. Basically most of that is from an engineering 
standpoint--building the materials upon which cells can grow--
but you can't do one without the other, so you have to invest 
in the cells that will replenish tissue.
    With cartilage we think this is really important because it 
will delay the need for total knee or total hip replacement.
    Senator Harkin. Well, that is one of the big problems of 
stem cell research. Whether it's adult stem cells or it's 
embryonic stem cells or placental stem cells or amniotic stem 
cells and that is to do just this.
    Dr. Katz. Right.
    Senator Harkin. Are you getting research requests in those 
areas?
    Dr. Katz. Yes, actually we're probably not able to support 
all of the outstanding applications that we get, but 
fortunately there are other Institutes. The National Institute 
of Biomedical Imaging and Bioengineering, with which we work 
very closely in this area, has a major investment in trying to 
understand some of the really fundamental areas, much more 
proximal to the tissue part of the investment.
    In other words, our focus is on the translational part of 
tissue engineering and our major focus is not only in 
cartilage, but also in skin because as you know, wound healing, 
burns, are a very, very big problem. There have been products 
on the market with regard to regenerative skin products, but 
not in the area of cartilage and people are actually trying to 
regenerate bone as well and other tissues as well.

                             OSTEOARTHRITIS

    Senator Harkin. Just a couple of other items here, on 
osteoarthritis. I see glucosamine and chondroitin and SAM-E out 
there touted for relieving the effects or curing, at least 
mitigating the effects of osteoarthritis. What can you tell me 
about those?
    Dr. Katz. With the tremendous support that we've had, about 
8 years ago we embarked on a study with the National Center for 
Complementary and Alternative Medicine and they actually took 
the lead after they were established, but we work closely with 
them.
    The study was a four-arm clinical trial to address the 
question of whether glucosamine and chondroitin sulfate, which 
are used very widely for osteoarthritis, were actually 
beneficial.
    The results of that study came out early last year and 
showed that glucosamine and chondroitin sulfate in mild 
osteoarthritis, do not help much. In moderate to severe 
osteoarthritis, they are thought to be beneficial. Those 
studies need to be validated, certainly.
    Our particular interest in that trial continues, because we 
also supported an ancillary study to look for structural 
changes. In other words, we didn't want to lose the opportunity 
of just seeing whether these compounds were beneficial in terms 
of symptoms, so we invested in x-ray studies and MRI studies to 
see whether there was actually improvement in the widening of 
the joint space, and the results of those studies are soon to 
come out.
    We don't know the results. It's a blinded study, but I 
assure you, it will come out very soon and I will send you 
those results. I understand the investigators are going to try 
to have the results by the time of the American College of 
Rheumatology meetings in October, but I can't tell you for 
sure. I did check on it actually yesterday with Dr. Clegg, who 
runs that study from Utah.

                          AUTOIMMUNE DISEASES

    Senator Harkin. I would like to know about that. There's 
just one other, or two other areas I want to cover with you. 
Autoimmune diseases, your Institute handles autoimmune 
diseases, lupus, and scleroderma. Again, it's hard in many of 
these to get a proper diagnosis. Sometimes it takes a long 
time, years, before the patient finds out what they have. When 
they have the doctor says, there's not much we can do.
    Again, are these conditions on the rise? It seems to me 
just to the untrained eye, seems to me that these are on the 
rise or I'm getting more information about it. What progress 
are we making in understanding and treating these autoimmune 
diseases?
    Dr. Katz. So, I don't know if it's on the rise. I can tell 
you when I was a medical student going on the wards in 1965, 
the patient with lupus, who had central nervous system 
involvement, was basically considered dead, no treatment, no 
hope for a patient like that. I think nowadays we're diagnosing 
patients much earlier.
    We have much better diagnostic tools in all of these areas 
whether its scleroderma, whether it's lupus, whether it's 
rheumatoid arthritis. The diagnosis is made earlier, number one 
and number two, getting to the treatment side of it, in the 
last years, there's been much more learned in terms of 
approaches to the treatment.
    So at the NIH Clinical Center there was a tremendous 
investment in the use of an immunosuppressive agent, which was 
a cancer chemotherapeutic agent, cyclophosphamide. For many 
years, as a consequence of long-term investment in the 
intramural program on the Bethesda campus, treatment with 
cyclophosphamide was thought to be the best way to prevent 
renal disease.
    Nowadays, there are new approaches. Last year there was a 
study using a drug that's called CellCept with probably fewer 
side effects than long-term use with cyclophosphamide has. Most 
recently we've been investing in studies in lupus and 
dermatomyositis, another autoimmune disease, using a drug 
called, rituximab.
    Now, what is rituximab? Rituximab is an antibody that 
actually kills off cells that produce autoantibodies. So it 
kills the cells that produce the autoantibodies in lupus and 
presumably in dermatomyositis and in other of these autoimmune 
diseases. So basically, there are new drugs that are being used 
to try to intervene in the earliest stage.
    We're trying to identify those patients who are most 
susceptible to more severe disease, and this has been the 
approach to new therapy. So I think there's much greater hope. 
Lupus and other of these diseases have been chronic diseases. 
For some of these diseases, rheumatoid arthritis, for example, 
there are now studies being done for early intervention to 
actually stop the progression and even potentially cure the 
disease, if there's very early intervention.
    It goes back to what Dr. Rodgers was saying about diabetes. 
What do we know about early intervention? In order to do early 
intervention, one needs to have a good diagnostic test to know 
that that person is going to progress in terms of, 
particularly, rheumatoid arthritis and I assume the same in 
diabetes.
    Senator Harkin. Do you know of any research being done to 
look at any connection between autoimmune diseases and 
vaccines? Now here's why I ask that question and I brought it 
up the other day at a hearing on autism. By the time a baby is 
now 1 and a half or 2 years old, 31 vaccines. Of course, when I 
was young we didn't have any of that stuff, now 31. 
Individually, they're fine. The real question that I have and 
others have is, put together in that short space of time, in a 
small person, that there's some thought that this may lead to 
the prevalence of autoimmune diseases and I don't know what 
research is being done on that. Do you know?
    Dr. Katz. I don't.
    Senator Harkin. Could you find out for me?
    Dr. Katz. I certainly can. I'll send you a note for the 
record. Actually, I think Dr. Fauci, who's the Director at the 
NIAID, can answer that question directly when he testifies 
before this subcommittee.

                              FIBROMYALGIA

    Senator Harkin. Tell him to be prepared for that one.
    I just want to know what research is being done in that 
area.
    Now, fibromyalgia. I have two former staff persons of mine 
with fibromyalgia and my niece now and I watch what's happened 
to them. This is really debilitating. They can't work. They're 
in pain all the time, tired, depression. They say there is no 
cure. They just feel like they are going to spend the rest of 
their lives with it so that kind of feeds on depression.
    Again, tell me about research in the area of fibromyalgia. 
Any hope for any of these patients?
    Dr. Katz. There is hope. Actually we're just finishing up a 
clinical trial on gabapentin which is being used in some 
patients. I will send you the results of those studies. They 
should be out very, very shortly. This is a double-blind study 
led by an investigator in Cincinnati, Dr. Arnold I believe.
    Senator Harkin. What is the name of that?
    Dr. Katz. Gabapentin. G, A, B, A, P, E, N, T, I, N. It's a 
pain relieving medication, but there are other approaches that 
we've taken all along the way in fibromyalgia. It's a multi-
system disease, as you know and can affect different organ 
systems in different people, affects women primarily but it 
also can affect men--it certainly can affect men.
    The approaches have been from the standpoint of self 
efficacy and have been used with patients who have rheumatic 
diseases and this is that the patients themselves can do 
something about it. They can energize their physicians to treat 
whatever their symptoms are because we don't know the 
underlying cause of it. It is not a muscle disease. For a while 
it was thought to be. Some people called it fibromyositis, but 
it's not a muscle disease at all.
    It's a multi-system disease. You described it perfectly. It 
affects various organs, and it does produce depression as many 
of these chronic diseases with unrelenting pain produce 
depression. So, there's a lot of research going on there.
    How does exercise fit into it? Those are the types of 
studies that we're doing. We're happy to provide you with more 
information on that.
    [The information follows:]

           Department of Health and Human Services,
                             National Institutes of Health,
                                   Bethesda, Maryland, May 7, 2007.
Hon. Tom Harkin,
U.S. Senate, Washington, DC 20510.
    Dear Senator Harkin: I am writing to follow-up on the issues that 
you raised at the April 20, 2007, hearing on the Burden of Chronic 
Diseases with respect to selected activities of the National Institute 
of Arthritis and Museuloskeletal and Skin Diseases (NIAMS), a component 
of the National Institutes of Health (NIH).
    First, I would like to provide you with a brief update on recent 
progress that we have made in understanding and treating fibromyalgia 
syndrome. For your reference, I have enclosed two articles from the 
scientific journal Arthritis and Rheumatism that I think will be of 
interest. The first reports on the results of a randomized, double-
blind, placebo-controlled trial supported by the NIAMS to assess the 
efficacy and safety of gabapentin in patients with fibromyalgia. 
Overall, the researchers found that this drug, an anti-convulsant 
approved by the Food and Drug Administration, is safe and efficacious 
for the treatment of pain and other symptoms, such as sleep 
disturbance, associated with this condition. Further, the scientists 
reported that, although patients taking gabapentin in this study 
experienced more dizziness, sedation, lightheadedness, and weight gain 
than those taking placebo, in general the medication was well-
tolerated.
    In the second enclosed article, researchers funded by the Institute 
describe their assessment of social functioning and peer relationships 
in adolescents with juvenile primary fibromyalgia syndrome (JPFS). 
Their findings, based on data collected from the patients themselves, 
as well as from their teachers and peers, suggest that adolescents with 
JPFS experience more difficulties with peer relationships compared with 
matched adolescents without a chronic illness, placing the JPFS 
patients at risk for social isolation from their peers and psychosocial 
adjustment problems. Additional studies are needed to determine the 
specific links between JPFS and social challenges in adolescents, as 
well as to identify the most effective interventions to facilitate 
psychosocial adjustment and improve the overall sense of well-being for 
this population.
    Second, as I noted at the hearing, we are awaiting results from the 
ancillary study of the NIH's Glucosamine/chondroitin Arthritis 
Intervention Trial (GAIT), which is looking at whether glucosamine and 
chondroitin sulfate can alter the progression of osteoarthritis (OA), 
such as delaying the narrowing of the affected joint spaces. As soon as 
those results are published, we will send you and your staff a copy of 
the article, along with a brief overview of its conclusions.
    Finally, you asked me about the findings of Dr. John Sarno, who 
looked at the relationship between back pain and stress management. I 
am now reading some of Dr. Sarno's work, and I will write to you under 
separate cover about how his research helps inform our knowledge base.
    We very much appreciate your active interest and support of the 
work of the NIAMS and the NIH. Please do not hesitate to contact me 
directly at (301) 496-4353 if I may provide you with any additional 
information.
            Sincerely yours,
                    Stephen I. Katz, M.D., Ph.D., Director,
      National Institute of Arthritis and Musculoskeletal and Skin 
                                                          Diseases.

    Senator Harkin. There doesn't seem to be any precursors at 
all. It just seems to be very random. I don't know if any 
genetic studies have been done.
    Dr. Katz. Genetic studies have been done; unfortunately the 
person who led those studies died, but those studies are 
actually going on. Unfortunately, it also occurs in children, 
not only in adults. In children it can manifest various 
symptoms of fibromyalgia.
    Senator Harkin. Children? I had not heard of that.
    Dr. Katz. It does occur in children.
    Senator Harkin. Well, I've seen it in late teens, early 
twenties, but.
    Dr. Katz. Children in the first decade, age eight to age 
ten, have symptoms of fibromyalgia.
    Senator Harkin. Is it really an autoimmune disease?
    Dr. Katz. There is no evidence that it is an autoimmune 
disease. Lots of people have looked, but there is no evidence 
that's it's an autoimmune disease.
    Senator Harkin. So we really don't have it classified yet?
    Dr. Katz. We have it classified as a pain syndrome. It's a 
multi-system pain syndrome, with the manifestations of the loss 
of cognition, for example, and loss of sleep. I'm sure these 
people whom you know share some of these symptoms--pain, 
really, all over their body and depression. Those are four of 
the most common of these symptoms of fibromyalgia, but we are 
supporting studies in these areas and hopefully they will yield 
useful information.

                     ALZHEIMER'S DISEASE TREATMENTS

    Senator Harkin. Dr. Hodes, Alzheimer's. You covered that 
quite a bit in your testimony. I had one question about a chart 
here, this one right here. You mentioned this drug, denepozil. 
Now I'm looking at this chart and don't understand it very 
well, but it almost seems like the other two have almost as 
much affect as denepozil.
    Dr. Hodes. I apologize for the complexity of what is a 
standard way of presenting the results of the clinical studies. 
What this shows is the time scale of the trial, which is about 
3 years. What you see at the top at zero means that no one has 
Alzheimer's disease to begin with and then over time, as that 
curve goes down, this is indicative of more and more people 
developing the disease.
    The placebo group represents the number of people 
developing Alzheimer's in the absence of intervention.
    Vitamin E is overlapping with that curve. Vitamin E had no 
effect whatsoever on disease progression, and donepezil, the 
yellow line above, shows a slower decrease that is a slower 
development of people with Alzheimer's disease over time.
    Senator Harkin. In the end it looks like it's even worse.
    Dr. Hodes. What's deceptive is that line, where it drops 
off at the end, really is the end of the study, and there are 
too few people to analyze. I think a more meaningful graph 
would not have shown that apparent drop. You can ignore that. 
It is at the end of the study, so few people reach that time 
point. The lines that go through the point before that drop 
that are really significant.
    Senator Harkin. Again, I don't know why they did vitamin E, 
but I keep hearing that ginkgobiloba is being prescribed more 
and more. How come that wasn't done, I wonder, in that?
    Dr. Hodes. So, there is a study of ginkgobiloba that is 
currently in progress being carried out again by the National 
Center for Alternative Medicine in collaboration with the NIA. 
It is expected that within a year or so, that study will reach 
completion and we will have the result.
    As you're leading to, there are a number of studies and 
anecdotal observations suggesting ginkgo might play a role, but 
no promising lead is being left unturned. We have pursued that. 
I would hope to have an answer shortly.
    Senator Harkin. There's another, I think over the counter 
thing, called huperzine. Is that right?
    Dr. Hodes. Yes.
    Senator Harkin. Three years ago, NIH launched the first 
study of huperzine A as a treatment for mild to moderate 
Alzheimer's because evidence from small studies suggest it may 
be effective as some of the drugs being used by Alzheimer's 
patients. What's the status of that trial?
    Dr. Hodes. It's also in progress. We don't have people who 
have used it long enough to have an answer, but it will be 
forthcoming.
    Senator Harkin. Well, it's been 3 years. How long is this 
trial going to be?
    Dr. Hodes. Typically, what occurs when a study begins is 
the starting point is when subjects begin to enter and of 
course, they all don't enter at once. So, again, it may take 1 
to 2 years for all of the patients to enter into the study and 
then, in the case of Alzheimer's disease, when we study the 
onset by clinical symptoms, generally it's necessary to follow 
up people for 2, 3, 4, or even 5 years.

                  ALZHEIMER'S DISEASE AND NEUROIMAGING

    This is one of the reasons I was emphasizing the potential 
importance of surrogate markers, such as neuroimaging, where 
we're hopeful that when we can image objectively the lesions of 
Alzheimer's in the living person and track this over time, we 
have more rapid, more objective signs of whether an 
intervention is effective or not, and we won't have to follow 
so many people for so long before we have the outcome of each 
of these trials.
    Senator Harkin. That's good. Four months ago researchers 
supported by your Institute reported finding a new imaging 
molecule that could lead to an earlier diagnosis of Alzheimer's 
disease. Can you tell me a little bit more about that?
    Dr. Hodes. So there have been two molecules described and 
studied that function in neuroimaging. One, illustrated in the 
slide that I showed you, was this, which is called Pittsburgh 
compound B. We described this one to you a couple of years ago. 
This bonds with apparent specificity the amyloid protein that 
is in the plaques, one of the lesions of Alzheimer's disease.
    The newer, more newly described compound developed by a 
group at UCLA has a similar effect but appears to be capable of 
detecting both the amyloid plaques and the other lesion of 
Alzheimer's disease, the so-called neurofibrillary tangles.
    So studies are currently ongoing to determine the relative 
merits of each of these in tracking the disease to see first, 
the degree to which they correlate with disease progression and 
the diagnosis.
    If they pass this first hurdle--that is, they appear to be 
good correlates of clinical disease--then the next step is to 
then see how effective they'll be in monitoring the success of 
interventions to treat or to prevent disease, because some of 
these lesions can be seen in these individuals before there are 
any symptoms.
    Of course, the great hope is that the disease can be 
detected before damage has caused symptoms to individuals and 
that that is the point at which intervention will prevent 
damage. In all likelihood the task of reversing damage, once it 
involves death of the brain cells is going to be far more 
difficult than prevention, a theme which you've heard across a 
number of disorders and diseases.
    Senator Harkin. Well, but again, you raise another 
question. If you've got early diagnosis, that's fine. What do 
you do about it? What hope do you hold out there for people 
that they can actually slow it down or stop it?
    Dr. Hodes. That's a very important point. At this point in 
time for Alzheimer's disease, one very important and real 
advantage of early diagnosis is that it allows people to enter 
studies of interventions to see what will work at an early 
point unless or until the time when we have effective 
interventions. You're quite right.
    One can ask this question--what is the usefulness for early 
diagnosis? In fact real bioethical issues exist about whether 
individuals should seek early diagnosis or early information 
about genetic risks until the time when there is something to 
be done about it. It's very much an individual choice but where 
I think it is far more clear cut is in the area of research to 
try to develop interventions and prevention there. We want to 
test those interventions on individuals who have early pre-
clinical signs of disease.
    Senator Harkin. Ok, I want to sort of join up you and Dr. 
Nabel here.
    We talked about early childhood physical activity and 
diets. Now, let's shift to the elderly in our society. 
Anecdotally, I suppose, what I've observed and others, is that 
a lot of times elderly people who are on a lot of drugs and 
taking a lot of drugs and interventions that if given a better 
diet and exercise and social interaction, they can actually get 
off a lot of those drugs and live healthier so you did this.

       PHYSICAL ACTIVITY IN PREVENTING DISABILITY IN THE ELDERLY

    You have a life clinical trial which was testing the 
effects of a physical activity program versus a health 
education program in preventing major disability among the 
elderly, so you've been doing some of that. Tell us about it.
    Dr. Hodes. I'd be happy to comment on a number of trials in 
this area. LIFE is a study that was carried out in pilot form. 
It's still in pilot form. It's a very substantial study to look 
at individuals who are known to be at high risk for developing 
disability. The end point of this study is loss of the ability 
to walk at least a quarter mile, which turns out to be a very 
good predictor of quality of life and independence.
    Individuals known by their characteristics to be at high 
risk for falling into this category were initiated into this 
study and were treated with a very responsible program: either 
conventional information (you should exercise, you should go on 
this diet) or a much more explicit and rigorous controlled, 
clinical intervention.
    As a pilot, the initial study was largely to determine 
whether this was a practical trial, whether people would 
comply, and whether it was safe. By all those accounts the 
answers were very positive.
    But even more so, despite the fact that it was not 
initially predicted to have sufficient power to see an effect, 
it did detect an effect, even in the pilot version. The 
intervention was capable of preventing people from becoming 
disabled, from losing the ability to walk--to remain mobile. 
This is an example of a study now that's going to be carried to 
a more extensive level to produce really significant outcomes. 
It will be a very expensive and extensive study. This study 
relates to some of the things my colleagues have said, too, 
that although in some ways it is self-evident, exercise must be 
good.
    This is actually already, to our knowledge, the largest 
randomized trial to look at the effect of exercise on outcomes 
such as this (e.g., the prevention of disability and the 
preservation of mobility and independence.) So things that may 
seem intuitive need to be addressed scientifically.
    If we can prove that an intervention such as this is 
important, then we would hope that these interventions can 
translate much more to the public.

                         EXERCISE AND DIABETES

    On the general theme that older people can profit very much 
from behavioral interventions such as exercise and diet: I 
alluded to, very briefly, a study carried out in connection 
with NIDDK that looked at individuals who are at high risk to 
develop diabetes over the next year or two. Study participants 
were young adults when they entered, middle aged, or 
individuals 60 and over.
    The study, again, compared a placebo group, which was 
responsibly educated but received no specific treatment, with 
metformin, an oral drug that is used to treat diabetes. The 
third arm was a behavioral intervention, which was a moderate 
diet and exercise intervention. It was interesting not only 
that the study was carried out prospectively, but that it was 
terminated prematurely.
    Now we fear often premature termination because of side 
effects. This study was terminated because the treatment was 
proving to be so effective that it was deemed irresponsible to 
continue and not to inform subjects of the results.
    The results were further interesting in terms of the 
effective age for each intervention. Both the drug and the 
behavioral interventions worked at the youngest age group, 
approximately and substantially able to reduce the incidence of 
diabetes by some 50 percent or so.
    In the older age group, and this was not predicted, the 
drug did not work. However, and this was also not predicted, 
the exercise and diet intervention was more effective than it 
was in any other age group, producing a 71 percent decrease in 
diabetes.
    So this said a number of things. It said older individuals 
are quite capable of modifying their behavior. Furthermore, 
when they do modify their behavior, it's possible for this to 
make a difference.
    Again, together with NIDDK, this study is continuing. 
Further questions we are exploring include whether these 
interventions will, in subsequent years, as we follow these 
individuals, translate into a reduction of cardiovascular 
events, of eye changes, of all of the kidney changes, of all of 
the very important sequelae of diabetes. The potential 
significance of this study--I don't think it can be 
overemphasized.
    If these behavioral interventions are in fact capable of 
producing a 71 percent decrease in diabetes in this older age 
group, where the risk is the highest, the consequences for 
quality of life or our healthcare system may be enormous and 
could translate, as has also been a theme here, into the next 
challenge: To educate the health providers and the public and 
to achieve compliance.
    Senator Harkin. But therein lies, of course, this is not 
your area, but for us, as policymakers lies a problem. That is 
Medicare doesn't reimburse for anything like that. Medicare 
reimburses for surgery or whatever later on, but not for the 
kind of interventions you're talking about.
    Dr. Hodes. Well, again, as I expressed, we at NIH feel our 
role is to develop the evidence base that will then inform 
policy makers.
    Senator Harkin. Well, we should be informed on that and 
quite frankly, I need to get what you just told me, Dr. Hodes, 
I need to get in a nice short form and with some of the data 
that you have, this could be very helpful. If it is that 
startling, 71 percent, then it seems to me that, just really 
informs us as to what we ought to be doing to change how we use 
Medicare for reimbursements.
    That is pretty startling; I've never heard this before.
    Dr. Rodgers. We'd be happy to provide you with that.
    Senator Harkin. Can you help us with this too?
    Dr. Rodgers. Absolutely. One interesting aspect about this, 
as Dr. Hodes recognized and commented upon, is that after the 
study is over, we have a follow on study to actually see 
whether, in fact, this intervention will have persistent, 
sustained beneficial effects. From a cost effective analysis, 
the original cost of the study has already been paid as these 
people continue to show positive benefits.
    This spreads the cost over a number of years in terms of 
cost effectiveness. So as we envision the follow on to these 
studies, we're really doing the economic analysis to provide 
you and your committee members with additional cost 
effectiveness and outcome data.
    Senator Harkin. Well I really want to get my hands on this. 
I want to get it better in my own head as to what this study, 
how you did it, what the results were, what some of the data 
show. So if you could provide that, I would sure appreciate it.
    Dr. Hodes. Dr. Rodgers and I will certainly work on that.
    [The information follows:]

           Department of Health and Human Services,
   National Institute of Diabetes and Digestive and Kidney 
                                                  Diseases,
                                  Bethesda, Maryland, May 17, 2007.
Hon. Tom Harkin,
U.S. Senate, Committee on Appropriations, Labor, HHS, Education 
        Subcommittee, Washington, DC.
    Dear Mr. Fatemi: Enclosed please find information about the 
Diabetes Prevention Program (DPP) clinical trial, in follow-up to my 
discussion with Senator Harkin and National Institute of Aging 
Director, Dr. Richard Hodes, at the Senate Appropriations Committee 
Theme Hearing on the Burden of Chronic Disease, April 20, 2007.
    The enclosures include a three page synopsis which focuses on the 
aspects of the research that were discussed at the hearing, and also 
provides some updates on related, more recent work, and on our efforts 
to translate these important results. Also included are the New England 
Journal of Medicine article that first reported the central DPP 
findings, NIDDK press releases issued regarding that result and 
subsequent developments, information on the Small Steps, Big Rewards 
program of our National Diabetes Education Program, and an NIA-prepared 
summary of some non-DPP studies that also show the value of diet and 
exercise interventions in elderly populations.
    Please let me know if you would like additional information.
            Sincerely yours,
                                     Griffin Rodgers, MD., M.A.C.P.

Enclosures
                 The Diabetes Prevention Program (DPP)
    The Diabetes Prevention Program was the first major, randomized, 
multi-site clinical trial to demonstrate that type 2 diabetes could be 
prevented or delayed in individuals at high risk for developing the 
disease. Led by the National Institute of Diabetes and Digestive and 
Kidney Diseases (NIDDK), with support from the National Institute on 
Aging (NIA) to allow inclusion of a significant number of participants 
over age 60, it was conducted in 3,234 people with impaired glucose 
tolerance (IGT)--now commonly known as pre-diabetes. This three-year 
trial compared three preventive approaches: standard medical advice 
about diet and exercise, intensive lifestyles modification aimed at 
losing 5 percent to 7 percent of body weight through diet and a 
moderate, consistent increase in physical activity (e.g., walking 5 
days a week for 30 minutes a day), and treatment with metformin, an 
oral drug commonly used to treat individuals who already have type 2 
diabetes. The goal of the study was to determine if it is possible to 
stave off progression to type 2 diabetes in the estimated 54 million 
American adults who do not yet have the full-blown disease, but whose 
risk factors put them on the path to developing it.
    Major Findings.--As reported in the February 7, 2002, issue of the 
New England Journal of Medicine, the DPP demonstrated that the 
lifestyle intervention reduced risk for type 2 diabetes by a dramatic 
58 percent. The metformin intervention reduced risk by 31 percent. 
These interventions worked in all ethnic and racial minorities studied 
and in both men and women. Participants over 60 years of age responded 
particularly well to the lifestyle intervention, showing a 71 percent 
risk reduction, whereas both metformin and the lifestyle intervention 
were similarly effective for the younger participants (ages 25 to 44) 
and for participants who were very obese.
    Public Health Campaigns Launched Based on DPP Findings.--Based on 
the DPP findings, in 2002 the National Diabetes Education Program 
(NDEP)--which is sponsored by the NIH and the CDC with over 200 private 
partners--launched a new campaign called ``Small Steps. Big Rewards. 
Prevent Type 2 Diabetes.'' This educational campaign emphasizes the 
effectiveness of a healthier lifestyle in preventing the disease. The 
campaign includes: lifestyle change tools for the public similar to 
those used in the DPP; a health care provider's tool kit; participation 
of businesses and consumer-based programs as partners in diabetes 
prevention; and messages and materials for a national public awareness 
campaign including TV, radio, and print public service announcements. 
Subsequently, tailored campaigns were developed with materials directed 
toward the African American, Hispanic/Latino American, American Indian 
and Alaska Native, and Asian American and Pacific Islander populations.
    In 2005, the NDEP reached out to older adults at risk for type 2 
diabetes with the campaign, ``It's Not Too Late To Prevent Diabetes. 
Take Your First Step Today,'' and developed tailored materials for 
seniors to motivate them to make modest lifestyle changes to prevent 
the disease. The most recent undertaking of the NDEP is a new 
educational campaign on gestational diabetes mellitus (GDM), which also 
builds upon the prevention message of the DPP. GDM is a form of the 
disease that occurs during pregnancy endangering both the mother and 
the offspring and placing them at risk of developing type 2 diabetes at 
a later point in life.
    Translational Research Efforts.--An NIDDK initiative focused on 
``Translational Research for the Prevention and Control of Diabetes and 
Obesity'' supports studies to translate recent advances in the 
prevention and treatment of diabetes and obesity into clinical practice 
for individuals and communities at risk. Several studies supported 
under this initiative involve communities with large minority 
populations disproportionately burdened by type 2 diabetes and obesity, 
and focus on translating and tailoring the positive prevention message 
of the DPP for ``real-world'' settings. Examples of studies in the area 
of diabetes prevention are developing interventions to promote physical 
activity; testing integrated primary care and web-based intervention on 
preventing diabetes in adolescents at high-risk for developing type 2 
diabetes, testing the effectiveness of a healthful lifestyle 
intervention designed to reduce behavioral and clinical risk factors 
for type 2 diabetes in pregnant and postpartum African American and 
Latino women; and a family-based intervention, for families with at 
least one member who has type 2 diabetes, to help the whole family 
learn how they can adopt healthy lifestyles that are known to reduce 
risk for diabetes or its complications and better utilize existing 
community resources. In particular, two NIDDK translational research 
grants are currently supporting a pilot project in which YMCA staff 
deliver the DPP lifestyle intervention at YMCA Centers. If the program 
proves to be effective, the YMCA organization will explore ways to 
expand the program to its 2,617 centers nationwide. Preliminary data 
from this project are extremely promising.
    Other Important DPP Results.--Since the 2002 publication of the 
landmark DPP findings, important new results have continued to flow 
from analyses of the original DPP data and samples and from a follow-up 
study of participants in the DPP, the DPP Outcomes Study (DPPOS). These 
include:
    Genetic Variant Linked to Type 2 Diabetes.--A genetic analysis of 
DPP participants who did and did not go on to develop type 2 diabetes 
has confirmed that a version of the gene TCF7L2 is the most important 
genetic risk factor for the disease. Importantly, researchers showed 
that even this serious genetic risk does not make type 2 diabetes 
inevitable: the lifestyle intervention was protective, whether or not 
participants had this genetic risk factor.
    DPP Lifestyle Intervention Reduced Incontinence.--In addition to 
delaying or preventing diabetes, losing a modest amount of weight 
through dietary changes and increased physical activity reduced the 
occurrence of urinary incontinence in women with pre-diabetes. In the 
National Health and Nutrition Examination Survey 2001-2002 sample, one 
out of three women with diabetes or prediabetes levels reported weekly 
or more frequent episodes of urinary incontinence. As reported in the 
February 2006 issue of Diabetes Care, the DPP lifestyle intervention 
was particularly effective in reducing episodes of stress 
incontinence--leakage of small amounts of urine during physical 
movement, such as coughing, sneezing, and exercising.
    Diabetes Eye Changes Occur Earlier Than Previously Recognized.--
Previous studies have not accurately defined when type 2 diabetes 
begins, so it was not known if diabetic eye damage begins during pre-
diabetes, when blood glucose levels are higher than normal but not yet 
in the diabetes range. DPP investigators found diabetic retinopathy in 
nearly 8 percent of pre-diabetic participants. These findings suggest 
that retinopathy--which often leads to blindness--is starting earlier 
and at lower glucose levels than previously thought. They also 
reinforce the benefits that could be gained if patients with newly 
diagnosed type 2 diabetes were screened for retinopathy so that vision-
preserving therapies might be applied in a timely manner.
    Future Directions.--The Diabetes Prevention Program Outcomes Study 
(DPPOS) is investigating the durability of the effects of the DPP 
interventions in preventing or delaying type 2 diabetes, and how the 
intervention impacts the development of cardiovascular disease and 
other complications of diabetes. Cardiovascular disease accounts for 
two thirds of diabetes deaths. While rates of cardiovascular disease 
are increased two- to four-fold in diabetes, they are also increased by 
about 50 percent in pre-diabetes. Rates of heart attack, stroke, 
cardiovascular death and other diabetes complications will be 
ascertained through this follow-up study to determine the value of the 
DPP interventions in preserving health and limiting morbidity in people 
with pre-diabetes. In addition, translational research efforts have 
been initiated to develop more cost-effective methods of achieving the 
lifestyle change that delayed or prevented diabetes, and better methods 
to identify those with prediabetes.
    Diabetes Costs and DPP Cost-Effectiveness.--According to the 
American Diabetes Association, the per capita annual cost of health 
care for people with diabetes was $13,243 in 2002, while health care 
costs for people without diabetes amounted to $2,560 that year (Diab 
Care 26:917-932, 2003). An estimated 54 million Americans are at risk 
for type 2 diabetes. Nearly 21 million Americans already have diabetes, 
of which 90 to 95 percent is type 2 diabetes. The overall cost of 
diabetes--direct medical plus indirect economic cost--in the United 
States was estimated at $132 billion in 2002.
    A cost-effectiveness model estimates that the DPP lifestyle 
intervention would cost society about $8,800 and metformin would cost 
about $29,900 per quality-adjusted life-year saved over the lifetime of 
a patient--costs that are within the range that are typically 
acceptable for health care interventions (Ann Intern Med 142: 323-332, 
2005). The cost-effectiveness data will be reanalyzed in 2008 based on 
data from the DPPOS, which will follow participants' weight and 
diabetes onset for 5 additional years. If the intervention proves to be 
durable in its effect, it will greatly increase the estimated cost-
effectiveness. Preliminary DPPOS weight data are particularly promising 
in the older subgroup of participants.
    According to 2005 estimates, more than 6 million of those who have 
diabetes are undiagnosed--many of them elderly. Much larger numbers of 
those with pre-diabetes are also undiagnosed. A new Medicare benefit 
beginning in 2005 paid for diabetes testing, which may help identify a 
larger pool of people who can benefit from the DPP intervention.

       OTHER BENEFITS OF LIFESTYLE INTERVENTIONS IN OLDER ADULTS

    The National Institute on Aging has several studies which suggest 
that physical exercise may prevent physical disability, including 
impaired mobility, in both healthy and frail older adults. To develop 
definitive evidence, NIA and grantee researchers have developed the 
Lifestyle Interventions and Independence in Elders (LIFE) study, a 
clinical trial testing the effects of a physical activity program 
versus a health education program among older Americans. A successful 
pilot study (LIFE-P) completed in 2005, demonstrated that a structured 
physical activity improved 400-meter walking ability and speed in 
participants (ages 70-89 years) who were at an identified risk for 
mobility disability.
    Other studies have examined the protective benefits of diet and 
exercise on cognition. For example, in one recent study, increased 
vegetable consumption was found to reduce risk of cognitive decline in 
women. In another, certain mental exercises were found to help older 
individuals maintain their cognitive abilities for up to 5 years. These 
kinds of interventions hold promise to help preempt disease and 
disability and help personalize health care.
  --Physical activity or exercise as a possible lifestyle factor 
        involved in maintaining cognition and preventing cognitive 
        decline has been identified from epidemiological studies of 
        humans in groups or in large populations. Recent examples 
        include:
    --Higher levels of long-term physical activity in older women were 
            strongly associated with better cognitive performance and 
            less cognitive decline [Weuve et al., 2004].
    --Older women with higher levels of baseline physical activity were 
            less likely to develop cognitive decline [Yaffe et al., 
            2001].
    Encouraging results from several NIA-funded clinical studies show 
that aerobic exercise has a short term positive effect on some areas of 
cognition.
    --A meta-analysis of exercise interventions indicated robust but 
            selective effects of physical activity on cognitive 
            function in older adults, with the largest fitness-induced 
            benefits occurring for executive control processes 
            [Colcombe & Kramer, 2003].
    --Research comparing older adults with high levels of aerobic 
            fitness to older adults with low levels of aerobic fitness 
            revealed declines in size of several brain cortical regions 
            with age but that the losses were substantially reduced as 
            a function of cardiovascular fitness [Colcombe et al., 
            2003].
    --A small randomized trial of 6 months duration demonstrated that 
            older adults who received aerobic training (walking) showed 
            substantial improvements in performance on tasks requiring 
            executive control compared with anaerobically trained 
            (stretching & toning exercises) adults [Kramer et al., 
            1999].

    Senator Harkin. Well it would be very helpful. I'm running 
out of time, but Dr. Rodgers, there's one other, a couple of 
other things I wanted to ask you.
    We talked about adult diabetes, how about juvenile 
diabetes, type 1. I understand you and Dr. Fauci's Institute 
are working together on ways to prevent juvenile diabetes, any 
progress?
    Dr. Rodgers. That is right. We have a number of studies 
conducted in collaboration with the National Institute of 
Allergy and Infectious Diseases. There are large consortia. The 
Allergy and Infectious Disease Institute has what's called the 
Immune Tolerance Network with the goal of preempting autoimmune 
diseases early on with a variety of drugs similar to the type 
that Dr. Katz mentioned to you. We want to see if, at the very 
first step of the autoimmune disease, one could use these 
antibodies or other forms of therapy to interrupt the 
autoimmune response in type 1 diabetes and thereby preserve the 
beta cell function.
    One of the benefits that really derive from genetic studies 
is that we know which patients are at risk of developing 
diabetes. We can account for about 50 percent of that genetic 
risk currently. We're looking for the other genetic 
associations, but it is this Immune Tolerance Network, in a 
number of Institutions here in the United States and also in 
Canada, that is really looking very carefully at ways of 
interrupting this immune response very early to preserve beta 
cell function and thereby diminish or prevent these 
complications.
    Our Institute is involved in a number of trials as well. I 
mentioned continuous glucose monitors. Through our clinical 
trials network called TrialNet, we're also looking at a number 
of interventions early on.
    One other approach to try to determine the early aspects of 
the disease actually relates to a question you asked Dr. Katz a 
moment ago, about studies that, for example, might look for 
triggers of autoimmune diseases. I think you raised that 
question.
    We have a study that is ongoing, called the TEDDY study, T, 
E, D, D, Y. This is a study that looks at the environmental 
triggers of diabetes of youth by following kids who are at high 
risk for developing type 1 diabetes. The plans now are to 
follow them from birth through 15 years of age.
    The idea is that we will have them come in periodically to 
obtain urine, blood, stool samples, to take very careful looks 
at their dietary history, vaccine history, so that we can 
determine the trigger that sets the immune system against their 
pancreas and actually leads to autoimmune type 1 diabetes.
    This is a fairly long study; 15 years we have to follow 
them. We estimate the study won't be completed until the year 
2021. It is very important if it turns out that it is a virus; 
for example, some people speculate that it could be a 
rotavirus, or intestinal virus. Then, a vaccine in susceptible 
individuals may be highly effective.
    We're also, at the same time, looking at the other genetic 
determinants, susceptibility genes, because as I indicated, we 
know about 50 percent of the responsible factors but we want to 
look for the others.
    Senator Harkin. I understand, very good. Well, this has 
been a very, very informative meeting and I appreciate it very 
much.

                             LOW BACK PAIN

    Oh, there's just one last thing I have to ask you, Dr. 
Katz. Low back pain, how could I have forgotten to ask you 
about low back pain. Talk about epidemics. I want to ask you 
this, have you ever heard of, or come across, approaches, 
studies, done by Dr. John Sarno in New York City? Does that 
name ring a bell at all with you?
    Dr. Katz. It does not.
    Senator Harkin. Well, I was recently at the hospital for 
special surgery up in New York and I'm not going to go into my 
own history of that, but having had some problems with low back 
pain in the past. Again, a friend of mine in the medical field 
said that I should see this Dr. Sarno, who has written a couple 
of books. He's a medical doctor.
    I forget where he went to school, Harvard, Yale, one of 
those fancy schools and he had been in Kenya for some years and 
he was interested in why certain people had back pain and 
certain people didn't and he came to the conclusion in one of 
his books that of disc problems, collapsed discs.
    If that was really the problem, if that was really the 
cause of back pain then 9 out of every 10 adults would have 
back pain because all of our discs, as we age, degenerate, but 
he started finding people with horribly degenerated discs who 
had no back pain whatsoever.
    There are others who had herniated discs and had back pain. 
So he didn't think that was much of a correlation. So he began 
to look at other things.
    Well, to make a long story, short, when I was at the 
hospital for special surgery, I'd mentioned this and they've 
all heard of this guy. They knew who he was, but his approach 
was that most, with the exception of, what do you call it when 
your thing narrows up?
    Dr. Katz. Spinal stenosis.
    Senator Harkin. Spinal stenosis, yes. With the exception of 
that or cancer of the spine or other things that would, MRIs, 
for example. With that exception he felt that most low back 
pain was caused by stress through his studies.
    I really want you to look at this because his theory--and 
now I'm going beyond my knowledge base here--was that stress 
leads to lack of oxygen in muscles and when the muscles have a 
lack of oxygen, that affects your nerves and that once you 
start to have back pain due to stress, then that leads you to 
have more stress. This hit home with me because once you start 
having lower back pain, you start saying I can't do this. I 
can't move that way. I've got to be careful and then that gets 
you more stressed out. It seems to feed on itself.
    So his theory was that the first avenue of approach in 
dealing with back pain, with the exception of really physical, 
structural problems that you have, is to examine the stress 
level of people and to try to get them off of the stress, that 
type of thing. Either through drugs or whatever, just whatever 
other interventions might be applicable there so it wasn't 
surgery, or steroid injections, that type of thing. So I just 
bring that up, if anyone in your Institute could take a look at 
that.
    Dr. Katz. We will.
    Senator Harkin. I would appreciate that. I'm very intrigued 
by it and he seems to be a very knowledgeable doctor and has 
done some interesting research.
    Dr. Katz. I think his points about pain are very 
generalizable, as we talked about with fibromyalgia. Chronic 
pain syndromes cause depression and it feeds on itself.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Harkin. Sure it does, exactly. Well, I just wanted 
to bring that up. I made a note on that one to ask you about 
that one before you left.
    Dr. Katz. Thank you.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

               Questions Submitted by Senator Tom Harkin

                                 SODIUM

    Question. Dr. Nabel, salt is widely recognized as a significant 
cause of high blood pressure, which, in turn, is a significant cause of 
heart attacks and strokes. Please provide the Subcommittee with 
detailed information on what the NHLBI is doing to achieve its goal of 
reducing the general public's consumption of sodium, including any 
efforts to find acceptable salt substitutes.
    Answer. The NHLBI supports an extensive portfolio of research 
projects on the causes of cardiovascular disease and on strategies to 
prevent and manage it. This includes research on salt and its role in 
development of high blood pressure. Recent studies continue to support 
the recommendations of the U.S. Dietary Guidelines regarding 
consumption of salt and sodium. Of particular relevance are NHLBI-
funded clinical trials which found that blood pressure can be lowered 
by following a particular eating plan--called the Dietary Approaches to 
Stop Hypertension (DASH)--that emphasizes fruits, vegetables, whole 
grains, and fat-free or low-fat milk and milk products with a reduced 
content of saturated fat, trans fat, and cholesterol. The DASH eating 
plan is lower in sodium than the typical American diet, and research 
has shown that stricter limitations in sodium intake produce even 
greater blood pressure lowering.
    The NHLBI focuses national attention on high blood pressure and 
reduction of salt and sodium intake through its ``Preventing and 
Controlling High Blood Pressure: Mission Possible'' effort. Recently 
the Institute, in collaboration with the Centers for Disease Control 
and Prevention, the American Heart Association, and the Cardiovascular 
Health Council, assembled and made available a variety of tools based 
on the Mission Possible materials for use by State health departments 
in their public education programs. One key component of the Mission 
Possible program is the DASH eating plan, and the DASH fact sheet was 
the mostly frequently used document by the States in their outreach 
activities. The NHLBI Mission Possible Web site features a variety of 
educational resources for use in program planning and implementation.
    The NHLBI has an extensive outreach and education program that uses 
lay health workers to engage communities in the prevention of heart 
disease and the promotion of healthy lifestyle behaviors. As respected 
members of their communities and effective educators, lay health 
workers serve as extenders of care between health care settings and 
patients/families, especially within underserved and low-resource 
communities. A heart health curriculum for training lay health workers 
has been developed for use particularly in high-risk population 
subgroups such as African Americans, Latinos, and American Indian/
Alaska Natives and Filipinos. It is designed to build community 
capacity to engage in heart disease prevention and health promotion 
activities. Sessions of the curriculum address the major sources of 
dietary sodium (e.g., processed food, ``fast'' food, restaurant food) 
and provide instruction on how to read nutrition facts labels to 
compare the amounts of sodium in foods. Rather than promote use of 
``salt substitutes,'' the sessions focus on ways that individuals can 
develop their own alternatives to salt based on cultural taste 
preferences.

                                  LAM

    Question. Dr. Nabel, I appreciate your assurances at the hearing 
that LAM remains a high priority for NIH despite the decision to end 
the LAM longitudinal study. Many LAM patients who have enrolled in NIH 
clinical studies remain confused about whether they will continue to be 
treated at the NIH clinical center. The website http://
patientrecruitment.nhlbi.nih.gov/LAM.aspx suggests that eligible 
patients will receive an evaluation at the center. Please clarify 
whether that is still the case.
    Answer. New subjects are being enrolled into the longitudinal study 
at the Clinical Center to screen for inclusion in the MILES study and 
for inclusion in translational research studies. Subjects are not being 
enrolled for longitudinal follow-up. This is a transitional situation 
to ensure access of LAM patients to studies while the LAM Foundation, 
in collaboration with NHLBI, updates its data base of physicians across 
North America with the interest and expertise required to provide 
optimal care for LAM patients. We are now updating the website to 
indicate that new participants are not being enrolled in a longitudinal 
study.

                          BLOOD CELL FORMATION

    Question. Dr. Rodgers, NIDDK supports research into basic 
mechanisms of blood cell formation and function, as they are intimately 
linked to determining the health risks of different diseases and in 
developing novel therapies for treatment. An example of this is the 
study of anemias of inflammation and chronic disease, which would 
greatly improve our understanding of chronic infection and immune 
activation, severe trauma, heart disease, arthritis, and diabetes. 
NIDDK held a workshop on this topic in 2006; what is NIDDK currently 
doing on this topic?
    Answer. The anemia of inflammation and chronic disease is very 
common and is a major cause of reduced red blood cell mass that often 
accompanies aging. It is characterized by a decreased availability of 
iron for support of red blood cell production, caused largely by 
acquired abnormalities in both iron absorption and release of iron from 
tissue stores.
    As you mention, the NIDDK convened a two-day workshop in May 2006 
that focused on this common form of anemia. The workshop featured 
current insights into the clinical presentation and underlying causes 
of this anemia. It also highlighted unanswered questions and promising 
new opportunities for basic and translational research. Based on 
scientific recommendations from this workshop, the NIDDK, in 
collaboration with other Institutes, plans to issue a Program 
Announcement in 2007 to encourage and promote research that will lead 
to advances in the detection, prevention, and treatment of the anemia 
of inflammation and chronic disease. The Institute is also preparing a 
Congressional Appropriations Committee Report on hematology research at 
NIDDK that will include this area of research.

                                  PKD

    Question. Dr. Zerhouni, it has come to my attention that, over 
recent years, certain ``coding errors'' have occurred regarding NIDDK's 
public disclosure of the amount of dollars allocated to specific 
research areas. My understanding is that these errors may have led the 
NIDDK to significantly inflate the actual amount of Federal funding 
that was allocated to polycystic kidney disease (PKD) research. For 
instance, the NIH has publicly reported that overall Federal PKD 
funding for fiscal year 2003 was $37.3 million. However, because of the 
presence of certain errors in the method of reporting, the actual 
fiscal year 2003 funding level may have been much lower. If upon 
further review the actual funding for fiscal year 2003 and other years 
is found to be substantially understated, this would present a very 
troubling development for the 600,000 Americans with PKD and the PKD 
research community in that they rely heavily on this funding for 
clinical trials that could lead to a treatment for PKD. My question is: 
What caused these ``reporting errors'' to take place, and what is being 
done to correct the situation? Would you please provide the 
Subcommittee with accurate funding levels for PKD research from fiscal 
year 2000 through fiscal year 2006, broken down by individual Institute 
and Center, specifically for NIDDK, NHGRI and NCRR?
    Answer. The NIDDK considers advancing PKD research a very high 
priority, and has built a strong portfolio of investigator-initiated 
research grants, research centers, and pivotal clinical studies. Driven 
by major advances in the field, NIH funding for PKD research has 
increased substantially over the past ten years. Your understanding 
that funding for certain years may have been lower than was reported is 
based largely on changes in reporting methodology instituted after 
fiscal year 2003 that changed how project dollars are attributed to the 
research related to PKD. Importantly, the changes do not imply a 
diminished commitment by the NIH to PKD research. The official NIH 
report for PKD research funding for fiscal years 2000 through 2006, by 
Institute and center, is:

                                            [In thousands of dollars]
----------------------------------------------------------------------------------------------------------------
                                                                  Fiscal year
                             -----------------------------------------------------------------------------------
             I/C                 2000        2001        2002        2003        2004        2005        2006
                                actual      actual      actual      actual      actual      actual      actual
----------------------------------------------------------------------------------------------------------------
NIDDK.......................     $15,166     $18,085     $24,586     $31,365     $32,579     $24,076     $30,202
NHGRI.......................  ..........  ..........  ..........       4,988         281         339         336
NCRR........................  ..........         659         814         924         956         977       1,281
                             -----------------------------------------------------------------------------------
      Total.................      15,166      18,744      25,400      37,277      33,816      25,392      31,819
----------------------------------------------------------------------------------------------------------------

    With respect to the above data, the NHGRI beginning in fiscal year 
2004 changed its methodology used to calculate funding amounts on 
projects relevant to PKD. The change that NHGRI made for reporting PKD 
research impacted only one large project. Previously, 100 percent of 
its funding had been reported as PKD research. As a result of the 
methodology change in fiscal year 2004, only five percent of the 
project is now reported as PKD research. This change reduced the total 
NIH funding figure from fiscal year 2003 to fiscal year 2004 by more 
than $4 million.
    In fiscal year 2005, the NIDDK changed its methodology and began to 
report funding for only the directly-relevant portion of large research 
projects, such as clinical trials and research centers, instead of 
reporting 100 percent of the project amounts. For example, for large 
kidney disease clinical trials, the NIDDK reported only the proportion 
of funds that were related to the number of PKD patients who 
participated in such trials. This change in methodology resulted in 
additional downward adjustments of funding figures.
    In an effort to be completely transparent regarding the 
methodological change that occurred, the NIH has presented this 
information, along with detailed grant listings, to the Polycystic 
Kidney Disease Foundation.
    It is important to re-emphasize that these changes do not imply a 
diminished commitment to PKD research; rather, they reflect a change in 
the methodology used to determine the reported funding.
                                 ______
                                 
            Questions Submitted by Senator Daniel K. Inouye

                     DIABETES AND NATIVE HAWAIIANS

    Question. Dr. Rodgers, the prevalence of diabetes is much higher 
among Native Hawaiians compared to other members of society. Native 
Hawaiians and other Pacific Islanders aged 20 years or older are more 
than two times as likely to have diagnosed diabetes as whites after 
adjusting for population age differences. In 2004, Native Hawaiians had 
the highest mortality rate as a result of diabetes mellitus in the 
State. What efforts has your NIDDK taken to understand diabetes in 
Native Hawaiians?
    Answer. The NIDDK is continuing its support of diabetes research 
and education efforts for Native Hawaiians and other Pacific Islanders 
disproportionately burdened by type 2 diabetes. The NIDDK is supporting 
the Diabetes Prevention Program (DPP) Outcomes Study, which is 
following the Native Hawaiian and other participants in the original 
DPP clinical trial to assess the long-term effects of the 
interventions. The DPPOS has a site in Hawaii. The landmark DPP 
multicenter clinical trial demonstrated that people at increased risk 
for type 2 diabetes can prevent or delay disease onset through 
relatively modest changes in diet and moderate physical activity.
    The NIDDK is also supporting a study that is expected to provide a 
better understanding of dietary and behavioral factors related to 
excess body weight and diabetes in Native Hawaiians. This information 
can help to identify preventive strategies to modify lifestyle factors. 
The National Center on Minority Health and Health Disparities supports 
a Hawaii EXPORT Center, which aims to reduce or eliminate diabetes 
related health disparities in Native Hawaiians and other Pacific 
Islanders through grass roots partnerships to foster research, research 
capacity building, and community outreach. The National Heart, Lung, 
and Blood Institute supports a study examining heart disease in Native 
Hawaiians; diabetes is a major contributor to heart disease.
    We are also intensifying research on type 2 diabetes in children, 
which is an emerging public health issue that predominantly affects 
minorities. To determine the prevalence and incidence of both type 1 
and type 2 diabetes in children, the NIDDK is supporting the CDC-led 
SEARCH for Diabetes in Youth epidemiological study. One of the six 
nationwide SEARCH centers is in Hawaii. SEARCH is providing important 
information on how to characterize childhood diabetes.
    To disseminate the positive results of the DPP, the NIDDK and CDC 
co-sponsored National Diabetes Education Program developed the ``Small 
Steps. Big Rewards. Prevent Type 2 Diabetes'' educational campaign, 
which includes materials tailored for Pacific Islanders. The NIDDK also 
supports research efforts to translate advances in the prevention and 
treatment of diabetes and obesity into clinical practice for 
individuals and communities at risk.

                              HEPATITIS B

    Question. Dr. Rodgers, 1 out of 10 Asian Americans are affected 
with hepatitis B, which, along with hepatitis C, is associated with an 
increased incidence of liver cancer. In fact, liver cancer is the only 
cancer experiencing continuing increases in mortality. It is my 
understanding that the best treatment protocols for hepatitis B and C 
are really effective only in approximately half of the cases. In your 
testimony, you discuss the use of biomarkers, which may allow for early 
screening and diagnosis of the disease. Dr. Rodgers, how can biomarker 
technology be used to diagnose and treat those patients who will 
respond to the treatments and thus spare the expense, not to mention 
the harsh side effects, of treating patients who will not respond?
    Answer. Though new treatments are now available for chronic 
hepatitis B that are effective in the majority of patients, the only 
effective therapy for chronic hepatitis C remains a standard 
combination of antiviral drugs (peginterferon alfa and ribavirin). 
Unfortunately, only about half of patients with chronic hepatitis C 
respond to this antiviral therapy.
    To understand and improve upon this response rate, the NIDDK is 
engaging in several ongoing studies focused on such issues as 
identifying biomarkers to assess response to antiviral therapy for 
hepatitis C in different study populations. These investigations 
include the Study of Viral Resistance to Antiviral Therapy of Chronic 
Hepatitis C (Virahep-C) in African American and Caucasian American 
adults; the trial on Peginterferon and Ribavirin for Pediatric Patients 
with Chronic Hepatitis C (Peds-C); and the trial on Hepatitis C 
Antiviral Long-term Treatment against Cirrhosis (HALT-C). Through these 
NIDDK-supported efforts, researchers are identifying potential 
biomarkers to predict hepatitis C treatment response, such as gene 
products induced by interferon, which modulates the body's immune 
defense system.
    In addition to these ongoing NIDDK-supported efforts, other 
promising potential venues for research to develop biomarkers for 
various diseases include biomarker initiatives sponsored by the NIH and 
a new Biomarkers Consortium administered by the Foundation for the NIH.

                         ASTHMA AMONG HAWAIIANS

    Question. Dr. Nabel, about 4.3 percent of Hawaiians have asthma. 
Native Hawaiian adults had a much higher prevalence of asthma compared 
to other adults in Hawaii--71 percent higher than the total State 
prevalence. In Hawaii, children have the highest rates of asthma. 
Recently, the CDC funded the Hawaii Department of Health (HDOH) to 
establish a lung function monitoring program and asthma intervention 
for children from eight schools in Hilo, Hawaii, near the Kilauea 
Volcano. Currently, HDOH is finishing an assessment of the health 
effects that may be associated with potentially toxic volcanic 
emissions from the Kilauea Volcano. How can the NIH contribute to a 
greater understanding of asthma among Hawaiians?
    Answer. The NHLBI supports a research project titled ``Does Shared 
Decision-Making Improve Adherence in Asthma?'' for which one of the 
study sites is in Hawaii. Results from this study can be expected to 
contribute importantly to our understanding of effective ways to 
improve asthma control and reduce asthma burden among Hawaiians. The 
project will evaluate two different educational interventions for 
clinicians to use with their asthma patients and it will compare 
results among three different study centers--Hawaii; Oakland, 
California; and Portland, Oregon. Thus, data from the study will 
provide critical insights into ethnic and cultural differences in 
asthma management. The NHLBI will work with the investigators to 
disseminate the findings, giving guidance to clinicians and patients 
alike about new ways to reduce the burden of asthma.
    NHLBI-supported research on the origins of asthma includes projects 
that explore the interactions between genetics, exposures to 
environmental factors such as allergens and respiratory tract 
infections, and the development of the immune system. Several 
epidemiologic studies are investigating the impact of exposures to air 
pollutants on the development of asthma and the progression of asthma 
severity in children. All of these studies include children of diverse 
ethnicity from throughout the United States. Data from these studies 
will be available to the research community to examine and compare 
asthma development in children from Hawaii.
                                 ______
                                 
              Questions Submitted by Senator Arlen Specter

                          ALZHEIMER'S DISEASE

    Question. Dr. Hodes, several years ago, a vaccine for Alzheimer's 
disease was touted as a potential cure for the disease. What progress 
has been made toward creating a vaccine for Alzheimer's disease? Does a 
vaccine remain a likely treatment for Alzheimer's Disease? What other 
progress has been made to address this devastating disease?
    Answer. The vaccine approach that was used in a clinical trial for 
treatment of Alzheimer's disease had previously been shown to 
successfully reduce deposits of beta-amyloid (the major component of 
the plaques that develop in the brains of people with AD) in mice, and 
to improve performance on memory tests in these animals. Unfortunately, 
preliminary clinical trials in humans had to be stopped because of 
potentially life-threatening brain inflammation that occurred in some 
participants. The pharmaceutical industry and NIA-supported 
investigators are continuing to refine this strategy in animal models 
of AD, and hope to find ways to maintain the therapeutic effects of the 
vaccine while reducing unwanted side effects. For example, NIA 
investigators are studying several novel immunogens that show promise 
for future AD vaccines that can reduce brain beta-amyloid load without 
the adverse inflammatory side effects of the original vaccine. In 
addition, several pharmaceutical companies have recently obtained 
permission from the FDA to test several of these new strategies for 
safety in early stage clinical trials.
    Another promising approach is passive immunization, in which 
antibodies that can bind directly to beta-amyloid are injected into a 
patient's body. Several studies over the past few years have indicated 
that passively administered anti-beta-amyloid antibodies can 
effectively remove beta-amyloid peptides from the brain. One passive 
immunization approach utilizes Intravenous Immunoglobulin or IVIg. IVIg 
contains naturally-occurring antibodies against beta-amyloid, and 
preliminary studies in humans have shown that IVIg may improve 
cognition. In addition, research has demonstrated that IVIg increased 
levels of anti-beta-amyloid antibodies in plasma and promoted clearance 
of beta-amyloid from cerebrospinal fluid. The NIA is funding a Phase 
III clinical trial of IVIg through the Alzheimer's Disease Cooperative 
Study (ADCS), a large consortium of clinical research sites throughout 
the country, to test whether IVIg is useful clinically for treating AD.
    NIA investigators continue to study other promising approaches to 
delaying or preventing the onset of AD. Such approaches focus on a 
number of health, lifestyle, and environmental factors that could make 
a difference in preventing or delaying the onset of AD. For example, 
NIA investigators are studying whether lowering cholesterol and high 
blood pressure may decrease a person's risk for AD. Too much insulin in 
the blood (which happens as a result of insulin resistance) may 
encourage inflammation and oxidative stress, which are thought to 
contribute to the damage seen in AD. Another promising area of research 
focuses on highly active molecules called free radicals. Some 
population and animal studies suggest that antioxidants from dietary 
supplements or food may provide some protection against this damage 
(called oxidative damage), but other studies show no effect.
    NIA investigators are also studying the impact of regular social 
engagement and intellectual stimulation as strategies to prevent or 
delay the onset of AD.
    NIA continues to conduct and support a broad portfolio of research 
to develop new therapeutic approaches and prevention strategies for AD.

                             HEALTHY AGING

    Question. Dr. Hodes, in your written testimony you note that 
certain simple lifestyle changes may induce beneficial effects on 
cognition and overall health as we age. Could you please expand on your 
statement by giving some specific examples of these simple lifestyle 
changes?
    Answer. Knowing how the brain ages provides important information 
on which to base strategies for maintaining and enhancing cognition 
through biological and behavioral interventions. For example, it was 
recently shown that some new neurons form in adulthood in certain 
regions of the human brain, contrary to prevailing beliefs. This 
advance presents the possibility that methods could be found to 
compensate for neuron loss and cognitive decline resulting from disease 
or traumatic injury. Behavioral strategies also are being developed to 
maintain cognitive function. For example, several NIA studies suggest 
that physical exercise may prevent physical disability, including 
impaired mobility, and perhaps cognitive decline, in healthy and frail 
older adults. To develop definitive evidence, NIA and grantee 
researchers developed the LIFE (Lifestyle Interventions and 
Independence in Elders) study, a clinical trial testing the effects of 
a physical activity program vs. a health education program among older 
Americans. A successful pilot study (LIFE-P) completed in 2005 showed 
both feasibility and positive preliminary data, permitting design and 
consideration of a large-scale clinical trial.
    Other research indicates that higher levels of long-term physical 
activity in older women were strongly associated with better cognitive 
performance and less cognitive decline. Older women with higher levels 
of baseline physical activity were less likely to develop cognitive 
decline. Encouraging results from several NIA-funded clinical studies 
show that aerobic exercise has a short term positive effect on some 
areas of cognition. For example, a meta-analysis of exercise 
interventions indicated robust but selective effects of physical 
activity on cognitive function in older adults, with the largest 
fitness-induced benefits occurring for executive control processes. 
Research comparing older adults with high levels of aerobic fitness to 
older adults with low levels of aerobic fitness revealed declines in 
size of several brain cortical regions with age but that the 
degeneration was substantially reduced as a function of cardiovascular 
fitness. A small randomized trial of 6 months duration demonstrated 
that older adults who received aerobic training (walking) showed 
substantial improvements in performance on tasks requiring executive 
control compared with an aerobically trained (stretching & toning 
exercises) adults.
    NIA co-sponsored the Diabetes Prevention Program (DPP), which was 
led by the National Institute of Diabetes and Digestive and Kidney 
Diseases. The DPP was the first major, randomized, multi-site clinical 
trial to demonstrate that type 2 diabetes could be prevented or delayed 
in individuals at high risk for developing the disease. This three-year 
trial compared three preventive approaches: standard medical advice 
about diet and exercise; lifestyles modification aimed at losing 5 
percent to 7 percent of body weight through diet and a moderate, 
consistent increase in physical activity (e.g., walking 5 days a week 
for 30 minutes a day); and treatment with metformin, an oral drug 
commonly used to treat individuals who already have type 2 diabetes. 
Participants over 60 years of age responded particularly well to the 
lifestyle intervention, showing a 71 percent risk reduction in the 
incidence of diabetes, as compared to groups treated with metformin or 
standard medical advice. Another observation of these data is that the 
lifestyle intervention had increasingly greater impact with increasing 
age (from age 25 to over 60) while the metformin treatment had 
progressively less impact with increasing age.

                              NEUROIMAGING

    Question. In 2004, you launched a neuro-imaging program to develop 
techniques that will help researchers identify Alzheimer's much 
earlier, and also assist in developing new treatments. What's been 
accomplished and when do you expect to complete this project?
    Answer. The Alzheimer's Disease Neuroimaging Initiative (ADNI) is a 
5-year public-private partnership with the Foundation for NIH and 
industry that will determine the ability to detect brain and biological 
changes before memory decline and other symptoms appear, allowing the 
effectiveness of drugs to be evaluated at the earliest possible time. 
The study is planned to continue through 2009. ADNI recently completed 
recruitment of 800 older adults for the study. Approximately 200 
cognitively normal older people will be followed for 3 years, 400 
people with mild cognitive impairment will be followed for 3 years, and 
200 people with early AD will be followed for 2 years. Researchers will 
compare neuroimaging, biological (analyzed from samples of blood and 
cerebrospinal fluid), and clinical information from the participants, 
looking for correlations among the data to develop standards for 
tracking the progression of memory decline.
    Knowledge gained from these scans and other tests may lessen the 
time and cost of testing drugs and to bring treatments to patients much 
sooner.
    Among ADNI's early achievements is the creation of a publicly 
accessible database available to qualified researchers worldwide. To 
date, over 200 scientists have requested access to the database, which 
is available through the ADNI Web site, http://www.loni.ucla.edu/ADNI. 
It contains thousands of magnetic resonance imaging (MRI) and positron 
emission tomography (PET) scan brain images.
    The project's principal investigator, Dr. Michael Weiner at the 
University of California, San Francisco, will present a progress report 
on ADNI in June 2007 in Washington, D.C., during the Alzheimer's 
Association International Conference on the Prevention of Dementia. 
Other findings will be presented by a dozen other ADNI scientists. 
Among their findings:
  --A University of California, San Diego, study found that semi-
        automated analyses of MRI and PET images could detect early 
        changes in the thickness of the cerebral cortex that could add 
        to other information on brain anatomy to predict a person's 
        conversion from mild cognitive impairment to Alzheimer's.
  --A study at Banner Alzheimer's Institute, Phoenix, compared changes 
        over six months between PET scan images from healthy older 
        adults, people with mild cognitive impairment and people with 
        Alzheimer's. The study found that brain images could be 
        correlated with patients' symptoms and that comparisons of 
        images made at different clinical sites were valid, which is 
        necessary to document before using PET scans in future clinical 
        trials.
  --A Mayo Clinic, Rochester, Minn., study found that use of an 
        anatomical model of a brain (or phantom) can be used to monitor 
        performance of MRI scanners, making sure they remain accurate 
        over time. ADNI will produce MRI images on 800 volunteers using 
        80 MRI scanners over five years. Use of the phantom could 
        improve reliability of ADNI results and of those subsequent 
        clinical trials.
  --A University of Pennsylvania, Philadelphia, study compared analyses 
        of samples of cerebrospinal fluid collected from study 
        participants and analyzed at seven laboratories. The study 
        evaluated differences within and between the labs' performance. 
        This validation study will help ensure that ADNI methods for 
        measuring biomarkers are accurate and comparable across 
        laboratories.

                           DRUGS FOR CHILDREN

    Question. Dr. Katz, on April 11, 2007, I met with Mrs. Lori Todaro 
and a group of mothers from PA. Mrs. Todaro's son, Anthony, has been 
participating in an NIH protocol since 2003 and his been receiving his 
medication through that protocol. I understand that patients like Mrs. 
Todaro's son, once they are no longer participating in the NIH 
protocols, will need to find other ways to obtain and pay for these 
drugs. In many instances, the drugs are not covered by the insurance 
companies because they are approved for specific illnesses, but not 
approved for use for other disorders (in this case periodic fever 
syndrome). What can NIH do to ensure that these children continue to 
receive drugs for the treatment of their disease after the protocols 
have ended?
    Answer. All patients who are treated at the NIH are part of a 
clinical protocol--whether it is an observational (natural history) 
study, or a trial to test an experimental therapy. Patients who meet 
the criteria for our clinical studies--whether they are children or 
adults--are given the appropriate medications for the duration of their 
participation. Once a study has ended, however, the NIH is not able to 
continue to provide medications since this is beyond the agency's 
authority. Nonetheless, we fully understand the challenges that 
patients and their families face when needed medications are no longer 
available through a clinical study. In light of this, we encourage 
patients and their physicians to work with insurance companies to 
arrange appropriate coverage.

                       OSTEOARTHRITIS INITIATIVE

    Question. Dr. Katz, in your written testimony you note the 
implementation of an osteoarthritis initiative. I understand that this 
initiative is a public-private partnership between the NIH and private 
industry that seeks to improve diagnosis and monitoring of 
osteoarthritis. Please give us some specifics on the initiative and 
update us on the progress being made.
    Answer. The NIAMS places a high-priority on studies to identify 
risk factors and biomarkers of disease, in an effort to facilitate the 
early identification of signs and symptoms, and to develop 
interventions that are more effective. To this end, the Institute will 
continue its commitment to a novel public-private partnership to 
improve prevention of osteoarthritis (OA), or degenerative joint 
disease. The Osteoarthritis Initiative (OAI) is a long-term effort, 
developed with support from numerous NIH components, private sector 
sponsors, and with the participation of the Food and Drug 
Administration, to create a publicly-available research resource to 
identify and evaluate biomarkers of OA for use in clinical research. 
The study has close to 4,800 participants who are at high risk for knee 
OA, or with relatively early disease. At present, clinical data from 
approximately half of the OAI participants are available for use in 
research projects, as are images (both x-ray and magnetic resonance) 
from more than 350 study subjects.
    Over the next 5 years, the OAI will provide an unparalleled, state-
of-the-art longitudinal database of images and clinical outcome 
information, as well as biological specimens such as blood and urine 
samples, available to researchers worldwide to facilitate the discovery 
of biomarkers for development and progression of OA. To date, there are 
over 500 registered users of the OAI clinical dataset, and over 30 
users of the related images. In this effort, a biomarker would be a 
physical sign or biological substance that indicates changes in bone or 
cartilage. Today, 35 million people--13 percent of the U.S. 
population--are 65 and older, and more than half of them have 
radiological evidence of OA in at least one joint. By 2030, an 
estimated 20 percent of Americans--about 70 million people--will have 
passed their 65th birthday and will be at increased risk for OA. Thus, 
the OAI provides a critical research resource to the scientific 
community at a time when greater numbers of Americans are affected by 
OA.

                          MUSCLE DEGENERATION

    Question. Dr. Katz, I understand that your Institute, together with 
the Neurology Institute, funded research showing that a common blood 
pressure drug reduces muscle degeneration in mouse models of Duchenne 
muscular dystrophy. Could you please describe that research and any 
implications that it may have on human treatments for Duchenne muscular 
dystrophy?
    Answer. NIH-supported researchers at Johns Hopkins University 
recently demonstrated that the weakness and muscle wasting that occur 
in a mouse model of Duchenne muscular dystrophy could be delayed by six 
to nine months of treatment with losartan, a drug approved by the Food 
and Drug Administration for the treatment of high blood pressure. In 
addition to its known mechanism of action, the researchers demonstrated 
that another action of losartan is to block the effects of transforming 
growth factor beta (TGF-?), a protein present in the diseased muscle 
that limits regeneration and promotes the replacement of muscle with 
fibrous scar-like tissue (fibrosis). The dystrophic mice treated with 
losartan exhibited increased muscle mass and strength and decreased 
fibrosis in comparison to untreated dystrophic mice. Additional 
clinical research is needed in order to further examine the use of 
losartan as a potential treatment for individuals with Duchenne 
muscular dystrophy. However, this discovery is an excellent example of 
how a drug already approved for one disease may have a potential 
therapeutic application for another disease.

                       HEART DISEASE IN CHILDREN

    Question. Dr. Nabel, it is my understanding that heart defects are 
the most common type of birth defect. What efforts are being made by 
your Institute to address heart disease in children and in infants?
    Answer. The NHLBI has a long history of supporting research in 
congenital heart disease, which dates back to 1949 when the first grant 
was awarded to explore surgical treatments for ``blue babies.'' Today 
the Institute continues to recognize the public health importance of 
congenital heart disease, and is addressing the problem through an 
extensive portfolio of basic, translational, and clinical research, as 
well as efforts to educate the public about the importance of pediatric 
research.
    To encourage translational research, the NHLBI established the 
Specialized Centers of Research in Pediatric Cardiovascular Disease in 
1994 with the purpose of encouraging a clinical focus to bench 
research. In 2003, the NHLBI revamped the program to encourage more 
clinical research and renamed it the Specialized Centers of Clinically 
Oriented Research in Pediatric Heart Development and Disease. The NHLBI 
increased its investment to accommodate the costs of clinical research, 
and funded 4 centers conducting cutting-edge research on the causes, 
treatments, and outcomes of congenital cardiac malformations.
    In 2001, the NHLBI launched the Pediatric Heart Network (PHN), 
which heralded a new era in congenital heart disease clinical 
investigation. With 8 principal sites and several additional auxiliary 
sites, the PHN has undertaken 7 studies in its first 5 years, a 
remarkable track record for any clinical network. One of these studies 
is a comparison of two surgical procedures for newborns who have such 
severe congenital heart disease that they require lifesaving surgery 
during the first week of life. This study, which began recruitment in 
2005, represents the first time in the history of the specialty that a 
new surgical procedure has been compared systematically to the standard 
procedure. The success of the PHN was widely acknowledged when it was 
chosen in 2006 as a network that exemplified ``best practices'' through 
the NIH Roadmap program Inventory and Evaluation of Clinical Research 
Networks. One of its practices that merits special mention is its 
function as an active and nurturing training ground for fellows and 
junior faculty interested in clinical research.
    Through the PHN and other activities, NHLBI is also taking the lead 
in educating patients and families about research on children with 
congenital heart disease and, more broadly, on pediatric research in 
general. The PHN's public web site, www.PediatricHeartNetwork.org, 
provides information to parents (and community physicians) about 
participating in research as well as about PHN studies, and offers 
direct access to NHLBI's pediatric cardiologist and pediatric cardiac 
study coordinator when parents have questions. Also through the PHN, 
the NHLBI is funding a documentary resource for families and 
researchers that will guide families, in simple language, through the 
research process, and tell the stories of a diverse group of parents 
about their participation in research. Although resources similar to 
this exist for specific disease conditions, no other resource that 
applies to pediatric research generally, or that is accessible to 
families from all walks of life, is currently publicly available.

                        WOMEN AND HEART DISEASE

    Question. Dr. Nabel, I am concerned that while heart disease is the 
leading cause of death of women in the United States, but many women do 
not perceive heart disease as a top health risk. I understand that the 
NIH Heart Truth Campaign is raising women's awareness of heart disease. 
What results have you seen so far from the Heart Truth Campaign as it 
celebrates its 5th anniversary?
    Answer. The Heart Truth campaign, sponsored by the NHLBI, continues 
to reach millions of women across the country, raising awareness about 
heart disease--the #1 killer of women. The Red Dress, introduced by the 
NHLBI as the national symbol for women and heart disease awareness, 
serves as a powerful reminder for women to talk with their doctors 
about heart disease and to take action to lower their risk.
    Considerable progress has been made since the campaign began five 
years ago. Awareness among women that heart disease is their leading 
cause of death grew from 34 percent in 2000 to 55 percent in 2005. In 
2007, 57 percent of U.S. women recognized the Red Dress as the national 
symbol for women and heart disease, up from 39 percent in 2006 and 25 
percent in 2005.
    The Heart Truth campaign partners, including corporations, other 
government agencies, the U.S. fashion industry, health professionals, 
nonprofit and women's organizations, and media outlets, have helped to 
extend the campaign's reach. Over 350 locally sponsored Heart Truth 
events, many in high-risk areas, have been held since the campaign 
began. Media outreach and partnership development have resulted in an 
impressive 1.5 billion media impressions to date, including 486 million 
from Fashion Week 2007. Since 2003, The Heart Truth and Red Dress 
symbol have been promoted on 109 million product packages and in 
newspaper advertising inserts with a combined circulation of 509 
million.
    The campaign launched ``The Heart Truth Champions'' program in 
April 2006, which recruited health advocates and educators in local 
communities to increase awareness about women and heart disease. To 
date, the champions have conducted more than 60 community events to 
raise awareness of women's heart disease and screen for heart disease 
risk factors. The Heart Truth has also formed partnerships with leading 
national organizations and media outlets representing women of color, 
and is engaging in national and local activities, including a faith-
based initiative, to reach these women. Moreover, the NHLBI has awarded 
grants to three national organizations for women of color that have 
significant membership and outreach potential on the regional and local 
levels. The grantees will implement a variety of national, regional, 
and local heart health awareness activities based on The Heart Truth 
and on two NHLBI-sponsored community-based minority outreach programs--
With Every Heartbeat is Life and Su Corazon, Su Vida.

                                DIABETES

    Question. Dr. Rodgers, I understand that several lines of research 
are showing promise in addressing type 1 and type 2 diabetes. I noted 
the recent publication of findings suggesting that adult stem cells may 
be useful in treating new onset diabetes. Could you please describe 
progress being made in this area and explain why this treatment appears 
to only be useful in new onset diabetes? What progress has been made in 
using stem cells to make insulin-producing cells?
    Answer. Indeed, there have been encouraging results from studies of 
several approaches to treating diabetes. One reason why a particular 
approach might be successful only in new onset type 1 diabetes is that 
these patients often have some insulin-producing capacity remaining. 
This is sometimes referred to as the ``honeymoon phase'' of the 
disease. In theory, a treatment might prolong this honeymoon phase, 
reducing or eliminating the need for insulin administration either 
permanently or temporarily. Some approaches we are investigating, for 
example, seek to interfere with the autoimmune destruction of the 
insulin-producing beta cells of the pancreas, which could conceivably 
allow for their re-growth. Other recent studies include a private 
company's reported generation of insulin-producing cells from human 
embryonic stem cells (Stem Cells Express, published on-line May 17, 
2007), and a similar, private foundation-supported finding using 
umbilical cord (``adult'') stem cells (Cell Proliferation, 40:367). The 
Type 1 Diabetes Special Statutory Funding Program supports the NIDDK-
administered Beta Cell Biology Consortium (BCBC), which has a goal of 
facilitating interdisciplinary approaches that will advance 
understanding of the development and function of beta cells. BCBC 
investigators are therefore probing the pathway and signals involved in 
producing beta cells from both adult and embryonic stem cells. It is 
hoped that new insights about the development and differentiation of 
stem cells, obtained through BCBC studies, will contribute to research 
progress in making or regenerating insulin-producing beta cells.

                          ARTIFICIAL PANCREAS

    Question. I understand that some efforts are underway toward the 
development of an artificial pancreas as a way to help people better 
manage their diabetes. This device would continuously measure the 
glucose levels in the body and then dispense doses of insulin based on 
those measurements. Can you comment on the role the National Institutes 
of Health has played in the development of this technology and why, 
from your perspective it might be exciting?
    Answer. The NIH is playing an important role in the development of 
an artificial pancreas, a device that would essentially ``close the 
loop'' between the measurement of glucose levels in the body and the 
therapeutic delivery of insulin. For example, the NIH supported the 
development of continuous glucose monitors recently approved or under 
consideration for approval by Food and Drug Administration (FDA). These 
monitors are an essential first step in making an artificial pancreas. 
Moreover, an NIH initiative led by the National Institute of Child 
Health and Human Development (NICHD) is testing glucose monitoring 
technologies for use in children. We are also working with researchers 
and industry, as well as sister agencies, to overcome scientific 
obstacles to achieving the goal of an artificial pancreas. For example, 
in December 2005, the NIDDK, the Juvenile Diabetes Research Foundation 
International, and the FDA hosted a key workshop with academic and 
industry representatives to examine challenges and opportunities for 
artificial pancreas development. The NIH now participates in a new FDA-
led interagency working group to provide scientific information that 
can assist FDA in its decision-making regarding new artificial pancreas 
technologies. The new technologies are exciting because they could 
revolutionize care for people with diabetes. They could enable precise 
control of blood glucose to help avert complications, and also reduce 
the likelihood of dangerous episodes of low blood sugar--thereby 
improving patients' health and well-being.

                          DIABETIC RETINOPATHY

    Question. I understand that diabetic retinopathy is the leading 
cause of blindness in working age adults. Can you tell the Committee 
about progress and potential research opportunities to prevent this 
complication of diabetes?
    Answer. We believe that the NIH is making substantial progress 
toward the prevention and treatment of diabetic retinopathy. A landmark 
NIDDK-supported clinical trial in people with type 1 diabetes, the 
Diabetes Control and Complications Trial (DCCT), showed that intensive 
control of blood sugar levels reduced risk for developing diabetic 
retinopathy by over 70 percent. It is estimated that patients on 
intensive therapy who maintain near normal blood sugar for life could 
gain, on average, an extra eight years of sight. For people who have an 
advanced stage of diabetic retinopathy, laser surgery and appropriate 
follow-up care can reduce the risk of blindness by 90 percent. This 
progress has had significant positive impacts on patients' health and 
quality of life. The National Diabetes Education Program, co-sponsored 
by the NIDDK and the Centers for Disease Control and Prevention, is 
spreading the word about the vital importance of blood glucose control 
in preventing complications, such as retinopathy in people with 
diabetes. The National Eye Institute's (NEI) Diabetic Eye Disease 
Public Education Program, part of the National Eye Health Education 
Program, seeks to increase awareness among people with diabetes that 
diabetic retinopathy is treatable, and that when caught in time, it 
need not lead to blindness.
    We are now working to identify additional strategies for prevention 
or treatment. For example, the NEI leads the Type 1 Diabetes Special 
Funding Program-supported Diabetic Retinopathy Clinical Research 
Network. This is a nationwide network of eye doctors and researchers 
supporting clinical trials and studies of diabetic eye diseases. 
Examples of potential therapeutic agents currently being tested for 
diabetic eye disease by this network are drugs that inhibit excessive 
new blood vessel growth in the eye--a process called angiogenesis. The 
NIH also supports a pipeline to propel progress in drug development by 
facilitating research to identify promising therapeutic targets and 
agents in the laboratory. It also generates animal models that mimic 
human complications of diabetes. Moreover, the NIH tests promising 
agents in these animal models, and tests promising therapies in people. 
Lastly, results from the NIDDK's Diabetes Prevention Program clinical 
trial suggest that diabetic retinopathy develops even earlier than was 
previously recognized. Diabetic retinopathy was found in people with 
pre-diabetes, and researchers are now examining whether the 
interventions that were successful in delaying progression from pre-
diabetes to diabetes will also slow development of retinopathy. 
Continued research on prevention and early detection of this 
complication is critically important.

                                OBESITY

    Question. There has been an alarming increase in obesity in this 
Nation, especially in youth. This Committee has recognized and 
highlighted this trend with initiatives focusing on wellness, physical 
activity, and nutrition. In your testimony you mentioned a school based 
intervention study regarding obesity called the HEALTHY trial. Please 
expand upon your description of this trial and give us a time line for 
this important research.
    Answer. The HEALTHY trial, which was launched in August 2006, will 
investigate whether a concerted, integrated program in middle schools 
will help reduce the prevalence of obesity-related harbingers of type 2 
diabetes. The trial enrolled sixth graders and is following them 
through the end of eighth grade. The majority of children enrolled in 
the study are from minority groups disproportionately burdened by type 
2 diabetes, including Hispanics and African Americans. Half of the 42 
enrolled schools are receiving the intervention, which consists of 
improving cafeteria lunches, vending machine offerings, and physical 
education, as well as promoting behavioral change. HEALTHY will examine 
changes in the students' body mass index, as well as changes in their 
blood glucose and blood insulin levels, to determine if the 
interventions are effective in reducing these risk factors for type 2 
diabetes.
    The timeline for this study is: (1) recruitment and baseline data 
were collected in the first semester of sixth grade (Fall 2006); (2) 
the intervention will be administered from the second semester of sixth 
grade (Winter 2007) through the second semester of eighth grade (Spring 
2009); and (3) the final data collection will be performed in the 
second semester of eighth grade (Spring 2009). Data analysis is 
expected to continue through 2010.

                    EARLY DETECTION OF LIVER CANCER

    Question. Dr. Rodgers, it is my understanding that liver cancer is 
the only cancer experiencing continuing increases in mortality and 
treatment options for physicians remain limited. However, with early 
detection the chances for recovery are much increased. In your written 
testimony, you noted the Biomarkers Consortium, a public/private 
partnership to accelerate the development of biomarkers to facilitate 
accurate and early diagnosis of disease. Would the development of liver 
cancer biomarkers be within the scope of the Biomarkers Consortium? 
What other ailments might be targets for biomarker development?
    Answer. The NIDDK and other NIH Institutes and Centers, such as the 
National Cancer Institute (NCI), are keenly interested in efforts to 
develop biomarkers for early detection of liver cancer, which occurs 
largely in individuals with chronic liver diseases such as hepatitis B 
and C. The Foundation for the NIH (FNIH) administers the Biomarkers 
Consortium. This Consortium--along with other biomarker development 
initiatives sponsored by the NIH--is a promising potential venue for 
research to develop and qualify biomarkers for various diseases. 
Approval of specific projects for the Biomarkers Consortium will be 
made by members of its Executive Committee, which includes 
representatives from the FNIH, the NIH, the Food and Drug 
Administration, the Centers for Medicare and Medicaid Services, 
pharmaceutical companies and trade groups, and non-profit advocacy 
groups. This public-private partnership could decide to pursue 
biomarkers for aspects of liver disease, such as identifying early 
forms of liver cancer.
    NIH research on liver diseases is guided in part by recommendations 
contained in the Action Plan for Liver Disease Research, which was 
developed by the NIH in 2004 in response to congressional interest. The 
Action Plan includes research goals to develop and validate biomarkers 
for the early detection of hepatocellular carcinoma (HCC), a common 
form of liver cancer. In a recent review of progress toward achieving 
the Action Plan's research goals, external experts highlighted advances 
being made toward developing biomarkers for early detection of HCC in 
high-risk individuals. These advances are facilitated by programs such 
as the NIDDK-supported Hepatitis C Antiviral Long-term Treatment 
Against Cirrhosis (HALT-C) trial and the NCI-sponsored Early Detection 
Research Network.
    The NIDDK is also pursuing biomarker development for other 
conditions within its mission. For example, one of the first projects 
being undertaken by the Biomarkers Consortium is focused on discovering 
new biomarkers of type 2 diabetes and pre-diabetes, based on an NIDDK 
pilot study. The Institute also supports efforts to develop biomarkers 
for diseases of the kidney, genitourinary tract, and digestive, 
hematologic, endocrine, and metabolic systems, as well as for obesity.

                         CHRONIC KIDNEY DISEASE

    Question. Dr. Rodgers, it has come to my attention that recent 
studies have shown that cardiovascular disease is the number one cause 
of death for people with Chronic Kidney Disease (CKD). I understand 
that the rate of death from cardiovascular disease may be between 10 to 
30 times greater in the 20 million Americans currently suffering from 
some form of CKD than in the general population. What are you, in 
cooperation with NHLBI, doing to address this growing problem? What 
else could be done? Is there a coordinating committee?
    Answer. The NIDDK and NHLBI recognize the problem of cardiovascular 
disease (CVD) in people with chronic kidney disease (CKD), and are 
working together to address it. For example, the NIDDK is supporting a 
kidney study as part of NHLBI's Genetic Epidemiology Network of 
Arteriopathy (GENOA) study. The project is assessing the kidney 
function in a subset of GENOA's patients to learn more about the 
genetic factors that influence kidney function in people with high 
blood pressure.
    Another example of collaboration between the NIDDK and NHLBI on CVD 
and CKD is an upcoming meeting entitled ``Scientific Forum of Chronic 
Kidney Disease (CKD): Opportunities from Observational Cohort 
Studies.'' This scientific workshop will examine the opportunities to 
study CVD and CKD that are presented by a number of NHLBI-supported 
cohort studies. These studies include the Jackson Heart Study, the 
Coronary Artery Risk Development in Young Adults (CARDIA) Study, and 
the Cardiovascular Health Study (CHS). The meeting will be held June 4, 
2007. A goal of this meeting is to enhance collaboration between 
investigators to maximize information from cohort studies supported by 
NHLBI in order to better understand the relationship between CVD and 
CKD. We are hopeful that this meeting will aid our pursuit of promising 
future research directions.
    It has long been known that high blood pressure, elevated blood 
fats, high blood sugar, tobacco use, and physical inactivity are all 
important, traditional risk factors for cardiovascular disease in 
patients with chronic kidney disease. However, the relative importance 
of each of these risk factors is not known compared to nontraditional 
risk factors such as chronic inflammation, infection, oxidative stress, 
and elevated levels of homocysteine. To address this gap in knowledge, 
the NIDDK is funding the Chronic Renal Insufficiency Cohort (CRIC) 
Study. CRIC is a prospective study of over 3,000 people with mild to 
moderate CKD that is examining nontraditional risk factors for 
progression of CKD and development of end-stage renal disease. 
Importantly, it is also examining nontraditional risk factors for CVD 
and measures of CVD progression in these patients.
    The statutory Kidney, Urologic, and Hematologic Diseases 
Interagency Coordinating Committee, which is Chaired by the Director of 
NIDDK's Division of Kidney, Urologic, and Hematologic Diseases, 
encourages cooperation, communication, and collaboration among all 
Federal agencies involved in kidney disease research. Members share 
information and advice about ongoing, new, and planned activities and 
identify potential areas of collaboration. Members include 
representatives from the CDC, VA, IHS, FDA, and other Federal agencies.

                          SUBCOMMITTEE RECESS

    Senator Harkin. Well listen, thank you all very much, very 
informative. I enjoy these sessions. I think they inform us, or 
me anyway and my staff and those who actually work in this 
area.
    So I thank you all and thank you for being here this 
morning. Thank you for the work you do. The subcommittee will 
stand in recess to reconvene at 1:30 p.m., Monday, May 7 in 
room SD-116.
    [Whereupon, at 11:32 p.m., Friday, April 20, the 
subcommittee was recessed, to reconvene at 1:30 p.m., Monday, 
May 7.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              


                          MONDAY, MAY 7, 2007

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 1:31 p.m., in room SD-116, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senator Harkin.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENT OF DR. JEREMY BERG, DIRECTOR, NATIONAL 
            INSTITUTE OF GENERAL MEDICAL SCIENCES

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. The Committee will come to order.
    This is the subcommittee's fourth hearing on the National 
Institutes of Health this year. We've heard from nine 
institutes, today we'll hear from four more: The National 
Institute of General Medical Sciences, the National Human 
Genome Research Institute, the National Library of Medicine, 
and the National Institute of Biomedical Imaging and 
Bioengineering.
    We asked these four Institutes to appear together because 
they're all involved in expanding the frontiers of science. 
Unlike many of the institutes at NIH, none of these are charged 
with attacking a particular disease. Instead, they develop 
cutting-edge tools and resources that benefit research on all 
diseases--things like sequencing the human genome, combining 
huge, easily searchable databases, developing new imaging 
technology or basic research training.
    What I'd like to ask is if each of you could speak for 5 to 
7 minutes. Summarize the research that you've overseen over the 
past year or so, and give us a look ahead at the initiatives 
that you are planning for fiscal year 2008 and beyond.
    Senator Specter cannot be here today, but I will keep the 
record open for his opening statement, and any questions that 
he might want to submit.
    At the outset, I just want to thank each one of you for the 
work that you do in the Institutes that you direct, all that 
you're doing to improve people's health. We are grateful for 
your dedication and skill, each and every one of you, for so 
many years.
    I started these forums--these hearings, like this--I don't 
know if you've talked to any of your fellow Institute 
Directors, but I feel it's good to be able to get into these in 
a little bit more depth. Actually, the first person that 
started these in this room, and having them in this manner was 
Senator Lowell Weicker, and I was a freshman Senator at the 
time. I just thought they were great sessions for us to learn 
more in depth about what the Institutes are doing, and that's 
why we're doing it in this manner again.
    So, I've had, basically, four at a time, like this, and try 
to group them in some kind of a semblance of rationality of 
what the Institutes were doing.
    So, I'd like to, again, just kind of get into it. I'll have 
some questions when you finish, but I'd like to just go 
through, perhaps all the Directors once, I may even ask you a 
question in between, so we have kind of a free-flow, more than 
any structured kind of a presentation.
    So, I will start first with Dr. Jeremy Berg, Director of 
the National Institute of General Medical Sciences since 2003. 
He received his M.S. in Chemistry from Stanford, his Ph.D. in 
Chemistry from Harvard. His own research focuses on the way 
that proteins regulate gene activity.
    Dr. Berg, welcome and please proceed. By the way, all of 
your statements will be made a part of the record in their 
entirety.

                  SUMMARY STATEMENT OF DR. JEREMY BERG

    Dr. Berg. Well, thank you very much, Senator Harkin, both 
for your leadership and for this opportunity.
    NIGMS, the National Institute of General Medical Sciences, 
is often referred to as the ``basic science institute,'' 
because we support research on fundamental biological 
processes. As one measure of how successful this approach has 
been, NIGMS has supported a total of 62 Nobel Prize winners 
over the 45-year history of the Institute, including three this 
past year.
    The research that NIGMS has supported has also done things 
like enabling the Human Genome Project and contributed 
substantial, to the technology that led to the biotechnology 
industry, which current estimates indicate has created about 
200,000 jobs in the United States and has an annual revenue 
base in the United States of about $40 billion.
    The research that we support really depends on scientists 
working on the advances that others have made in the past, as 
all of our research does. One illustration of this, there's a 
handout which I think you have a copy of----
    Senator Harkin. Or, do I have it?
    
    

                                Figure 1

    Dr. Berg. Figure 1 reveals the so-called ``Central Dogma'' 
of molecular biology. This goes back to the 1960's, and shows 
the information flow from DNA, where the genetic information is 
stored, through RNA, and converted into proteins, which are the 
molecules that do most of the work in the body.

                             RNA VERSUS DNA

    Senator Harkin. What's the difference between RNA and DNA?
    Dr. Berg. Chemically, there's a very minor difference, 
there's one extra hydroxyl group in RNA. The major difference: 
is that DNA is very stable, and is present in the cell very 
robustly. RNA is used much more as a signal or a messenger, so 
the DNA information is translated to RNA, that's then used, and 
the RNA is degraded, in general, very rapidly. It is a way of 
sending a message out, and then the message is destroyed, so 
the new messages can----
    Senator Harkin. So, RNA exists for short periods of time?
    Dr. Berg. Most RNAs exist for just seconds or a few 
minutes, some much longer than that.
    But, as you'll see in one of the examples I've described, 
RNA is also very actively involved in many processes, some of 
which we're just beginning to understanding.
    Even though this idea has been around for 50 years or so, 
there are still lots of new discoveries, both bolstering it and 
adding new loops to this simple information diagram.
    The Nobel Prize last year in chemistry went to Roger 
Kornberg for determining the structure of RNA polymerase. This 
is something that's been known since the late 1960s, and is 
exactly how the information in DNA is converted into RNA. It 
was known that there was this very important and very 
complicated protein enzyme, RNA polymerase, that converts the 
information in DNA into RNA. See figure 2.



                                Figure 2

    It was known to be very complicated, and starting about 20 
years ago, Dr. Kornberg made it one of his missions in life to 
figure out what this enzyme looked like, in order to understand 
how it works. It is the key protein which collects information 
and figures out which genes should be turned on and which ones 
should be turned off.
    He was funded for a long period of time when he started on 
this quest, and I must say, personally, that I think a lot of 
people regarded it a sort of a Don Quixote-esque quest to go do 
something very important, but that had a very small chance of 
ever succeeding.
    Starting in 1999, he got the first real glimmers that he 
was going to succeed. Subsequently, he has been reporting more 
and more interesting structures, revealing the overall 
structure, which is incredibly complicated, and how it works--
both the chemical mechanism, and now more and more information 
about how it collects information from the outside, and from 
the other things within the cell.
    This really sets the stage for a much deeper understanding 
of gene regulation, a process that is fundamental to many 
aspects of health, and also a mechanism that is regulated in 
diseases like cancer and many others as well.
    The other Nobel Prize that we supported was in physiology 
and medicine to Andrew Fire and Craig Mello for something that 
was really much more of a discovery, something that was 
completely unanticipated, which is that RNA actually regulates 
itself. The discovery was the result of an experiment that 
turned out very differently than they thought, and they were 
clever enough to realize that there was something very 
interesting going on. It was an experiment that was predicted 
not to work, that worked. They followed that up, and discovered 
this process which we call RNA interference, or RNAi, which 
allows small pieces of RNA, that are either present in the 
cell, or introduced into the cell, to shut down genes in a very 
specific way. Again, this was something that was completely 
unanticipated.
    One measure of how important it is, is Fire and Mello's 
discovery was reported in 1998, and they won the Nobel Prize 
only 8 years later, which is incredibly fast on the Nobel Prize 
timescale. One, RNAi is a fundamentally important discovery, 
second, it's a very powerful research tool. See figure 3.



                                Figure 3

    As investigators are building on the work from the Human 
Genome Research Institute, one of the questions they are 
pursuing is, what does each gene do? RNAi gives a way for 
scientists to specifically go through and turn off one gene at 
a time in a given cell type, then see what happens. The tool 
just didn't exist before, and it has dramatically cut down the 
cost of doing this type of gene-by-gene analysis.
    The second really exciting thing about RNAi, is that it's 
immediately adaptable to new therapeutics, and there are a 
large number of different therapeutics being developed using 
RNAi. The most advanced is a treatment for macular 
degeneration, which is now in Phase II clinical trials. 
Basically, there's a specific RNA molecule that can be injected 
directly into the eye to shut down the expression of a 
particular protein, which blocks the process that underlies 
macular degeneration.
    There are many other areas that are being advanced with 
RNAi. One particularly exciting area is pandemic influenza. 
With RNAi, one of the challenges of planning for pandemic 
influenza is the virus has not yet--thank goodness--been 
transferred from birds into humans to a very large degree. If 
we have to wait for that to occur to develop medicine, or 
develop a vaccine, that puts in a lag-time which could be very 
devastating to the human population. With RNAi, we already know 
a lot about influenza viruses, and can find things which are 
common to all of the different influenza viruses, and 
potentially develop a therapy or a sort of a vaccine-like 
treatment that will be completely independent of the strain, 
some sort of a universal flu vaccine.
    Again, this is still very much in development, and there 
are lots of problems to be solved. The RNAi approach opens up a 
new avenue, which has the potential to save hundreds of 
thousands of lives, and billions of dollars to the world 
economy.
    In terms of the future, there are two important aspects. 
First off, although we can't anticipate and predict what new 
discoveries will be made, we can anticipate that they will 
occur. If you look at what's happened since the Central Dogma 
was first coined, on average about, every 5 years there's some 
new, revolutionary discovery that no one anticipated and that 
really changes the landscape of biomedical research. We still 
don't think we know all there is to know by any stretch of the 
imagination, so there will be new discoveries. I can't tell you 
what they will be, but I can tell you that they will exist.
    To foster those sorts of discoveries, NIGMS has been 
involved in two new programs: one is the NIH Director's Pioneer 
Award, which was started a few years ago as part of the NIH 
Roadmap; and more recently, the NIH Director's New Innovator 
Award, which was started this year, thanks to the funds that 
were provided in the joint resolution.
    The idea of these awards is really to encourage the 
scientific community to send forth their most creative ideas, 
really out of the box sorts of things, and have a home for 
funding some of those ideas. We want to push the sort of 
creative things that might be difficult to fund in the 
relatively conservative environment that we find ourselves in.
    The second thing that we're sure we're going to have to 
deal with is complexity. If you look at the last handout, even 
though the Central Dogma is relatively simple, it's occurring 
with, about 20,000 genes. There are many other modifications to 
the Central Dogma that we know occur, and all of these things 
take place in concert in each of thousands of different cell 
types in our body and respond to interactions from other cells 
and environmental signals. We need to find the sort of 
conceptual frameworks for dealing with systems that are this 
complicated. We know what the parts are now, but trying to 
understand systems or machines, this is complicated, really a 
daunting challenge.

                           PREPARED STATEMENT

    We have a program, Centers for Systems Biology, which is 
bringing together biologists, computer scientists, and other 
people who are accustomed to dealing with this sort of 
complexity to try to take the first baby steps to address this. 
Not only do we have to deal with complexity, but also 
variations from individual to individual, which are key to 
health and disease. With the information that's coming from 
NHGRI and other Institutes, we now are starting to know more 
and more about what sort of variability there is, and we're 
trying to stay ahead of the curve in developing conceptual 
frameworks and tools that will help us interpret this 
information when it becomes available.
    So, with that, thank you very much.
    [The statement follows:]

                 Prepared Statement of Dr. Jeremy Berg

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2008 President's budget request for the National 
Institute of General Medical Sciences (NIGMS). The fiscal year 2008 
budget includes $1,941,462,000.
    Throughout its 45-year existence, NIGMS has been a wellspring of 
discovery. The fundamental knowledge generated by NIGMS research 
impacts every other NIH component and has broad applications in the 
pharmaceutical and biotechnology industries. NIGMS contributes to the 
health of the biomedical research enterprise in other important ways, 
as well. A prime example is our cutting-edge research training program, 
which produces a substantial number of well-prepared new scientists. 
Their ideas and talents contribute to our growing knowledge base, 
allowing continued progress toward treatments and cures for countless 
diseases that rob us of friends, family, and years of productive life.

                     NURTURING INTELLECTUAL CAPITAL

    When discussing science and medicine, we often focus on compelling 
research advances and medical breakthroughs. But behind every ``what'' 
is a ``who,'' a creative individual asking and answering a crucial 
question--the brainpower driving scientific progress. NIGMS is 
steadfast in its commitment to nurturing and maintaining this 
intellectual capital through its significant support of investigator-
initiated research and research training.
    In the context of this opening statement, it has become habit to 
reference the past year's NIGMS-supported Nobel Prizes. Of course, this 
is a ritual I am extremely proud to continue by reporting that the 2006 
prizes in the two areas most relevant to biomedicine, physiology or 
medicine and chemistry, went to three NIGMS grantees. But I would like 
to go further, using the prize-winning research to show you how NIGMS 
support creates opportunities for major discoveries to happen.
    Two geneticists, Andrew Fire and Craig Mello, received the 2006 
Nobel Prize in physiology or medicine for their discovery of a gene-
controlling mechanism called RNA interference. Their breakthrough came 
about by surprise, when they had the keen insight to figure out why an 
experiment failed. Fire and Mello's seminal finding, made relatively 
recently in 1998, has dramatically transformed biomedical research and 
has already led to new treatments that are being tested in the clinic 
for a range of diseases.
    The 2006 Nobel Prize in chemistry is a very different story. In 
this case, the achievement resulted from painstaking persistence on a 
fundamentally important question. The prize went to a biochemist who 
refused to give up on a problem that even today would be perceived as 
ferociously difficult. Combining biochemical research with novel 
biophysical methods, Roger Kornberg captured a detailed, three-
dimensional snapshot of the enzyme that reads our genes. This work has 
deeply enriched our understanding of one of the most fundamental life 
processes: how DNA gets copied into RNA. While the mindset, creativity, 
and acumen were Kornberg's, decades of unwavering NIGMS support enabled 
him and a talented set of coworkers to pursue this groundbreaking 
accomplishment, which has had a significant impact on biomedical 
research.

                         TOOLS BREED INNOVATION

    To capitalize on creative ideas, scientists need tools as well as 
funding. These tools can take many forms, from new technologies to 
model organisms. Research with bacteria, yeast, insects, worms, and 
rodents continues to confirm that the basic operating principles are 
nearly the same in all living things, and that studies in other 
organisms yield important knowledge applicable to human health.
    Thus, we are no longer surprised to learn that a gene or a process 
in a mouse, a worm, or a fruit fly is the same, or very similar, as 
that in a person. Examples of high-impact research done using model 
organisms abound, including the 2006 Nobel Prize-winning discoveries, 
which were made in roundworms and yeast. A more recent study in 
roundworms showed how early cell damage contributes to the development 
of Huntington's disease. The researchers who did this work discovered 
that an error in how proteins fold leads to the massive protein 
clumping inside cells that typifies Huntington's disease. Because 
protein clumping is also linked to other neurological conditions such 
as Alzheimer's and Parkinson's diseases, it is likely that this work 
will have far-reaching implications.
    Along with essential new knowledge about life processes, health, 
and disease, basic research can yield technologies with direct medical 
relevance. A case in point is an unexpected discovery by bacteriologist 
Yves Brun. While studying bacteria to better understand cell division, 
he found that the organisms produce a remarkable, natural form of 
``superglue.'' Additional studies revealed that the bacterial glue is 
the strongest biological adhesive ever measured, capable of holding 
nearly 5 tons per square inch. What's more, it doesn't dissolve in 
water. Brun is now working to learn more about the properties of the 
natural glue, which could be an ideal candidate for a surgical 
adhesive.
    For a further demonstration of uncharted exploration as a powerful 
engine of discovery, consider the study of the three-dimensional 
structures of biological molecules. This research, which relies heavily 
on tools and expertise from the physical sciences, has been a prime 
source for the development of life-saving medications like those used 
to treat AIDS, many types of cancer, asthma, and several other health 
conditions. NIGMS has provided significant support for structural 
studies and other research at the interface of the biological and 
physical sciences. In addition, we continue to communicate and 
collaborate with Federal agencies focused on the physical sciences to 
maximize the benefit of our funding activities to the scientific 
community.
    Of course, technology is only useful if it is available and 
affordable to many bright minds across the country. Every investment 
NIGMS makes has this end goal in mind, and currently the Institute is 
supporting several databases, materials repositories, genetic and 
genomic tools, and other shared resources that provide vital 
information and equipment to thousands of biomedical researchers. The 
Institute's team science efforts in such areas as high-throughput 
protein structure determination (the Protein Structure Initiative), how 
genes affect individual responses to medicines (the Pharmacogenetics 
Research Network), and new approaches to significant and complex 
biomedical problems via collaborations among scientists from diverse 
fields (``glue grants''), have all matured to a level where the fruits 
of progress are being shared widely with scientists everywhere.

                        INVESTING IN THE FUTURE

    Perhaps the most important element in determining the future of 
biomedical research is providing young people with opportunities to 
develop an understanding of the scientific process and to become 
fascinated with the challenges and opportunities that scientific 
careers present. Who will make the discoveries that will drive research 
in the future? If we went back in time, could we have known that Fire, 
Mello, Kornberg, and many other unnamed scientists would have gone so 
far in advancing our understanding of key life processes?
    Some individuals can hardly avoid catching the science bug. Roger 
Kornberg grew up in a household dominated by science: His father, 
Arthur (also a long-time NIGMS grantee), shared the Nobel Prize in 
physiology or medicine when Roger was 12 years old. Roger took 
advantage of the many opportunities available to him and began learning 
about science at a very early age.
    Most people, however, do not grow up in such a rich scientific 
environment. Take Ryan Harrison, who caught the science bug a few years 
ago, while attending a Baltimore City public high school that has a 
large population of underrepresented minority students. Ryan, the son 
of a teacher and a former corrections officer, met Jeffrey Gray, a 
biophysicist at Johns Hopkins University, through an outreach program. 
Ryan spent 2 years working in Gray's laboratory and then came in 5th 
place in the Intel Science Talent Search, the most prestigious high 
school science competition in the country. He continues to pursue 
research as an undergraduate at Johns Hopkins, and we look forward to 
following his progress and achievements.
    In order to address the health needs of our Nation, we must tap the 
full diversity of the talent pool of our country to attract the best 
minds into research. NIGMS has been a pioneer in this arena through its 
programs that provide opportunities for underrepresented minorities to 
pursue scientific careers. We recognize that underrepresentation is a 
challenging and complex problem. Single interventions are unlikely to 
effect lasting, multidimensional changes in diversity. As these 
programs mature, we are committed to conducting and rigorously 
evaluating the effectiveness of a broad range of biomedical workforce 
diversity programs.
    Once scientists have embarked on their careers, we must continue to 
provide opportunities for them to contribute fully to biomedical 
research. An effort to do just that is the new NIH Pathway to 
Independence award, which facilitates the transition of highly 
promising postdoctoral scientists from mentored to independent research 
positions. NIGMS was delighted this year to receive, and fund, a 
healthy number of applications for this unique program. In addition, we 
continue to give special consideration to regular research grant 
applications from new investigators as another way to help them get a 
solid start.
    We also realize the need for scientists to be able to test 
unconventional, potentially paradigm-shifting hypotheses and use novel, 
innovative approaches to solve difficult technical and conceptual 
problems that impede scientific progress. Toward this end, we are 
developing a new grant program based primarily on the innovativeness 
and potential impact of a scientist's ideas. We will launch the program 
later this year and anticipate that it will serve as a model for other 
NIH institutes and centers. The design of this program has benefited 
from our experience with the NIH Director's Pioneer Award program, an 
intriguing experiment on how to fund scientific research that is part 
of the NIH Roadmap for Medical Research.
    Through the efforts I have described today, we hope to continue our 
strong record of identifying and supporting the talented and creative 
scientists whose work paves the way for future medical advances.
    Thank you, Mr. Chairman. I would be pleased to answer any questions 
that the Committee may have.

    Senator Harkin. Thank you very much, Dr. Berg. I've got 
some follow on things, but we'll move on through here.
    Dr. Francis Collins, has served as Director of the National 
Human Genome Research Institute since 1993, received his Ph.D. 
from Yale University, and his M.D. from the University of North 
Carolina School of Medicine. Dr. Collins has discovered 
numerous important disease genes, and is well known for his 
leadership from the beginning to the end of the Human Genome 
Project.
    Again, my thanks for your leadership in that area, but I 
continue to hear just glowing comments, last week, about your 
presentation to our group about a week and a half ago. It was 
just a great presentation.
    Welcome, again, Dr. Collins, to the committee, and please 
proceed.

STATEMENT OF DR. FRANCIS S. COLLINS, DIRECTOR, NATIONAL 
            HUMAN GENOME RESEARCH INSTITUTE
    Dr. Collins. Thank you, Senator Harkin, thank you for those 
kind comments about the event 10 days ago.
    I'm very happy to be here with my colleagues, as part of 
this hearing on Frontiers of Science, and ever since this 
Congress--led by your vision, Senator Harkin--got the Human 
Genome Project off the ground, we've had the privilege of 
working at that frontier. I'm pleased to report, we've made a 
lot of progress in the 4 years since the Human Genome Project 
completed all of its goals, in April 2003, famously ahead of 
schedule, and famously under budget--we've used that foundation 
to build a real future for personalized medicine.
    You're going to hear a lot more about exciting developments 
in that regard in the coming weeks and months, describing 
dramatic genetic discoveries for common diseases, with 
important public health consequences.
    Let me tell you about one that's particularly exciting for 
me. Just last week in Science magazine there were two reports 
about identifying genetic risks for heart disease, for heart 
attacks, specifically. These funded--one of them by the Heart, 
Lung and Blood Institute--are very important, because they scan 
the entire genome and identified a region that confers a 
substantial increased risk of heart attack in an area of the 
genome we had no idea was involved in this disease before.
    But stunningly, just a week before, my team and two other 
teams, who had been studying Type II Diabetes, the adult-onset 
form of diabetes, reported also in Science magazine, the 
identification of a total of 10 genes involved in that 
important disease, where as previously, only three had been 
known.
    Stunningly, one of the regions of the genome identified in 
the diabetes study appears to be the same one that is involved 
in heart attack. Nobody expected this. This is like winning the 
lottery 2 weeks in a row by picking the same number. It just 
shouldn't happen. After all, the genome is a big place. But 
instead, we've zeroed in on this place on chromosome 9, which 
must be a very important part of the genome in terms of its 
role in human health, and identified ways in which it can 
influence risk of diabetes on the one hand, and heart attack on 
the other. Everybody involved in these studies is scratching 
their heads, not having expected this outcome, but clearly 
we're onto something pretty important.
    Now this kind of discovery can open new doors to prevention 
and treatments. Take diabetes, for instances, where we sorely 
need that. Estimates are we spend $132 billion a year in the 
treatment of diabetes and its complications, as well as the 
consequences to the 21 million Americans who have this disease, 
as far as loss of work, and premature mortality and morbidity. 
Yet, we don't really understand that disease nearly as well as 
we need to, in terms of the precise molecular basis of what's 
going on.
    With this outpouring, now, of these 10 new gene variants, I 
would say, only three of which you might have guessed at, and 
the others are complete surprises--we can finally shine a light 
on this mysterious disease in a way that should, both offer us 
the chance to do better prevention, and we know prevention can 
work for diabetes. We know that if you identify the people at 
high risk, and get them into an exercise program, you can 
reduce their chance of becoming diabetic by as much as 58 
percent.
    We can also use these new discoveries to pinpoint pathways 
for which new drug therapies could be designed, instead of 
continuing the same process we have up until now, based upon 
what we knew about the disease, now we know so much more.
    How did this come about? Well, in the little handout, 
figure 4 and I hope it's somewhere there in your little pile. 
Okay, so this is a simple diagram that shows what it is that 
geneticists are doing now with common diseases, which we 
couldn't do before. 




                                Figure 4

    It looks very simple in this cartoon--basically, you 
identify people with the disease, the affecteds, as it were, 
and you identify controls, that is, people who clearly don't 
have the disease--and then you want to check, across the entire 
genome, places where there are difference in the spelling, 
``variants'' as we call them, and see, are there any out there 
that look like Variant B--where, in my color-coding here, the 
orange spelling of Variant B is more common in the 
``affecteds'' than the ``unaffecteds'' and that will tell you 
that Variant B may be a risk factor for that disease.
    Most of the variants in the genome aren't going to look 
like B, they're going to look like A, where there really isn't 
any difference, because most variation doesn't affect diabetes.
    But, the problem with this strategy was, until very 
recently, we didn't have the power to do this. Because, while 
this cartoon looks very simple, to do this right, you need 
1,000 or more affected individuals, and 1,000 or more 
unaffected individuals, and we thought you might have to check 
as many as 10 million different places in the genome in order 
not to miss the answer.
    Well, the HapMap came along, a project which I had the 
privilege of leading, as a natural follow-on the Human Genome 
Project, which basically built a catalogue about all of these 
variants, and figured out how they traveled in neighborhoods, 
so that you didn't have to check all 10 million if you chose 
wisely, you could choose a much smaller set, and they served as 
proxies for the ones that you didn't actually look at. That 
made it possible to do something which, 5 years ago, would have 
cost $10 billion, the study of diabetes that I just mentioned. 
Now we can do that for less than $1 million. I don't know too 
many areas of science where costs have come down by that kind 
of curve, in just 5 years.
    If you look at the next image figure 5, the next thing in 
your little packet, you can see what the consequences of this 
are starting to be, in terms of this are starting to be, in 
terms of discovery, so above the line are, in fact, major 
common diseases for which we have been learning about genetic 
factors involved, and you can see, as we sort of blow up the 
scale here, in the last 2.5 years, a lot of findings coming 
along, prostrate cancer, lupus, macular degeneration, 
inflammatory bowel diseases, Type 2 Diabetes, psoriasis, heart 
attack.




                                Figure 5

    I put bipolar disease on here, because in a publication 
tomorrow in a major journal, there will be a description of 
what happened to a group at the NIH, led by Dr. McMahon that 
applied this same strategy to looking at manic-depressive 
illness, and came up with a very surprising finding of a gene 
that appears to be involved in that disease, that maybe is even 
involved in the lithium pathway, which makes a certain amount 
of sense, but it's not a gene that anybody would have guessed 
that. I hear through the rumor mill, there are other studies of 
bipolar disease, also using this same new, very powerful 
strategy, discovering similar findings.
    So, this is really the year, where all of a sudden, we're 
going to learn a great deal about the genetics of common 
disease, with many consequences, and if you go to the last 
picture here, it's an attempt to show how that's going to play 
out in terms of the practice of medicine.
    The top part of the diagram, figure 6, which says, 
``Accelerated By Human Genome Project,'' is what's now 
happening--the ability to identify these genetic risk factors 
using the tools that have come out of this effort.




                                Figure 6

    What happens next, in the clinic, is going to be the 
ability, diagnostically, to predict who's at risk, and if you 
have an intervention that will reduce that risk, people will 
probably be interested, especially now that we're seeing the 
Genetic Information Nondiscrimination Act getting close to 
passage, finally----
    Senator Harkin. Finally.
    Dr. Collins [continuing]. Which will mean that people won't 
be afraid to take advantage of that information, as they have 
been in the past.
    We'll also be able to use these same tools for 
pharmacogenomics, this effort to identify the right drug at the 
right dose for the right person, knowing that we're all a 
little different there, too, the same tools can be used to 
figure out why that is.
    Perhaps most importantly in the long term, these gene 
discoveries shine a bright light on pathogenesis that gives you 
the chance to develop treatments that will be more efficacious, 
because they're really targeted towards the primary problem, 
and perhaps, if we do this right, also less likely to cause 
side effects, because you are going right to the primary 
problem.
    So, it's a very exciting time for this kind of strategy. 
How are we able to do that? I should bring along my show-and-
tell here, I brought you a couple of chips to indicate the kind 
of technologies that have come out of this sort.
    Senator Harkin. What am I looking at?
    Dr. Collins. The one in the little plastic case, here, is 
an Affymetrix Gene Chip, this one chip can be used to detect 
50,000 different variable places in the genome in one 
experiment. This particular company, Affymetrix, was actually 
founded on an NIH SBIR grant from the Genome Institute, about 
14 years ago, and has now become a major contributor to the 
revolution in genomic medicine that we see.




    The other one, called Illumina, is a separate company, what 
you're looking at there is a microscope slide, and you see 
stripes on it, each one of those stripes has about 60,000 
different DNA spelling detectors, so it is basically a 
detector, and so with the whole slide, you can then look at a 
very large number of variations in a single DNA sample, and 
test those extremely reliably, and for a cost of about an 8th 
of a penny per particular genotype, per particular DNA 
spelling. Again, that's come down dramatically in cost, over 
the last 5 years.




    So, these are exciting times, not only are we focused on 
this approach to look at those variants in the genome, I might 
mention, we're also pushing hard, Senator, to get to the point 
of being able to sequence anybody's complete genome, all of the 
letters of their 3 billion letter code, for $1,000.
    Senator Harkin. I read that in your testimony.
    Dr. Collins. Yeah, that's ambitious, isn't it?
    Senator Harkin. Yeah.
    Dr. Collins. A couple of years ago, it would have cost $10 
million, we are now probably on the brink of a totally new 
technology, really turning out to work in high throughput that 
will bring that cost down to, perhaps, $100,000 for human 
genome. So that's three orders of magnitude--I'm sorry, two 
orders of magnitude in a fairly short period of time.
    To get down to $1,000, we've got two more orders of 
magnitude to go, but that's an explicit goal of our Institute, 
working with other collaborators, and we are putting a lot of 
our own technology development money into that. So, imagine 
what that's like, that you get your entire genome set?
    Senator Harkin. What makes you think you can do that?
    Dr. Collins. We don't have to----
    Senator Harkin. That's a big order.
    Dr. Collins. It is. We don't have to violate any laws of 
physics, though, it is quite possible to do this, so investing 
in various technologies, and Dr. Pettigrew has some of these 
same approaches in his portfolio, particularly using 
nanotechnology, one of the more promising ideas, is you take a 
nanopore, a tiny little pore in a membrane, and you thread DNA 
through it in a way that there's a change in the electrical 
current as each base goes by, whether it's an A, or a C, or a 
G, or a T, it gives you a slightly different signal. People are 
seriously looking at that, as a way to read out--very fast--
because DNA would just fly through this pore, from a single 
molecule of DNA--a very large amount of DNA sequence.
    Whether that's actually going to work in practice? I guess 
I'd give it about a 50/50 chance right now, but there are other 
kinds of technologies right behind it, that are also lining up 
to do this. I'm counting on the ingenuity of the investigators 
that have already pushed this envelope so far, that I would 
think it would be a mistake for anybody to bet against it, and 
we do expect that the $1,000 genome will be a reality, sometime 
in the next 10 years.
    One of the areas, just to conclude, that we're specifically 
focused on, in terms of applying all of these technologies, is 
cancer.
    So, working with the Cancer Institute, we have gotten 
together in a partnership called the Cancer Genome Atlas, where 
we are applying, not only DNA sequencing technology, but also a 
host of other ways of looking at what's going on in cancer, in 
terms of which genes are turned on or turned off, which parts 
of the genome are duplicated or deleted.
    We have a large number of investigators all working 
together, initially on brain tumors, on ovarian cancer, and on 
lung cancer. But, if this pilot looks as promising as we expect 
it to, we hope to expand that to perhaps as many as 50 
different cancer types, after the pilot concludes in a period 
of 3 years. That's a very exciting project, and all of the data 
is being placed into a database, where any qualified 
investigator can see it right away, following up again on our 
premise that data access is really important, for speeding up 
this kind of research.

                           PREPARED STATEMENT

    So, in this brief time, I'm just scratching the surface of 
some of the things that are happening now in the field of 
genomics. Having been at NIH for 14 years, people are 
occasionally asking me, ``Well, aren't you getting tired of it? 
Isn't it time to move on?'' My only answer is, ``This is the 
best part.'' This is the part that we really worked to get to, 
where we have the foundation, and now we can apply it in ways 
that are really going to transform medicine.
    Thank you, Senator, I'd be glad to answer your questions.
    [The statement follows:]

              Prepared Statement of Dr. Francis S. Collins

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2008 President's budget request for the National Human 
Genome Research Institute (NHGRI). The fiscal year 2008 budget included 
$484,436,000.
    The theme of this hearing is ``The Frontiers of Science.'' In 
leading the Human Genome Project, we at NHGRI have had the privilege of 
working at the frontiers for many years. And the projects I will 
describe today demonstrate how research at NHGRI is advancing ever more 
rapidly to catalyze a true revolution in medicine.
    In February 2006, the Department of Health and Human Services 
announced the creation of two related groundbreaking initiatives in 
which NHGRI is playing a leading role. The Genetic Association 
Information Network (GAIN) and the Genes, Environment and Health 
Initiative (GEI) will accelerate research on the causes of common 
diseases such as asthma, schizophrenia, the common cancers, bipolar 
disease, diabetes, and Alzheimer's disease and help develop strategies 
for individualized prevention and treatment, thereby moving towards the 
possibility of personalized medicine.
    GAIN is a public-private partnership among the NIH, the Foundation 
for the NIH, Pfizer, Affymetrix, Perlegen, the Broad Institute, and 
Abbott. GEI is a trans-NIH effort combining comprehensive genetic 
analysis and environmental technology development to understand the 
causes of common diseases. Both GEI and GAIN are powered by completion 
of the ``HapMap,'' a detailed map of the 0.1 percent variation in the 
spelling of our DNA that is responsible for individual predispositions 
to health and disease. Beginning in fiscal year 2007, GAIN will produce 
data to narrow the hunt for genes involved in six common diseases and 
GEI will provide data for approximately another 15 disorders. 
Additionally, GEI will develop enhanced technologies and tools to 
measure environmental toxins, dietary intake and physical activity, and 
an individual's biological response to those influences.

                       ONGOING NHGRI INITIATIVES

Use of Comparative Genomics to Understand the Human Genome
    NHGRI continues to support sequencing of the genomes of non-human 
species because of what they say about the human genome. The honey bee 
genome was published in the journal Nature in October. This bee's 
social behavior makes it an important model for understanding how genes 
regulate behavior, which may lead to important insights into 
depression, schizophrenia, or Alzheimer's disease. The genome of the 
sea urchin was sequenced and analyzed in November, revealing unexpected 
sophistication among its sensory and immune system genes.
Medical Sequencing
    When it becomes affordable to sequence fully any individual's 
genome, the information obtained will allow estimates of future disease 
risk and improve the prevention, diagnosis, and treatment of disease. 
NHGRI is particularly interested in having a sequencing program that 
both drives technology and produces data useful to biomedical research. 
To this end, NHGRI has developed a medical sequencing program that 
utilizes DNA sequencing to: identify the genes responsible for dozens 
of relatively rare, single-gene diseases; sequence all of the genes on 
the X chromosome from affected individuals to identify the genes 
involved in ``sex-linked'' diseases; and survey the range of variants 
in genes known to contribute to certain common diseases.
Sequencing technology advances, on the way to the $1,000 genome
    DNA sequencing enables a detailed ordering of the chemical building 
blocks, or bases, in a given stretch of DNA, and is a powerful engine 
for biomedical research. Though DNA sequencing costs have dropped by 
three orders of magnitude since the start of the Human Genome Project 
(HGP), sequencing an individual's complete genome for medical purposes 
is still prohibitively expensive. However, bold new advances in 
sequencing technology developed by NHGRI-funded researchers promise to 
reduce this cost greatly. NHGRI's ultimate vision is to cut the cost of 
whole-genome sequencing to $1,000 or less. This could potentially 
enable sequencing of individual genomes as part of routine medical 
care, providing health care professionals with a more accurate means to 
predict disease, personalize treatment, and preempt the occurrence of 
illness.
New findings in genetics of common disease
    Technology development and new research approaches enabled by the 
HGP, the HapMap, and related NIH initiatives have led to important new 
understanding of the role of genetic factors in a number of common 
diseases. For instance, the Hap Map made possible research that 
recently identified two major genes that influence risk for developing 
adult macular degeneration, a leading cause of vision loss, with those 
at lowest risk having <1 percent chance of developing the disease, and 
those at highest risk a 50 percent chance (Klein et al., Science 2005; 
Yang et al., Science 2006). Other similarly derived recent discoveries 
include that variations in the genes TCF7L2 (Helgasson et al., Nature 
Genetics 2007) and SLC30A8 (Sladek et al. Nature 2007) elevate risk for 
developing type 2 diabetes, variations in the genes IL23R (Duerr at 
al., Science 2006) and ATG16L1 (Hampe et al., Nature Genetics 2007) 
affect risk for Crohn's disease, a gene on chromosome 8 plays a role in 
prostate cancer, and the gene SORL1 (Rogaeva et al., Nature Genetics 
2007) plays a role in Alzheimer's disease. Each of these discoveries 
opens a new door toward prevention and treatment.
Knockout Mouse Project
    The technology to ``knockout'' or inactivate genes in mouse 
embryonic stem cells has led to many insights into human biology and 
disease. However, gene knockout cells in mice have been made available 
to the research community for only about 10 percent of the estimated 
20,000 mouse genes. Recognizing the wealth of information that mouse 
gene knockouts cells provide, NHGRI coordinated an international 
meeting in 2003 to discuss the feasibility of a comprehensive project. 
These discussions have now resulted in a trans-NIH, coordinated, 5-year 
cooperative research plan that will produce gene knockout cells in mice 
for every mouse gene and make these mice available as a community 
resource.
Chemical Genomics and the Molecular Libraries Roadmap Initiative
    The NHGRI has taken a lead role in developing a trans-NIH chemical 
genomics. Part of the NIH Roadmap, this project offers public-sector 
researchers access to high throughput screening of libraries of small 
organic compounds that can be used as chemical probes to study the 
functions of genes, cells, and biological pathways. This powerful 
technology provides novel approaches to explore the functions of major 
cellular components in health and disease. In its first year, the ten 
centers in the Molecular Libraries Screening Centers Network entered 
screening data from 45 assays in the PubChem database at the National 
Library of Medicine. The team also published a new high-throughput 
screening approach that is speeding the production of data to be used 
to probe biological activities and identify leads for drug discovery.

                      NEW AND EXPANDED INITIATIVES

Population Genomics
    To promote application of genomic knowledge to health, NHGRI 
recently established an Office of Population Genomics. The mission of 
the office is to stimulate multi-disciplinary epidemiology and genomics 
research and develop new resources for the study of common disease. It 
will take on challenges such as developing standards for genetic and 
phenotypic data and improved analytic strategies for relating them, 
stimulating novel research approaches, and supporting cross-
disciplinary training to prepare researchers for new opportunities to 
improve health made possible through programs such as GEI and GAIN. 
This February, NHGRI's Advisory Council approved two new initiatives in 
this area. One funds development of a ``basic tool set'' for phenotypic 
and environmental exposure measurements in large-scale genomic 
research; the other supports existing biorepositories to conduct 
genome-scale studies with phenotype and environmental measures in 
electronic medical records. In the tradition of the HGP, the Office 
will promote widespread sharing of data, to stimulate the broadest 
possible application of knowledge and maximize public benefit.
The Cancer Genome Atlas (TCGA)
    The Cancer Genome Atlas (TCGA) is a joint NCI-NHGRI effort to 
accelerate understanding of the molecular basis of cancer through 
application of genome analysis technologies. Technologies developed by 
the HGP and recent advances in cancer genetics have made it possible to 
envision mapping the changes in the human genome associated with all 
forms of cancer. TCGA began in 2006 with a 3-year, $100 million pilot 
project to determine the feasibility of a full-scale effort to explore 
the universe of genomic changes involved in all human cancers. Over the 
3 years, NCI and NHGRI each plan to contribute a total of $50 million. 
The first diseases being explored are glioblastoma multiforme, ovarian 
cancer, and squamous cell lung cancer. TCGA will provide (1) new 
insights into the biological basis of cancer; (2) new ways to predict 
which cancers will respond to which treatments; (3) new therapies to 
target cancer at its most vulnerable points; and, (4) new strategies to 
prevent cancer.
The Human Microbiome
    There are more bacteria in the human gut than human cells in the 
entire human body. Furthermore, gut microbes have a profound effect on 
many human physiological processes, such as digestion and drug 
metabolism, and play a vital role in disease susceptibility and even 
obesity. The human microbiome project represents an exciting new 
research area for NHGRI, which, except for the bacterium E. coli, has 
focused its large-scale sequencing program on higher organisms rather 
than bacteria. Sequencing the genomes of 100 microorganisms that 
represent a significant, but unknown, fraction of all microbes in the 
human gut should provide a more complete picture of this aspect of 
human biology than has been available previously.

                        OTHER AREAS OF INTEREST

The U.S. Surgeon General's Family History Initiative
    The family medical history is an effective and inexpensive means to 
determine more accurately an individual's risk for specific diseases; 
however, it is underutilized in health care. The U.S. Surgeon General's 
Family History Initiative was established to focus attention on the 
importance of family history, and NHGRI has taken a lead role in this 
initiative. To further the effort in 2006, NHGRI selected the 12,000 
employees at Brigham and Women's Hospital for a 1-year demonstration 
project to educate and engage the health care community about the 
family history. To spread the importance of family history to the 
public, the software tool, ``My Family Health Portrait,'' was enhanced 
for easier use, and resource materials were distributed to chronic 
disease and genetics experts in the State health departments of every 
U.S State and territory.
Genetic Discrimination
    NHGRI remains concerned about the impact of potential genetic 
discrimination on research and clinical practice. A wealth of research 
has demonstrated that many Americans are concerned about the possible 
misuse of their genetic information by insurers or employers. The 
Genetic Information Nondiscrimination Act of 2007, S. 358, and its 
companion House bill, H.R. 493, are presently under consideration by 
the Congress. In 2005, the administration supported S. 306, the Genetic 
Nondiscrimination Act of 2005. In January of this year, President Bush 
visited the NIH and reiterated the administration's desire to see 
Congress pass a bill to protect Americans from genetic discrimination.
    Thank you, Mr. Chairman. I hope I have offered you an informative 
view of the newest frontiers of science from the front lines of genomic 
science. I would be pleased to answer any questions that the Committee 
might have.


    Senator Harkin. Thank you, Dr. Collins. I want to come back 
to this knock-out project. I don't understand it, but I want to 
understand it a little bit more, but we'll get to that later.
    Dr. Donald Lindberg has served as the Director of the 
National Library of Medicine since 1984. He has an M.D. from 
Columbia University. Dr. Lindberg is a noted pathologist and a 
pioneer in applying computer technology to health care.
    Dr. Lindberg, welcome again to the committee. You've been 
here many, many times over the years. Good to see you again.

STATEMENT OF DR. DONALD A.B. LINDBERG, DIRECTOR, 
            NATIONAL LIBRARY OF MEDICINE
    Dr. Lindberg. Thank you, Senator Harkin.
    Senator Harkin. Please proceed.
    Dr. Lindberg. Since 1836, the National Library of Medicine 
(NLM) has been extremely fortunate to have received good help 
and consistent funding from the Congress. Thanks for this, and 
for today's opportunity to be present, again, before the 
committee.
    What does NLM do? Libraries, we too, are really part of 
science infrastructure. For much of our history, it was 
sufficient for NLM to acquire, organize and disseminate 
biomedical knowledge from the world for the benefit of the 
public health. But, biomedical knowledge has radically changed, 
both in volume and in form, and now, in addition to doctors and 
scientists, we also serve the public directly.
    To do this work, we now spend a lot of time, money, effort 
and space in creating and maintaining the electronic networks, 
databases, and information technology standards. These are 
essential now to support both new discoveries, and the use of 
these in good patient care. The number of papers we're indexing 
has gone up roughly 100-fold, database entries 1,000-fold. In 
addition, we now link genetic data directly online to the 
formulary and even the three-dimensional structures of the 
small molecule and protein products, pretty different from the 
old days.
    These, and over 40 highly specialized NCBI databases are 
important to researchers exploring the questions, how genes 
work, and how genomic medicine can help us. In some ways, the 
task of helping patients and families to understand their 
medical situations, is as difficult--maybe more difficult--as 
helping the scientists.
    Taking both groups together, we responded by computer to a 
billion online inquiries last year. They tell me that--
petabytes and all of that doesn't mean too much to most 
people--but basically every 3 days, we download an amount of 
data totally equivalent to the contents of the Library of 
Congress. So, this information is really used.
    NLM is the largest medical library in the world and, by 
far--more than even an ordinary modern library. Since our 
beginning, Congress added a number of explicit 
responsibilities, and I'll mention some. The two large ones, of 
course, are the Lister Hill Center for communications research, 
and more recently, NCBI for biotechnology information.
    In addition, we have responsibility for collection of 
information on toxicology, environmental health, healthcare 
technology, and most recently, for the establishment of a 
national--speedily becoming international--clinical trials 
registry.
    So, we're infrastructure. As such, we note that scientific 
infrastructure responsibilities, and hence, expenses, must 
increase faster than the growth of the experimental science we 
serve. This is because all of the Institutes share Dr. Collins' 
infectious belief that molecular biology and whole genome 
studies are science's best bet. I do, too.
    Thus, more experimental data needs to be acquired, 
organized and made available online to investigators. 
Successful databases grow in size, and in the number of users, 
and the costs go up, even with increases in our efficiency.
    We are most grateful to the committee for increases in 
funding, specifically for that which it provided for this 
purpose this year.
    Some might think that infrastructure role a bit dull, but 
for us, with the current growth of insights and discoveries 
stemming from use of our information service, it's more like a 
great roller coaster ride on a sunny day.

                       ELECTRONIC HEALTH RECORDS

    I want to mention very briefly, we have an interest in the 
full deployment of electronic health records. Across the United 
States, this is one of our top priorities. It's one of the 
Department's top priorities. It's important for two major 
reasons.
    First, long experience has shown that quality control 
warnings, clinical guidelines, best practices are simply so 
numerous and complex that they are not helpful when left to 
either doctors or patients alone to remember and use. We need 
computer-based medical informatics support. NLM does, in fact, 
support informatics research and training in the universities. 
We ourselves produce and disseminate information technology 
standards nationally, and as an official HHS function.
    Electronic health records are key for a second important 
reason, namely to get family and genomic studies into the 
patient record.

                    ACCESS TO SCIENTIFIC LITERATURE

    Briefly, the future now holds new discoveries that will 
come from new directions and new measurements, such as the 
genomic work that Dr. Collins describes. These will be based on 
ready access to full text sources of scientific literature and 
scientific databases, but new discoveries will also come from 
reexamination of some old ideas.
    The following shows Barry Marshall and Robin Warren on 
October 4, 2005, receiving their telephone call from the Nobel 
Prize Committee in Stockholm; lifting a glass, of course, on 
the occasion.

               [From The New York Times, October 4, 2005]

 Two Win Nobel Prize for Discovering Bacterium Tied to Stomach Ailments

                        (By Lawrence K. Altman)



     Barry Marshall and Robin Warren, celebrating their Nobel Prize

    . . . ``made an irrefutable case that the bacterium Helicobacter 
pylori'' causes ulcers and other diseases. . . .
    . . . A famous experiment Dr. Marshall conducted on himself. . . .
    . . . Dr. Marshall said that information he obtained from the 
National Library of Medicine, a part of the National Institutes of 
Health in Bethesda, Md., aided his discovery. . . . Dr. Marshall worked 
in a hospital in Port Hedland, in the Australian outback about 1,000 
miles from Perth. . . .
    . . . bundles of references . . . ``a whole lot of literature 
showing that many patients with ulcers had gastritis that the ulcer 
experts in the 1980's had forgotten about.''

    The prize honored their discovery that--and proof--that 
peptic ulcer is actually caused by infection by a bacterium, 
Helicobacter pylori--not by neurosis, stress, spicy food or all 
the other nonsense we used to be taught about.
    Now, when he received the call, Marshall immediately said 
to the press, ``Information from the National Library of 
Medicine aided my discovery.'' Dr. Marshall himself worked in a 
hospital in Port Hedland, Australia in the outback, 1,000 miles 
even from Perth, but he got what he described as ``bundles of 
references'' showing that many patients with ulcers had 
gastritis that the ulcer experts had forgotten about.
    So, of course, we're grateful for this discovery, and for 
the acknowledgement. But frankly it makes one hope that 
whatever else in medicine is not true will also get re-examined 
by some doubters with library cards.

                         NLM FUTURE PRIORITIES

    Now, for the next year, just three areas we have great 
interest in. Dealing with the space problem, which we're 
seriously at NLM and the committee has helped us with that in 
the past by providing money for planning. We are also very keen 
on the outreach to consumers, patients' families and the 
public, and the NIH MedlinePlus magazine, which again, you 
helped us with a Capitol Hill launch. That was great.
    Senator Harkin. Yeah, I remember that. Yep, yep.
    Dr. Lindberg. Mary Tyler Moore. Then we think we ought to 
be doing something more in our Long-range Planning Committee 
from the Board of Regents thinks that we ought to be doing more 
to try to be involved in helping the country with disaster--at 
least health information management. So those are our hopes and 
desires.
    Senator Harkin. Yeah, it was, a nice event. How often do 
you come out with that?
    Dr. Lindberg. Quarterly.
    Senator Harkin. Quarterly. Online also?
    Dr. Lindberg. Online also. Anyone can actually request it 
online and get it free.
    Senator Harkin. Yeah, oh, I understand. Yeah.

                           PREPARED STATEMENT

    Dr. Lindberg. Lance Armstrong was on the cover of the first 
edition, as you remember. He was helpful, too.
    Senator Harkin. Oh yeah?
    Dr. Lindberg. Mary Tyler Moore was on the cover of the 
second edition.
    [The statement follows:]

             Prepared Statement of Dr. Donald A.B. Lindberg

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Library of Medicine 
(NLM) for fiscal year 2008, a sum of $312,562,000.
    The National Library of Medicine has a remarkable track record of 
preserving the past while serving the present and preparing for the 
future. A just completed Long Range Plan done by the Library's Board of 
Regents lays out in broad terms the challenges the Library will face 
over the next decade and charts a course for action to successfully 
meet these challenges.
    Prominent among the challenges is the need to create the 
information resources essential to achieving the goal of ``personalized 
medicine,'' in which prevention and treatment strategies are tailored 
to an individual's specific genetic make-up. The first step is to 
provide huge linked databases and software tools that allow scientists 
to correlate clinical, genomic, and chemical compound data with 
published research findings to determine how genetics and a person's 
environment interact to cause disease and to identify potential new 
therapies. Such resources, now being developed by NLM, will speed 
scientific discovery and can ultimately transform medical care by 
allowing clinicians to customize treatments to a patient's genetic 
characteristics.
    In an era of increasing chronic disease, a related challenge is the 
need to empower people with the knowledge and motivation to improve 
their health and play a more active role in their health care. The 
information that pours out of the Nation's laboratories--and often 
finds its way into the public media--has the potential of improving the 
health status of our citizens. The National Library of Medicine has 
created heavily used Web-based information services aimed at the 
public. These services transmit the latest useful findings in lay 
language and provide guidance that can be easily understood by the 
public. NLM works with libraries and community-based organizations to 
increase public awareness and use of these valuable resources.
    Electronic health records with advanced decision support 
capabilities will be essential to achieving personalized medicine and 
will also help people manage their own health. Much of the seminal 
research work in this arena was supported by the National Library of 
Medicine or undertaken by people who received NLM-funded informatics 
education. This work builds on two decades of research and development 
of the Unified Medical Language System (UMLS) resources which help 
computer systems behave as if they ``understand'' the language of 
biomedicine. The NLM also serves as an HHS coordinating center for 
standard clinical vocabularies and supports, develops, or licenses for 
U.S.-wide use key clinical vocabularies.
    No information source is useful if it is unavailable. A third major 
challenge facing the National Library of Medicine is ensuring 
uninterrupted access to critical information resources in the event of 
disaster or other emergency, natural or man-made. As recent hard 
experience demonstrated, this requires careful advanced planning, 
strong inter-organizational arrangements, and skillful management of 
information during the emergency, in addition to robust technical 
backup arrangements for computer and communication systems. NLM's new 
Long Range Plan specifically recommends that the Library establish a 
new Disaster Information Management Research Center and ensure 
effective recognition and use of libraries as a major and largely 
untapped resource in the Nation's disaster management efforts.
    This opening statement is built around these three themes--
scientific information resources that can lead to personalized 
medicine, information services that enable greater personal involvement 
in health and health care, and marshalling the Library's resources to 
assist the country's in emergency situations.

          SCIENTIFIC INFORMATION RESOURCES--NEAR AND LONG TERM

    Fueled in part by funding from the National Institutes of Health, 
the pace of discovery in today's world of biomedical research is 
amazing. The NLM is now at the center of much biomedical research--not 
only receiving, storing, and disseminating published research results, 
but actually serving as a crossroads for the genomic and other data 
coming from laboratories around the world. NLM databases and systems 
are essential tools in all aspects of biomedical research. Users 
conducted more than 1 billion searches of them in the last year.
    The core of the National Library of Medicine is its expanding 
collection of more than 8 million books, journals, and other materials. 
The Library subscribes to more than 20,000 periodicals of which some 
5,000 are indexed for Medline/PubMed, the immense online database of 
the journal literature. From the more than 16 million records in 
Medline/PubMed one may link to a tremendous variety of relevant Web-
accessible online resources at NLM and elsewhere. NLM's National Center 
for Biotechnology Information (NCBI) has already begun building the 
Medline/PubMed of the future by redesigning its displays and interfaces 
to make it easy for users to see important links and retrieve 
information they might not otherwise have noticed.
    The NCBI is the source of GenBank, the genetic sequence databank 
that contains all publicly available DNA sequences. GenBank is produced 
from thousands of sequence records submitted directly from researchers 
and institutions prior to publication. NCBI has also created PubChem, a 
repository for what are called ``small molecules'' that are crucial in 
drug development. Small molecules are responsible for the most basic 
chemical processes that are essential for life and they often play an 
essential role in disease.
    The NCBI's effective performance on these and other trans-NIH 
priorities has earned NLM a prominent role in the important new Genome-
Wide Association Studies (GWAS) project. GWAS is an NIH-wide initiative 
directed at understanding the genetic factors underlying human disease. 
It involves linking genotype data with phenotype information in order 
to identify the genetic factors that influence health, disease, and 
response to treatment. NCBI is building the databases to incorporate 
the clinical and genetic data, link them to the NLM's molecular and 
bibliographic resources and, for the first time, make these data 
available to the scientific and clinical research community. dbGaP 
(database of Genotype and Phenotype) debuted in December 2006 to 
archive and distribute data from Genome-Wide Association Studies.
    PubMed Central, a Web-based archive of biomedical journal 
literature also developed by the NCBI for the NIH, provides free access 
to the full-text of peer-reviewed articles. PubMed Central is also home 
to full-text journal articles submitted by scientists with NIH funding 
under the NIH Public Access policy.
    NLM's Lister Hill National Center for Biomedical Communications 
also produces important tools for biomedical and informatics research, 
including digital image libraries--sets of image data that can be used 
in research, clinical care, and training. In one example, NLM is 
currently collaborating with NIH and other researchers to develop 
advanced imaging analysis tools for research in human papillomavirus 
infection and cervical neoplasia. The tools will allow effective 
analysis of some 100,000 images of the uterine cervix and they will 
become the primary resource for professional training and testing in 
this field. Another set of imaging tools being widely applied in the 
scientific community, for education and other purposes, is related to 
the ``Visible Humans.'' These two enormous data files (one male and one 
female) were created under the guidance of the Lister Hill Center and 
provide detailed image data sets that serve as a common reference for 
the study of human anatomy, for testing medical algorithms, and as a 
model for image libraries that can be accessed through networks.

                  INFORMATION SERVICES FOR THE PUBLIC

    The audiences served by the Library have multiplied in recent 
years. In addition to providing researchers and health care providers 
with access to scientific information, the NLM also now has services 
for the public--from elementary school children to senior citizens. The 
Library's main portal for consumer health information is MedlinePlus, 
available in both English and Spanish. Much of this information is 
based on research done or sponsored by the NIH Institutes. In addition 
to more than 700 ``health topics'' (main entries on diseases and 
disabilities), MedlinePlus has interactive tutorials that are useful 
for persons with low literacy, medical dictionaries, a medical 
encyclopedia, directories of hospitals and providers, surgical videos 
that show actual operations, and links to the scientific literature. 
Just last September we launched here in the Congress a major initiative 
to put into doctors' offices and share with the public good health 
information in the form of a new publication, the NIH MedlinePlus 
Magazine. We were joined in unveiling the publication by Senator Tom 
Harkin and Congressman Ralph Regula.
    Several databases for consumers are byproducts of research in NLM's 
Lister Hill Center. One of these is the ClinicalTrials.gov database, 
which describes clinical research studies funded by NIH and others 
around the world. The site contains information on more than 37,000 
federally and privately supported trials and is searched daily by some 
30,000 people. Another Lister Hill Center database is the Genetics Home 
Reference, a Web site for consumer-friendly information about genetic 
conditions and the genes or chromosomes related to those conditions.
    NLM's toxicology and environmental health program also produces 
heavily used consumer information resources. The Household Products 
Database provides easy-to-understand data on the potential health 
effects of more than 2,000 ingredients contained in more than 6,000 
common household products. The colorful Tox Town looks at an ordinary 
town and points out many harmful substances and environmental hazards 
that might exist there. ToxMystery, an unusual interactive Web site for 
children between the ages of 7-10, provides an animated, game-like 
interface that prompts children to find potential chemical hazards in a 
home.
    Of inestimable help to the NLM in meeting its varied 
responsibilities--both to the scientific community and to the public at 
large--are the 5,800 member institutions of the National Network of 
Libraries of Medicine. The Network comprises eight Regional Medical 
Libraries, 120 ``resource libraries'' primarily at schools of the 
health sciences, and thousands of hospital libraries and community-
based organizations. Together they form an efficient way to ensure that 
the published output of biomedicine is easily accessible by scientists, 
health professionals, and the public. They cover the critical ``last 
mile'' to familiarize researchers, health professionals and the public 
and to develop sustainable partnerships with community organizations to 
improve access to health information for underserved populations.

            MANAGING VITAL INFORMATION IN TIMES OF DISASTER

    A number of NLM's advanced information services and tools are 
designed for use by emergency responders when disaster strikes. The 
Library has a history of providing assistance in such cases, for 
example the gas leak disaster in Bhopal, India, in the eighties, and 
Hurricane Mitch and the earthquakes in Central America in the nineties. 
NLM's TOXNET, a cluster of databases covering toxicology, hazardous 
chemicals, toxic releases, environmental health and related areas, 
provides a foundation for services to first responders, such as WISER 
(Wireless Information System for Emergency Responders). Used in 
Louisiana after Hurricane Katrina, WISER provides information via 
handheld mobile devices to help identify unknown substances.
    Among other such projects, the Library: (1) supported pioneering 
work on automated biosurveillance, self-healing wireless networks, and 
smart tags to track patients during emergencies; (2) built the 
Influenza Virus Resource with the National Institute of Allergy and 
Infectious Diseases to provide vaccine researchers access to genomic 
data of many influenza strains; (3) developed OSIRIS (Open Source 
Independent Review and Interpretation System), a software package to 
assist in identifying 9/11 victims' remains via DNA; (4) worked via the 
National Network of Libraries of Medicine to re-establish and maintain 
a level of health information services in the Katrina-affected region; 
and (5) developed the Radiation Event Medical Management (REMM) system, 
in collaboration with the HHS Office of Public Health Emergency 
Preparedness, the National Cancer Institute, and the CDC.
    In summary, the National Library of Medicine is well positioned to 
make a maximum contribution to the Nation's health--by making 
increasing amounts of scientific data available to researchers and 
health practitioners, by contributing to the national effort to improve 
the information infrastructure of the health care system, by providing 
to the public access to authoritative information for use in 
maintaining their personal health, and by enabling health sciences 
libraries to make substantial contributions of disaster information 
management. All of these activities will depend on a strong and diverse 
workforce for biomedical informatics research, systems development, and 
innovative service delivery. To that end, the National Library of 
Medicine will continue its longstanding support for post-graduate 
education and training of informatics researchers and health sciences 
librarians and redouble its efforts to improve the diversity of these 
fields.

    Senator Harkin. Right, right.
    Thank you very much, Dr. Lindberg.
    Now we turn to Dr. Roderic Pettigrew, first appointed as 
the first Director of the National Institute of Biomedical 
Imaging and Bioengineering in 2002. He received his M.S. in 
Nuclear Medicine and Engineering from Rensselaer Polytechnic 
Institute and a Ph.D. in Applied Radiation Physics from 
Massachusetts Institute of Technology and an M.D. from 
University of Miami School of Medicine. His own research has 
focused on imaging of the heart using MRI. Interesting.
    Welcome, Dr. Pettigrew. Please proceed.

STATEMENT OF DR. RODERIC I. PETTIGREW, DIRECTOR, 
            NATIONAL INSTITUTE OF BIOMEDICAL IMAGING 
            AND BIOENGINEERING
    Dr. Pettigrew. Thank you, Senator Harkin. It is my pleasure 
to report to this committee, the remarkable advances that have 
been made in another frontier of science, that of medical 
technology. This field claims the top ring advance in clinical 
medicine of the last quarter century, three-dimensional human 
imaging via magnetic resonance imaging, or MRI, and computed 
tomography, or CT.
    In addition, the U.S. medical technology industry has grown 
to be a $90 billion enterprise with positive trade surplus, and 
perhaps more importantly, these technologies have significantly 
improved the Nation's health care.
    My Institute, the National Institute of Biomedical Imaging 
and Bioengineering is the youngest at the NIH and leads the 
development of a broad range of emerging biomedical 
technologies. It was created to focus on the science of 
technological innovation, create new tools that will improve 
our understanding of disease, and translate these types of new 
knowledge into practical solutions.
    Our research domain is the interface of the physical and 
the life sciences, and our vision is one of disease detection 
on a personalized basis, sufficiently early to pre-empt serious 
consequences of many illnesses, such as heart disease and 
cancer.
    When therapies are needed, these too, will be personalized, 
and targeted to the offending biologic process. I offer from 
our young, but broad, portfolio illustrative examples, and you 
have a handout.
    Senator Harkin. Got it here.
    
    

                                Figure 1

    Dr. Pettigrew. See figure 1.
    These are three examples, or from three areas that are 
already transforming modern healthcare. We have just heard 
about the tremendous advances being made in understanding the 
genetic basis of disease, such as diabetes and heart disease 
from Dr. Collins. The use of DNA sequences and genetic 
variations, as determined in HapMap studies, combined with 
advanced bioengineering technologies is beginning to be used 
for routine diagnostics at the first point of physician 
contact, and this, we term the point of care. A practical 
example of a very recent development of a DNA-based 
electrochemical sensor that can quickly identify the specific 
bacteria responsible for an infection is shown here.
    This is actually similar to the type of chip that Dr. 
Francis Collins gave you. Normally, identifying bacteria 
responsible for urinary tract infections or infections in 
general, takes about 2 days. But, with the euro-sensor that you 
see there, this can be accomplished in about 30 minutes. This--
--
    Senator Harkin. What you mean, is the specific type of the 
bacteria can be identified.
    Dr. Pettigrew. Yes.
    Senator Harkin. Within 30 minutes.
    Dr. Pettigrew. That's right.
    Senator Harkin. Okay.
    Dr. Pettigrew. Thank you for clarifying that, the bacteria 
specifically responsible for the urinary tract infections can 
be identified in 30 minutes, from the normal panoply of 
bacteria that are commonly responsible for this type of 
infection.
    This also allows for a more personalized prescription of 
the most specific and effective antibiotic treatment, and helps 
reduce the growing problem of antibiotic resistance caused by 
non-specific use of antibiotics.
    Perhaps more importantly, Senator, this type of device as 
indicated, is indicative of the type of exciting technological 
innovation that is leading to tools for personalized 
diagnostics on a routine basis. These systems, like the one you 
have on the board there, obviously are portable, they employ 
nanotechnologies that are ultimately responsible for this type 
of portability, and as a result of the portability, these can 
be available in all communities, including the rural and 
underserved areas.
    Another example of an engineered point of care diagnostic 
device is figure 2, a contact lens that senses the glucose in 
tear fluid, and shows a level of glucose simply by changing 
colors.



                                Figure 2

    A second area of transformative technology supported by my 
Institute is tissue engineering and regenerative medicine. 
This, as you heard from the National Institute of Arthritis and 
Musculoskeletal Disease, in the earlier testimony session, is 
an emerging technology in which tissues are grown to repair or 
replace diseased or damaged tissues or organs. 



                                Figure 3

    Figure 3 shows a subject who has a ruptured Achilles tendon 
in the upper left quarter panel. You can see the defect which 
was completely re-grown after placing a matrix material seeded 
with biologically active molecules. In the bottom right quarter 
panel, you can see the placement of this matrix material, on 
which normal Achilles tendon tissue was re-grown. Six months 
after this particular procedure, this individual patient had a 
normal tendon repair.



                                Figure 4

    Figure 4, the innovation is on a larger anatomic scale. 
This example illustrates the additional modern advances of 
image-guided interventions, or also team or inter-disciplinary 
science, as it has been referred to in the recent past.
    These are areas that we also specifically promote at our 
Institute. The problem being addressed in that particular 
handout that you have is identifying in the brain the very tiny 
site responsible for epileptic seizures, while also identifying 
surrounding normal critical structures. The goal is to show all 
of this structural, metabolic and electrical information in 
three dimensions to the surgeon with live updates while he or 
she is operating, so as to affect a successful removal of the 
offending tissue with minimal damage to the normal brain 
tissues.
    The team involved in this study is truly inter-
disciplinary. It involves a neurosurgeon, mechanical engineer, 
radiologist, computer scientist, bioengineer and so forth, all 
who have worked together to dramatically transform the way in 
which brain surgery will be performed.
    Specifically, this team already reports being able to treat 
up to 60 percent more patients with epilepsy, and in doing so, 
they've also been able to reduce the operating time by 1.5 
hours, and perhaps even as importantly, if not more so, they 
accomplish this with no neurologic deficits after the operative 
procedure.

                           PREPARED STATEMENT

    In the future, the vision of an even earlier, preemptive 
identification of disease will be achieved, as will less 
invasive approaches to treatment, which will target disease at 
the cell, and molecular, level. The NIBIB is working to create 
more of these types of transforming technologies, that will 
help realize this vision and improve the Nation's health.
    I thank you for this opportunity to present this overview, 
and also will be delighted to respond to any questions that you 
might have.
    [The statement follows:]

             Prepared Statement of Dr. Roderic I. Pettigrew

    Mr. Chairman and Members of the Committee: I am pleased to present 
the fiscal year 2008 President's budget request for the National 
Institute of Biomedical Imaging and Bioengineering (NIBIB). The fiscal 
year 2008 budget included $300,463,000.

                BRIDGING THE PHYSICAL AND LIFE SCIENCES

    The mission of the NIBIB is to improve human health by extending 
the frontiers of biomedical science, through the development and 
application of innovative biomedical technologies. A major focus of 
NIBIB is bridging the physical and life sciences in order to develop 
new biomedical technologies and methodologies that have a profound, 
positive impact on human health. Translating these technological 
breakthroughs from the bench to bedside is also a very important aspect 
of the NIBIB mission, and is demonstrated in some of the examples given 
below.

            TRANSLATING EMERGING TECHNOLOGIES INTO PRACTICE

A Quantum Project to Treat Stroke
    Ultimately, NIBIB seeks to translate technological advances into 
solutions that improve human health by reducing disease burden and 
enhancing quality of life. To accomplish this goal, NIBIB must be well-
positioned to utilize ideas and techniques that are at the cutting edge 
of science. Also, NIBIB must be bold and far-reaching in generating 
some of its initiatives in order to more rapidly facilitate discoveries 
and translate them to clinical practice. NIBIB recently launched the 
Quantum Grants Program, which supports very high impact, high risk, 
interdisciplinary and transformative research focused on major 
biomedical problems. The goal of this program is to solve or 
dramatically improve a major, previously intractable medical problem 
through the development and application of new and/or emerging 
technologies. Interdisciplinary teams of scientists will conduct 
collaborative research resulting in a prototype product, technology or 
procedure that promises to solve a significant healthcare problem, and 
that can be translated into clinical practice in an accelerated time 
frame. The first grant, awarded in September 2006, aims to develop a 
novel treatment for stroke, based on implantable units that will lead 
to neurovascular regeneration of cerebral tissue. This is the first 
application that has as its target, a treatment for stroke that seeks 
to restore functional tissue.
Seeing and Treating Heart Arrhythmias
    Heart arrhythmias are a major health problem. In particular, atrial 
fibrillation, a disorder found in about 2.2 million Americans, is a 
significant cause of stroke. This occurs when a blood clot forms in the 
fibrillating heart chamber and then breaks loose and travels to the 
brain. Minimally invasive surgery can be used to treat atrial 
fibrillation. However, the procedure is complicated and lengthy, often 
lasting many hours. NIBIB investigators are developing new imaging 
techniques that permit the abnormal electrical activity to be 
identified and mapped onto a patient-specific image of the heart. This 
potentially permits the procedure to be done in one hour instead of 
six. Beyond the time saving, this approach has the potential for lower 
cost, decreased exposure to x-rays, greater success rates, and fewer 
complications. The effort involves collaboration between radiologists, 
computer scientists, bioengineers, and cardiologists.
    Addressing heart diseases of a medically underserved population is 
the central focus of the Jackson Heart Study. The National Heart, Lung 
and Blood Institute, the National Center for Minority and Health 
Disparities, and NIBIB co-fund this study to assess risks factors for 
cardiovascular diseases, including diet, exercise, and co-morbidity 
factors such as diabetes and obesity.
Help for the Paralyzed
    Paralyzed or ``locked in'' individuals who retain normal cognitive 
function but are unable to move parts of their bodies to communicate 
now have a means of using the computer, based on an interface 
technology developed by NIBIB grantees. Brain waves, detected by a 
skullcap with attached electrodes, are decoded and used to communicate 
with a computer. By simply thinking of the letters, the user can spell 
words on the computer. No interaction with a keyboard or mouse is 
required. Over the past year, a team of neuroscientists has worked 
intensively to move this system from the laboratory to home use. For 
one NIH-funded neuroscientist with late-stage amyotrophic lateral 
sclerosis (ALS, or Lou Gehrig's Disease), this device has enabled him 
to continue his research. ``I couldn't work independently without it,'' 
he wrote recently for an article posted on the NIBIB web site entitled 
``Brain-Computer Interfaces Come Home.''
       nanotechnologies for personalized and preemptive medicine
Point-of-Care Systems
    Empowering clinicians to make decisions at the bedside, or the 
point-of-care, has the potential to profoundly impact health care 
delivery and to help address the challenges of health disparities. The 
success of a potential shift from curative to predictive, personalized, 
and preemptive medicine will rely in part on the development of 
portable diagnostic and monitoring devices for near-patient testing. 
The NIBIB has contributed to advances in this area by funding the 
development of sensor and platform-based microsystem technologies. 
These instruments combine multiple analytical functions into self-
contained, portable tabletop devices that can be used by non-
specialists to rapidly detect and diagnose disease, and can enable the 
selection of a definitive therapy at the time of the visit to the 
physician. A prototypic example under development and funded by NIBIB 
can identify, from a single drop of urine, the DNA of the specific 
bacteria responsible for a given urinary tract infection. Moreover, 
this test can be completed in just a few minutes, compared to the 2 
days often required by standard culture techniques.
    A second example is in the area of improved diabetes control 
through non-invasive continuous glucose monitoring. Several NIBIB-
funded researchers are working to engineer such a device. One has 
developed a contact lens that changes colors in response to the 
concentration of glucose in tears. The lens wearer can compare the 
color of the contact lens to a chart in order to determine his glucose 
concentration. If indicated, medications to control blood glucose, such 
as insulin, can then be administered.

            NEXT GENERATION MINIMALLY-INVASIVE TECHNOLOGIES

Restoring Touch in Robot-assisted Surgery
    Robot-assisted surgery is expanding the applications and reducing 
the complications of minimally invasive surgery. Nonetheless, this 
expansion has been inhibited due in part to the lack of a sense of 
touch. When surgeons operate on their own, their hands provide 
important tactile feedback. Although all fields of surgery could 
benefit from tactile feedback, cardiac surgery is among the fields that 
have the most to gain. Because of the large number of sutures used, the 
delicate tissues involved, and the need for precise work, tactile 
feedback is essential in cardiac surgery. An NIBIB-funded research team 
is working closely with a cardiac surgeon to create a robotic system 
that delivers required touch sensitivity. Use of this system could 
result in fewer broken sutures, more consistent application of force to 
tissues during surgery, and suture knots with superior ability to stay 
together. This system is now in development, and it could also serve as 
an important teaching tool for surgical residents. Rather than the 
current practice of teaching students exclusively on live patients, new 
surgeons could obtain more extensive practice in the lab before 
performing live surgery. Using computer algorithms that recognize 
motion, a trainee's movements can also be compared to an expert's 
performance and assessed.

     NON-SURGICAL BIOPSY THROUGH NEW APPROACHES TO OPTICAL IMAGING

    The diagnosis of many conditions such as cancer depends on 
microscopic evaluation of tissue samples. Typically these samples go 
through a process of fixation and staining before they are looked at 
under a microscope in the pathology laboratory. NIBIB researchers have 
made significant progress in developing techniques to image tissue in 
place without the need for surgical biopsy, fixing, and staining. This 
new imaging approach makes use of the different fluorescent 
characteristics of normal and diseased tissue, and offers the potential 
for examining the tissue at the point of care, in the operating room or 
medical office. Many potential human applications exist, including 
imaging tissues that form as a sheet such as the bladder or bowel 
lining. Physicists, biophysicists, imagers, engineers, biologists and 
clinicians are working together to advance this technology.

         FEEDING AND SUSTAINING THE SCIENTIFIC TALENT PIPELINE

Interdisciplinary Training Programs
    An important goal of the NIBIB is to train a new generation of 
researchers equipped to meet the modern needs of interdisciplinary and 
transdisciplinary research. The Institute's proactive approach is to 
develop creative and flexible opportunities that will fill critical 
gaps in the career continuum while also enhancing the participation of 
underrepresented populations. As examples, the NIBIB has a program to 
co-train basic and clinical investigators, a Residency Supplement 
Program to provide research experiences to clinical residents and 
fellows, and postdoctoral support programs for interdisciplinary 
training to individual postdoctoral fellows.
    The NIBIB also supports and participates in a number of programs to 
address gender and diversity issues in biomedical imaging and 
bioengineering. The NIBIB partners with the NSF in the University of 
Maryland, Baltimore County, Meyerhoff Scholarship Program alliance. 
This has been an exceptionally effective diversity honors program. 
Eighty-five percent of the 511 students who have graduated since 1993 
have earned a science, technology, engineering, or math doctoral 
degree.
    The NIBIB has also partnered with the Howard Hughes Medical 
Institute to support the HHMI-NIBIB Interfaces Initiative, a program to 
develop new curricula to train Ph.D.-MD level scientists at the 
interface of the physical and life sciences and give them the knowledge 
and skills needed to conduct research. Collectively, these programs 
will help to train a new generation of researchers equipped to better 
meet the challenges of the 21st Century.
    Once trained, it is critical that we encourage those who aspire to 
be great scientists to pursue research careers. New investigators are 
the innovators of the future and their entry into the ranks of 
independent researchers is essential to the health of the research 
enterprise. In addition, the recent closure of the Whitaker 
Foundation--a catalyst in the evolution of bioengineering as a 
forefront discipline--has left many in the scientific community 
concerned about new and early career investigators. For these reasons, 
the NIBIB is specifically targeting new investigators for special 
funding consideration. This policy has proved to be successful; in 
fiscal year 2006 nearly one-third of the NIBIB-funded traditional 
research grant investigators were new NIH investigators. The NIBIB also 
participates in the trans-NIH ``Pathways to Independence'' program 
which will support recently trained scientists conducting independent, 
innovative research.

    Senator Harkin. Thank you very much, Dr. Pettigrew.

                           NIH COLLABORATION

    You know, it just seems like, every one of you, in your 
written testimony that I read, and sort of what you were saying 
here, you're all involved in this sort of personalized 
medicine. I guess I'm curious about that, and how that is 
proceeding, and whether or not there's enough correspondence, 
or I think, overlap--what's the word I'm searching for, when 
you talk together?
    Multiple Speakers. Collaboration.
    Senator Harkin. Collaboration, thank you, that's the word--
is there enough collaboration going on among you and other 
people at NIH on this? Is this a direction that's sort of, 
something new at NIH that I'm picking up on? Is there enough 
collaboration? I just throw it out there for anybody.
    Dr. Lindberg. I think it's endorsed by all.
    Senator Harkin. Yeah?

                         PERSONALIZED MEDICINE

    Dr. Collins. If you've seen Dr. Zerhouni's presentations--
and I know you have because he's been in front of this 
committee, he has very articulately, I think, put forward this 
notion of the four P's--of personalized, preemptive, predictive 
and participatory--as the emblems that need to be applied to 
medicine of the future, if we're going to move away from 
treating advanced disease in a direction that, in fact, 
prevents that disease in the first place, because clearly we 
can't sustain the curve we're on right now, as far as 
healthcare costs.
    I think we are all very much attached to that vision as the 
promise of the future. You know, you wouldn't go to a shoe 
store and just pick up a pair of shoes without noticing what 
size it was, and carry it off to the cashier. But, for 
medicine, we've been doing the one-size-fits-all approach, most 
of the time, because it was the best we could do, we didn't 
have enough information about how to personalize the prevention 
strategy, so everybody kind of got told to do the same thing, 
and most of the time they ignored us. Or the treatment 
strategies, because, you know, you had a diagnosis, well, 
here's what you're supposed to do, but that might not be the 
right drug for that person.
    We now have, I think, a golden opportunity to really change 
that perspective into one that is much more individualized, 
recognizing that while we're a lot alike, we're also different 
in really important ways that affect our chances of getting 
sick, and our abilities to prevent that. I do think--to answer 
your question about collaboration, this is one of the major 
topics the Institute Directors have gotten together on, the 
road map the common fund, has provided opportunities to bring 
projects of this sort more to the forefront, even when no 
single institute could do.
    So, certainly for me, after being at NIH for 14 years, I've 
not seen an atmosphere more in favor of collaboration and 
sharing of initiatives and willingness to not worry too much 
about which Institute gets the credit than what I see right 
now. Of course, in times of budget constraints, it's even more 
critical to do that, it's critical at any time. But now, with 
things being so tight, I don't think any of us want to let an 
opportunity go by that we might be able to get together and do.
    That also extends to collaborations outside of NIH. One of 
our big projects to look at the genetics of common disease is a 
public/private partnership where a good deal of the costs of 
the project are being covered by a pharmaceutical company, even 
though they get no benefit from it, other than the assurance 
that it's going to get done right, and the data will be 
accessible to them and everybody else and everybody else at the 
same time.

                           NIH COLLABORATIONS

    Senator Harkin. Anybody else on that?
    Dr. Collins. Just on pharmacogenetics, pharmacogenomics, 
are the differences in responses to drugs, that's actually a 
trans-NIH program that's been in place before the Roadmap, the 
pharmacogenetics research network and then now involves, I 
think, 10 or 11 different Institutes and Centers, working on 
different diseases and different drugs, but sharing a common 
knowledge base, and sharing expertise in how to design trials 
appropriately, and, I mean, use the available technology. I 
think it's very much a collaborative effort that's much more 
than the sum of the parts, because it's been so well 
coordinated from the get-go.
    Senator Harkin. In the back of my mind in all of this is 
that the cost of healthcare keeps going up and up and up and 
up. It seems like every time we come up with new discoveries, 
it just costs more money. So, should we quit discovering 
things?
    Dr. Lindberg. I'd like to comment on the collaboration, 
because----
    Senator Harkin. Oh, okay. Because I want to follow-up on 
this idea that I was, just a--but, go ahead, go ahead, on the 
collaboration, go ahead.
    Dr. Lindberg. Well, often we've been asked, ``Do you ever 
collaborate with anyone?'' I always come prepared with, 
starting to make a list, and it's--it always is a very, very 
long list for NLM----
    Senator Harkin. Yeah.
    Dr. Lindberg [continuing]. Because it's natural to 
collaborate.
    But, I think in this list that I made for this particular 
moment, in case you asked, I was surprised to find that we're 
actually, there's more collaboration within HHS than I've ever 
seen in 23 years.
    For example, we work with FDA now, you know, when you get a 
medication, there's a little tiny thing in there that tells you 
all the things that could happen, and if you can, got eyesight 
good enough----
    Senator Harkin. You need a 50 power magnifying glass, 
that's for sure.
    Dr. Lindberg. Yeah, I mean, it's a totally ridiculous 
thing.
    But anyway, we have a team that has worked to produce a new 
thing through a RX Norm that's a new way to identify those 
drugs, and it was done with VA and with FDA, surprisingly 
enough, and FDA now sends us, every day, 300 or 400 new sort of 
packaging of that stuff, so it can go up online, and an 
ordinary person can read and halfway understand it.
    That's--that's sort of amazing. We're working with the 
Office of the Secretary on a Radiation Event Medical Management 
little, a chippy, like this one, and--for toxicology with the 
National Institute of Environmental Health, and also the CDC, 
so actually, there's more collaboration in the health agencies 
than I've seen in past years. Of course, lots at NIH, as well.
    I think you'd--I think you actually can be sure that that's 
happening.
    Senator Harkin. That's good, that's reassuring.
    Dr. Berg. Senator, can I comment, briefly on your point 
about costs going up?

                           HEALTH CARE COSTS

    Senator Harkin. Yes.
    Dr. Berg. With improved diagnostics--and actually knowing 
what disease it is that you're treating, and treating the right 
people--I think there's a real hope that the costs will go 
down. One example is breast cancer treatment. One of the first 
personalized medicine products that's out there is a gene chip 
that looks at expression patterns and is reasonably good at 
predicting whether or not someone is likely to benefit from 
chemotherapy.
    Senator Harkin. Yeah.
    Dr. Berg. The potential consequences of this is that you do 
this test early on and only treat the people who are likely to 
benefit from the very expensive treatment. Don't treat in the 
same way, people who aren't going to benefit from the expensive 
treatment anyway.
    Senator Harkin. Well, it was said to me once, you know, if 
you took the money that goes into health care now, how many 
trillion is it now? Whatever it is. I don't think people would 
mind so much the expenditure, in terms of percentage GDP if, in 
fact, that money went for preventative medicine, early 
detection, so that people didn't have to go through these 
excruciating illnesses, and have to go through chemos and 
radiation and all of the other things you go through--we've 
done pretty well there, in terms of patching and fixing and 
mending later on, but that costs a lot of money.
    In fact, it ought to be shifted, now, to an earlier point 
in time for identification, risk factors, and then getting 
people on the right course of action as they go through their 
life to prevent the onset of illness--I don't think there would 
be that much consternation on the spending of money. Most of 
the people just see it as just going for the same old, you 
know, patch and fix me up once I get in trouble.
    So, I'm encouraged that, what you're all talking about here 
is moving that point of interaction with the patient earlier on 
some point in time. That's going to cost money. It's going to 
cost money, but hopefully as we reach--as we develop these new 
research regimes, and new techniques, new interventions, that 
some of the other stuff will start coming down. That's our 
hope, anyway. I hope it's not a false hope.
    Dr. Collins. No, I think that's a very wise vision, and one 
that could be achieved, it really does require a change in 
mindset, and of course, it requires a change in reimbursement 
also----
    Senator Harkin. That's true.
    Dr. Collins [continuing]. In terms of how health care is 
paid for in this country.
    Senator Harkin. That's the ticket.
    Dr. Collins. Which is a big issue.
    Senator Harkin. Is how we reimburse.
    Dr. Pettigrew. If I could just interject here, and follow-
up on an earlier question--what you just described, Senator, is 
the paradigm that we currently operate under in health care, 
and that is a curative paradigm.
    Senator Harkin. Sure.
    Dr. Pettigrew. Where the response is after there's a 
symptom, and an obvious problem. And, what you also described 
is, where we're headed and going as a preemptive paradigm, in 
which technologies--like the one we've talked about, that we've 
all talked about--will be able to provide an indication that 
there is a developing disease, early enough so that we can 
intervene at a time where the technologies that we have to 
prevent serious consequences, are effective.
    You notice that all of us sounded the same tone of 
personalized health care. I think the reason for that, is that 
the more that we learn about disease, the more we appreciate 
that a disease that has a given name can be quite different in 
different people, and typically is quite different in different 
people. So, Dr. Berg mentioned breast cancer as an example, and 
we know that there are significant differences in the gene 
expression patterns associated with breast cancer, and 
consequently, the treatment should be different--it's not a 
one-size-fits-all-type of paradigm or approach. That is 
certainly where we're headed.
    I think all of the technologies that we certainly support, 
really are aimed at being able to see things when they are 
earlier in the disease process, and in addition to that, 
developing therapies which are very targeted, specifically to 
the offending biologic process.

              NIH GENES, ENVIRONMENT AND HEALTH INITIATIVE

    Dr. Collins. Senator, can I add one other thing to this 
discussion, because I think it's a really important one, and 
that is the importance of paying attention to the environmental 
contributions, as well as the genetic ones. I think sometimes 
people get the sense that we're so excited about genetics--and, 
believe me, some of us are--that we're ignoring the fact that 
common diseases like heart disease and diabetes and cancer, are 
some interplay between hereditary predisposition, and some 
environmental trigger, and we need to understand both.
    We particularly need to understand the environment, because 
that's the part we might be able to change in somebody who's at 
high risk, in order to reduce that risk.
    In that regard, and this also plays into your question 
about collaboration, there is this initiative called the Genes, 
Environment, and Health Initiative, which has now participation 
by virtually all of the NIH Institutes, and for which $40 
million a year have been allocated for the current year, and 
three more years after this, assuming the budget allows for 
that.
    This is explicitly an intent to both identify what 
hereditary factors are involved in common disease, but also to 
develop new and more accurate technologies for assessing 
environmental exposures--in the air, in the water--and also 
what the effect of those exposures are on the individual. So, 
you not only want to know what's out there, and you not only 
want to know what the body burden is, you want to know what the 
response was, biologically, of that person. Because it might 
have been that a particular substance was handled just fine by 
one person, was actually quite dangerous for another.
    David Schwartz, the Director of NIEHS, and myself, are co-
leading this effort, this Genes, Environment and Health 
Initiative, and already a large number of scientists have 
gotten engaged in helping to lead this, and we will fund, in 
the next few months, a substantial number of new proposals to 
try to accomplish this hand in hand, not studying genes in 
isolation, or environment in isolation, but really getting 
those two fields together, in a cohesive way. And, I think 
that's a very exciting and timely effort, at the present time, 
where we could finally really begin to get our minds around 
what are the causes of these common disorders, and what we 
could do about it.

                         KNOCKOUT MOUSE PROJECT

    Senator Harkin. One other thing you mentioned in your 
written testimony, you didn't mention it here, was this--tell 
me about this Knockout Mouse Project, I just don't understand 
it.
    Dr. Collins. All right, I'm happy to, Senator. That's 
another example of a wonderful collaborative effort, because 
this involves 19 Institutes that have gotten together to 
support this.
    So, what's a Knockout Mouse? Probably conjures up images of 
people in a boxing ring punching a little rodent, that's not 
quite what we had in mind.
    Senator Harkin. Or just rubberstamping the same mouse or 
something, I don't know.
    Dr. Collins. No, the idea here is, the mouse remains our 
best laboratory research model for trying to understand human 
disease, and mice have about 20,000 genes, just like humans do. 
If you can find a human gene and look at it, you can almost 
certainly find the mouse homologue of that gene, and it will 
have a similar sequence. Many times, what we've learned about 
human diseases, in terms of exactly what's wrong when a gene is 
misspelled, we've learned first by looking at what happens when 
that gene is misspelled in the mouse, because there we can do 
breeding, we can do careful examination in ways that we can't 
with people.
    So, about 2000 or so, mouse genes have been systematically 
knocked out, that is, inactivated, to see what the consequences 
would be. That has been a major part of NIH-funded research 
now, for more than 20 years. But, it's been done in an 
individual laboratory way. Many of the papers in the medical 
literature describe the consequences of these knockouts, and 
it's taught us a prodigious amount about biology and disease.
    But, we think we've reached a point where this kind of 
cottage industry knockout is maybe not the way to go forward. 
We want to see what happens, now, systematically, if you were 
to knock out, one at a time, all 20,000 genes, and do it in a 
sort of Genome Project mindset where you would do it with high-
efficiency, low-cost, and easy access to the outcome. That's 
been another problem, some of the mouse knockouts have been 
made multiple times, because people haven't been willing to 
share, and we want to make sure that this time these are all 
made in a way that anybody with a good idea can get access.
    So, all of the institutes got together--even in a tough 
budget time--and agreed to donate parts of the budget here to 
make this happen, and we also joined up, quite vigorously, with 
the Europeans, who have a similar interest in this, and the 
Canadians, who have a similar interest. Just this past March, 
we had an international meeting in Brussels, where we pulled 
together an International Knockout Mouse Consortium, with all 
agreeing to work together to get this done, as quickly as 
possible, at low cost as possible, with high quality, and to 
make all of these mice accessible to any investigator who wants 
it.
    So, basically, what we're going to end up doing here, is 
saving the NIH a ton of money.
    Senator Harkin. Help me understand this, you're going to 
knock out one gene----
    Dr. Collins. At a time.
    Senator Harkin [continuing]. At a time.
    Dr. Collins. Yes. These days that can be done in a sort 
high through-put way.
    Senator Harkin. So then you've got a mouse with a gene 
knocked out.
    Dr. Collins. Yes.
    Senator Harkin. What are going to do with that mouse?
    Dr. Collins. So, basically, those will be available as 
frozen embryonic stem cells to anyone who then wants to 
investigate that one, and see, ``Okay, what happens when that 
gene is knocked out?'' We, at the present time, we don't have 
the funds to take all 20,000 and put them through a very 
elaborate set of measurements to see, ``Well, is there a 
problem with the nervous system, is there a problem with the 
blood system, do they have some birth defect of some sort?'' 
We're going to count on the community to, one by one, as they 
get interested in a particular knockout, to do that, and then 
put that information in the public domain. But, what we won't 
expect them to do, is to actually go and do this tricky thing 
of knocking out that specific gene, which people have been 
doing, but at a very inefficient sort of basis.
    Senator Harkin. How long will it take you to do this?
    Dr. Collins. Five years is the estimate, to get all 20,000 
of these knocked out and available, I hope we can do it sooner.
    Senator Harkin. They're done in different places around the 
globe?
    Dr. Collins. So we at NIH, we're funding two major centers 
to do this, but in Europe, there's a major center, in Canada, 
there's a major center. We are all now working together to make 
it clear that we don't duplicate the effort--each center has 
their own list of which genes they're responsible for, we watch 
closely to see what progress is being made, we'll reassign some 
if people fall behind in one place, and get the centers that 
are going faster to pick up the slack, just like the Genome 
Project, it's international, it requires a lot of careful 
management and tracking, but it's very achievable.
    Senator Harkin. That's interesting. The one thing that 
comes to mind is that if I'm not mistaken, genes interplay. So, 
if you knock out one gene, maybe that doesn't do much. But, 
maybe if you knocked out one 10 notches down, it might have 
another effect.
    Dr. Collins. It's a very good point, Senator, and in fact, 
if you have them all generated as knockouts one at a time, by 
mouse breeding, you can make any combination you would then, 
like, to look at the interactions.
    Senator Harkin. Yeah, I guess that----
    Dr. Collins. That's the beauty of being able to figure out 
who mates with whom--which you can do in the mouse cages.
    Senator Harkin. I guess that just comes about through 
various studies and things, and looking at different genes that 
have an effect on one thing or another, and matching those up. 
Yeah, I can see how that would work.
    Dr. Collins. So, take for cancer, for instance, what we're 
learning about these ``tumor suppressor'' genes, that is, genes 
that normally keep cells from growing out of control when 
they're not supposed to. A lot of what we've learned is to 
knock those genes out in the mouse, those mice generally do 
develop a cancer of some sort, you can then understand by 
breeding in other kinds of mouse genetic changes, is there some 
way to suppress that cancer, by activating some other part of 
the pathway--exactly like you say. It's a very powerful system. 
You can do some of these things by cells growing in laboratory 
dishes, but there's no substitute, really, for having an intact 
animal, where you have complete control over the whole system.

                         EXPLANATION OF HAPMAP

    Senator Harkin. Explain that HapMap to me again.
    Dr. Collins. Yeah, what is this thing?
    Senator Harkin. My question is, cost reduction on studies?
    Dr. Collins. Yes.
    Senator Harkin. Detailed map of the one-tenth percent 
variation--tell me about that?
    Dr. Collins. All right, sure, I'm happy to, this is one of 
my favorite topics, Senators.
    So, your DNA and mine are 99.9 percent the same, that would 
be true if I picked anybody else to compare myself to, we're 
all that similar. But, that point .1 percent is still a lot of 
differences, because the genome is such a big place, with 3 
billion letters in the genome, .1 percent of that, well, that's 
still 3 million changes between you and me, and if we looked at 
the whole room, and asked, ``How many places are there in the 
genome where, as a roomful of people, we have common 
differences?'' I'm not going to talk about the rare ones that 
you might find only once, but the common ones, because those 
are the ones that often drive the risk of common diseases--
there would be about 10 million of those in the whole genome.
    So, in that collection of 10 million variants, there are 
some we really want to discover, that play a role in diabetes 
risk, or heart disease or cancer or asthma or schizophrenia. 
Yet, finding which one is a real needle in a haystack.
    What HapMap set out to do, was two things. One was, first 
of all, to build that catalog of those 10 million variations, 
because when HapMap started in 2002, we only knew of about 2 
million, and we clearly needed a more thorough look.
    But, the other thing that HapMap did, which turned out to 
be an incredibly useful shortcut, was it figured out that these 
variations in the genome are not traveling independently of 
each other. They're basically traveling in neighborhoods. So, 
if there's a neighborhood on a chromosome where you have 30 or 
40 SNPs, there's a good chance if you check two or three of 
those, and see what their variation is--a SNP, by the way, is a 
Single Nucleotide Polymorphism which is just a fancy word for 
saying a ``difference in DNA spelling.'' If you check two or 
three out of those 30 or 40, you can probably predict what the 
others are going to be without even looking at them, and that's 
a reflection of the fact that we're a young species, and these 
segments of the chromosomes, neighborhoods, if you will, have 
been traveling in unbroken form since our common ancestors.
    Well, you see how that's valuable. That means, if you're 
looking for a variant that plays a role in asthma, for 
instance, you don't have to check all 10 million. If you check 
a carefully chosen 300,000, it turns out, is about the number--
and I say carefully chosen because you've got to know what the 
boundaries of these neighborhoods are, some of them are little, 
some of them are bigger, what HapMap did was to tell you how 
those neighborhoods are organized--then for a fraction of the 
effort, you can actually look at the entire genome, and you 
won't miss the answer, you'll find the neighborhood where the 
culprit is hiding. That saves about a factor of 30 or 40 in the 
amount of work you have to do.
    That, plus these technologies, like these chips that I 
brought to show you--which have greatly cut down the laboratory 
costs, mean that we got from this $10 billion price tag for 
doing a diabetes study, to less than 1 million, and that is a 
profound change in the space of just 5 years.
    So, HapMap plus technology forward is a magnitude drop in 
cost. Phenomenal.

                           INTRAMURAL PROGRAM

    Senator Harkin. All right, nice explanation.
    Dr. Berg, I want to ask you some--I was reading over your 
testimony, you mentioned Jeffrey Gray and Ryan Harrison, caught 
the bug, he was in high school, he met a person at Johns 
Hopkins through an outreach program, he spent 2 years working 
in his laboratory, came in fifth place in the Intel Science 
Talent Search, et cetera, et cetera--what outreach program got 
him interested?
    Dr. Berg. There's a program he attends at the Baltimore 
Polytechnic Institute that has a program of scientists from 
around the area who can come and just give talks about what 
careers in science. I think it was when he was in 10th grade he 
went to one of these, and thought this sounded, he didn't----
    Senator Harkin. It wasn't an outreach program from you?
    Dr. Berg. It wasn't supported by NIH, no. Although we do 
have programs--not at the high school level--but at other 
levels that try to do the same sort of thing.
    Senator Harkin. I guess that was my question. Is there a 
specific program for high school kids to intern with scientists 
in labs that's backed by NIH? Is there such a thing?
    Dr. Berg. We have a diversity supplement program for high 
school kids. If someone has a lab and wants to have a high 
school kid come in and work in their lab, there's a way of, to 
get some support through that program for a particular person. 
But it's an NIH-wide program.
    Senator Harkin. What do you mean, it's NIH-wide, I mean, 
don't you handle it?
    Dr. Berg. Every Institute has their own version of it. For 
us, it's a supplement to a grant. So if they have a grant from 
NIGMS, they can apply, but if they have a grant from any other 
institute, they can apply as well, and that particular grant is 
supplement.
    Dr. Collins. The other big program we have is summertime 
internships in the intramural program at NIH, we have hundreds 
of high school students who compete avidly for the opportunity 
to come and spend 10 or 12 weeks in a laboratory. Generally, in 
my lab, I take one or two each summer. They are full of talent, 
it's a very competitive program----
    Senator Harkin. High school? High school?
    Dr. Collins. High school kids. We also take college kids, 
but the high school program is very hotly sought after.
    Senator Harkin. How about--that would be a limited number, 
I mean, these come here for your intramural program.
    Dr. Collins. Right.
    Senator Harkin. But, I mean, this kid was at a lab at Johns 
Hopkins?
    Dr. Berg. Yes, he is now an undergraduate at Johns Hopkins, 
and working.
    Senator Harkin. How about when he was a high school 
student, he worked in a lab?
    Dr. Berg. Right.
    Senator Harkin [continuing]. At Johns Hopkins?
    Dr. Berg. Right.

                         ADOPT A SCHOOL PROGRAM

    Senator Harkin. How much of this is done around the 
country? We've got labs all over the country that are funded by 
NIH. Do we have any program, that you know of, do you know of 
any program at NIH where high school students, who have 
exhibited an interest in science, and would like to spend an 
internship, a summer, testing out whether or not they really 
want to get into this kind of research, and do that? Is there 
a----
    Dr. Lindberg. This is a little bit harder to do than it 
sounds like, but we're trying to get at that.
    I should say, first of all, that many of the Institutes at 
NIH have an Adopt-A-School Program. We, for instance, have 
adopted, in Series Two inner-city high schools in The District 
of Columbia and that's pretty successful, so there's a lot of 
movement back and forth there. But, I mean, high school kids 
are young, so they can't just drop out and tool around, they 
might get a summer. But, anyway, we're trying hard to do that, 
we've had several outreach programs with high school--large 
numbers of high schools, five or six together, for instance, 
New York we just did, with NYU being the host.
    You can get them for a day, and that's about it. We tried 
one in Chicago, and they, the schools let us down on the 
transportation with busses, and we had--so we had those kind of 
basic problems.
    I would say the best program that I know of is in Houston, 
and it's the, now-called the Michael DeBacky High School for 
Science, and it's associated with Baylor. It's taken them over 
25 years to get the thing really working, it took 20 years 
before they even called it the Michael DeBacky School, but he 
and the other Baylor faculty have pitched in, and it is, again, 
an inner-city school, but it's got something like 98 percent of 
the kids going into college, and most of those going into 
science. So, it's a very intense activity, but a very 
successful one.
    We're trying to follow that model, of course.
    Dr. Berg. Let me add one other program, so, another way 
that we try to influence early science education is we have a 
series of curriculum supplements that are developed that we 
make available to teachers from around the country, and NIGMS 
developed one less than 2 years ago on doing science, so it's 
not on any particular disease, but it's about the scientific 
process, curiosity, and designing experiments and controlled 
experiments, intended for 7th and 8th graders, and that is--was 
developed in partnership with the NIH Office of Science 
Education. We went through all 25,000 copies of it in, I think, 
a little less than a year, I think it's the first--most widely-
distributed supplement that they've done. So, this gives tools 
for the, for teachers to develop strong programs.
    Senator Harkin. How many students come out to NIH every 
summer for this?
    Dr. Collins. I don't know the exact numbers, it's in the 
hundreds.
    Senator Harkin. Oh, yeah?
    Dr. Collins. Yes, and every university I know----
    Senator Harkin. These are high school kids, they've got a 
place for them? I'm getting into the weeds now, on this, but 
I'm really curious as to----
    Dr. Collins. I can get you those numbers, Senator. I don't 
actually know how many high school, how many college are there 
in the summer, but the place is crawling with summer trainees, 
which makes it a great place to be in the summertime, all kinds 
of irreverent questions being asked about science.
    Every university that I've ever been involved in has a 
similar program in the summer in their own location to try to 
bring students in.
    One thing we do, on April 25, which is DNA Day every year, 
because of the publication of Watson and Crick's paper in 1953 
on April 25--we send all of our post-docs and graduate students 
out to high schools, and they spend the day, all over the 
country, talking about the excitement about the science that's 
happening as a consequence of our understanding of DNA. That's 
been, this has been the fifth year we've done that, this year. 
It is both great for the students, and it also activates the 
post-docs to take this on as part of their own professional 
future, that they're going to spend some part of their time 
reaching out to high schools in their own vicinity, and trying 
to teach about what they do.
    Senator Harkin. I'm looking for, I just, ideas, ways of 
which we get high school students interested, provide access to 
post-docs and people like that who can kind of bring them along 
a little bit.
    Dr. Lindberg. I can give you another number, because every 
summer we bring a dozen to 15 students from this inner-city 
school, and we used to bring six faculty. So that we were, we 
thought, helping them. I would say that the net results of that 
is that the students are fantastic, they're really good, and I 
think they make progress even in the course of one short 
summer, and the faculty flunk.
    We've stopped--we think that's throwing good money after 
bad, and we stopped supporting it. We still bring the students. 
But, they have different things to learn, I mean, for instance, 
the first bunch we brought through, we gave them--like you're 
giving us--5 minutes to say something about what do they 
accomplish in the course of the summer, and two actually passed 
out, I mean, this was a tremendously threatening thing. You 
know, a board room, and all of these adults, and you know, it 
was awful. So, we decided that, you know, one of the top things 
they've got to learn over the course of the summer, is stand up 
and make a presentation, look in the eye and tell you, and that 
is top of the list, and they do very, very well. Now, they're 
actually doing multi--they're doing Power Point and Keynote and 
all of these kinds of things.

                             PUBLIC ACCESS

    Senator Harkin. Yeah, sure.
    There's a lot of talk about publication of research 
articles, and how soon it should be done. We're getting input 
from private publications and others, I don't know the answer, 
but I just want to know--if Congress were to require that all 
NIH-funded research articles be deposited in the PubMed Central 
Database, which is the public access plan that NIH has 
proposed--how would that improve scientists' ability to conduct 
research?
    Dr. Lindberg. Well, I think it probably would improve it 
quite a bit. I mean, one of our tests, probably, is from PubMed 
Central right now, and that is the place that these things 
would go and the proposals that we've described. The number 
that are coming in voluntarily is way less than 5 percent of 
the amount that should come in, but lots of other sources are 
putting in articles, that are free forever, the publishers and 
so forth--there's a million articles now in that three set, and 
it's very, very heavily hit, something like 12 million per 
month get looked at.
    If you looked at it another way, like, ``Are all of those 
of any interest?'' Well, 75 percent are of interest. This 
includes many that we're scanning in from, well, the old 
issues, let us say, when one publisher says, or society, ``You 
may have this thing,'' then we say, ``Okay, if at our expense 
you would allow us to go and scan in all of these old ones, 
back to Volume 1, Number 1, you know, which you have copyright 
to,'' so they have a right to say yes or no, would you do that, 
and then we'll do that if it can be made freely available 
forever.
    Well, lots have said yes, and the Wellcome Trust in England 
has partnered with us on that, I mean, they, it's dollar for 
dollar, although actually the pound is going up faster than the 
dollar has, so we've made a little money on the deal, and so 
that's going forward very, very well, and that's part of this 
experiment, in which I said, David Lipman is here, he can 
confirm all of this for me, but he tells me that 75 percent of 
those articles do get used right away, so they are of real 
interest. I think it would make a big difference.

                         MEDLINE PLUS MAGAZINE

    Senator Harkin. Well, I appreciate that for the record. We 
don't really know exactly what we're going to do yet.
    But, I wanted to ask you about MedLine Plus magazine.
    Dr. Lindberg. Great, I love it.
    Senator Harkin. Again, I've felt for a long time that----
    Dr. Lindberg. There's a new one.
    Senator Harkin [continuing]. That NIH--yeah, you just 
showed it to me.
    Dr. Lindberg. Yeah, okay, good.
    Senator Harkin. I've got it right here, I have it right 
here. I have felt for a long time that NIH had to be more 
aggressive in getting their stuff out to the general public, 
both at basic science base, but also in translation, so people 
can understand it. That's why I was happy to join you when you 
started putting this magazine out, because this is readable. I 
mean, you know, even I can understand some of this stuff.
    So, I think it's a great resource. And, again, I'd like to 
see copies of this in every doctor's office around the country. 
People ought to come in, and they ought to have access to it, 
and online, you say they can get access online now.
    Dr. Lindberg. Yeah, but most people don't yet have 
computers and access.
    Senator Harkin. I understand that.
    Dr. Lindberg. I'd like to see it, just as you say, sitting 
in that waiting room, when they're so boring.
    Senator Harkin. Well, how many copies are you putting out?
    Dr. Lindberg. Well, we're putting out around 50,000 right 
now, between 40,000 to 50,000, and that's being financed partly 
by the Friends of NLM found the money to do this, some 
contributions from the NIH Institutes on a passing-the-hat 
basis. In order to do what you said, we think that we probably 
could do it by--there are around 500,000 doctor's offices, so 
if you schedule, say, three per office, that would be 1.5 
million each quarter, 6 million per year, would cost around 
$3.6 million.
    Senator Harkin. $3.6 million per year?
    Dr. Lindberg. Yeah, and we have about $.4 million, so we're 
lacking $3.2 million. How to get it, obviously would be 
childishly simple, to get it through advertising, but that 
would defeat the purpose, we think, of the whole operation, 
so----
    Senator Harkin. Yeah, true.
    Dr. Lindberg [continuing]. We've just sworn we're not going 
to do that. So, we've got to get it either by private 
contributions, or appropriations.
    Senator Harkin. Well, would doctor's offices subscribe to 
it? I mean just, you know, would they pay for it out of their--
--
    Dr. Lindberg. I don't know, we could try it. We haven't 
tried it, I must say. But we could try it.
    Senator Harkin. There's some good stuff in here.
    Dr. Lindberg. Actually, it would be--it is the only case in 
which NIH is delivering information, publications, directly to 
patients. I mean, of course, there's lots of information on all 
of the Institutes' websites, just as ours, but that's a little 
different, that's not a publication, often it's as much for 
scientists as for patients, but this is aimed right at, between 
the eyes of the patient.
    I must say, I was interested in the conversations we've 
just had, because some of the things Dr. Collins spoke about 
are really, the doctors and the researchers. You're 
communicating with them magnificently, even if you've got to go 
to poor old Belgium to do it.
    But, a lot of the other things you spoke about first just 
won't happen, at all, unless the patients understand it, and 
agree to it. Including this environmental thing. Because, I 
mean, who knows where the exposure is, the patient is the 
expert on the exposure. Unless they believe in this, and 
participate and understand it, you know, maybe through this 
kind of a magazine, maybe through everyone else's efforts, none 
of this stuff will happen. First of all, if they don't trust 
us, I mean, you have now your Federal legislation pending, that 
would be a big help. But, I think they have to understand, as 
well.
    I mean, if this whole genetic experiment runs up against 
stem cells, that's, that we don't want to put up with, we don't 
want to have it stopped, we want it understood and welcomed.
    Senator Harkin. I missed that, if it's up against what?
    Dr. Lindberg. Well, if people were to conclude that the 
genetics, the experiments you're talking about have any sort of 
a political or religious bias, or----
    Senator Harkin. Oh.
    Dr. Lindberg [continuing]. Obstacle, that would be very, 
very bad. It would be incorrect, we don't want that to happen, 
but it would be an obstacle to getting this work done, this 
personalized health experiments. So, I think these magazines, 
this effort is an important one.
    Senator Harkin. Well, I'm just saying----
    Dr. Lindberg. I appreciate your help.
    Senator Harkin [continuing]. Is there, what more can we do? 
I mean, $3.2 million, that gets it to every doctor's office, 
now you want to get it also out to community health centers. I 
suppose maybe your doctor's offices include community health 
centers----
    Dr. Lindberg. Yeah.
    Senator Harkin [continuing]. Maybe.
    Dr. Lindberg. Well, I think the higher the volume, the 
less, you know the prices decrease. These things are about a 
dollar apiece, I think they can get it now for something like 
50 cents, that would give us our 6 million, if you get that, 
maybe we can drive it below that, find some other way to get it 
done. Because they can download them right now, free, and copy 
it themselves.
    Senator Harkin. I thought you said I could download this.
    Dr. Lindberg. You can, yes, yeah, sure. But, I don't know 
how many people would do it, maybe we can more people doing it, 
maybe that's what the doctors could do, instead of paying a 
fee.
    Senator Harkin. Yeah, still, people like to pick up stuff, 
and read it.
    Dr. Lindberg. I agree, I agree, I agree. But, I think the 
volunteer agencies, for instance, the alliances have been 
wonderful to work with, you have lots of work with them and----
    Senator Harkin. Which one can I get the money from?
    What are your budgets here?
    Dr. Berg. Senator, let me give you one other thing we've 
been doing, in terms of trying to communicate the basic science 
messages. It's an electronic newsletter called Biomedical Beat, 
where we go through the press releases for the investigators 
that we support, and write one- or two-paragraph, plain 
language, understandable, hopefully, descriptions of some of 
the advances. It's been growing for a little bit more than a 
year now, and the number of people who actually subscribe has 
increased.
    Senator Harkin. Let's take a look at that $3.2 million, 
huh?
    Dr. Lindberg. Yes, sir.
    Senator Harkin. All right.
    Dr. Lindberg. The price is good until midnight.

                       HUMAN MICRO BIOME PROJECT

    Senator Harkin. We'll see what we can do about that.
    Let's see, what else did I want to go over here?
    Dr. Collins, you mentioned the new effort called Human 
Micro Biome Project, trillion of microbes in the human gut, you 
went to talk about obesity and intestinal--could we also find 
out what causes irritable bowel syndrome and things like that, 
too? It seems to be an exponential rise up.
    Dr. Collins. So, this Micro Biome opportunity is another 
example of something we couldn't have dreamed of doing as 
recently as 3 or 4 years ago.
    You know, our bodies are both populated by microorganisms 
in various body cavities and orifices, some not proper to 
mention in a Senate hearing, and there are also, of course, 
many microorganisms in our skin. It's clear that we coexist 
with those organisms, happily most of the time, in fact it's 
clear they contribute to our health. But if something goes awry 
and the balance is off or you get the wrong microorganism in 
the wrong place, then one can result in an unfortunate disease 
situation.
    Yet, we don't know nearly enough about this. We've been 
limited in our understanding of microbiology by what kinds of 
bacteria we can actually culture in the laboratory. It's clear, 
that's only a tip of an iceberg. There's lots of other 
microbes, particularly in our GI tract, that you can't grow. 
Yet, they're there, and many of them are probably helping us 
and some of them have the capacity to hurt us. So, how would we 
get at those?
    Well again, the promise of being able to do very high 
through-put, very cheap DNA sequencing comes to mind, because 
these microbes have DNA also. DNA is their instruction book, 
just like ours. So, even if you can't culture them, you can 
determine what their DNA is by simply doing a--what we call a 
metagenomic experiment, where you make DNA from a whole 
collection of microbes and you read out the sequences and you 
piece together what must have been there.
    Again, because this would have been prohibitively expensive 
until 3 or 4 years ago, it hadn't been approached in a very big 
way.
    A very recent experiment that I think got everybody's 
attention about this, done by Jeff Gordon at the Washington 
University in St. Louis, relates to obesity. Where he was able 
to show--initially in mice, and then in people--that the 
particular collection of microbes in the gut have a lot to do 
with whether that mouse is going to be obese or not obese.
    In fact, you can take an obese mouse and put the microbes 
into that animal that had previously been in a skinny mouse, 
and the fat mouse starts to get skinny too, without any other 
change. So, there's something going on there, in terms of an 
interaction between the host and the bacteria that live in 
their intestinal tract. That's been possible also now to show 
with people, that a change in body weight can be accomplished 
by a change in microbes.
    Now, imagine what a wonderful circumstance that would be, 
if we could figure out how to help people lose weight or not 
gain weight, simply by altering their intestinal flora. It's 
not unimaginable that might not be the case.
    So, we have, in fact, again as a collaborative effort 
involving lots of institutes, come up with a plan, which we 
hope will be funded as part of the Common Fund--because this is 
one of those that touches upon all of the institutes you see 
here and many that you don't--to enable a really organized 
effort to try to characterize what bacteria are present in 
these various parts of the body. How variable are they from 
person to person? What happens when you take antibiotics for an 
ear infection? Does it just throw everything off? How long does 
it take it to recover?
    If you looked at identical twins, do they have the same 
microbes, or are they different? If they're different, why are 
they different? Particularly, what happens with inflammatory 
bowel disease or with vaginitis or with a particular kind of 
dental problem like periodontitis, that changes those microbial 
flora in a way that we currently really don't understand, that 
might lead you into a pretty good idea about how to correct the 
situation.
    So, it's very exciting. Again, another international 
opportunity here, because the Europeans are very interested in 
this and I think you're going to hear a lot about this in the 
course of the next 3 or 4 years as the amount of data we can 
generate really goes up very quickly. This instrument, this 
sensor that Dr. Pettigrew told you about, could, of course, be 
a way in which whatever we learn about microbes could be 
quickly translated into a diagnostic, yes, once you know what 
to put on that diagnostic in order to access what particular 
thing is there that you want to know about right away.
    Senator Harkin. Well, that's all well and good. I hope you 
don't mind if I remain skeptical.
    Dr. Collins. Don't mind at all.
    Senator Harkin. I mean come on, look, I mean, calories in, 
calories out. More calories in, less calories out, it's stored, 
it's stored as fat.
    Dr. Collins. We used to think it was just that simple. To 
first approximation it is, but clearly the microbes in your gut 
are a big part of your digestive process.
    Senator Harkin. It has to do with the rate of how fast you 
burn up your energy, too.
    Dr. Collins. Also, whether you're really efficient at 
absorbing what you take in, or whether some of it doesn't 
actually get absorbed. That has a lot to do with what goes on 
in the distal small intestine, and particularly the colon, and 
the microbes apparently have a bigger part of that. I think we 
were all surprised. I was skeptical too, until I saw this paper 
in Nature from Dr. Gordon. It looks quite compelling.
    It only takes a tiny change in your efficiency of absorbing 
what you eat over the course of many weeks to have a 
significant effect on what happens with body weight. It doesn't 
mean that it has to be this drastic difference based on what 
microbes are there. A little bit makes a big difference over 
the course of a long period of time.
    Senator Harkin. I, again, I remain skeptical. I just find 
that, it seems to me that we just need to change some diets and 
habits and what we consume as kids in this country, in terms of 
carbohydrates and fats and starches and sugars and everything 
else that we consume too much of. We get in these habits and 
habits are hard to break.
    Dr. Collins. Senator, I think you're absolutely right. This 
may be a modification of that fundamental principle that might 
make it a slightly easier case for somebody who's really 
struggling, but you're basically correct.
    Senator Harkin. That is true. Some people have different 
rates of metabolism. People have to exercise and eat less than 
other people in order not to become obese. I understand that, I 
understand.

                          MACULAR DEGENERATION

    I want to ask about macular degeneration. Dr. Berg, you 
talked about macular degeneration in a way--and I wrote this 
down--reverse damage. Is what you're doing, is it at the point 
of stopping it from progressing, or can you actually reverse 
the damage?
    Dr. Berg. This is not something that we're directly 
funding. The idea is that it does not reverse the damage, but 
stops the progression.
    Senator Harkin. Yeah.
    Dr. Berg. The way that the pathways contribute to the 
progression of a disease are understood, to some degree, you 
can block them with this RNA interference-based therapy.
    Senator Harkin. Where are we in that? I mean, are we in 
human trials right now?
    Dr. Berg. Yes, the phase one trials were successfully 
completed, the phase two trials are underway now.
    Senator Harkin. It actually stopped the degeneration?
    Dr. Berg. That's my understanding. The initial trials are 
just safety related, but they're into the phase two trials now 
and the expectation is that this therapy, if all goes well, 
will be on the market, I believe, in 2009.
    Dr. Lindberg. I think even before that, though, the eye 
guys have reported that, you know, once they've--well, first of 
all, the important thing is that a single gene could be seen as 
responsible for this disease, which was thought in the past to 
be one of these complex things that must be complicated, but 
wasn't.
    So, once having found that that has to do with capillary 
growth, the ophthalmologists just reached out and took a 
syringe full of Avastin and injected it in the globe. If you do 
this every 10 days for four or five times, you know, 
metaphorically, they give you back your driver's keys, you 
know, that you can go from those big things to those small 
things and you can drive a car again. So I mean, it's a pretty 
enthusiastic kind of response.
    Senator Harkin. Fascinating.
    Dr. Collins. This is really a wonderful success story and 
comes from several directions, Senator. So, basically, macular 
degeneration, particularly the wet type, does seem to be 
something that's gone awry, in terms of capillaries. But the 
treatment that Dr. Lindberg's referring to actually came out of 
the study of cancer, where we realized, particularly from the 
work of Judah Folkman, that cancer seems to have the ability to 
grow, particularly because it recruits blood vessels. Of 
course, if you can block the blood vessels, you can starve the 
tumor and it might be a very effective approach.
    That's what this drug Avastin is all about, it's an 
antibody against a particular factor, VEGF, which is what blood 
vessels need in order to proliferate. So, you're blocking that 
proliferation. It's a very powerful scheme.
    But, it turns out that this same strategy works quite 
nicely for this wet form of macular degeneration because, there 
again, your goal is to try to block the proliferation of these 
blood vessels that are causing the blindness issue. In fact, 
there is a fragment of Avastin that's called Lucentis, I think 
it is, which was approved by the FDA for treatment, which is 
just as effective but I gather, has some economic 
disadvantages.
    So, here we are in a circumstance where a disease that we 
considered to be both untreatable and probably not possible to 
understand, in the space of a short period of time, we've come 
a long way.
    The mention of genetics has also been a big surprise. Most 
people thought this disease, which comes on in your 70s, 80s, 
or sometimes even 90s, was not going to have anything to do 
with genetics. But it turns out there are a couple of genes 
which play the major role, along with smoking. If you basically 
can put those together, you can make a very strong prediction 
about who's at risk. Here's a chance to do prevention. Coming 
back to our idea about focusing on preventing the disease, 
instead of waiting until it happens.
    If we now know what the pathway is that causes risk here, 
which has something to do with inflammation, then perhaps by 
blocking inflammation in the eye, which we have drugs that are 
pretty good as anti-inflammatory agents, we might be able to--
with those people at very high genetic risk, to prevent them 
getting the disease in the first place. The Eye Institute is 
investigating that vigorously right now.
    Dr. Lindberg. But Avastin's pretty cheap.
    Dr. Collins. It is pretty cheap.
    Dr. Lindberg. It's an off-label use, of course, but, and I 
think the ophthalmologists are amazingly gutsy to do it. They 
impress me.
    Dr. Berg. The potential advantage of the RNA-based therapy, 
is the same pathway. What this RNA molecule does, it blocks the 
expression, not of VEGF, but the receptor, what VEGF docks 
into. As I understand it, what the trials have indicated is it 
might be longer lasting, so you wouldn't need to get these 
injections as frequently.

                          RNA AND FLU VACCINE

    Senator Harkin. You mentioned RNA also, in terms of 
pandemic flu virus. I've had different people in my office 
talking about, you know, producing the vaccines. You're right, 
we really have to wait until we find out exactly what strain it 
is that is going from human to human. Once you do that, then 
you can develop the vaccine, but it takes a while to develop 
the vaccine, obviously, ape-based, long time. Then there was 
another process. Cell-based.
    Then, someone came out and said, ``Oh, there's an RNA-based 
method and it's even quicker than anything.'' But you were 
talking about it in terms of, excuse me, getting all these 
different strains and finding some RNA-based system of covering 
them all, but that was different than what I had heard. What I 
had heard, you'd wait until you found out exactly what the 
strain was, then you would develop an RNA-based vaccine to that 
exact strain and you could do it in just a couple months or 
something like that. What am I not understanding here?
    Dr. Berg. Because we now have sequences of many flu 
strains, we can see which parts of the viral RNA genome are 
conserved. Those are things which presumably the virus can't 
change to avoid, without damaging itself. Because RNA 
interference is so general, you can target the RNA molecules 
anywhere you want. We can go after regions in the viral genome 
which don't vary from strain to strain. This concept has the 
potential to be something which I was very skeptical about, 
sort of a universal flu vaccine.
    Senator Harkin. Universal flu vaccine. Is that being 
pursued right now? Is that----
    Dr. Berg. It is. There's a company that's been developing 
it in partnership with Novartis (it originally started with an 
SBIR grant from NIH). Again, it's early stage, but----
    Senator Harkin. So how come they were talking to me about--
again, I'm just, I don't know much about this, everyone on my 
staff does, but I was led to believe that RNA could only be 
used to develop a vaccine for a specific strain, not for a 
universal vaccine. That's why I don't, I'm having a hard time 
understanding this.
    Dr. Berg. Right. This is a whole new world of therapeutics 
and, again, the macular degeneration example is the one that's 
most advanced. This requires a whole new pharmacology. We still 
don't know very much about how to deliver these RNA molecules 
as drugs.
    Senator Harkin. So it's possible----
    Dr. Berg. It's possible.
    Senator Harkin [continuing]. To get a universal flu 
vaccine, no matter what strain comes out.
    Dr. Berg. That's the promise. Again, this is very early----
    Senator Harkin. But again, should we be putting more energy 
and effort and money into that, or into building facilities 
that, when the strain comes out we can put people to work right 
away developing the vaccine on an RNA basis?
    Dr. Berg. For the time being, I would say, you absolutely 
need to continue to invest in the technology to make the 
vaccine available. The whole concept of this technology is only 
a few years old. There are lots of potential problems, such as 
how do you deliver RNA molecules? How do you keep them stable 
enough so that they work? There are lots of hurdles to be 
overcome, but advances in any one area have the potential to 
impact the whole field.
    Senator Harkin. My gosh, if you could develop a universal 
vaccine, that would be the answer to everything.
    Dr. Berg. Absolutely. We're investing, and NIAID is 
investing very heavily in moving this forward.
    Senator Harkin. When is Dr. Fauci here?
    Mr. Fatemi. May 21.
    Senator Harkin. Anyone here talk to the Doctor, tell him 
I'm going to ask him that.
    Dr. Berg. I will warn him.
    Dr. Collins. I have a feeling he'll hear about this.
    Senator Harkin. Warn him I'm going to tell him, ``Dr. 
Berg's got a different approach.''
    Dr. Berg. Well, they're the ones who are supporting it, so 
it really just stems from this discovery of RNA interference, 
which opened up this whole new approach and that's obviously an 
area where, if we could do it, it would have a huge impact.

                             NANOTECHNOLOGY

    Senator Harkin. Dr. Pettigrew, I didn't much get into it 
with you, but this whole area of nanotechnology that I know a 
little bit about, we hear it being applied in all different 
areas of physics and material sciences and things like that, 
nanotechnology, but I don't hear too much about it in health. 
Most of what I read about nanotechnology as to material 
sciences, physics, that type of thing, but--computers, but not 
too much in health. So what is there in nanotechnology that I 
don't know about? What implications does it have for health and 
health research?
    Dr. Pettigrew. Well, it's actually quite involved in 
health, and much of the technology that I refer to in my 
testimony regarding the ability to detect diseases at the 
cellular and molecular level would, in fact, involve devices 
that are constructed at the nanometer scale. As you know, a 
nanometer is a billionth of a----
    Senator Harkin. The delivery mechanism?
    Dr. Pettigrew. As a delivery mechanism, and also, as a 
mechanism for observing the response to a therapeutic 
intervention.
    For example, we've talked several times now about breast 
cancer and heart disease and so forth. One might envision--in 
fact, there is considerable work already under way in this 
area, to develop a probe that consists of a nanometer-sized 
particle, which carries three components on this particle. The 
first component is a homing agent that delivers the particle to 
the specific target, such as the HER2 receptor in breast 
cancer. The second component on this particle would be an 
imaging agent that allows you to see that, in fact, it went 
there. It also allows you to see how much went there, and the 
size of the tumor, in the case of cancer. The third thing would 
be to deliver a therapeutic agent, such as a gene that codes 
for vascular cell death, apoptosis, which actually has been 
demonstrated in some early studies.
    So, you'd have this one particle that is target-specific, 
goes directly to the target of interest, say a cancer cell, or 
the vascular supply to the cancer cell, as Francis mentioned 
about angiogenesis and the role that that plays, in which the 
goal is to destroy the antigenic activity.
    The gene is delivered specifically, by way of this targeted 
nanoparticle, to the cells that make up the lining of these 
tiny blood vessels, kills them, and destroys the vascular 
supply.
    So, I think that nanotechnology is very much involved. I 
don't know if you've had the NCI participate in the hearings 
yet, but when you talk with them, you'll hear about their large 
nanotechnology research effort aimed at developing just these 
kinds of probes. My Institute, as well, is very involved. We 
have a substantial part of our funding, is active in this, in 
this area. These devices are termed biosensors, in the sense 
that they send out a signal when they interact with the 
particular biologic process you're trying to discover.
    Another example would be to identify tumors on the basis of 
the enzymes that they produce, such are protease, which lyses 
proteins. You have a structure that's constructed in such a 
way, and this is nanometers in size, that it has two components 
linked chemically by a bridge. The two components are such that 
one emits light and the other one absorbs light.
    When they're closely constructed, the emitted light is 
absorbed by the counter-component, but the bridge is 
constructed in such a way that is it lysed specifically by the 
enzyme that the cancer produces. So, when this nanostructure 
reaches the cancer, and is tailored to be lysed by a specific 
protease, that lyses, breaks these two components apart and, as 
a result of that, you can see it and you see the light.
    So, the detection of light means that you've found the 
cancer. This allows you to identify cancer at an early stage, 
this is where the preemption comes in, is because you can 
identify it at the cellular stage. Also, monitor the response 
to various therapies. So----
    Senator Harkin. This is part of translating what you're 
doing into actual?
    Dr. Pettigrew. Yes. Yes. Absolutely. So again, just to 
emphasize, I mean, much of the work that's going on now in 
developing innovative new technologies that will allow you to 
identify disease early on, this happens at the nanometer scale, 
one. Then two, deliver therapy specifically targeted to that 
expression of the disease in that individual, also done by 
nanotechnology.

                  GENE THERAPY RESEARCH IN EYE DISEASE

    Senator Harkin. Anything else, Dr. Collins, about gene 
therapy--what was that dog's name?
    Lancelot, the dog. I met Lancelot the dog a few years ago 
and Lancelot was blind and they did gene therapy and the dog 
sees. I understand that's now been done, replicated on a number 
of other dogs. I think the last I heard they were now going to 
primates.
    Dr. Collins. Going to primates called people.
    Senator Harkin. Oh, I thought we were just going into----
    Dr. Collins. So, there is a clinical trial about to get 
underway, which is supported by NIH. Yeah, this is a really 
fascinating story. So, the condition here is Lever's congenital 
amaurosis.
    Senator Harkin. That's it.
    Dr. Collins [continuing]. Which causes blindness.
    Senator Harkin. Exactly.
    Dr. Collins. In this case, different than macular 
degeneration, it's a degeneration of the retina.
    Senator Harkin. Right.
    Dr. Collins. This particular version of it is caused by 
mutations in a gene called RPE65, which doesn't mean very much, 
but it turns out the briard dogs have this same genetic 
problem, which is why Lance was such a good model to try it 
out. I've also seen the films of these dogs before and after 
treatment, which are really dramatic----
    Senator Harkin. It's dramatic.
    Dr. Collins [continuing]. Going from bumping into 
everything to clearly having a good grasp of what's around them 
through their corrected vision.
    So, this is a circumstance where gene therapy injected into 
the eye, carrying in the gene therapy vector, the right version 
of this gene to make up for the fact that the one that the 
patient has is not working, shows a lot of promise. In fact, I 
don't know whether, in fact, they've enrolled the first 
patients. This must be about the time where they were getting 
ready to do so, and I think I just saw last week, there's also 
a study getting underway in Europe for the same condition also 
using the same gene therapy vector. So, I think we all wait 
with bated breath to see if what worked so nicely for the dogs 
is going to work for people as well, with, I think, a good 
reason for optimism.
    Senator Harkin. That's great. That's great. That would be 
under probably the National Eye Institute I assume, right?
    Dr. Collins. Yeah.
    Senator Harkin. But you, obviously know about it since it 
has to do with genes and everything.
    Dr. Collins. Yeah, exactly, but Dr. Sieving could tell you 
even more.
    Senator Harkin. Exactly.
    Well, thank you all very much, thank you again for your 
leadership, all that you're doing at NIH.
    Does anybody have any last thing for the record, before 
we----
    Dr. Pettigrew. Yeah, I just wanted to comment on the 
earlier question regarding training for students.
    Senator Harkin. Yeah.
    Dr. Pettigrew. While I think it is more of a challenge to 
get high school students at the NIH, we do have two programs 
directed at undergraduate students, both on the NIH campus 
where we bring in a group of undergraduate students, and train 
them specifically in bioengineering, and we also have a 
program, in conjunction with the National Science Foundation 
where we establish 10 sites around the country at 10 
universities, where students at the undergraduate level, and 
early graduate level, come and work specifically in these areas 
of new technologies.
    Senator Harkin. Mm hm.
    Dr. Pettigrew. We have a third program that we've recently 
created in partnership with the Howard Hughes Medical 
Institute, to develop a new training curricula, focusing 
specifically on team science and interdisciplinary sciences, as 
I mentioned before, which is very much one of the waves of the 
future, where you bring together scientists of multiple 
disciplines.
    We think that these will be the scientists of the future, 
and that in order to really make that a reality, that the 
curricula that exists today need to be modified, so that the 
languages of these different disciplines--mathematicians, and 
biologists and physicists talk in different languages and know 
different things--are brought together and understand human 
biology and disease, as well as a physical science world, so 
that once they finish school, the can serve and function more 
effectively in a team science situation.
    Dr. Collins. Senator, if I could----
    Senator Harkin. Yeah.
    Dr. Collins [continuing]. Just as one final comment, 
express thanks from all of us, to you and Senator Specter for 
the leadership that you've shown through these years in 
supporting NIH. In my 14 years at the Institution, I've never 
seen more scientific opportunity, more excitement, more young 
scientists champing at the bit to jump in and solve problems 
that are going to have profound implications on human health. 
It is really a remarkable time.
    Yet, we are caught in this dilemma where, we're not limited 
by ideas, we're not limited by talent, we're not limited by 
potential for transforming medicine, we're really limited by 
the ability to take the resources that we've got and try to 
stretch them as far as we can. We really appreciate the way in 
which you and Senator Specter have led this process to try to 
make it possible for us to do as much as we can.
    This diabetes discovery that I'm so excited about, just in 
the last 2 weeks, opens up a whole new set of opportunities in 
terms of prevention and treatment----
    Senator Harkin. Sure.
    Dr. Collins [continuing]. Yet when I look and see that we 
spend the equivalent of one latte per year, per American, on 
diabetes research--not a venti, mind you----
    More like a grande--it does seem sort of discordant, we 
could do so much more.
    Senator Harkin. Well, thank you all very much, thanks, Dr. 
Collins. Well, it's been a great partnership with Senator 
Specter and with me, and over all of these years, and we've 
seen some great things happen, and right now we're really 
concerned about the budget crunch, and the fact that we've 
doubled the funding at NIH, but now it's been leveling off and 
it's going back, and we never, ever intended for that to 
happen. We wanted to get it on a higher plateau, and then keep 
going up. We're both very dismayed by this, and we're going to 
try to everything we can to get a better allocation this year 
for NIH.
    But, that's just another battle we'll have to fight, I 
guess, on the budget.
    But, I agree with you, there's just a lot of exciting 
things out there. I mean, this is why I really talked about 
these young people, getting young people enthused and excited 
about a career in science, and getting them when they're young. 
I think during that period when we were doubling it, I kept 
asking questions about it, because young people now see that 
they could have a career in research, and I don't want to 
destroy that, I don't want to have them say, well, maybe yes, 
maybe no.
    Dr. Lindberg. Now they're stranded.
    Senator Harkin. Yeah.
    We've floated them out there, now they're stranded out 
there. So, hopefully we can fix that, with better budgets and 
that kind of thing.
    Dr. Lindberg. Many thanks for all you've done.

                     ADDITIONAL COMMITTEE QUESTIONS

    Senator Harkin. There will be some additional questions 
which will be submitted for your response in the record.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]


               Questions Submitted by Senator Tom Harkin

                             NLM FACILITIES

    Question. Dr. Lindberg, I understand that NLM faces increasingly 
stringent space constraints stemming from the continued expansion of 
its collections, the growing need for computing infrastructure for 
storage, search and retrieval of electronic media and the successful 
implementation of its many important programs. Can you provide some 
examples of how space limitations affect the Library's ability to 
fulfill its many functions for information services, research and 
training?
    Answer. Space limitations affect a range of NLM operations and 
services.
    NLM's onsite space for new manuscript collections, such as the 
papers of eminent biomedical scientists and the records of important 
professional societies and foundations is at capacity. It is 
anticipated that the Library may be completely out of space for all 
collections, including printed books and journal volumes, films, 
pictures, and electronic collections, by 2010, even projecting a yet-
to-be seen decline in hard copy publications. NLM serves as an archive-
of-last-resort for the health community, provides access to materials 
that are not available elsewhere in the world and preserves materials 
that other health sciences libraries discard. Due to space limitations 
NIH no longer maintains on-campus training facilities used to teach NIH 
researchers and other staff to use NLM's search and retrieval systems. 
The rate of expansion NLM's National Center for Biotechnology 
Information (NCBI) has been partially governed by the speed with which 
NIH can locate and reconfigure office and work space for NCBI staff in 
other on-campus facilities.
    NLM's Go-Local service provides consumers and physicians with links 
from Medline search results to facilities that provide related health 
care services within their geographic regions. Existing facilities 
support 17 Go-Local sites, which cover one-quarter of the U.S. 
population. Additional space would be needed for servers that would 
allow expansion of Go-Local to cover the entire U.S. population. Space 
is also one factor that could delay the addition of servers and storage 
devices needed to house the molecular sequences data key trans-NIH 
research initiatives, such as whole genome association studies and 
metagenomics projects.
    Question. Can you tell us what steps NLM and NIH are taking to 
address these concerns and what more is needed?
    Answer. NLM is implementing a number of steps to provide additional 
space for its collections and operations. NLM currently leases space in 
other buildings, both on- and off-campus. As of spring 2007, NLM leased 
approximately 33,000 square feet of space in other on-campus facilities 
and approximately 23,000 square feet of office space off-campus. These 
figures compare to 312,000 square feet of space in the two NLM 
buildings (Bldgs 38 and 38A). In coming months, NIH has arranged for 
NLM to take occupancy of additional on-campus space to house staff of 
the NCBI. In addition, NLM plans to lease off-campus space for the 
expansion of NLM's computer facilities. To make additional space for 
its physical collections, NLM also plans install additional compact 
shelving in building 38. This will require structural reinforcement of 
the building to support the additional load of more densely packed 
books and manuscripts.
    Question. How cost-effective is it to lease additional space/
facilities?
    Answer. On campus, administrative space can be leased at a rate of 
approximately $19 per square foot, compared to approximately $37 off 
campus. Rental of on-campus space involves additional costs associated 
with moving NLM staff to the new site and relocating displaced NIH 
staff to other--typically off-site--facilities. Other costs must also 
be taken into account. In evaluating options for expanding its computer 
facilities, NLM found local expansion considerably less expensive than 
off-site locations due in no small part to the lower cost of 
electricity on campus.
    Question. What is the status of plans to construct the new building 
at the National Library of Medicine for which planning funds were 
appropriated several years ago?
    Answer. Architectural plans were completed in 2003 for a building 
that would provide additional space for Library collections and 
collaborative workspace for NLM's expanding research and development 
capabilities, in particular those of the NCBI. NIH did not request 
funding for construction in the fiscal year 2008 Budget.
                                 ______
                                 
            Questions Submitted by Senator Daniel K. Inouye

                       BASIC BEHAVIORAL RESEARCH

    Question. Dr. Berg, over the past 8 years, this subcommittee and 
our colleagues in the other body have pressed the NIH to find or assign 
a home for basic behavioral research at your institute. The NIH has not 
responded to positively to this matter even though this same request 
was a recommendation of the National Academy of Sciences and of 
Director Zerhouni's advisory committee. It is also a part of the NIGMS 
statute. Basic behavioral research needs dedicated leadership at the 
NIH in this important field of science. When will it be possible for 
NIH to respond favorably to this request?
    Answer. Basic behavioral research, like basic biomedical research, 
is supported throughout the NIH, both in disease- and stage-of-life-
specific institutes and in the institutes and centers with more general 
missions. An analysis performed by the working group of the Advisory 
Committee to the Director, NIH, indicated that nearly $1 billion in 
basic behavioral research is supported across NIH, including support 
within NIGMS. There is, and should be, basic behavioral research 
supported by each of the Institutes that relates to its mission.
    The authorization language for NIGMS states: ``The general purpose 
of the National Institute of General Medical Sciences is the conduct 
and support of research, training, and as appropriate, health 
information dissemination, and other programs with respect to general 
or basic medical sciences and related natural or behavioral sciences 
which have significance for two or more national research institutes or 
are outside the general area of responsibility of any other national 
research institute.'' In response to congressional inquiries and in 
keeping with this mission, NIGMS has initiated two programs recently. 
The first, ``Collaborative Research for Molecular and Genetic Studies 
of Basic Behavior in Animal Models,'' is intended to facilitate 
research involving basic behavioral scientists and investigators with 
expertise in modern molecular biology and/or genomics. The second, 
``Predoctoral Training at the Interface of the Behavioral and 
Biomedical Sciences,'' will support institutional training grants that 
provide new scientists with rigorous and broad training in behavioral, 
biological, and biomedical sciences. These new programs reflect the 
potential high impact of integrating behavioral and biological 
approaches to advance fundamental understanding and yield new 
approaches to promoting human health and treating disease.
    The NIH Office of Behavioral and Social Sciences Research (OBSSR) 
was established by Congress to stimulate research in behavioral and 
social sciences research throughout NIH and to integrate these areas of 
research across the NIH institutes and centers. Coordination across NIH 
is also enhanced by the establishment of the Division of Coordination, 
Portfolio Analysis, and Strategic Initiatives by the NIH Reform Act of 
2006. NIGMS and the other institutes and centers are working with OBSSR 
and the new division to ensure that NIH supports a broad portfolio of 
basic behavioral research to further the broad NIH mission. This broad 
base of support provides a wide range of opportunities for behavioral 
scientists to find support for their research that is relevant to the 
NIH mission. In addition, basic behavioral research, just like basic 
biological and chemical research, that underpins the NIH mission at a 
deeper level, can find support at the National Science Foundation.

                  INFORMATION RESOURCES FOR HAWAIIANS

    Question. Dr. Lindberg, last year you visited one of our native 
Hawaiian programs at Papa Ola Lokahi. I am most appreciative of the 
National Library of Medicine's continued interest in increasing access 
to health information and health resources for Native Hawaiians. What 
were your impressions of the Native Hawaiian programs at Papa Ola 
Lokahi?
    Answer. An NLM team visited Hawaii in July 2006 and came away 
impressed with the effectiveness of Papa Ola Lokahi in working with 
Native Hawaiian communities and health providers.
    Question. How can the National Library of Medicine and Papa Ola 
Lokahi work together to increase access to healthcare information in 
Hawaii?
    Answer. The National Library of Medicine and Papa Ola Lokahi are 
working together in a variety of ways to improve access to healthcare 
information in Hawaii. Working with Papa, NLM has supported two pilot 
projects--one to strengthen the community library at Miloli'i so that 
residents have online access to health information; a second to install 
a computer in the waiting room of the Waimanalo Health Clinic so that 
patients can access health information. Both projects have made very 
good progress and are nearing completion. Also, with NLM support, Papa 
organized a one-day meeting in July 2006 to discuss needs and options 
for preserving and strengthening the collections of Native Hawaiian 
Health materials. The meeting was attended by various Hawaiian museum, 
archival, academic, and community organizations with an interest in 
this topic. NLM was pleased with Papa's work to arrange and conduct 
this meeting, and is exploring possible follow up. NLM has also 
provided support to Papa for improvement of Papa's web site, and, 
earlier, for participation of two Papa staff persons in NLM's Native 
American Internship Program. Additionally, Papa is represented on the 
NLM-supported Health Information Task Force of the National Congress of 
American Indians. And a Papa staff person was invited to participate in 
the NLM-sponsored Tribal Outreach Conference held in July 2006 in 
Albuquerque, NM. NLM will continue its multi-dimensional relationship 
with Papa Ola Lokahi in order to enhance access to healthcare 
information throughout Hawaii.
                                 ______
                                 
              Questions Submitted by Senator Arlen Specter

                             PUBLIC ACCESS

    Question. Dr. Lindberg, please provide the following information on 
eligible articles deposited with NIH under the NIH Public Access 
Policy. Please include all articles that are eligible for deposit under 
the policy, including manuscripts and final published articles 
submitted by authors and publishers:
    (1) The total number of articles that have been deposited with NIH 
since the May 2, 2005 implementation date and the overall percentage of 
deposits to date. Please describe how you arrived at the total number 
of eligible articles.
    (2) The month-by-month deposits of articles, shown as a percentage 
of eligible articles available for deposit, and as a monthly total of 
the number of deposited articles from May 2005 to April 2007.
    Answer. (1) Total articles deposited with NIH under the NIH Public 
Access Policy, May 2, 2005 to April 30, 2007
    Articles deposited under the Public Access Policy: 6,196
    Total articles eligible for deposit under the Public Access Policy: 
142,000
    Percent Deposited: 4.4 percent.
    Using 2005 publication data as a baseline, we estimate that 71,000 
articles per year (or 5,916 per month) should have been deposited as a 
direct result of the Policy. This is a conservative baseline because of 
a general upward trend in publication rates from year to year.
    (2) The month-by-month deposits of articles, shown as a percentage 
of eligible articles available for deposit, and as a monthly total of 
the number of deposited articles from May 2005 to April 2007.

        TABLE 1.--AVAILABLE ARTICLES BY MONTH, AS OF MAY 31, 2007
------------------------------------------------------------------------
                                    Articles      Eligible    Percent of
             Month               deposited \1\    articles      target
------------------------------------------------------------------------
May 2005.......................           110         5,916          1.9
June 2005......................           107         5,916          1.8
July 2005......................           186         5,916          3.1
August 2005....................           146         5,916          2.5
September 2005.................           146         5,916          2.5
October 2005...................           156         5,916          2.6
November 2005..................           143         5,916          2.4
December 2005..................           161         5,916          2.7
January 2006...................           208         5,916          3.5
February 2006..................           172         5,916          2.9
March 2006.....................           175         5,916          3.0
April 2006.....................           166         5,916          2.8
May 2006.......................           231         5,916          3.9
June 2006......................           220         5,916          3.7
July 2006......................           160         5,196          2.7
August 2006....................           168         5,916          2.8
September 2006.................           252         5,916          4.3
October 2006...................           302         5,916          5.1
November 2006..................           317         5,916          5.4
December 2006..................           482         5,916          8.1
January 2007...................           746         5,916         12.6
February 2007..................           651         5,916         11.0
March 2007.....................           639         5,916         10.8
April 2007.....................       \2\ 152         5,916          2.6
                                ----------------------------------------
      Total....................         6,196       142,000          4.4
------------------------------------------------------------------------
\1\ Articles that are approved for release in PubMed Central, including
  articles that may not actually be released until 12 months after
  publication, as specified by the author.
\2\ Authors of articles submitted in April 2007 have only had a few
  weeks to review and approve them after conversion to the PubMed
  Central archival format. We expect the number of approved articles for
  April to rise in the coming weeks to the same level as for previous
  months, as authors have time to respond.

    At the request of publishers, NLM deployed a mechanism in December 
2005 (http://www.nihms.nih.gov/publishers.html#q2) to allow publishers 
to deposit author manuscripts on behalf of their authors. The welcome 
growth in deposits from September 2006 forward has been due mostly to a 
large publisher, Elsevier, beginning to use this system. As of April 
2007, Elsevier is submitting all of its author manuscripts based on NIH 
funded research.
    Author manuscripts need to be converted to an archival format for 
posting on PubMed Central. This conversion must be verified by the 
author. When author manuscripts are submitted by the authors 
themselves, the authors almost always complete this verification step. 
However, NIH is only able to post a portion of bulk deposits being made 
by Elsevier to PubMed Central, because many authors do not follow up 
with the necessary verification and approval. Author participation is 
voluntary under the policy.
    In previous reports on the Policy, we counted the initial 
submissions of files as the number of manuscript deposited. (The actual 
number of articles that could be publicly released was slightly lower, 
but the difference was not significant as long as the majority of 
deposits were made by individual authors.) However, because of the 
large dropout rate associated with Elsevier's bulk deposits in recent 
months, it is more accurate to count as deposits only those articles 
that have the author's final approval for release in PubMed Central. 
These numbers include author manuscripts that may not actually be 
released until 12 months after publication, as specified by an author.
    This more accurate measure of compliance applies to all of the 
articles reported in Table 1. As a result of this change in metrics, 
the deposits for 2005 and the first half of 2006 will be slightly lower 
than the corresponding numbers in earlier reports to Congress.
    For reference, Table 2 shows the total number and percent of author 
manuscripts sent to NIH via bulk deposit, made by Elsevier between 
September 2006 and April 2007. The right column shows the number that 
received the author's final approval for release to PubMed Central and 
is included in Table 1.

     TABLE 2.--ELSEVIER BULK DEPOSIT SUBMISSIONS, AS OF MAY 31, 2007
------------------------------------------------------------------------
                                               Manuscripts
                                  Manuscripts    approved
              Month               sent to NIH   for public     Percent
                                    via bulk    release by
                                    deposit      authors
------------------------------------------------------------------------
September 2006..................           77           52         67.5
October 2006....................           76           42         55.3
November 2006...................          204          120         58.8
December 2006...................          521          251         48.2
January 2007....................          711          398         56.0
February 2007...................          796          419         52.6
March 2007......................          810          389         48.0
April 2007......................        1,012          106     \1\ 10.5
                                 ---------------------------------------
      Total.....................        4,207        1,777        (42.2)
------------------------------------------------------------------------
\1\ Authors of articles submitted in April 2007 have only had a few
  weeks to review and approve them after conversion to the PubMed
  Central archival format. We expect the number of approved articles for
  April to rise in the coming weeks to the same level as for previous
  months, as authors have time to respond.

    We should note that Bulk Deposit is only one method by which 
publishers can submit content to PubMed Central. Under the Public 
Access Policy, two scientific societies have signed agreements to 
deposit all of their final published articles based on NIH funded 
research to PubMed Central. These PubMed Central (NIH Portfolio) 
agreements will result in 100 percent of their deposited articles 
posted on PubMed Central without author involvement.
    Independent of the Policy, a number of journals routinely deposit 
their complete contents in the PubMed Central archive. Many, including 
the Proceedings of the National Academy of Sciences and the eleven 
journals of the American Society for Microbiology, have been doing so 
since 2000 or 2001, years before the Public Access Policy took effect. 
Authors who publish in these journals do not have to deposit their 
manuscripts based on NIH funded research under the Policy, because a 
copy of the journal's published article is already available to the 
public through PubMed Central. These articles were not included in the 
baseline total of articles eligible to be deposited under the Policy 
(71,000 per year or 5,916 per month) and, therefore, are not included 
in Table 1. Approximately 700 articles based on NIH-funded research 
come into PubMed Central each month from regularly participating 
journals.

                          SUBCOMMITTEE RECESS

    Senator Harkin. Well, thank you all very much, and thanks 
for taking the time to come down here today, and your 
expertise, and wish you the best, and keep on doing what you're 
doing.
    May 21 will be our next NIH hearing.
    Thank you very much. The subcommittee will stand in recess 
to reconvene at 2 p.m., May 21, 2007, in room SD-116.
    [Whereupon, at 3:29 p.m., Monday, May 7, the subcommittee 
was recessed, to reconvene at 2 p.m., Monday, May 21.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              


                          MONDAY, MAY 21, 2007

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 2 p.m., in room SD-116, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin, Cochran, and Stevens.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENT OF DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL 
            INSTITUTE OF ALLERGY AND INFECTIOUS 
            DISEASES

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. The Subcommittee on Labor, Health and Human 
Services, and Education, and Related Agencies will come to 
order.
    I just thought that before we begin today's hearing I want 
to take a moment to offer my condolences to everyone, through 
you, at NIH over the recent passing of Dr. Steve Straus, the 
founding Director of the National Center for Complementary and 
Alternative Medicine. It's an enormous loss to science and to 
his many friends and colleagues at NIH where he worked for 27 
years. We always knew that Steve was a man of great integrity 
and skill and dedication. That was apparent from his many 
scientific accomplishments.
    But during his 2\1/2\ year battle with brain cancer we also 
witnessed his courage and his grace. He fought a valiant fight 
and was a teacher until the end. We were lucky to have him as 
NCCAM's founding director.
    He and I had many, many conversations and meetings on 
alternative medicine, complementary medicine, where we're going 
and how we fold that in with other mainstream research. I think 
he's one of those people of whom we can truly say that he did 
make the world a better place.
    So, this is the fifth of six hearings on the National 
Institutes of Health that the subcommittee will hold this year. 
We've heard from 13 Institutes so far. Today we'll hear from 
five more: the National Institute of Allergy and Infectious 
Diseases, the National Cancer Institute, the National Center 
for Research Resources, the National Institute of Nursing 
Research and the National Center on Minority Health and Health 
Disparities.
    I'll ask each Director to speak 5 to 7 minutes. In the 
spirit of how we've been doing this if I think of something 
while you're doing it I may even ask you a question at that 
time or--I excuse myself right now for interrupting. But we'll 
try to go through all of the testimonies and we'll just open up 
for general discussion after that.
    I kind of like this format a little bit more than the 
formal one of sitting at a dais and that type of thing. I'd 
rather have more of a free flow of a discussion, sometimes even 
amongst you sitting across the table from me.
    I think we learn a lot more and we get a better flavor for 
exactly what we're doing here. I know that C-SPAN and others 
pick this up. I look upon this as a way of also of teaching the 
public, getting information out to the public in a format in 
which they can get a better handle on just exactly what NIH is 
doing and what the different Institutes are doing.
    So with that I'll start us here on my left. Dr. Anthony 
Fauci has served as Director of the National Institute of 
Allergy and Infectious Diseases since 1984. He received his MD 
degree from Cornell University Medical College. He has 
testified before this subcommittee many, many times over the 
years on everything from AIDS to pandemic flu to bioterrorism. 
I took over the Chair of the subcommittee in 1989. That was the 
first time I met Dr. Fauci.
    So, welcome back, Dr. Fauci. All your statements will be 
made a part of the record in their entirety. Like I said if you 
could take 5 to 7 minutes or so, sum it up. I'd sure appreciate 
it.

               SUMMARY STATEMENT OF DR. ANTHONY S. FAUCI

    Dr. Fauci. Thank you very much, Mr. Chairman and thank you 
for the opportunity to talk to you today a little bit about the 
activities of the National Institute of Allergy and Infectious 
Diseases.
    I'm going to talk from some visuals that are right in front 
of you--right in front of you there.
    Senator Harkin. Okay.
    Dr. Fauci. I believe that's the top one. If you turn the 
page and look at the first slide.



    I want to use that to tell you something that I know that 
you're familiar with. But for the sake of the record I will 
just mention very briefly what the mandate and the mission of 
the National Institute of Allergy and Infectious Diseases is. 
As you know it's responsible for the bulk of NIH research in 
the disciplines of immunology, microbiology and infectious 
diseases.
    We're driven by two major issues. One is the scientific 
opportunity and the other is the public health need. You know 
about what we do from the much publicized issues such as HIV/
AIDS, pandemic influenza and bio-defense. But we also have 
responsibility for emerging/re-emerging microbes, vaccinations 
and immunizations for adults and children, the development of 
antibiotics, vaccines as well as the study of diseases of the 
immune system, including the important issue of immunological 
tolerance, which has a great potential in many areas of 
medicine that go well beyond our Institute's mandate.
    If you look at the next slide--I talk also here about what 
I call the dual mandate. Because in addition to all that we do, 
as every other Institute does, maintain a robust, basic and 
clinical research portfolio. For us it's microbiology, 
infectious diseases and the immune system. For Dr. Niederhuber, 
it's cancer and down the line. They each have what they do and 
what their Institute is responsible for.


    When I refer to our dual mandate I mean that we also need 
to be able to respond very rapidly to new infectious disease 
threats. You know we've discussed this at many hearings that 
we've had together on issues such as: HIV/AIDS, SARS, et 
cetera.
    In fact if you go to the next slide. This is a slide I must 
have shown to you, Mr. Chairman, over the years since 1989 
about 10 different times. The reason I can show you this--I 
hope without your getting bored, is that each year we add one, 
two and sometimes three, new emerging infectious diseases. In 
fact the print has gotten so small there that we're sort of 
running out of space. We started out with HIV/AIDS there, but 
you see there are many others that are emerging and re-emerging 
infectious diseases.



    Of particular note this time is one that we've just 
recently added, which I hope we get a chance to discuss in the 
question period. That is extensively drug resistant 
tuberculosis, which is an issue that poses a significant threat 
to us. Also there are multiple drug resistant microbes like 
staphylococcus and enterococcus as well as things like the E. 
coli contamination of our spinach and our lettuce that was a 
major challenge just some months ago.
    If you go to the next slide it really describes 
schematically, how we accomplish this. The NIAID research, for 
example on emerging and re-emerging infectious diseases is, as 
with all Institutes, based on a fundamental matrix of basic 
research which we hopefully then apply to the things that we 
need to do for the American public. In our case, it's the 
development of countermeasures, for example, in the forms of 
diagnostics, therapeutics and vaccines.



    What I'd like to do in the next couple of slides is just go 
over with you some of the selected accomplishments which are 
also selected opportunities. So I'll go through them rapidly 
with you. If you look at HIV/AIDS, there has been this year, in 
addition to the great accomplishments of drugs that have 
essentially transformed the lives of HIV infected individuals. 
We know now that there have been a total, in a conservative 
estimate of about 3 million years of life saved in the United 
States on the basis of the anti-HIV therapeutic regimens that 
have been used.


    This year we have a couple of new drugs that are very 
exciting and will in fact, even improve that menu of drugs that 
we have available. In addition we have expanded HIV vaccine 
trials that we have embarked upon: one in collaboration with 
Merck and one with the Vaccine Research Center at the National 
Institutes of Health. In addition there are new tools for 
improvement such as the announcement that you probably heard of 
a few months ago about the protective effect of medically 
supervised adult circumcision for the prevention of HIV 
infection.
    If you move on to malaria there have been some exciting new 
issues that have come up. For example, the sequencing of the 
parasite itself, and at least two or three of the vectors, 
namely the mosquitoes that cause it, allow us to get a greater 
insight into transmissibility, as well as drug resistance to 
the standard malaria anti-parasitic drugs.
    In influenza we're pleased to mention to you something that 
was announced just a short time ago, is that at our last 
hearing I mentioned to you that we were in the process of 
developing a pre-pandemic influenza vaccine. Just last month 
the FDA has approved that as an approved vaccine. We still need 
to make better vaccines for pandemic flu but we have at least 
one that's approved by the FDA.

                      UNIVERSAL INFLUENZA VACCINE

    Senator Harkin. That's not a universal?
    Dr. Fauci. No, no. We'll get to that, hopefully, in the 
questions. This isn't a universal--this is for the H5N1 bird 
flu.
    Senator Harkin. Specifically.
    Dr. Fauci. Specifically for the bird flu.

                EMERGING/RE-EMERGING INFECTIOUS DISEASES

    Then on the next slide I mention tuberculosis. I mentioned 
in my very earlier comments the real threat that we're seeing 
with this extensively drug resistant tuberculosis. NIAID has 
developed a strategic plan, very rapidly, which just this 
morning, at our National Advisory Council was presented to them 
for their final comments before we actually make it public. 
We'd be happy to provide that to you and your staff if you'd 
like it.



    Then finally potential bio-terror agents, we've enhanced 
the infrastructure. Again a year or two ago I showed you the 
blueprints for the physical infrastructure that we were going 
to do. Several of those buildings are either near completion or 
actually up or--and operational such as the building on the NIH 
campus, building 33.
    So if we go now to the last slide. I just want to close by 
saying that I've been talking to you about the threats of 
emerging and re-emerging infections and how the NIH research 
endeavor can meet these challenges, hopefully. I refer to it on 
this slide as a perpetual challenge because microbes will 
continue to emerge and re-emerge and nothing that we can do 
because of their evolutionary capability is going to allow us 
to completely eliminate the threat.


                           PREPARED STATEMENT

    Dr. Fauci. The best that we can do and I think it's 
something very important, is to maintain that balance by a very 
robust, research portfolio that can be wedded to our public 
health endeavors. We appreciate you and the committee for the 
support that you've given us over so many years. Thank you very 
much.
    [The statement follows:]

               Prepared Statement of Dr. Anthony S. Fauci

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Institute of Allergy 
and Infectious Diseases (NIAID) of the National Institutes of Health 
(NIH). The fiscal year 2008 budget includes $4,592,482,000.
    The mission of NIAID is to conduct and support research to 
understand, treat, and prevent infectious and immune-mediated diseases. 
Infectious diseases include well-known killers such as HIV/AIDS, 
malaria, tuberculosis, lower respiratory infections and diarrheal 
illnesses; naturally emerging or re-emerging threats such as pandemic 
influenza and SARS; and ``deliberately emerging'' threats from 
potential agents of bioterrorism. Preemptive medicine, in the form of 
vaccines and other prevention tools, is a major focus of the NIAID 
research portfolio in infectious diseases. Immune-mediated disorders 
include autoimmune diseases such as type 1 diabetes, lupus, and 
rheumatoid arthritis as well as asthma, allergies, and problems 
associated with transplanted tissues and organs. Here again, preemptive 
medicine is an important component of our research efforts, as NIAID 
extramural scientists work to predict, prevent, and treat immune-
mediated diseases more effectively.
    The NIAID mission has two distinct mandates. First, NIAID must plan 
and execute a comprehensive, long-term program of basic and clinical 
research on well-recognized endemic infectious and immune-mediated 
diseases. Second--and in this case distinctive among the NIH 
Institutes--NIAID must respond quickly with targeted research to meet 
new and unexpected infectious disease threats as they arise, often in 
the form of public health emergencies.

              EMERGING AND RE-EMERGING INFECTIOUS DISEASES

    Despite advances in medicine and public health such as antibiotics, 
vaccines, and improved sanitation, the World Health Organization (WHO) 
estimates that infectious diseases still account for approximately 26 
percent of all deaths worldwide, including about two-thirds of all 
deaths among children younger than 5 years of age. Moreover, the 
pathogens we face are not static, but change dramatically over time as 
new microbes emerge and familiar ones re-emerge with new properties or 
in unusual settings.
    Influenza is a classic example of a re-emerging disease. Because 
circulating human influenza viruses continually accumulate small 
changes, a new vaccine must be made for each influenza season. When an 
influenza virus emerges that has undergone a major genetic shift such 
that the global population has limited natural immunity but the virus 
can be easily transmitted among people, a worldwide pandemic can 
result. Three influenza pandemics occurred in the 20th century, 
including the 1918 pandemic that killed more than 50 million people 
worldwide.
    It is imperative that we take a preemptive approach to the 
possibility that a new influenza virus will emerge to cause a 1918-like 
pandemic. How well we do that, however, depends to a large extent on 
improving how we cope with seasonal influenza, which kills an average 
of about 36,000 people in the United States each year. Control of both 
seasonal and pandemic influenza requires development of and access to a 
sufficient supply of effective vaccines and antiviral drugs, effective 
infection control measures, and clear public communication. In this 
regard, NIAID research has directly laid the foundation for improved 
influenza vaccine manufacturing methods, new categories of vaccines 
that may work against multiple influenza strains, and the next 
generation of anti-influenza drugs. Certain of these goals will be 
accomplished through basic research projects intended to increase our 
understanding of how animal and human influenza viruses replicate, 
interact with their hosts, stimulate immune responses, and evolve into 
new strains. Other goals will be accomplished through targeted 
projects, such as a program to screen compounds for antiviral activity 
against influenza viruses.
    Since last year, we have made substantial progress in influenza 
vaccine research. The inactivated-virus H5N1 vaccine currently 
stockpiled by the Department of Health and Human Services has been 
shown in NIAID-sponsored clinical trials to be safe and capable of 
inducing an immune response predictive of being protective against the 
H5N1 virus in healthy adults, children, and seniors. Although the 
vaccine dose required to induce this response is high, studies on 
enhancing the immune response to lower doses by employing immune 
enhancers called adjuvants are showing promising preliminary results. 
NIAID also is collaborating with industry to pursue several other 
vaccine strategies in addition to inactivated virus H5N1 vaccines. For 
example, trials of cold-adapted, live-attenuated H5N1 vaccine 
candidates are underway, as is a Phase I clinical test of a novel DNA 
H5N1 vaccine candidate developed at the NIAID Vaccine Research Center.
    We also have made progress in antiviral drug and diagnostic test 
research over the past year. An NIAID program that screens both 
licensed drugs and new drug candidates--first in cell culture systems 
and then in animal models--has identified several promising anti-
influenza candidates that are now being further developed in 
partnership with industry sponsors. These include FluDase, which binds 
host cell receptors to prevent viral entry; T-705, which inhibits 
replication of viral RNA; and Peramavir, which inhibits an influenza 
enzyme called neuraminidase. Research into influenza diagnostics is 
being vigorously pursued. For example, NIAID-funded researchers, 
working in collaboration with scientists at the Centers for Disease 
Control and Prevention, have reported encouraging results with a 
potentially revolutionary diagnostic device called the MChip, which is 
capable of quickly and accurately identifying many influenza viruses, 
including H5N1.
    Tuberculosis (TB) is another emerging threat, especially with 
regard to new and dangerous drug-resistant forms of Mycobacterium 
tuberculosis that are being seen with increasing frequency. About one-
third of the global population is latently infected with the TB 
bacterium. WHO estimates that 8.9 million TB cases occurred in 2004, as 
did 1.7 million TB deaths; active TB is especially common among people 
with HIV. Currently, about 20 percent of new TB cases are a multi-drug 
resistant form (MDR-TB), meaning that they are resistant to two common 
and inexpensive antibiotics and are thus far more difficult to treat 
than uncomplicated TB cases. However, an even more resistant form, 
called extensively-drug resistant TB (XDR-TB), has appeared. XDR-TB 
already accounts for about 10 percent of all MDR-TB cases, that is, two 
percent of all new TB cases.
    The emergence of XDR-TB was not unexpected, but was a predictable 
consequence of imperfect compliance with the long and complex regimens 
needed to treat TB. We have long supported a large portfolio of 
research to develop new drugs, vaccines, and diagnostics for TB and to 
evaluate improved treatment and prevention regimens. As a result of 
that sustained effort, the ``pipeline'' of new countermeasures for TB 
is robust. At least nine new drugs are currently in clinical trials, 
including SQ-109, a promising candidate being developed in a private-
public partnership with Sequella, Inc. After a hiatus of 60 years in 
which no new TB vaccines were clinically tested, nine candidates are 
now in human trials, and at least ten more are in preclinical 
development. In addition, to ensure that the NIAID TB research program 
continues to contribute effectively to the global response to this 
increasing threat, the Institute has developed a comprehensive 
strategic plan for MDR/XDR-TB that will help guide our research 
efforts. .
    Influenza and TB are just two of many emerging and re-emerging 
infections on which NIAID conducts research. Malaria, long a leading 
cause of death worldwide, has become even more problematic because of 
the emergence of drug-resistant malaria parasites and insecticide-
resistant mosquito vectors. NIAID supports a large portfolio of malaria 
research that has generated many promising drug and vaccine candidates, 
some of which are now in clinical trials; this research is related to 
the President's Malaria Initiative, which was discussed at the December 
2006 White House Malaria Summit. In addition, NIAID conducts research 
on many other less common, but nonetheless important tropical diseases 
such as leishmaniasis, trypanosomiasis, hookworm, and lymphatic 
filariasis, which exact an enormous toll worldwide.

                           HIV/AIDS RESEARCH

    In the almost 26 years since it was first recognized, the acquired 
immune deficiency syndrome (AIDS) has become a global catastrophe. An 
estimated 39.5 million people worldwide are infected with HIV, the 
virus that causes AIDS. In 2006 alone, an estimated 4.3 million people 
were newly infected with HIV, and 2.9 million died of AIDS.
    Although the global HIV situation remains grim, our government's 
investment in HIV research has generated many solid successes, and the 
healthy pipeline of new drugs, vaccines, and other prevention methods 
promises more successes in the future. Antiretroviral therapies made 
possible by NIAID-supported research have transformed HIV from an 
almost uniformly fatal infection into a manageable chronic condition. 
In this regard, a recent study concluded that since 1996 these 
antiretroviral medications have saved at least 3 million years of life 
in the United States alone. These life-saving therapies are now 
reaching the developing world: 1.6 million persons are now receiving 
antiretroviral therapy, more than half of them with support from the 
President's Emergency Plan for AIDS Relief (PEPFAR). In addition to 
these accomplishments, several new generation antiviral drugs that 
target HIV in novel ways are in the final stages of development.
    Prevention efforts continue to be a major component of NIAID's HIV 
research program. We have improved our ability to prevent mother-to-
child transmission. Research to develop topical microbicides capable of 
blocking HIV transmission during sexual contact is proceeding 
vigorously. And in December 2006, two NIAID-supported trials in Kenya 
and Uganda showed that medically supervised circumcision of adult males 
can significantly lower their risk of contracting HIV through 
heterosexual intercourse. The most powerful tool to prevent HIV 
infection would be a safe and effective HIV vaccine. NIAID is currently 
supporting 20 clinical trials of HIV vaccine candidates. Seven of these 
have moved beyond initial Phase I safety and immunogenicity testing. 
For example, in January 2007, a Phase IIb ``proof of concept'' trial of 
a non-replicating adenovirus vector modified to contain three HIV genes 
opened in South Africa. A related trial of the same candidate is 
ongoing in volunteers from North America, South America, Australia, and 
the Caribbean in collaboration with Merck pharmaceutical company. The 
NIAID Vaccine Research Center has also developed an HIV vaccine 
candidate that is currently being tested in Phase II trials, with an 
international Phase IIb efficacy trial set to begin later in 2007. 
Because of the enormous need for human testing of HIV drug, vaccine, 
and other prevention strategies, we recently reorganized our HIV/AIDS 
clinical trials network to make our clinical research capacity more 
efficient so that we can continue to meet evolving global AIDS research 
challenges. Additionally, NIH will contribute $300 million to the 
Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria in fiscal year 
2008.

                          BIODEFENSE RESEARCH

    The possibility that terrorists will use a biological agent to 
mount an attack is a serious threat to the citizens of our nation and 
the world. Research to preempt and mitigate this threat is a key focus 
of NIAID, and complements our role in meeting the challenges of 
naturally emerging and re-emerging infectious diseases. Our strategic 
planning for biodefense research includes three essential pillars: 
infrastructure needed to safely conduct research on dangerous 
pathogens; basic research on microbes and host immune defenses that 
serves as the foundation for applied research; and targeted, milestone-
driven development of medical countermeasures to create the vaccines, 
therapeutics and diagnostics that we would need in the event of a 
bioterror attack. These efforts enhance not only our preparedness for a 
bioterrorism attack, but for naturally occurring endemic and emerging 
infectious diseases as well.
    NIAID has undertaken a substantial expansion of biocontainment 
research facilities, which will greatly enhance our ability to safely 
and efficiently conduct research on infectious agents. For example, 
through its extramural program, NIAID is supporting the construction of 
two National Biocontainment Laboratories capable of safely containing 
the most deadly pathogens, as well as thirteen Regional Biocontainment 
Laboratories nationwide. Three intramural biocontainment labs--on the 
NIH campus, on the National Interagency Biodefense Campus at Fort 
Detrick in Fredrick, Maryland, and at the NIAID Rocky Mountain 
Laboratories in Hamilton, Montana--are either complete or well under 
construction. In addition to these facilities, NIAID has established a 
nationwide network of ten Regional Centers of Excellence (RCEs) for 
Biodefense and Emerging Infectious Diseases Research, which conduct 
research and development activities and provide training for future 
biodefense researchers.
    The Institute's efforts have already yielded substantial dividends 
as described in our periodic progress reports, the latest of which was 
issued in January 2007. For example, new or improved vaccines and 
therapies against anthrax, smallpox and Ebola virus have shown great 
promise; among these is ST-246, a promising smallpox drug candidate 
that protects both rodents and nonhuman primates from lethal challenge.
    NIAID also has been assigned the responsibility to coordinate 
research to develop countermeasures against a range of radiological and 
chemical threats. We have established eight Centers for Medical 
Countermeasures against Radiation and four Centers for Countermeasures 
against Chemical Threats; in addition, basic and applied research is 
moving rapidly. We continue to coordinate and collaborate on these 
important components of our national security with our sister 
Institutes at NIH as well as interagency partners, including the 
Department of Defense, Department of Energy, and Department of Homeland 
Security.

                  RESEARCH ON IMMUNE-MEDIATED DISEASES

    Autoimmune diseases, allergic diseases, asthma and other immune-
mediated diseases are significant causes of chronic disease and 
disability in the United States and throughout the world. NIAID-
supported research in immune-mediated diseases has led to significant 
advances in our understanding of how to manage these diseases.
    One promising strategy to treat and prevent immune-mediated 
diseases is the induction of immune tolerance. Immune tolerance 
therapies are designed to ``reprogram'' immune cells to eliminate 
injurious immune responses, such as those seen in autoimmune diseases, 
while preserving protective responses needed to fight infection. NIAID 
has established a comprehensive program in immune tolerance research, 
including basic research, preclinical testing of promising strategies 
in nonhuman primates, and clinical evaluation through the Immune 
Tolerance Network (ITN). In an important study of people with severe 
diabetes, the ITN has shown that the transplantation of pancreatic 
cells can improve blood sugar control, protect patients from severely 
low blood sugar, and, in a few cases, relieve patients of the need for 
insulin injections; unfortunately, insulin independence was not 
sustained in most subjects. Further research is underway to improve 
this promising procedure.
    Last year, NIAID-supported scientists reported the identification 
of new ways to non-invasively assess the risk of kidney graft rejection 
by using gene-expression based biomarkers of immunologic activity 
present in urine. These investigators are now conducting a multi-center 
study to validate these approaches that potentially could allow 
physicians to predict, prevent, and treat kidney rejection more 
effectively.
    NIAID remains committed to improving the health of children with 
asthma, particularly those who live in our Nation's inner cities. The 
NIAID-supported Inner City Asthma Consortium (ICAC) has undertaken two 
important efforts in this area. The ICAC is conducting the Urban 
Environment and Childhood Asthma (URECA) Study. Five hundred and fifty 
inner-city children have been enrolled at birth and will be followed 
prospectively during childhood. The goals of the study are to identify 
the immunologic causes of the development of recurrent wheezing, a 
surrogate marker for asthma in children under three, and to monitor the 
development of food allergies in this patient population.

                               CONCLUSION

    The research conducted at NIAID and at NIAID-sponsored laboratories 
encompasses a broad array of basic, applied and clinical studies. This 
research has resulted in tangible benefits to the American public and 
to individuals throughout the world. By supporting talented researchers 
and emphasizing a balance of basic studies and targeted research, we 
will continue to develop innovative interventions to prevent, diagnose, 
and treat the wide range of infectious and immune-mediated diseases 
that afflict humanity.

                         COORDINATION WITH CDC

    Senator Harkin. Would it be safe to say, Dr. Fauci that 
your Institute probably intersects with CDC more than any other 
Institute?
    Dr. Fauci. I would think that would be safe to say. Several 
of the other Institutes do interact with CDC. But since CDC is 
responsible for the disease surveillance of those precise 
diseases, those emerging infections, that we are responsible 
for the research that develop the counter measures. There's a 
natural marriage between our Institutions in working together.

                COORDINATION WITH DEPARTMENT OF DEFENSE

    Senator Stevens. Dr. Fauci, we've put up a lot of money 
through the defense bill for similar endeavors. Do you 
coordinate with them?
    Dr. Fauci. Indeed we do, Senator Stevens. In fact, we have 
very robust collaborations with them. A couple of examples have 
been influenza, the bio-defense, the HIV and malaria as just 
four examples of things that we work very, very closely with 
the Department of Defense.
    In fact, we have cooperative agreements with them. In our 
bio-defense area we actually have a facility that's with them 
up at Fort Detrick. So the Department of Defense, NIH, NIAID 
interaction is very, very healthy.
    Senator Stevens. So there's not a redundancy there. You are 
keeping that coordinated, so it's not going to be.
    Dr. Fauci. It's complementary as opposed to redundant.
    Senator Stevens. Thank you.
    Senator Harkin. Now we turn to Dr. John Niederhuber, who 
became Director of the National Cancer Institute in September 
2006. Also served as NCI's acting Director and Deputy Director. 
He received his MD from the Ohio State University School of 
Medicine and his research at the NCI has focused on the study 
of tissue stem cells as the cell of origin for cancer. 
Interesting.
    Dr. Niederhuber, thank you very much for being here. You 
may proceed.

STATEMENT OF DR. JOHN E. NIEDERHUBER, DIRECTOR, 
            NATIONAL CANCER INSTITUTE, NATIONAL 
            INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH 
            AND HUMAN SERVICES
    Dr. Niederhuber. Chairman Harkin, Senator Stevens and 
members of the staff, thank you for the opportunity to testify 
today on behalf of the National Cancer Institute and the 
National Institutes of Health.
    Over the next few minutes, I would like to describe some of 
the progress NCI has made in cancer research along with some of 
the exciting opportunities we are pursuing.
    For 2 years now we have seen unprecedented decreases in the 
actual number of cancer deaths nationally. That is remarkable 
news considering cancer is largely a disease of aging and as 
you know our country is not only growing older, its population 
is also growing.
    Today's progress is occurring in no small part because 
researchers are coming to understand cancer's basic biologic 
processes. The sequencing of a human genome, a singular 
landmark in biomedical research, is providing a foundation for 
NCI's new Center of Human Cancer Genomics. Its mission is to 
systematically identify all important inherited and acquired 
genetic alterations that now contribute to a person's cancer 
risk and if cancer occurs, that cancer will behave. We are 
diligently working to understand these genetic changes and 
apply them to cancer prevention and to cancer treatment.
    Consider if you will that under the microscope, diffused, 
large B-cell lymphoma tumors from different patients look the 
same. However, when subjected to gene expression analysis, they 
have distinct genetic signatures. These differences in their 
genetic signature predict prognosis and enable us to 
individually characterize a patient's cancer and match him or 
her with the best treatment. Importantly, this is not a 
futuristic technique. We are already beginning to apply this 
technology in clinical settings such as lymphoma, lung and 
breast cancer.
    At the same time we are learning more about the mechanisms 
of a cancer cell including a small subset of cells within the 
tumor that drive the steps of invasion and growth. This subset 
of cells may enable the tumor to spread. Interestingly, these 
cells have stem cell like characteristics.
    Evidence is building that these so called cancer 
initiators, or transformed tissue stem cells are the driving 
force behind many tumors, and are the basis for long term risk 
of cancer recurrence. Clearly these cells will be a necessary 
target for treatment of the future.
    As we move toward an era of personalized medicine, advanced 
technologies will play a significant role in cancer prevention 
and preemption telling us in real time if a new drug treatment 
is reaching its target within the cell, if the novel drug is 
saturating that target, or if it is changing the function of 
the target. These early phase tests in patients will make go or 
no go decisions possible within hours, not within months for 
early cancer drug development, thus shortening development time 
and greatly decreasing cost.
    We also realize, however, that most cancer patients have 
yet to see the benefits of our science. Too many patients lack 
the means, the mobility or even the language capacity to travel 
to a premier facility. It is clear that access to care will be 
one of the greatest determinants of cancer mortality in the 
years ahead.
    Mindful of our mission to conduct research in all areas of 
science, including the behavioral sciences, such as how best to 
provide patient education and access to optimal care, NCI will 
in the next few weeks launch the pilot phase of a community 
cancer centers program that if fully implemented will bring 
state of the art cancer care to patients in community hospitals 
across the United States. This program will encourage and 
foster the collaboration of private practice medical, surgical 
and radiation oncologists with the opportunity for close links 
to NCI's research and to our NCI designated cancer centers.

                           PREPARED STATEMENT

    There is great cause for optimism in cancer science. But it 
must be tempered by an understanding of the hurdles we face. 
Cancer is a disease of staggering complexity with a singular 
name. Our progress is exciting. It is certainly encouraging, 
but we are continually challenged--challenged by our fellow 
citizens living with cancer to make faster progress.
    Thank you for the opportunity to testify before the 
Subcommittee this afternoon.
    [The statement follows:]

             Prepared Statement of Dr. John E. Niederhuber

                              INTRODUCTION

    I am most pleased to be before you today to report on the Nation's 
progress in cancer research. While there has been a steady decline in 
the cancer mortality rate (the number of cancer deaths per 100,000 
people) since 1991, we now have the excellent news that--for the second 
year in a row--there has been a decline in the absolute number of 
cancer deaths. In 2003, there were 369 fewer cancer deaths reported in 
the United States than in 2002. In 2004 (the most recent year reported) 
the decrease was almost ten times greater, at 3,014 [Figure 1]. This 
decline is even more significant when you consider that cancer is 
largely a disease of aging, and our population is not only growing in 
numbers, it is aging at an even greater rate. Progress is, indeed, 
heartening, but our work is not done. Too many of our citizens--
patients and families alike--continue to feel the pain and fear that 
come with the devastating news of a cancer diagnosis. 



  Figure 1.--The green line represents the cancer mortality rate per 
 100,000 population. The bars represent the actual recorded number of 
                  cancer deaths in the United States.

    While we measure our progress against cancer in terms of patients 
treated and lives saved, that effort also has a measurable economic 
impact. It has been projected that even a 1 percent decrease in cancer 
mortality will result in a $500 billion benefit to the U.S. economy 
(Murphy, K. and Topel, R., Journal of Political Economy, 2006; 114(5), 
871-904). In fact, such a benefit may ultimately be magnified many 
fold, because increasingly we recognize that cancer has become a model 
for developing our base of knowledge concerning many diseases. For 
example, the study of angiogenesis (blood vessel development) 
associated with tumor growth has been applied to greater understandings 
and treatment of macular degeneration, ischemic heart disease, diabetic 
wound healing, endometriosis and neurodegenerative illnesses. 
Furthermore, the unique capabilities of NCI's cancer researchers have 
been vital in other conditions. The identification of the AIDS virus 
and the development of assays to screen banked blood for the AIDS virus 
happened at the National Cancer Institute, where the current AIDS 
therapy regimen used around the world was also developed.
    Today, the NCI is leading the way in identifying the genetic, 
molecular, and cellular mechanisms associated with cancer--research 
fronts that hold great potential to enhance research and research 
collaboration against other diseases, as well. Building upon the 
sequencing of the human genome and working in our newly developed 
``Center for Human Cancer Genomics,'' NCI is systematically identifying 
all the important inherited and acquired genetic alterations that 
contribute to cancer susceptibility. We are cataloguing genetic changes 
involved in the process of a normal cell becoming malignant, and we are 
applying this knowledge, in order to identify people at increased risk 
for developing cancer, prevent and detect cancer at its earliest, most 
treatable stages, and identify new targets for highly selective and 
specific therapeutic agents.

                        A RECORD OF REAL SUCCESS

    The past year for cancer research and development has been one of 
substantial and heartening achievement. We are expanding both our 
knowledge and the technology tools to understand the mechanisms of 
cancer. Importantly, we are seeing scientific advances being rapidly 
applied to predict and preempt cancer.
  --We reached an important public health milestone in June 2006, when 
        the FDA approved a vaccine that prevents infection by the two 
        types of the human papillomavirus (HPV) responsible for up to 
        70 percent of cervical cancer cases worldwide. We can all take 
        great pride in the fact that our Nation's strong commitment to 
        and investment in cancer research at NCI led to this approval.
  --Researchers have begun to survey the human genome for DNA variants, 
        to identify genes that predict risk for common cancers. 
        Capitalizing on new knowledge of human genetic variation and 
        technical advances in whole-genome scanning, The Cancer Genetic 
        Markers of Susceptibility (CGEMS) project is currently 
        targeting genes that increase the risk of prostate and breast 
        cancer [Figure 2]. Work is beginning on a similar study for 
        pancreatic cancer. These studies of large numbers of patients 
        will be useful both for understanding causal pathways and for 
        developing preventive interventions. DNA variants found to be 
        associated with cancer risk will rapidly be made available 
        publicly to the scientific community through the NCI cancer 
        Biomedical Informatics Grid (caBIG?) database.
        
        

 Figure 2.--Previously developed technologies are used to analyze DNA 
                 specimens from large patient cohorts.

  --Genomic technology is already being applied to explain why some 
        patients with diffuse large B-cell lymphomas (DLBCL) live 
        longer and respond better to therapy than others [Figure 3]. 
        Under the microscope, the DLBCL cancer cells from every patient 
        look the same, but genetic differences have been shown to 
        predict good versus poor prognosis. As a result of this 
        research, it may be possible to determine which patients are 
        most likely to respond to a specific treatment, thus sparing 
        those patients unlikely to see a significant benefit the side 
        effects of a failed treatment.
        
        

 Figure 3.--Previously developed technologies are used to analyze DNA 
                 specimens from large patient cohorts.

            delving deeply into the cancer cell environment
    Building on the success of the CGEMS project in identifying 
inherited genetic risks, the NCI and the National Human Genome Research 
Institute have launched a pilot phase of The Cancer Genome Atlas 
(TCGA), a collaboration designed to determine the feasibility of using 
large-scale genome analysis technology to identify important genetic 
changes involved in cancer. TCGA is currently studying lung, brain 
(glioblastoma), and ovarian cancers--which collectively account for 
more than 210,000 cancer cases each year in the United States.
    Other initiatives are expanding our study of the cancer cell--and 
the networks and the cellular microenvironment that also appear to be 
significantly involved in tumor development and metastasis. These 
studies of molecular carcinogenesis are being conducted at the single-
cell or the subcellular level, using high-resolution, three-dimensional 
electron microscopy. These technologies allow us to look within the 
nucleus to study differences in chromosome movement and location during 
stages of abnormal cell growth.
    On another front, there is increasing evidence that cancer ``stem 
cells'' or ``cancer initiator'' cells are both the driving force behind 
many cancers and the basis for long-term risk. The presence of such 
cells, first demonstrated in acute myeloid leukemia patients, provides 
a different and exciting model with which to further explore cancer 
biology. NCI is establishing a group of scientists across the National 
Institutes of Health interested in embryogenesis and cancer stem cell 
biology, in order to advance the study of the underlying mechanisms in 
these processes.

               ADVANCED TECHNOLOGIES ACCELERATE PROGRESS

    It is clear that the area of advanced technologies development is 
absolutely essential and critical in creating tools for speeding up and 
enabling the discovery process. In addition to the genomic technology 
projects (CGEMS and TCGA), NCI is investing in the development of 
critical technology platforms in a number of other strategic areas, 
such as nanobiology, proteomics and computational biology.
    Recognizing the key role of biospecimens in all of biomedical 
research, not just cancer research, NCI has led a pioneering effort to 
provide the first guidelines that standardize and enhance specimen 
collection and biorepositories. These guidelines have made it possible 
for NCI to develop a common biorepository infrastructure that promotes 
resource-sharing and enables data comparison among research 
laboratories, while also ensuring patient protection and ethical 
integrity.
    We also believe that advanced imaging technologies will play a 
significant role in the prevention and preemption of cancer, as well as 
in making ``go or no-go'' decisions for early oncologic drug 
development. The NCI is working now in the aforementioned subcellular 
space, to be able to view--in real time--the interactions between drugs 
and cells and the resulting secondary functional changes. The NCI is 
developing new targeted and non-targeted molecular imaging agents for 
use as lymphatic markers, angiogenic markers, and surrogate markers for 
drugs that enhance quantitative methods to measure early, real-time 
tumor response. These technologies are further examples of NCI 
initiatives that produce benefits that will be realized across multiple 
areas of biomedical research.

                       INTERAGENCY COLLABORATIONS

    Addressing cancer requires work across institutional and sector 
boundaries, so members of the Department of Health and Human Services 
(DHHS) family of agencies, other federal offices, and the private 
sector can share knowledge and partner in the development of systems-
based solutions. NCI has long been at the forefront of research and 
development of biomarkers for use in diagnosis and treatment for 
cancer. Now, a Biomarkers Consortium launched last year includes 
participants from the Foundation for the NIH, NIH, FDA, CMS, and 
private industry--with the goal of validating biological markers for a 
variety of diseases, including cancer. The first project approved by 
the Consortium is the evaluation of an imaging agent that detects an 
increase in cell metabolism characteristic of tumor growth. NCI is 
conducting trials in lung cancer and non-Hodgkin's lymphoma that use 
this ability to view cellular metabolism to monitor tumor masses for 
increased activity (cell growth) or decreased activity (cell death) 
during the early stages of anticancer treatment.
    The joint NCI-FDA Interagency Oncology Task Force (IOTF), 
established in 2003 to enhance and accelerate the overall process of 
developing new cancer interventions, released two new guidance 
documents and a final rule intended to streamline the early clinical 
development of new drugs and biologics for cancer and other diseases. 
This has enabled the first-in-human ``Phase 0'' trial (a step before 
the classic Phase 1 level of drug study) that measures the activity of 
a new drug in a limited number of patients using a single, small dose 
of the study agent, prior to the traditional dose-escalation, safety 
and tolerance studies. Phase 0 will substantially compress drug 
development time.

           TRAINING THE NEXT GENERATION OF CANCER RESEARCHERS

    Cancer is one of the most exciting and innovative areas of medical 
research. It takes a superbly trained, highly effective workforce to 
make discoveries, to translate them into new interventions, and to put 
the improved knowledge base and cutting-edge tools to work for 
patients. NCI will continue to play an important role in developing the 
cancer research workforce in the United States and in other countries. 
We stand firmly by the Institute's commitment to provide unparalleled 
training opportunities for talented researchers from a wide variety of 
disciplines to advance their careers. In fact, many of the current 
programs at NIH had their origins in the NCI.
    Of special significance are minority training programs, such as the 
Continuing Umbrella of Research Experiences (CURE), which begins with 
talented minority high-school students and continues progressively and 
selectively through long-term funding to qualified minority students 
interested in scientific, cancer research-related careers.

                   REACHING THE PATIENT AND COMMUNITY

    NCI must continue to make progress for each cancer patient. Yet, 
the recent report on cancer deaths that showed a decrease in deaths 
nationally also confirms a troubling fact: Minority and low-income 
populations shoulder a disproportionate cancer burden and are not 
benefiting equally from important advances. We must bring the best 
science to patients, 85 percent of whom are treated in the communities 
where they live. With that obligation in mind, NCI is launching a pilot 
of the Community Cancer Centers Program (NCCCP). This pilot project 
will study how best to provide easily accessible, state-of-the-art, 
multi-specialty cancer care and earliest phase clinical trials research 
to patients in their communities. Through this program we will also 
learn best how to educate patients concerning risk, healthier living, 
screening practices, clinical trial participation, survivorship, and 
end-of-life issues.
    This program is about bringing the newest science to patients where 
they live--a challenge that is more critical now than at any time in 
our history. Our nation's healthcare system faces many looming 
stresses, particularly in light of the fact that the first wave of baby 
boomers turns 65 in 2011. With the graying of a generation comes the 
need for a new way to confront the diseases of aging--and especially to 
anticipate what will be a marked increase in cancer incidence. That 
makes even more important our efforts to develop advanced technologies 
that will eventually lead to the genomic and proteomic breakthroughs 
essential to enable us to preempt disease at earlier stages.
    There is great cause for optimism, but an optimism that should be 
tempered by an understanding of the very real hurdles to progress we 
still face. These are challenges that we must address as a community. 
In doing so, the encouraging trends of decreasing death rates from 
cancer will become the rule, not the exception. We will learn how to 
deliver the best of our science to everyone--not just a few.

    Senator Harkin. Thank you, Dr. Niederhuber. Let's go on 
here unless you have a specific question right now.
    Senator Stevens. No.
    Senator Harkin. Dr. Barbara Alving was named as the 
Director of the National Center for Research Resources in 
April, although she served as acting Director before that. Her 
medical degree is from Georgetown University School of 
Medicine. Dr. Alving has published more than 100 papers in the 
areas of thrombosis and hemostasis.
    Dr. Alving, welcome to the committee.

STATEMENT OF DR. BARBARA M. ALVING, DIRECTOR, NATIONAL 
            CENTER FOR RESEARCH RESOURCES
    Dr. Alving. Thank you. Mr. Chairman, Senator Stevens, It's 
a great honor to discuss the mission and activities of the 
National Center for Research Resources today.
    The research center is very different from the two ICs that 
you've heard about earlier. They are categorical. They're 
focused on specific disease areas, specific missions. The 
National Center for Research Resources, which is greater than a 
$1 billion center. Is really focused on providing the 
infrastructure and support to investigators and institutions 
throughout the country. That can really provide the support for 
studies in the categorical diseases.

                  CLINICAL AND TRANSLATIONAL RESEARCH

    What we are focusing on at NCRR is clinical and 
translational research. By that, we're focusing on the ability 
to go from very basic studies, into preclinical studies, into 
clinical trials, and dissemination out into the public. The 
NCRR is very well situated for this.
    For example, we have a division of comparative medicine 
that provides animal resources for the preclinical studies that 
are needed to test drugs before they go into clinical trials. 
We fund the eight national primate centers. I might add we also 
support Chimp Haven for the long-term retirement of those 
chimpanzees that have been involved in research.
    We fund biomedical technology resources that provide 
cutting edge research in new imaging techniques that can then 
be used in clinical trials.
    We fund the General Clinical Research Centers that have 
been situated at academic institutions throughout the country 
to provide better ways to conduct clinical trials and the 
resources needed for biostatistics. What's very exciting is 
that this program of General Clinical Research Centers is now 
transitioning into a very large program known as the Clinical 
and Translational Science Awards.
    In addition we fund outreach programs through our Science 
Education Partnership Awards that allow investigators to 
actually partner with museums to have public displays on, for 
example, research opportunities, discussions of stem cell 
research, so that children throughout school systems can learn 
much more about the type of science, as well as the chronic 
diseases that are being studied in this country.
    On the second slide here you see a little swirly area which 
represents a clinical and translational science award for an 
academic health center. As we have said, the General Clinical 
Research Centers that are funded throughout the United States 
are now going to be the academic health centers transitioning 
into receiving these clinical and translational science awards.


    This means that each academic health center that receives 
such an award agrees to form a home for clinical and 
translational science. This will make all of our studies much 
more efficient, so that we can bring new research and new drugs 
out into the public much more rapidly and train a new 
generation of clinical and translational researchers. So 
they'll know how to interact with the FDA and they'll 
understand the rules. They will know how to develop better ways 
of doing clinical trials so that we can have more rapid accrual 
and less time delay and less expense.
    Each of these academic health centers has agreed to form 
partnerships with the others, so this is really a consortium, 
and they will interact with industry as well as with other 
organizations such as Kaiser Permanente and the VA. These 
organizations are very rich in informatics and we want to bring 
interoperable informatics information systems throughout the 
country.
    The third slide shows the United States in yellow. The 
little red stars show the first 12 CTSAs that have been awarded 
throughout the country. This was done in October 2006, along 
with 52 planning grants. By 2012, we hope to have 60 CTSA 
awards at a total annual cost of $500 million per year. But we 
fund other large programs at NCRR, and we want to create a 
matrix of interactions with programs.



                    INSTITUTIONAL DEVELOPMENT AWARD

    In the fourth slide you see the IDeA program. I think 
Senator Stevens is probably very well aware of this program. It 
is providing funding to 23 States and Puerto Rico that receive 
less--historically a lower amount of NIH funding. This is 
usually due because they have rural populations or small 
populations. These awards are allowing students from 
undergraduate colleges to have access to research training in 
some of the larger universities in these States.




    We also realize they need to be connected because of their 
vast challenges of distance. So you see in the slide that shows 
the green States, those are the IDeA States red line which is 
Lariat. That's really a lasso to bring high speed information 
systems and fiber optic networks to six States that are very, 
very far apart that need to be connected. So through this 
Lariat project we've connected Hawaii, Alaska, Idaho, Nevada, 
Montana, and Wyoming. This provides the latest opportunities to 
conduct science through this high speed fiber optic system. It 
also has improved the economies of these States and allows the 
delivery of health care. We want to continue this in other 
areas.

               RESEARCH CENTERS IN MINORITY INSTITUTIONS

    If you go to the fifth slide to the map of the United 
States, you see another picture. You see the Research Centers 
in Minority Institutions. These are centers that include 
historically black academic health centers and Hispanic 
centers. These too, need to be linked up and have the latest 
opportunities.



    We provide funding to these centers to conduct clinical 
research and training as well as basic research. What we're 
doing now is encouraging them and they are very eager to link 
up into this new clinical and translational science program. So 
we have Meharry talking with Vanderbilt. Morehouse is talking 
with Emory. Charles Drew is talking with UCLA. How can they 
form partnerships? How can they provide outreach to the 
communities?

                        MATRIX OF OPPORTUNITIES

    Basically, at NCRR, we are now focusing throughout the 
center on translational and clinical sciences. We want to 
create a matrix of opportunities for this nationally, 
geographically and racially diverse matrix of academic health 
centers and other institutions. We want to include links to 
PHARMA, biotech, state and Federal agencies, as well as to CMS 
and the FDA, so that we can have a seamless interaction.

                           PREPARED STATEMENT

    The whole result of this will be to provide better access 
to health care to our diverse populations. We're very aware of 
the increased amount of money going to health care. We want to 
make this much more efficient. We want to train the new 
generations of investigators who have to carry out this work.
    Thank you for the opportunity to discuss this.
    [The statement follows:]

              Prepared Statement of Hon. Barbara M. Alving

    Mr. Chairman and Members of the Committee: It is a privilege to 
present to you the President's budget request for the National Center 
for Research Resources (NCRR) for fiscal year 2008. The fiscal year 
2008 budget includes $1,112,498,000. I appreciate this opportunity to 
discuss with you our vision of the future of health and medicine and to 
share ways NCRR programs are transforming clinical and translational 
research.
    The NCRR, which is one of the 27 Institutes and Centers at the 
National Institutes of Health (NIH), provides NIH-supported laboratory 
and clinical researchers with the infrastructure, tools, and training 
they need to understand, detect, treat, and prevent a wide range of 
diseases. With this support, scientists engage in basic laboratory 
research, translate these findings to animal-based studies, and then 
apply them to patient-oriented research. Through innovative programs 
and resources that transcend geographical boundaries, NCRR connects 
researchers with one another, and with patients and communities across 
the Nation. These connections bring together innovative research teams 
and the power of shared resources, multiplying the opportunities to 
improve human health.

                     TRANSFORMING CLINICAL RESEARCH

    Given its mission and support to more than 30,000 basic and 
clinical researchers, NCRR has become the leader of the NIH Roadmap for 
Medical Research effort to energize the discipline of clinical and 
translational research. To remove the barriers identified by the 
research community, NCRR launched the Clinical and Translational 
Science Award (CTSA) program, which is a national consortium designed 
to more rapidly and efficiently facilitate the transfer of discoveries 
made in the laboratory into new treatments for patients. Through the 
CTSAs, academic health centers are developing centers, departments, or 
institutions for interdisciplinary teams that cover the complete 
spectrum of research from basic biology to clinical medicine. These 
academic homes also will train the next generation of researchers in 
translational and clinical research.
    On September 30, 2006, we made the first CTSA awards to 12 academic 
health centers throughout the country. We will award the second group 
of CTSAs this fall. By 2012, the CTSA Consortium is expected to include 
approximately 60 CTSAs.
    The impact of the CTSA Consortium will be far greater than the 
number of awards made. The Consortium will develop better designs for 
clinical trials, forge new partnerships with health care organizations, 
and expand outreach to minority and medically underserved communities. 
The CTSAs will focus on both types of translational research--ensuring 
first that basic discoveries are applied to the clinic and second that 
they are further translated into community practice. Improving clinical 
research informatics will be a prominent focus of the Consortium. 
Institutions are taking steps to prioritize their efforts to ensure 
that standards are developed, interoperability is enhanced, and 
communication resources are accessible to researchers and their 
patients.
    To improve communication with the public and our stakeholders about 
our progress, as well as to foster collaborations within and beyond the 
Consortium, we recently launched the CTSAWeb.org site. I encourage you 
to visit the site and learn more about the CTSA Consortium. We also 
have started plans to evaluate the Consortium to ensure that the 
program spurs innovation, integration, inclusion, and dissemination.
    Already, we are starting to see significant changes within and 
across the CTSA institutions. As a result of this effort, academic 
health centers are developing new curriculums, revamping their 
organizational structures, creating unprecedented partnerships with 
other medical and research disciplines, and generating medical 
advances. For example, the Institute for Translational Medicine and 
Therapeutics (ITMAT) at the University of Pennsylvania--a trans-
institutional endeavor with the Children's Hospital of Philadelphia, 
the Wistar Institute, and the University of Sciences in Philadelphia--
is leading clinical and translational research and fostering 
interdisciplinary science. Now with the CTSA award, ITMAT will also 
become the home to new centers in bioinformatics, personalized 
medicine, imaging, and chemical biology. At the same time, the 
University of Texas Health Science Center at Houston CTSA is 
encouraging participatory research by connecting with Hispanic 
communities on the border. By linking with NCRR's Science Education 
Partnership Award program in Houston, this CTSA is improving the 
public's understanding of the importance of clinical trial 
participation. As the CTSAs begin to work together, the benefits of the 
program will extend to the greater research community and ultimately be 
incorporated into clinical care.
    I am pleased to report that this transformation is creating new 
energy and opportunities within NCRR and across the NIH. The CTSA 
initiative is further enhancing NCRR's long-standing investments in 
advancing translational research and providing new opportunities for 
community engagement. The addition of the CTSA Consortium to the matrix 
of NCRR programs is providing opportunities for increased cohesion and 
interaction throughout our entire research portfolio. Similarly, the 
truly trans-NIH nature of the CTSA program is facilitating interactions 
among the NIH Institutes and Centers and helping to ensure that the 
benefits of the Consortium are realized across the full spectrum of 
medical research.

                    ADVANCING TRANSLATIONAL RESEARCH

    Helping to propel the CTSA discovery engines are NCRR's 
translational research programs. Our readily available animal models 
and biomedical technology resources are fueling advancements in 
clinical care. We are exploring opportunities to enhance interactions 
among our translational programs and the CTSA Consortium to further 
capitalize on our research investments.
    Animal models are the bridge between basic science and human 
medicine. The NCRR provides such models through specialized laboratory 
animals, research facilities, and training. Linking NCRR's animal 
resources with CTSAs will allow for more seamless translation from pre-
clinical findings to clinical trials. This is already underway at two 
CTSAs, the University of California-Davis and the Oregon Health and 
Science University, which are connecting with the NCRR-supported 
National Primate Research Centers at their institutions. To provide 
researchers with easier access to animal models, and thus further 
accelerate translational research, we sponsored a workshop in 2006 to 
explore approaches to develop a resource that would enable researchers 
to find and use animal and other biological resources more efficiently. 
Based on stakeholder recommendations, we are planning to fund a 
comprehensive electronic catalog of animal model resources in fiscal 
year 2008.
    Technologies are critical throughout all stages of biomedical 
research--from basic discovery to clinical application. The NCRR 
support for biomedical technology (BT) resource centers provides 
researchers with a broad spectrum of technologies, techniques, and 
methods. Across the nation, researchers depend on these centers for a 
wide variety of clinical and translational studies. For example, 
researchers at the University of Illinois are developing software to 
help analyze the motions of viruses, so that they can better predict 
the virulence of these organisms. At the University of Wisconsin-
Madison, another BT resource center, researchers are using advanced 
nuclear magnetic resonance technologies to develop faster and more 
cost-effective methods for studying how biological systems work and 
respond to drugs. In the future, technologies developed at the BT 
resource centers may lead to discoveries that the CTSAs can translate 
into improved patient care.

                     ENHANCING COMMUNITY ENGAGEMENT

    The launch of the CTSA initiative has further enhanced our 
appreciation of the need to actively engage not only the researchers 
but also the American public. Our programs are providing opportunities 
for people in underserved communities to participate and shape medical 
research. Our innovative science education programs are inspiring 
children to pursue careers in biomedical research and are increasing 
the public's understanding of medicine. By reaching out to new 
collaborators and strengthening our partnerships, NCRR is facilitating 
connections that are sparking new discoveries and maximizing the 
effectiveness of the matrix of NCRR programs.
    NCRR has two successful programs that are creating new research 
opportunities for underserved communities. First, the Research Centers 
in Minority Institutions (RCMI) program increases the number of 
minority scientists engaged in biomedical research and enhances the 
research capacity and infrastructure at minority colleges and 
universities that offer doctorate degrees in health sciences. This 
program increases the number of minority scientists engaged in 
biomedical research and facilitates studies on minority health. Second, 
the Institutional Development Award (IDeA) program fosters health-
related research and increases the competitiveness of investigators at 
institutions in 23 states and Puerto Rico, which have historically low 
aggregate success rates for grant awards from the NIH. The IDeA program 
provides workforce development, research opportunities, science 
education, and extends high-speed connectivity to IDeA institutions to 
facilitate research collaborations. For example, NCRR funded the Lariat 
Project to provide six states (Alaska, Hawaii, Idaho, Montana, Nevada, 
and Wyoming) with high-speed, fiber-optic network connections. This 
project has improved not only research capacity in these states, but 
also enhanced their economic development, higher education, and 
healthcare opportunities. To ensure these underserved communities have 
access to innovative research opportunities, we are exploring ways to 
facilitate partnerships with these communities and the CTSAs.
    One of the many ways that community engagement is improving 
research is through a component of the IDeA program called IDeA 
Networks of Biomedical Research Excellence (INBRE) program. This 
program enables critical connections among different research 
institutions and facilities, as well as between mentors and students. 
For example, the Montana INBRE brought together the seven tribal 
colleges within the state to conduct collaborative research projects. 
Today, these tribal colleges, which prior to the INBRE program had not 
interacted on research projects, are working together to identify 
research areas and collaborate with other undergraduate institutions 
within Montana.
    Community engagement is synonymous with the NCRR Science Education 
Partnership Award (SEPA) program. By bringing together active 
biomedical and clinical researchers with educators, community leaders, 
and other interested organizational leaders, SEPA is stimulating public 
interest in health issues and encouraging young people to pursue 
careers in medical research. SEPA grantees currently collaborate with 
several RCMI and IDeA institutions and are beginning to make similar 
connections through CTSA community engagement activities. At Jackson 
State University, RCMI- and IDeA-funded researchers have partnered with 
the Jackson Public Schools through a SEPA grant to provide mentoring 
and research internships for students and professional development for 
teachers. Another SEPA project at the University of Utah, offers over 
100 online activities, podcasts, and virtual labs on topics ranging 
from cloning to stem cells.
    Innovative partnerships are providing the cohesion needed to ensure 
that the matrix of NCRR programs results in a maximum return on 
investment for all Americans. We are expanding our outreach efforts 
with the pharmaceutical industry, healthcare organizations and 
providers, and other Federal agencies, such as the Food and Drug 
Administration and the National Science Foundation. These collaborative 
partnerships will not only enable us to make research discoveries 
faster, but will ensure that these discoveries are quickly translated 
into improved patient care.

                               CONCLUSION

    Through our matrix of programs and partnerships, NCRR expects to 
fulfill its charge to transform the practice of clinical and 
translational research and in turn, improve the future of health and 
medicine. The launch of the CTSA Consortium marks an exciting time in 
the history of NIH and for our Nation. It further enhances NCRR's long-
standing investment in basic, translational, and clinical research. Our 
innovative programs and partnerships are maximizing our research 
investment to ensure that medical advances are reaching the people who 
need them.

    Senator Harkin. Dr. Alving, thank you very much.
    Now we turn to Dr. Patricia Grady, who has served as the 
Director of the National Institute of Nursing Research since 
1995. She pursued her graduate education at the University of 
Maryland, receiving a Master's Degree from the School of 
Nursing and a Doctorate in Physiology from the School of 
Medicine. Dr. Grady's scientific focus is primarily in stroke 
research.
    Dr. Grady, welcome back to the committee.

STATEMENT OF DR. PATRICIA A. GRADY, DIRECTOR, NATIONAL 
            INSTITUTE OF NURSING RESEARCH
    Dr. Grady. Thank you, Mr. Chairman. I appreciate the 
opportunity to present to you, Senator Stevens and the staff, a 
brief description of some of the activities that are going on 
at the National Institute of Nursing Research.
    The NINR supports clinical and basic research to establish 
a scientific basis for the care of individuals across the life 
span. NINR's research has contributed to improving the health 
of the American people for more than two decades. Our 20th 
anniversary provided an opportunity to look toward the future 
and update our strategic plan which formulates innovative ways 
to address the major health challenges facing our Nation, 
including the concurrent trends of an aging population, a 
growing racial and cultural diversity, an increasing reliance 
on technology and a rising demand for nurses.
    In response to these and other challenges, you heard the 
Director of NIH call for a new kind of health care system. In 
the spirit of today's hearing I would like to briefly describe 
for you important research that is preemptive and predictive 
and how that research is shaping our vision for the future.
    The first preemptive example could have major implications 
for improving the lives of premature infants and their parents. 
Current practice during the birth of a pre-term infant is to 
clamp the umbilical cord immediately after delivery. However, 
delayed cord clamping has been shown to have certain advantages 
for the infant.
    In a recent study, NINR supported investigators compared 
the effect of immediate verses delayed umbilical cord clamping. 
The results of this simple modification were very encouraging. 
Infants in the delayed cord clamping group had nearly a ten-
fold lower rate of late onset infection and nearly a three-fold 
lower rate of brain hemorrhage. Each of these complications 
carries a high risk of disease, disability and death.
    Another study tested the effect of a coping intervention 
for parents of pre-term infants, in which parents participated 
in a program about prematurity, infant behaviors and infant 
development. The effect of this program was dramatic. Parents 
demonstrated improved parenting behaviors and reported 
decreased stress levels. Moreover, the infants averaged 3.8 
fewer days in the Neonatal Intensive Care Unit, which 
translated to a savings of roughly $5,000 per infant.
    Developing preemptive strategies to reduce the risk factors 
for cardiovascular disease is another important research focus 
for us. A group of investigators tested a community based 
behavioral educational intervention to improve blood pressure 
management among young African American men. The intervention 
reduced blood pressure and subsequently reduced by half the 
incidence of left ventricular hypertrophy, a form of heart 
damage caused by high blood pressure.
    We've also made strides in studying and preventing medical 
errors that continue to trouble our hospitals and clinics. For 
example, surgical sponges accidentally left inside patients can 
lead to complications ranging from infection to death. NINR 
investigators demonstrated that a radio frequency 
identification tag system for surgical sponges could quickly 
and accurately detect the presence of sponges retained at 
surgery. This is just one example of the type of innovative 
research needed to reduce the adverse health effects and 
significant cost implications associated with medical errors.
    Investigators have also demonstrated a clear link between 
low nurse staffing levels and an increase risk to patients.
    Senator Harkin. What?
    Dr. Grady. Low nurse staffing levels and an increased risk 
to patients. Decreased nurse staffing levels are associated 
with increased mortality and morbidity, specifically, 
infections and other complications. These studies highlight the 
importance of the growing national nursing shortage upon the 
health of our population.
    Finally, nowhere is the need for better preventive and 
preemptive efforts greater than in the minority communities and 
in other underserved populations. Recently scientists reported 
the first randomized controlled trial of a culturally tailored 
HIV risk-reduction program for Hispanic adolescents, a program 
that was successful in reducing risky behaviors for up to 1 
year.
    Another group of scientists developed an intervention that 
reduced stress and depression in low income single mothers, 
improving their ability to care for their children. Programs 
such as these are critical for reducing health problems in 
vulnerable communities and demonstrate the progress we have 
made already.
    Let me now provide you with a few examples of new methods 
for predicting the needs of patients and for anticipating ways 
to proactively maintain quality of life for patients and their 
caregivers. One example of predictive illness management comes 
from NINR's research on the care of patients at the end of 
life. As you probably know, NINR is the lead institute at NIH 
for this important area of research.
    One of our research teams characterized the functional 
decline in patients with specific illnesses in the last year of 
life. Trajectories range from--sudden, unexpected death to 
variations in illness and recovery, to steady and irreversible 
decline. This knowledge helps caregivers to better anticipate 
the course of illness, allowing the health team to tailor 
treatment strategies and improve quality of care.
    Yet another study showed that minority patients who used 
spiritual coping are more likely to want aggressive care at the 
end of life such as life support, tube feeding or mechanical 
ventilation. Such findings can allow caregivers to better 
incorporate the culturally based needs and desires of patients 
and their families.

                           PREPARED STATEMENT

    In conclusion, NINR is strongly committed to the NIH vision 
of a healthier Nation. We are proud of the important progress 
we have made toward this goal and we look forward to continued 
successes. We stand ready to address tomorrow's challenges 
based upon our 20 years of scientific accomplishments. Thank 
you, Mr. Chairman, Senator Stevens. I'd be happy to answer any 
questions that you or the Committee might have.
    [The statement follows:]

              Prepared Statement of Dr. Patricia A. Grady

    Mr. Chairman and Members of the Committee: I appreciate the 
opportunity to present the fiscal year 2008 President's budget request 
for the National Institute of Nursing Research (NINR). The fiscal year 
2008 budget included $137,800,000.

                              INTRODUCTION

    The mission of the NINR is to support clinical and basic research 
that establishes a scientific basis for the care of individuals across 
the lifespan--from management of patients during illness and recovery 
to the reduction of risks for disease and disability, the promotion of 
healthy lifestyles, promoting quality of life in those with chronic 
illness, and care for individuals at the end of life. NINR's research 
programs also place special emphasis on eliminating health disparities 
and on the health issues faced by the underserved.
    NINR's research has contributed to improving the health of the 
American people for more than two decades. In 2006, NINR concluded the 
year-long observance of our 20th anniversary at NIH. During that 
period, we took stock of our scientific accomplishments, recognized our 
contributions to clinical practice, and launched a newly revamped web-
site in support of our stakeholders. We also assessed the future role 
of nursing science in addressing the major health challenges of our 
Nation: an aging population; a growing racial and cultural diversity 
and the attendant health disparities; an increasing reliance on 
technology in health care settings; and a rising demand for nurses. 
Within this context, NINR developed a new, forward-looking Strategic 
Plan.
    NINR's new 5-year Strategic Plan elucidates a unified framework for 
addressing the dynamic health care landscape. The Plan leverages key 
strengths of the NINR research community and focuses on areas of 
critical research opportunity including: Self-Management, Symptom 
Management, and Caregiving; Health Promotion and Disease Prevention; 
Research Capacity Development; Technology Integration; and End-of-Life. 
Pursuing this strategy, we seek to apply NINR's resources to the areas 
of public health which have the greatest needs, and in which NINR can 
have the greatest impact.
    Allow me to briefly describe our programs within this framework, 
highlight recent accomplishments, and share our vision for the future.

                         NINR RESEARCH PROGRAMS

    Self-management, Symptom Management, and Caregiving.--NINR's focus 
on the quality-of-life science continuum comprises three key research 
concepts: self-management, symptom management, and caregiving. Self-
management science explores strategies that empower individuals to be 
more involved in their own health practices. Symptom management science 
focuses on biological and behavioral components of health and illness 
that improve the management of symptoms. Caregiving science addresses 
the quality-of-life dimensions experienced by care recipients as well 
as formal and informal caregivers across diverse health care settings.
    Improving Care of Premature Infants.--According to the Centers for 
Disease Control and Prevention (CDC), half a million preterm infants 
are born in the United States each year, carrying a significant risk of 
death and disability, and often requiring care in a neonatal intensive 
care unit (NICU). In addition, their parents endure high levels of 
stress, anxiety, and depression (Miles, 1999; Singer, 1999, Wereszczak, 
1997).
    In one study, NINR-supported investigators assessed the effect of 
``immediate'' (7 seconds) versus ``delayed'' (32 seconds) umbilical 
cord clamping on health parameters of preterm infants. Compared to the 
immediate clamping group, infants in the delayed group had nearly a 10-
fold lower rate of late-onset septic infection, which carries a high 
risk of morbidity and mortality (IOM, 2006), and nearly a 3-fold lower 
rate of intraventricular hemorrhage, which carries a risk of 
developmental deficits (IOM, 2006).
    Another study by NINR-supported investigators assessed the effect 
of an educational program on the psychological care needs of parents of 
preterm infants. Utilizing the Creating Opportunities for Parental 
Empowerment (COPE) educational program, parents were taught about 
prematurity, infant behaviors, and infant development. As a result, 
parents demonstrated improved parenting behaviors and reported 
decreased stress levels. Meanwhile, the infants averaged 3.8 fewer days 
in the NICU than controls, which translated to a savings of roughly 
$5,000 per infant (Melnyk, 2006).
    Taken together, these studies demonstrate the significant potential 
benefits of combining a minor modification to a medical procedure at 
virtually no cost and an educational program during the care of preterm 
infants to improve health outcomes while reducing health expenditures. 
Their adoption into standard practice, and the exploration of 
additional approaches, could result in a more robust reduction in 
prematurity-related complications in early childhood, disability, 
death, and health care costs in excess of the $2.5 billion in estimated 
potential savings through the COPE intervention alone ($5,000 savings 
per infant multiplied by the estimated 500,000 preterm infants born in 
the United States each year).
    Quality-of-life research directly impacts populations across the 
lifespan from the very early stages of life. In 2007, NINR plans to 
support research on symptom clusters in cancer and immune diseases, as 
well as biobehavioral research methods.
    Health Promotion and Disease Prevention.--Within Health Promotion 
and Disease Prevention, NINR scientists explore dimensions of behavior, 
health in community settings, patient safety, and the biological 
factors useful in ensuring long-term positive health outcomes.
    Culturally-tailored HIV/AIDS Intervention for Hispanic Youths.--
According to the CDC, the incidence of acquired immune deficiency 
syndrome (AIDS) is up to three times higher among Latino adolescents 
than among their white counterparts (CDC, 2004). NINR-supported 
scientists tested a culturally-tailored HIV education program called 
``Cuidate! (Take Care of Yourself)'' among Hispanic adolescents. 
Compared to controls, youths in the program were 34 percent less likely 
to report having had sexual intercourse in the past 3 months, 47 
percent less likely to report having multiple partners across the 
follow-up period, and reported more consistent use of condoms. This 
study demonstrates the benefits of a customized, population-specific 
intervention and highlights its potential to reduce health disparities 
if applied across a range of settings (Villaruel, 2006; Jemmott 1998).
    In 2007 NINR plans to support research that incorporates an in-
depth knowledge of cultural factors into HIV prevention studies among 
young people.
    Research Capacity Development.--NINR is engaged in enhancing the 
research capacity of nursing science. NINR supports pre- and post-
doctoral training through both individual and institutional training 
grants. NINR also supports Research Centers to establish and maintain 
hubs of research, such as the NINR Nursing Partnership Centers on 
Health Disparities, which bring together colleagues from research 
intensive institutions and minority-serving schools of nursing, with 
the goals of exploring health disparities research questions and 
training investigators from underrepresented populations.
    In 2008, NINR will support academic research enhancement 
opportunities in minority-serving institutions.
    Technology Integration.--NINR's focus on improving health care and 
quality of life encompasses the development, use, and adaptation of 
technologies. Functional technologies that assist patients and those 
that facilitate reporting of biological indicators of health and 
disease status form the framework of the technology integration 
program, including uses of technology for telemedicine, patient 
education, communication, and patient safety.
    Radiofrequency Identification (RFID) and Patient Safety.--The 
Institute of Medicine (IOM) estimates the cost of medical errors to be 
over $37 billion annually; nearly half is associated with preventable 
errors; and, up to 98,000 deaths each year are attributable to medical 
errors (IOM, 1999). Currently, certain medical errors such as the 
retention of surgical sponges within patients after surgery persist. 
NINR-supported scientists have demonstrated that a radiofrequency 
identification (RFID)-tag system for surgical sponges accurately 
detected the presence of sponges retained at the surgery site after 
wound closure was simulated. If implemented into practice, this 
approach may not only contribute to the reduction of medical errors, 
but also decrease both the time spent in the hospital as well as heath 
care expenditures.
    In 2008, NINR plans to support studies focused on stimulating 
technological strategies that improve health outcomes through the Small 
Business Innovation Research (SBIR) and Small Business Technology 
Transfer (STTR) Programs.
    End-of-Life.--The science of end-of-life explores research 
questions of this complex period for dying persons, family members, and 
both professional and informal health care providers. End-of-life 
scientists seek to understand not only biological aspects of dying, but 
also the needs of dying persons, including symptom relief, decision-
making, advance directives, and palliative care. In addition, issues of 
culture, age, spiritual beliefs, and disease-specific considerations 
are included in research strategies.
    Chronically Critically Ill and End-of-Life Care Preferences.--
Patients who are or may become chronically critically ill may benefit 
from having advance directives in place should they lose the ability to 
communicate their preferences. NINR-supported investigators examined 
the frequency of documentation of advance directive choices of 1,128 
patients hospitalized with a chronic critical illness. Results indicate 
that about two-thirds did not have an advance directive to document 
their care preferences, and may benefit from an educational program in 
end-of-life care and documenting their preferences.

                               CONCLUSION

    NINR's dedicated investigators act on their clinical experience and 
insight to develop and test innovative solutions to the major health 
challenges facing our society. Equipped with a new Strategic Plan, we 
aim to sustain the pace of nursing science discoveries in the years 
ahead by bringing together innovation and determination within a 
strategic framework to improve clinical practice and patient care. With 
20 years of research, NINR has garnered expertise for new opportunities 
to address tomorrow's challenges.Thank you, Mr. Chairman. I will be 
happy to answer any questions that the Committee might have.

    Senator Harkin. Thank you very much, Dr. Grady.
    Now we turn to Dr. John Ruffin, who is the Director of the 
National Center on Minority Health and Health Disparities. He's 
led the effort at NIH to promote minority health and reduce 
health disparities for over 15 years and oversaw the 
development of the first Comprehensive Health Disparities 
Strategic Plan at NIH.
    Dr. Ruffin, welcome to the committee. Please proceed.

STATEMENT OF DR. JOHN RUFFIN, DIRECTOR, NATIONAL CENTER 
            ON MINORITY HEALTH AND HEALTH DISPARITIES
    Dr. Ruffin. Thank you, Mr. Chairman, Senator Stevens. Today 
I'm here to give you a brief report on the progress the 
National Center on Minority Health and Health Disparities and 
the National Institutes of Health is making to promote the 
improvement of health among our Nation's racial and ethnic 
minority population. To advance research toward eliminating 
health disparities among all affected populations including the 
medically underserved, poor and rural populations.
    Senator Specter, I'm sure you will recall the hearings that 
you and others convened in the late 1990s on minority health 
and health disparities. I participated in many of those 
hearings which ultimately led to the creation of the NCMHD. The 
release of the Institute of Medicine report entitled, ``Unequal 
Treatment'', came right on the heel of the Center's creation. 
That report, you will recall, was a vivid depiction of the 
state of affairs of the health care system and health among 
this Nation's diverse population.
    Six years ago Congress established the NCMHD and gave us 
the authority to be the focal point at the National Institutes 
of Health for Minority Health and Health Disparities research. 
We took that authority seriously and have established the basis 
to fulfill our mission. There are a number of things that we 
know related to minority health and health disparities and then 
there are some unknowns that we continue to work toward 
understanding.
    For example, what we have not yet uncovered is the cause of 
health disparities. We still do not know why racial and ethnic 
minorities and poor populations across this Nation continue to 
be burdened by diseases and conditions like HIV/AIDS, cancer, 
infant mortality, mental health and stroke, for example. What 
we do know is that there are multiple factors that contribute 
to disparities in health.
    These are the types of issues that we are seeking to 
understand through our own research at the NCMHD as well as 
through the research efforts of the Institutes and Centers that 
my colleagues around the table spearhead, and other Institutes 
and Centers at NIH that are not represented here today.
    Our approach to health disparities is multi-proned. Through 
research we study the diseases, the conditions, and the issues 
to gain insight into the core of the problem. To conduct 
research we have to have the capacity, the facilities and the 
workforce to carry out the studies. We also need to have the 
community involved, not only as research subjects, but actively 
engaged in planning and conducting research, translating the 
research results and--disseminating the information back into 
the communities.
    To get at this, you, the Congress, statutorily mandated 
four initiatives that would set the framework for us to 
accomplish our goals in these areas. Those are our Centers of 
Excellence program, Research Endowment Program, Loan Repayment 
Program and the Community Based Participatory Research Program.
    If you look at figure 1 the map, which I gave to you in the 
book there, you will note that geographically our programs are 
in every State except Vermont and Delaware. So we have set the 
foundation by implementing the programs that you mandated.



    So what difference are we making to eliminate health 
disparities using this multifaceted strategy? If you look at 
the Centers of Excellence, much of the multidisciplinary 
research that we are conducting in communities across the 
country is being carried out through the Centers of Excellence 
Program that you authorized. We have funded 76 Centers 
nationwide since 2002.
    Our research endowments have led to the establishment of 
educational and training facilities such as pharmacy and public 
health schools. We've helped approximately 17 institutions to 
build their competitive edge for health disparities research. 
In order to attract the best and the brightest to the health 
profession, we have made loan repayment awards to about 1,100 
highly qualified doctorate level health professionals. An 
estimated two-thirds of the graduates have secured academic or 
research positions.
    Imagine cutting edge biomedical research being led within 
our communities by members of the community. That's what our 
Community-Based Participatory Research Program is about. We 
launched this three-phase program in 2005. We received an 
overwhelming number of applications, approximately 180. Today 
we are supporting 25 grants under this program.
    Mr. Chairman, our portfolio at the NCMHD is small in terms 
of dollars and numbers of programs, but that does not prevent 
us from fulfilling our mission. Collaboration is a large part 
of what we do within the NIH and with other agencies including 
my colleagues represented at this table.
    Some of the initiatives within their health disparities 
portfolio that we have helped to support include: the Health 
Disparities Nursing Research Center for the National Institute 
of Nursing Research, the Bioethics Center at Tuskegee 
University with the National Center for Research Resources, 
research on autoimmune disease with the National Institute of 
Allergy and Infectious Diseases and the Vanderbilt-Meharry 
Comprehensive Cancer Center with the National Cancer Institute.
    In conclusion, the NCMHD is making progress to predict and 
preempt disease through its Centers of Excellence and Community 
Based Participatory Research Program. We're building a 
culturally, competent workforce to deliver personalized 
medicine using the loan repayment program. Our Community-Based 
Participatory Research Program also embraces a critical element 
of medicine and that is the participatory aspect.
    Overall, our contribution has heightened awareness about 
health disparities, has increased the Nation's capacity to 
conduct health disparities research, recruited, trained and 
attracted an increasing cadre of individuals to research 
careers on minority health and health disparities and 
germinated innovative and productive partnerships involving the 
community. But we have barely touched the surface. There is far 
more to be done.

                           PREPARED STATEMENT

    The success of our health disparity effort, Mr. Chairman, 
depends upon our ability to further develop and sustain good 
models that we have all established. I thank you for the 
opportunity to brief you today.
    [The statement follows:]

                 Prepared Statement of Dr. John Ruffin

    Mr. Chairman and Members of the Committee: I am pleased to present 
the President's budget request for the National Center on Minority 
Health and Health Disparities (NCMHD) for fiscal year 2008, a sum of 
$194,495,000, which represents a decrease of $895,000 over the 
comparable fiscal year 2007 appropriation.
    At the turn of the 21st century, the issue of health disparities 
was still a pervasive public health challenge. Racial and ethnic 
minority and medically underserved populations were suffering 
disproportionately from disease and death; individuals living in 
medically underserved communities in rural or urban cities were also 
experiencing similar disparities in health status and health outcomes; 
there was a national need for minority scientists in biomedical, 
clinical, behavioral, and health services research. There were very few 
racial and ethnic minorities in science, technology or engineering. 
This raised concern about the future of these fields and their 
potential to eliminate health disparities given the nation's changing 
demographics, and the projected significant increase of racial and 
ethnic minority populations.
    This depiction of health in America was a part of the impetus for 
the creation of a national Center to address minority health and health 
disparities. Recognizing the gaps and the challenges, and understanding 
the promise of biomedical research, the Congress wisely established the 
National Center on Minority Health and Health Disparities (NCMHD) on 
the premise that through research, training, dissemination of 
information, and other programs, minority health would be improved, and 
health disparities would be reduced in the short-term and eliminated in 
the long-term. The NCMHD has embraced multiple partnerships as the 
guiding principle for understanding and addressing this national health 
crisis.
    While the overall health of the American population has improved, 
sadly, health disparities have not declined. Nevertheless, within the 
past six years the investments of the NCMHD have positively impacted 
communities throughout this nation and globally. Our contributions have 
heightened awareness about the seriousness of health disparities; 
increased the nation's capacity to conduct health disparities research; 
recruited, trained and attracted an increasing cadre of individuals 
from health disparity populations to research careers on minority 
health and health disparities; and germinated novel and productive 
partnerships involving the community.

                    UNDERSTANDING HEALTH DISPARITIES

    The Centers of Excellence program has become a leading force for 
research into various diseases and health conditions in health 
disparity populations such as HIV/AIDS, mental illness, obesity, 
diabetes, cardiovascular disease, stroke, infant mortality, and cancer. 
Collectively, these Centers have published more than 200 articles on 
the priority diseases/conditions and issues related to minority health 
and health disparities among all racial and ethnic minority, medically 
underserved, and low-income populations. Leveraging of resources and 
expertise with other NIH Institutes and Centers and federal agencies, 
and among our grantees has fortified our capacity to conduct research 
into the most critical diseases and issues concerning disparities in 
health. Basic, clinical, social science and behavioral studies are 
examining the many factors that are believed to contribute to poor 
health in our communities. Understanding the cause of disparities in 
health is pivotal in determining and applying appropriate preventive, 
diagnostic, and treatment modalities.
    Access to health care is a major health problem that potentially 
perpetuates health disparities. Those who have more resources are 
better positioned to benefit from costly new discoveries in science and 
medicine. An estimated 45 million Americans have no health insurance, 
most of them being racial and ethnic minority, rural, and low-income 
populations. A lack of access can delay timely medical care and 
increase the effects of disease without proper treatment. A study 
examining adherence to cervical cancer screening guidelines among 
publicly housed Hispanic and African-American women, found that only 62 
percent of those sampled had received a screening for cervical cancer 
within the past year. 29 percent of the participants noted that no 
health care provider had ever notified them that they needed a 
screening test for cervical cancer. In this study, Hispanic and older 
women were far less likely to adhere to screening guidelines. The 
results prove the need for continued and increased efforts to ensure 
that medically underserved racial and ethnic minority women have access 
to cancer screening services. Understanding the complex nature of 
health disparities and the influence of socio-economic, biological, 
environmental, behavioral, and other factors, remains a research 
challenge that we must continue to examine through pioneering research.

             TRAINING THE WORKFORCE: REMOVING THE BARRIERS

    Access to health care is a multi-pronged problem that is 
complicated by the shortage of health professionals from underserved 
communities. Racial and ethnic minorities make up only 14 percent of 
the physicians in America. The NCMHD and its partners have been working 
to diversify and strengthen the science workforce through training. 
Two-year loan repayment awards have alleviated the financial burden of 
pursuing higher education for approximately 1,100 health professionals. 
These trainees with MD, PhD, DDS, and other doctorate level science 
degrees, engage in research, health promotion, and outreach activities 
in numerous disciplines to heighten awareness and deepen our 
understanding of specific diseases and conditions, and issues in health 
disparities.
    Racial and ethnic minorities represent 64 percent of the current 
pool of NCMHD loan repayment awardees. An estimated two-thirds of the 
graduates have secured academic or research positions. The funding 
provided by loan repayments have helped to advance the careers of 
awardees and expose them to additional funding sources for their 
research activities. The program is slowly, but evidently achieving its 
mission to recruit and retain highly qualified health professionals in 
the workforce. In 2006, endowment funding supported the training of two 
Native American students completing the four-year Doctor of Pharmacy 
program at the University of Montana. This is a significant 
accomplishment because of the critical need to create permanent tenure 
track positions for Native Americans. At the University of Wisconsin at 
Madison, School of Public Health, the infrastructure established with 
NCMHD funding has helped to secure funds for a Health Disparities 
Research Scholars Training Program. This five-year training program 
will commence in Spring 2007 and it is anticipated that it will 
increase the number of researchers committed to health disparities. We 
will continue to enhance our focus on the recruitment and retention of 
individuals of health disparity populations to develop a culturally 
competent and well-trained workforce to address the burden of health 
disparities in our diverse communities.

                     CREATING THE COMPETITIVE-EDGE

    The quality of health among health disparity populations, and the 
delivery of health care can be improved by training a diverse workforce 
that is representative of the community being served. However, in order 
to conduct innovative research, it is essential to have the right 
capacity such as the facility, faculty, students, and training 
programs. Notable progress has been made in developing research 
capacity at more than 40 academic institutions.
    Having an endowed chair signals an institution's strength in a 
specific discipline. It is an incentive for a medical school to recruit 
and retain the most preeminent faculty in a given field, and adds 
credibility to its medical education program. Endowed chairs 
traditionally have been located at the most prestigious medical 
schools. NCMHD funding has established endowed chairs at three 
minority-serving institutions, Meharry Medical College, Morehouse 
School of Medicine, and the University of Hawaii. These endowed chairs 
are vital to building a critical mass of distinguished scientists in 
cancer, cardiovascular disease, diabetes, neuroscience, women's health, 
and Native Hawaiian health. This will place these institutions on the 
competitive edge to advance their study of minority health and health 
disparities in these fields. At Meharry, the endowed chair funds have 
helped to recruit a nationally renowned scientist to lead its Center 
for Excellence in Health Disparities Research in HIV/AIDS.
    Research capacity in terms of physical infrastructure has increased 
considerably at several institutions after obtaining NCMHD funding. In 
some instances, facilities for health disparities research did not 
exist prior to NCMHD Centers of Excellence funding. Today, Charles R. 
Drew University has space totaling 8000 square feet, New York 
University 3,900 and Claflin University 3,403 square feet dedicated to 
conducting health disparities research. As a result, these institutions 
have been able to expand their research and training activities. The 
University of South Carolina-Claflin EXPORT Center recently erected a 
Molecular Virology Laboratory at Claflin University which houses state-
of-the-art equipment for microscopic gene cell isolation and 
examination, where HIV viral load assays for example, can now be 
studied. The University of New Mexico houses the only School of 
Medicine in the state, and endowment funds have helped to establish the 
Institute of Public Health to address chronic health issues among low 
income and racial and ethnic minority populations.

                         VALUE OF PARTNERSHIPS

    Our success in eliminating health disparities will ultimately 
depend on our ability to translate the lessons learned from our 
research endeavors, into usable tools and programs for the community. 
We have expanded our partnership base, and moved beyond the tradition 
of limiting partnerships to academic institutions, into domains where 
we can have the capacity to respond to health disparities in any form. 
We have continued collaborations NIH-wide, across the Department of 
Health and Human Services, and with other agencies such as the 
Department of Justice. Our efforts also have engendered unique 
partnerships between academia and the community; the community and 
local, state or federal agencies; research-intensive institutions and 
minority-serving institutions; and among NCMHD Centers of Excellence 
within a given state and state health agencies.
    In partnership with the National Institute of Environmental Health 
Services, the private sector, universities and schools, molds and other 
allergens that may trigger asthma in children are being studied post-
Katrina. In conjunction with the DHHS Office of Minority Health we 
mobilized our Centers of Excellence to respond to emergency health 
needs in the community and offer research opportunities at NIH for 
scientists after Hurricane Katrina. Today, the community is benefiting 
from electronic medical records, and telemedicine programs that are 
being incorporated into the health care infrastructure. In Oklahoma we 
have been able to reach more than 65,000 American Indians through a 
partnership of the Oklahoma Project EXPORT Center with nine tribes. The 
power and impact of our partnerships has touched the global community 
from state to state to places like Asia, Africa, Europe and the 
Caribbean where our students and faculty engage in research training.

                           IMAGINE THE FUTURE

    We have begun to set the foundation through our research, training, 
capacity development, and outreach efforts to transform the health of 
this nation, but we have barely touched the surface. There is far more 
to be done. In three years, according to the Healthy People 2010 
report, health disparities should be eliminated. However, the recent 
Midcourse Review of the report underscores the fact that not enough has 
been done overall to demonstrate any significant decline in health 
disparities.
    Imagine a Nation where differences in health status and health 
outcomes no longer exist among populations. Imagine a nation where all 
Americans can lead a long and healthy life. Imagine a country where all 
Americans can access quality health care. Imagine physicians and health 
care professionals of all racial and ethnic backgrounds, in any 
specialty, practicing in every community across this country. Imagine 
cutting-edge biomedical research being led within our communities by 
members of the community. Imagine the discovery of solutions for 
critical diseases like diabetes, mental illness, cardiovascular 
disease, HIV/AIDS or obesity emerging from a community lab.
    At the NCMHD we are cognizant that no single entity alone can solve 
the complex problem of health disparities. The sustainability and 
success of our health disparities efforts depends on strategic 
partnerships. We will continue to expand our network to address the 
diseases and issues that are already familiar to us, and examine new 
and emerging health disparities challenges in prisons, housing 
communities, or among our men. We must also be able to respond to 
health crises as they arise. Novel and multi-faceted strategies must be 
exercised and increased at the community, national and global level if 
we are to succeed in using the power of biomedical research to 
transform the health of racial and ethnic minority and medically 
underserved populations and eliminate the scourge of health 
disparities.

                             NCMHD PROGRAMS

    Senator Harkin. Thank you very much, Dr. Ruffin. I assume 
on this map you gave us, that CBPR, the green dot, is Community 
Based Participatory Research?
    Dr. Ruffin. That's correct, sir.
    Senator Harkin. We don't know how many are in each State. 
We just know there's something going on there, right?
    Dr. Ruffin. I think I can also tell you we've established 
25 of those programs thus far. I think I have a map that I 
might be able to share with you that shows the distribution of 
those 25 programs.
    Senator Harkin. Tell me again what's that loan repayment 
program? How does that work?
    Dr. Ruffin. The loan repayment program is where we pay back 
the loans of individuals who go into health disparities 
research. These individuals get about $35,000 a year, principal 
and interest is paid as a repayment for those individuals to go 
into health disparities research. It is modeled a lot like the 
AIDS-Loan repayment program which many of you are familiar 
with, except in this case, our loans are given to not just MDs 
but to all health professionals.
    Senator Harkin. Would that be nurses too?
    Dr. Ruffin. Nurses, dentists, individuals in clinical 
psychology, sociology, all of the medical professions are 
eligible to apply for these loan repayment programs.
    Senator Harkin. Interesting. I have to find out more about 
that.

                                VACCINES

    Dr. Fauci, I would like to talk a little bit about 
vaccines. As you know we have provided over $6 billion to HHS 
to prepare for a flu pandemic. A lot of that money is to 
develop both egg-based and cell-based vaccine capacity in this 
country. We've been through that many times.
    But in the case of a pandemic even after spending this 
money, it will take us months to develop a vaccine that will be 
effective against the strain of flu that proves to be able to 
be transmitted from human to human. It will still take time.

                           UNIVERSAL VACCINE

    Now, I've heard a lot about this idea of a universal 
vaccine. One that would be effective against all strains of 
flu, a vaccine that could be stockpiled now, made immediately 
available at the time of a pandemic or one that could be 
routinely administered to people giving them immunity in 
advance of a pandemic in certain areas.
    I recently met with some people who were developing a DNA 
based vaccine that identifies proteins. It was very interesting 
to me--that are common to all strains of flu. And I understand 
your Institute has supported some of this work. I just need to 
know more about this. Is there this possibility that we could 
get this universal vaccine that--since we identify proteins 
that are the same in all the different flus? Is this possible?
    Dr. Fauci. It is conceptually possible. I think over time 
it will be likely.
    When you look at a flu virus the major components that we 
traditionally over the years have made vaccines against, have 
been the H and the N proteins that are on the surface. They 
stand for hemagluttinin and neuraminidase. That's the reason 
when you hear about flu--you name flus by the differences, 
H5N1, H3N2.
    Now the good news is that the body makes a really good 
immune response against the H and the N. The bad news is that 
the H and the N change from influenza to influenza. Which is 
the reason why each season, to get a perfect match, most of the 
time you have to fine tune and tweak the vaccine a bit so that 
it's a little bit different than the one you did the year 
before to get optimum and maximum protection.
    The concept that you're referring to, Mr. Chairman, is the 
idea of getting the components of the virus that don't change 
from strain to strain and season to season. Two of those 
proteins are the M2 or the matrix protein, and the NP or the 
nuclear protein. They don't seem to change from strain to 
strain. So then you--you ask the obvious question. If I was 
infected with seasonal flu 3 years ago, why am I not protected 
against the seasonal flu the next year or the year after?
    The reason is the body does not make a very robust immune 
response against the M protein and the NP. So the strategy that 
we're working on with the people that you mentioned is to get 
those proteins and put them in a very immunogenic form. So that 
the body makes a very robust immune response that would cross 
over and help protect not only against this season's flu, but 
next season's flu and the year after.
    Also, theoretically if you do it right, you could get a 
universal vaccine that would even be protective against a wide 
variation. The way we're seeing with the H5N1. Because the H5N1 
that's circulating in birds in south east Asia right now, is 
very much different from the H3N2 that we all get exposed to 
every season. So that's the concept and the strategy of a 
universal vaccine.
    The results that we're getting, preliminarily, in animal 
studies are really rather encouraging. Now you know in vaccine 
work it takes years to go from the concept to something that's 
in a bottle for people to use. But, I, myself am quite 
encouraged about that possibility.
    Senator Harkin. So you're funding research on this?
    Dr. Fauci. Oh, absolutely. We're funding research by our 
extramural grantees and contractors. We're collaborating with 
some of the pharmaceutical companies. For example Merck itself 
is working on a M2 vaccine. We're doing intramural research.
    You mentioned the DNA approach. Where you can take the gene 
of any particular protein and code it for the protein that you 
want and essentially say I'm going to inject somebody with the 
DNA. That DNA will then cause the body to express the protein 
on a cell that makes a good immune response. At the Vaccine 
Research Center under Dr. Gary Nabel, at the NIH, that's what 
we're doing with HIV. It's easily done also in influenza.

                   FUNDING INFLUENZA VACCINE RESEARCH

    Senator Harkin. Do you think we're putting enough resources 
into that on the balance of things? This is very promising.
    Dr. Fauci. It is very promising. It's very promising.
    Senator Harkin. It would be a big deal.
    Dr. Fauci. It would. It would. As you know I've always told 
you over the years you never ask a scientist if you put enough 
in. Enough is when you get the answer. We are putting a 
substantial amount. We are concerned as we all are with--when 
we have a flat budget will we be able to take advantage of some 
of the opportunities that would arise. So we have to be very 
careful in our prioritization. But we're putting substantial 
resources into it.

                    VACCINES AND AUTOIMMUNE DISEASE

    Senator Harkin. Two other things. I just want to ask one 
about vaccines and I want to ask about allergies.
    Children get a lot of vaccines by the time they're three 
years old. I've heard estimates ranging from 18 to almost 30. 
Having a new grandchild myself last year, their parents are 
looking at all the shots that this kid is supposed to get by 
the time they're, well, 1 and then by 2. It was pretty darn 
close to 30.
    I've heard a lot of concerns. That, you know--while each of 
these vaccines are very good in terms of saving lives, building 
immunity that maybe collectively, putting them all together 
could lead to autoimmune diseases later in life. I've heard a 
lot of this, read about it. So, again, I want to know, what 
kind of research is being--done on that aspect of all of these 
together effecting autoimmune diseases later in life?
    Dr. Fauci. It's obviously a good question because it is a 
matter of concern to some people. There have been studies done 
looking at retrospective data of children who get vaccinated as 
to whether or not there's this propensity to autoimmunity.
    The basis of that concern, I think is the basis of why you 
really do want to vaccinate people because in people who have a 
genetic predisposition to autoimmunity, it is often triggered 
by an infection. We know that, for example with certain of the 
autoimmune diseases like lupus and rheumatoid arthritis and 
things like that.
    So the question is mimicking the infection by a vaccine 
going to induce autoimmunity. The answer is in studies that 
have been pretty carefully done, no. But, importantly, the 
infection itself is a much more potent potential inducer of 
autoimmunity than is the vaccine that you give to somebody to 
prevent the infection.
    So if we didn't vaccinate people and they actually got 
these infections that would be an even worse scenario. So if 
you're asking me, I can give the example: I have three children 
and they've gotten all the vaccinations. I feel very, very 
comfortable with having my children vaccinated with the menu of 
vaccines that are all recommended.
    So, the concern is understandable. The research in the 
studies that have been done to see if there is a connection 
have all indicated that there is not.

                             FOOD ALLERGIES

    Senator Harkin. One last thing, allergies. A friend of mine 
in Iowa--we're just talking about kids and our kids, grandkids. 
It turned out that their little boy had developed severe food 
allergies.
    You and I have talked about this before in previous 
hearings. Three hundred percent increase in the number of 
pediatric food allergy cases over the past 10 years. That's 
alarming.
    Dr. Fauci. Yes.
    Senator Harkin. What's going on? You know, what is 
happening out there?
    Dr. Fauci. To be honest with you, we don't know. There are 
some theories about that, but food allergy is something that we 
have now, we have had for some time. But even most recently 
based on the data you're talking about, are taking it very, 
very seriously.
    Not only is food allergies--and certainly the recognition 
of and probably the reality of, more than just the recognition 
of are increasing. Not quite sure why that has occurred. I'm 
certain that there are factors that are not fully appreciated 
by us right now. But the thing that worries us is that some of 
these food allergies are more than just trivial. You can 
actually get anaphylaxis. One of the important ones, for 
example, is--is peanut allergies is really, really tough.

                       PEANUT ALLERGIES IN CHINA

    Senator Harkin. I've heard. Now tell me if I'm wrong on 
this. Have you ever heard this about kids in China eating a lot 
of peanuts there. But they don't get peanut allergies. But we 
get peanut allergies here. Have you ever heard such a thing?
    You haven't heard that one?
    Dr. Fauci. I haven't heard that but I thought you were 
going to say that the Chinese were putting something in it that 
is toxic.
    Senator Harkin. No, it's just that China grows a lot of 
peanuts, like ours. The kids eat a lot of peanuts. But they 
have nowhere near the peanut allergies we have in this country. 
I was operating under the assumption that was factual data. I 
don't know.
    Dr. Fauci. I've not heard this.
    Senator Harkin. Look into that.
    Dr. Fauci. I certainly will. I certainly will.

                      RESOURCES FOR FOOD ALLERGIES

    Senator Harkin. But--again, with the 300 percent increase 
do we have enough resources going into that? It's our resources 
again.
    Dr. Fauci. It's the same answer to the question. We are 
doing a substantial amount. We could do more. Definitely.
    Senator Harkin. I'm told that NIH hosted an expert panel on 
food allergies in the spring of 2006. Last year. The 
participants developed a proposed road map to guide future 
research. But it has been a year now and I understand the road 
map still hasn't been approved. Give me an update on that, 
would you?
    Dr. Fauci. We met with that group in my conference room 
about 3 months ago. We walked away from that with them. They 
are quite satisfied with the portfolio that we've put together. 
With regard to a strategic plan that's almost a logistic thing, 
about getting a plan and a plan approved through the Department 
and what have you.
    But the research that we're doing right now on food 
allergy, we've developed a very good relationship with the 
constituency groups on that. I have a lot of responses to that 
meeting that were very favorable.
    Senator Harkin. Well, alright. I just wondered what was 
happening there. I just--you can jump in anytime, just jump in 
if you have some things you want to cover. Go ahead.

                COORDINATION WITH DEPARTMENT OF DEFENSE

    Senator Stevens. Tony, what about coordinating what you're 
doing with the other agencies? We're putting a lot of money in 
defense for investigation dealing with substances that might be 
used by terrorists for instance. Are you working with them too?
    Dr. Fauci. Yeah. There is a rather excellent coordination, 
Senator Stevens, between ourselves, the Department of Homeland 
Security and the Department of Defense. In fact, we feel very 
good about that. We were doing that--we've developed a good 
relationship with them.
    Even antedating bio-defense because a lot of the things 
that they have done for force protection, malaria, and things 
like that, we have worked very closely with them. When the bio-
defense issue arose following 9/11, we, in fact, strengthened 
our interaction with them. With the new Department of Homeland 
Security, we're even coordinating very nicely with them.

              BIOLOGICAL, RADIOLOGICAL, OR CHEMICAL ATTACK

    Senator Stevens. That was going to be my next question 
because it just seems with the world wide impact of the 
terrorist movements that they're going to turn to substances 
one of these days. Are we prepared for that?
    Dr. Fauci. We are not totally prepared. I would be 
misleading you if I told you we're totally prepared for any 
biological, radiological, or chemical attack that we have. But 
since 2002, we have built up a rather robust research and 
development portfolio and have made some significant advances.
    Obviously, you never know where, when or if a terrorist is 
going to strike in a biological, radiological, chemical way. 
But we have countermeasures now that we didn't have before. We 
were completely vulnerable to a smallpox attack. We had 18 
million doses of smallpox vaccine in our reserve. Right now we 
have over 400 million. That's happened just over the past 
couple of years.
    Senator Stevens. That was my next follow up because it 
seems to me that we're doing a lot of research and prevention, 
but what about reaction to such events when they take place. 
That seems to be the area that we could be most effective.
    Dr. Fauci. Right.
    Senator Stevens. We can't immunize everybody against 
anything.
    Dr. Fauci. Sure.
    Senator Stevens. But we can get prepared for specific 
problems that might arise. Are we doing that?
    Dr. Fauci. We are. We are, Senator. I'll give you two 
examples that are actually very important examples.
    You talk about treatment. We've never had any treatment for 
smallpox or pox viruses. There is a drug that we've helped 
develop with a pharmaceutical company called ST-246 which is 
very effective in an animal model against smallpox. You may 
have read in the newspaper about a military person who was 
getting vaccinated for smallpox with vacinea didn't fully 
realize that his child had eczema. When you expose the wound of 
a smallpox inoculation to a child with eczema, they can get an 
eczema vaccinatum which is a very terrible disease.
    The child did get it accidentally, and doctors tried 
everything with the child and we brought this drug in. They 
treated the patient with the drug and the child has made a very 
remarkable recovery. So that's a--N equals one in medicine that 
doesn't mean anything, but this, I think, is an important 
indication that we now have an important drug.
    We also have some antitoxins that we didn't have, for 
example against anthrax. We've developed the first Ebola 
vaccine that, I think is a very important advance.
    Senator Stevens. What about post exposure to nuclear. I 
heard the other day about something that would reduce the after 
effects of nuclear exposure.
    Dr. Fauci. Right.
    Senator Stevens. Is that really an accomplished fact.
    Dr. Fauci. What we are doing and we've had to partner with 
our colleagues from the cancer community, with the National 
Cancer Institute is to develop better versions of the drugs 
that are used on patients following a radiation to rescue bone 
marrow. For example, to allow the bone marrow to regenerate in 
a much more rapid and efficient way than it would to wait for 
it to normally respond. That's the main nuke-rad counter 
measure that we have.
    Senator Stevens. Are we stockpiling that?
    Dr. Fauci. Yes, we are. We have that in the National 
Strategic Stockpile.

                              NCI FUNDING

    Senator Stevens. Dr. Niederhuber, if I may? I was really--
you know we doubled the research money for you in one period 
that Connie Mack and bipartisan effort. We did that over one 
period. I think it was a little less than 10 years. Are we 
going to look at a necessity to double it again in the next 
decade?
    Dr. Niederhuber. Well, living as we have for the past 3-4 
years with a less than inflation budget has certainly taken its 
toll on the programs. If you calculate that up it's about a 12 
percent decrease from where we might want to be at this point.
    Senator Stevens. Well, since you had 125 percent increase 
in the past years before that. Where do you think you'd stand 
if we hadn't done it?
    Dr. Niederhuber. Oh, I think we would be much worse off in 
the country as a whole. I think the increase that Congress, in 
its wisdom, legislated and appropriated did a great job in this 
country in building up research infrastructure that was 
lagging. We built about $16 billion worth of new research space 
at our Research Universities across the country. I think that 
was badly needed.
    Having come recently from the academic community we had 
some real pent up needs in the academic community. We were able 
to increase our faculties where we needed to in the biomedical 
research arena. So I think this was all, Senator Stevens, very 
needed.
    The issue I think for us, as a country, has been that when 
you build up you need to keep moving with inflation in order to 
maintain what you've built. I think that's the issue that we 
are facing.

                          GENERATIONAL CANCER

    Senator Stevens. That's reasonable, I think.
    Let me ask you a personal question. I had three generations 
of pancreas--pancreatic cancer ahead of me and I got prostate 
cancer. Now someone told me the other day that in all 
likelihood I had the same cancer. Is that possible that it 
migrated to my predecessors but didn't migrate for me?
    Dr. Niederhuber. Well, I don't think I would look at it 
quite that way, having been involved with managing and 
operating on patients with pancreatic cancer for most of my 
career, I think these are two separate diseases. They each have 
specific risk factors. I could share that with you.
    Senator Stevens. I just want to know what to tell my sons.
    Dr. Niederhuber. Well, I think the thing to tell your sons 
is that we're working hard to better understand the risk. What 
I was going to say that actually in July of this year our 
Center of Excellence in the National Cancer Institute focused 
on trying to understand risk in populations and risk for 
developing different cancers. We've just finished a whole 
genome scanning project in prostate and in breast and this July 
we'll launch one specifically in pancreatic cancer. So it's 
relevant to your question, Senator.
    Senator Stevens. Well, let me know will you?
    Dr. Niederhuber. I certainly will.
    Senator Stevens. What do I tell them--follow their 
grandfather, their great grandfather?
    Dr. Niederhuber. Live healthy, exercise, eat well.

         ATTRACTING STUDENTS TO SCIENCE AND TECHNOLOGY CAREERS

    Senator Stevens. Which one should they be careful of? 
Anyway, let me ask you, Ms. Alving.
    Are you familiar with Norm Augustine's report titled: 
``Rising Above the Gathering Storm'', which discuses the 
problem of having enough students turning to the study of 
science and technology?
    Dr. Alving. Yes, Senator. We're very aware of this at NIH.
    Senator Stevens. But what are all of you doing about that? 
All of you have basic money, research money. I understand what 
you're doing Dr. Ruffin. That's very good.
    We do the same thing by the way. We pay some of our staff 
who have high loans, before they migrate out to where they get 
paid more. So we have a little bit of a fund here. We can sort 
of entice them to stay a year or two longer. But are you doing 
anything about the concepts of trying to attract students into 
the areas so that you're not the last of the breed in terms of 
scientists who are studying these things for us?
    Dr. Alving. Yes we are, Senator. I would say that NCRR is 
working very diligently on this. The other Institutes and 
Centers are working on this, as well, because across NIH we 
recognize this as a very large challenge. We also recognize----
    Senator Stevens. Let me interrupt you. Do you have 
internships for people in college to attract them so they'd be 
interested to go to graduate school? Do you reach out to 
people?
    Dr. Alving. Absolutely. For example, let's look at the IDeA 
program that I mentioned earlier. I personally visited Montana 
this last year and I saw how the investigators at the more 
research intensive universities are reaching out to the tribal 
colleges. So there are now research projects underway at the 
tribal colleges. The tribal students can go to the University 
of Montana and really envision research careers.
    I remember one young man told his father he was going into 
biomedical research. He was Native American. His father said 
well, that's not what we do. But he said yes, this is what I do 
want to do.
    So we are reaching out to students, I would say, of all 
ages, because to really attract students into research and into 
biomedical careers, you really have to get them at a very young 
age. In one of our SEPA programs, our Science Education 
Partnership Awards, one of our very fine investigators has 
developed a bus in Boston that actually is well equipped as a 
laboratory. It's even visited the NIH campus.
    The bus goes throughout Boston. So it goes into the 
underserved areas. Students can get onto this bus, which is a 
traveling mobile lab, and learn about DNA and learn some of the 
simple experiments. In fact, I think this has been really 
replicated throughout many of the States.
    So we're really attacking this, I think, at multiple 
levels. We're reaching out to the Hispanic community as well. 
And many of our very well funded researchers have very active 
programs where they serve as mentors and bring high school 
students into their labs. It's probably still not enough, but 
we're all very aware.
    Senator Stevens. If this Nation has a problem--the problem 
is the downward trend of our students who seek graduate 
education in science, technology, and engineering, which are 
very difficult areas of study. We've got to find some way to 
move out and give them incentives to continue.

                           CONGENITAL DEFECTS

    I know I'm using my time. Dr. Grady, I just recently came 
about in connection with a relative. The problem of a defective 
heart valve which came from, they tell me, from what you 
mentioned, a problem at birth. Now what my question to you is 
have we any way to check this as people grow older? Whether 
they do have those defects that develop because of improper 
handling at birth?
    Dr. Grady. There are a number of tests that are now 
available where we can through imaging and other diagnostic 
tests tell very early on in children if there is a 
developmental defect.
    Senator Stevens. I'm talking about this person's almost 60. 
He was just determined--to have blood clots going to the brain. 
Suddenly they find out that was--escaped through some valves 
that have been defective since child--since birth. Now I--and 
he's had exams. He's been in the service. Why doesn't--why 
won't that show up on exams?
    Dr. Grady. Well, it turns out that many of us have 
problems, birth defects, congenital defects that we are really 
unaware of. Sometimes we die without being aware of them. But 
now that the life expectancy of the average American is longer, 
many of these things which would not have surfaced before are 
now surfacing.
    Senator Stevens. But how can we--can we discover them?
    Dr. Grady. Up until recently the imaging technology and the 
other technologies that we had were not able to. But we now 
have imaging technologies which have a very high resolution. 
You can tell things are happening in tissue that are structural 
and even metabolic disorders much earlier in life.
    Senator Stevens. Those valves could be discovered with the 
proper test?
    Dr. Grady. Yes. Very likely they could have been.
    Senator Stevens. Are we developing any indications that 
would lead people to take those tests?
    Dr. Grady. Actually there is a move on for people to do 
screening, whole body scans, et cetera and much higher 
technological screening early on in life. Some of these things, 
as we're all aware of, are not covered by insurance so people 
opt not to do them. But I think the technology is now becoming 
available and people's awareness that they should screen for 
things and that they should have check ups early is much 
higher. So hopefully, we'll be catching these earlier.
    Senator Stevens. We saw something that both the government 
and the insurers are not going to pay the cost of scans, 
particularly full body scans.
    Dr. Grady. That is currently the situation. There is a 
great deal of discussion, whether or not they should be 
available and for what particular conditions they would be most 
helpful.

                           MEDICAL SCREENING

    Senator Stevens. This is very disturbing. This person is 
now blind, partially. He's got tunnel vision because of those 
clots and had no idea that that existed. I was told it could 
have been diagnosed at any time prior to that if he had had the 
proper exposure to the scans. But I don't know how.
    We've got all these systems. I don't know how we can get so 
that subjective to the people who need help, know that need 
help. Is that part of any of the studies we're making? How do 
we find out who needs this help?
    Dr. Grady. It is a problem in that we are trying to inform 
people. But we also have difficulty getting people to come in 
for screening exams which we know are helpful: mammography, 
breast cancer screening, and there are a number of other 
screenings that people do not necessarily take advantage of.
    We are studying--we're funding a number of studies however, 
that look at what it takes to get people incentivized to come 
in for screening. We have some very interesting information 
related to, you mentioned relatives, related to mothers and 
daughters. Daughters being more tuned into health prevention, 
getting mothers to come in, senior citizens and younger people, 
et cetera. So we're working on a number of techniques to 
incentivize people to come in for screening.
    Senator Stevens. I was told last week that there is now a 
system where you can go and have your--what your gene chain set 
out. They can compare that to the types of illnesses that come 
from these genes that you are determined to have and they can 
then give you a prediction on what you're going to suffer. I 
said why don't we all get that? They said, well, it's cost. 
That it's not available to the average income person today. Are 
we going to get to where we can get that for the average 
person?
    Dr. Grady. Well, it is true that it is not covered by 
insurance but also--we're not quite there yet where these tests 
are 100 percent accurate.
    For some things such as stroke, we have developed and 
identified risk factors. We can weigh each one and there's a 
whole scale where you plug in your blood pressure, your age, et 
cetera. Then you can alter--what if your blood pressure came 
down a certain amount and you get a score which you can then 
program. If I alter my diet, if I lower my blood pressure, if I 
exercise more, that will reduce my chance of getting a stroke 
by x percent or so many points. So I think we are moving in 
that direction in some areas, but we're really not there yet.
    Senator Stevens. Maybe some of us don't want to know that's 
the problem.
    Senator Harkin. Do you have thoughts on what Senator 
Stevens just asked?
    Dr. Niederhuber. I was just going to comment that we--all 
of the Institute Directors were at a conference all day on 
Friday at the NIH and during that day we were talking about 
some of the latest technology coming online to do rapid 
sequencing. I believe, you can correct me, colleagues, if I'm 
wrong, but I believe the quote was that, ``with this new 
technology today we can sequence half of our genome in 3 days 
at about $3,000.''
    So you can see how quickly within the next few years we 
will be approaching our goal of being able to sequence the 
entire genome of you as a patient within 3 or 4 hours for 
$1,000.
    Senator Stevens. Would it be cost effective for us to do 
that publicly?
    Dr. Niederhuber. Well, that's a very good question, 
Senator. I think that we all recognize in the science community 
that this information, this alphabet if you will, is the base 
of the information. We know that we have a lot more work to do 
in taking that code, if you will and understanding what that 
code means in terms of the proteins that our cells produce.
    The changes in those proteins as they're produced and how 
they relate to what makes you function and you as an individual 
and your diseases and me, as an individual and my diseases. So 
we have a lot to build on. But that is like the periodic table 
of chemistry, if you will. It is the information based upon 
which we will gain this kind of knowledge and this kind of 
understanding of the disease. It's a step, but a very important 
step.

                                GENOMICS

    Dr. Fauci. Can I add we should be careful though not to 
think that if you--if we, even if we get it inexpensively that 
if you get your genome and you look at your sequence, you're 
going to know exactly what's going to happen to you. That's--
most diseases are multigenic. They rely a lot on interaction 
between the genetic factors and the environment.
    So although you could get some probabilities there's still 
going to be the need for the broad, healthy things you need to 
do no matter what your genome is. So we spoke about that also.
    Senator Stevens. I said it was the last question. But I 
forgot this one.

                              END OF LIFE

    Dr. Grady, you gave us this chart, tracking patient 
disability in the last year of life identifies opportunities to 
tailor interventions. We were told last year that in the last 2 
years of the person's life they would probably spend as much 
money for health care as they've spent in all previous years. 
Are you suggesting here that there's some way to alter that?
    Dr. Grady. Your statement is true. What we are suggesting 
is that these are trends. So it's a very large population study 
but it gives parameters within which you can better be able to 
predict what a course of illness may be like. That doesn't mean 
it will necessarily be that way for each individual person, but 
it gives you parameters.
    So it gives you a sense of what one could expect and 
hopefully to be able to better plan. It's an imperfect system 
when translated to single individuals but it does give the 
patient, the family, and the health care team some idea.
    Senator Stevens. Are you suggesting you think science can 
tell us when a disease is really terminal no matter what 
happens?
    Dr. Grady. We're still not there yet. It's very difficult. 
You can, as we all know, predict within some time frames. But 
still individuals are very different from person to person. So 
you have guidelines, but I would not be offering a finite 
timeline.
    Senator Harkin. Well, I want to pick up a little bit of 
what Senator Stevens just said this end of life care. I just 
wrote it down here. It's got to be more rational, caring and 
cost effective.
    A lot of it is just irrational. The way it's administered. 
I don't know if it's more caring for a person to--to do 
expensive operations or anything like that knowing full well 
that the end of life is coming anyway than it is to just give 
him palliative care. Address yourself to that too.
    Most--our health care system is not very good when it comes 
to palliative care--and then so a lot of people stay in acute 
care until they die. It just costs a fortune.
    Dr. Grady. It's very complicated, Senator, both Senators. 
What we found out so far--we've just scratched the surface.
    What we've found out so far however that is disturbing is 
that some of the things that we could do we are not doing 
consistently. For example, pain management. We know a great 
deal about pain management and our ability to handle pain in 
these stages of life. Yet, we find great disagreement between 
what the health team advises, what the patient says they want 
and what the family says that they think the patient wants.
    So whether it's an intensive care unit setting or a hospice 
setting or chronic care setting, we find great disagreement. 
This is all within the therapeutic window of pain medication 
that could be administered that would be safe to administer. So 
that's one thing we know.
    The other thing we have found is that--that many patients 
do not have advanced directives. They haven't really thought 
ahead. They haven't talked with their family, but even if they 
have many of the systems that we have are required. They 
basically are not allowed to withhold treatment, even if that 
is the patient's request.
    So if in an emergency the ambulances are called or 
anything, it doesn't usually matter in practice if the person 
says no advanced measures.
    Senator Harkin. What would you think about that? I've never 
talked to Senator Stevens about this but this idea of having 
advance directives? People don't. They just don't think about 
it. Maybe when people get on Medicare that ought to be a part 
of when you qualify for Medicare that you ought to have a 
requirement that you have some kind of advance directive.
    Dr. Grady. Well if the person would have an opportunity to 
do that it would at least allow them to think about it. It 
would give the family some sense of where they should go and 
some guidance. It turns out the other studies we've done that 
look at the caregivers of terminal patients that the largest 
stress for them is reported to be that they didn't know what 
their family member wanted. They had to make a decision really 
acting in the dark by their report. That they felt was, by 
their report, almost as stressful as seeing the disability.
    Senator Stevens. But is that partly related to the 
liability factor of the caregiver in case another person--
family member says you could have saved them and you didn't.
    Dr. Grady. There seems to be a great deal of anxiety about 
that.
    Senator Stevens. Well, I think, Senator Harkin is right. I 
think we ought to try to do something. I witnessed my first 
father-in-law after he had brought back to life. He was a 
minister and a grand man. He was in his mid 90s. I never heard 
him swear in his life, but he swore at the doctor that brought 
him back to life. He died about 2 months later and I think that 
is a very unfortunate thing. He did not have a directive. But 
there ought to be something to deal. Maybe we could tie to 
Medicare.
    Senator Harkin. I've thought about that. I hear this all 
the time. There is a liability problem there. People don't 
think about it. Families don't know what to do.
    Senator Stevens. I see my friend is here. I'm late for 
another appointment. So thank you very much, Senator.
    Senator Harkin. Thank you, Senator Stevens.
    I want to follow up on one thing and that's on the nursing 
shortage.
    Dr. Grady. Yes.

                            NURSING SHORTAGE

    Senator Harkin. We had a hearing on global health a few 
weeks ago. We talked about the brain drain and other countries.
    What's happening in other countries is a lot of their 
nurses especially in health care professionals are getting 
their degrees and that kind of thing. Then they come here, 
better paying jobs. We have a shortage of nurses here now so we 
started looking into this.
    Well then, what did we find out? There's a shortage of 
nurses in this country. There's a demand for nurses. American 
Schools of Nursing last year turned away 42,866 qualified 
applications for baccalaureate and graduate programs due to a 
shortage of nurse faculty.
    Dr. Grady. That is correct.
    Senator Harkin. Now, we're in a real problem here.
    Dr. Grady. We are.

                         TRAINING NURSE FACULTY

    Senator Harkin. We need more nurse faculty. But if we don't 
have the slots for them, it seems to me pretty soon, they're 
going to start retiring and we're going to have fewer and 
fewer. I don't know.
    Your Institute supports a lot of nurse faculty through 
research grants. So what role does your Institute play in 
increasing the number of nurses trained here in America, 
especially teaching nurses, faculty--teaching nurses? I don't 
mean just nurses that are out in the community, but I mean 
teaching.
    Dr. Grady. Senator Harkin, those are the nurses that we 
support in our training line. We have 7 percent of our budget 
devoted to training.
    Senator Harkin. 7?
    Dr. Grady. Yes, 7 percent, which is twice the NIH average. 
So we're dedicating a reasonable chunk of our budget to 
training. The people that we train are those individuals who 
become the teaching faculty. We train them to do research, but 
that's what faculty do on campuses of Schools of Nursing across 
our country.
    So we have designed a number of programs to try to get 
these students in early. We work with the K through 12 
programs. We work with the other graduates to encourage them to 
get doctorates. We also have what we call fast track programs 
so that they come into the baccalaureate program, come out with 
their Ph.D. without stopping.
    Senator Harkin. Thank you. What if you were advising us? If 
you could say here's what we're going to do. What would we do 
say; give us 3, 5 years. What would a 5-year plan look like to 
get more teaching faculty in this country?
    Dr. Grady. I think the 5-year plan would have some loan 
repayment, but I think that looking at loan repayment or 
service repayment. For example and this dates back to the older 
days, but we used to, if people had supported education that 
they would not have to pay back the loans, but they would pay 
back in service, teaching at schools as faculty, et cetera. I 
think maybe something of that sort.
    Incentives to get people into the field earlier, I think 
there is a real sense and this is partly what we're working on 
internally is people are expected to get their advanced 
education but they're expected to work along the way because it 
is clinical profession. So we are trying to help design 
programs so that that is not necessary.
    Believe it or not, many States require, in order to teach 
in a School of Nursing, that you have to have a Masters in 
Nursing and not just get your Bachelor's and then go on to a 
Ph.D. So there are a number of issues that we're working on. 
But it is safe to say that that the demand over the next 10 
years is going up in excess of 20 percent. We're only supplying 
another 6 percent.
    So we need programs that are attractive. We need programs 
to help retention. We have programs to help get people in but 
we need to figure out how to retain them. I think we need also 
to work on the quality of life issues such as loan repayment.
    Senator Harkin. Well, we need some advice. I mean if you 
turn away 42,000 last year. I assume the same will happen this 
year, maybe more.
    Dr. Grady. Yes. We are, as you had identified very 
astutely, expecting an increased retirement. It turns out that 
faculty in Schools of Nursing tend to retire earlier than 
later, 62 versus 65 or so on. So we really are getting a crunch 
from several directions. So we're hard pressed to try to design 
as many programs as possible to get people in and to make the 
field as attractive so that they will stay in.

                            NURSING RE-ENTRY

    Senator Harkin. Let me ask you this. I was amazed to 
discover in my State of Iowa a few years ago that there are a 
lot of nurses in my State, and I'm sure it must be true in 
other States. They went to nursing school. They became an RN. 
They were an RN for a while. They got married, started having 
families. They got out of nursing, raised their families. Kids 
are grown. They may not have been in nursing for 15, 18, 20 
years. I was amazed to find out how many there were in my 
State.
    So I began asking a few of them once I found out. In 
meeting people you never knew they were nurses. You meet them 
in other walks of life and find out they were a nurse. Would 
they ever think about going back into it. And they said, Oh, 
yes. But you know I don't, you know, have the wherewithal. It 
costs money to get retrained, go back to school. You know we're 
now in our late 30s, 40s. You know, yeah, if I had the ability 
or had the financial resources and stuff.
    I just wonder if there's an untapped pool out there of 
nurses who may be in their late 30s, early 40s that would get 
back in if they had the wherewithal to do so.
    Dr. Grady. I believe there is, Senator. We've been talking 
with some of the schools about a re-entry program and with the 
AACN about re-entry programs. That is precisely what you're 
describing. To get people to come back in, if they have 
incentives.
    You know it probably would not take a great deal of 
incentive. But to get people to think about it and to try to 
figure out some creative ways to get people back into the 
field. It is a wasted resource. Basically if people would like 
to come back to work, they have the background. I think it's an 
untapped resource.
    Senator Harkin. We ought to look--we ought to just see if 
there's some suggestions out there.
    Dr. Grady. I'd love to--we'd love to work on this, with 
you.

            SUPPORT FOR WOMEN PURSUING PROFESSIONAL CAREERS

    Dr. Alving. The reason I'm nodding my head is that if you 
look at medical schools now, about 50 percent of the students 
in medical schools are women. We have a very big problem in 
this country in that there's very little support, child care 
support for example, for women who are trying to pursue 
professional careers. So this pertains to veterinarians, of 
whom 80 percent of the students are women, nurses and now 
physicians.
    So I think we're going to have to think about some sort of 
ability to provide resources, child care, for those 
professional women. These nurses might not even drop out. They 
might stay in if they felt that their families and their 
children could have the appropriate type of child care.
    Other countries have organized centers where they can, you 
know, provide day care. So that's another component of it. But 
I do support re-entry. I would also support it if they could 
only drop back to half time and not drop out, because once you 
drop out it's harder to re-enter. You lose confidence and 
that's a little bit more difficult.
    Senator Harkin. Interesting concept. I'm justified that the 
programs--programs for specified for certain groups like 
nurses. That's interesting.
    Dr. Ruffin. Senator Harkin, I think one of the areas too 
where we need to pay more attention is to our 2 year 
institutions around the country. This is an untapped resource 
to a great extent. I think that the attitude as it relates to 2 
year colleges around the country has changed.
    It used to be that the thinking was that individuals would 
go to the 2 year institutions to sort of bone up for the 4 year 
experience. That attitude is totally gone. We have great 
instructors now at these 2 year schools and good students at 
these 2 year institutions.
    The problem is we're not bridging them. They're not 
transitioning to the 4 year institutions. We need more bridging 
programs that we can tap that vast resource of individuals who 
are at these 2 year institutions and begin to bridge them into 
our 4 year institutions in those challenging programs like 
nursing.
    That's one of the areas that I think we need to concentrate 
on. It is a place where we need to visit that we haven't put 
much attention on.
    Senator Harkin. Very good. Dr. Niederhuber, let me ask you 
before I just turn to Senator Cochran.
    I just wanted to ask you about clinical trials. Flat 
budgets for NCI over the past few years have taken a toll on 
clinical trials. When we finalized the fiscal year 2007 budget 
earlier this year, NCI was asking the cooperative groups that 
run cancer trials to trim their cost by 10 percent and reduce 
the number of open slots for patients by 3,000. Are those 
figures still accurate? I mean we did put some more money, as 
you know, in.
    Dr. Niederhuber. When we were trying to guess what that 
2007 appropriation might be we were forced to ask everyone to 
do a worst case scenario. So they did work on a 10 percent cut. 
We actually, just the past few days, have been meeting together 
at NCI to put in place our funding program for the cooperative 
groups that are the bulk of the grants that support clinical 
trials research across the country, as you know.
    It looks like it's going to be closer to a 5 percent 
decrease from last year. But that still translates into a 
decreased number of trials that will be open and a decreased 
number of patients that will go on trials as you understand.
    One of the difficulties with this uncertainty in the budget 
for the clinical trials aspect of research, it's complicated to 
explain, but part of the support goes for infrastructure, bio-
statistics and just the infrastructure people that have to be 
there. Another part of the budget is a bit of a guess in that 
we set aside resources that pay on a per patient basis. So as a 
patient goes on trial, that capitation gets allocated to cover 
part of those costs. It doesn't in any way cover the cost of a 
patient going on clinical trial. We're lucky in most trials if 
we come even close to 50 percent of the cost.
    So, the problem the community at large is facing across the 
academic universities is not knowing exactly how that budget is 
going to grow or stay flat over the next few years. They have 
to be very careful on deciding to start a trial, get it up, and 
get it in place. That takes time and commitment. Not knowing 
for sure if the dollars are going to be there to support that 
trial in the second, third, and fourth years.
    One of the things we do not want to do is to have to stop a 
trial in the middle. That would be a disaster. We just wouldn't 
want to do that. So I think that what I am seeing is that my 
community is being a little cautious in the number of trials 
they're willing to open up and willing to start because they 
can't predict down the road 2008, 2009, and 2010, what the 
resource flow is going to be.
    Do you follow that? It's a complex issue. It's hard to 
explain a little bit until you get your hands into it.
    Senator Harkin. But you can assure that this 10 percent cut 
is no longer valid because of the----
    Dr. Niederhuber. It's not going to be that much in 2007. 
It's going to be closer to 5 percent.
    Senator Harkin. We need some kind of--I'll have to think 
about that a second. I have a question about pancreatic cancer, 
but I wanted to turn first to Senator Cochran.
    Senator Cochran. Mr. Chairman, thank you very much for 
convening this hearing.
    It is good to meet with the heads of the different 
Departments at NIH where you're undertaking very important 
research. We appreciate the hard work that all of you are 
doing.
    We want to be sure that the budget request is as generous 
as it can be as well as the appropriations that follow. That 
when we approve a budget for this next fiscal year it reflects 
our genuine concern about doing the best we can do in 
developing research programs that will give us answers to 
problems relating to health and disease, infectious diseases, 
all the gamut of subjects that the Institute is working to help 
us understand.

               PANDEMIC FLU AND OTHER INFECTIOUS DISEASES

    I noticed that in Dr. Fauci's National Institute of Allergy 
and Infectious Diseases, you're doing a good bit of work in 
Avian flu and some other areas of that kind. I wonder what 
progress, if you can tell us is being made in coming up with 
new ways of dealing with some of those challenges of infectious 
diseases.
    Dr. Fauci. Well we have a very extensive portfolio in 
emerging and re-emerging infectious diseases, as you know. That 
is a major component of what we do. You mentioned pandemic flu 
and the concern that we have now because of the activity that 
is going on with bird flu particularly in south east Asia.
    What's happened over the last year since I testified before 
the committee is some significant advances in that regard. We 
tend to link, Senator Cochran, our preparedness for seasonal 
influenza with that of pandemic. We feel as a group that we 
don't prepare well enough for seasonal flu. We have not 
advanced the vaccine technology for seasonal flu. The shots 
that you and I get every year that everyone else gets every 
year or should get every year, we haven't advanced that 
technology to the 21st century. We really need and we are not 
only re-looking at it but really transforming it.
    For example, we make influenza vaccines now by growing them 
in eggs and then harvesting the virus in a very antiquated 
process which has great restrictions on scalability and the 
amount you can make. We've invested a lot of money to get the 
more up to date, 21st century methodologies for vaccine, either 
growing it in cells or doing recombinant DNA technology. We've 
made some significant advances in that regard.
    I mentioned before you came in that the pre-pandemic 
influenza vaccine for H5N1 that we tested over the past couple 
of years has now been approved by the FDA as a licensed 
vaccine. What we need to do and are doing rather successfully 
is applying, for example, the technology of adjuvants, which is 
a substance which enhances the body's response to a vaccine so 
you can get away with a much lower dose and can scale up 
rapidly.
    So I would report to you today that the work on emerging 
infections in general but in particular with regard to your 
question about pandemic flu is coming along very well.

                           HEALTH DISPARITIES

    Senator Cochran. That's very encouraging. We appreciate the 
good work that you're doing. I noticed in one of my staff memos 
here that a recent report indicated that one of our counties in 
Mississippi has the highest mortality rate from breast cancer 
in the Nation. That stopped me. It's twice the national average 
in Madison County, Mississippi.
    I wonder, we've talked about disparities. I think this 
might be something that the Research Centers in Minority 
Institutions program may be involved in. Dr. Alving, I think 
you'd know about that and can contribute something to our 
knowledge about what progress we're making at the National 
Center on Minority Health and Health Disparities.
    Dr. Alving. At the National Center for Research Resources 
we fund the RCMIs, or the Research Centers in Minority 
Institutions. We also work with Dr. Ruffin of the National 
Center on Minority Health and Health Disparities. I think also 
at the NCI there is a very big program in minority centers in 
cancer outreach.
    I would wonder if there isn't a multi-factorial reason for 
this high mortality. The first question would be is it due to 
lack of screening. Second we would want to know that if there 
are women who have increased breast density which can also 
affect the screening results or the mammography. But I would 
really wonder about access to care and preventive measures.
    As you know, the NHLBI funds the Jackson Heart Study in 
Mississippi, which is not only an observational study, but is 
dealing with ways of getting the participants used to the idea 
of preventive care and screening. We and the Research Centers 
in Minority Institutions are setting up a translational 
research network, with Jackson State as the data coordinating 
center, where we can do improved outreach and clinical trials 
in minority populations and also work collaboratively with my 
colleagues here at the table.
    Senator Cochran. Let me ask Dr. Ruffin to comment on that 
too.
    Dr. Ruffin. Senator Cochran, I think that first of all what 
I would like to do is really congratulate the people in the 
State of Mississippi, if you're looking for an example of 
partnerships.
    I just believe that whatever the disease area happens to be 
whether it's heart disease in the case of what we're doing with 
NHLBI or whether it's breast cancer or any of the other 
studies, whether we're talking about just getting the 
communities to participate in a clinical trial, I think there's 
a model in Mississippi that ought to be emulated. That is the 
ability of the institutions in the State of Mississippi to come 
together and work together.
    We've got programs at the Center that are working. The one 
that you're referring to, the Center for Health Disparities in 
the State of Mississippi has brought all of the institutions 
there together. The University of Mississippi Medical Center, 
Tougaloo College, Jackson State and many other institutions 
come together to work on these issues. So I believe that 
irrespective of which disease we're talking about, because 
health disparities is a very complex issue, it deals with a 
whole plethora of different disease areas and you have so many 
experts there who are working on various aspects of this issue.
    I think that by bringing these individuals together and 
everybody working together and understanding where their 
various strengths and weaknesses are, we're going to get an 
answer to a number of very important questions here.
    Senator Cochran. Well, that's very encouraging and we 
appreciate your hard work and efforts in that regard. Now, you 
mentioned, was it Dr. Niederhuber or Dr. Fauci, did you have a 
role--do you have a role in this specifically?

                       INFORMATION DISSEMINATION

    Dr. Niederhuber. Dr. Niederhuber. Dr. N. is easier.
    Senator, we as you might imagine at the Cancer Institute 
track very carefully the hot spots, if you will. We color them 
red. I don't know if that's significant politically or not but 
we know where those hot spots are for various cancers. Some of 
those areas are industrial; others are what you would call 
rural.
    Appalachia, if you go down through Appalachia we have very 
high incidence of certain kinds of especially female associated 
cancers. It's a multiple factorial problem. There's not one 
simple fix to this. Part of it has to do with education. Some 
of it has to do with socioeconomic status of those communities.
    We look also very carefully at the environment and whether 
there are environmental relationships that we can pin to risk. 
We look at the genetic changes in the population to see whether 
there's a relationship with the genetic background or inherited 
genetic patterns in those communities that relate to this risk 
as well.
    We're looking at all aspects of it. It's a very complicated 
issue. Certainly an awful lot of it though has to do with 
education and an opportunity or access to science, to care.
    As I mentioned in my opening statement before you arrived, 
Senator, we're launching in the next few days actually, 10 
pilot centers across the country that are specifically targeted 
at rural communities. Not universities, but in community 
environments around community hospitals and probably about 100 
to 250 bed facilities. The purpose of those pilots is to try to 
learn as much as we can about what we're going to need to do to 
bring the latest of our science, the latest of our discoveries 
directly to those people.
    We know that 85 percent of patients with cancer get the 
care for their cancer in the community where they live. They 
don't leave the community. They don't travel to M.D. Anderson 
in Houston or to Memorial Sloane Kettering or to Duke 
University or wherever. They stay right at home for a variety 
of reasons. Part of it has to do with age and the dependency on 
the family for support and care. That's just what's happening 
in this country.
    We have to understand that better. We have to understand 
how we're going to get our science, our discovery to people 
where they live.
    Senator Cochran. It's very interesting. Well, we thank you 
for the good work that you're doing. We appreciate your being 
here at the hearing. We look forward to continuing a close 
relationship with you as we go through the mark-up process. 
Thank you.

                         CANCER SPORE'S PROGRAM

    Senator Harkin. Thank you, Senator Cochran. As I said, Dr. 
Niederhuber, pancreatic cancer, number four killer among 
cancers. Once it strikes, very little hope. Senator Stevens had 
talked a little bit about that. It's one of the few cancers for 
which mortality rates are virtually the same today as they were 
30 years ago. So that makes the work of the three pancreatic 
cancer SPOREs so important, the Specialized Programs of 
Excellence.
    Dr. Niederhuber. Absolutely.
    Senator Harkin. I understand that NCI is considering 
changes to the SPORE program that could have a significant 
impact on pancreatic SPOREs. Could you tell me about your plans 
in that area?
    Dr. Niederhuber. Actually, I think that the changes that we 
have been making, Senator, have actually strengthened the 
program. We have been working very hard to keep as much 
resources, financial resources into this program as we have had 
in the past. So we've been scraping to do that.
    When I came onboard I looked at some of the struggles and 
some of the problems. Having come from the academic community 
and having been Cancer Center Director and knowing a little bit 
from the outside about the issues that this SPORE program has 
and how difficult it is to bring the basic scientist together 
with the clinical scientist. It's not an easy accomplishment 
for any university to build one of these programs, one of these 
collaborative efforts.
    So I began working directly with the currently funded 
leadership of the SPORE program across all of the diseases. 
Some of the things that we decided to do together, 
collectively, was one to have them come in separately.
    Senator Harkin. Individualized.
    Dr. Niederhuber. We would have the lung cancer programs all 
coming in at the same time but then not being able to come back 
in for 2 or 3 years for funding. That didn't make a lot of 
sense to any of us. So we've changed that structure around. 
We've put in place three separate times a year when anybody who 
comes together and creates a SPORE program in breast or 
prostate or pancreatic cancer. They have the resources to put 
into this and to compete for one of these grants. They can come 
in September/October or January/February or in the springtime.
    They also now have the opportunity, if the study section 
who reviews that application doesn't give it quite the score to 
get funding, a score level, they then have the opportunity to 
immediately respond to that, revise their application and come 
right back in. That was not something that existed before.
    I met with the SPORE PIs about 3 weeks ago at the American 
Association of Cancer Research meeting in Los Angeles, since 
they were mostly all there. We had a special opportunity for 
them to come and sit with me. I reviewed with them the funding 
plan we have put in place so that they could understand the 
resources and how the resources were being distributed. They 
could see the same detail that I have.
    I think they really appreciated that. It was the first time 
that anybody had been that open and shared with them the 
details of funding. We talked about the future. We talked about 
some innovative things that we might do with the program that 
might further enhance the SPORE program.
    So I think we have a very collegial working relationship 
with the research community that's committed to putting these 
grants together and to keeping them going. The goal is the best 
science.
    Senator Harkin. I understand but again I think there's some 
concern that the pancreatic cancer SPOREs will get squeezed 
out.
    Dr. Niederhuber. No. You're talking to a person who's spent 
his whole life doing pancreatic cancer surgery. So, I'm very 
committed to being sure we continue that.

                           PANCREATIC CANCER

    Senator Harkin. One last thing.
    Dr. Niederhuber. I'm hopeful that there will be other 
Institutions that will feel they have the resources, academic, 
and intellectual resources, to come in. If we get another good 
application that number is not frozen at three, we'll fund the 
best we can get.
    Senator Harkin. Ok. One last thing. Pancreatic cancer is so 
bad because there's no early detection.
    Dr. Niederhuber. Correct.
    Senator Harkin. Once you've found out and we all assume 
we've all had friends die of it. I just had one recently within 
the last couple of years who was my back seat guy when I flew 
in the Navy. Literally within, probably, 9 months he was dead.
    Dr. Niederhuber. Six months to a year.
    Senator Harkin. I've had others say the same thing. By the 
time you detect it, it's too late. What kind of hope can you 
give us? What kind of research is going on for some kind of 
early detection, methodology for pancreatic cancer?
    Dr. Niederhuber. If you remember in my opening presentation 
I highlighted that. Our genome-wide scanning that we are doing 
to look at large cohorts of patients to determine what genetic 
changes may be present in their genome, in their code of DNA, 
what changes they may carry with them that predict. For example 
we studied breast first, then prostate. We've learned quite a 
bit from that.
    We've had, I think, over the past 3 months, six papers I 
believe it is. Don't quote me for sure on that number. But I 
think it's six papers in Nature which is one of the leading 
journals as a result of that work in both prostate and breast. 
So in July of this year we will begin the same kind of study in 
pancreatic cancer.
    I am a person very interested in pancreatic cancer. I'm 
very excited about that because I think that's the first step 
in getting the kind of background information we need in terms 
of what changes may exist in your genome that says you've got a 
greater risk over your lifetime of developing this kind of 
cancer. It's a huge step for me, I think, in what we need to 
know. It will be a great foundation to build on. I hope that 
out of that we will get some clues of what kind of, we call 
them biomarkers, to look for in this particular cancer.

                              TUBERCULOSIS

    Senator Harkin. Thank you very much. Dr. Fauci, I'm hearing 
more and more about drug resistant tuberculosis. I just had a 
question on it this weekend from someone. How big is the threat 
and how prepared are we to deal with it?
    Dr. Fauci. It's a growing threat, Mr. Chairman that we're 
concerned about. As you know, TB is a very, very important 
global problem. One third of the world's population is infected 
with tuberculosis, not sick with it, but infected with it.
    Senator Harkin. One-third of the world's population is 
infected with tuberculosis.
    Dr. Fauci. One-third of the world's population is infected 
with tuberculosis, right. We get about 8 million new cases a 
year with 1.3 to 1.6 million deaths. Twenty percent of all of 
the tuberculosis active cases are multiple drug resistant. It 
means that it's resistant to the standard drugs that we use. 
But we do have alternative drugs. Ten percent of that 20 
percent have what we call extensively drug resistant 
tuberculosis or XDR as it's referred to. It's a growing 
problem.
    We are ratcheting up very aggressively our tuberculosis 
portfolio to address the issue of drug resistance. We just, as 
I mentioned earlier, put together a strategic plan that I 
presented to my National Advisory Council this morning. Then we 
will be formalizing that plan. It is a real serious problem.
    It was first brought to the attention of the scientific 
community from about 54 cases that were identified in South 
Africa, of which an astounding 52 died. That's a very, very 
high rate. The reason it is likely because they were also co-
infected with HIV. It isn't just confined to people with HIV.
    But when you say extensively drug resistant you mean that 
the standard INH and rifampicin, the drugs that you usually 
give. It's resistant to them. It's resistant to the 
fluoroquinilones and it's resistant to at least one injectable 
third-tier tuberculosis drug like amikasin and drugs like that. 
So it's a very serious problem.
    In some cases it is completely non-curable. So we have to 
work really fast to get other drugs into the pipeline. But 
importantly to make the right diagnosis because you get drug 
resistant TB by not properly treating regular TB, and you don't 
properly treat it because you don't diagnose it early enough. 
Then when you do, people don't come back for follow-up because 
they start to feel better right away. So we need to have a good 
screening process and a very sensitive diagnostic. All of that 
is part of our strategic plan that I was talking about a moment 
ago.

       MULTIPLE DRUG RESISTANT AND EXTENSIVELY DRUG RESISTANT TB

    Senator Harkin. I think most people would be alarmed to 
find out tuberculosis which we thought was in the Dark Ages has 
come back so strongly. I had not known that 1 out of 3, 30 
percent. That's alarming.
    From the figures that you gave me it's about--you say about 
20 percent are multiple drug resistant.
    Dr. Fauci. Ten percent of that 20 percent are extensive.
    Senator Harkin. So 2 percent are resistant to anything.
    Dr. Fauci. Right. Exactly.
    Senator Harkin. Is that in just a certain area of the 
world? Is that confined to a certain area?
    Dr. Fauci. Thirty-seven countries now have extensively drug 
resistant tuberculosis. There are a few cases we have in the 
United States that have been taken care of and contained. The 
problem is very serious in southern Africa. Interestingly we 
have a considerable number of cases in the Eastern European 
bloc countries and even in Korea. But there are 37 countries 
worldwide that have extensively drug resistant tuberculosis. 
That's reported.
    But given the fact that most of that one-third of the 
world's population is in the developing world in areas in Asia 
and India and China and in Africa. That's where you don't 
likely get the medical care to get the diagnosis to get it 
treated. So it's a problem that's probably underestimated. So 
I'm telling you it's 20 percent and then there's 10 percent of 
20. It's probably an underestimate as to what's really going 
on. It's a serious problem.
    Senator Harkin. Is it highly transmissible?
    Dr. Fauci. Well, it's transmissible like any tuberculosis. 
You need close continued contact and it's aerosolized droplets 
that contain the tuberculosis bacillus.
    Senator Harkin. Anthrax.
    Dr. Fauci. Yes.
    Senator Harkin. Recent estimates have said we need to be 
prepared for an anthrax attack. HHS has stockpiled anthrax 
vaccine and antibiotics. The problem with antibiotics is that 
they have to be administered shortly after any kind of attack 
or event. I've heard that there are other therapeutics that 
could target the toxins released by the anthrax bacteria and 
therefore could be effective even after the onset of symptoms.
    Dr. Fauci. Correct.

                   ANTHRAX ANTIBIOTICS AND ANTI-TOXIN

    Senator Harkin. Tell me more about that.
    Dr. Fauci. Sure. We started a program right at the point of 
a few months after the anthrax attacks here in our capital. One 
of the concerns we had is that we have very, very good 
antibiotics for anthrax. In fact, the clinical trial was done 
among Senate and House staff when they were given Ciprofloxacin 
following known exposure.
    In fact it's very interesting. Some of you may not know 
that when they did blood test screening of antibodies that many 
of the people who just did perfectly well because they took 
Ciprofloxacin or doxycycline. Actually you have proof that they 
were exposed, which means that if they did not take the 
antibiotic they very likely would have gotten sick. So the 
people who took the antibiotics did the really, the right thing 
about taking the antibiotics. I say that because we have good 
antibiotics.
    But what we are concerned about is, remember, several of 
the postal workers here in the city who were misdiagnosed 
initially. Then when they finally had the right diagnosis and 
were put on Ciprofloxacin, they were so advanced in the disease 
that the circulating anthrax toxin was the thing that killed 
them as opposed to the replicating anthrax bacillus.
    So, what we've done and we've been rather successful at it 
is to develop antibodies against the toxin itself. So if you 
have the antibiotic, prevents the replication of the bacteria, 
but the anti-toxin neutralizes the circulating toxin which is 
the thing that actually caused the death of several of those 
people. So we do have it. Some of it is already in the 
stockpile and we're working on even better ones.
    Senator Harkin. I was not aware of that.
    Dr. Fauci. Yeah, yeah, it's true.
    Senator Harkin. You actually have it in the stockpile now.
    Dr. Fauci. We have an order for it through Bioshield.
    Senator Harkin. Again this would be effective even after I 
become symptomatic--after the symptoms arise. You could target 
that? You say you're working on others, you mean there's----
    Dr. Fauci. There are multiple--there are three major toxins 
and we have antibodies to all of them. One of the ones, the 
lethal toxins that are the ones that we're most concerned 
about. We have now molecular biological techniques where we're 
trying to make monoclonal antibodies against. Monoclonal 
antibodies in anybody you actually code and manufacture to make 
only the response against a particular toxin you're worried 
about.
    Senator Harkin. How certain are you? I mean, what's the 
success rate if you had 100 people who became symptomatic with 
anthrax and you gave them this vaccine? What's the survival 
rate?
    Dr. Fauci. It depends when you get it. I have to tell you 
being an infectious disease person and having taken care of a 
lot of people who have advanced septicemia and shock. Once a 
person goes into the toxic septicemia of endotoxic or other 
types of shock the salvage rate of those individuals is very 
low.
    So I think even with an anti-toxin, if given early enough, 
before you have a lot amount of accumulated toxin, it would 
probably increase the salvage rate and decrease the morbidity 
and mortality significantly. I can't put a number on it for you 
because the clinical trial has not been done. So it would be 
folly for me to say, oh it's a 90 percent, 80 percent. We just 
don't know. We just don't know.
    Senator Harkin. How soon?
    Dr. Fauci. I hope we never have to test it.
    Senator Harkin. How will you know? How will you ever know?
    Dr. Fauci. We'll know when we have another attack.
    Senator Harkin. That's about the only way.
    Dr. Fauci. We have animal models which have worked very, 
very well in the animal models. But again we always be 
careful--if you tell me based on the animal model would I 
project that it would be a success I would say yes. But I have 
to be very cautious because there's a big leap between a 
successful animal model and what works in the human.

                           CANCER STEM CELLS

    Senator Harkin. I've got to go but a couple of things I 
wanted to cover. Cancer stem cells. There's an idea that within 
a tumor there are cancer stem cells are really the driving 
force. That if we could just figure out how to get to those 
stem cells and target those that we would have a better success 
rate in curing cancer. What can you tell me about that?
    Dr. Niederhuber. Well, it's a very exciting area of 
research. It is not a totally new concept. It's really an old 
concept. But it has come back in just the past few years.
    An example, Senator Harkin, a year ago at the AACR, the big 
national research meeting, there were maybe 20, 25 papers. This 
year there were over 225 papers at the meeting. So it just 
shows you how the community has become excited and interested 
in this concept.
    So we know that within our tissues, the normal tissues of 
our body there are cells that are responsible for regenerating 
those tissues. Let's take the lining of the intestine, the 
colon, for example. We know that there are what we call tissue 
stem cells that have a certain division property that allows 
them to regenerate that lining of the colon.
    So the concept is that the genetic changes that occur that 
lead to a cancer may have to occur in those cells, in those 
tissue stem cells, in order for the cancer to become a 
significant lesion--to have the property or potential for 
invasion and the potential for spread. In the tumor the bulk of 
the tumor cells don't carry that kind of genetic imprint.
    It's like thinking of the cell as an orchestra. Some of the 
instruments that give that orchestra in that cell the 
properties of being stem like in character are in a 
subpopulation of the tumor, maybe 1 percent, maybe as much as 2 
percent of the tumor. The bulk of the cells in the tumor don't 
have that set of instruments playing at that particular moment.
    We think we're doing a good job of getting rid of the bulk 
of the tumor but what gets left behind is that one percent of 
cells that can lie quiescent in the tissues of the body for a 
number of years. Those of us who practice oncology over the 
years have been always puzzled by seeing a patient with breast 
cancer seemingly cured 15 years or so later coming back with 
the disease seemingly everywhere. It may be part of the 
explanation of this.
    So without question we need to learn more about these 
cells. We need to learn what gives them resistance to the 
therapies that we use. We know that they have certain 
properties that can pump drugs that get into the cell 
immediately back out of the cell. So there are a lot of things 
that are--that make them more difficult to target. Maybe we 
haven't been specifically targeting them in the ways that we 
need to.
    Some of the new research is showing pathways that are 
unique to those cells. That is, signal pathways within the cell 
and potential ways to target them that are unique. So I think 
you'll see over the next few years a lot more research going on 
that is trying to get at that population of cells, better 
characterizing it and better targeting it for therapy.

                   NATIONAL PRIMATE RESEARCH CENTERS

    Senator Harkin. Thank you very much. I have a couple of 
last questions for Dr. Alving. This subcommittee has been very 
supportive of the primate centers. We included report language 
in a lot of our past bills, so I was disappointed to see in 
your budget request that your plans cut the funding for the 
centers by $1.7 million for a total of $72.3 million. What's 
the reason for that cut in the primate centers?
    Dr. Alving. This was in the congressional justification 
estimate and now the fiscal year 2007 joint resolution, which 
was a higher change from the CJ. But what we have had to do and 
what we are doing throughout the NCRR is to look at where we 
can best put our resources.
    We are actively working with the primate centers to better 
manage the consortium. We're saying that they need to work 
together as a consortium in managing their animal facilities 
and in managing the breeding of the animals. We're very 
supportive of the work and they also are working with the 
CTSAs. So if we have improved funding we will be able to put 
more money into that program.
    Senator Harkin. Your budget request cut that funding.
    Dr. Alving. This was according to the amount of money that 
we had allocated as we went across the budget. We will put this 
money back in. We also are committed----
    Senator Harkin. So, if we--I mean, excuse me for 
interrupting. So if we do better than the President's budget 
will you put that money back in?
    Dr. Alving. Yes. Yes, we will.
    Senator Harkin. Ok.
    Dr. Alving. But also realize, Mr. Chairman, that we are 
working on building up our CTSAs and that's another challenge 
in NCRR. As we are building the primate centers, we'll be 
working with the CTSAs. For example, two of our CTSA awardee 
institutions, Oregon and UC Davis have primate centers. Those 
primate centers are working in that consortium as well.
    But we are very supportive of the primate centers. They're 
doing excellent work. I visited four out of eight of them. We 
want to work with them as a consortium to support them.

                       GCRC TRANSITION INTO CTSA

    Senator Harkin. Ok. Well we'll try to put some more money 
in there for it. It's not that big. One last question on the 
CTSAs. As you say you're building them up, but what happens to 
the General Clinical Research Centers? I guess they're going to 
be folded into them or something like that?
    Dr. Alving. There will be a transition into the Clinical 
and Translational Science Awards. For example, of the first 12 
CTSA awards that were provided, 16 General Clinical Research 
Centers were included. Those have become part of the CTSAs.
    We're also emphasizing pediatrics in the CTSAs. For 
example, at the University at Pennsylvania, two General 
Clinical Research Centers were folded into that CTSA award, one 
from the Children's Hospital of Pennsylvania, one from the 
University of Pennsylvania. Now they are absolutely working 
together.
    Senator Harkin. So you can assure me there will be no 
diminution of training researchers the next generation in 
translation and clinical research because of this new 
structure.
    Dr. Alving. What we're really building is the training of 
the clinical researchers because the GCRC program never 
included training. So this is a big component of the new CTSAs.
    Senator Harkin. Thank you. Any last things from anyone else 
that I didn't touch on or that you wanted to express yourself 
on before I gavel this closed here? I thought it was a very 
good hearing. I think we got a lot out and a lot of good 
information.
    Again, I thank you all very much for your leadership in all 
these various areas. I just hope that we can get a little bit 
better budget than what the President requested. We will. We'll 
get better than what the President requested. And now we're 
looking ahead to see how we can repair some of the damage of 
the last few years. The 12 percent or 13 percent that we've 
come down in NIH over the last 4 or 5 years and we've got to 
get it back up again. But that's our problem. We'll see if we 
can do better on that.
    So with that, thank you very much. We have one more group 
from NIH and we haven't scheduled a hearing but I assume it 
won't be this week and it won't be next week because we're not 
here. So it will be sometime in June we'll have the last set of 
hearings.

                     ADDITIONAL COMMITTEE QUESTIONS

    So I thank you very much and we will keep the record open 
for any questions that other Senators who weren't here today 
have for you that they might submit in writing.
    [The following questions were not asked at the hearing, but 
were submitted to the Department for response subsequent to the 
hearing:]

               Questions Submitted by Senator Tom Harkin

                     FOOD ALLERGIES AND ANAPHYLAXIS

    Question. Dr. Fauci, children who have had atopic dermatitis, also 
known as eczema, are more likely to have severe food allergies and 
asthma. Has the NIAID considered the possibility of funding a 
complementary initiative, perhaps in coordination with the NHLBI, on 
atopic dermatitis as it relates to asthma and food allergy?
    Answer. The National Institute of Allergy and Infectious Diseases 
(NIAID) is committed to supporting research to better understand the 
relationship of atopic dermatitis (AD) to asthma and other allergic 
diseases, particularly food allergy. At this time, the NIAID is 
supporting several studies in this area. The Consortium of Food Allergy 
Research is conducting an observational study of the development and 
loss of tolerance to foods in a cohort of 400 children, ages three to 
twelve months, at a high risk of developing food allergies, including 
children with AD. The study will correlate biological markers and 
immunologic changes associated with the development of peanut allergy 
and the resolution of allergies to egg and cow's milk, and evaluate 
genetic and environmental influences on these food allergies.
    Another NIAID-sponsored program, the Immune Tolerance Network, is 
conducting two clinical trials related to food allergy and AD. The 
first will determine whether feeding a peanut-containing snack to young 
children at risk of developing peanut allergy will prevent development 
of this allergy. The subjects are children between 4 and 10 months of 
age with AD and/or allergy and they will be followed until they reach 5 
years of age. The second clinical trial is enrolling children with AD 
who are between the ages of 18 and 30 months and at high risk for 
developing allergies. This trial will determine whether oral 
administration of cat, grass, and house dust mite allergens will 
prevent the development of allergy to these and other allergens and 
asthma in these children.
    The NIAID Inner-City Asthma Consortium is conducting the Urban 
Environment and Childhood Asthma (URECA) observational study, which 
will assess antibodies to milk, egg white, and peanut in infants at 
risk for developing allergic diseases, including asthma, allergic 
rhinitis, and AD. The study will look for a correlation between food 
allergies and the onset of asthma later in life.
    Lastly, the NIAID currently collaborates with NHLBI on two 
initiatives related to asthma. One of these, Immune System Development 
and the Genesis of Asthma, includes a grant which studies the 
relationship of AD to asthma.
    Question. What plans does NIAID have to encourage research 
applications on anaphylaxis? Has the NIAID considered the need for 
clinical studies of emergency room treatment for anaphylaxis?
    Answer. To address the problem of anaphylaxis, the NIAID is 
pursuing two major approaches: expanding support for research on the 
causes, treatment, and prevention of allergic diseases, including food 
allergies and food-allergy-induced anaphylaxis; and supporting national 
and international conferences that will disseminate new knowledge and 
promote a more cohesive approach to the diagnosis, prevention, and 
clinical management of anaphylaxis.
Expanding research
  --The Report of the NIH Expert Panel on Food Allergy Research 
        discussed food-induced anaphylaxis in detail and emphasized the 
        need to study the pathogenesis of severe food allergy.
  --The NIAID-funded Consortium of Food Allergy Research is conducting 
        an observational study of the natural history of food allergy, 
        which is expected to provide new information about severe 
        allergic reactions and anaphylaxis. In addition, the Consortium 
        is conducting a clinical trial focused on severe food allergy, 
        which will use increasing oral doses of egg to treat patients 
        with severe egg allergies.
  --The NIAID has just announced a new initiative, Exploratory 
        Investigations in Food Allergy, which encourages studies on 
        severe life-threatening food allergy.
Supporting national and international conferences
  --The NIAID, in partnership with the Food Allergy and Anaphylaxis 
        Network (FAAN), a patient advocacy group, convened meetings in 
        2004 and 2005 to establish clinical criteria to identify cases 
        of anaphylaxis with high precision, review evidence on the most 
        appropriate clinical management of anaphylaxis, and outline 
        research needs in this area. Participants included experts and 
        representatives from professional, governmental, and lay 
        organizations. The proceedings of these symposia were published 
        in the March 2005 and February 2006 issues of the Journal of 
        Allergy and Clinical Immunology.
    The NIH Expert Panel on Food Allergy Research considered the need 
for clinical studies of emergency room treatment for anaphylaxis and 
presented its recommendations as part of its report.
    Question. Does NIAID make information available to health 
professionals about the best approaches to treating food allergy?
    Answer. The Consortium of Food Allergy Research was initiated in 
2005 to develop new approaches to treat and prevent food allergies. As 
such, one of the goals of the Consortium is the development, 
implementation, and dissemination of educational programs for children, 
their parents, and pediatric health care workers. In addition, the 
Consortium supports preclinical research, observational studies, and 
immune-based clinical trials for treatment or prevention of food 
allergies.
    To ensure that the information on diagnosis, prevention and 
management of anaphylaxis is developed and widely disseminated to the 
medical community, NIAID, in collaboration with FAAN and the American 
Academy of Allergy, Asthma and Immunology, is organizing a series of 
meetings. These are scheduled to begin in July 2007 and will develop 
evidence-based guidelines for the diagnosis and management of food 
allergy, including anaphylaxis.

                        TOBACCO-RELATED RESEARCH

    Question. Dr. Niederhuber, in March, you told NCI's Board of 
Scientific Advisors that the Tobacco Control Research Branch has been 
cut by $6.5 million between fiscal year 2004 and fiscal year 2007. Are 
those numbers still correct? If so, can you tell us how cutting back on 
this type of research will affect our ability to prevent tobacco-
related cancers?
    Answer. The Tobacco Control Research Branch (TCRB) budget was $19.2 
million in fiscal year 2004. We are still in the process of making 
final funding decisions, but the current estimate for fiscal year 2007 
is $12.7 million, which is a reduction of $6.5 million from fiscal year 
2004. Part of the reduction during the period between fiscal year 2004 
and fiscal year 2007 was due to the expiration of some tobacco control 
research initiatives. However, additionally, the period following the 
doubling of the NIH budget has resulted in very difficult choices in 
terms of setting priorities and implementing funding decisions. The NCI 
Executive Committee and advisory boards have worked diligently to 
conduct strategic priority setting and decision making related to the 
scientifically appropriate distribution of resources. In order to 
pursue new and emerging opportunities in cancer research, we must make 
choices about which programs and research initiatives come to an end.
    In terms of planning for the future, scientists in TCRB are 
currently working on several new research concepts in response to the 
2006 NIH State of the Science Conference, ``Tobacco Use: Prevention, 
Cessation and Control,'' and other priority setting reports. NCI will 
use these concepts to develop and redirect initiatives in tobacco 
control research in the future.
    NCI's research efforts in the prevention and control of tobacco use 
are premised on three fundamental facts: all tobacco products are 
hazardous; there is no safe level of tobacco use or ETS exposure; and 
the only proven way to reduce the burden of disease and death due to 
tobacco products is to prevent their use and to assist those who use 
tobacco products to quit. Further progress in reducing tobacco use is 
an important challenge facing the public health, medical, and policy 
communities.
    The Tobacco Control Research Branch (TCRB) maintains a diverse 
portfolio of research and dissemination activities. Most noteworthy are 
the following:
  --Transdisciplinary Tobacco Use Research Centers (TTURC). The TTURCs 
        are a collaboration between NCI, NIDA, and NIAAA to study 
        tobacco use control and addiction research spanning diverse 
        areas ranging from molecular biology, genetics, neuroscience, 
        and epidemiology to imaging, primary care, behavioral science, 
        communication, health policy, biostatistics, economics, and 
        marketing. Collaborative research across disciplinary 
        boundaries permits scientific exploration of the complex and 
        interactive determinants of tobacco use.
  --Testing Tobacco Products Promoted to Reduce Harm is a program which 
        funds multidisciplinary research on the interplay of behavior, 
        chemistry, toxicology, and biology to determine the cancer risk 
        potential of reduced-exposure tobacco products.
  --Smokefree.gov is a state-of-the-art Web site developed by NCI in 
        collaboration with the Centers for Disease Control and 
        Prevention (CDC) and the American Cancer Society (ACS). It 
        offers science-based tools and support to help smokers quit. 
        Smokefree.gov complements the National Quitline Network that 
        has established a new state-supported national telephone number 
        so smokers in every state have access to information and 
        proactive smoking cessation counseling.
  --The Health Disparities Network is a unique endeavor to understand 
        and address tobacco-related health disparities by advancing 
        science, translating scientific knowledge into practice, and 
        informing public health policy. In partnership with the 
        Pennsylvania State University, core scientific activities are 
        focused on methodology, treatment/cessation, prevention, 
        translation/community, and policy. The formation of the network 
        fills a void by establishing a mechanism to bring together an 
        ethnically diverse group of researchers representing different 
        disciplines and interests to answer multiple questions related 
        to the research agenda in health disparities and explore 
        optimal mechanisms for translating research into practical and 
        effective community strategies.

                            MINORITY HEALTH

    Question. Dr. Ruffin, if the Subcommittee were able to provide 
additional funding for the Center over the President's budget request, 
what would be your top priority for how to spend it (e.g., health 
disparities research vs. research capacity-building and 
infrastructure), and why? Please be as specific as possible.
    Answer. The fiscal year 2008 President's Budget request of $194.5 
million will support NCMHD's highest priority research activities. 
However, if the NCMHD were to receive any additional funding over the 
President's budget request, those funds would go towards research 
capacity-building specifically in the area of training. Having a strong 
and culturally diverse workforce is vital to the ability of NCMHD to 
fulfill its mission to improve minority health and eliminate health 
disparities. NCMHD would place additional emphasis on recruitment and 
retention at every level of the pipeline.
    First, NCMHD would strengthen the retention component of the NCMHD 
Loan Repayment Program in order to keep more individuals from health 
disparity populations interested and involved in health disparities 
research, as well as attract young investigators from these populations 
to the biomedical research field in general.
    Second, NCMHD would be to further develop the capacity of our 
Centers of Excellence to enhance their capability in conducting 
research into the multi-factorial issues associated with health 
disparities. The research efforts of these Centers contribute 
significantly in enhancing the nation's understanding of health 
disparities, and offer the training and professional research 
environment required for the workforce to study minority health and 
health disparities issues.

                             FOOD ALLERGIES

    Question. Dr. Fauci, during the hearing, you indicated that the 
``roadmap'' which was developed by the leading food allergy researchers 
and experts in immunology after they met in March 2006 is still in the 
process of being approved. When will it likely be released?
    Answer. In March 2006, the National Institute of Allergy and 
Infectious Diseases (NIAID), on behalf of the Secretary of the 
Department of Health and Human Services, convened the NIH Expert Panel 
on Food Allergy. The Expert Panel met to review current basic and 
clinical research on food allergies and develop recommendations for 
enhancing and coordinating research activities concerning food 
allergies. The recommendations have now been posted on the NIAID 
website at http://www3.niaid.nih.gov/healthscience/healthtopics/
foodAllergy/ReportFoodAllergy.htm.
                                 ______
                                 
            Questions Submitted by Senator Daniel K. Inouye

                      NATIVE HAWAIIANS AND CANCER

    Question. Dr. Niederhuber, Native Hawaiians have a much higher 
mortality rate from cancer than other residents of the State. What 
efforts has the National Cancer Institute taken to understand cancer in 
Native Hawaiians?
    Answer. The National Cancer Institute (NCI) continues to support 
research to find the causes of cancer health disparities and to develop 
effective ways to improve cancer outcomes for Native Hawaiians. Among 
these continued efforts are: enhancing surveillance of Native Hawaiian 
populations to document the extent of cancer health disparities and 
monitor progress in improving cancer outcomes in these communities; 
empowering Native Hawaiian communities to participate in setting cancer 
research goals and priorities; assuring access to community-based 
health care that is culturally and linguistically appropriate; 
supporting infrastructure for Native Hawaiian communities that promotes 
cancer awareness, supporting research education and training in cancer 
prevention and control research by Native Hawaiian researchers, and 
supporting the development of evidence-based information and 
interventions to improve cancer outcomes in Native Hawaiian 
communities.
Community Networks Program
    Two of NCI's Community Networks Programs continue to address Native 
Hawaiian populations: 'Imi Hale--Native Hawaiian Cancer Network, and 
WINCART: Weaving an Islander Network for Cancer Awareness, Research and 
Training. These five-year grants, engage in cancer education, 
community-based participatory research and training targeted 
specifically to the Native Hawaiian population.
    The Native Hawaiian Cancer Network, 'Imi Hale, is located in 
Honolulu, Hawaii and collaborates with key partners at the community, 
state, and national levels to provide support systems and expertise to: 
(1) provide a core organizational infrastructure; (2) increase 
utilization of proven interventions to reduce disparities; (3) increase 
the number of Native Hawaiians participating in community-based 
research to reduce cancer health disparities through recruitment, 
training, and mentorship; (4) promote research that focuses on the 
spectrum of issues relevant to cancer health disparities, with an 
emphasis on developing interventions that can be used in and by Native 
Hawaiian communities; and (5) provide evidence-based information on 
reducing cancer health disparities to decision and policy makers at the 
community, local, state, and Federal levels.

                                WINCART

    WINCART aims to: (1) identify multilevel barriers to cancer control 
among Pacific Islanders; (2) improve access to and utilization of 
existing cancer prevention and control services for these communities; 
(3) conduct community-based participatory research; (4) increase the 
number of Pacific Islander researchers through training, mentorship, 
and research projects; (5) sustain community-based education, training, 
and research activity through government and organizational 
collaborations; and (6) disseminate research to aid in the reduction of 
health disparities among Pacific Islander communities. Research 
activities focus on obesity, tobacco, cancer screening, survivorship, 
and recruitment of Pacific Islanders into clinical trials. The Network 
works with the NCI-supported Cancer Information Service to develop 
culturally and linguistically appropriate educational materials.
    nci surveillance of cancer health in native hawaiian populations
    NCI continues to strengthen the Surveillance Epidemiology and End 
Results (SEER) Program which has expanded its surveillance coverage and 
activities to capture 70 percent of Native Hawaiians and Pacific 
Islanders in the surveillance network. These include cancer 
surveillance, behavioral risk factor surveillance, health information 
and health services data, and epidemiologic data. This expansion is 
critical to uncovering the extent of the cancer problem and monitoring 
progress in eliminating cancer disparities in Native Hawaiian and 
Pacific Islander communities.

                CANCER IN PACIFIC ISLAND SUBPOPULATIONS

    The NCI also recognizes the dramatic disparities found in many 
Pacific Island subpopulations, including rural Native Hawaiian 
populations. Through the Minority Institution/Cancer Center Partnership 
Program, NCI supports a research partnership between the University of 
Guam, and the Hawaii Cancer Research Center to address the cancer 
research needs of Guam and adjoining Islands.
    Through the Cancer Information Service, NCI supports efforts to 
provide NCI products, resources and services, including promotion of 
the Clinical Trials Education Series and clinical trials to individual 
hospitals in Hawaii approved through the American College of Surgeons 
Commission on Cancer (ACoS). In addition, CIS provides professional 
training in cancer and cancer clinical trials throughout Hawaii, raises 
awareness among Kauai Community College (KC) nursing students about 
cancer clinical trials, and promotes access and dissemination of NCI 
cancer clinical trials resources. These efforts have improved screening 
rates among Hawaii's medically underserved populations.

                                NURSING

    Question. Dr. Grady, could you discuss the funding rates of the 
NINR compared to other institutes at the NIH? What percentage of 
nursing studies are co-funded with other institutes? What are your 
impressions of co-funded studies?
    Answer. NINR, like the rest of NIH, calculates success rates by 
dividing the number of research project grant (RPG) applications 
selected for funding in a given fiscal year by the total number of RPG 
applications reviewed during that year. In fiscal year 2006, NINR had a 
success rate of 18 percent, slightly lower than the overall rate of 20 
percent for NIH as a whole. NINR has historically had success rates 
lower than the NIH average; however, success rates can and do fluctuate 
from one year to another based on both the number of applications 
received and the overall NINR budget. In fiscal year 2006, NINR chose 
to devote about 72 percent of its budget to the support of RPGs.
    In fiscal year 2006, approximately 7 percent of NINR-supported 
research grants were co-funded by one or more of the other NIH 
Institutes and Centers (ICs). However, co-funding is only one aspect of 
NINR's overall collaborative effort across NIH. In today's increasingly 
complex, interdisciplinary research environment, NINR views trans-NIH 
collaborations as an important part of its research mission. In 
addition to co-funding research, other such efforts include: co-
sponsoring new research initiatives with other ICs, leading the NIH 
effort in end-of-life research, and maintaining leadership roles in 
trans-NIH activities such as the NIH Pain Consortium, Public Trust 
Initiative, and Roadmap. Greater collaboration with other ICs increases 
both the visibility of nurse scientists in the greater research 
community and trans-NIH awareness of research areas traditionally 
associated with nursing science, such as symptom management and disease 
prevention. Interdisciplinary collaborations also provide our own 
investigators with opportunities to expand the breadth of their work 
into areas of research not previously associated with nursing science.

                       NIAID AND NATIVE HAWAIIANS

    Question. Dr. Fauci, in your testimony, you indicate that 
autoimmune diseases, allergic diseases, asthma and other immune-
mediated diseases are significant causes of chronic disease and 
disability in the United States and throughout the world. With respect 
to asthma and lower respiratory disease, Native Hawaiian adults have a 
much higher prevalence of asthma compared to other adults in Hawaii--71 
percent higher than the total State prevalence. How can the NIAID 
contribute to a greater understanding of the asthma among Native 
Hawaiians?
    Answer. Native Hawaiians, along with other minority U.S. 
populations, have higher asthma prevalence. A recent Centers for 
Disease Control and Prevention report indicates that the prevalence of 
asthma in children in Hawaii, is among the highest in the Nation. The 
National Institute of Allergy and Infectious Diseases (NIAID) welcomes 
research grant applications focusing on the causes of increased asthma 
prevalence and morbidity. While the NIAID is not currently supporting 
research that investigates asthma in Native Hawaiians, the Institute is 
actively supporting research in other groups who have high asthma 
prevalence and morbidity.
    One of the Institute's initiatives is the Inner City Asthma 
Consortium (ICAC), which aims to identify the causes for increased 
asthma prevalence and morbidity and develop effective management 
approaches in urban, minority children populations.
    Additionally, the NIAID and the National Heart, Lung, and Blood 
Institute (NHLBI) co-sponsor the ``Immune System Development and the 
Genesis of Asthma'' program, which supports research on changes in 
immune function that occur early in life and lead to the development of 
asthma.
    Information gained from these studies will enhance our 
understanding of the mechanisms of increased asthma in specific 
populations. We hope that this understanding can be extended to Native 
Hawaiians and can lead to measures of prevention and therapy that will 
ameliorate this significant health problem.

                              DENGUE FEVER

    Question. Dr. Fauci, in 2001, Hawaii experienced an outbreak of 
dengue fever that lasted 8 months, in which over 1,500 people 
experienced severe sickness. Worldwide, dengue fever kills 
approximately 25,000 each year, and it is estimated that there are 
between 50 million and 100 million cases of dengue fever illness each 
year. Given the impact of this disease on my constituents, what efforts 
has the NIAID taken towards vaccine development?
    Answer. The National Institute of Allergy and Infectious Diseases 
(NIAID) is currently supporting several research projects to develop a 
safe and effective vaccine against dengue fever. Development of a 
dengue vaccine is challenging because of several factors, chiefly, the 
requirement that a dengue vaccine be tetravalent, that is, 
simultaneously protective against all four dengue serotypes. 
Researchers at the NIAID have developed components of a tetravalent 
dengue vaccine that are undergoing clinical testing. Other efforts to 
develop a vaccine against dengue fever include support of the following 
research projects:
  --Preclinical and clinical development of a recombinant subunit 
        vaccine against the 4 dengue serotypes (Hawaii Biotech, Inc., 
        Aiea, HI): Additional formulation studies and toxicology 
        testing are currently ongoing in preparation for a Phase I 
        clinical trial planned for 2008.
  --Preclinical development of live attenuated vaccine against the 4 
        dengue serotypes (InViragen, LLC., Mount Horeb, WI): Extensive 
        safety and efficacy testing is currently being conducted in 
        different animal models in preparation for a Phase I clinical 
        trial.
  --Development of a microneedle array system for delivery of a DNA 
        tetravalent dengue vaccine in the skin (Cyto Pulse Sciences, 
        Glen Burnie, MD): This vaccine is currently being tested for 
        immunogenicity in different animal models, and the microneedle 
        array will be tested in human volunteers for safety.
  --Development of dengue virus replicon system to measure dengue virus 
        neutralizing antibodies in the serum (Integral Molecular, 
        Philadelphia, PA): This assay will be evaluated using serum 
        samples of patients who are hospitalized with dengue fever in 
        Nicaragua.
  --Recombinant envelope protein domain III as a candidate subunit 
        dengue vaccine (University of Texas Medical Branch, Galveston, 
        TX): The long-term goal of this project is the development of a 
        candidate subunit vaccine that induces neutralizing antibodies 
        for all four flaviviruses that cause dengue fever.
    Question. When may we expect to have an effective product?
    Answer. The candidate vaccines listed previously are moving through 
the product development pipeline. However, the challenges facing the 
development of a safe and effective vaccine are still significant. The 
timeline for a vaccine product to be manufactured for use in the United 
States depends upon a manufacturer successfully completing late-stage 
clinical trials, including a Phase IV population effectiveness trial 
and submitting the results to the Food and Drug Administration for 
licensure. This can be a lengthy process and can extend several years 
after clinical trials have been completed.
    Question. Which other States may be affected in the near future?
    Answer. According to the Centers for Disease Control and Prevention 
(CDC), there is a small risk for dengue outbreaks in the continental 
United States. However, the epidemic in Hawaii in 2001 serves as a 
reminder that many states in the United States are susceptible to 
dengue epidemics. In particular, states in southern and southeastern 
United States, where the Aedes aegypti mosquito is found, are at risk 
for dengue transmission and sporadic outbreaks (http://www.cdc.gov/
ncidod/dvbid/dengue/index.htm).
    Question. What impact, if any, could global warming have on the 
spread of dengue-carrying mosquitoes?
    Answer. Environmental events, such as climate shifts, weather 
changes, and deforestation, can affect infectious diseases, 
particularly vector-borne diseases such as dengue virus. High 
temperatures, in combination with favorable rainfall patterns, could 
prolong the disease transmission season in places where the virus 
already exists or expand the ranges of the mosquito vectors to places 
where the disease is not usually found, such as Hawaii and the southern 
region of the continental United States.

                         TERRORISM PREPAREDNESS

    Question. Dr. Fauci, the NIAID has been assigned the responsibility 
to coordinate research to develop countermeasures against a range of 
radiological and chemical threats. You describe how the Centers for 
Medical Countermeasures against Radiation coordinate activities with 
interagency partners, including the Department of Defense, Department 
of Energy, and Department of Homeland Security. Could you describe 
ongoing research of medications that would provide protection against 
radiation in the event of a small nuclear weapon or a dirty bomb?
    Answer. The National Institute of Allergy and Infectious Diseases 
(NIAID) is currently evaluating multiple compounds, including many 
drugs that are licensed for other indications, for use as 
countermeasures to combat the effects of an incident involving release 
of radioactive material. This research is part of the NIAID radiation 
and nuclear countermeasures program, which is guided by the NIH 
Strategic Plan and Research Agenda for Medical Countermeasures Against 
Radiological and Nuclear Threats.
    Examples of specific NIAID-supported research initiatives include:
  --Research on all elements of radiation injury and the development of 
        products that can be licensed and included in the Strategic 
        National Stockpile.
  --Programs to screen candidate compounds for use as radiation 
        countermeasures. These programs have tested 40,000 compounds 
        and identified 52 for further evaluation.
  --Development of improved forms of the chelating agent 
        diethylenetriaminepentaacetic acid (DTPA). A chelating agent is 
        a compound that binds to a radionuclide and facilitates and 
        accelerates its elimination from the body.
  --Research on 29 candidate drugs that exhibit activity against a 
        broad range of radionuclides that might be used in radiological 
        dispersion devices or ``dirty bombs'', including several that 
        currently lack effective treatment approaches, such as 
        Strontium 90 and Cobalt 60.
    Research to develop medical countermeasures to treat radiation 
injury remains in the early stages of development; significant research 
and pre-clinical testing is needed before we will have candidate 
products developed to treat radiation injury that can move forward for 
licensure.
                                 ______
                                 
              Question Submitted by Senator Arlen Specter

                             OVARIAN CANCER

    Question. Dr. Niederhuber, as you are aware, there is currently no 
early detection method for ovarian cancer. Because of this, more than 
75 percent of women diagnosed with ovarian cancer die within five years 
of being diagnosed. If we were to find these cancers early, the 
mortality rate falls dramatically to about 15 percent. And, ovarian 
cancer is not alone; similar statements could be made for pancreatic 
cancer. Please share NCI's strategy for fiscal year 2008 regarding 
early detection research, such as biomarkers, for cancers like ovarian 
and pancreatic, where the incidence numbers are smaller than, say, 
breast or prostate cancer, but the mortality rates are much higher.
    Answer. NCI launched the Pancreatic Cancer Cohort Consortium 
(PanScan), which is conducting whole genome scans of common genetic 
variants in 1,200 pancreatic cancer cases and 1,200 controls from 12 
cohorts to identify markers of susceptibility to pancreatic cancer. The 
promising genetic variants (single nucleotide polymorphisms (SNPs) 
identified will be validated by testing data from participants in a 
pancreatic cancer case-control consortium. It is anticipated that SNPs 
that are highly likely to be markers for genetic variants related to 
pancreatic cancer risk will emerge from this analysis as they have in 
similar studies on prostate and breast cancers, and lead to further 
studies of gene-gene and gene-environment interactions with pancreatic 
cancer risk factors. It is hoped that the PanScan will lead to 
identification of not only susceptibility genes but early markers for 
disease. This would be particularly useful for pancreatic cancer which 
is usually diagnosed at an advanced stage.
    There are also several projects being conducted on ovarian and 
pancreatic cancer in NCI's Early Detection Research Network (EDRN). 
Scientists are conducting research to enhance early detection of 
ovarian cancer. EDRN plans to screen serum DNA from larger cohorts of 
early ovarian cancer patients and controls collected by the EDRN- and 
SPORE-funded clinical centers for validating the optimized panel of 
genes for early detection and risk assessment. There are also a number 
of similar studies to discover biomarkers for the early detection of 
pancreatic cancer.
    NCI launched a unique program in September 2006, the NCI's Clinical 
Proteomic Technologies Initiative (CPTI). CPTI represents a highly-
organized approach to apply proteomic technologies and data resources 
to support the discovery of biomarkers for the early detection of 
cancer and to monitor therapeutic outcomes. CPTI will advance the field 
of clinical cancer proteomics through the development of an integrative 
team framework that networks multiple research laboratories to permit 
large-scale, real-time exchange and application of existing and newly 
developed protein measurement technologies, biological resources, and 
data dissemination. Efforts will include refining and standardizing 
technologies, reagents, methods, and analytic platforms in order to 
ensure reliable and reproducible identification, quantification, and 
validation of proteins from complex biological mixtures; and evaluating 
new technological approaches to identify proteins that occur during 
cancer development.
    In December 2005, leaders from NCI and the National Human Genome 
Research Institute (NHGRI) launched The Cancer Genome Atlas (TCGA) 
Pilot Project, a comprehensive effort to accelerate understanding the 
molecular basis of cancer, and was the result of a ``blue-ribbon'' 
committee of the nation's leading scientists. Cancer includes more than 
200 different diseases, each with a set of genetic changes that results 
in uncontrolled cell growth. The purpose of the Cancer Genome Atlas 
pilot is to test the feasibility of completely sequencing and 
cataloging the full range of genetic defects in 3 tumor types--brain 
(glioblastoma), lung and ovarian cancers, leading the way to a better 
understanding of all cancers.

                          SUBCOMMITTEE RECESS

    Senator Harkin. Thank you all very much. The subcommittee 
will stand in recess.
    [Whereupon, at 4:10 p.m., Monday, May 21, the subcommittee 
was recessed, to reconvene at 10 a.m., Friday, June 22.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              


                         FRIDAY, JUNE 22, 2007

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 10 a.m., in room SD-116, Dirksen 
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
    Present: Senators Harkin, Reed, Specter, and Cochran.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENT OF RUTH L. KIRSCHSTEIN, M.D., ACTING 
            DIRECTOR, NATIONAL CENTER FOR COMPLEMENTARY 
            AND ALTERNATIVE MEDICINE

                OPENING STATEMENT OF SENATOR TOM HARKIN

    Senator Harkin. The Subcommittee on Labor, Health and Human 
Services will come to order. This is the last of our six 
hearings we have had on the National Institute of Health. We 
have heard from 18 Institutes so far, today we will hear from 
five more. The National Center for Complementary and 
Alternative Medicine, the National Institute of Dental and 
Craniofacial Research, the National Institute of Environmental 
Health Sciences, the National Eye Institute, and the National 
Institute of Child Health and Human Development.
    I want you all to know, I've really enjoyed the informality 
of these hearings. This is just like we've had all of the other 
ones, actually. When I first came on this committee in 1985, 
Senator Weicker, had sort of established this process of having 
these kinds of hearings. I thought they were very informative, 
and this is the way we have done it. I kept thinking, up until 
the mid-1990's I wanted to re-institute, reinstate that again.
    I found that these hour and a half or 2 hour hearings that 
we have had, for me, it's like being in class again. I get to 
learn a lot of things I didn't know about, and it's extremely 
informative, not just for me, but for our staffs on both sides, 
and people right here. I think we get a little bit more in-
depth knowledge of what each of the Institutes are doing, what 
we're looking ahead for, and I think it gives us a better idea 
of, perhaps, where our allocations of money ought to be going. 
So, it has been great to get into little bit more in depth than 
we have had.
    I just want to say a few words about the fiscal year 2008 
budget that we marked up yesterday, by the way. We proposed a 
$1 billion increase for NIH. This will allow NIH, for the first 
time since fiscal year 2005, to plan on increasing the average 
cost of new grants by 3 percent. I know that's not big, but 
it's better than what we have had, and it will provide the 
full-blown committed level for non-competing grants for the 
first time.
    We also increased the common fund by 10 percent. We've set 
aside the full amount to continue the National Children's 
Study, and provided additional support for young investigators. 
I know Senator Specter and I both wish we could have done more 
for NIH, and who knows, when it goes to conference, maybe we 
will even do more. We don't know, but we'll do as much as 
possible.
    I want to thank both Senator Specter and Senator Cochran 
for their support of NIH, and for this proposal that we have, 
that we passed yesterday in full committee.
    With that, I will yield to my colleague, and good friend, 
Senator Specter.

               OPENING STATEMENT OF SENATOR ARLEN SPECTER

    Senator Specter. Thank you very much, Mr. Chairman. Thank 
you, ladies and gentlemen for coming in today. The work of this 
subcommittee is well known, and our vigorous advocacy for NIH, 
and is even better known for our success in raising the funding 
level through the efforts of Senator Harkin, Senator Cochran 
and others on this committee.
    When I take a look at the complementary alternative 
medicine line, my recollection is it was $7 billion before my 
wife told me how important it was. I shared that information 
with Senator Harkin. We have talked about the change of the 
gavel being seamless--it doesn't matter who is there. Senator 
Cochran has been a member of this subcommittee longer than 
either of us has--and as chairman and ranking member of the 
full committee, and has given tremendous support to these 
efforts.
    I wanted to come by to send my personal greetings to you. I 
regret that I have commitments in Pennsylvania today. Friday is 
the day when we try to take care of the home front, except 
Senator Harkin who works 7 days a week, so he schedules 
hearings on Friday morning. You can shoot a canon through the 
Senate and the House today and have no risk of hitting anybody. 
Except for Senator Harkin and Senator Cochran. So, I'm going to 
excuse myself, but my staff will stay and report to me of the 
preceding, and I will be following it very closely.
    Senator Harkin. Thank you very much, Senator Specter, have 
a good weekend.
    Senator Cochran, did you have a statement?

                   STATEMENT OF SENATOR THAD COCHRAN

    Senator Cochran. Mr. Chairman, I'm pleased to join you and 
Senator Specter to welcome our panel of witnesses to the 
committee today. We appreciate the opportunity to continue our 
review of the fiscal year 2008 budget request for the National 
Institutes of Health.
    Today, we have five representatives of different Institutes 
conducting research to talk about their requests for the coming 
year, and we appreciate the participation of this panel in 
hearing and discussing with us your plans for the coming year.
    The National Center for Complementary and Alternative 
Medicine has provided, for the last 7 years, a foundation of 
scientific research in the emerging area of alternative 
medicine and therapy. Dr. Stephen Straus served as the 
Institute's first Director. We convey our condolences to the 
NIH family for the recent loss of Dr. Straus. A great deal was 
accomplished under his leadership to further our understanding 
of alternative therapies, and their role in integrating 
medicine.
    Also, the role that dental health plays in ones overall 
well being has received more attention recently. The death of a 
12-year-old child in Maryland due to a dental infection raised 
awareness of the importance of good dental care. I am co-
sponsoring legislation--the Children's Dental Health 
Improvement Act of 2007--with Senators Bingaman and Cardin, 
which seeks to provide disadvantaged children with better 
access to dental services. The work being done by the National 
Institute of Dental and Craniofacial Research is important to 
improving dental health for all Americans.
    We're learning that a number of conditions afflicting our 
population are connected to environmental factors. It's 
important that we extend our resources from simply treating 
existing diseases, to identifying ways to prevent them. As we 
learn more about the impact the environment has on different 
disease processes, we're better positioned to identify 
prevention measures. The work in this area through the National 
Institute of Environmental Health Sciences is very important, 
and I look forward to hearing about recent advances in this 
research.
    In my State of Mississippi, diabetes is a very challenging 
situation, presents a very challenging situation. There's been 
a big increase in the prevalence, and this causes many 
complications to the health of our citizens. What was once 
thought to be an adult disease is occurring now more often in 
children, as we see numbers of overweight and obese young 
people increase. Progress in this area is very important to me. 
We have more diabetes as a percentage of our State's population 
than any other State in the union. So, progress in this area 
could help a significant number of people.
    I'm not going to go through the list and talk about every 
Institute that is represented here today, but issues like 
infant mortality, the National Children's Study being done at 
NIH through the National Institute of Child Health are 
uncovering disparities which need our attention, and your 
suggestions as to what we can do about this in terms of 
national policy and funding priorities.
    Dr. Zerhouni has testified before this committee on a 
number of occasions, in March, he talked about the medical 
advances resulting from NIH-supported research, and we are 
aware of the importance of our continuing to be generous in the 
appropriation of funds for these activities--translating basic 
science, knowledge into improved and lifesaving therapies is 
very challenging, but it is very important as we work to 
improve the work being done by our Federal Government agencies. 
I appreciate the hard work all of you are turning in, and your 
dedication to ensuring that NIH is successful in these 
important areas of inquiry.
    Thank you, Mr. Chairman.
    Senator Harkin. Thank you, Senator Cochran.
    Let's just go from left to right. I would like to ask each 
of you, all of your statements will be made a part of the 
record in their entirety. I would just like to ask if each of 
you would just please speak for five to seven minutes, and 
we'll just go from left to right, then we'll just open it up 
for kind of general discussion at that point in time.
    First I will introduce Dr. Ruth Kirschstein who I don't 
really need to introduce very much, I'll do it anyway. She has 
served as Acting Director of NCCAM since August 2006. I want to 
join with Senator Cochran in expressing my condolences on Dr. 
Straus' passing. He fought that brain cancer for a long time, 
it kept coming back, and right up until the end, just did an 
outstanding job of leading that Institute.
    But, Dr. Kirschstein's career at NIH spans 33 years. In 
1974, became the first woman to serve as the Institute 
Director, head of the NIGMS, and her positions also included a 
2-year period as Acting Director of all of NIH, and I remember 
we worked together at that time. In 2002, I had the great 
pleasure of surprising her by re-naming the National Research 
Service Awards, as the Ruth L. Kirschstein National Research 
Service Awards.
    Dr. Kirschstein, welcome back, as we have for so many 
years, back to the committee, and please proceed as you so 
desire.

              SUMMARY STATEMENT OF DR. RUTH L. KIRSCHSTEIN

    Dr. Kirschstein. Thank you, Mr. Chairman, Senator Cochran, 
and Senator Reed. I want to thank you also for providing us 
with the opportunity today to discuss NCCAM's vision for the 
future, and to tell you how much we at NIH are grateful for 
your ongoing support, and thank you for your efforts on behalf 
of the health of the American public. Today as Senator Harkin 
has said, I'm here as the Acting Director of the National 
Center for Complementary and Alternative Medicine. I'm 
delighted to be back, and to see you once again.
    I have some material from NCCAM, which I want to provide to 
you, I think some of you have a strategic plan, but just in 
case, since NCCAM was established by Congress, thanks to your 
vision, Mr. Chairman, the Center has built a global scientific 
research enterprise, for the study of complementary and 
alternative medicine.
    The progress that has been made in understanding the 
scientific basis of CAM is greatly attributable, as you said, 
to the leadership of Dr. Stephen Straus, NCCAM's founding 
Director. And I want to thank you and your staff for your 
kindness in postponing the hearing on the day of his funeral, 
and to thank the staff for attending the funeral.

                          INTEGRATIVE MEDICINE

    Today, we know that many Americans are using CAM modalities 
in an effort to promote health and well-being, and to preempt 
disease, and that it is driven largely by consumer demand for 
complementary and alternative medicine. Integrative medicine is 
rapidly becoming the major force-shaping healthcare in the 
United States.
    Integrative medicine makes use of both conventional and 
complementary therapies to address all aspects of health and 
wellness. In addition, we know well, that better communication 
between patients and their medical practitioners is absolutely 
vital to ensure well-coordinated, comprehensive and safe care.
    In NCCAM's pursuit of rigorous science to understand 
complementary and alternative medicine, is the foundation that 
will build the evidence to facilitate the adoption of 
integrative medicine in our society. Our efforts to study and 
understand CAM continue to grow, and in the past year we have 
launched three new activities, a new program to assess the 
potential of community-based, primary care research networks, 
which will increase our knowledge about the efficacy and the 
cost-effectiveness of CAM modalities, as well as the safety of 
the approaches.
    We're also studying the mechanism of action underlying 
manipulative and body-based practices, such as chiropractic. 
We're developing innovative tools and technologies to study the 
biologically based aspects of mind body intervention.
    Our overall strategy is to support a diverse portfolio of 
basic translational and clinical studies. The study of 
acupuncture is an example of this approach. Clinical studies 
have demonstrated the potential of acupuncture for a number of 
conditions, such as osteoarthritis, and the basic and 
translational research using state-of-the-art neuroimaging 
technology has now elucidated mechanisms of brain function that 
have direct relevance to pain relief.
    Advances of similar importance are beginning to emerge in 
other areas. In the last year alone, NCCAM supported-research 
has demonstrated the potential of CAM for addressing a number 
of conditions, and I would like to give you a few examples.
    The spice turmeric, which has long been important as a 
component of Ayurvedic medicine, is being used in the treatment 
of many inflammatory disorders. Preliminary evidence shows that 
turmeric contains specific compounds that may have anti-
arthritic activity. This suggests potential ways in which 
turmeric may be used, and could yield insights into the 
mechanisms of arthritic disease.
    In another example, we have supported studies of the herb 
Ginkgo Biloba. This is a popular dietary supplement that is 
purported to promote brain health. Our studies in animal models 
of Alzheimer's disease have found that ginkgo reduces both the 
formation of the specific brain abnormalities that are also 
seen in humans, as well as preventing the paralysis seen in 
these animals.
    These studies of animal models are very important, and will 
serve as leadership into the hypothesis that is now being 
tested in a large clinical trial of Ginkgo--the prevention of 
dementia. This trial is supported, not only by NCCAM, but by a 
number of the other institutes.
    A very recently recognized clinical trial which you have 
referenced in your folders relates to Tai Chi, which is a 
traditional Chinese form of exercise. This modality may help 
older adults avoid getting shingles by increasing their 
immunity to the varicellis osta virus, and enhancing the body's 
immune response to the vaccine.
    Shingles, you know, affects the nerves, and causes pain and 
blistering in adults. There is a picture (Figure 1) of that in 
your folders. Shingles is caused by the same virus that causes 
Chicken Pox in children. Tai Chi combines aerobic activity, 
relaxation and meditation, and the combination of the shingles 
vaccine and Tai Chi out does the vaccine alone. This study was 
supported by the National Institute on Aging and NCCAM.


                           RESEARCH TRAINING

    But in addition, Senator Harkin alluded to the importance 
of research training. NCCAM mandate to train the next 
generation of CAM researchers. This must involve collaborations 
between CAM practitioners, and experienced scientists, and it's 
absolutely fundamental to our approach to research training and 
career development.
    Since its inception, NCCAM has increased the percentage of 
funds committed to research, training and career development 
from 1.3 percent in 1999, to 8.3 percent in fiscal year 2006.

                                OUTREACH

    Now, the other, and third, component of our mission, is to 
provide authoritative, evidence-based information on CAM. We 
have a growing communications program that distributes 
information in English and Spanish, and in both print and 
electronic form, and includes CAM on PubMed, which is a 
database developed in partnership with the National Library of 
Medicine. It indexes more than 470,000 articles related to CAM.
    We have an online continuing education program that offers 
information on a variety of topics, to help professionals and 
to the public. In addition, this year, we have a new patient 
provider educational initiative to encourage communication 
between patients and physicians about CAM use. The program, 
which is outlined in two pieces of paper in your folder 
(exhibits A&B), is called, ``Time to Talk,'' to ensure 
physicians talk to their patients, and that patients talk to 
their physicians about the use of CAM. It will ensure safety 
and integrated health care. We look forward to building on 
NCCAM's foundation of scientific accomplishments in 2008. We 
will include new activities, such as the partnership with the 
Centers for Disease Control and Prevention to support the first 
national, population-based survey, assessing CAM use among the 
United States' pediatric population. This survey will help to 
fill an important information gap, and help NCCAM to set 
additional priorities.





    Finally, we are also launching a new initiative to examine 
the potential influence of genetic variation on the likelihood 
of response to selected CAM interventions.
    With these, and other studies, NCCAM will continue to 
provide leadership in the research area.

                           PREPARED STATEMENT

    Thank you, Mr. Chairman. I thank Senator Specter, Senator 
Cochran, and Senator Reed for your continued support. I would 
be pleased to answer any questions.
    [The statement follows:]

             Prepared Statement of Dr. Ruth L. Kirschstein

    Mr. Chairman and members of the committee: I am pleased to be here 
to present the President's fiscal year 2008 budget request of 
$121,268,000 for the National Center for Complementary and Alternative 
Medicine (NCCAM).
    In the 7 years since it was established, NCCAM has built a global 
enterprise of scientific excellence and leadership in research on 
complementary and alternative medicine (CAM). NCCAM-supported studies, 
carried out at more than 260 institutions, encompass the wide range of 
CAM practices and have resulted in more than 1,500 scientific papers 
published in peer-reviewed journals. The progress that has been made by 
the research community in understanding the scientific basis of CAM is, 
in large part, attributable to the leadership of Stephen E. Straus, 
M.D., NCCAM's director from 1999 to 2006. Under his leadership, CAM 
research has been established as a legitimate field of scientific 
inquiry that is laying the scientific foundation for the emerging 
discipline of integrative medicine.
    This effort continues. In the past year, NCCAM has launched studies 
to: (1) develop innovative tools and technology for studying 
biologically based and mind-body interventions; (2) assess the 
potential of community-based primary care research networks to increase 
scientific knowledge about the safety, efficacy, and cost effectiveness 
of CAM; and (3) increase scientific understanding of the mechanisms 
underlying manipulative and body-based practices.

            NCCAM'S ROLE AND THE CHANGING NATURE OF MEDICINE

    Large numbers of American health care consumers are using CAM 
modalities in an effort to preempt disease and disability or promote 
health and a sense of well-being. Despite the relative paucity of 
information about the effectiveness and safety of these uses, Americans 
are de facto personalizing medicine through approaches that often 
require their active ongoing participation in a diverse variety of 
health practices and behavior change approaches.
    Driven largely by consumer demand for CAM, integrative medicine--
which can be defined as a health care approach that makes use of all 
appropriate evidence-based disciplines, therapies, and health care 
professionals to achieve optimal health and healing--is rapidly 
becoming a major force shaping health care systems in the United States 
and around the world. At the same time, studies continue to show that 
open communication between conventional medical practitioners and their 
patients about CAM use is uncommon. Such communication is vital to 
ensure well-coordinated, comprehensive, and safe care.
    The ultimate goal of NCCAM is to inform, through science, the 
discipline of integrative medicine. Thus, NCCAM's mission is to support 
rigorous research intended to fill the CAM knowledge gap; train CAM 
researchers; and disseminate authoritative information regarding CAM to 
the public (only one in three of whom consult their physicians about 
their CAM use), and to physicians and other health care professionals 
who rarely ask patients about CAM use.

           BUILDING THE EVIDENCE BASE OF INTEGRATIVE MEDICINE

    Because CAM interventions are widely used by the public, NCCAM 
supports a diverse portfolio of basic, translational, and clinical 
studies. The benefits of this strategy are well illustrated by the 
example of acupuncture. Clinical trials supported by NCCAM have 
documented the efficacy and safety of this widely used CAM practice in 
many but not all conditions studied. More recently, basic and 
translational research employing state-of-the-art neuroimaging 
technology has led to important insights into the mechanisms of action 
for acupuncture's effects, and has elucidated mechanisms of brain 
function that will have direct relevance to other approaches to pain 
relief.
    Advances of similar importance are emerging in other areas of CAM 
research. As is the case with acupuncture, clinical and preclinical 
information fills gaps in knowledge about a number of CAM practices and 
builds a fuller understanding of what CAM can offer. Whether a study's 
result is positive or negative, we expand our knowledge not only about 
the tested therapy, but also learn more about the condition it is 
supposed to treat. Several examples from the past year illustrate this 
point further:
  --Arthritis.--As the U.S. population ages, the need for better, 
        safer, and more effective treatments for arthritis increases. 
        Through basic studies, NCCAM-supported investigators determined 
        that extracts of the spice turmeric, an important component of 
        Ayurvedic medicine that is used in the treatment of a number of 
        inflammatory disorders, contains specific compounds with anti-
        arthritic activity, as well as others that can inhibit this 
        activity. This research suggests the need for further 
        investigation of the potential of turmeric, points toward ways 
        in which its use might be optimized, and yields insight into 
        the mechanisms of arthritic disease.
  --Neurodegenerative Diseases.--Ginkgo biloba is a dietary supplement 
        widely used for its purported beneficial effects on brain 
        function. NCCAM-funded investigators studying it in an animal 
        model of Alzheimer's disease found that it reduces both the 
        formation of the specific brain abnormalities seen in humans, 
        and the resulting paralysis seen in the animals. These 
        experiments lend support to the hypothesis that Ginkgo biloba 
        may be useful in slowing the progression of Alzheimer's 
        disease. That hypothesis is being tested in a large clinical 
        trial of Ginkgo biloba for the prevention of dementia, 
        supported by NCCAM and several other NIH Institutes.
  --Yoga for Chronic Low Back Pain.--Chronic low back pain is prevalent 
        and has few treatment options. NCCAM supported researchers have 
        concluded a randomized clinical trial studying the 
        effectiveness of yoga, exercise, or a self help book in 
        improving back function and decreasing chronic low back pain. 
        The results of the trial demonstrated that yoga was more 
        effective and produced longer-lasting pain relief than exercise 
        or the self-help book.
  --Menopause and Black Cohosh.--Given concerns about the use of 
        hormone replacement therapy to treat symptoms of menopause, 
        many women have turned to the dietary supplement black cohosh 
        for relief, although evidence supporting this approach has been 
        scant. In 2006, a clinical trial supported by the National 
        Institute on Aging and NCCAM failed to show relief of 
        menopause-associated symptoms by treatments containing black 
        cohosh. Two other large clinical trials of black cohosh 
        continue.

            TRAINING THE NEXT GENERATION OF CAM RESEARCHERS

    The rigorous basic, translational, and clinical research required 
to understand integrative medicine must involve collaborations between 
CAM practitioners and experienced scientists. This multidisciplinary 
approach is the fundamental tenet of NCCAM's strategy in support of 
research training and career development. Since its inception, the 
Center has increased the percentage of funds committed to research 
training and career development--from 1.3 percent in fiscal year 1999 
to 8.3 percent in fiscal year 2006--to support research training, 
career development, and educational opportunities. Recipients of CAM 
doctoral degrees are now among those eligible for National Research 
Service Awards, as well as for the NIH-wide loan repayment program.

                  DELIVERING AUTHORITATIVE INFORMATION

    NCCAM is recognized as a source of authoritative, evidence-based 
information on CAM. Information on CAM treatments, herbs and dietary 
supplements, advice for consumers, research results, and clinical 
trials are available in English and Spanish in print and electronic 
form. In 2006, NCCAM's website, cited by Prevention magazine for ``Best 
Alternative Medical Information,'' had more than 2.6 million visitors. 
CAM on PubMed, a database developed in partnership with the National 
Library of Medicine, now indexes more than 467,000 articles related to 
CAM. NCCAM's online continuing education program offers information on 
a variety of topics to the public and health professionals. Of 
particular note is a new patient/provider education initiative--``Time 
to Talk''--that encourages informed and open communication between 
patients and physicians about CAM use, to ensure safe, integrated, 
personalized and participatory care.

                             GOING FORWARD

    NCCAM will build on the foundation of scientific accomplishment and 
leadership that it has established during its first 7 years. Specific 
new activities planned for fiscal year 2008 include the following:
  --Working in partnership with the Centers for Disease Control and 
        Prevention, NCCAM will support the first national, population-
        based survey assessing CAM use among the U.S. pediatric 
        population. This study will fill an important information gap 
        in knowledge of CAM use in children and help NCCAM and the 
        broader scientific community in establishing pediatric CAM 
        research priorities.
  --A new initiative will examine the potential influence of genetic 
        variation on the likelihood of response to selected CAM 
        interventions. This phenomenon, an important factor in the 
        variation observed in responsiveness to conventional medicine, 
        will be examined through linking new basic research to ongoing 
        clinical trials, maximizing the value of the investment in 
        both.
  --A multidisciplinary workshop will bring together scientists from a 
        broad range of the physical, social, and biological sciences to 
        explore novel methodologies for clinical research of complex 
        CAM approaches that make up whole medical systems.
    Through these and other activities, NCCAM will continue to provide 
leadership in establishing the emerging discipline of integrative 
medicine. Thank you, Mr. Chairman. I would be pleased to answer any 
questions that the committee may have.

    Senator Harkin. Thank you very much. That last point, I 
want to follow up on in open questions on this.
    Now we'll move to Dr. Lawrence Tabak, who became Director 
of the National Institute of Dental and Craniofacial Research 
in 2000, received his D.D.S. in dentistry from Cornell, his 
Ph.D. in Biology from Sunni at Buffalo. He's also one of the 
co-chairs of an effort to promote inter-disciplinary team 
science at NIH.
    Dr. Tabak, welcome.

STATEMENT OF DR. LAWRENCE A TABAK, D.D.S, Ph.D., 
            DIRECTOR, NATIONAL INSTITUTE OF DENTAL AND 
            CRANIOFACIAL RESEARCH
    Dr. Tabak. Thank you, Mr. Chairman. I would like to thank 
you, Senator Cochran, and Senator Reed, for providing us with 
the opportunity to discuss our vision for the future, and of 
course, I want to thank each of you for your steadfast support 
of the National Institutes of Health.
    This morning I would like to discuss the NIDCR strategies 
to address the many complex diseases and conditions that fall 
within the mission of our Institute. I hope you have these 
materials. If not, I would just give them to you.
    As you can see, in the first figure, Figure 1, that I 
provided, complex diseases are those resulting--if I could 
refer you to Figure 1 of the handout that I've provided to you, 
complex diseases and conditions are those that result from an 
interplay between and among one's genes and environment, 
infectious agents and behavior, societal issues and the 
unknown.


                         EARLY CHILDHOOD CARIES

    One good example of a complex disease is early childhood 
caries, and if I could refer you to the next figure, Figure 2, 
you can see that in this condition, primary teeth can be 
decayed down to the gum line. This is a condition that is found 
disproportionately amongst underrepresented minority children. 


    NIDCR supports a research centers program to reduce oral 
health disparities, and we presently have 5 centers based 
around the country. What is unique about these centers is that 
they are embedded within their communities. What is needed to 
overcome conditions such as early childhood caries, are 
inexpensive, simple and culturally acceptable interventions.
    One such example is the use of a fluoride varnish, which 
has been worked on in a study conducted by the center at the 
University of California, San Francisco. What they have shown 
is that this approach can be highly effective in preventing 
early childhood caries in the very young, and in children at 
greatest risk.

                  SMOKING, GENETICS, AND CLEFT PALATE

    If I can refer you to the next figure, Figure 3--gene-
environment interactions, are typified by recent studies, which 
are summarized in this figure, conducted by NIDCR-supported 
investigators at the University of Iowa, together with 
colleagues at NIEHS. This work showed that babies of European 
ancestry--up to 25 percent of them, and up to 60 percent of 
babies of Asian history lack a gene. That is important in 
detoxification of cigarette smoke. If a pregnant woman smokes 
15 cigarettes a day, and lacks this important factor, the 
chances of her baby clefting increases 20-fold.


                              CHRONIC PAIN

    NIDCR scientists at the University of North Carolina are 
slowly unraveling the genetic basis of chronic pain by studying 
patients with temporomandibular muscle and joint disorder. If I 
can refer you to Figure 4, differences in susceptibility to 
pain correlate with the levels of a particular enzyme, the so-
called COMT enzyme. On the left-hand portion of this figure, 
you see individuals who have low pain sensitivity and very high 
levels of this enzyme. Then at the far end, those which have 
the highest pain sensitivity have very low levels of this 
enzyme. This makes sense because this enzyme is involved in the 
transmission of pain and this enzyme is involved in breaking 
down the transmitters of pain. So, if you have large levels of 
this enzyme, you are less susceptible to painful activity.



    What's very, very important about this is, for the first 
time we're beginning to understand the true biological basis 
for diseases and conditions, such as TMJ, which heretofore had 
proved very enigmatic. We now understand the real biological 
basis for these diseases and conditions. By unraveling the 
molecular basis, we have an opportunity for early detection and 
diagnosis, as well as potential interventions in the future.

                              ORAL CANCER

    If I can refer you to the next figure please, Figure 5. You 
see an example of an oral cancer. Oral cancer kills. The best 
hope is to detect cancer at its earliest stage. NIDCR has 
invested in a comprehensive tool kit of complimentary 
diagnostic approaches that will lead to bio-markers with both 
diagnostic and predictive value. An exciting advance in bio-
markers research has been the use of saliva as a diagnostic 
fluid. 


                          SALIVARY DIAGNOSTICS

    If I can refer you to the final figure, figure 6. On the 
left you see a lab on a chip, which currently is the size of a 
U.S. dime. This lab on a chip can already analyze multiple 
markers simultaneously, including the genetic signatures that 
are associated with oral cancers. What we have done is married 
the expertise of bioengineers with the knowledge of oral 
biologists and what is in saliva to create this program. 
Ultimately we will be able to use saliva to measure a wide 
range of bio-markers. It doesn't take too much imagination to 
see that if we can shrink the size of that lab on a chip from 
the size of a U.S. dime down to the size of a pinpoint, we 
would have the opportunity to place that device in the mouth, 
so that we could have the opportunity for real-time 
surveillance, constantly. Of course, this is the ultimate goal 
with this program.


                           PREPARED STATEMENT

    I appreciate the opportunity to tell you about these few 
exciting new approaches to address the many complex diseases 
and conditions that affect oral, dental, and craniofacial 
tissues. This is a time of tremendous scientific opportunity 
for oral health research, and of course, I would be pleased to 
answer any questions that you have.
    Thank you.
    [The statement follows:]

              Prepared Statement of Dr. Lawrence A. Tabak

    Mr. Chairman and members of the committee: I am pleased to present 
the President's budget request for the National Institute of Dental and 
Craniofacial Research (NIDCR) of the National Institutes of Health 
(NIH). The fiscal year 2008 budget request for NIDCR is $389,722,000.
   facing the future: integrative approaches to advance public health
    Innovation has long been the great engine of progress in American 
life, including the tremendous progress made in improving the Nation's 
oral health over the last half century. From the tube of fluoridated 
toothpaste in the medicine cabinet to the high-resolution digital X-ray 
unit in the dentist's office, scientific innovations have helped more 
people than ever keep their teeth for a lifetime.
    The Nation's oral and craniofacial researchers stand on the 
threshold of even greater innovations to improve the lives of millions 
of Americans. No longer must they attempt to understand health and 
disease one gene and protein at a time. Today, they can click the 
computer mouse on their desks and call up vast databases of biological 
information. In essence, thousands of pieces to the biological puzzle 
are now on the table. If we meet the challenge to integrate the 
pieces--intentionally blurring in the process the lines that have 
defined the traditional research disciplines--great progress can be 
made in understanding the molecular underpinnings of oral and 
craniofacial health and disease. This year, I would like to offer a few 
of the many examples of how integrative science will lead to greater 
innovation. I'd also like to highlight how this innovation ultimately 
will lead to more personalized dentistry and medicine in which 
treatment can be tailored to a patient's specific disease and 
healthcare needs.

              CRANIOFACIAL CONSTRUCTION AND RECONSTRUCTION

    The human face has been celebrated in art and literature since time 
immemorial and rightfully so. It is among the body's most distinctive 
structures and, is also one of the most developmentally complex 
structures of nature. Tremendous progress has been made in recent years 
in unraveling the genetic programs that are activated in the embryo to 
produce the face and the skull. Similar progress has been made in 
pinpointing which genes can go awry to produce a cleft lip and/or 
palate.
    But much work remains. We must decipher the developmental programs 
that give rise to the various craniofacial tissues, hard and soft. By 
knowing how the craniofacial complex is assembled, it will be possible 
to better reassemble tissues that are damaged, either at birth or due 
to injury later in life. Exciting research is under way to explore the 
viability of regenerating damaged bone, teeth, and soft tissues with 
stem cells, novel biomaterials, and growth-promoting proteins. NIDCR-
supported researchers recently reported success using stem cells to 
engineer a replacement root/periodontal complex that could support a 
porcelain crown and provide normal tooth function in studies with mini 
pigs. Other investigators are well on the way to creating a replacement 
gum tissue that can be produced in sufficient quantity to repair large 
oral defects.
    The developmental programs will be helpful not only in treating 
craniofacial abnormalities but in preventing them. This year, for 
example, a team of NIDCR grantees determined that women who smoke 
during pregnancy and carry a fetus whose DNA lacks both copies of a 
gene involved in detoxifying cigarette smoke substantially increase 
their baby's chances of being born with a cleft lip and/or palate. 
About a quarter of babies of European ancestry and possibly up to 60 
percent of those of Asian ancestry lack both copies of this gene. This 
finding reinforces in a concrete, personal way the public health 
message that women, especially those who are pregnant, should not 
smoke.

                          HEAD AND NECK CANCER

    The NIDCR also has made a major investment in promoting integrative 
approaches to head and neck cancer. Our intent is to move beyond the 
current imprecise clinical definitions of these tumors, which are 
generally based on their appearance and patterns under a microscope. We 
need to examine the genetic hard drives of these tumors' cells to 
understand their abnormal and often deadly behaviors. This work already 
is taking place. NIDCR scientists have compiled comprehensive profiles 
of proteins expressed in some head and neck cancers. This information 
should help in developing true biomarkers with diagnostic and 
prognostic value.
    NIDCR-supported scientists are also developing new and exciting 
visualization tools and approaches to improve diagnosis of oral cancer. 
One such tool being tested is called the VELscope. It is a simple 
hand-held device that emits a cone of blue light into the mouth, which 
excites various molecules within the tissue, causing the tissue to 
absorb the light's energy and re-emit it as visible fluorescence. 
Because changes in the natural fluorescence of healthy tissue generally 
are different from those indicative of developing tumor cells, the 
VELscope allows dentists to observe telltale differences.
    In a recent follow-up study, the scientists reported that the 
VELscope performed extremely well in accurately and rapidly 
delineating the real borders between tumor and healthy oral tissue 
during biopsies in the clinic. Intriguingly, 19 of the 20 examined 
tumors in the study had fluorescence changes that extended in at least 
one direction beyond the clinically visible tumor. These extensions, 
which are undetectable to the unaided eye and thus would likely not be 
excised, extended up to an inch beyond the visible lesion. Leaving 
these abnormal cells in the mouth increases the chance of other tumors 
arising over time. The instrument was developed as one component of an 
integrative approach to oral cancer detection and treatment that 
combines cytology, molecular biology, and staining to improve early 
detection. This finding and others will allow practitioners to gain a 
better molecular characterization of developing tumors, providing the 
intellectual basis for more personalized treatment and a future in 
which fewer people will undergo disfiguring surgery to fight the 
disease and/or die from these cancers.

                          SALIVARY DIAGNOSTICS

    Other diagnostic tools are under development as well. The NIDCR is 
a national leader in development of the use of saliva as a diagnostic 
fluid. Several Institute grantees are working to develop tiny automated 
machines, which can rapidly and precisely perform many diagnostic 
functions that previously required painful needle sticks. One group 
recently fabricated the first disposable, low-cost, miniaturized 
diagnostic platform that can process small amounts of saliva, amplify 
its DNA and detect the levels of genetic sequences of interest. Work is 
proceeding to ultimately create a fully functional hand-held instrument 
for everyday use to detect conditions ranging from oral cancer to 
cardiovascular disease to AIDS.

              TEMPOROMANDIBULAR MUSCLE AND JOINT DISORDERS

    Integrative approaches are proving productive in our ongoing 
efforts to understand temporomandibular muscle and joint disorders, or 
TMJDs. Previously, NIDCR-supported scientists found that different sets 
of common sequence variations in the COMT gene correlate with low, 
moderate, and high susceptibility to chronic pain. This finding makes 
good biological sense. The COMT gene encodes an enzyme that helps to 
inactivate nerve signaling compounds and stop the transmission of an 
unpleasant sensation. The scientists recently showed that each of these 
sets of sequence variations changes the resulting structure of the 
corresponding messenger RNA. When a gene is expressed, it is copied 
into messenger RNA which, like an order form, contains the information 
to produce a specific protein. The scientists determined that the 
genetic variations that correlate with high sensitivity to pain produce 
messenger RNA with long, rigid loops in their structure, which reduces 
the rate of COMT protein synthesis and thus slows the nerve's ability 
to turn off an unpleasant sensory signal. The likely result: those with 
the ``sensitive'' variations will personally experience the sensation 
of pain longer and possibly more intensely.
    Such findings are particularly exciting because these studies could 
not have been conducted just a generation ago. Not enough was known 
about the basic mechanisms of pain. But as more of the biochemical 
pieces to the puzzle are found in the years ahead, great progress in 
controlling pain will be possible, and the NIDCR will help in leading 
the way for all those battling chronic pain conditions, including 
TMJDs, to find relief through a more accurate diagnosis and more 
personalized care.

        DENTAL DISPARITIES: RIGOROUS SCIENCE, PRACTICAL RESULTS

    It now has been 7 years since the U.S. Surgeon General issued the 
report Oral Health in America. As many will recall, that report pulled 
together for the first time the stark statistics of the Nation's 
``silent epidemic'' of tooth decay and other oral diseases among its 
minority and underserved populations. The reasons for these disparities 
are complex, but two facts were indisputable in the report: Many oral 
diseases are either preventable or easily controlled, and new 
strategies are needed to ensure that all Americans are aware of and 
ultimately benefit from the latest research advances.
    To meet this need, the Institute established five Centers for 
Research to Reduce Oral Health Disparities in 2001. This approach 
allows scientists to assemble multi-disciplinary research teams that 
lend a greater wealth of expertise to understand and address the 
complex elements underlying oral health disparities at the community 
level. Building on the knowledge and evidence amassed by the initial 
health disparities centers, the Institute has begun preparations to re-
compete its center grants with a specific public health aim. That aim 
is to assemble a more seamless investigative team structure that can 
take a well-defined clinical issue and with the participation of a 
community-based population, test the effectiveness of promising 
interventions on a wider scale. This approach holds considerable 
promise to yield rigorous science, participatory research with those in 
underserved communities, and a significant reduction in oral health 
disparities.

                    PRACTICE-BASED RESEARCH NETWORKS

    The Institute awarded grants in early 2005 that established three 
regional practice-based research networks, or PBRNs. Their mission is 
to create networks of practicing dentists and dental hygienists with 
their patient populations to participate in clinical studies on a 
variety of pressing everyday issues in oral healthcare. In 2006, the 
PBRNs were enlisted to investigate an important emerging health issue. 
Millions of Americans currently take a type of drug called 
bisphosphonates, typically to ease cancer-related pain or to prevent 
osteoporosis. But recent reports indicate that newly formulated 
bisphosphonates can cause in some people a debilitating thinning of the 
jawbone called osteonecrosis. What remains unclear is the prevalence of 
this unwanted side effect and, more importantly, who precisely is at 
risk. A few years ago, NIDCR would have lacked the clinical 
infrastructure in place to investigate these and other related 
questions. The PBRNs have changed the equation. The NIDCR has rapidly 
organized the needed studies to investigate the problem and will 
provide in the near future more meaningful data for the millions of 
Americans at risk.
    Traditional research approaches have produced extraordinary 
benefits to the Nation's public health. But we now face a new 
scientific frontier, and new possibilities confront our researchers. 
These opportunities require novel approaches that fall under the rubric 
of integrative science. From this coordinated approach to science, the 
biological complexity before us will give way to simplicity and once 
unimaginable public health advances in which personalized health and 
medicine become a reality.

    Senator Harkin. Thank you very much, Dr. Tabak.
    Next, we will turn to Dr. David Schwartz, Director of the 
National Institute of Environmental Health Sciences. He has 
been Director since 2005, earned his M.D. from the University 
of California, San Diego, and his Ph.D. degree from Harvard 
School of Public Health. But most importantly of all, he spent 
the better part of 12 years at the University of Iowa. Is that 
about right?
    Dr. Schwartz. Very formative years.
    Senator Harkin. His own research focuses on environmental 
lung diseases. Dr. Schwartz, welcome to the committee.

STATEMENT OF DR. DAVID SCHWARTZ, M.D., DIRECTOR, 
            NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH 
            AND SCIENCES
    Dr. Schwartz. Thank you very much, Mr. Chairman, Senator 
Cochran, and Senator Reed. It's a pleasure to be here, thank 
you for providing us the opportunity to discuss our collective 
vision for the future of medical research.
    I do have a handout that may be of help to the members of 
the committee.
    Just by way of introduction, NIEHS protects the Nation's 
health by understanding the role of the environment, in terms 
of the development and also the distribution of disease in 
society. Our view is, understanding the causes of disease will 
provide the types of insights that are absolutely necessary to 
preventing disease in society. That's the focus of the 
Institute. The work of NIEHS in the past has improved the 
average length and quality of life by looking at disease 
etiology, and also prevention of exposures that are relevant to 
disease etiology.
    If you look at the second page of the handout, Figure 1, I 
will give you two examples of work that has been done in the 
past at NIEHS that exemplifies this approach. The two examples 
focus on air pollution and lead exposure. NIEHS funded a very 
important study called ``The Six City'' study, that focused on 
air pollution and identified air pollution as a major cause of 
morbidity and mortality, especially as related to heart and 
lung disease.



    In the graph on the left-hand panel, the letters on the 
graph refer to the six different cities that the study was done 
in. You can see very clearly, as you move from left to right, 
that the level of air pollution increases, and the mortality, 
and also the morbidity, from lung and heart disease increases.
    As a result of this very compelling research, new standards 
were adopted by the EPA under the Clean Air Act, which changed 
the standards in the United States for air pollution. As a 
result, there have been marked decreases in the level of air 
pollution, but marked improvements in morbidity and mortality 
related to air pollution exposure.
    The second example is an example of collaborative work 
between NIEHS and the National Institute of Children's Health 
and Human Development. On the right-hand side, the second 
figure on the second page shows a very striking relationship 
between the concentration of lead in the blood of children, and 
IQ. The higher the lead levels, the lower the IQ. This research 
resulted in the elimination of lead in gasoline, and 
subsequently resulted in improvements--substantial decreases--
in the concentration of lead in the blood of children around 
the United States.

                             STRATEGIC PLAN

    If you look at the next page of the handout, figure 2, 
between 2005 and 2006, shortly after my arrival at NIEHS, we 
developed a strategic plan, and our strategic plan lays out a 
very clear vision--to prevent disease and improve human health 
by using environmental sciences to understand human biology and 
human disease. Embedded in this plan, we have several 
challenges that face us, that keep us focused on our mission--
our mission focusing on specific exposures and diseases that 
are relevant to those specific exposures.




    If you look at page four of the handout, Figure 3, we have 
developed 7 specific goals that help keep us on track in terms 
of the development of research priorities at NIEHS that are 
consistent with our strategic plan. So, although we've made a 
lot of progress in each one of these goals, and we've 
implemented programs in each one of these goals, I just want to 
tell you about three distinct programs.



               HEAD-OFF ENVIRONMENTAL ASTHMA IN LOUISIANA

    The first program is called the HEAL Program. It stands for 
Head-off Environmental Asthma in Louisiana, and it's based on 
in fact that children moving back to New Orleans are at very 
high risk for the development of asthma, as a result of 
exposure to a contaminated environment--the molds and the 
bacteria that have overgrown many of the environments in New 
Orleans as a result of Hurricane Katrina.
    This is a collaborative project, and it's a community-based 
project. The community is very, very involved in this project, 
and the Department of Public Health is very involved in this 
project, as is Tulane University. It's a collaboration between 
NIEHS and the National Center on Minority Health and Health 
Disparities, and also the Merck Childhood Asthma Network. It 
represents a public/private partnership, in addition to a 
collaboration within NIH. Again, the project is focused on an 
intervention program, and studying that intervention program to 
see if we could reduce the burden of airway disease in these 
children that are at very, very high risk of developing and 
exacerbating their underlying airway disease.

                    TRAINING AND CAREER DEVELOPMENT

    The second area of development that I want to highlight is 
in training and career development. We've revitalized our 
training--in fact, our training programs now go all the way 
from high school through college, including training for 
foreign scientists. The training reaches out to minority 
students, as well as physicians-scientists--two very important 
groups that are underrepresented in the NIEHS portfolio--and 
also focuses on new investigators to help them develop a focus 
in environmental sciences and have an opportunity for research 
in environmental sciences.

                        EXPOSURE BIOLOGY PROGRAM

    The third area I want to highlight is the development of 
personalized measures of exposure, very similar to what Dr. 
Tabak was talking about, in terms of these miniaturized 
exposure measurements and biological response indicators, that 
are very important in terms of identifying how much someone has 
been exposed to, and how biologically responsive someone is to 
that exposure.
    If you look at the next page of the handout, Figure 4, you 
can see that we've developed a program called the Exposure 
Biology Program that is part of the Genes, Environment, and 
Health Initiative. This new initiative is supported by all 
institutes across the NIH, and is led by me and Francis Collins 
and at NHGRI. The overall goal of the Exposure Biology Program 
is to develop personalized sensors of exposure, and also, 
biological response indicators. Step back for a second, and 
consider how we're able to precisely measure genetic variation 
across the human genome and how crude our tools are to measure 
individual differences in terms of environmental exposures--and 
you realize very quickly that this program is essential to be 
able to look at the interaction between genes and environment, 
in terms of the risk of developing disease. After all, for the 
foreseeable future, our main way of preventing disease will be 
to intervene in the environment, not to intervene genetically.




    So, it's essential that we understand this relationship 
between genes and environment, as a way of understanding risks 
related to human health. Outgrowths of the Exposure Biology 
Program might include specialized wrist bands or smart shirts 
that could alert a person, or a physician, to an exposure that 
could be detrimental to an individual's health.

                             OPPORTUNITIES

    If you turn to the last page of the handout, Figure 5, as 
we look forward, we're focused on three main opportunities. 
First, as I mentioned, through the Exposure Biology Program, 
we're developing these personalized measures of exposure and 
response indicators.



    Second, we're focusing on a number of new research programs 
on complex diseases, such as asthma and neurodegenerative 
diseases and arthritis, that are caused by both genetic and 
environmental factors. We believe very strongly that the 
environment will be very helpful in identifying the genes that 
are important in terms of the risk of developing disease.
    The third aspect that we're focused on is populations that 
are exposed to high concentrations of toxins, such as arsenic, 
or high concentrations of air pollution, so that we can reduce 
the burden of disease in these populations and improve health.

                           PREPARED STATEMENT

    So, I want to thank you for your attention. I look forward 
to your questions, and I would yield to my colleagues, and look 
forward to the informal discussion that we will have following 
everyone's formal presentation.
    [The statement follows:]

                Prepared Statement of Dr. David Schwartz

                              INTRODUCTION

    Lives saved by environmental health research can be counted in 
millions. By the Environmental Protection Agency's (EPA) estimates on 
air pollution alone, the Nation's commitment to cleaner air will 
prevent 23,000 premature American deaths; 1,700,000 new asthma attacks 
or aggravation of chronic asthma; 67,000 new cases of acute and chronic 
bronchitis; 22,000 respiratory-related hospital admissions; and 42,000 
cardiovascular hospital admissions (EPA 410-R-99-001) by the year 2010. 
The commitment to new air standards arose from NIEHS-supported research 
on air pollution such as the Six-Cities Study which revealed important 
associations between air pollution and mortality from respiratory and 
cardiovascular disease.
    Air pollution is only one example of the public health impact of 
environmental health research. Studies on adverse effects of lead, much 
of it funded by NIEHS, revealed lead-associated decrements in the IQ 
scores of young children, as well as increased tendencies by affected 
children to aggressive behaviors. It was these types of neurobehavioral 
problems that led the Nation to ban sources of lead contamination, a 
move that has led to a 78 percent decrease in average blood lead levels 
in this country (JAMA, 272:284-91 (1994)) and a corresponding 
improvement in the health of our children. Further NIEHS-supported 
research involving adults found that long-term exposure to lead is 
associated with an increased risk of high blood pressure 
(hypertension), kidney problems and cataracts. Reduced lead levels in 
the environment are expected to translate in the future into a 
decreased incidence of hypertension, kidney failure, and cataracts 
among the elderly.
    NIEHS-supported researchers have made other recent discoveries with 
high potential for public health impact. Some examples include 
identification of a novel biological mechanism that controls airway 
tone and could be targeted for the treatment of asthma; discovery of 
important mechanistic linkages between exposure to inhaled particulate 
matter and cardiovascular disease; new insight into regulatory 
mechanisms within the brain that affect learning and memory; and 
identification of the structural basis of errors in DNA synthesis that 
may result from environmental stress and have profound effects on a 
variety of human diseases, including cancer.
    As these examples illustrate, environmental health science can 
exponentially return its investments on improvements in a wide spectrum 
of diseases and disabilities. Operating on multiple molecular and 
cellular pathways, environmental agents can track these complex 
molecular pathways that lead to chronic diseases such as cancer, birth 
defects, hypertension, and neurological disorders. Because 
environmental agents often operate early in the disease process, they 
can be useful for identifying very early events in disease, suggesting 
ways to diagnose and remedy diseases before they progress. The 
challenge now is to develop techniques needed to assess environmental 
exposures as they operate at the level of individual health. This will 
require the development of sensitive devices that can assess the 
environmental exposures to which individuals are exposed in their daily 
lives. Ideally, these small, specialized, wearable sensors would 
measure environmental exposures, as well as the actual biological 
changes that arise as early markers of response in environmental 
agents. Such devices would allow scientists and physicians to access 
the more dynamic, real-world exposures of the American population and 
would provide information that could be useful to identify very early 
events in disease, suggesting ways to diagnose and remedy diseases 
before they progress.
    Many of NIEHS' recent achievements have been possible because of 
powerful tools used to study events at the genetic and molecular level 
that would have been impossible ten years ago. With so many promising 
avenues to explore, NIEHS developed a new strategic plan, New Frontiers 
in Environmental Health Sciences and Human Health (www.niehs.nih.gov/
external/plan2006/home.htm) that focuses on three major challenges and 
seven specific goals to prevent disease and improve human health by 
using environmental sciences to understand human biology and human 
disease. Steps to implement the Strategic Plan have led to research in 
exposure biology (personalized measures of exposure), epigenetics 
(inheritance not based on the sequence of DNA), comparative genomics 
(use of model systems to understand the biological effects of 
environmental exposures), translational research (integrating basic and 
applied sciences to understand the effect of the environment on human 
health), and focused training and career development programs to expand 
the workforce in environmental sciences. Our success will be measured 
in the disease and suffering that we are able to prevent.

                        EXPOSURE BIOLOGY PROGRAM

    The Exposure Biology Program, a component of the larger Genes, 
Health and Environment Initiative at the National Institutes of Health 
(NIH), was created to develop tools to precisely measure the exposure 
to chemical/biologics, dietary changes, physical activity, psychosocial 
stress, and addictive substances and subsequently assess the effect of 
these exposures on human health. This program will produce non-invasive 
tools that can be used to track exposures critical to human health. 
While new technology will be developed, this program will also borrow 
and re-engineer tools from other fields that have focused on measuring 
various component of the environment. Possibilities include the use of 
molecularly imprinted polymers that show promise in identifying 
antibodies, enzymes, and animal tissues or cells; small labs-on-a-chip 
that can be made through recent advances in silicon and glass 
micromachining; and the use of nanoparticles in biomolecular sensors. 
These technologies would be combined with new techniques to assess co-
modifiers of response such as diet and physical activity. As these 
technologies are incorporated into large-scale epidemiological studies, 
much of the background ``noise'' obscuring our ability to identify 
environmental components of disease will be reduced. Furthermore, the 
program is soliciting researchers to develop these new tools in ways 
that can also provide insight into the molecular underpinnings of 
disease response, thus identifying therapeutic targets for 
intervention.
    One exciting outgrowth of this project will be in the area of 
personalized and participatory medicine. The sensor technologies 
developed through the Exposure Biology Program are envisioned to be 
small, portable devices that can measure actual exposures to 
environmental agents, as well as monitor diet, physical activity, heart 
rate and respiration. An example would be a device that could alert an 
individual with asthma to dangerous air pollution levels. Another 
example would be a device that could determine harmful pesticide levels 
and cross-reference this information with an individual's own genetic 
risk profile for neurodegenerative diseases like Parkinson's disease. 
Alternatively, data derived from such sensor devices could be used by 
physicians to tailor treatment and prevention strategies based on 
actual exposure risks. The strategies could range from altering the 
environment or modifying behavior through disease risk education to 
selecting pharmaceutical treatments that would more accurately target 
the underlying molecular changes resulting from environmental 
exposures.

                EPIGENETICS--BEYOND THE SEQUENCE OF DNA

    The field of epigenetics is uniquely related to environmental 
health sciences. Epigenetics refers to a modification of gene 
expression that does not involve a change in gene sequence; rather, a 
sometimes slight modification of DNA or its associated proteins or 
sugars that can dramatically change gene function, sometimes into 
subsequent generations. Almost all known factors causing epigenetic 
change are from the environment, diet, or supplements. Epigenetic 
mechanisms are being linked to multiple illnesses, including cancer, 
cognitive dysfunction, and respiratory, cardiovascular, reproductive, 
autoimmune, and neurobehavioral diseases.
    Recently, NIEHS developed a program in epigenetics that supports 
research to understand how the epigenome is affected by environmental 
exposures and how this ultimately affects human health. This field is 
particularly promising in identifying how early life exposures can 
generate disease outcomes later in life. One purpose of this program is 
to identify critical windows of susceptibility to epigenetic changes, 
particularly during pregnancy, early life, and puberty. The fruits of 
this research will help us develop biomarkers of early exposure, as 
well as identifying possible therapeutic strategies to prevent disease 
later in life.

                  CLINICAL AND TRANSLATIONAL RESEARCH

    In the summer of 2007, NIEHS will complete construction of its 
first clinical research unit that will be used to study how human 
subjects respond to a variety of environmental stressors. This facility 
will foster integrated, interdisciplinary research opportunities 
between our basic and clinical scientists to speed the translation of 
knowledge from bench to bedside. NIEHS' Office of Translational 
Research is also focusing on taking discoveries from our basic and 
population-based studies and translating them into research findings 
that have direct relevance to human health and disease. New integrative 
research programs are designed to promote an interdisciplinary approach 
to focus environmental sciences on important human health conditions. 
Two examples are the extramural DISCOVER (Disease Investigation through 
Specialized Clinically Oriented Ventures in Environmental Research) 
Program and the intramural Director's Challenge. The approach being 
taken in these programs is to closely integrate basic, mechanistically 
driven laboratory research directly with patient-oriented research to 
speed the translation of the environmental health sciences into 
clinical and public health applications. Awards made under both the 
intramural program and the DISCOVER Centers will be for multi-project, 
interdisciplinary programs to understand the etiology, pathogenesis, 
prognosis, and epidemiology of disease processes such as respiratory 
diseases, cancer, or neurodegenerative diseases.

                    WORKFORCE TO MEET NEW CHALLENGES

    The much greater complexity of research techniques and the new 
focus on human health and disease requires a new, specialized 
workforce. The new environmental health workforce must be increasingly 
collaborative and must have skills to work across multiple research 
disciplines. NIEHS is refashioning its training program in order to 
produce researchers with the skill sets needed in the future. For 
promising high school and college students, the Short Term Educational 
Experiences for Research (STEER) program provides needed support for 
attracting and developing this next generation of environmental health 
scientists. NIEHS and NHGRI developed a collaborative training program 
for pre- and post-doctoral students in environmental genetics. The 
Outstanding New Environmental Scientists Award (ONES) program is a new 
way to recruit talented young independent researchers into 
environmental health science research. These programs complement 
existing training programs and, in concert, will help develop a 
workforce that can meet the many demands of environmental health 
research.

                                SUMMARY

    The opportunities within environmental health sciences are greater 
than ever. New programs initiated this past year will produce a more 
sophisticated understanding of the environmental components of disease, 
as well as a better knowledge of how individuals vary in their response 
to exposures. This information will enhance our ability to develop 
personalized approaches that can decipher an individual's actual 
exposures, their individual risks for adverse effects from these 
exposures, and ultimately lead to a customized strategy for reducing 
these risks and circumventing undesirable health outcomes. This more 
extensive understanding of environment-disease associations will, in 
the aggregate, lead to improved intervention and therapeutic strategies 
that can lessen the disease burden of our citizens. I would be happy to 
answer your questions.

    Senator Harkin. Thank you very much, Dr. Schwartz.
    Now, we'll turn to Dr. Paul Sieving. He became Director of 
the National Eye Institute in 2001, received his M.D. and a 
Ph.D. in biomedical engineering from the University of Illinois 
and conducted research focused on retinal conditions, such as 
retinitis pigmentosa.
    Dr. Sieving, welcome to the committee.

STATEMENT OF DR. PAUL A. SIEVING, M.D., Ph.D., 
            DIRECTOR, NATIONAL EYE INSTITUTE
    Dr. Sieving. Thank you, Senator Harkin and congratulations 
on saying retinitis pigmentosa. That's a big word as are many 
of the words we use in medicine, but these words have very 
important implications for disease and health of the American 
people. As Director of the National Eye Institute, it's my 
privilege to tell you, to report to you today on some of the 
remarkable advances that are happening in vision research.
    We are at a precipice in medicine as I've heard my 
colleagues also report, where we're really able now to move 
from basic research into the phase of improving health. In my 
case, the eye health of the American people. It's a very 
exciting time. With the support of the United States Congress 
our vision scientists are developing treatments to prevent 
vision loss and, even more remarkably, in some cases to 
partially restore sight for some common eye diseases, including 
age related macular degeneration that affects the older age 
population. Conditions that affect children, such as amblyopia, 
start in childhood, but the vision loss can persist for a 
lifetime.
    I think all of us can understand and appreciate that the 
loss of sight really affects people in a fundamental way. It 
threatens independence. It is socially isolating, we can't look 
at one another. It affects the quality of life. The number of 
the eye diseases that we suffer actually increase with age. 
They strike later in life. As the American people live longer 
and the baby boom generation ages, unfortunately, we can expect 
an increasing prevalence and incidence of some of these 
conditions that are related to aging.

                    AGE-RELATED MACULAR DEGENERATION

    I would like to focus my comments on one storyline of 
remarkable success involving age-related macular degeneration 
or AMD. This is a condition in which central vision is 
affected. You look at the person sitting across from you and 
his or her face dissolves into a blur. It's difficult to see 
the face of a friend. It's difficult to read a book. Obviously 
driving a car, that privilege is lost. Even simple things, such 
as cooking, those simple tasks become very difficult.
    But, the last 2 years have been a watershed time for AMD, 
both in terms of new treatments, remarkable new treatments and 
genetic factors that are now coming online. Over the past 2 
years, attention to a particular molecule called vascular 
endothelial growth factor, just about as big a word as 
retinitis pigmentosa. Vascular endothelial growth factor or 
VEGF is a molecule that was pursued quite vigorously by the 
cancer research community for many years. It turns out that 
abnormal blood vessel growth is also involved in one of the 
severe forms of age-related macular degeneration, causing 
abrupt loss of central vision. Now, over the past 2 years, an 
anti-molecule, anti-VEGF, administered to the eye, injected 
into the eye, literally, can stabilize the vision. In some 
cases, even improve reading ability somewhat.
    Senator Cochran, you mentioned the incidence of diabetes in 
your State. Diabetes is a problem of blood vessels that also 
involves the blood vessels in the eye, as you alluded to, and 
causes a condition called diabetic retinopathy, a blood vessel 
problem in the eye. So, this same molecule, the VEGF molecule 
is involved and anti-VEGF therapy is now being tried for 
diabetic retinopathy. We can hope that that will be successful. 
But, we need to intervene at an earlier course of disease.
    I would like to go over some old ground that I have 
presented here to this committee previously, called the Age-
Related Eye Disease Study, in which prevention was the focus. 
This was an NEI sponsored study. It ran for 7 years. It focused 
on the daily use of antioxidant vitamins and minerals.
    After work, hard experimental work with some 4,000 
individual subjects, participants, it was found that this 
approach delayed the onset to serious vision loss and advanced 
macular degeneration, delayed that by about 25 percent. That is 
a remarkable success. So, that if this dietary intervention 
could be fully utilized by the American people who need 
treatment, we could anticipate over the next 5 years, it would 
rescue the vision of some 300,000 people. In that study, the 
AREDS study, is now in a second phase of AREDS2, testing other 
dietary components, such as DHA or omega-3 fish oils.
    But, let's move back even one step further. So far we've 
talked about treatments and prevention, but we can actually go 
right to the root causes of AMD by looking at the genetic 
factors that predispose us, literally sitting around this 
table, to have AMD in later ages. Now, we have suspected for 
many years that genetic factors play a role in developing AMD 
and just 2 years ago, in April 2005, 26 months ago, the NEI-
supported researchers identified the first gene that 
predisposes to developing AMD in a large population. One gene, 
first time in history, a remarkable event. In the intervening 
26 months, four additional genes have been found. So now, there 
are five genetic risk factors that are contributing, we 
believe, about 75 percent of the risk for those of us around 
the table to ultimately develop AMD.
    These genes are also surprising in their molecular theme, 
their biological theme. They're in the immune system of the 
body, the complment cascade. The first factor was complment 
factor H. Another gene was complment factor B. These are 
components that operate normally in the body's immune defense 
against microbial infections. The way we think about it is, 
it's suboptimal control of this very vigorous defense system in 
the body. A normally protected pathway in which suboptimal 
control leads to chronic inflammation of the tissues of the 
retina and ultimately causes AMD to develop.
    This gives us then the first handle on something that, in 
fact, we can take to the American people from this very basic 
genetic study. That is the recognition that the environmental 
factors, as my colleague next to me has just mentioned, and 
lifestyle factors play on this genetic background to further 
increase the risk of us developing AMD.

                                EYEGENE

    This, my mentioning of these four or five genes for AMD are 
just part of the genetic story that is now rapidly evolving. 
There are some 450 genes that have been found to cause eye 
disease. These diseases include cataracts, glaucoma, 
strabismus, retinal disorders, corneal opacities, eye motility 
problems. With this wealth of genetic information, the Eye 
Institute, over the past 2 years, has a developed a 
collaborative national network of research laboratories to 
support genetic testing.
    We are calling this eyeGENE. You can go to Google and type 
in ``NIH eyeGENE'' and come up with a few pages on it. It is a 
consortium of 20 universities across the country that 
participates actively, with oversight, and setting directions 
to make available genetic information, both to research, to 
move the research along to appropriate conclusions. At the same 
time, as a corollary to provide genetic direct information to 
families. The research group is really quite excited about 
that. We will have a centralized registry for research data 
mining. We will have a secure blood collection for research, a 
research repository. EyeGENE is now receiving samples from 
physicians across the country.
    So, what I have given you is what I think is a very 
exciting story of treatment for macular degeneration, genes for 
macular generation, the ability to provide information to all 
of us before we are, literally, patients. So that, perhaps, we 
can avoid becoming a patient for these conditions. I think this 
is in the tradition, as I'm hearing, already down the table of 
real opportunities for personalized and certainly, ultimately, 
participatory medicine. The first time in history, I think, we 
are really making tremendous progress. So, it is a rich and 
rewarding opportunity for us to move forward.

                           PREPARED STATEMENT

    With that, thank you for the opportunity to testify. And, I 
will certainly be pleased to answer questions.
    [The statement follows:]

               Prepared Statement of Dr. Paul A. Sieving

    Mr. Chairman and members of the committee: I am pleased to present 
the fiscal year 2008 President's budget request for the National Eye 
Institute (NEI). The fiscal year 2008 budget includes $667,820,000 in 
the President's request.
    As the Director of the NEI, it is my privilege to report on the 
many research opportunities that exist to reduce the burden of eye 
disease.

                    AGE-RELATED MACULAR DEGENERATION

    The loss of sight affects us in fundamental ways, threatening 
independence, mobility and quality of life. Most eye diseases strike 
later in life. Thus, as life expectancy has increased and the baby boom 
generation ages, more Americans are becoming susceptible to vision loss 
and blindness. One such disease, age-related macular degeneration 
(AMD), is the leading cause of legal blindness. Based on published 
study data, 8 million older-age Americans are at high risk to develop 
advanced AMD. AMD causes a progressive loss of central vision, making 
it difficult to read, recognize faces, drive a car, or perform even 
simple tasks that require hand-eye coordination.

                          ANGIOGENESIS AND AMD

    Angiogenesis is the term used to describe the growth of new blood 
vessels. Angiogenesis plays a crucial role in the normal development 
and maturation of tissues. It also plays a role in many diseases, 
including eye diseases such as diabetic retinopathy, retinopathy of 
prematurity and advanced AMD. In advanced AMD, new blood vessels grow 
abnormally beneath the retina. These abnormal blood vessels leak blood 
and fluid, producing scarring and severe vision loss.
    NEI-supported researchers have established that a protein called 
vascular endothelial growth factor (VEGF) plays an important role in 
triggering angiogenesis in AMD and diabetic retinopathy. Thus, VEGF is 
an important target for drug development. Two anti-VEGF therapies have 
recently been approved by the FDA for the treatment of AMD. More 
recently, NEI-supported researchers have found that in animal models, 
combination therapies that control diverse elements of angiogenesis can 
completely inhibit some forms of abnormal blood vessel growth. Anti-
VEGF therapies are also being evaluated in clinical trials for diabetic 
retinopathy. NEI and NIH have invested considerable resources in 
understanding and controlling angiogenesis. That investment is already 
paying handsome dividends.

                       DISEASE MECHANISMS IN AMD

    Another critical area in developing treatments of AMD is to 
identify the causes and mechanisms of the disease early in its 
pathology. Researchers have long held that AMD can result from the 
confluence of genetic predisposition and chronic exposure to 
environmental risk factors, such as diet and smoking. In this scenario, 
a gene or genes contain subtle variations that hamper cellular function 
but may not necessarily cause disease directly. However, years of 
cumulative environmental insult can further strain the underlying 
genetic predisposition and trigger disease.
    On the genetic side of the equation, NEI-supported investigators 
have identified common variations in four genes that are associated 
with AMD and may account for 75 percent of the risk of developing AMD. 
Two of these genes--complement factor H (CFH) and complement factor B 
(BF)--contain instructions to encode proteins that help regulate the 
body's immune defense against microbial infections. This defense, 
called the complement system, provokes inflammation, a common response 
to foreign pathogens. It is thought that certain variations in these 
genes result in sub-optimal control of the complement system and cause 
chronic inflammation. Chronic inflammation may damage tissues of the 
retina and could lead to AMD.
    Chronic inflammation is thought to play a role in many other common 
diseases beyond the eye, such as Alzheimer's disease, Parkinson's 
disease, multiple sclerosis, kidney disease, stroke, and 
atherosclerosis. Although the cells, tissues, and molecular events in 
these diseases are diverse, they may share some common disease 
mechanisms that present an opportunity to cross pollinate findings from 
diverse research areas.
    The genetic discovery of the possible role of inflammation and the 
immune system in AMD is a watershed moment. We have now uncovered a 
possible central disease mechanism that may lead to a better 
understanding of this major disease and the development of therapies 
that prevent vision loss. We now hold the possibility to learn an 
individual's risk vulnerability well before the disease is detectable 
clinically, and to intervene effectively, thereby preempting the 
disease process at its early stages.

                      PUBLIC HEALTH AND PREVENTION

    Another critical and fruitful area of research is the development 
of public health strategies to prevent or delay AMD. Several 
epidemiologic studies, published in the 1990s, found evidence to 
suggest that diets rich in leafy green vegetables, which contain 
antioxidants, might be associated with a reduced risk of AMD. To 
leverage these findings, the NEI initiated a large, multi-center 
prospective study and clinical trial called the Age-Related Eye Disease 
Study (AREDS). Data from the AREDS study, published in 2001, found that 
over a 5-year period, a daily formulation of antioxidant vitamins and 
minerals (vitamins C, E, beta-carotene and zinc with copper) delayed 
the onset of advanced AMD by 25 percent.
    An estimated 8 million older-age Americans are at high risk to 
develop advanced AMD and vision loss. Of these 8 million, 1.3 million 
will develop advanced AMD within 5 years. However, now with the 
successful AREDS treatment, 300,000 of these individuals could be 
rescued from severe vision loss associated with advanced AMD over a 5-
year period. This simple and relatively inexpensive dietary 
intervention offers to the American public a valuable intervention to 
prevent severe vision loss and to reduce the need for more aggressive 
and expensive therapies.
    On the heels of this success, the NEI launched AREDS2. One of the 
primary objectives of AREDS2 is to determine whether oral 
supplementation with lutein and zeaxanthin and/or omega-3 long-chain 
polyunsaturated fatty acids will further decrease the progression to 
advanced AMD or formation of cataract. Previous NIH-funded studies have 
found high concentrations of these nutrients in the macula of the eye. 
Moreover, several studies have found an inverse relationship between 
dietary intake of these compounds and AMD. AREDS2 could result in a 
more effective but still inexpensive treatment regimen to prevent 
severe vision loss.

                            GENOMIC MEDICINE

    AMD research is but one example of genomic medicine, the effort to 
diagnose and treat patients at the molecular level. Over the past 15 
years, NEI-supported researchers have identified more than 450 genes 
that are involved in various eye and vision diseases. Considerable 
progress has been made in understanding the resultant disease 
mechanisms, and treatments are now beginning to emerge. As genomic 
medicine progresses, we must grapple with the obvious opportunity and 
challenge of genotyping individuals with eye disease and delivering 
therapies that are specifically tailored to the individual patient. 
This personalized approach to medicine is vital to improving the health 
of all Americans.
    The NEI initiated eyeGENE to address this issue. EyeGENE is an 
organized national network of research laboratories to support genetic 
testing for individuals with eye diseases. As testing services are not 
routinely available, the diagnostic information from eyeGENE will 
directly benefit such patients and families. The initiative will 
significantly aid vision research through a centralized registry that 
can be used to locate individuals who may wish to participate in 
clinical trials for new therapies. eyeGENE fills a critical research 
need that will advance the field. It includes a secure research blood 
collection and a centralized research repository of disease phenotype 
features which coupled to genes that cause disease will allow for the 
creation of the large datasets necessary to identify novel genetic risk 
factors and other epidemiologic questions. Programs like eyeGENE will 
drive genomic research and become the necessary fabric for individuals 
to benefit from advances in genomic medicine.

                          ADDITIONAL ADVANCES

    Recently, a number of developments have added further excitement to 
the field of vision research. The NEI is supporting projects that 
address the possible restoration of vision in blinding retinal 
degenerative diseases by building on recent advances in cell 
transplantation and precursor cell biology, including the use of bone 
marrow stem cell transplantation, and on ``re-engineering'' the 
production of light-sensitive proteins in retinal neurons.
    Research will continue in efforts to control angiogenesis in a 
number of eye diseases, and will include the conduct of clinical trials 
in this area. In support of this research is the Diabetic Retinopathy 
Clinical Research Network (DRCR.net). This collaborative network, 
supported by the NEI, is dedicated to facilitating multicenter clinical 
research on diabetic retinopathy, diabetic macular edema and associated 
conditions. The DRCR.net supports the identification, design, and 
implementation of multicenter clinical research initiatives focused on 
diabetes-induced retinal disorders. Principal emphasis is placed on 
clinical trials, but epidemiologic outcomes and other research may be 
supported as well. The DRCR.net was formed in September 2002 and 
currently includes more than 150 participating sites (offices) with 
more than 500 eye care providers throughout the United States. The 
success of this new model for bringing improved treatments for diabetic 
retinopathy more rapidly to patients is dependent upon the active 
participation of clinical research centers across the United States, as 
well as the participation of the patients they treat.
    Program plans for fiscal year 2008 include pursuing the research 
finding of several genes involved in Leber's Hereditary Optic 
Neuropathy, a genetic disease that frequently results in a substantial 
loss of central vision. The development of animal models carrying these 
mutations could lead to successful gene-based therapy for this disease. 
Research will also pursue remarkable new findings about how the 
activity of certain brain cells allows us to perceive a stable view of 
our surroundings despite constant head and eye movements, as 
highlighted in NEI's strategic plan. This research will help us to 
understand better the neural control of eye movements and associated 
disorders, and may have applicability in other sensory systems.

    Senator Harkin. Thank you Dr. Sieving.
    Now, we'll end with Dr. Duane Alexander, served as the 
Director of the National Institute of Child Health and Human 
Development since 1986. As I understand, you were there since 
1968, is that right?
    Dr. Alexander. That's right.
    Senator Harkin. Received his M.D. from Johns Hopkins 
University, some research specializes in developmental 
disabilities. Welcome, again, back to the committee. Dr. 
Alexander, please proceed.

STATEMENT OF DR. DUANE F. ALEXANDER, M.D., DIRECTOR, 
            NATIONAL INSTITUTE OF CHILD HEALTH AND 
            HUMAN DEVELOPMENT
    Dr. Alexander. Thank you, Mr. Chairman. I'd like to join 
with my colleagues in thanking you and the committee members 
for holding this hearing, and for your many years of strong 
support for the NIH that's allowed us to do what we've 
accomplished.
    Since the National Institute of Child Health and Human 
Development was established nearly 45 years ago, our scientists 
have made discoveries that have improved the health and well 
being of children and adults.
    For example, our research has contributed largely to the 
Nation's 70 percent reduction in infant mortality rate over 
that span of time, and 93 percent reduction in transmission 
rate from mother to child of the AIDS virus, the near 
elimination of five major causes of mental retardation, 
successful treatments for infertility, an effective 
intervention for reducing a major cause of premature birth, and 
many other benefits.
    Our current research agenda builds on its past discoveries, 
addresses some of our country's and the world's most crucial 
health needs, and moves us closer to predicting or pre-empting 
diseases and conditions such as infertility, birth defects, 
disability from limb loss and infant mortality from premature 
birth.

                         FERTILITY PRESERVATION

    One area of our current focus is fertility preservation for 
women facing cancer treatment. The chemotherapy and radiation 
used to treat cancer can irreparably damage the body's 
reproductive tissues, and render both men and women infertile.
    Males may have the pre-treatment option of storing their 
frozen sperm for later use, but no comparable option currently 
exists for women. Eggs seldom survive the freezing and 
subsequent thawing process required for storage. However, our 
scientists are developing new techniques to protect the egg 
during the freezing, thawing and maturation process. When a 
woman who has had chemotherapy or radiation is ready to start a 
family, these follicles can be thawed and then cultured. The 
resulting eggs could be fertilized, and implanted in the uterus 
to establish a pregnancy.

                         PREVENTING DISABILITY

    Preventing disability by newborn screening is another 
current emphasis for the Institute. It allows us to predict 
whether an infant has one of hundreds, literally, of genetic or 
metabolic disorders by testing a single drop of a newborn's 
blood, and treating the condition as soon as it's identified, 
preempting the infant's early death, or a lifetime of mental 
retardation or physical disability.
    The screening and treatment, developed in large part 
through NICHD research, now is provided universally in the 
United States, but only for a few disorders.
    One such disorder is congenital hypothyroidism. It occurs 
once about 3,000 births, affecting 1,300 children every year in 
the United States. Without treatment, the child with congenital 
hypothyroidism will suffer irreparable brain damage within 
months, and require a lifetime of special care.
    However, as a result of our research, children with 
congenital hypothyroidism are now routinely identified at birth 
and given treatment immediately. One thyroxin pill daily spares 
them from the brain damage that would otherwise result, thus 
eliminating congenital hypothyroidism as a significant cause of 
mental impairment. The cost of treatment is just a few pennies 
a day. The lifetime amount of dollar savings is about $140 
million a year, and the human suffering prevented is priceless.

                           NEWBORN SCREENING

    An NICHD initiative to develop the technology to markedly 
expand newborn screening to hundreds of conditions is being 
funded in fiscal year 2007, and will expand in 2008 by 
establishing a national network to pilot test these new 
successful treatments. This is a card (Exhibit A) that they use 
in New York State newborn screening program. Each State runs 
its own program, and determines which conditions it screens 
for. You can tell from what's listed here that we have moved in 
just the last year from a system which screened for 3 to 5 
conditions only, to where a majority of States are now using 
tandem mass spectrometry to screen for 30 disorders, and we're 
working with other technology developments using micro array 
chips, luminex beads, or others to markedly expand this to 
literally hundreds of genetic disorders, immunodeficiency 
diseases, muscular dystrophies, and other conditions.


                       NECROTIZING ENTEROCOLITIS

    Another cause of infant mortalitym, that NICHD is attacking 
is necrotizing enterocolitis (NEC). We have made major advances 
against other causes like respirator, distress syndrome, severe 
jaundice, meningitis or sudden infant death syndrome, but NEC 
is a continuing problem. In 40 years, we've really made little 
progress against this condition. It causes death or disability 
by destroying the intestines of premature infants, and it 
attacks about one-tenth of all infants under 1,500 grams.
    Our efforts have identified some potential treatments. One 
is epidermal growth factor, which in mice and rats is highly 
protective against NEC. Another human study, has demonstrated 
that interleukin-10 in breast milk is highly protective.
    These and other potential treatments for NEC are going to 
be tested in a special initiative, launched by NICHD, about to 
be published, and funded in 2008.

                         MEDICAL REHABILITATION

    As our country's armed forces return from stations abroad, 
and as the Nation's population continues to age, increased 
attention is needed on medical rehabilitation, to prevent 
immobility and dependence. Among the initiatives in the NICHD 
portfolio is developing mechanical limbs that allow for better 
comfort at the socket and improved mobility. Advances in this 
area can be particularly helpful to veterans who have lost 
limbs in combat.
    One exciting new finding from this research is a new type 
of prosthetic arm, that connects in a way that allows the 
amputee to use it simply by thought--thinking about using the 
arm stimulates the chest muscles that are tied into it to 
contract with relative ease, and move the arm with greater 
speed and precision.
    Researchers hope to use similar technology to restore 
natural movement and sensation to the limbs of individuals 
paralyzed by injury or stroke.

                           PREPARED STATEMENT

    Mr. Chairman, committee members, I would like to thank you 
again for your continued support of our research, as we try to 
understand disease, and improve the health and well-being of 
men, women, children and future generations. I'll be pleased to 
answer any questions.
    [The statement follows:]

              Prepared Statement of Dr. Duane F. Alexander

    Mr. Chairman and members of the committee: I am pleased to present 
the fiscal year 2008 President's budget request for the National 
Institute of Child Health and Human Development (NICHD). The fiscal 
year 2008 budget includes $1,264,946,000.
    With continuous support from this committee, the NICHD has made 
significant discoveries that have improved the health and well-being of 
children and adults. For instance, in the 45 years since the NICHD was 
founded, our research has been largely responsible for a decline in 
infant mortality of more than 70 percent, a 93 percent reduction in the 
rate of mother-to-child transmission of the AIDS virus, the elimination 
of five major causes of mental retardation, successful treatments for 
infertility, an effective intervention for reducing a major cause of 
premature birth, and many other benefits. Our scientists around the 
country are grateful to this committee for providing the opportunity to 
pursue research in these areas.
    The Institute's research agenda builds on the discoveries from the 
last decade, addresses some of our country's and the world's most 
critical health needs, and moves us closer to major breakthroughs 
against diseases and conditions such as infertility, birth defects, 
infections, limb loss, premature birth, and maternal death.

         PRESERVING FERTILITY FOR WOMEN FACING CANCER TREATMENT

    The chemotherapy and radiation used to treat cancer can irreparably 
damage the body's reproductive tissues and render men and women 
infertile. Males may have the pre-treatment option of storing their 
frozen sperm for later use, but no comparable option currently exists 
for women. Eggs seldom survive the freezing and subsequent thawing 
processes required for storage. Currently, the only option for women 
facing the prospect of such infertility is in vitro fertilization and 
long-term storage of the embryos, which tolerate freezing. However, 
this option is not always suitable. Young women with cancer may be 
forced to forego having their own children in order to receive life-
saving treatment. The NICHD's new Fertility Preservation Research 
Program seeks to develop treatments to preserve fertility among 
patients with cancer or environmental risks for infertility. Building 
on current research, such as using a gelatin mixture to surround the 
follicle containing the egg, our scientists will be developing new 
techniques to protect the egg during the freezing, thawing, and 
maturation process. The goal is to allow a small section of the ovary 
to be removed and frozen for later use. When the woman is ready to 
start a family, the frozen follicles could be thawed and then cultured. 
The resulting eggs could be fertilized and implanted in the uterus to 
establish a pregnancy.

          PROTECTING OUR CHILDREN AS WE TREAT THEIR ILLNESSES

    The Best Pharmaceuticals for Children Act (BPCA)--enacted by 
Congress to increase information about the safety, usefulness, and 
dosage of medications for infants and children--is an important part of 
the nation's ongoing effort to assure that our treatments for children 
do not harm them. As we have learned, children's immature body systems 
and metabolic rates make pediatric clinical trials essential for 
studying the impact of widely prescribed drugs on children and infants. 
Within its work on the BPCA, the NICHD, in consultation with the Food 
and Drug Administration, identifies and prioritizes drugs for pediatric 
clinical study. The NICHD collaborates with manufacturers and academia 
in designing and implementing preclinical and clinical studies of drugs 
that are widely used or integral to the care of children with specific 
medical conditions. Currently 29 studies are under way evaluating drugs 
to provide information for labeling to guide pediatric use.

           PREVENTING DISABILITIES THROUGH NEWBORN SCREENING

    Imagine being able to know if an infant has one of hundreds of 
genetic or metabolic disorders by testing a single drop of a newborn's 
blood. Imagine being able to treat the condition as soon as it is 
identified, sparing that infant an early death or a lifetime of mental 
retardation or physical disability. This screening and treatment, 
developed in large part through NICHD research, now is provided 
universally in the United States for a few such disorders. For example, 
the National Newborn Screening and Genetic Research Center reports that 
congenital hypothyroidism (CH) occurs once in every 3,000 births, 
affecting 1,300 children each year in the United States. Without 
treatment, an infant with CH will suffer irreparable brain damage 
within months and require a lifetime of special care. Because an NICHD 
grantee developed a screening test for the disorder in the 1970s, 
children with CH are now routinely identified at birth and treatment 
begins immediately. One thyroxine pill daily spares them from the brain 
damage that would otherwise result, thus eliminating CH as a 
significant cause of mental impairment. The cost of treatment: a few 
pennies a day; the lifetime net dollar savings: $140 million each year; 
the human suffering prevented: priceless.
    Currently, the number of conditions for which newborns are screened 
varies widely from state to state. The March of Dimes notes that nearly 
all of the 4.1 million American infants born each year undergo 
screening for some disorders, and about 5,000 are diagnosed with an 
abnormality. Treatments exist for the conditions for which we now 
screen, as well as for others for which screening is not yet possible. 
To remedy this situation, the NICHD is funding a series of contracts to 
develop gene-based technologies that can identify hundreds of rare 
genetic disorders in a single test. In addition, the Institute will 
fund new projects to spur research on new treatments for potentially 
screenable disorders. Examples of conditions in these categories are 
Spinal Muscular Atrophy, the leading genetic cause of infant death, and 
Fragile X Syndrome, the leading inherited cause of mental retardation. 
Expanded efforts in fiscal year 2008 will include creating a multi-site 
newborn screening translational research network to test the most 
promising new screening technologies and experimental treatments in 
collaboration with state newborn screening programs.

            REDUCING ANOTHER CAUSE OF INFANT MORTALITY: NEC

    Through research led by the NICHD, one cause of infant mortality 
after another has yielded to treatments based on new discoveries. 
Respiratory distress syndrome, severe jaundice, meningitis, and Sudden 
Infant Death Syndrome cause far fewer deaths today. One remaining 
problem is necrotizing enterocolitis (NEC). This condition affects 10 
to 12 percent of infants weighing less than three pounds, and about 30 
percent of those affected will not survive. NEC attacks and destroys 
their intestines. Unfortunately, its incidence and mortality rate have 
not changed in 40 years. Now, new NICHD studies give hope that 
prevention or effective treatment can become a reality. One study in 
mice demonstrated that epidermal growth factor, administered orally, 
was highly protective against NEC. Another study, in humans, 
demonstrated protection against NEC from interleukin--in breast milk. 
These and other potential therapies will be tested in a new NICHD 
initiative on NEC to be launched in fiscal year 2008.

                    DEVELOPING IMPROVED PROSTHETICS

    As the country's Armed Forces return from stations abroad, and as 
the nation's population continues to age, increased attention is needed 
on medical rehabilitation. The Institute's National Center for Medical 
Rehabilitation Research is a leader in such efforts and provides a 
Federal focal point for research in this important field. Among the 
initiatives in the Center's portfolio is developing mechanical limbs 
that allow for better comfort and mobility. Advances in this area can 
be particularly helpful to veterans who have lost limbs in combat. One 
exciting new finding from this research: an amputee can move and have 
functional use of a prototype prosthetic arm simply by thought. 
Thinking about moving the arm stimulates the chest muscles to contract. 
Microprocessors in the arm read the nerve signals sent by the chest 
muscles, and movement flows with relative ease and greater speed and 
precision. Researchers hope to use similar technology to restore 
natural movement and sensation to the limbs of individuals paralyzed by 
injury or stroke.

              HELPING DEVELOPING NATIONS OVERCOME DISEASE

    Every 30 seconds, malaria takes the life of a child somewhere in 
the world. The mosquito-borne disease kills more than one million 
people each year and severely sickens millions more in developing 
countries, crippling economic growth. It is one of the world's leading 
health concerns. Researchers at the NICHD's Laboratory of Developmental 
and Molecular Immunity--in partnership with researchers in the Malaria 
Vaccine Development Branch of the National Institute of Allergy and 
Infectious Diseases, and the Biotechnology Unit of the National 
Institute of Diabetes and Digestive and Kidney Diseases--may have a 
solution.
    These researchers have developed an experimental vaccine that stops 
the spread of malaria, mosquito by mosquito. The vaccine eliminates the 
parasite responsible for malaria from the digestive tract of a malaria-
carrying mosquito after it has fed on the blood of a vaccinated 
individual. Future bites from this mosquito then no longer transmit the 
disease. If it is proven safe and effective, the vaccine could free 
entire geographic regions from this destructive disease.
    The NICHD's research investments to improve health in developing 
nations go beyond laboratory benches. The Institute supports the Global 
Network for Women's and Children's Health Research, an initiative 
devoted to addressing the leading causes of illness and death in 
pregnant women and their infants in developing countries. This year one 
network study, a randomized double blind clinical trial conducted by 
birth attendants in rural India, demonstrated that giving women a 
single dose of misoprostol, a uterine muscle constrictor, just after 
delivery nearly eliminated the incidence of severe post-partum 
hemorrhage, a leading cause of maternal mortality in developing 
countries worldwide. India immediately took action to make misoprostol 
treatment available as standard care throughout the country, and other 
nations are doing the same. This one simple and cost effective 
intervention will save the lives of millions of women throughout the 
developing world.
    Mr. Chairman and members of the committee, I would like to thank 
you for your continued support of the Institute's research as we strive 
to understand disease and improve the health and well-being of men, 
women, children, and future generations in the United States and around 
the world. I will be pleased to answer any questions.

    Senator Harkin. Dr. Alexander, thank you very much.
    It's hard to know where to begin, but thank you all very 
much for excellent testimony. Very pointed, very to the point. 
We might as well start where we started with Dr. Kirschstein.

           RESPONSE TO COMPLEMENTARY AND ALTERNATIVE MEDICINE

    I'm very interested in what you mentioned about looking at 
genetic variations, and I want you to just tell me a little bit 
more about that, because it seems to me, every time we talk 
about people who have had an experience with a complementary or 
alternative medicine approach, were over the counter or 
something like that. Sometimes it seems to work for some 
people, and it doesn't for others. So, why does it work for 
some, and not for others? So, maybe there is some genetic 
variation there that allows for something to be done, and is 
therapeutic, but on the other hand, for someone else it isn't. 
Is that what you're looking at?
    Dr. Kirschstein. That's what we plan to look at. We know 
that that's true, also, for the use of more conventional drugs. 
We know that the people respond differently to drugs, and that 
there are times when the dose has to be cut, or they actually 
have to substitute one drug for another. We don't have that 
knowledge about these complementary materials, particularly the 
biologically based ones that people have been using on their 
own that they can purchase in various stores. This is what we 
want to take a look at, now that we know so much about the 
sequencing of the genome and the variation as to what could be 
happening. We're going to launch studies to that effect. We 
have not started as yet.

  NATIONAL ADVISORY COUNCIL ON COMPLEMENTARY AND ALTERNATIVE MEDICINE

    Senator Harkin. I see. I just want to cover one other thing 
with you, Dr. Kirschstein, and that is the structure of the 
advisory council.
    Dr. Kirschstein. Yes, sir?
    Senator Harkin. Here's the law that set it up.
    First of all, you know we had it first as the Office of 
Alternative Medicine, and then we changed it to NCCAM, and when 
we changed it to NCCAM in 1998, many people were disappointed 
in how the structure of the advisory panels had been set up 
previous to that. So, we wrote into law certain guidelines, put 
it right into the law. Of the 18 appointed members, 12 shall be 
selected from among the leading representatives of the Health 
and Scientific Disciplines, relative to the activities of the 
NCCAM. Particularly, representatives of the health and 
scientific disciplines in the area of complementary and 
alternative medicine members shall be practitioners licensed in 
one or more of the major systems with which the Center is 
involved.
    Then it says, ``Six shall be appointed by the Secretary 
from the general public and shall include leaders in the fields 
of public policy, law, health policy, economics, and 
management. Three of the six shall represent the interests of 
individual consumers of complementary and alterative 
medicine.''
    I understand that earlier this week you named six new 
members to the advisory Council. I've had concerns about this 
going clear back to 1991. As you know, as I said, I just read 
to you that 50 percent of the Council's non-staff members 
should be licensed CAM practitioners. Three, as I mentioned, 
from the consumer population. I don't believe that statute has 
always been met, and I want to ask you, where do we stand now 
with these additions to the panel? If you don't know that, you 
can respond to me later on.
    Dr. Kirschstein. I will expand on the question for the 
record.
    [The information follows:]

  National Advisory Council on Complementary and Alternative Medicine
    Question. The statute for the National Center for Complementary and 
Alternative Medicine (NCCAM) stipulates that at least half of the 
members of NCCAM's Advisory Council, who are not ex officio members, 
shall include practitioners licensed in one or more of the major 
systems with which the Center is concerned, and at least three 
individuals representing the interests of individual consumers of 
complementary and alternative medicine. How close is NCCAM coming to 
meeting the law?
    Answer. There are several factors that influence the composition of 
NCCAM's National Advisory Council:
  --NCCCAM's mission encompasses a diverse body of research. The scope 
        of NCCAM's research includes all organ systems and medical/
        scientific disciplines, as well as a range of CAM modalities 
        and practices within the four major CAM domains or systems 
        (manipulative and body-based practices, biologically based 
        practices, energy medicine and mind-body medicine) as well as 
        the whole medical systems of which they are a part. The 
        collective expertise of NCCAM's Advisory Council, which is 
        responsible for second-level peer review of the grant 
        applications that NCCAM receives, must reflect this diversity.
  --Regulation of and licensure to practice any medical or CAM 
        discipline is within the purview of the states, and 
        requirements vary widely. For example:
    --All states license chiropractors.
    --All states license medical doctors and most include within the 
            medical licensure standards degrees obtained from schools 
            of osteopathy.
    --Most states have some form of licensure for practitioners of 
            acupuncture and/or oriental medicine and practitioners of 
            massage therapy.
    --A large majority of states do not have any specific form of 
            licensure for practitioners of naturopathy or homeopathy.
    --Specific licensure does not exist in any state for many of the 
            CAM disciplines involved in research grant applications 
            reviewed by NCCAM's Advisory Council. Of these disciplines, 
            many can be legally practiced for health care purposes by 
            or under the auspices of licensed medical providers, such 
            as allopathic physicians, doctors of osteopathy, or 
            licensed mental health care professionals, and always 
            within the legal framework and limitations of their 
            licensed discipline.
    Table 1, attached, lists the current NCCAM Advisory Council 
members, their areas of CAM and/or medical/scientific expertise, and 
their research and professional interests relevant to their service on 
the council. The table illustrates how the composition of the Advisory 
Council reflects the need to simultaneously address relevant statutory 
requirements, and to ensure appropriate scientific and CAM expertise 
needed to carry out its charge.
    The terms of four Council members listed in Table 1 (Calabrese, 
Ezzo, Manyam, and Pickar) expire in 2007. Those members are slated to 
be replaced by six individuals whose appointments are in the final 
stages of completion. Table 2 lists the areas of CAM, medical/
scientific expertise, and the research and professional interests 
relevant to the Advisory Council for the pending new members.
    NCCAM will continue to assure that it has an appropriately 
qualified and balanced Advisory Council, as required by statute, that 
permits the Center to support the highest quality of scientific 
investigation of CAM, such as the examples highlighted in my testimony 
before the Subcommittee.

                           TABLE 1.--NATIONAL ADVISORY COUNCIL FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE--MEMBERSHIP, EXPERTISE, AND RESEARCH/PROFESSIONAL INTERESTS
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
         Member degree(s)                      Institution location                   CAM expertise          Medical/scientific expertise       Professional/research interests and activities
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Lori Alvord, MD \1\ \2\...........  Dartmouth Medical School, Hanover, NH.....  Native American Medicine.  Surgery.........................  Integrative medicine.
                                                                                                                                             Health services research on patterns of care for
                                                                                                                                              Native Americans.
Stephen Barnes, Ph.D.\1\..........  U Alabama at Birmingham, AL...............  Botanicals/natural         Biochemistry....................  Botanical research.
                                                                                 products.                 Pharmacology....................  Research on diseases of aging and chronic disease
                                                                                Pharmacognosy............  Toxicology                         prevention.
Carl Calabrese, ND, MPH \2\ \3\...  National College of Natural Medicine,       Naturopathy..............  Clinical research...............  Clinical research on CAM natural products.
                                     Portland, OR.
Sheldon Cohen, Ph.D.\1\...........  Carnegie Mellon, U Pittsburgh, PA.........  .........................  Psychology......................  Role of stress, coping, and social support in
                                                                                                           Mind-body medicine..............   health and weal-being.
                                                                                                           Psychosomatics                    Psychoneuroimmunology.
Fabio Cominelli, MD, Ph.D.\1\.....  U Virginia, Charlottesville, VA...........  Gastroenterology.........  Inflammatory bowel diseases
                                                                                Cell biology.............  Mucosal immunology
Silvia Corvera, MD................  U Massachusetts Medical School, Worcester,  .........................  Endocrinology...................  Type II diabetes and metabolic syndrome.
                                     MA.
Jeaneette Ezzo, Ph.D., MsT, MPH     James P. Swyers Enterprises, Takoma Park,   Massage therapy..........  Epidemiology....................  Systematic reviews evaluating CAM evidence base.
 \2\ \3\.                            MD.                                                                   Biostatistics...................  Health policy--breast cancer advocacy.
Joan Fox, Ph.D....................  Case Western Reserve, University,           Reiki....................  Cell biology....................  Cardiovascular disease; mechanisms of action of
                                     Cleveland, OH.                                                                                           mind-body practices affecting cardiovascular
                                                                                                                                              disease.
Marjorie Gass, MD \1\ \2\.........  U. Cincinnati, Cincinnati, OH.............  .........................  Obstetrics and Gynecology.......  Women's health.
                                                                                                                                             Osteoporosis, menopause.
Ted Kaptchuk, OMD, LAc............  Harvard Medical School, Osher Institute,    Asian medicine...........  ................................  Acupuncture.
                                     Boston, MA.                                Acupuncture..............                                    Clinical and basic research on the placebo effect
                                                                                                                                              and its implications for practice and research
                                                                                                                                              methodology.
Bala Manyam, MD \3\...............  Hindu University of America Odessa, FL....  Ayurveda.................  Neurology.......................  Research on movement disorders.
                                                                                                                                             Ayurvedic herbal medicine approaches to Alzheimer's
                                                                                                                                              disease.
Joel Pickar, DC, Ph.D.\2\ \3\.....  Palmer College of Chiropractic, Davenport,  Chiropractic.............  Physiology......................  Neurophysiology of chiropractic manipulation.
                                     IA.
Bruce Redman, DO..................  U of Michigan, Ann Arbor, MI..............  Osteopathy...............  Clinical trials.................  Immunotherapeutic approaches to treatment of
                                                                                                                                              cancer.
Danny Shen, Ph.D..................  University of Washington Seattle, WA......  .........................  Pharmacokinetics................  Herb-drug interactions.
                                                                                                           Pharmacology
                                                                                                           Toxicology
Frank Torti, MD, MPH \1\..........  Wake Forest U School of Medicine Winston    .........................  Oncology........................  Cancer biology.
                                     Salem, NC.                                                                                              Antioxidants and cytokines.
Stephanie Vogel, Ph.D.............  U of Maryland Baltimore, MD...............  .........................  Immunology......................  Mechanisms of immune defense.
                                                                                                           Microbiology
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The appointment of these six individuals was announced on June 21, 2007.
\2\ Public member.
\3\ Terms expire in 2007.


     TABLE 2.--NATIONAL ADVISORY COUNCIL FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE--EXPERTISE AND RESEARCH/
                              PROFESSIONAL INTERESTS OF MEMBERS PENDING APPOINTMENT
----------------------------------------------------------------------------------------------------------------
                                            Medical/scientific           Professional/research interests and
Pending          CAM expertise                  expertise                            activities
----------------------------------------------------------------------------------------------------------------
  1 \1\Naturopathy                   ...........................  Integrative oncology.
                                                                  Cancer Prevention.
                                                                  Public policy.
  2 \1\Osteopathy                    ...........................  Osteopathic practitioner.
  3 \1\Chiropractic                  Clinical trials............  Research on CAM treatments for low back
                                                                   pain, neck pain, asthma, infantile colic,
                                                                   and headache.
      4Acupuncture                   Psychiatry.................  Practice of acupuncture.
  5 \1\Qi Gong                       Biochemistry...............  Cell biology.
       Tai Chi                       Biophysics.................  Research on mechanisms of action of qigong
                                     Cell biology...............   and acupuncture.
                                                                  Teaching of Oriental Medicine.
      6                              Internal medicine..........  Cardiovascular Disease.
                                     Cardiology.................  Epidemiology of cardiovascular disease in
                                     Epidemiology...............   African Americans.
                                                                  Epidemiology and preventive medicine.
----------------------------------------------------------------------------------------------------------------
       \1\ Public member.

    Dr. Kirschstein. I do know we have tried very hard to 
fulfill the law. We submit two names for each spot on the 
advisary council. We have been in discussion with the people 
who have worked on this, and we are always working to improve 
the submissions for the advisory council.
    On the other hand, we need a very balanced advisory 
council, because we need individuals who can take a look at 
things like the genetic variation studies that we will be 
setting up. So, this is a challenge to us, and we're going to 
work hard to meet it.
    Senator Harkin. I appreciate that, Dr. Kirschstein, could 
you please get to my staff within the next week or so, the 
rundown of the members, the six that have been appointed, I 
want to know how close we've come to meeting the law?
    Dr. Kirschstein. Yes, sir, I will do that.
    Senator Harkin. I'm still concerned about that.
    Dr. Kirschstein. I will work with you on it.
    Senator Harkin. I appreciate that. It's something, as you 
know, I've been hot on this for a long time.
    Dr. Kirschstein. Yes.

                     CAM AND INFLAMMATION RESEARCH

    Senator Harkin. I don't mean to let up on it.
    It's interesting that you mentioned in your written 
statement--I read it last night--but you mentioned something 
about the use of turmeric as an anti-inflammatory thing. Is 
that investigation ongoing right now?
    Dr. Kirschstein. Yes, sir. It is an investigation ongoing 
right now, and some preliminary data have indicated that it has 
anti-inflammatory effects, and possibly anti-arthritic effects, 
therefore we are planning to expand those studies.
    Senator Harkin. I've always asked a lot of doctors--if you 
look at my hands and look at my two little fingers, there's 
little bumps on the last thing of that digit--do you know what 
that's called?
    Dr. Kirschstein. I have one called----
    Senator Harkin. What's that called?
    Dr. Kirschstein. Osteoarthritis.
    Senator Harkin. What is that called? Aheberden's nodes, but 
it's only because it comes to the little fingers and the 
thumbs, basically where it affects--there was a Scottish doctor 
that found this, and it's prevalent among people from that area 
of the world--Scotland, Ireland, it happens to be where my 
ancestors come from. But, a very painful, arthritic conditions.
    It's interesting, because you know, I've been interested in 
complementary and alternative medicine for a long time. I was 
in Iowa last fall in the campaign and what do you do during the 
campaign? You shake a lot of hands. Well, these can be very 
painful, can you imagine shaking hands with this? It was so 
painful, I couldn't even stand to shake hands.
    I just happened at that time to have dinner with a couple 
of doctor friends of mine, brothers, Dr. Neil Sahai and his 
brother Sabash, they're from India. They have a medical 
practice in Webster City, Iowa, and they invited me over for 
dinner, great family. Their mother was there, and the best 
Indian food I've ever had in my life. So, I went there for 
dinner, just as a social thing, I know them. I was complaining 
about my hands hurting. I had arthritis in my fingers, and Neil 
Sahai, Dr. Sahai said, ``Well, I think I may have something to 
help you from India, we've got this, something called 
turmeric.''
    Well, I'd kind of heard of that as a spice before, and so 
he asked me to take two of these every day for a month, and 
just see if it had any effect, and I didn't change any other 
thing I did in my life. I changed nothing in terms of my eating 
habits or sleep, basically went on as I've been going, except I 
started taking this turmeric every day, and after about 30 some 
days or something, I just had no problem, and I have no more 
pain left in my hands at all. I take turmeric every day now. 
Now, is that the reason for it? I don't know. All I can tell 
you, I didn't change anything else. It's interesting, when I 
read your testimony last night I thought, ``Oh my gosh,'' I 
thought maybe it was just mental stuff with me, I didn't know 
what was going on. It was amazing, I had to have that happen.
    Dr. Kirschstein. Maybe next year or the year after, the 
permanent Director of NCCAM will be able to tell you the 
answer.
    Senator Harkin. Well, it's just interesting that you're 
interested in that, and looking at it. Anyway, I didn't mean to 
get into my own health thing or anything like that.
    Well, I have a lot more questions, but Senator Cochran, I 
would yield to you for another 5 or 10 minutes, and then I'll 
come back.
    Senator Cochran. Mr. Chairman, one thing that could have 
helped your hand is you quit running for President, you don't 
have to shake as many hands.

                       NATURAL RESEARCH PRODUCTS

    Senator Harkin. That's a good point.
    Senator Cochran. I think it's very interesting, to hear the 
testimony this morning. I've enjoyed the opportunity to hear 
your remarks about the different areas of inquiry the National 
Institutes of Health is engaged in, and your areas of 
expertise.
    I remember, too, in connection with dietary supplements, 
there's a growing popularity among American people in these 
kinds of things, and at our University of Mississippi, there's 
a natural products center that has been established, and it's 
been working now for some time, exploring health beneficial 
uses of natural products.
    It all started, frankly, with an idea someone had for 
undertaking marijuana research, and it's the only place in the 
country that I know about where the Government actually 
encourages the growing of marijuana, and testing and analysis, 
and trying to figure out what the medicinal properties might be 
that can be useful, and that has expanded now to include a lot 
of other areas of inquiry. It's become an international center 
for research and exchange of information, and we're very proud 
to host that in our State in Mississippi.
    I just wonder if the National Institute has had any 
connection or correspondence, communication with people down 
there who are working in these areas.
    Dr. Kirschstein, do you know of any connection or exchange 
of information?
    Dr. Kirschstein. We have a great deal of contact with the 
people down there, indeed we support research at the University 
of Mississippi on natural products botanical center, and we 
just--there was recently a meeting there which we helped 
support, so we're very active in that area, sir.

                     CAM AND PEDIATRIC POPULATIONS

    Senator Cochran. I know that one area of interest is in 
alternative medicine for children. I know I grew up in a family 
that didn't believe in taking medicine. My mother always said, 
``If you eat right, you don't have to take medicine, you'll be 
healthy.'' If you exercise and do all of these right things. Of 
course I've learned later that it's probably the genetic 
properties we were born with have an awful lot to do with good 
health, too, and disposition towards disease and illness.
    How important is it for us to concentrate on education in 
these areas of factual information that could be helpful, at 
least, to reducing anxieties, contributing to unnecessary use 
of medicines, if we can change the mindset by just improving 
the level of knowledge and understanding and appreciation of 
what the facts are? What really does matter in good health, for 
children, particularly?
    Dr. Kirschstein. It's extremely important. Dr. Alexander, 
of course, can expand on this. But one of the reasons we are 
doing this survey with the CDC is to determine how extensive 
the use of complementary and alternative practices is in 
children. We know that their parents are using a great deal of 
this, and therefore some of them, of course, are giving similar 
treatments or modalities to their children. We really don't 
have good follow up on that, and we need to begin to do some 
research, being very mindful that the child is not just a 
little adult--there are differences between children and 
adults. We must be sure that we are protecting our children at 
the same time, and that we know what we're giving them.
    The other part about education is that what we know, 
Senator Cochran, is that people, consumers, of complementary 
medicines and alternative medicines, when going to the regular 
practitioner, their doctors do not tell them that they are 
using the alternative or complementary products, and vice 
versa. The doctors do not ask them. As a result, the 
communication about all of the materials that an individual is 
using does not get transmitted. That is why we have started 
these new campaigns--education in this field, just like in all 
medical fields--is very important.

                             PRETERM BIRTHS

    Senator Cochran. Thank you. I know, Dr. Alexander mentioned 
in his testimony the problem of premature births. I think the 
statistics that we have show that this has increased by 30 
percent, just in the last 20 years. That is a substantial 
number, it's now the leading cause of newborn death. What 
factors, do you think, are the cause, or can be attributed to 
the pre-term births? What do we do in terms of national policy 
or education to improve on these numbers?
    Dr. Alexander. This is a real puzzle to us, Senator 
Cochran, because there's no question about these statistics. 
The change, the increase in premature birth is real. It's also 
accompanied by an increase in low birth weight, not 
unexpectedly.
    After many years in which this declined, it has now started 
to go up again, and the trend has persisted in spite of our 
efforts to reverse it. So, people talk about a variety of 
things that may be contributing to it. One of the first things 
people talk about is the increased prevalence of assisted 
reproductive technology--invitro fertilization, and other 
efforts to assist people who are infertile to have children. 
For a variety of reasons--sometimes because multiple fetus 
pregnancy is established--two, three, four, fetuses--all of 
which tend to increase the likelihood of prematurity. We have 
now, 1 to 2 percent of our population born as a consequence of 
assisted reproductive technology. So, as that has increased, 
the likelihood of prematurity has increased. What we're trying 
to do here with the obstetric community is encourage, when 
people do IVF, only to put one embryo back, and to establish a 
pregnancy with a single embryo, rather than two, three, four, 
five, as has been done in the past to increase the likelihood 
of establishing the pregnancy. That is one tactic.
    In addition to that, there probably is a factor of 
increased efforts to save very, very low birth weight babies, 
so that babies that might have been classified previously as 
still births, now are classified as live births, and are 
entered as babies who are live births, and thus contribute to 
infant mortality, whereas previously they would have been 
considered stillbirths because they were so small, that no 
efforts were made to help them start breathing or start a heart 
rate. That is another factor.
    But, there are others that we just don't understand. We're 
in the process of working with the Office of the Surgeon 
General to put together a report on prematurity that was called 
for by the Preemie Act that the last Congress passed. So, we're 
involved in that, and we hope through our very intense 
examination of that, which follows on the work of an Institute 
of Medicine committee focusing on prematurity, we will learn 
some more useful routes to pursue to try to get at this 
question of what is causing the increase, and what can we do to 
reverse it?
    Senator Cochran. Thank you. Thank you, Mr. Chairman.
    Senator Harkin. Thank you, Senator Cochran.

                TEMPOROMANDIBULAR JOINT/MUSCLE DISORDERS

    Dr. Tabak, I think you and I talked about this a long time 
ago. That included report language, for many years, on TMJ, and 
you mentioned it briefly. We discussed it several years ago 
again. Very briefly, could you tell what advances have been 
made recently in the area of TMJ? On the muscle and joint 
disorders? Are you doing some research on regenerating damaged 
bone and tissue, but just again, give me a couple of minutes on 
that.
    Dr. Tabak. Surely, and thank you for the question.
    We've actually done quite a bit in this area. The most 
important thing is that we are now attracting researchers with 
different talent sets to study this enigmatic set of diseases 
and conditions. We have finally been able to attract 
geneticists, neurologists, neuroscientists, individuals who are 
able to look at the entire system, as opposed to the very 
specific joint.
    By bringing in these additional people with their 
expertise, we're beginning to get a much more balanced view of 
this complex, and probably heterogeneous, set of diseases and 
conditions. The work that you alluded to, work related to 
replacement of diseased joints, is ongoing. We have a very 
extensive bioengineering program, which makes use of advanced 
material development. The materials are not stagnant, they are 
typically impregnated with so-called growth factors, similar to 
those that Dr. Sieving spoke to you. These growth factors can 
help inform the surrounding cells as to what they should be 
doing to facilitate regeneration and regrowth. So, we're really 
looking at this at all levels.
    A final point that I will make is that we recently funded a 
longitudinal study at the University of North Carolina termed 
OPERA, which is looking at individuals before they even develop 
symptoms of temporomandibular joint/muscle disorders. What 
we're doing in this prospective longitudinal study is 
collecting a large amount of data--including biological 
samples--so that as the individuals within the cohort begin to 
develop symptoms and evidence of disease, we will have already 
banked materials. Once and for all we can begin to get insight 
into the very earliest stages of the disease, so that we can 
begin to pick out those people in the community who are most at 
risk. I think that's going to be a very important adjunct.
    We have programs to look at the very earliest stages of the 
disease. We have programs looking at the disease as it 
currently exists, and then we have the programs at the end 
stages, where we are recreating the joint for those individuals 
who have had extensive joint destruction.
    Senator Harkin. Very good, I'll keep on top of this. We've 
been on it for several years, and I'm really interested in, 
again, pushing this ahead and advancing the early detection of 
that, and intervention on that program.

                                 AUTISM

    Dr. Schwartz, let's talk a little bit about autism. You 
didn't really cover that in your testimony, but we just had a 
hearing on that, and it was the first hearing we've had on this 
committee just looking at autism.
    Anyway, you look at it, autism is almost epidemic right 
now. The increases over the last 2 years have been phenomenal, 
and the number of kids diagnosed with autism. Again, we're 
looking at things like, we know the earlier you get to it, 
there are certain interventional-type programs you can do that 
can lessen the effects of autism later on.
    But, still, kids have autism. We don't know whether it's 
genetic or environmental, and it seems to be, in taking with 
CDC, maybe it's some genetic, maybe some environmental. Maybe 
the two feed off of each other. I'm wondering, what are you 
doing in your Department, what are you doing, looking at any 
environmental aspects of autism? Any correlative types of 
things that deal with autism and the environment?
    Dr. Schwartz. I agree with you entirely. I think a very 
important area of health research in the United States, with 
the changing patterns of disease. It looks like environment is 
playing an important role in terms of increasing the risk of 
developing disease, the patterns of disease, the severity of 
disease, or the type of disease that children are presenting 
with. Because we recognize that, we have been working in a very 
focused way to address this issue of autism. In fact, we've 
increased our funding from 2006 to 2007 from $1.8 million to 
$3.5 million in the area of autism.
    We have a new study that we are funding at the University 
of California in Davis, UC Davis.
    Senator Harkin. Just stop right there a second. Okay, tell 
me again, how much you're spending this year, on autism?
    Dr. Schwartz. In 2007, $3.5 million.
    Senator Harkin. That's all you're spending on looking at 
environmental aspects of autism? Is that what you're saying?
    Dr. Schwartz. That's correct.
    Senator Harkin. Out of $637 million?
    Dr. Schwartz. That's correct. As I said, we have doubled 
the amount from 2006 to 2007.
    Senator Harkin. Okay, but I'm just wondering why we haven't 
been doing more before that. I'm always interested when people 
tell me they've doubled, or something's gone up by 100 percent, 
I always try to remember, and remind people that zero to 1 is 
an infinite increase. So, it depends on where you're starting 
from.
    Dr. Schwartz. In the climate of a flat budget, we have 
increased the investment in this area, because we recognize the 
importance of this. So, let me just tell you the things we're 
doing, and that we're planning to do, because I think it really 
gets at your questions which are, what will our investment be 
over the next several years, and how seriously do we take this 
disorder?

                            AUTISM RESEARCH

    In terms of the $3.5 million, we just initiated a very 
large, prospective study of children at risk of developing 
autism to try to identify the factors that pre-date the 
development of autism to understand the biological signals, and 
also the genetic factors, as well as the environmental 
exposures, that are related to the development of autism.
    That's one thing. The second thing is that we're working 
with the Centers for Disease Control to make their panel of 
exposure measurements, which constitutes about 150 biological 
exposure measurements, available to these long-term 
epidemiological studies to try to understand whether pesticides 
in the blood, or solvents, or metals in the blood are related 
to the risk of developing autism in these populations that have 
already been established.
    The third thing that we have done is we recently helped 
develop a conference with the Institute of Medicine focusing on 
the environment and autism. Dr. Alexander was involved in that 
conference. Dr. Insel, Director of the National Institute of 
Mental Health, was also involved in that conference, and we 
identified several areas of potential collaborative activities 
in the area of autism that we want to pursue further. So, we're 
currently in discussions with the National Institute of Mental 
Health--one other thing, we are newly supporting this year are 
the Autism Centers of Excellence. One of those Centers will be 
supported by NIEHS. That will be in the 2008 budget, so that is 
not counted in the $3.5 million.
    Now, one of the areas we're developing in collaboration 
with the National Institute of Mental Health is to take our 
Environmental Health Science Centers and when they are co-
localized with the Autism Centers of Excellence, we will 
provide extra support for those two areas of expertise, to 
collaborate effectively on how the environment is affecting 
autism.
    Senator Harkin. Okay. In a recent issue of Discover 
Magazine, I think there was a cover story on autism, yes, and 
it had an interesting map. This was of the State of Texas, and 
it had a map of the State of Texas, like three maps. One showed 
the number of reported cases of autism in young children. I 
think it was, maybe, 10 years ago. I could be off on that, but 
some time ago. The next map showed the use of, by county by 
county, it was a map of the counties of Texas. I think it was 
EPA data showing the amount of, levels of, I don't know if they 
were carcinogenic, but of different compounds in the 
environment that was, sort of, toxic. It had a lot to do with, 
I think, petrochemicals. It had a lot to do with pesticides, 
herbicides, a whole panoply of things, a whole bunch of things.
    Then, the next map showed the increase in the rate of 
autism. You overlay that map and it is just amazing. It's just 
about the same. So again, this is your department, right?
    Dr. Schwartz. That is correct.
    Senator Harkin. It seems to me that you really ought to be 
really pushing the envelope on this to try to find these kind 
of patterns and getting more scientists involved and getting 
more grants. I don't know what the rate or what the kind of 
proposals that are coming in that actually get through the peer 
review process. I would be interested in knowing what 
percentage or how many of the peer reviewed client proposals 
that come through, requests that come through to study the 
environmental aspect of the impact on autism. How many of those 
are being granted?
    Dr. Schwartz. A great question.
    Senator Harkin. Is it 15, is it 20?
    Dr. Schwartz. We can provide that information to you.
    [The information follows:]
               Success of NIEHS Autism Grant Applications
    The NIEHS received eight research applications for projects 
focusing on autism in fiscal year 2006. Three of the proposals, or 37.5 
percent, were funded. This percentage is substantially higher than the 
success rate of the overall NIEHS portfolio and demonstrates the 
Institute's commitment to autism research as a program priority.

    Dr. Schwartz. It is more than 20 percent. It's probably 30 
or 40 percent. I think we are looking at this as a challenge 
and also an opportunity for the field of environmental 
sciences.

                               THIMEROSAL

    Senator Harkin. Are you looking, there was for some time 
this thought that Thimerosal was a leading cause. Medical 
professionals and researchers said that that's not the case. 
CDC basically testified that they did not think there was a 
correlation there, but there's other thoughts that it's the 
amount of vaccinations that are given to kids before the age of 
2. Now, it's like 25 or 26 or something like that.
    Do you know, Dr. Alexander?

                             IMMUNIZATIONS

    Dr. Alexander. If you add all the diseases together and the 
number of immunizations you get for each one of them, that's 
about the right ballpark.
    Senator Harkin. Somewhere between 20 and 30. I know my 
grandson, they're just wrestling with that right now, but this 
is something relatively new. I mean new in the last 20 years or 
so. We never did that before.
    Dr. Alexander. But, there's been no thimerosal in any of 
these vaccines for the last 5 years.
    Senator Harkin. Not the thimerosal, I'm just saying maybe 
it's the number of these and the cumulative effect it has. As 
you said, these are not just little adults. Everything is 
different in a baby and you're talking about giving between 20 
and 30 immunizations between, before they're 2-years-of-age. 
There's some thought that maybe just the accumulation of that 
may have some affect on autism.

                       NATIONAL CHILDREN'S STUDY

    Now again, I don't know and I don't know if any research is 
being done into that either through you or through you.
    Dr. Alexander. Let me tell you something that is about to 
be done. It's a payoff benefit from the National Children's 
Study that you made reference to earlier. NIEHS and EPA and CDC 
are joined with the NICHD and many other institutes in the 
planning for this study. One of the things that will be looked 
at as a key outcome is autism. With a prevalence of six per 
thousand, we will have 600 kids and 99,000 controls. So, we 
will have information on these children including DNA from both 
parents and the child and siblings, we will have prenatal 
exposures of the mom to a large number of environmental factors 
and toxins and substances and so forth. We will be sampling the 
child from birth with umbilical cord blood etc. and we will be 
following the environment that the child lives in, measuring 
environmental exposures. We will measure the vaccinations and 
immunizations the child gets, the whole course of their medical 
history.
    Senator Harkin. Are you talking about the children study?
    Dr. Alexander. Yes.
    Senator Harkin. That longitudinal study?
    Dr. Alexander. Right, and that will be providing us with 
this information that there is no other source to get. It will 
all be obtained prospectively and we'll be able to analyze, not 
just one thing at a time, but we'll be able to analyze gene-
environment interactions, the interactions between different 
environmental exposures and each other, and we will be able to 
look at that in relationship to family history.
    You made reference earlier with Dr. Kirschstein as to 
whether there were genetic variations and susceptibility to 
things, this is one of the things we'll be able to look at in 
the National Children's Study with validity, because it's 
collected prospectively, and we have a large sample size of 
100,000 children 200,000 parents.
    Senator Harkin. Okay, since we're on that--as you know, 
I've been a strong supporter of that, and we put the money in 
this year to continue that again. Where are we on this 
children's study? How far along are we in terms of identifying, 
fitting that 100,000 pool?

                             NCS STUDY PLAN

    Dr. Alexander. Okay, with the funding that you provided 
this year, the $69 million that you added to the appropriations 
for 2007, we will be recruiting the first one-third of the 105 
sites around the country who will be conducting the study. 
Those will be funded by September 30. That is $32 million of 
the funds that you provided. The 7 Vanguard centers that have 
been funded for the last year and a half to start some of the 
piloting for this study will be funded with about $20 million 
this year to markedly expand their efforts and get them ready, 
so that they can start to actually enroll subjects for the 
study, for the pilot phase by July 2008.
    The following year, another third of the sites will be 
added, then the following year, another third. So, we will be 
actually starting the actual recruitment of the full study 
cohort in 2009, with a pilot cohort from the Vanguard sites in 
July 2008. We also will be using the funds to set up the sample 
repository center, the laboratories that are going to be doing 
the analyses, the informatics and data collections systems, all 
of which will be electronic, so that those funds are going to 
be put to good use in 2007.
    Senator Harkin. Well, that is encouraging, and we need to 
move ahead as aggressively as possible, and I would like to 
know from you if the funding levels are adequate to move it as 
aggressively as possible? I know these things--some of these 
things take time, and no amount of money can move some of these 
things, because you just have to set up the structures, and 
have to identify the people and that kind of thing. But I would 
like to know whether or not we can move more aggressively on 
that.

                            AUTISM RESEARCH

    But I want to make the point that we shouldn't, Dr. 
Schwartz, that we--both Dr. Alexander--that we shouldn't have 
to just wait 10 or 15 or 20 years to get data and information 
from the children's study.
    Dr. Alexander. We will have all of the kids with autism 
diagnosed by age 3, so we don't have to wait 15 years. We'll be 
doing those analyses as quickly as we can have the data 
available.
    Dr. Schwartz. That is precisely why we're funding focused 
studies on the environment and autism today.
    Senator Harkin. Yes, that's my point, we can't just wait.
    Dr. Schwartz. We initiated a cohort study in October 2006--
that's $1.5 million each year to support a study that focuses 
on children at very high risk of autism, and looks at 
environmental causes of autism in relation to the development 
of the disorder.
    Senator Harkin. When you say environmental, that also might 
include immunizations?
    Dr. Schwartz. Absolutely, absolutely. Also thimerosal.
    Senator Harkin. But we don't use thimerosal any longer.
    Dr. Schwartz. So we do have studies. The thimerosal 
question is not completely a moot issue, and we have studies 
that are looking at the relationship between mercury and brain 
damage in primates and in animal models, and we're still in the 
process of doing that research.
    Senator Harkin. I thought it was a well-known fact that 
mercury in the bloodstream does affect the brain.
    Dr. Schwartz. It does affect the brain. The question is, 
does it affect the brain in terms of the risk of developing 
autism.
    Senator Harkin. I don't know the answer to that question, 
obviously. Okay, I just, again, need to keep--I want you to 
keep us up to speed, and keep my staff up to speed on what your 
Institute is doing in this area of autism.
    Dr. Schwartz. We can provide you that information.
    [The information follows:]

                         NIEHS Autism Research

    NIEHS is actively investigating possible environmental factors in 
autism risk, including studies of gene-environment interaction. These 
are some of the projects being funded:
  --The NIEHS Center for Children's Environmental Health and Disease 
        Prevention Research at the University of California (UC) Davis 
        is building on its earlier finding of immune dysfunction in 
        autism and is currently focusing on the interplay of immune, 
        genetic and environmental factors in autism susceptibility.
  --NIEHS is expanding support for continuation of enrollment in 
        another large, ongoing study at UC-Davis (CHARGE) to provide 
        the ability to detect gene-environment interactions in distinct 
        subgroups of children.
  --An epigenetic study of genes implicated in autism and their 
        interactions with neurotoxicants is also being conducted at UC-
        Davis.
  --NIEHS is funding a promising project at Johns Hopkins to develop a 
        sensitive biomarker for the immunotoxic effects of mercury (and 
        use it to compare families with and without autism).
  --NIEHS helped to plan and conduct the recent Institute of Medicine 
        workshop on Autism and the Environment: Challenges and 
        Opportunities for Research to examine the most promising 
        scientific opportunities for improving the understanding of 
        potential environmental factors in autism.
  --The NIEHS is contributing funding for the Autism Centers of 
        Excellence. Some funds are being committed in fiscal year 2007, 
        and a larger investment is planned for fiscal year 2008.
  --NIEHS plans to fund a new 5-year prospective cohort study of 
        pregnancies at high risk for autism beginning in fiscal year 
        2008.
  --NIEHS is a contributor to the National Database for Autism Research 
        (NDAR). The initial phase is focused on developing a clinical 
        module which will serve as a data repository for the ACE 
        investigators. The plan is ultimately to expand the NDAR to 
        other investigators and other types of autism research beyond 
        clinical research. NIEHS contributed $250,000 in fiscal year 
        2006.

                            ASTHMA RESEARCH

    Senator Harkin. Asthma--more and more kids getting asthma, 
it's amazing. But tracking with autism, what is going on? Why 
are so many kids getting asthma today, what's happening?
    Dr. Schwartz. Asthma is a classic example of a disease that 
is clearly increasing in prevalence, and our genetics are not 
changing to alter the risk of developing the disease, so the 
environment is contributing substantially to the risk of 
developing asthma. Environments like the environment in New 
Orleans, environments that are heavily contaminated with micro-
organisms, are risky, environments for the development of 
airway inflammation. That is one of the reasons that we're 
studying that population very carefully, to try to identify 
ways in which we can intervene to decrease the risk of asthma.
    Senator Harkin. I can't tell you how many people I've 
talked to in the last several years that come up to me and, in 
different settings, and have said, ``You know, I've never had 
allergies before I came to Washington, DC.'' That, a lot of 
people say that. There's something happening around here, I 
don't know what it is.
    Dr. Schwartz. There's a very interesting process that's 
occurring. There's definitely an interaction between airway 
inflammation that is caused by environmental pollutants, and 
the risk of developing allergic responses in the body. We're 
spending $40 million a year on our asthma portfolio. So, this 
is something we're actively engaged in to try to understand how 
these air pollutants are altering----
    Senator Harkin. When you say asthma, that's allergies also, 
right?
    Dr. Schwartz. There is a non-allergic form of asthma as 
well. Individuals who work in the hog industry can develop 
asthma caused by microbial contamination alone without any 
allergic response. They develop the same exact symptoms and 
signs of asthma that someone who has allergic asthma.

                        HEALTH EFFECTS OF NOISE

    Senator Harkin. One other area I want to cover with you, 
Dr. Schwartz, before I leave you here is, you didn't cover it 
in your thing, and I want to know if your Institute covers 
this--noise. Noise, the environmental aspects of noise, and 
what it is doing to kids today, and all of us. The noise levels 
we're subjected to all of the time, whether it's jet aircraft, 
automobile noise, just the noise around, is phenomenal. Kids 
with those plugs in their ears, listening to their iPods, and 
you don't know what volume you've got them cranked up to, but I 
suspect the volume--the more the volume gets cranked up, the 
more they lose their hearing. They keep cranking it up all of 
the time. So, talk to me about what your Institute is doing in 
looking at the environmental aspects of noise, and its effect. 
Its behavioral effect, not just the effect on loss of hearing, 
maybe neurobiological types of effects it might have on an 
individual, are you looking at that?
    Dr. Schwartz. We have a relatively small portfolio in terms 
of noise, and the portfolio that we have in relation to noise 
relates to occupational or excessive environmental exposures to 
noise.
    The Dr. Battey's institute.
    Senator Harkin. The National Institute on Deafness.
    Dr. Schwartz. They're looking at the pathophysiologic 
effects of noise.
    Senator Harkin. That's what he's looking at. I'm just 
talking about the environmental aspects, and how that impacts. 
Are you coordinating with them on that?
    Dr. Schwartz. Any time we have an opportunity to, we do. I 
don't know the specifics, and I can get that specific 
information back to you, in terms of what studies are being 
supported by NIEHS, and what studies are coordinated with the 
other institutes. I just don't have that information for you.
    Senator Harkin. Well, give us some information on what 
you're looking at in terms of noise, and what kind of research 
you're doing in terms of the effect of noise on our bodies, on 
our physiological things, and what happens with behavioral 
aspects of noise.
    Again, I read these articles in Science magazine, I read 
about certain thoughts that a lot of this noise is causing 
people to behave in odd ways. Maybe altering brain patterns and 
brain waves. I don't know. I'm just saying there's some bits 
and pieces, some research in different places going on about 
this, and I don't know who, among all of your institutes out 
there, covers this. If it's not you--I don't know if it's Dr. 
Battey or not. I would like to find out that answer. But it 
seems to me it is an environmental aspect.
    Dr. Schwartz. I'll get you that information.
    [The information follows:]

            Research on the Health Effects of Noise Exposure

    Environmental noise is certainly a ubiquitous exposure and one that 
is understudied. A recent review \1\ of the published literature 
underscores the difficulty of conducting this research. Both active 
coping strategies employed by noise-exposed people as well as 
subconscious physiological adaptation to noise complicate the ability 
to perform good studies. Furthermore, clinical expression of these 
stress reactions in the form of symptoms can take many years to occur. 
In reviewing the existing work, the authors state that:
---------------------------------------------------------------------------
    \1\ Stansfeld SA, Matheson MP, 2003. Noise pollution: non-auditory 
effects on health. British Medical Bulletin 68: 243-257.

    ``The evidence for effects of environmental noise on health is 
strongest for annoyance, sleep and cognitive performance in adults and 
children. Occupational noise exposure also shows some association with 
raised blood pressure. . . . The effects of noise are strongest for 
those outcomes that, like annoyance, can be classified under `quality 
---------------------------------------------------------------------------
of life' rather than illness.''

    That said, the authors also recognize that ``the interaction 
between people, noise and ill-health is a complex one,'' and that 
further study is needed. It may be that adaptation to noise carries its 
own health costs, or that noise can combine with other physiological or 
chemical stressors to lead to greater health impacts than noise 
exposure alone.
    NIEHS has funded research in the past on effects of noise (with or 
without concomitant ototoxic chemical exposure) on hearing loss. 
Current research applications on noise exposure resulting in hearing 
loss are typically assigned to the National Institute on Deafness and 
Other Communication Disorders. NIEHS has also funded research looking 
at effects of noise-induced stress on intestinal disease and presence 
of reactive oxygen species in rats. No specific noise-related 
solicitations are planned in the current budget, but investigator-
initiated grants would be welcomed and carefully considered. In 
addition, noise is an exposure category proposed for study in the 
National Children's Study, for which NIEHS has been a contributor of 
both funding and expertise through the planning phase.

    Senator Harkin. I'd like to kind of know who's looking over 
that.

                     AGE-RELATED EYE DISEASE STUDY

    Dr. Sieving, you mentioned the AREDS Study. It showed that 
certain supplements, beta-carotene, Vitamin C, and E, and Zinc 
can slow the progression of AMD, macular degeneration. Well, 
okay, so that's useful once a person has been diagnosed with 
AMD, is that right? But how about before? Is there any evidence 
that these can help prevent a person from getting AMD in the 
first place? Also, direct yourself to the use of lutein, I 
don't know if you mentioned that or not, but is there not some 
scientific evidence that lutein acts as a preventative, or is 
there not?
    Dr. Sieving. Those are very interesting questions. As you 
have stated, the first AREDS study explored anti-oxidants, 
principally, Vitamins A, C, E, and some minerals. The design of 
the study--when you don't know what the answer will be, you 
have to design a question that will get you the first phase of 
it, and the first phase of the answer was to look at the 
conversion from early stage AMD to later stage AMD, and it was 
found that these factors--anti-oxidants--were effective in 
slowing, retarding that progression.
    Senator Harkin. When you said delay, by 25 percent, delay 
for how long? 1 year? 2 months? 5 years?
    Dr. Sieving. That would be the perspective you and I would 
have as the person taking it, in terms of delaying, or 
decreasing the conversion from one State to another. That is a 
population statement. So it is slowing the conversion rate. The 
actual delay in time is the more difficult question to get at.
    Senator Harkin. You're saying the 25 percent of the 
population had a delayed onset?
    Dr. Sieving. That's correct, yes.
    Senator Harkin. I still don't know how much of a delayed 
onset, or did it just vary?
    Dr. Sieving. The slope, as you look at time. The proportion 
of individuals who went on to develop AMD over this 5-year 
interval was about a 25 percent reduction. So, one can think in 
terms of years of putting off the conversion for some 
individuals. The study was not sensitive at the level of 
asking, is it going to help people who have not yet been 
identified or diagnosed with some early stage of AMD.
    Senator Harkin. Now, are these helpful in preventing, how 
about lutein?
    Dr. Sieving. The question of lutein is the subject of the 
next phase of this called AREDS 2. It's lutein, zeaxanthin and 
the fish oil, omega-3 fatty acid or fish oil, DHA. So, we hope 
that we will have an answer in a few years on your question of 
lutein.
    [The information follows:]

                            Lutein Research

    NCCAM has funded an exploratory study at the Johns Hopkins 
University to investigate the effects of lutein, an antioxidant that is 
part of the carotenoid family, to address retinitis pigmentosa, which 
is an eye disease that causes loss of night vision and peripheral 
vision, and, possibly blindness. Currently, NCCAM has no ongoing 
research on lutein.

    Dr. Sieving. There is the expectation, at least, in part of 
the practicing community of physicians, ophthalmologists, that 
lutein is beneficial in retarding the conversion to active 
vision loss from advanced AMD, and that's the reason for doing 
the study.
    Senator Harkin. Dr. Kirschstein, do you know if NCCAM is 
doing anything in that area?
    Dr. Kirschstein. I do not know. I will check on it, but I 
don't think so. I think Dr. Sieving, the Office of Dietary 
Supplements may also be doing some things, and of course, 
anything that they fund, would be in conjuction with NCCAM, or 
other ICS. They do not have the authority to fund grants.

                              GENE THERAPY

    Senator Harkin. Good point. Well, and also--I understand 
that more dogs have joined Lancelot.
    Dr. Sieving. Nearly 50.
    Senator Harkin. Nearly every year, I keep hearing they're 
now going to move into primates. And then I heard recently they 
were actually going to start doing this gene therapy in humans, 
where are we?
    Dr. Sieving. Well, I'm pleased to tell you, on the 
international world scale, we have crossed your threshold of 
moving it to people. There are four groups internationally, two 
in this country, one in France, one in England, considering the 
question of whether gene delivery into people will restore 
vision, will do something beneficial for vision. And the first 
of the groups to accomplish this is in London at the Institute 
of Ophthalmology. A scientist by the name of Robin Ali, who, I 
think it would now it would be 3 months ago, had done the 
injections of this gene construct called RPE 65, in two 
individuals to my knowledge. Looking forward in future attempts 
over the next 2 months, we can expect similar experiments to be 
done in Senator Specter's home State at the University of 
Pennsylvania. That study has been funded by the American people 
through the NIH National Eye Institute, and we will have a 
second opportunity to see whether there is benefit to doing 
this gene therapy in people.
    Senator Harkin. So again, just to make sure I understand 
this, a couple of people have already been, already agreed to 
undergo this gene therapy in London? This year you will have 
some more people who will be willing to undergo this, here in 
the United States?
    Dr. Sieving. That is correct. Just for the others around 
the table, the condition that is being treated is a form, a 
genetic form, of childhood blindness. In this case, the absence 
of an enzyme, genetic absence of an enzyme called RPE 65, the 
lack of that enzyme prevents the retina from responding to 
light, and hence, the individual has no vision, and is blind. 
When that was done in Lancelot, who you met, that dog has this 
RPE 65 deficiency, and by injecting the gene construct into 
that dog, the dog can now nearly play Frisbee with you, and can 
certainly walk the halls of Congress and look at you. That is 
an extremely exciting possibility.
    As I think about opportunities to move forward on an 
experimental basis, on gene delivery as a concept in medicine, 
this is a designer circumstance to try.
    Senator Harkin. So, the first humans in the United States 
will be at the University of Pennsylvania, is that what you 
said?
    Dr. Sieving. Yes, it's a consortium between Pennsylvania 
and Florida.
    Senator Harkin. How many, do we know?
    Dr. Sieving. It will be a handful. The question the first 
time through is, one can think of this on two planes, one can 
think of the people who could potentially benefit, we hope they 
do, and it will be a small number. On the other side, this will 
be a big advance, like a moon shot to get a person to the 
moon--this is a big advance for the concepts and the validity 
of gene therapy, if these experiments are successful.
    So, we're hoping.
    Senator Harkin. So, will this be publicized? I mean, I 
would be interested in finding out how soon after a person--and 
I don't even know the process, how many injections they have to 
have?
    Dr. Sieving. One.
    Senator Harkin. Just one? Just one? I thought it was a 
pattern you had to go through.
    Dr. Sieving. No, the delivery of genetic material is 
courtesy of a virus, an adenor virus. Once that virus 
introduces the gene into the cell, it persists there. In the 
case of Lancelot, Lancelot had one injection, now some 5 years 
ago, and this dog is still seeing. So, it would be one 
injection.
    Senator Harkin. How soon after that injection would we know 
whether or not it worked?
    Dr. Sieving. Well, in the mouse, the biology in the mouse 
says that within 60 days or fewer, the transfer of the gene 
into the cell and the activity in the cell can make this 
protein. So, it should be short order, it should be on the 
order of weeks to months.
    Senator Harkin. But you don't know when this is going to 
happen.
    Dr. Sieving. We have a good idea of when it will happen.
    Senator Harkin. Is it this summer?
    Dr. Sieving. We expect this summer. Obviously, for 
something like this, we are helping to take a close and careful 
look at the safety, getting the trial started, and the first 
outcome of the study will be announced as a safety outcome. If, 
in fact, the individual recovered some form of vision, that 
would be a bonus, and quite a delightful bonus.
    Senator Harkin. That's very informative. I appreciate that. 
We will be following that.
    Dr. Sieving. We will keep you informed, obviously.
    Senator Harkin. We'll follow that very closely.

                             READING FIRST

    Dr. Alexander, I know time is running out, and I have to 
leave here in a few minutes, but I just wanted to go over one 
thing with you.
    NICHD's involvement in a program called Reading First, a 
lot of congressional interest in this area. Education's 
Inspector General found the Department officials mismanaged the 
program, steered school contracts to publishers they favored 
away from others, flagrantly ignored Federal laws on 
maintaining local and State control of school curricula. Not 
me, that's the Inspector General of the Department of Education 
said that, and we've been looking into it.
    As to be expected, the Education Inspector General focused 
mainly on the activities of the Education Department employees, 
but a former NICHD researcher named Reid Lyon also played a 
huge role in how Reading First was implemented. Lyon, a reading 
specialist, was the Chief of the Child Development and Behavior 
Branch under you. According to one news article, he said he 
spent more than half of his time between 2002 and 2004 on 
Reading First. E-mail showed that he frequently advised the 
Reading First Director Mr. Chris Doherty on how to run the 
program. He wasn't simply offering general advice, there were 
detailed discussions about how particular districts were using 
Reading First grants. We also know that Dr. Lyon wrote on 
numerous occasions to Margaret Spellings, the current Secretary 
of Education when she was Domestic Policy Advisor at the White 
House on this program.
    Now, again, I can understand that an NIH researcher who's 
an expert on reading might occasionally be called upon by the 
Department of Education to offer some expert advice when 
they're called upon. But, I don't expect someone like that to 
spend more than half of his time trying to advise another 
agency on how to run their programs, it doesn't smell right, 
there's something wrong there.
    Now, again, I know that Dr. Lyon is no longer there, he now 
works for a for-profit education company. That's fine, if he 
wants to be an advocate for that, that's what he should be. So, 
I would hope that the Chief of the Child Development and 
Behavior branch would have other things to do than like this.
    So now, again, we have a replacement coming up. Has that 
replacement been named yet?
    Dr. Alexander. Yes.
    Senator Harkin. Oh, you do have a replacement?
    Dr. Alexander. For Dr. Lyon, as chief of that branch? Yes. 
Dr. Peggy McCardle. She's been in there as branch chief for 
almost 2 years.
    Senator Harkin. Two years? I didn't know that. Is this 
person spending more time, spending half his time on Reading 
First?

                         READING FIRST SCIENCE

    Dr. Alexander. No, I think she's spending virtually no time 
on it. Dr. Lyon's time when he was involved with this, was when 
he was on detail to the White House, and was not in charge of 
the branch. Basically, that was turned over to Dr. McCardle on 
an acting basis. I have no direct knowledge on what Dr. Lyon's 
interactions were, specifically. I know that he was called upon 
frequently by the Reading First program, and the Department of 
Education in other areas as well, for advice on the scientific 
basis for different types of approaches to reading instruction. 
The legislation related to Reading First required that the 
programs have demonstrated efficacy in a scientific fashion, of 
their effectiveness in being able to result in children 
learning to read in an effective way.
    Much of the question that came to Dr. Lyon, in my 
understanding, was in terms of whether programs that were 
proposed for use in Reading First were, in fact, scientifically 
validated, research-based programs, and the advice that he 
provided was evaluating the quality of the science that was 
done in evaluating those programs. Sometimes it was very weak 
science, weak to none. Other programs have been very thoroughly 
and rigorously evaluated, and to my knowledge, and what we 
really have the authority and authorization to do, was to 
provide information and advice as to the scientific validity of 
these programs. How rigorously have they been evaluated for 
their effectiveness as a teaching method? That was a 
requirement in order for them to be funded as part of Reading 
First.
    So, that was the nature of the interaction, to my 
knowledge.
    Senator Harkin. Well, I know that, because I was very much 
involved in writing that law.
    Dr. Alexander. You were, indeed.
    Senator Harkin. In the other hat I wear on the other 
committee, and I had been following this very closely with my 
staff, and a number of these programs in a certain State were 
scientifically valid, they were passed, the scientific reviews 
and all of that. But a funding pattern emerged, that when these 
programs were evaluated and it all came down, that they had to 
use this one program, this one certain program, all of these 
things seemed to trace back, in many ways, to Dr. Lyon.
    I thought that was an odd situation, that someone from NIH 
would be so heavily involved in trying to choose one over the 
other, when they were basically scientifically validated, and 
saying, ``Well, yeah, they may be scientifically valid, they 
may all meet the scientific requirements, but this one is 
best.'' That is not--that was never, that should never have 
been his job.
    That's sort of water over the dam, but I just, again, I 
hope that we don't go through that again. It was kind of 
disturbing to me to see that that had happened, and that is why 
I asked the question about the new replacement, which I didn't 
know was there, and how much they were spending. Like I said, I 
don't mind if they're called upon for expert advice, I mean, 
that's fine--that is what they should be doing. But it seemed 
like he went overboard in being involved in how this was being 
run.

                        SPINAL MUSCULAR ATROPHY

    The last thing I wanted to cover with you is SMA. As you 
know, I've been very much involved with this ever since I first 
learned its leading genetic cause of death in small kids, and 
then how much we were looking at it, and you and I talked about 
this before, on SMA, and I've talked to Dr. Landis about it, 
also. I talked about this with Dr. Landis just a few weeks ago, 
there's some breakthrough work that NINDS is doing in this 
area.
    But, you have funded, as I understand, two small grants on 
SMA in the past few years. Since it is a leading genetic cause 
of death to infants and toddlers, I think I would have expected 
that NICHD would take a larger role than it has thus far, so 
I'm just wondering, where are you in SMA research in the coming 
year?
    Dr. Alexander. Well, last year, we funded four grants, or 
parts of four grants, focusing largely on improving newborn 
screening, and developing the capability for doing newborn 
screening for the disorder, and we additionally funded two 
grants that came in, in response to our program announcement 
for developing new therapeutic approaches to disorders that 
could potentially be diagnosed by newborn screening.
    The best progress we have to report is that in one of the 
grants, Dr. Tom Pryor at Ohio State has, in fact, developed a 
very successful approach to newborn screening for SMA. With the 
technology that he has, he's gotten samples from the filter 
paper blood spots like I just handed out to you, several 
hundred with SMA, several hundred carriers, and several hundred 
normals. They have 100 percent success in diagnosing every case 
of SMA, 100 percent success in identifying every carrier, 100 
percent success in determining unaffected individuals.
    He's also developed a methodology for incorporating this 
onto the luminex-bead system, which is one of the systems we're 
testing for new applicability. The SMA community is so excited 
and enthusiastic about this, that they've actually petitioned 
the Secretary's Advisory Committee on screening of infants and 
children for genetic disorders for inclusion of this in newborn 
screening regimens.
    So, we are very excited about this approach, we think this 
is probably going to be the one that can be incorporated, it 
can be done in a very cost-effective way, and that we will have 
the newborn screening, and as the SMA advocacy groups point 
out, all of the evidence is that it is essential to begin 
treatment at birth, or as close to birth as possible. Because 
the moms protect the fetus during development, these babies are 
pretty much okay at birth. If we can get the treatment to them, 
and have an effective treatment, that is going to be key.
    We also have two grants that are working on new treatment 
methodologies for this. There are two different approaches--one 
is to increase the production of a protein that doesn't work 
very well, another is to try and skip a codon, that is, 
blocking the formation of the normal proteins, so that we 
produce more normal protein. We're testing both of these, and 
we're hopeful that we're going to have, not just the prenatal 
diagnosis methodology, but a treatment methodology as well. 
That is where we are.
    Senator Harkin. That's good. That is good news. So that is 
what is going to be happening in the future.
    Dr. Alexander. Yes, we will continue with that.
    Senator Harkin. Now, I can't leave that without--one thing 
leads to another, don't you know? I learned about SMA and I get 
to learning about causes, and I meet with families, well then I 
start thinking about Fragile X Syndrome also, which is another 
one. Now I find out that's a leading cause of mental 
retardation, genetic cause of retardation. So, then I'm 
wondering, where are you going in that?

                   NEW APPROACH TO NEWBORN SCREENING

    Dr. Alexander. Similar story, we're working on newborn 
screening. We funded a grant several years ago, to develop and 
evaluate newborn screening for this condition, with the support 
of parents and advocacy groups. The test that we thought was 
going to work, didn't, another one that we thought was going to 
work didn't, we're now on a third approach to the newborn 
screening. This one looks like it's going to work, but we're 
still in the final testing for that. That is the essential 
component for that grant, in order to be able to diagnose this 
in newborns.
    In terms of therapy, we're farther away from that than we 
are, probably, with SMA. Although different approaches are 
being tried, we have nothing that looks real promising right 
now. But, the parent and advocacy groups still say we want to 
diagnose this in newborns, if at all possible, because we would 
like to be able to plan for these children, we'd like to 
intervene as early as possible with ancillary kinds of 
treatments, and we would like to know for our family planning 
purposes whether we have this problem, because these kids are 
often not diagnosed until 3, 4, 5, 6 years of age, and there's 
often another child born by then.
    Senator Harkin. Doesn't that, doesn't that gene just go 
through one parent or the other?
    Dr. Alexander. Yes, the mother.
    Senator Harkin. Okay, that's good information, that's good 
information. Okay, any last things before we all get out of 
here and go to lunch, or something like that? I want to thank 
all of you for coming down, it's been a good session. As I 
said, I always learn a lot of things at this, it's like being 
in class again.
    So, I thank you very much. Thanks for all of your 
leadership, Dr. Alexander. Thanks for the SMA work you're 
doing, we appreciate that. You're going to get back to me on 
some of this stuff.

                     ADDITIONAL COMMITTEE QUESTION

    There will be an additional question which will be 
submitted for your response in the record.
    [The following question was not asked at the hearing, but 
was submitted to the Department for response subsequent to the 
hearing:]

                Question Submitted by Senator Tom Harkin

                             DOWN SYNDROME

    Question. An estimated 350,000 Americans have Down syndrome. Yet 
the fiscal year 2008 proposed budget calls for spending just $13 
million on research concerning this condition--down 43 percent from the 
fiscal year 2003 level of $23 million. Why has funding for Down 
syndrome research declined so dramatically?
    Answer. The senator's funding figures for NIH-supported research on 
Down syndrome are correct. Although NICHD has the scientific lead on 
this issue, a number of other Institutes and Centers also contribute 
resources to address this condition. However, due to the competitive 
nature of the peer review process, the number of successful 
applications proposing research on Down syndrome has decreased, and 
thus funding contributed by ICs to such research has decreased.
    However, research on Down syndrome is an important part of NIH's 
research portfolio. In fact, to facilitate research on Down syndrome 
across the NIH, NICHD took the lead in pulling together a working group 
of these ICs in 2006. NICHD, NINDS and NIA form the steering committee 
for the group, which has been meeting regularly with the goal of 
producing a NIH research plan for Down syndrome in the fall of 2007. In 
addition to compiling the NIH-funded research in this area, literature 
reviews are being conducted so that new research is complementary and 
not duplicative. The working group sponsored two major scientific 
meetings, in March 2007 and July 2007, to get input from that 
community, as well as from national constituency organizations 
representing individuals with Down syndrome and their families. Input 
on the plan, which will address strategies for basic and clinical 
research on the genetics of Down syndrome, its developmental 
consequences, and its impact on cognition and synaptic function, will 
be actively sought prior to its publication.

                         CONCLUSION OF HEARINGS

    Senator Harkin. So, thank you all very much, that concludes 
our hearings.
    [Whereupon, at 12:07 p.m., Friday, June 22, the hearings 
were concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]


  DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, AND EDUCATION, AND 
          RELATED AGENCIES APPROPRIATIONS FOR FISCAL YEAR 2008

                              ----------                              

                                       U.S. Senate,
           Subcommittee of the Committee on Appropriations,
                                                    Washington, DC.

                       NONDEPARTMENTAL WITNESSES

    [Clerk's note.--The subcommittee was unable to hold 
hearings on nondepartmental witnesses. The statements and 
letters of those submitting written testimony are as follows:]
        Prepared Statement of the Academy of Radiology Research
    This statement is submitted on behalf of the Academy of Radiology 
Research, an alliance of 23 scientific and professional societies with 
a membership of more than 40,000 radiologists, imaging scientists, and 
allied professionals. The Academy is also supported by national 
organizations representing more than 100,000 radiologic technologists.
    In addition, I am also representing the Coalition for Imaging and 
Biomedical Engineering Research (CIBR). CIBR is a permanent coalition 
of radiology, imaging, and bioengineering societies; imaging equipment 
and medical device manufacturers; and patient advocacy groups. What 
unites all of these diverse groups is the common recognition that new 
imaging and biomedical engineering techniques and technologies can 
transform medical science and produce dramatic improvements in the 
detection, diagnosis, and treatment of a broad range of diseases and 
conditions.
    The purpose of my statement is to urge the Appropriations Committee 
and Congress to make an investment this year that will foster 
innovation in imaging and produce a new revolution in medical science 
and health care driven by technology development. Recognizing the 
significant budgetary challenges we face at present, it is critical 
that the Federal Government take full advantage of the scientific 
opportunities that offer the best prospects for improving the 
capability of physicians to diagnose and treat a broad range of 
diseases and conditions. Imaging is one such area of scientific 
opportunity. For that reason, we request that the committee increase 
the appropriation in fiscal year 2008 to $350 million for the National 
Institute of Biomedical Imaging and Bioengineering (NIBIB), the newest 
Institute at the National Institutes of Health and the primary home for 
basic research in imaging at the NIH.
    The NIBIB is not the sole home for imaging research at the NIH. 
Indeed, the National Cancer Institute was the primary supporter of 
imaging in the years before the NIBIB was established. With strong 
support from NCI Director John E. Niederhuber and leadership from Dr. 
Dan Sullivan, the NCI Cancer Imaging Program continues to grow and push 
the boundaries of knowledge. I hope that the committee will support the 
growth of NCI initiatives in areas such as imaging as a biomarker for 
drug development, the development of new image-guided ablative 
therapies, and computer-assisted methods of combining imaging and other 
clinical data.
    While the extramural community strongly supports imaging research 
programs at the NCI and other Institutes, the NIBIB is the Institute 
charged with developing new imaging techniques and technologies with 
broad clinical and research applications. Investing in the NIBIB yields 
dividends for all of the other Institutes in the form of new tools for 
studying the specific diseases that constitute the missions of those 
Institutes. It also pays large dividends for patients, who will benefit 
from new imaging techniques that improve medical care and reduce the 
need for more invasive, painful, and expensive procedures.
    A good example is the first grant made by the NIBIB in 2002--a 
Bioengineering Research Partnership award to a multi-institutional 
group led by Dr. James Duncan of Yale University. With this support 
from the NIBIB, Dr. Duncan and his team have been developing new, 
image-guided surgical techniques for treating patients with certain, 
severe forms of epilepsy. The results have been dramatic. A patient who 
has undergone this surgery recently told the House Medical Technology 
Caucus that the number of seizures she suffered daily dropped from more 
than 30 to zero. After years enduring a severe disability that affected 
virtually every area of activity, she was suddenly given her life back.
    As with many imaging research projects, however, the longer-term 
payoff will be much greater. This research is producing data from the 
brain that is helping scientists to understand brain structure and 
function in general. Moreover, this new information about the brain 
will improve our understanding of Parkinson's Disease, autism, 
Alzheimer's Disease, dementia, and other disorders. Finally, the 
techniques developed with this grant could have much broader 
applications, such as the use of imaging to guide cancer therapy to 
destroy tumors or to deliver drugs to precise locations in the brain in 
order to treat a variety of neurological disorders. Thus, a project to 
improve the lives of epilepsy patients will eventually produce new 
treatments for many more people with a range of neurological disorders. 
This is typical of NIBIB and imaging initiatives.
    The NIBIB, is different from other Institutes. As NIBIB Director 
Roderic I. Pettigrew has observed, ``In other Institutes they utilize 
tools. In this Institute, we discover tools.'' These tools are used by 
investigators at the other Institutes both to improve our understanding 
of disease processes and as a principal component in new therapies. 
Optical imaging, for example, is an emerging technology that uses light 
waves to produce high-quality images. Based on early research, the use 
of optical imaging to diagnose and treat breast cancer appears to be 
especially promising. This technology may allow physicians to 
investigate large sections of tissue rapidly for cancerous growths, to 
guide surgery to remove tumors, and to scan effectively for additional 
disease. As optical imaging develops, physicians and scientists will 
have a new tool with applications to a wide spectrum of diseases. It 
also promises to be safer and less expensive than earlier technologies.
    The last Congress overwhelmingly approved the National Institutes 
of Health Reform Act of 2007, which called for a renewed emphasis on 
trans-NIH research and a special focus on research at the nexus of the 
physical and life sciences. NIBIB is well positioned to make good on 
Congress's intent in both areas. The NIBIB, by its nature, is perhaps 
the most collaborative and interdisciplinary of all the Institutes and 
Centers at the NIH. In its first years, the NIBIB has pioneered 
collaborative projects with other Institutes to develop new techniques 
with applications to specific diseases. NIBIB is also NIH's most 
prominent ``bridge'' to the physical sciences. Three examples clearly 
illustrate NIBIB's unique collaborative roll.

                       IMAGE GUIDED INTERVENTION

    Despite its prominence in modern-day medicine, surgery remains in a 
relatively primitive state. Although improvements in surgical 
techniques abound, costs are high, invasive procedures are still the 
norm, and surgeons continue to rely on pre-operative images. 
Significant improvements to the current state of surgery are well 
within our reach. Highly exacting image-guided intervention could 
potentially minimize invasiveness, greatly reducing patient recovery 
time and the costs associated with it. With the acquisition and use of 
real-time (moving) 3D images, surgeons will move far beyond pre-op 
images to observe blood flow patterns, identify clot risks and ``see'' 
brain, nervous and electrical functions during surgery. Other advances 
bridging nano and imaging technologies together could permit surgeons 
to visualize and operate at the cellular level. In general, with 
additional research, surgical tools will be smaller, less expensive, 
and easier to manipulate.
    The field of image-guided interventions is at a critical juncture. 
The NIBIB leads the Interagency IGI Group, a trans-agency special 
interest group including representation from seven Federal agencies as 
well as 13 NIH Institutes and Centers. The need to support further 
research and development in IGI was documented at a January 2006 
retreat of the Interagency IGI group. NIBIB-support has already led to 
major advances in this area and the Institute is poised to lead the 
technological advances that will revolutionize IGI in the future.

                  IMAGING AT THE POINT OF PATIENT CARE

    Medical imaging is critical for quality health care. Yet, 
sophisticated imaging services remain widely unavailable to many 
patients in small clinics and hospitals in rural and low-income 
communities. The development of low cost, portable imaging devices 
could extend point of care , modern diagnostic imaging techniques to 
millions of underserved Americans. Recent advances in miniaturization 
of electronic hardware and improved software may allow the development 
of widely available low-cost ultrasound devices to diagnose 
complications of pregnancy, hemorrhage associated with trauma, renal 
obstructions and other significant medical conditions. Similar advances 
in optical imaging may herald wider access to optical probes capable of 
early detection of cervical cancers. Additionally, advances in the 
electronic transmission of images can allow specialists located 
thousands of miles away to evaluate these point of care images and 
prescribe appropriate clinical treatment for millions of underserved 
patients.
    Reduction of health disparities through new and affordable medical 
technologies is an explicit goal in NIBIB's Strategic Plan, and the 
Institute was established with this as one of its primary research 
initiatives. NIBIB has been a steady proponent of this research and 
recently launched a new initiative to develop low-cost imaging 
subsystems which attracted the attention of the Gates Foundation, as 
low-cost technologies are mutual priorities for both organizations. 
NIBIB is also spearheading the creation of a network of point-of-care 
research centers. Given NIBIB's strategic priority for developing low-
cost imaging technologies, its leadership in this field, and its focus 
on point-of-patient-care technologies, NIBIB is ideally suited to lead 
a new major program to bring the benefits of advanced imaging 
technologies to all Americans.

                           TISSUE ENGINEERING

    The rapid development of transplant medicine along with the aging 
of the baby boomer generation have caused increased demand for tissues 
and organs far exceeding the available donor organs. As of May 2006, 
there were over 90,000 people on the waiting list for donor organs. 
Many of these individuals will die before a suitable organ can be 
found. By providing tissues and organs ``on demand,'' regenerative 
medicine will improve the quality of life for individuals and reduce 
healthcare costs. A recent report by the Department of Health and Human 
Services (2020: A New Vision--A Future for Regenerative Medicine http:/
/www.hhs.gov/reference/newfuture.shtml) underscores the need for a 
cohesive Federal initiative in this area. The NIBIB is poised to lead 
this initiative into the future.
    Tissue Engineering is the cornerstone of regenerative medicine. It 
involves the growth and engineering of living, functional, tissues and 
organs. The long-range goal of tissue engineering is to use these 
tissues and organs to restore, maintain, or enhance function lost due 
to age, disease, damage or congenital defects. Tissue engineering has 
already seen some spectacular human successes, including nearly-
complete regeneration of a severed finger and a functional bladder 
grown ex-vivo, as well as animal studies where motor function has been 
largely restored in a rat with a damaged spinal cord. Despite these 
successes, much still needs to be done to better understand why tissue 
regeneration starts and stops and to develop technologies to grow and 
preserve larger quantities of tissue.
    Clearly tissue engineering is an emerging multidisciplinary field 
at the interface of the life and physical sciences. Thus, it is no 
surprise that NIBIB exerts a leadership role in the Multi-Agency Tissue 
Engineering working group for the President's National Science and 
Technology Council. Given its pivotal role in this area, NIBIB requires 
additional resources to fund the science necessary to accelerate 
advances in this critical area of biomedical science.
    The current budget proposals for fiscal year 2008 do not measure up 
to the scientific opportunities in imaging. To be sure, these are 
stringent budgetary times. In such circumstances, the unique 
collaborative role of NIBIB offers the valuable potential for synergies 
with other NIH Institutes and other agencies of government that will 
stretch the value of scarce research dollars and expand the 
translational potential of the joint studies that are undertaken. 
Surely this is what Congress had in mind when it placed so much 
emphasis on breaking down the barriers separating the various 
Institutes, and disciplines at NIH. The NIBIB can only realize its vast 
collaborative and translational potential if it grows at a reasonable 
rate. As the newest of the NIH Institutes, it did not share in the 
doubling of the NIH budget that ended just as the new century began.
    Failure to invest adequately in the NIBIB will have at least two 
negative consequences. First, scientific opportunities to improve 
diagnosis and treatment of a wide range of diseases will be, at best, 
delayed and could be lost. NIBIB Director Rod Pettigrew has proposed a 
program of ``quantum'' projects designed to produce major breakthroughs 
in health care and medical science. Without additional resources, this 
initiative will surely be postponed or scaled back. Moreover, advanced 
research in other Institutes aimed at specific diseases will be set 
back by the delay in developing leading-edge imaging techniques that 
enable advanced research.
    Second, it will discourage the large group of researchers who have 
been attracted to the NIH for the first time. Scientists in fields such 
as physics, mathematics, and computer science have been drawn to the 
NIBIB as a home for research that ties together the physical and 
biological sciences. Congress clearly sees such interdisciplinary 
research as the future of biomedical science, but that future could be 
delayed significantly if top scientists are discouraged from even 
submitting applications because funds are not available to support good 
research.
    For these reasons, I hope that the committee will increase the 2008 
appropriation for the NIBIB to $350 million and consider a multi-year 
plan to build toward a budget that will enable the Institute to fulfill 
its collaborative mission.
    The Congress created the NIBIB in 2000 to be different from the 
other Institutes. It is different because its primary mission is 
technology development. It is different because it does not focus on a 
single disease or organ system; instead, it is charged with developing 
new technologies with broad applications to many diseases and 
conditions. It is different because its foundation in the physical 
sciences separates it from the Institutes based on the biological 
sciences.
    To a significant extent because of these differences, the NIBIB 
represents the future of interdisciplinary, team-driven biomedical 
science that is changing health care. I hope that the Congress will 
provide the resources needed to fulfill its promise.
                                 ______
                                 
             Prepared Statement of the AIDS Action Council

    I am pleased to submit this testimony to the members of this 
committee on the importance of increased funding for the fiscal year 
2008 HIV/AIDS portfolio. Since 1984, AIDS Action Council has worked to 
enhance HIV prevention programs, research protocols, and care and 
treatment services at the community, State, and Federal level. AIDS 
Action's goals are to ensure effective, evidence-based HIV care, 
treatment, and prevention services; to encourage the continuing pursuit 
of a cure and a vaccine for HIV infection; and to support the 
development of a public health system which ensures that its services 
are available to all those in need. On behalf of AIDS Action Council's 
diverse membership, comprising community-based HIV/AIDS service 
organizations, prevention services, public health departments, and 
education and training programs, I bring your attention to issues 
impacting funding for fiscal year 2008.
    Despite the good news of improved treatments, which have made it 
possible for people with HIV disease to lead longer and healthier 
lives, stark realities remain:
  --There are between 1.1 and 1.2 million people living with HIV in the 
        United States.
  --Half a million HIV positive people in the United States do not 
        receive regular medical care including treatment for their 
        disease.
  --Between 200,000 and 300,000 people in the United States do not know 
        that they are HIV positive.
  --There are at least 40,000 preventable, new HIV infections each 
        year. Approximately half of these infections occur in youth 
        aged 13-24
  --Between 14,000-16,000 people die from HIV related causes each year.
  --While African Americans comprise only 12 percent of the United 
        States population, they account for approximately half (49 
        percent) of those infected with HIV/AIDS and 70 percent of new 
        HIV infections each year.
  --HIV was the #1 cause of death for Black women, aged 25-34, in 2004 
        the most recent year we for which have data.
  --According to a CDC study released in 2005, 46 percent of urban 
        African American men who have sex with men (MSM) were HIV-
        positive.
  --70 percent of HIV positive people depend on Federal programs to 
        receive HIV treatment, care, and services.
    The Federal Government's commitment to funding research, 
prevention, and care and treatment for those living with HIV is 
critical. Despite this commitment, we are not doing enough. We need 
more prevention, more treatment and care and more research to slow and 
eventually reverse this epidemic.
    AIDS Action Council concurs with many in the HIV community that 
increased support for HIV care and treatment, research, and prevention 
are critical. The community has come together under the umbrella of the 
AIDS Budget and Appropriations Coalition with the community funding 
request for the HIV domestic portfolio for fiscal year 2008. The 
numbers requested represent that community work. These requests have 
been submitted to the committee.
    The Ryan White Comprehensive AIDS Resources Emergency (CARE) Act, 
administered by the Health Resources and Services Administration (HRSA) 
and funded by this subcommittee, provides services to more than 533,000 
people living with and affected by HIV throughout the United States and 
its territories. It is the single largest source of Federal funding 
solely focused on the delivery of HIV services. CARE Act programs have 
been critical to reducing the impact of the domestic HIV epidemic. Yet 
in recent years, CARE Act funding has decreased through across-the-
board rescissions. The rescissions in fiscal year 2005 and fiscal year 
2006 that were executed on all non-defense and non-homeland security 
discretionary spending during the final negotiations of the bills had a 
devastating impact on the HIV/AIDS portfolio in general, and on the 
Ryan White CARE Act in particular.
    Now in its 17th year, the Ryan White CARE Act was reauthorized by 
the 109th Congress. The changes made by reauthorization, combined with 
the late enactment of fiscal year 2007 funding, has created the 
potential for crisis within the CARE Act. It is AIDS Action's hope that 
this subcommittee will recognize and address the true funding needs of 
the care programs within the domestic HIV/AIDS portfolio and make 
significant increases in all aspects of the HIV funding portfolio.
    Five new jurisdictions were added to Ryan White CARE Act's Title I 
as transitional grant areas (TGAs), but no new funding was added for 
the Title I grantees in fiscal year 2007. Some of the services provided 
under Title I include physician visits, laboratory services, case 
management, home-based and hospice care, and substance abuse and mental 
health services. With the new reauthorization these services will be 
even more dedicated towards funding core medical services and to 
ensuring the ability of patients to adhere to treatment. These services 
are critical to ensuring patients have access to, and can effectively 
utilize, life-saving therapies. AIDS Action along with the HIV/AIDS 
community recommends funding Title I at $840.4 million.
    Title II of the CARE Act ensures a foundation for HIV related 
health care services in each State and territory, including the 
critically important AIDS Drug Assistance Program (ADAP) and Emerging 
Communities Program. Title II base grants (excluding ADAP and Emerging 
Communities) was the only program to receive an increase from 
$331,000,000 in fiscal year 2006 to $406,000,000 in fiscal year 2007 
for a total increase of $75,800,000. AIDS Action along with the HIV/
AIDS community recommends funding for Title II base grants at $463.4 
million.
    The AIDS Drug Assistance Program (ADAP) provides medications for 
the treatment of individuals with HIV who do not have access to 
Medicaid or other health insurance. According to the National ADAP 
Monitoring Project, approximately 96,404 clients received medications 
through ADAP in June 2005. The President recommends an increase of 
$25.4 million for the critical AIDS Drug Assistance Program (ADAP) in 
his fiscal year 2008 budget. However this amount is far too low. AIDS 
Action along with the HIV/AIDS community recommends an increase of 
$232.9 million for ADAP for fiscal year 2008. This request is derived 
from a pharmacoeconomic model to estimate the amount of funding needed 
to treat ADAP eligible individuals in upcoming Federal and State fiscal 
years.
    Title III of the Ryan White CARE Act awards grants to community-
based clinics and medical centers, hospitals, public health 
departments, and universities in 22 States and the District of Columbia 
under the Early Intervention Services program. These grants are 
targeted toward new and emerging sub-populations impacted by the HIV 
epidemic in urban and rural settings. Title III funds are particularly 
needed in rural areas where the availability of HIV care and treatment 
is still relatively new. AIDS Action, along with the HIV/AIDS 
community, requests is an increase of $87,800,000.
    Title IV of the Ryan White CARE Act awards grants under the 
Comprehensive Family Services Program to provide comprehensive care for 
HIV positive women, infants, children, and youth, as well as their 
affected families. These grants fund the planning of services that 
provide comprehensive HIV care and treatment and the strengthening of 
the safety net for HIV positive individuals and their families. AIDS 
Action and the HIV/AIDS community request is an increase of 
$46,400,000.
    Under Part F, the AIDS Education and Training Centers (AETCs) are 
the training arm of the Ryan White CARE Act; they train the healthcare 
providers, including the doctors, advanced practice nurses, physicians' 
assistants, nurses, oral health professionals, and pharmacists. The 
role of the AETCs is invaluable in ensuring that such education is 
available to healthcare providers who are being asked to treat the 
increasing numbers of HIV positive patients who depend on them for 
care. Additionally, the AETCs have been tasked with providing training 
on Hepatitis B and C to CARE Act grantees and to ensure inclusion of 
culturally competent programs for and about HIV and Native Americans 
and Alaska Natives. However no funding was added for additional 
materials, training of staff, or programs. AIDS Action and the HIV/AIDS 
community request a $15.3 million increase for this program.
    Also under Part F, Dental care is another crucial part of the 
spectrum of services needed by people living with HIV disease. 
Unfortunately oral health is one of the first aspects of health care to 
be neglected by those who cannot afford, or do not have access to, 
proper medical care removing an opportunity to catch early infections 
of HIV. AIDS Action and the HIV/AIDS community request a $5.9 million 
increase for this program.
    AIDS Action and the HIV/AIDS community estimate that the entire 
Ryan White CARE Act portfolio needs $2,794,300,000 for fiscal year 2008 
to address the true needs of the over 1 million people that the Centers 
for Disease Control and Prevention (CDC) estimates are living with HIV 
in the United States. The fiscal year 2007 funding that was allocated 
was just over $2 billion ($2,112,000,000). This is a significant 
shortfall from the actual needs of people living with HIV.
    The Minority AIDS Initiative directly benefits racial and ethnic 
minority communities with grants to provide technical assistance and 
infrastructure support and strengthen the capacity of minority 
community based organizations to deliver high-quality HIV health care 
and supportive services. HIV/AIDS in the United States continues to 
disproportionately affect communities of color. The Minority AIDS 
Initiative provides services across every service category in the CARE 
Act and was authorized for inclusion within the CARE Act for the first 
time in the 2006 CARE Act reauthorization. It additionally funds other 
programs throughout HHS. AIDS Action and the HIV/AIDS community request 
a total of $610 million for the Minority AIDS Initiative.
    The Housing Opportunities for People with AIDS (HOPWA) program, 
administered by the U.S. Department of Housing and Urban Development 
(HUD), is another integral program in the HIV care system. Stable 
housing is absolutely critical to the ability of people living with HIV 
to access and adhere to an effective HIV treatment plan. Stable housing 
plays a key role in HIV prevention; lack of housing is a known risk 
factor for HIV. Although HOPWA is not part of the Labor, Health and 
Human Services Appropriations bill, AIDS Action urges all 
Appropriations Committee members to support this critical program. AIDS 
Action requests that $454,000,000 should be appropriated to the HOPWA 
program for fiscal year 2008.
    According to CDC estimates contained in the agency's December 2005 
HIV/AIDS Surveillance Report, 956,019 cumulative cases of AIDS have 
been diagnosed in the United States, with a total of 518,037 deaths 
since the beginning of the epidemic. As funding has remained 
essentially flat for more than 6 years, new infections also have 
stubbornly remained at the level of 40,000 per year. Dr. David 
Holtgrave, chair of the Johns Hopkins Bloomberg School Department of 
Health, Behavior and Society, has convincingly shown that there is a 
strong correlation between the lack of funding increases and the 
failure to reduce the number of new HIV infections. Therefore, AIDS 
Action Council estimates that the CDC HIV/AIDS, STD, and TB prevention 
programs will need $1,597.3 million in fiscal year 2008 to address the 
true unmet needs of prevention in HIV/AIDS, STDs, and TB.
    Research on preventing, treating and ultimately curing HIV is vital 
to the domestic control of the disease. The United States must continue 
to take the lead in the research and development of new medicines to 
treat current and future strains of HIV. Primary prevention of new HIV 
infections must remain a high priority in the field of research. It is 
essential that NIH continues its groundbreaking research to secure a 
prevention vaccine and continue to research promising treatment 
vaccines that may help HIV positive people maintain optimal health. 
Research on microbicides [gels, creams or other substances that prevent 
the sexual transmission of HIV and other sexually transmitted 
infections (STIs) when applied topically] for vaginal and anal sexual 
intercourse is also critical. Continued research on new medications for 
drug resistant strains of HIV is also critical. Finally, behavioral 
research to increase knowledge of sexual behavior and research to help 
individuals delay the initiation of sexual relations, limit the number 
of sexual partners, limit high-risk behaviors related to alcohol and 
substance use and move from drug use to drug treatment are all 
critically important. NIH's Office of AIDS Research is critical in 
supporting all of these research arenas. AIDS Action requests that the 
National Institutes of Health AIDS portfolio be funded at $3.2 billion 
for fiscal year 2008 an increase of $300 million over fiscal year 2007.
    HIV is a continuing health crisis in the United States. On behalf 
of all HIV positive Americans, and those affected by the disease, AIDS 
Action Council urges you to increase funding in each of these areas of 
the domestic HIV/AIDS portfolio. Help us save lives by allocating 
increased funds to address the HIV epidemic in the United States.
                                 ______
                                 
              Prepared Statement of the Alpha-1 Foundation

    Agency Recommendations:
    1. NIH: The Alpha-1 Foundation requests an allocation in the budget 
to enable the NIH, NHLBI to focus additional research leading to a 
better understanding of Alpha-1, including improved management and 
therapeutic approaches. The Foundation observes that much can be 
learned by studying the biology of Alpha-1, a human model of 
environment-gene interaction, which will inform Chronic Obstructive 
Pulmonary Disease (COPD) and liver cirrhosis, both of which are major 
public health concerns. The Foundation requests cooperation between 
NHLBI, NIDDK, NHGRI, and other institutes to enhance targeted 
detection, raise public awareness about Alpha-1 and provide appropriate 
information to health professionals. The Foundation recommends 
achieving these goals through use of the NHLBI Rare Lung Diseases 
Consortium and the COPD Clinical Research Network.
    2. NIH: The Foundation commends NHLBI for their national launch of 
the COPD Awareness and Education Campaign titled ``COPD Learn More 
Breathe Better'' and recommends that NHLBI continue to enhance its 
portfolio of research and education on the fourth leading cause of 
death in the United States, Chronic Obstructive Pulmonary Disease 
(COPD), including genetic risk factors such as Alpha-1 Antitrypsin 
Deficiency.
    3. NIH: The Alpha-1 Foundation notes that the severe adult-onset 
lung disease caused by Alpha-1 stems directly from the protein 
secretion abnormality in the livers and lungs of affected individuals. 
Alpha-1 has also been shown to be a risk factor for hepatitis C and B 
infection. The Foundation requests that NIDDK collaborate with NHLBI, 
NCI and other institutes to enhance its research portfolio, encourage 
detection, raise public awareness and provide appropriate information 
to health professionals. The Foundation encourages the use of the NIDDK 
Cholestatic Liver Disease Consortium to achieve these goals.
    4. NIH: The Foundation notes that given the link between 
environmental factors and the onset of Alpha-1 related COPD, the 
committee encourages NIEHS to develop research initiatives to explore 
gene environment interaction research and develop support for public 
private partnerships.
    5. CDC: The Foundation requests that CDC develop a program to 
promote early detection of Alpha-1 so that individuals can engage in 
preventative health measures and receive appropriate therapies which 
significantly improve their health status. The Foundation requests a 
public private partnership to actively support Alpha-1 targeted 
detection efforts that utilize public and professional education 
regarding chronic obstructive lung disease, both genetic and tobacco 
related.

                               DISCLOSURE

    Title: Rare Lung Disease Clinical Research Network Grant #1 U54 
RR019498-01
    Principal Investigator: Bruce C. Trapnell, M.D., University of 
Cincinnati Medical School
    Dates: 09/01/03 through 08/31/08
    Total Costs--$5,520,790
    The Foundation receives a small percentage of this grant as the 
coordinating center.
    Thank you for the opportunity to submit testimony for the record on 
behalf of the Alpha-1 Foundation.

                         THE ALPHA-1 FOUNDATION

    The Alpha-1 Foundation is a national not-for-profit organization 
dedicated to providing the leadership and resources that will result in 
increased research, improved health, worldwide detection and a cure for 
Alpha-1 Antitrypsin (Alpha-1) Deficiency. The Foundation has built the 
research infrastructure with private investment, funding over 
$28,000,000 in grants from basic to social science, establishing a 
national patient registry, tissue and Biobank, translational 
laboratory, assisting in fast track development of new therapeutics, 
and stimulating the involvement of the scientific community. The 
Foundation has invested the resources to support clinical research 
uniquely positioning ourselves for a perfect private public 
partnership. There is a lack of awareness of the insidious nature of 
the early symptoms of the lung and liver disease associated with this 
genetic condition by both medical care providers and the public. It is 
our hope that the Federal Government will leverage the Foundation's 
investment with support for a national Alpha-1 targeted detection 
program.

                ALPHA-1 IS SERIOUS AND LIFE THREATENING

    Alpha-1 is the leading genetic risk factor for Chronic Obstructive 
Pulmonary Disease (COPD) and is often misdiagnosed as such. Alpha-1 
afflicts an estimated 100,000 individuals in the United States with 
fewer than 5 percent accurately diagnosed. These are people who know 
they are sick and as yet have not put a name to their malady. Although 
Alpha-1 testing is recommended for those with COPD this standard of 
care is not being implemented. In addition, an estimated 20 million 
Americans are the undetected carriers of the Alpha-1 gene and may pass 
the gene on to their children. Of these 20 million carriers, 7-8 
million may be at risk for lung or liver disease.
    The pulmonary impairment of Alpha-1 causes disability and loss of 
employment during the prime of life (20-40 years old), frequent 
hospitalizations, family disorganization, and the suffering known only 
to those unable to catch their breath. Fully half of those diagnosed 
require supplemental oxygen. Lung transplantation, with all its 
associated risks and costs, is the most common final option. Alpha-1 is 
the primary cause of liver transplantation in infants and an increasing 
cause in adults. Alpha-1 liver disease currently has no specific 
treatment aside from transplantation. The cost to these families in 
time, energy and money is high and often devastating. Alpha-1 also 
causes liver cancer.
    Alpha-1 is a progressive and devastating disorder that in the 
absence of proper diagnosis and therapy leads to premature death; in 
spite of the availability of therapeutics for lung disease and 
preventative health measures that can be life-prolonging. It is 
estimated that untreated individuals can have their life expectancy 
foreshortened by 20 or more years. Yet early detection, the avoidance 
of environmental risk factors and pulmonary rehabilitation can 
significantly improve health.

                            ALPHA-1 AND COPD

    As the forth leading cause of death, COPD is a major public health 
concern. Data indicates that not all individuals who smoke develop lung 
disease leading many to conclude that COPD has significant genetic and 
environmental risk factors. As the most significant genetic risk factor 
for COPD, Alpha-1 has much to tell us about the pathogenesis of lung 
disease. Discoveries and advances made in Alpha-1 will impact the 
larger 12-24 million individuals living with COPD.

                               DETECTION

    The Alpha-1 Foundation conducted a pilot program in the State of 
Florida where we garnered the knowledge and experience necessary to 
launch an awareness and National Targeted Detection Program (NTDP). The 
goals of the NTDP are to educate the medical community and people with 
COPD and liver disease, alerting them that Alpha-1 may be an underlying 
factor of their disease; and stimulating testing for Alpha-1. This 
effort will uncover a significant number of people who would benefit 
from early diagnosis, treatment and preventative health measures.
    The Foundation distributes the American Thoracic Society/European 
Respiratory Society (ATS/ERS) ``Standards for the Diagnosis and 
Management of Individuals with Alpha-1 Antitrypsin Deficiency'' to 
physicians, nurses and respiratory therapists. Additionally, health 
care practitioners and the COPD community are being targeted through 
press releases, newsletter articles and various website postings.
    The national implementation of the NTDP is enhanced through the 7 
Clinical Resource Network Centers of the National Heart, Lung, Blood 
Institute of the National Institutes of Health; 51 Foundation 
affiliated Clinical Resource Centers; large pulmonary practices and 
various teaching hospitals and universities. The NTDP also employs a 
direct to consumer approach targeted to people with COPD.
    The Alpha-1 Foundation's Ethical Legal and Social Issues (ELSI) 
Working Group endorsed the recommendations of the ATS/ERS Standards 
Document which recommends testing symptomatic individuals or siblings 
of those who are diagnosed with Alpha-1. Early diagnosis in Alpha-1 can 
significantly impact disease outcomes by allowing individuals to seek 
appropriate therapies, and engage in essential life planning. 
Unfortunately, seeking a genetic test may lead to discrimination 
against individuals who have no control over their inherited condition. 
The absence of Federal protective legislation has caused the ELSI to 
recommend against population screening and genetic testing in the 
neonatal population. The Foundation is encouraged that the House has 
passed the Genetic Information Nondiscrimination Act of 2007 out of 
committee and may soon take this measure up on the House floor.
    The Alpha-1 Coded Testing (ACT) Trial, funded by the Alpha-1 
Foundation and conducted at the Medical University of South Carolina 
offers a free and confidential finger-stick test that can be completed 
at home. The results are mailed directly to the participants. The ACT 
Trial has offered individuals the opportunity to receive confidential 
test results since September 2001.

                            ALPHA-1 RESEARCH

    The Alpha-1 Foundation believes that significant Federal investment 
in medical research is critical to improving the health of the American 
people and specifically those affected with Alpha-1. The support of 
this subcommittee has made a substantial difference in improving the 
public's health and well-being.
    The Foundation requests that the National Institutes of Health 
increase the investment in Alpha-1 Antitrypsin (AAT) Deficiency and 
that the Centers for Disease Control and Prevention initiate a Federal 
partnership with the Alpha-1 community to achieve the following goals:
  --Promotion of basic science and clinical research related to the AAT 
        protein and AAT Deficiency;
  --Funding to attract and train the best young clinicians for the care 
        of individuals with AAT Deficiency;
  --Support for outstanding established scientists to work on problems 
        within the field of AAT research;
  --Development of effective therapies for the clinical manifestations 
        of AAT Deficiency;
  --Expansion of awareness and targeted detection to promote early 
        diagnosis and treatment.
                                 ______
                                 
           Prepared Statement of the Alzheimer's Association

    Chairman Harkin, ranking member Specter and members of the 
subcommittee, thank you for the opportunity to submit testimony 
regarding funding for key programs that address the enormous 
demographic and economic impact that Alzheimer's disease presents to 
our society.
    Last month, the Alzheimer's Association released a comprehensive 
report indicating that Alzheimer's is much more pervasive than we 
thought. The report confirms that more than 5 million people in the 
United States are living with Alzheimer's disease today, including 
200,000 or more under the age of 65. This is a 10 percent increase from 
previous estimates, but it is only the tip of the iceberg. By mid-
century, as many as 16 million Americans will have the disease. We will 
see half a million new cases of Alzheimer's this year alone. That means 
someone in America is developing Alzheimer's disease every 72 seconds!
    The report also sheds new light on dramatic shift in mortality 
among Americans. A diagnosis of Alzheimer's is a death sentence and 
death rates for Alzheimer's a rising dramatically, up nearly 33 percent 
in just 4 years while other leading causes of death--heart disease, 
stroke, breast and prostate cancer--are declining. Alzheimer's is the 
seventh leading cause of death for people of all ages and the fifth 
leading cause of death for people age 65 and older. The absence of 
effective disease modifying drugs, coupled with the aging of the baby 
boomers, makes Alzheimer's the health care crisis of the 21st century.
    Alzheimer's already costs the Nation $148 billion a year. Medicare 
alone spent $91 billion on beneficiaries with the disease in 2005 and 
Medicaid spent another $21 billion. By 2015 those two programs will be 
spending more than $210 billion just on people with Alzheimer's. The 
disease is also overwhelming health and long term care systems: 25 
percent of elderly hospital patients, 47 percent of nursing home 
residents, and at least 50 percent of people in assisted living and 
adult day care have Alzheimer's or another dementia.
    The impact of Alzheimer's on American families is just as 
devastating. Today at least 10 million family members provide unpaid 
care. In Iowa, these caregivers are providing nearly 81 million hours 
of care a year; in Pennsylvania, almost 375 million hours. Nationwide, 
the work Alzheimer caregivers are doing is valued at nearly $83 billion 
and consumes 8.5 billion hours annually.
    Alzheimer's disease is exploding into an epidemic that will 
undermine all of our best efforts to control health care costs, assure 
access to quality care, and protect the retirement security of 
generations to come. This is the reality of Alzheimer's disease. It is 
not a pretty picture. But it is a picture that we can change. Today, 
there is real hope that we can get Alzheimer's under control, that we 
will find the ways to prevent millions from ever getting the disease, 
and that for those who do get it; we can change it from a death 
sentence to a manageable chronic illness.
    Today, the Alzheimer research community can report genuine, 
tangible, quantifiable hope for effective prevention and treatment of 
Alzheimer's disease. Within the next 3 years, it is very likely that we 
will have disease-modifying drugs that could fundamentally change the 
nature of Alzheimer's. If we succeed, for millions of Americans, a 
diagnosis of Alzheimer's disease will no longer be a death sentence but 
the beginning of a manageable chronic illness.
    The drugs being tested are very different from the ones now on the 
market. Current drugs treat the symptoms of Alzheimer's but leave the 
underlying disease untouched. While they do help some patients 
temporarily, the predictable progression to death continues along the 
cruel path we know too well. The new drugs are designed to attack the 
disease directly. Results to date are very encouraging. These drugs are 
safe. Patients tolerate them well. And they appear to show significant 
positive impact, slowing the progression of the disease. Higher doses 
or combination drugs might arrest the process completely. One of the 
drugs currently in clinical trials could go to the Food and Drug 
Administration for review as early as this fall.
    The other exciting news is that scientists are rapidly gaining 
knowledge about genetic and other risk factors of Alzheimer's disease, 
and developing techniques to detect early changes in the brain well 
before symptoms appear. These discoveries will let the medical 
community identify persons at risk of Alzheimer's, diagnose pre-
symptomatic disease, and begin treatment in time to prevent development 
of dementia altogether.
    All of this good news is the direct result of your decision to 
double funding for the National Institutes of Health. The influx of 
resources moved Alzheimer research from a backwater of obscurity to 
perhaps the single most visible, most competitive, and most exciting 
field in the neurosciences. This is the key to drug discovery. Drug 
development does not start or end with pharmaceutical companies. It 
begins at NIH-funded laboratories at academic health centers, where 
scientists uncover the molecular basis of disease, identify treatment 
strategies, and develop the research methods and techniques that make 
clinical investigation possible. Clinical trials depend on the 
expertise of NIH-funded investigators, and many require direct NIH 
funding because the drugs under investigation are not protected by 
patent.
    The emphasis on the fundamental role of NIH funding is critical 
because there is still so much work to be done. We are right to be 
excited about treatments that attack the amyloid plaques, one of the 
primary hallmarks of Alzheimer's disease. But they will not likely be 
the complete answer. Like cancer and heart disease, Alzheimer's is a 
complex puzzle. Solving it will involve multiple strategies. There are 
already a number of other potential targets for intervention--including 
the chemical basis of the tangles in the brain that are the other 
hallmark of Alzheimer's, the relationship between heart and vascular 
disease and Alzheimer's, the connection to Type 2 diabetes, the role of 
nerve growth factors, and the interaction of environment, life style 
choices, and genetics in the development of disease.
    If science can validate the prevailing wisdom about amyloid, and if 
researchers can refine these other theories, then every major 
pharmaceutical company will begin bringing new drugs into human 
clinical trials. That will not happen, however, unless Congress 
provides the funds to sustain the Alzheimer research enterprise. 
Despite its devastating consequences, research on Alzheimer's disease 
remains seriously under-funded.
    In 2003, annual NIH funding of Alzheimer research peaked at $658 
million. The scientific community is living off the results of that 
investment, but we now risk losing that momentum. Since 2003, there has 
been a slow, steady decline in funding--down to $643 million this year 
and even less if Congress approves the President's fiscal 2008 budget 
request. In constant dollars, the drop is devastating--a 14 percent 
decline in overall funding at the National Institute on Aging (NIA) 
alone.
    This is happening at a time when the scientific opportunities have 
never been greater. There are more highly promising avenues of inquiry 
to explore than ever before. And researchers now have research tools at 
their disposal, involving genetics and imaging, that can help get 
better, quicker answers. But scientists cannot use those tools without 
adding funds to existing projects.
    The slow down in funding is already having an impact in the 
Alzheimer research community. NIA is funding less than 18 percent of 
the most highly rated investigator-initiated projects it receives--down 
from a 30 percent success rate in 2003. What is more, the first-year 
grants that are awarded are funded at 18 percent below the level 
recommended by NIA's own independent review panels. There are no 
inflationary adjustments in the out-years or for existing projects. 
This means that most scientific opportunities are left on the table, 
and the successful ones are being seriously under-funded. It also means 
that some of the most promising clinical trials--the way to translate 
basic research findings into effective treatments--will be delayed or 
scrapped altogether. Conversations within the Alzheimer research 
community confirm that we are at risk of losing a generation of 
scientists, young investigators who are either choosing less 
traditional careers or are leaving research altogether. These brilliant 
minds are our greatest resource, and we should be applying them to our 
most difficult problems. Only money will bring them back.
    These budget cuts are not just killing research projects. They are 
killing the minds of millions of Americans. And they are killing our 
chances of getting health care spending under control. If we let the 
disease continue on its current trajectory, in less than 25 years 
Medicare will be spending almost $400 billion on 10 percent of its 
beneficiaries--those with Alzheimer's. That is almost as much as we are 
spending in the entire Medicare program for all beneficiaries today.
    We can cut that spending dramatically--saving over $50 billion 
annually--within just 5 years of even modest breakthroughs that would 
delay the onset of Alzheimer's and slow its progression. And we can 
also save millions of families from devastation. Within 20 years of a 
breakthrough, there would be 3.7 million fewer cases of Alzheimer's in 
the United States than there are today--in spite of the rapid aging of 
the baby boomers. And among those who would still develop the disease, 
most would never progress beyond the mild stages of the disease and 
could continue to live productively with their families in the 
community.
    We cannot win this fight against Alzheimer's without an all-out 
commitment from Congress and from every relevant part of the Federal 
Government--especially NIH and the Food and Drug Administration (FDA). 
The Alzheimer's Association is working closely with all these agencies 
to maximize our mutual efforts within the limits imposed by existing 
law and resources. We are proud of our longstanding partnership with 
the National Institute on Aging and the tremendous commitment of Dr. 
Richard Hodes and his dedicated staff. We are also gratified by the 
response of the Food and Drug Administration to our Effective 
Treatments Initiative, to increase its focus on Alzheimer's and to 
bring patients and caregivers into the drug review process.
    Mr. Chairman and subcommittee members--we are in a race against 
time. With every year that passes, we risk losing that race. The 
Alzheimer's Association respectfully requests that you provide 
sufficient resources for NIH in the fiscal year 2008 Labor/HHS/
Education Appropriations bill so that funding for Alzheimer research 
can be increased by $125 million. The Association also seeks continued 
support for proven programs that are serving hundreds of thousands of 
Alzheimer families, including $1 million for the 24/7 Alzheimer's Call 
Center and $12 million for the Alzheimer's Disease Matching Grants to 
States Program administered by the Administration on Aging. Services 
provided by the Call Center include access to professional clinicians 
who provide decision-making support, crisis assistance and education on 
issues caregivers face every day. The Call Center also provides 
referrals to local community programs and services. The Alzheimer's 
Disease Matching Grants to States Program provides funds to States for 
the development of innovative and cost effective programs that 
influence broader healthcare systems and provide community-based 
services for those with Alzheimer's and their caregivers. The program 
has a special emphasis on reaching hard-to-reach and underserved people 
such as minorities, low income persons, and those living in rural/
frontier communities. 38 States, including Iowa, are currently 
participating in the program.
    In addition, we urge you to increase funding for the Centers for 
Disease Control & Prevention (CDC) Brain Health Initiative to $3 
million. Since fiscal year 2005, Congress has provided approximately 
$1.6 million annually to the CDC to develop and implement the first 
single-focused effort on brain health promotion. As a result of this 
initial support, the CDC and the Alzheimer's Association have begun 
collaborating on a multi-faceted approach to brain health that includes 
both programmatic and public health research components. This 
Initiative is currently focused on four primary activities: development 
of a Roadmap to Maintaining Cognitive Health, implementation of 
community demonstration programs, creation of communication linkages 
with the public, and elevation of brain health research. Increasing 
support for this Initiative to $3 million would allow for broader 
dissemination of the Roadmap to Maintaining Cognitive Health, provide 
funds to expand the community demonstration projects to other high 
risk, underserved populations, specifically the Hispanic/Latino 
population and support the development of a strategic initiative for 
early detection and secondary prevention of Alzheimer's disease, 
including consideration of appropriate screening/diagnostic tools, 
needed education strategies, and appropriate follow up to diagnosis.
    We urge Congress to add the funding we need to break through the 
finish line ahead of the baby boomers who are nipping at our heels. The 
funding for Alzheimer research and care programs that we seek requires 
a modest investment in total Federal budget terms but it has the 
potential for enormous returns--in reduced health and long-term care 
costs to Federal and State budgets and in improved quality of life for 
millions of American families.
    Thank you again for the opportunity to submit this testimony for 
the record.
                                 ______
                                 
    Prepared Statement of the American Academy of Family Physicians

    The 93,800 members of the American Academy of Family Physicians are 
grateful for this opportunity to submit for the record our 
recommendations for Federal fiscal year 2008 to the Senate 
Appropriations Subcommittee on Labor, Health and Human Services, and 
Education.
    The American Academy of Family Physicians (AAFP) is one of the 
largest national medical organizations, representing family physicians, 
family medicine residents, and medical students nationwide. Founded in 
1947, our mission has been to preserve and promote the science and art 
of family medicine and to ensure high-quality, cost-effective health 
care for patients of all ages. We believe that Federal spending policy 
can help to transform health care to achieve optimal health for 
everyone.
    We recommend that, as an essential part of that policy, the fiscal 
year 2008 Appropriations bill to fund the Departments of Labor, Health 
and Human Services and Education should restore funding for health 
professions training programs, increase our investment in the Agency 
for Healthcare Research and Quality and continue support for rural 
health programs.

     HEALTH RESOURCES & SERVICES ADMINISTRATION--HEALTH PROFESSIONS

    For the last 40 years, the health professions training programs 
authorized under Title VII of the Public Health Services Act have 
evolved in order to meet our Nation's changing health care workforce 
needs.
    Section 747 of Title VII, the Primary Care Medicine and Dentistry 
Cluster, is aimed at increasing the number of primary care physicians 
(family physicians, general internists and pediatricians) as well as 
the number of highly-skilled health care professionals to provide care 
to the underserved. Section 747 offers competitive grants for family 
medicine training programs in medical schools and in residency 
programs.
    The value of these grants extends far beyond the medical schools 
that receive them. The United States lags behind other countries in its 
focus on primary care. However, the evidence shows that countries with 
primary care-based health systems have population health outcomes that 
are better than those of the United States at lower costs.\1\  Health 
Professions Grants are one important tool to help refocus this Nation's 
health system on primary care.
---------------------------------------------------------------------------
    \1\ Starfield B, et al. The effects of specialist supply on 
populations' health: assessing the evidence. Health Affairs. 15 March 
2005.
---------------------------------------------------------------------------
Disease Prevention
    First of all, Federal support of Title VII, section 747 for primary 
care training is critical to increase the number of family physicians 
whose specialty emphasizes a broad range of skills in caring for the 
whole patient regardless of age, gender or medical condition. Primary 
care provided by family physicians looks to a patient's total health 
needs and is strongly oriented toward preventing illness and injury.
Chronic Care Management
    Second, primary care is ideally suited to managing chronic disease. 
Regrettably, nearly one in five Americans lacks access to primary 
medical care for regular and on-going care. A recent study ``found 56 
million Americans of all income levels, race and ethnicity, and 
insurance status have inadequate access to a primary care physician due 
to shortages of these physicians in their communities.'' \2\
---------------------------------------------------------------------------
    \2\ National Association of Community Health Centers, The Robert 
Graham Center. Access Denied: A Look at America's Medically 
Disenfranchised. March 2007.
---------------------------------------------------------------------------
Lower Costs
    Americans with a ``medical home'' to provide primary care for such 
basic needs as treating ear infections, controlling high blood 
pressure, or managing diabetes have better health outcomes at a lower 
cost of care.\3\  Without adequate numbers and distribution of primary 
care physicians, we cannot provide the quality of preventive care 
designed to avoid costlier services in hospital emergency departments.
---------------------------------------------------------------------------
    \3\ Ibid.
---------------------------------------------------------------------------
Primary Care Physician Shortages
    Support for family medicine training programs is needed to address 
insufficient access to primary care services which is caused by both an 
overall shortage and an uneven distribution of physicians. Family 
medicine is a critical part of the solution to providing high-quality, 
affordable and accessible health care to everyone.
    On March 15, 2007, the annual National Resident Matching Program 
announced results showing the number of medical students choosing 
careers in family medicine remains stagnant, raising concerns the 
primary care physician workforce will not be adequate to meet the needs 
of an aging population with an increased prevalence of chronic disease.
    The AAFP's 2006 Family Physician Workforce Reform report called for 
a workforce of 139,531 family physicians, or a ratio of 41.6 family 
physicians per 100,000 U.S. population by 2020. To meet that demand, 
our medical education system must produce 4,439 new family physicians 
annually.
    In the 2007 National Resident Matching Program 2,313 applicants 
matched to family medicine residency positions compared with 2,318 in 
2006. Also down was the total number and percentage of U.S. students 
who match to family medicine: 1,107 or 7.8 percent of participating 
U.S. graduates matched to family medicine this year, compared to 1,132 
or 8.1 percent in 2006. This year, there were 106 fewer family medicine 
residency positions offered than in 2006.
    Last fall, the AAFP Congress of Delegates, in recognition of the 
need for more family physicians to meet the escalating health care 
needs of the American people, called for preferential funding for 
section 747 as well as those training programs that produce physicians 
from underrepresented minorities, or those whose graduates practice in 
underserved communities or serve rural and inner-city populations.
    In opposition to funding for Health Professions Grants, the 
administration cited an Office of Management and Budget 2002 Program 
Assessment Rating Tool (PART) assessment of Title VII that called the 
program ineffective. In fact, data show that medical schools and 
primary care residency programs funded by Title VII section 747 do 
disproportionately serve as the medical education pipeline that 
produces physicians who go on to work in Community Health Centers and 
participate in the National Health Service Corps to treat underserved 
populations.\4\ 
---------------------------------------------------------------------------
    \4\ University of California, San Francisco.
---------------------------------------------------------------------------
    In order to achieve a valid OMB PART analysis, the Health 
Professions program must be given clear goals and objectives. The 
Advisory Committee on Training in Primary Care Medicine and Dentistry 
called for by the Health Professions Education Partnership Act of 1998 
has proposed steps to clarify, in the authorizing law, the purpose and 
objectives of Title VII, section 747. AAFP is working with the 
authorizing committees to ensure that the reauthorization addresses 
these recommendations.
    Although the Title VII programs intended to support the preparation 
of an effective, diverse primary care workforce have been repeatedly 
targeted for elimination in Presidential budget requests, the committee 
has provided appropriations for these important accounts. The final 
spending resolution for fiscal year 2007 provided $184.75 million, a 
27.2 percent increase above the fiscal year 2006 level for all of Title 
VII. The Primary Medicine and Dentistry Cluster, section 747, received 
an increase of 19.6 percent from the fiscal year 2006 level to $48.85 
million. However, this level falls far short of the appropriation of 
$92 million provided in fiscal year 2003.
    The AAFP is committed to a high level of support for education in 
family medicine residency programs and family medicine departments and 
divisions in medical schools.
    We hope that the committee will make an adequate investment in a 
well-prepared primary care workforce in order to provide improved 
health care at a reduced cost.
    AAFP recommends an increase in the fiscal year 2008 appropriation 
bill for the Health Professions Training Programs authorized under 
Title VII of the Public Health Services Act. We respectfully suggest 
that the committee provide at least $300 million for Title VII, 
including $92 million for the section 747, the Primary Care Medicine 
and Dentistry Cluster, which will restore this vital program to its 
fiscal year 2003 level.

               AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

    The mission of the Agency for Healthcare Research and Quality 
(AHRQ)--to improve the quality, safety, efficiency, and effectiveness 
of health care for all Americans--closely mirrors AAFP's own mission. 
AHRQ has a unique responsibility for research to inform decision-making 
and improve clinical care. In addition to AHRQ's charge to evaluate 
health care practice cost-effectiveness, the agency is engaged in the 
effort to advance personalized health care with the Health Information 
Technology Initiative.
Health Information Technology
    The initial work by AHRQ to facilitate the adoption of health 
information technology is important to improve patient safety by 
reducing medical errors and to avoid costly duplication of services. 
AAFP recognizes that health information technology, used effectively, 
can transform health care. It is vital that AHRQ, as the lead Federal 
agency, have the necessary resources to promote standards for 
portability and interoperability which ensure that health data is 
appropriately available and privacy protected.
Comparative Clinical Effectiveness Research
    According to the Centers for Medicare and Medicaid Services' 
National Health Statistics Group, health care spending will double to 
$4.1 trillion and account for 20 percent of every dollar spent by 2016. 
Our Nation must invest in the study of health care practice in order to 
improve outcomes and minimize unnecessary costs. One important tool to 
accomplish this is AHRQ's analysis of clinical effectiveness and 
appropriateness of health services and treatments. This practical 
research will improve Federal programs such as Medicare, Medicaid and 
SCHIP as well as privately-financed health care.
    AAFP recommends an increase in the fiscal year 2008 appropriation 
bill for the Agency for Healthcare Research and Quality (AHRQ). We 
respectfully suggest that the committee provide at least $350 million 
for AHRQ, an increase of $31 million above the fiscal year 2007 level.

                         RURAL HEALTH PROGRAMS

    Family physicians provide the majority of care for America's 
underserved and rural populations.\5\  Despite efforts to meet 
shortages in rural areas, there continues to be a shortage of 
physicians. Studies, whether they be based on the demand to hire 
physicians by hospitals and physician groups or based on the number of 
individuals per physician in a rural area, all indicate a need for 
additional physicians in rural areas. Continued funding for rural 
programs is vital to provide adequate health care services to America's 
rural citizens. We support the Federal Office of Rural Health Policy; 
Area Health Education Centers; the Community and Migrant Health Center 
Program; and the NHSC. State rural health offices, funded through the 
National Health Services Corps budget, help States implement these 
programs so that rural residents benefit as much as urban patients.
---------------------------------------------------------------------------
    \5\ U.S. Department of Health and Human Services, Centers for 
Disease Control and Prevention, National Center for Health Statistics, 
Division of Data Services. National ambulatory medical care survey.
---------------------------------------------------------------------------
                                 ______
                                 
        Prepared Statement of the American Academy of Pediatrics

    This statement is endorsed by: Ambulatory Pediatric Association and 
Society for Adolescent Medicine.
    There can be no denying that there have been numerous and 
significant successes in improving the health and well-being of 
America's children and adolescents, from even just decades ago. Infant 
and child mortality rates have been radically lowered. The number of 2-
year-olds who have received the recommended series of immunizations is 
at an all-time high, while vaccine-preventable diseases such as 
measles, pertussis, and diphtheria have decreased by over 98 percent. 
Teen pregnancy rates have declined by 28 percent over the last decade. 
Still, despite these successes, far too many children and adolescents 
in America continue to suffer from disease, injury, abuse, racial and 
ethnic health disparities, or lack of access to quality care. In 
addition, more than 9 million children and adolescents through the age 
18 remain uninsured. Clearly there remains much work to do.
    As clinicians we not only diagnose and treat our patients, we must 
also promote strong preventive interventions to improve the overall 
health and well-being of all infants, children, adolescents and young 
adults. The AAP, SAM and APA have identified three key priorities 
within this committee's jurisdiction that are at the heart of improving 
the health and well-being of America's children and adolescents: access 
to health care, quality of health care, and immunizations. A chart at 
the end of this statement will offer funding recommendations for other 
programs of importance to the child and adolescent community.

                                 ACCESS

    We believe that all children, adolescents and young adults should 
have full access to comprehensive, age-appropriate, quality health 
care. From the ability to receive primary care from a pediatrician 
trained in the unique needs of children and adolescents, to timely 
access, to pediatric medical subspecialists and pediatric surgical 
specialists, America's children and adolescents deserve access to 
quality pediatric care in a medical home. Given the recent cuts to the 
Medicaid program and fiscal belt-tightening in the States, 
discretionary programs now more than ever provide a vital health care 
safety net for America's most vulnerable children and youth.
    Maternal and Child Health Block Grant.--The Maternal and Child 
Health (MCH) Block Grant Program at the Health Resources and Services 
Administration (HRSA) is the only Federal program exclusively dedicated 
to improving the health of all mothers and children. Nationwide, the 
MCH Block Grant Program provides preventive and primary care services 
to over 32 million women, infants, children, adolescents and children 
with special health care needs. In addition, the MCH Block Grant 
Program supports community programs around the country in their efforts 
to reduce infant mortality, prevent injury and violence, expand access 
to oral health care, and address racial and ethnic health disparities. 
Moreover, the MCH Block Grant Program includes efforts dedicated to 
addressing interdisciplinary training, services and research for 
adolescents' physical and mental health care needs, and supports 
programs for vulnerable adolescent populations, including health care 
initiatives for incarcerated and minority adolescents, and violence and 
suicide prevention. It also plays an important role in the 
implementation of the State Children's Health Insurance Program 
(SCHIP). One of the many successful MCH Block Grant programs is the 
Healthy Tomorrows Partnership for Children Program, a public/private 
collaboration between the MCH Bureau and the American Academy of 
Pediatrics. Established in 1989, Healthy Tomorrows has supported over 
150 family-centered, community-based initiatives in almost all States, 
including Ohio, Wisconsin, New York, California, Rhode Island, and 
Maryland. These initiatives have addressed issues such as access to 
oral and mental health care, obesity, injury prevention, and enhanced 
clinical services for chronic conditions such as asthma. To continue to 
foster these and other community-based solutions for local health 
problems, in fiscal year 2008 we strongly support an increase in 
funding for the MCH Block Grant Program to $750 million.
    Family Planning Services.--The family planning program, Title X of 
the Public Health Services Act, ensures that all teens have 
confidential access to valuable family planning resources. For every 
dollar spent on family planning through Title X, $3 is saved in 
pregnancy-related and newborn care costs to Medicaid. Title X--which 
does not provide funding for abortion services--provides critically 
needed preventive care services like pap tests, breast exams, and STI 
tests to millions of adolescents and women. But over 9.5 million cases 
of sexually transmitted infection (STIs) (almost half the total number) 
are in 15-24 year olds, and over 30 percent of women will become 
pregnant at least once before age 20. Teen pregnancy rates continue to 
vary between racial and ethnic groups, and nearly half (48 percent) of 
all teens say that they want more information from--and increased 
access to--sexual health care services. Responsible sexual decision-
making, beginning with abstinence, is the surest way to protect against 
sexually transmitted infections and pregnancy. However, for adolescent 
patients who are already sexually active, confidential contraceptive 
services, screening and prevention strategies should be available. We 
therefore support a funding level in fiscal year 2008 of $385 million 
for Title X of the Public Health Service Act.
    Mental Health.--It is estimated that over 13 million children and 
adolescents have a mental health problem such as depression, ADHD, or 
an eating disorder, and for as many as 6 million this problem may be 
significant enough to impact school attendance, interrupt social 
interactions, and disrupt family life. Despite these statistics, the 
National Institute of Mental Health (NIMH) estimates that 75-80 percent 
of these children fail to receive mental health specialty services, due 
to stigma and the lack of affordability of care and availability of 
specialists. Grants through the Children's Mental Health Services 
program have been instrumental in achieving decreased utilization of 
inpatient services, improvement in school attendance and lower law 
enforcement contact for children and adolescents. We recommend that 
$112 million be allocated in fiscal year 2008 for the Mental Health 
Services for Children program to continue these improvements for 
children and adolescents with mental health problems.
    Child Abuse and Neglect.--Recent research from the CDC's Adverse 
Childhood Experiences study and others demonstrates that childhood 
trauma may contribute significantly to the development of numerous 
adult health conditions, including alcoholism, drug abuse, heart 
disease and more. However, few Federal resources are dedicated to 
bringing the medical profession into full partnership with law 
enforcement, the judiciary, and social workers, in preventing, 
detecting, and treating child abuse and neglect. We urge the 
subcommittee to provide an increase of $10 million in fiscal year 2008 
for the Center for Disease Control and Prevention's National Center for 
Injury Prevention and Control to establish a network of consortia to 
link and leverage health care professionals and resources to address--
and ultimately prevent--child maltreatment. We also support the 
recommendation of the National Child Abuse Coalition to fund the Child 
Abuse Prevention and Treatment Act program at $200 million.
    Health Professions Education and Training.--Critical to building a 
pediatric workforce to care for tomorrow's children and adolescents are 
the Training Grants in Primary Care Medicine and Dentistry, found in 
Title VII of the Public Health Service Act. These grants are the only 
Federal support targeted to the training of primary care professionals. 
They provide funding for innovative pediatric residency training, 
faculty development and post-doctoral programs throughout the country. 
For example, a pediatrician in New Jersey stated the following: 
``Reduction in Title VII funding would negatively impact all areas of 
our current activities, including recruitment of under-represented 
minority trainees and faculty, cultural competency initiatives, 
clinical experiences for aspiring health professionals and patient care 
for thousands of underserved urban infants, children and adolescents.''
    Through the continuing efforts of this subcommittee, Title VII has 
provided a vital source of funding for critically important programs 
that educate and train tomorrow's generalist pediatricians in a variety 
of settings to be culturally competent and to meet the special health 
care needs of their communities. We recommend fiscal year 2008 funding 
of at least $40 million for General Internal Medicine/General 
Pediatrics. We also join with the Health Professions and Nursing 
Education Coalition in supporting an appropriation of at least $550 
million in total funding for Titles VII and VIII. We support the 
administration's increase in funding for Community Health Centers, a 
key component with Title VII to ensuring an adequate distribution of 
health care providers across the country; but we emphasize the need for 
continued support of the training and education opportunities through 
Title VII for health care professionals, including pediatricians, who 
provide care for our Nation's communities.
    Independent Children's Teaching Hospitals.--Equally important to 
the future of pediatric education and research is the dilemma faced by 
independent children's teaching hospitals. In addition to providing 
critical care to the Nation's children, independent children's 
hospitals play a significant role in training tomorrow's pediatricians 
and pediatric subspecialists. Children's hospitals train 30 percent of 
all pediatricians, half of all pediatric subspecialists, and the 
majority of pediatric researchers. However, children's hospitals 
qualify for very limited Medicare support, the primary source of 
funding for graduate medical education in other inpatient environments. 
As a bipartisan Congress has recognized in the last several years, 
equitable funding for Children's Hospitals Graduate Medical Education 
(CHGME) is needed to continue the education and research programs in 
these child- and adolescent-centered settings. Since 2000, CHGME 
hospitals accounted for nearly 87 percent of the growth in pediatric 
subspecialty training programs and 68 percent of the growth in 
pediatric subspecialty fellows trained. We are extremely disappointed 
in the 63 percent reduction in funding proposed by the administration 
for the CHGME program, and join with the National Association of 
Children's Hospitals to restore funding to $330 million for the CHGME 
program in fiscal year 2007. The support for independent children's 
hospitals should not come, however, at the expense of valuable Title 
VII and VIII programs, including grant support for primary care 
training.

                                QUALITY

    Access to health care is only the first step in protecting the 
health of all children and youth. We must ensure that the care provided 
is of the highest quality. Robust Federal support for the wide array of 
quality improvement initiatives, including research, is needed if this 
goal is to be achieved.
    Emergency Services for Children.--One program that assists local 
communities in providing quality care to children in distress is the 
Emergency Medical Services for Children (EMSC) grant program. There are 
approximately 30 million child and adolescent visits to the Nation's 
emergency departments every year. Children under the age of 3 years 
account for most of these visits. Up to 20 percent of children needing 
emergency care have underlying medical conditions such as asthma, 
diabetes, sickle-cell disease, low birth weight, and bronchopulmonary 
dysplasia. In 2006, the Institute of Medicine's report Emergency Care 
for Children: Growing Pains acknowledged the many achievements of the 
EMSC program in improving pediatric emergency care and recommended that 
it be funded at $37.5 million. In order to assist local communities in 
providing the best emergency care to children, we once again reject the 
administration's proposed elimination of the EMSC program and strongly 
urge that the EMSC program be maintained and adequately funded at $25 
million in fiscal year 2008
    Agency for Healthcare Research and Quality.--Quality of care rests 
on quality research--for new detection methods, new treatments, new 
technology and new applications of science. As the lead Federal agency 
on quality of care research, the Agency for Healthcare Research and 
Quality (AHRQ) provides the scientific basis to improve the quality of 
care, supports emerging critical issues in health care delivery and 
addresses the particular needs of priority populations, such as 
children. Substantial gaps still remain in what we know about health 
care needs for children and adolescents and how we can best address 
those needs. Children are often excluded from research that could 
address these issues. The AAP and endorsing organizations strongly 
support AHRQ's objective to encourage researchers to include children 
and adolescents as part of their research populations. We also support 
increasing AHRQ's efforts to build pediatric health services research 
capacity through career and faculty development awards and strong 
practice-based research networks. Additionally, AHRQ is focusing on 
initiatives in community and rural hospitals to reduce medical errors 
and to improve patient safety through innovative use of information 
technology--an initiative that we hope would include children's 
hospitals as well. Through its research and quality agenda, AHRQ 
continues to provide policymakers, health care professionals and 
patients with critical information needed to improve health care and 
health disparities. We join with the Friends of AHRQ to recommend 
funding of $350 million for AHRQ in fiscal year 2008.
    National Institutes of Health.--Over the years, NIH has made 
dramatic strides that directly impact the quality of life for infants, 
children and adolescents through biomedical and behavioral research. 
For example, NIH research has led to successfully decreasing infant 
death rates by over 70 percent, increasing the survival rates from 
respiratory distress syndrome, and dramatically reducing the 
transmission of HIV from infected mother to fetus and infant from 25 
percent to just 1.5 percent. NIH is engaged in a comprehensive research 
initiative to address and explain the reasons for a major public health 
dilemma--the increasing number of obese and overweight children and 
adults in this country. Today U.S. teenagers are more overweight than 
young people in many other developed countries. And the Newborn 
Screening Initiative is moving forward to improve availability, 
accessibility, and quality of genetic tests for rare conditions that 
can be uncovered in newborns. The pediatric community applauds the 
prior commitment of Congress to maintain adequate funding for the NIH. 
We remain concerned, however, that the cumulative effect of several 
years of flat funding will stall or even set back the gains that were 
made under the years of the NIH's budget doubling. We urge you to begin 
to restore the funding lost over these last years. We support the 
recommendation of the Ad Hoc Group for Medical Research for a funding 
level in fiscal year 2008 of $30.8 billion an increase of 6.7 percent 
over the fiscal year 2007 joint resolution for the NIH In addition, to 
ensure ongoing and adequate child and adolescent focused research, such 
as the National Children's Study (NCS) led by the National Institute 
for Child Health and Human Development (NICHD), we join with the 
Friends of NICHD Coalition in requesting $1,337.8 billion in fiscal 
year 2008. Moreover we recommend that the NCS be adequately funded in 
fiscal year 2008 at $110.9 million to allow for the continued 
implementation of the NCS and bring us closer to the first results from 
this landmark study. We are greatly disappointed by the 
administration's failure to include the NCS in its budget proposal 
2008. This large longitudinal study, authorized in the Children's 
Health Act of 2000, will provide critical research and information on 
major causes of childhood illnesses such as premature birth, asthma, 
obesity, preventable injury, autism, development delay, mental illness, 
and learning disorders.
    We commend this committee's ongoing efforts to make pediatric 
research a priority at the highest level of the NIH. We urge continued 
Federal support of NIH efforts to increase pediatric biomedical and 
behavioral research, including such proven programs as targeted 
training and education opportunities and loan repayment. We recommend 
continued interest in and support for the Pediatric Research Initiative 
in the Office of the NIH Director and sufficient funding to continue 
the pediatric training grant and pediatric loan repayment programs both 
enacted in the Children's Health Act of 2000. This would ensure that we 
have adequately trained pediatric researchers in multiple disciplines 
that will not come at the expense of other important programs.
    Finally, as clinicians, we know first-hand the considerable 
benefits for children and society in securing properly studied and 
dosed medications. Proper pediatric safety and dosing information 
reduces medical errors and adverse events, ultimately improving 
children's health and reducing health care costs. But there is little 
market incentive for drug companies to study generic or off-patent 
drugs--older drugs that are widely used therapies for children. The 
Research Fund for the Study of Drugs, created as part of the Best 
Pharmaceuticals for Children Act of 2002, provides support for these 
critical pediatric testing needs, but unfortunately is currently funded 
at an amount sufficient to test only a fraction of the NIH and FDA-
designated ``priority'' drugs. Therefore, we urge the subcommittee to 
provide the NIH with sufficient funding to fund the study of generic 
(off-patent) drugs for pediatric use.

                              IMMUNIZATION

    Pediatricians, working alongside public health professionals and 
other partners, have brought the United States its highest immunization 
coverage levels in history--over 92 percent of children received all 
vaccinations by school age in 2004-2005. We attribute this, in part, to 
the Vaccines for Children (VFC) Program, and encourage Congress to 
maintain its commitment to ensuring the program's viability. The VFC 
program combines the efforts of public health and private pediatricians 
and other health care professionals to accomplish and sustain vaccine 
coverage goals for both today's and tomorrow's vaccines. It removes 
vaccine cost as a barrier to immunization for some and reinforces the 
concept of vaccine delivery in a ``medical home.'' Additional section 
317 funding is necessary to provide the pneumococcal conjugate vaccine 
(PCV-7), a vaccine that prevents an infection of the brain covering, 
blood infections and approximately 7 million ear infections a year, to 
those remaining States that currently do not provide it. Increased 
section 317 funding also is needed to purchase the influenza vaccine--
now recommended for children between the ages of 6 months and 5 years 
of age. This age cohort is increasingly susceptible to serious 
infection and the risk of hospitalization. And an increase in funding 
is needed to purchase the recently recommended rotavirus vaccine, 
tetanus-diptheria-pertussis (Tdap) vaccine for adolescents and the 
meningococcal conjugate vaccine (MCV). Meningococcal disease is a 
serious illness, caused by bacteria, with 10-15 percent of cases fatal 
and another 10-15 percent of cases resulting in permanent hearing loss, 
mental retardation, or loss of limbs. And additional funding is 
important to provide the HPV vaccine recommended by the ACIP.
    The public health infrastructure that now supports our national 
immunization efforts must not be jeopardized with insufficient funding. 
For example, adolescents continue to be adversely affected by vaccine-
preventable diseases (e.g., chicken pox, hepatitis B, measles and 
rubella). Comprehensive adolescent immunization activities at the 
national, State, and local levels are needed to achieve national 
disease elimination goals. States and communities continue to be 
financially strapped and therefore, many continue to divert funds and 
health professionals from routine immunization clinics in order to 
accommodate anti-bioterrorism initiatives or now pandemic influenza. 
Moreover, continued investment in the CDC's immunization activities 
must be made to avoid the reoccurrence of childhood vaccine shortages 
by providing and adequately funding a national 6 month stockpile for 
all routine childhood vaccines--stockpiles of sufficient size to insure 
that significant and unexpected interruptions in manufacturing do not 
result in shortages for children.
    While the ultimate goal of immunizations clearly is eradication of 
disease, the immediate goal must be prevention of disease in 
individuals or groups. To this end, we strongly believe that CDC's 
efforts must be sustained. In fiscal year 2008, we recommend an overall 
increase in funding to $802.4 million $257.5 million over the 
President's request to ensure that the CDC's National Immunization 
Program has the funding necessary to accommodate vaccine price 
increases, new disease preventable vaccines coming on the market, 
global immunization initiatives--including funds for polio eradication 
and the elimination of measles and rubella--and to continue to 
implement the recommendations developed by the IOM.

                               CONCLUSION

    We appreciate the opportunity to provide our recommendations for 
the coming fiscal year. As this subcommittee is once again faced with 
difficult choices and multiple priorities we know that as in the past 
years, you will not forget America's children and adolescents.
                                 ______
                                 
   Prepared Statement of the American Academy of Physician Assistants

    On behalf of the more than 60,000 clinically practicing physician 
assistants in the United States, the American Academy of Physician 
Assistants is pleased to submit comments on fiscal year 2008 
appropriations for Physician Assistant (PA) educational programs that 
are authorized through Title VII of the Public Health Service Act.
    A member of the Health Professions and Nursing Education Coalition 
(HPNEC), the Academy supports the HPNEC recommendation to provide at 
least $300 million for Title VII programs in fiscal year 2008, 
including a minimum of $7 million to support PA educational programs. 
This would fund the programs at the 2005 funding level, not accounting 
for inflation.
    The Academy believes that the recommended restoration in funding 
for Title VII health professions programs is well justified. A review 
of PA graduates from 1990-2004 reveals that graduates from Title VII 
supported programs were 67 percent more likely to be from 
underrepresented minority backgrounds and 49 percent more likely to 
work in a Rural Health Clinic than graduates of programs that weren't 
supported by Title VII funding.
    Title VII safety net programs are essential to the training of 
primary health care professionals and provide increased access to care 
by promoting health care delivery in medically underserved communities. 
Title VII funding for PA programs is especially important since it is 
the only Federal funding available to these programs, on a competitive 
application basis.
    The Academy is extremely concerned with the administration's 
proposal to eliminate funding for most Title VII programs, including 
training programs in primary care medicine and dentistry. These 
programs are designed to help meet the health care delivery needs of 
the Nation's Health Professional Shortage Areas (HPSAs). By definition, 
the Nation's more than 5,500 HPSAs experience shortages in the primary 
care workforce that the market alone can't address. In addition, the 
Health Resources and Services Administration (HRSA) predicts that there 
will be a need for over 11,000 health care professionals to implement 
the President's Community Health Center (CHC) Initiative. The increased 
funding for these CHCs will provide medical care to approximately 6 
million people in the United States. Title VII serves as crucial 
funding for the pipeline of health professionals that serve CHCs today.
    We wish to thank the members of this subcommittee for your 
historical role in supporting funding for the health professions 
programs, and we hope that we can count on your support to restore 
funding to these important programs in fiscal year 2008 to the fiscal 
year 2005 funding level.

               OVERVIEW OF PHYSICIAN ASSISTANT EDUCATION

    The typical PA program consists of 26 months of instruction, and 
the typical student has a bachelor's degree and about 4 years of prior 
health care experience. The first phase of the program consists of more 
than 400 hours in classroom and laboratory instruction in the basic 
sciences, over 75 hours in pharmacology, approximately 175 hours in 
behavioral sciences, and almost 580 hours of clinical medicine.
    The second year of PA education consists of clinical rotations, 
which typically includes more than 2,000 hours or 50-55 weeks of 
clinical education, divided between primary care medicine and various 
specialties. During clinical rotations, PA students work directly under 
the supervision of physician preceptors, participating in the full 
range of patient care activities, including patient assessment and 
diagnosis, development of treatment plans, patient education, and 
counseling. All PA educational programs are accredited by the 
Accreditation Review Commission on Education for the Physician 
Assistant.
    After graduation from an accredited PA program, physician 
assistants must pass a national certifying examination jointly 
developed by the National Board of Medical Examiners and the 
independent National Commission on Certification of Physician 
Assistants. To maintain certification, PAs must log 100 continuing 
medical education credits every 2 years, and they must take a 
recertification exam every 6 years.

                      PHYSICIAN ASSISTANT PRACTICE

    Physician assistants are licensed health care professionals 
educated to practice medicine as delegated by and with the supervision 
of a physician. In all States, physicians may delegate to PAs those 
medical duties that are within the physician's scope of practice and 
the PA's training and experience and are allowed by law. Physicians may 
also delegate prescriptive privileges to the PAs they supervise. PAs 
are located in almost all health care settings and medical and surgical 
specialties. Sixteen percent of all PAs practice in non-metropolitan 
areas where they may be the only full-time providers of care (State 
laws stipulate the conditions for remote supervision by a physician). 
Approximately 48 percent of PAs work in urban and inner city areas. 
Approximately 38 percent of PAs are in primary care. In 2006, an 
estimated 231 million patient visits were made to PAs and approximately 
286 million medications were prescribed or recommended by PAs.

     CRITICAL ROLE OF TITLE VII PUBLIC HEALTH SERVICE ACT PROGRAMS

    A growing number of Americans lack access to primary care either 
because they are uninsured, underinsured, or they live in a community 
with an inadequate supply or distribution of providers. The growth in 
the uninsured U.S. population increased from approximately 32 million 
in the early 1990s to almost 47 million today. The role of Title VII 
programs is to alleviate these problems by supporting educational 
programs that train more health professionals in fields experiencing 
shortages, improving the geographic distribution of health 
professionals, and increasing access to care in underserved 
communities.
    Title VII programs are the only Federal educational programs that 
are designed to address the supply and distribution imbalances in the 
health professions. Since the establishment of Medicare, the costs of 
physician residencies, nurse training, and some allied health 
professions training have been paid through Graduate Medical Education 
(GME) funding. However, GME has never been available to support PA 
education. Furthermore, GME was not intended to generate a supply of 
providers who are willing to work in the Nation's medically underserved 
communities. That is the purpose of the Title VII Public Health Service 
Act programs.
    In addition, as evidence indicates that race and ethnicity 
correlate to persistent health disparities among U.S. populations, it 
is essential to increase the diversity of health care professionals. 
Title VII programs seek to recruit students who are from underserved 
minority and disadvantaged populations. This is particularly important, 
as studies have found that those from disadvantaged regions of the 
country are three to five times more likely to return to underserved 
areas to provide care.

              TITLE VII SUPPORT OF PA EDUCATIONAL PROGRAMS

    Targeted Federal support for PA educational programs is authorized 
through section 747 of the Public Health Service Act. The program was 
reauthorized in the 105th Congress through the Health Professions 
Education Partnerships Act of 1998, Public Law 105-392, which 
streamlined and consolidated the Federal health professions education 
programs. Support for PA education is now considered within the broader 
context of training in primary care medicine and dentistry.
    Public Law 105-392 reauthorized awards and grants to schools of 
medicine and osteopathic medicine, as well as colleges and 
universities, to plan, develop, and operate accredited programs for the 
education of physician assistants with priority given to training 
individuals from disadvantaged communities. The funds ensure that PA 
students from all backgrounds have continued access to an affordable 
education and encourage PAs, upon graduation, to practice in 
underserved communities. These goals are accomplished by funding PA 
educational programs that have a demonstrated track record of (1) 
placing PA students in health professional shortage areas; (2) exposing 
PA students to medically underserved communities during the clinical 
rotation portion of their training; and (3) recruiting and retaining 
students who are indigenous to communities with unmet health care 
needs.
    The PA programs' success is linked to their ability to creatively 
use Title VII funds to enhance existing educational programs. For 
example, PA programs in Texas use Title VII funds to create new 
clinical rotation sites in rural and underserved areas, including new 
sites in border communities, and to establish non-clinical rural 
rotations to help students understand the challenges faced by rural 
communities. One Texas program uses Title VII funds for the development 
of Web based and distant learning technology, so students can remain at 
clinical practice sites. A PA program in New York, where over 90 
percent of the students are ethnic minorities, uses Title VII funding 
to focus on primary care training for underserved urban populations by 
linking with community health centers, which expands the pool of 
qualified minority role models that engage in clinical teaching, 
mentoring, and preceptorship for PA students. Several other PA programs 
have been able to use Title VII grants to leverage additional resources 
to assist students with the added costs of housing and travel that 
occur during relocation to rural areas for clinical training.
    Without Title VII funding, many of these special PA training 
initiatives would not be possible. Institutional budgets and student 
tuition fees simply do not provide sufficient funding to meet the 
special, unmet needs of medically underserved areas or disadvantaged 
students. The need is very real, and Title VII is critical in meeting 
that need.

    NEED FOR INCREASED TITLE VII SUPPORT FOR PA EDUCATIONAL PROGRAMS

    Increased Title VII support for educating PAs to practice in 
underserved communities is particularly important given the market 
demand for physician assistants. Without Title VII funding to expose 
students to underserved sites during their training, PA students are 
far more likely to practice in the communities where they were raised 
or attended school. Title VII funding is a critical link in addressing 
the natural geographic maldistribution of health care providers by 
exposing students to underserved sites during their training, where 
they frequently choose to practice following graduation. Currently, 31 
percent of PAs met their first clinical employer through their clinical 
rotations.
    The supply of physician assistants is inadequate to meet the needs 
of society, and the demand for PAs is expected to increase. A 2006 
article in the Journal of the American Medical Association (JAMA) 
concluded that the Federal Government should augment the use of 
physician assistants as physician substitutes, particularly in urban 
CHCs where the proportional use of physicians is higher. The article 
suggested that this could be accomplished by adequately funding Title 
VII programs. Additionally, the Bureau of Labor Statistics projects 
that the number of available PA jobs will increase 49 percent between 
2004 and 2014. Title VII funding has provided a crucial pipeline of 
trained PAs to underserved areas.
    Despite the increased demand for PAs, funding has not 
proportionately increased for Title VII programs that are designed to 
educate and place PAs in underserved communities. Nor has Title VII 
support for PA education kept pace with increases in the cost of 
educating PAs. A review of PA program budgets from 1984 through 2004 
indicates an average annual increase of 7 percent, a total increase of 
256 percent over the past 20 years, yet Federal support has decreased.

              RECOMMENDATIONS ON FISCAL YEAR 2008 FUNDING

    The American Academy of Physician Assistants urges members of the 
Appropriations Committee to consider the inter-dependency of all public 
health agencies and programs when determining funding for fiscal year 
2008. For instance, while it is important to fund clinical research at 
the National Institutes of Health (NIH) and to have an infrastructure 
at the Centers for Disease Control and Prevention (CDC) that ensures a 
prompt response to an infectious disease outbreak or bioterrorist 
attack, the good work of both of these agencies will go unrealized if 
HRSA is inadequately funded. HRSA administers the ``people'' programs, 
such as Title VII, that bring the results of cutting edge research at 
NIH to patients through providers such as PAs who have been educated in 
Title VII-funded programs. Likewise, training is the key to emergency 
preparedness, and Title VII, section 747, is the ideal mechanism for 
educating primary care providers in public health competencies that 
ensures the CDC has an adequate supply of health care providers to 
report, track, and contain disease outbreaks.
    The Academy respectfully requests that Title VII health professions 
programs receive $300 million in funding for fiscal year 2008, 
including a minimum of $7 million to support PA educational programs. 
Thank you for the opportunity to present the American Academy of 
Physician Assistants' views on fiscal year 2008 appropriations.
                                 ______
                                 
   Prepared Statement of the American Association for Cancer Research

                           EXECUTIVE SUMMARY

    The American Association for Cancer Research (AACR) would like to 
thank Members for their support of National Institutes of Health (NIH) 
and National Cancer Institute (NCI) research on the biology, treatment 
and prevention of the more than 200 diseases called cancer. The AACR, 
with more than 25,000 members worldwide, represents and supports 
scientists by publishing respected, peer-reviewed scientific journals, 
hosting international scientific conferences, and awarding millions of 
dollars in research grants. Together, we have made great strides in the 
war on cancer, but much remains to be done. One in four deaths in 
America this year will be caused by cancer. Cancer-related deaths will 
increase dramatically as the baby boom generation ages, and we must be 
prepared to prevent, treat, and manage the impending wave of new 
cancers.
    Cancer is no longer a death sentence thanks to decades of research 
and development made possible by strong commitments from Congress and 
the American people, but now that commitment is wavering. After 
expanding capacity during the NIH budget doubling, researchers at 
hospitals and universities across the country now face shrinking 
budgets. Promising young researchers, unable to secure grants, turn to 
other careers. This disruption of the research pipeline will slow the 
development of new treatments and set back America's biomedical 
leadership for decades to come.
    We are at the vanguard of a revolution in healthcare, where 
personalized treatment will improve health, reduce harmful side 
effects, and lower costs. We have the opportunity to build upon our 
previous investments and accelerate the research process. Now is the 
time to face the Nation's growing healthcare needs, reaffirm our role 
as world leaders in science, and renew our commitment to the research 
and development that brings hope to millions of suffering Americans. 
The AACR urges the U.S. Senate to support the following appropriations 
funding levels for cancer research in fiscal year 2008:
  --$30.8 billion for the National Institutes of Health, a 6.7 percent 
        increase over fiscal year 2007.
  --$5.8 billion for the National Cancer Institute (the NCI 
        Professional Judgment budget level), or, at a minimum, $5.1 
        billion, a 6.7 percent increase over fiscal year 2007.
    The American Association for Cancer Research (AACR) recognizes and 
expresses its thanks to the United States Congress for its longstanding 
support and commitment to funding cancer research. The completion of 
the 5-year doubling of the budget of the National Institutes of Health 
(NIH) in 2003 was a stunning accomplishment that is already showing 
impressive returns and benefits to patients with cancer. Recently, 
however, budgets for cancer research have declined; this commitment 
appears to be wavering. Budget doubling enabled a significant expansion 
of infrastructure and scientific opportunities. Budget cuts prevent us 
from capitalizing on them.
    Unquestionably, the Nation's investment in cancer research is 
having a remarkable impact. Cancer deaths in the United States have 
declined for the second year in a row. Last year's decline was the 
first such decrease in the total number of annual cancer deaths since 
1930 when record-keeping began. This progress occurred in spite of an 
aging population and the fact that more than three-quarters of all 
cancers are diagnosed in individuals aged 55 and older. Yet this good 
news will not continue without sustained and substantial Federal 
funding for critical cancer research priorities. The American 
Association for Cancer Research joins the broader biomedical research 
community in urging the United States Senate to support the following 
appropriations funding levels for cancer research in fiscal year 2008:
  --$30.8 billion for the National Institutes of Health, a 6.7 percent 
        increase over fiscal year 2007.
  --$5.8 billion for the National Cancer Institute (the NCI 
        Professional Judgment budget level), or, at a minimum, $5.1 
        billion, a 6.7 percent increase over fiscal year 2007.

             AACR: FOSTERING A CENTURY OF RESEARCH PROGRESS

    The American Association for Cancer Research has been moving cancer 
research forward since its founding 100 years ago in 1907. Celebrating 
its Centennial Year, the AACR and its more than 25,000 members 
worldwide strive tirelessly to carry out its important mission to 
prevent and cure cancer through research, education, and communication. 
It does so by:
  --fostering research in cancer and related biomedical science;
  --accelerating the dissemination of new research findings among 
        scientists and others dedicated to the conquest of cancer;
  --promoting science education and training; and
  --advancing the understanding of cancer etiology, prevention, 
        diagnosis, and treatment throughout the world.

                 FACING AN IMPENDING CANCER ``TSUNAMI''

    Over the past 100 years, enormous progress has been made toward the 
conquest of the Nation's second most lethal disease (after heart 
disease). Thanks to discoveries and developments in prevention, early 
detection, and more effective treatments, many of the more than 200 
diseases called cancer have been cured or converted into manageable 
chronic conditions while preserving quality of life. The 5-year 
survival rate for all cancers has improved over the past 30 years to 
more than 65 percent. The completion of the doubling of the NIH budget 
in 2003 is bearing fruit as many new and promising discoveries are 
unearthed and their potential realized. However, there is much left to 
be done, especially for the most lethal and rarer forms of the disease.
    We recognize that the underlying causes of the disease and its 
incidence have not been significantly altered. The fact remains that 
men have a 1 in 2 lifetime risk of developing cancer, while women have 
a 1 in 3 lifetime risk. The leading cancer sites in men are the 
prostate, lung and bronchus, and colon and rectum. For women, the 
leading cancer sites are breast, lung and bronchus, and colon and 
rectum. And cancer still accounts for 1 in 4 deaths, with more than 
564,830 people expected to die from their cancer in 2006. Age is a 
major risk factor--this Nation faces a virtual ``cancer tsunami'' as 
the baby boomer generation reaches age 65 in 2011. A renewed commitment 
to progress in cancer research through leadership and resources will be 
essential to dodge this cancer crisis.

                  FEDERAL INVESTMENT FOR LOCAL BENEFIT

    Nearly half of the NCI budget is allocated to research project 
grants that are awarded to outside scientists who work at local 
hospitals and universities throughout the country. More than 5,400 
research grants are funded at more than 150 cancer centers and 
specialized research facilities located in 49 States. Over half the 
States receive more than $15 million in grants and contracts to 
institutions located within their borders. Many AACR member scientists 
are engaged in this rewarding work. But too many of them have had their 
long-term research jeopardized by grant reductions caused by the flat 
and declining overall funding for the NCI since 2003. The AACR 
recommends, at a minimum, a 6.7 percent increase in funding for the 
National Cancer Institute to enable it to continue and expand its work 
on focused research questions.

           UNDERSTANDING THE CAUSES AND MECHANISMS OF CANCER

    Basic research into the causes and mechanisms of cancer is at the 
heart of what the NCI and many of AACR's member scientists do. Basic 
research is the engine that drives scientific progress. The outcomes 
from this fundamental basic research--including laboratory and animal 
research in addition to population studies and the deployment of state-
of-the-art technologies--will inform and drive the cancer research 
enterprise in ways and directions that will lead to unparalleled 
progress in the search for cures.

               ACCELERATING PROGRESS IN CANCER PREVENTION

    Preventing cancer is far more cost-effective and desirable than 
treating it. The NCI uses multidisciplinary teams and a systems biology 
approach to identify early events and how to modify them. More than 
half of all cancers are related to modifiable behavioral factors, 
including tobacco use, diet, physical inactivity, sun exposure, and 
failure to get cancer screenings. The NCI supports research to 
understand how people perceive risk, make health-related decisions, and 
maintain healthy behavior. Prevention is the keystone to success in the 
battle against cancer.

             DEVELOPING EFFECTIVE AND EFFICIENT TREATMENTS

    The future of cancer care is all about developing individualized 
therapies tailored to the specific characteristics of a patient's 
cancer. Noteworthy recent advances in this area have included the 
development of oral versions of medicines that were formerly only 
available by injection, thus improving patients' quality of life; and 
the discovery of intraperitoneal (IP) chemotherapy--delivering drugs 
directly to the abdominal cavity--that can add more than a year to 
survival for some women with ovarian cancer.

                  OVERCOMING CANCER HEALTH DISPARITIES

    Some minority and underserved population groups suffer 
disproportionately from cancer. Solving this issue will contribute 
significantly to reducing the cancer burden. Successful achievements in 
this important area include the development and dissemination of the 
patient navigator program that assists patients and caregivers to 
access and chart a course through the healthcare system, and the NCI 
Cancer Information Services Partnership Program that provides 
information and education about cancer in lay language to the medically 
underserved through community organizations.

             AACR'S INITIATIVES AUGMENT SUPPORT FOR THE NCI

    The NCI is not working alone or in isolation in any of these key 
areas. NCI research scientists reach out to other organizations to 
further their work. The AACR is engaged in scores of initiatives that 
strengthen, support, and facilitate the work of the NCI, including:
  --sponsoring the largest meeting of cancer researchers in the world, 
        with more than 17,000 scientists and 6,000 abstracts featuring 
        the latest scientific advances;
  --publishing more than 3,400 original research articles each year in 
        five prestigious peer-reviewed scientific journals, including 
        Cancer Research;
  --sponsoring the annual International Conference on Frontiers of 
        Cancer Prevention Research, the largest such prevention meeting 
        of its kind in the world;
  --raising and distributing more than $5 million in awards and 
        research grants.

 TRAINING AND CAREER DEVELOPMENT FOR THE NEXT GENERATION OF RESEARCHERS

    Of critical importance to the viability of the long-term cancer 
research enterprise is supporting, fostering, and mentoring the next 
generation of investigators. The NCI devotes approximately 4 percent of 
its budget to multiple strategies to training and career development, 
including sponsored traineeships, a Medical Scientist Training Program, 
special set-aside grant programs and bridge grants for early career 
cancer investigators. Increased funding for these foundational 
opportunities is essential to retain the scientific workforce that is 
needed to continue the fight against cancer.

                     INCREASE RESEARCH FUNDING NOW

    Remarkable progress is being made in cancer research, but much more 
remains to be done. Cancer costs the Nation more than $209 billion in 
direct medical costs and lost productivity due to illness and premature 
death. Respected University of Chicago economists Kevin Murphy and 
Robert Topel have estimated that even a modest 1 percent reduction in 
mortality from cancer would be worth nearly $500 billion in social 
value. Investments in cancer research have huge potential returns. 
Thanks to successful past investments, promising research opportunities 
abound and must not be lost. To maintain our research momentum, the 
American Association for Cancer Research (AACR) urges the United States 
Senate to support the following appropriations funding levels for 
cancer research in fiscal year 2008:
  --$30.8 billion for the National Institutes of Health, a 6.7 percent 
        increase over fiscal year 2007.
  --$5.8 billion for the National Cancer Institute (the NCI 
        Professional Judgment budget level), or, at a minimum, $5.1 
        billion, a 6.7 percent increase over fiscal year 2007.
                                 ______
                                 
 Prepared Statement of the American Association of Colleges of Nursing

    The American Association of Colleges of Nursing (AACN) respectfully 
submits this statement highlighting funding priorities for nursing 
education and research programs in fiscal year 2008. AACN represents 
more than 600 schools of nursing at public and private universities and 
senior colleges with baccalaureate and graduate nursing programs that 
educate over 240,000 students and employ over 12,000 faculty members. 
These institutions are responsible for educating almost half of our 
Nation's registered nurses (RNs) and all of the nurse faculty and 
researchers. Nursing represents the largest health profession, with 
approximately 2.9 million dedicated, trusted professionals delivering 
primary, acute, and chronic care to millions of Americans.

                      NATIONWIDE NURSING SHORTAGE

    For nearly a decade, our country's health care system has been 
negatively impacted by a shortage of RNs. In 2002, the Joint Commission 
on Accreditation of Healthcare Organizations noted that the nursing 
shortage contributed to nearly a quarter of all unexpected incidents 
that adversely affect hospitalized patients. A more recent 
comprehensive analysis published in the March 2006 issue of Nursing 
Economic$ found that the majority of nurses reported that the RN 
shortage is negatively impacting patient care and undermining the 
quality of care goals set by the Institute of Medicine and the National 
Quality Forum. Unfortunately, reports reveal that the nursing shortage 
is not expected to diminish in the foreseeable future. The Bureau of 
Labor Statistics projects that more than 1.2 million new and 
replacement nurses will be needed by 2014. Government analysts further 
project that more than 703,000 new RN positions will be created through 
2014, which will account for two-fifths of all new jobs in the health 
care sector.
    A number of contributing factors add to the complexity and duration 
of the shortage. Within the next 20 years, there will be a wave of 
nurses retiring from the profession. According to the 2004 National 
Sample Survey of Registered Nurses released in February 2007 by the 
Federal Division of Nursing, the average age of the RN population in 
March 2004 was 46.8 years of age, up from 45.2 in 2000. With many 
nurses nearing the age of retirement, more nurses must enter the 
pipeline. However, the nursing profession is not growing to meet the 
demand of the shortage. While The National Sample Survey of Registered 
Nurses has indicated that the total RN population has increased at 
every 4-year interval since 1980, the growth from 2000 to 2004 was 
relatively low. The total RN population increased by only 7.9 percent 
in 2004. Earlier report intervals noted that the RN population grew by 
14.2 percent between 1992 and 1996.
    The approximately 1,500 schools of nursing nationwide have been 
working diligently to expand enrollments. AACN's 2006-2007 annual 
survey of 722 nursing schools with baccalaureate and graduate programs 
reveals that enrollments increased by 7.6 percent in entry-level 
baccalaureate nursing programs.
    This makes the sixth consecutive year of enrollment increases that 
can be attributed to a combination of Federal support, private sector 
marketing efforts, public-private partnerships providing additional 
resources to expand capacity of nursing programs, and State legislation 
targeting funds towards nursing scholarships and loan repayment. While 
essential and important, these efforts have not fully met the 
increasing demand for RNs.
    Health Resources and Services Administration (HRSA) officials 
stated in an April 2006 report that there must be a 90 percent increase 
in graduations from U.S. nursing programs in order to meet the demand 
for RN services. Yet, the inability of nursing schools to educate more 
RNs is the most urgent contributing factor that must be addressed in 
order to reverse the shortage and ensure that every patient receives 
the safest, highest quality health care. According to AACN's report on 
2006-2007 Enrollment and Graduations in Baccalaureate and Graduate 
Programs in Nursing, U.S. nursing schools turned away 42,866 qualified 
applicants to baccalaureate and graduate programs due to an 
insufficient number of faculty, clinical sites, classroom space, 
clinical preceptors, and budget constraints. Almost three quarters of 
the nursing schools responding to the AACN survey pointed to faculty 
shortages as a reason for not accepting all qualified applicants into 
nursing programs. Federal support must continue to play an integral 
role in our Nation's efforts to address the nursing and nurse faculty 
shortage as well as the constraints encountered by nursing's 
educational system.

    NURSING WORKFORCE DEVELOPMENT PROGRAMS: ADDRESSING THE SHORTAGE

    Acknowledging the severity of the Nation's nursing shortage, 
Congress passed The Nurse Reinvestment Act of 2002. This legislation 
created new programs and expanded existing Nursing Workforce 
Development authorities. Administered by HRSA under Title VIII of the 
Public Health Service Act, these programs focus on the supply and 
distribution of RNs across the country. The programs support individual 
students in their nursing studies through scholarships and loan 
repayment programs. Title VIII programs stimulate innovation in nursing 
practice and bolster nursing education throughout the continuum, from 
entry-level preparation through graduate study. They are the largest 
source of Federal funding for nursing education assisting students, 
schools of nursing, and health systems in their efforts to educate, 
recruit, and retain RNs and nurse faculty. In fiscal year 2006, these 
programs helped to educate over 48,000 nursing students and nurses 
through individual and programmatic support.
    However, funding for these authorities is insufficient to address 
the severity of the nursing and nurse faculty shortage. Currently, 
Nursing Workforce Development Programs receive $149.68 million, the 
same funding level as in fiscal year 2006. During the nursing shortage 
in 1974, Congress appropriated $153 million for nursing education 
programs. Translated into today's dollars, that appropriation would 
total $632 million, more than four times the current level. To fully 
meet the educational and practice demands of today's nursing shortage 
it would take billions of dollars.
    AACN respectfully requests $200 million for Title VIII Nursing 
Workforce Development Programs in fiscal year 2008, an additional 
$50.32 million over the fiscal year 2007 level. New monies would expand 
nursing education, recruitment, and retention efforts to help resolve 
all aspects adding to the nursing shortage.
Nurse Faculty Shortage
    AACN believes that the most effective strategy to resolve the 
nursing shortage is addressing the underlying nurse faculty shortage. 
The demand for nurse faculty far exceeds the rate at which nursing 
schools can educate them. HRSA reports that just 13 percent of the RN 
workforce holds either a master's or doctoral degree, the credentials 
required to teach. A Special Survey on Vacant Faculty Positions 
released by AACN in July 2006, reported a total of 637 faculty 
vacancies (8 percent vacancy rate) were identified at 329 nursing 
schools with baccalaureate and/or graduate programs across the country 
(almost two vacancies at each school of nursing). Most of the vacancies 
(53.7 percent) were faculty positions requiring a doctoral degree. 
Besides the vacancies, schools cited the need to create an additional 
55 faculty positions to accommodate student demand. The ability to 
increase the pool of educators becomes increasingly difficult when 
3,306 qualified applicants were turned away from master's programs and 
299 qualified applicants were turned away from doctoral programs in 
2006.
    The inability of nursing schools to educate, recruit, and retain 
qualified teachers is fueling the nurse faculty shortage. Potential 
faculty members graduating from schools of nursing are slow to rise. In 
2006, graduations from research-focused doctoral nursing programs were 
up by only 1.4 percent or six graduates from the 2005-2006 academic 
year. Complicating the problem further, those that are graduating from 
schools of nursing with a graduate degree are not choosing a career in 
education. An unpublished AACN study on employment plans found that 
almost a quarter of all graduates from doctoral nursing programs do not 
plan to work in academic settings. Higher compensation in clinical and 
private sector settings lures current and potential nurse educators 
away from the classroom.
    Furthermore, the demand for nurse faculty will continue to grow in 
the very near future as schools of nursing will experience an increase 
in faculty retirement. According to an article published in the March/
April 2002 issue of Nursing Outlook titled The Shortage of Doctorally 
Prepared Nursing Faculty: A Dire Situation, the average age of nurse 
faculty at retirement is 62.5 years. With the average age of 
doctorally-prepared faculty currently 53.5 years, a wave of retirements 
is expected within the next 10 years. Without sufficient nurse faculty, 
schools of nursing cannot expand enrollments, and the nursing shortage 
will continue to cripple our Nation's health care delivery system.

 REVERSING THE NURSE FACULTY SHORTAGE AND NURSING EDUCATIONAL BARRIERS

    The Nursing Workforce Development programs are essential in not 
only educating nurses, but more critically, in funding the education of 
additional nurse faculty. In fiscal year 2008, AACN recommends 
increasing funding for graduate education through the Advanced 
Education Nursing (AEN) Grants (Sec. 811) and bolstering funds for the 
Nurse Faculty Loan Program (Sec. 846A) as well as the Nurse Education, 
Practice, and Retention Grants (Sec. 831). These programs are essential 
in educating nurses, but more importantly in funding the education of 
nurse faculty, which allow schools of nursing to increase their student 
capacity.
    Advanced Education Nursing Program (Sec. 811).--These grants 
support the majority of nursing schools preparing graduate-level 
nurses, many of whom become faculty. Receiving $57.06 million in fiscal 
year 2007, this grant program helps schools of nursing, academic health 
centers, and other nonprofit entities improve the education and 
practice of nurse practitioners, nurse-midwives, nurse anesthetists, 
nurse educators, nurse administrators, public health nurses, and 
clinical nurse specialists. Out of the 114 applications reviewed for 
program grants in fiscal year 2006, 45 new grants were awarded and 112 
previously awarded grants were continued, totaling 157--the same number 
as in fiscal year 2004 and fiscal year 2005. In addition, 564 schools 
of nursing received traineeship grants, which in turn directly 
supported 9,000 individual student nurses. In fact, 2,105 nurses who 
received support from AEN grants in fiscal year 2006 are now practicing 
in underserved areas.
    Nurse Faculty Loan Program (Sec. 846A).--Designed to increase the 
number of nurse faculty, schools of nursing receive grants to create a 
loan fund through the Nurse Faculty Loan Program. To be eligible for 
these loans, students must pursue full-time study for a master's or 
doctoral degree. In exchange for teaching at a school of nursing, loan 
recipients will have up to 85 percent of their educational loans 
cancelled over a 4-year period. In fiscal year 2006, 67 new grants and 
26 continuing grants were awarded to schools of nursing. These grants 
are projected to assist 475 future nurse educators. Unfortunately, in 
fiscal year 2006 schools of nursing requested over three times the 
funds available to educate additional nurse faculty. In fiscal year 
2007, $4.77 million was appropriated. If the current funding was 
doubled to almost $10 million, based on fiscal year 2006 projections, 
nursing schools could educate over 900 future faculty members. Further, 
with an average faculty to student ratio of 1:10, those 900 faculty 
members could teach an additional 9,000 nurses each year.
    Nurse Education, Practice, and Retention Grants (Sec. 831).--These 
grants help schools of nursing, academic health centers, nurse-managed 
health centers, State and local governments, and health care facilities 
strengthen programs that provide nursing education. In particular, the 
Education Grants expand enrollments in baccalaureate nursing programs. 
In addition, they develop internship and residency programs to enhance 
mentoring and specialty training as well as provide for new technology 
in education, including distance learning.

                 NATIONAL INSTITUTE OF NURSING RESEARCH

    One of the 27 Institutes and Centers at the National Institutes of 
Health, the National Institute of Nursing Research (NINR) works to 
improve patient care and foster advances in nursing and other health 
professions' practice. The outcomes-based findings derived from NINR 
research are important to the future of the health care system and its 
ability to deliver safe, cost-effective, and high quality care. Through 
grants, research training, and interdisciplinary collaborations, NINR 
addresses care management of patients during illness and recovery, 
reduction of risks for disease and disability, promotion of healthy 
lifestyles, enhancement of quality of life in those with chronic 
illness, and care for individuals at the end of life. To advance this 
research, AACN respectfully requests a funding level of $150 million in 
fiscal year 2008, an additional $12.66 million over the $137.34 
million, NINR received in fiscal year 2007,
NINR Addresses the Shortage of Nurse Researchers and Faculty
    NINR allocates 7 percent of its budget, a high proportion when 
compared to other NIH institutes, to research training to help develop 
the pool of nurse researchers. In fiscal year 2005, NINR training 
dollars supported 80 individual researchers and provided 155 
institutional awards, which in turn supported a number of nurse 
researchers at each institution. Since nurse researchers often serve as 
faculty members for colleges of nursing, they are actively educating 
our next generation of RNs.

                               CONCLUSION

    AACN acknowledges the fiscal challenges that the subcommittee and 
the entire Congress must work within. However, the nursing shortage can 
no longer be explained by the need to simply increase the number of 
nurses in the workforce. A demand for nurse educators weighs heavily on 
the ability to increase the pool of future nurses. This element of the 
shortage has created a negative chain reaction--without more nurse 
faculty, additional nurses cannot be educated, and without more nurses 
the shortage will continue. Ultimately, this chain reaction will 
continue to place the health care delivery system at risk. Title VIII 
programs can help to break this chain. These authorities provide a 
dedicated, long-term vision for supporting the education of the new 
nursing workforce. Yet, they must receive additional funding to be 
effective. AACN respectfully requests $200 million for Title VIII 
programs in fiscal year 2008. Additional funding for these programs 
will assist schools of nursing to expand their programs, educate more 
nurse faculty, increase the number of practicing RNs, and ultimately 
improve the patient care provided in our health care system. AACN also 
requests $150 million for NINR so that nurse researchers can continue 
their work to improve the nursing care provided to all patients.
                                 ______
                                 
     Prepared Statement of the American Association of Colleges of 
                          Osteopathic Medicine

    On behalf of the American Association of Colleges of Osteopathic 
Medicine (AACOM), which represents the administrations, faculties, and 
students of all twenty-three colleges of osteopathic medicine in the 
United States, I am pleased to present our views on the fiscal year 
2008 appropriations for Health Professions Education Programs under 
Title VII of the Public Health Service Act.
    First, we want to express our profound concern at the devastating 
cuts sustained by the Title VII programs in appropriations for the last 
two fiscal years. The fiscal year 2006 Labor, Health and Human 
Services, Education and Related Agencies Appropriations bill cut Title 
VII programs from the fiscal year 2005 level by 51.5 percent. 
Unfortunately, the fiscal year 2007 funding level restored only a small 
fraction of these cuts.
    Health Professions Education Programs under Title VII are essential 
components of America's health care safety net. An adequate, diverse, 
well-distributed and culturally competent health workforce is 
indispensable to meeting our current and especially our future health 
service delivery needs. The Title VII programs have been especially 
valuable in our efforts to ensure continuation of this commitment. In 
Public Law 105-392, the Health Professions Education Partnership Act of 
1998, forty-four different Federal health professions training programs 
were consolidated into seven clusters. These clusters provide support 
for training of primary care medicine and dental providers; the 
establishment and operation of interdisciplinary community-based 
training activities; health professions workforce analysis; public 
health workforce development; nursing education; and student financial 
assistance. These programs are designed to meet the health care 
delivery needs of over 2,800 Health Professions Shortage Areas in the 
country. Many rural and disadvantaged populations depend on the health 
professionals trained by these programs as their only source of health 
care. For example, without the practicing family physicians who are 
currently in place, an additional 1,332 of the United States' 1,082 
urban and rural counties would qualify for designation as primary care 
Health Professions Shortage Areas.
    Title VII programs have had a significant impact in reducing the 
Nation's Health Professions Shortage Areas. Indeed, a 1999 study 
estimated that if funding for Title VII program were doubled, the 
effect would be to eliminate the Nations' Health Professions Shortages 
Areas in as little as 6 years. (Politzer, RM, Hardwick, KC, Cultice, 
JM, Bazell, C. ``Eliminating Primary Care Health Professions Shortage 
Areas: The Impact of Title VII Generalist Physician Education,'' The 
Journal of Rural Health, 1999: 15(1): 11-19).
    A study by the Robert Graham Center showed that receipt of Title 
VII family medicine grants by medical schools produced more family 
physicians and more primary care doctors serving in rural areas and 
Health Professions Shortage Areas. Over 69 percent of Title VII funded 
internal medicine graduates practice primary care after graduation. 
This rate is nearly twice that of programs not receiving Title VII 
funding.
    Among the programs within these clusters that have been especially 
important to enhancing osteopathic medical schools' ability to train 
the highest quality physicians are: General Internal Medicine 
Residencies; General Pediatric Residencies; Family Medicine Training; 
Preventive Medicine Residencies; Area Health Education Centers (AHECs); 
Health Education and Training Centers (HETCs); Health Careers 
Opportunity Programs (HCOP); Centers of Excellence (COE) programs; and 
Geriatric Training Authority.
    Accordingly, Mr. Chairman and Members of the subcommittee, AACOM 
recommends that the fiscal year 2008 funding for Title VII Health 
Professions Education Programs and the equally important programs under 
Title VIII, Nursing Education be at least $550 million. This figure is 
consistent with the fiscal year 2008 level recommended by the Health 
Professions and Nursing Education Coalition (HPNEC) for Titles VII and 
VIII.
    AACOM also strongly urges continuation of funding for the Council 
on Graduate Medical Education (COGME). Since its inception, COGME's 
diverse membership has given the health policy community an opportunity 
to discuss national workforce issues. The fifteen formal reports and 
multiple ancillary materials provided by COGME have offered important 
findings and observations in the rapidly changing health care 
environment and have argued for a system of graduate medical education 
that develops a physician workforce to meet the healthcare needs of the 
American people.
    Some of the more significant recommendations include:
  --Community-based education with an emphasis on primary care;
  --Continued progress toward a more representative participation of 
        minorities in medicine;
  --The development and maintenance of a workforce planning 
        infrastructure to improve the understanding, need and demand 
        forces;
  --The development of Federal-State partnerships to further workforce 
        planning; and
  --Encouragement and support for medical education and health care 
        delivery programs that increase the flow of physicians to rural 
        areas, with an emphasis on the smaller, more remote 
        communities.
    With a projected physician workforce shortage looming, the 
activities of COMGE have never been more important.
    Mr. Chairman and members of the subcommittee, we appreciate the 
opportunity to submit this statement. If you have any questions or 
require additional information, please contact me at (301) 968-4141 or 
[email protected], or Michael J. Dyer, AACOM's Vice President for 
Government Relations at (301) 968-4152 or [email protected].
                                 ______
                                 
 Prepared Statement of the American Association of Colleges of Pharmacy

       HHS SUPPORTED PROGRAMS AT COLLEGES AND SCHOOLS OF PHARMACY

    AACP and its member colleges and schools of pharmacy appreciate the 
continued support of the House Appropriations Subcommittee on Labor, 
Health and Human Services, and Education. The 97 accredited colleges 
and schools of pharmacy are engaged in a wide-range of programs that 
are supported by grants and funding administered through the agencies 
of the Department of Health and Human Services (HHS). We also 
understand the difficult task you face annually in your deliberations 
to do the most good for the Nation and remain fiscally responsible to 
the same. AACP respectfully offers the following recommendations for 
your consideration as you undertake your deliberations.

               AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

    AACP supports the Friends of AHRQ recommendation of $350 million 
for AHRQ programs in fiscal year 2008.
    AACP also recommends that the committee direct AHRQ to reestablish 
the provider-based research network grant program.
    The Institute of Medicine (IOM) published two reports in 2006 
regarding the reduction of medication use errors and how we can improve 
medication safety http://www.nap.edu/catalog/11623.html#toc and http://
www.nap.edu/catalog/11750.html#toc. Faculty at colleges and schools of 
pharmacy are actively engaged in teaching, research, and service to 
their communities that addresses nearly every one of these report 
recommendations. Our schools have significant community partnerships 
that can be furthered enhanced through congressional restoration of the 
provider-based research network program at AHRQ.
    AACP members are active grantees in AHRQ Effective Health Care 
Program, providing advice on how pharmacy and pharmaceutical technology 
reduce medical errors and provide for greater patient safety.

            CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

    The fiscal 2008 funding for the CDC should be increased to $6.44 
billion to restore funding for the preventive health and health 
services block grants, to restore the health promotion line item to at 
least fiscal year 2005 levels, and to allow the CDC to continue to 
focus on keeping our Nation well and healthy. AACP also supports the 
Friends of the National Center for Health Statistics (NCHS) 
recommendation that fiscal year 2008 funding be $117 million.
    The curriculum of the Nation's colleges and schools of pharmacy now 
includes significant focus on public health. Much of this focus is 
supported by research, information, and programs developed by the 
Centers for Disease Control and Prevention (CDC). For example, the 
public health elective offered by the University of Montana School of 
Pharmacy requires students to purchase the CDC's ``Epidemiology and 
Prevention of Vaccine-Preventable Diseases.''

          HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)

    AACP supports the Friends of HRSA recommendation of at least $7.65 
billion for HRSA in fiscal year 2008.
    Many research, education, and service activities at our Nation's 
colleges and schools are supported by HRSA. Over the last 6 years, HRSA 
and academic pharmacy have forged a much closer working relationship. 
This strengthened tie is increasing access to comprehensive pharmacy 
services, including better utilization of the 340B drug assistance 
program, for patients served by HRSA grantees and programs. Working 
more closely with academic pharmacy has also improved the care provided 
by HRSA supported providers as evidenced in the clinical pharmacy 
demonstration projects implemented in 18 community health centers 
across the country. The recognition of U.S colleges and schools of 
pharmacy as a resource to the public health safety-net providers can 
play a significant role in improving programs such as the Ryan White 
AIDS programs, including the AIDs Drug Assistance Programs, rural 
health and telemedicine programs, just as it has the community health 
centers program. We would encourage you to request that HRSA continue 
to utilize the academy as a resource for program improvement.
    As mentioned above, AACP members are actively engaged with many 
HRSA programs or with HRSA grantees. The following are examples of that 
engagement.

                        COMMUNITY HEALTH CENTERS

    AACP recommends that the subcommittee provide $100 million within 
the total funding appropriations to CHCs for the development of new 
comprehensive pharmacy programs. AACP further recommends that $50 
million be made available within the total CHC appropriation for the 
creation of shared teaching positions between CHCs and colleges and 
schools of pharmacy to develop and support comprehensive pharmacy 
services programs. Another option for integrating comprehensive 
pharmacy services into CHC services would be to place the cost 
associated with this integration into the base budget of CHC grants.
    Relationships between CHCs and academic pharmacists could decrease 
the gap between the ``bench'' and the ``bedside'' in medication 
management, resulting in more effective, cost-efficient medication 
therapy. CHCs and academic pharmacy institutions continue to forge an 
essential link towards improving the health care provided to patients. 
As the recognized key link in America's health safety net CHCs should 
be encouraged to improve or develop comprehensive pharmacy services 
within their institutions.

            TITLE VII HEALTH PROFESSIONS EDUCATION PROGRAMS

    AACP supports the Health Professions and Nursing Education 
coalition (HPNEC) recommendation of $300 million for Title VII programs 
in fiscal year 2008.
    For nearly every health profession tracked by the U.S. Bureau of 
Labor Statistics, high demand will remain for the foreseeable future. 
Interprofessional education has the potential to help improve health 
care quality and create greater efficiencies by allowing health 
professionals to work productively together. NIH has also recognized 
the growing acceptance of interprofessional research through the ``Road 
Map,'' including allowing multiple primary investigators. Colleges and 
schools of pharmacy are taking a leadership role in the creation of 
interprofessional approaches to health professions education. Faculty 
are working across disciplines to develop interprofessional programs 
and assess their effectiveness through: federally supported programs 
such as Area Health Education Centers across the country; organizations 
such as the Institute for Healthcare Improvement and the Association of 
Academic Health Center; and university level mandates such as that of 
the University of Minnesota. It is essential that Federal support for 
interprofessional education be maintained.

                     NATIONAL HEALTH SERVICES CORPS

    AACP recommends that funding for these programs continue to 
increase, at least at a rate that takes into account inflation, and 
waiting lists.
    As integral as the CHCs are, they require health professionals to 
provide the care. While the Title VII programs are essential in 
creating the education programs that create culturally competent health 
professionals able to provide team-based, patient-centered care, the 
NHSC is the program that gets those providers to the community in 
greatest need. Annual appropriations for the NHSC continue to increase 
in recognition of the role this program plays in helping to improve 
access to care in medically underserved and health professions shortage 
areas.

                     OFFICE OF RURAL HEALTH POLICY

    AACP recommends that the subcommittee fully restore funding to 
Rural Health Care Programs. The ORHP supported Rural Health Research 
Centers grant program is the only source of rural-specific health 
services research supported by the HHS. Rural Health Research Centers 
collaborate with schools and colleges of pharmacy in rural health 
research and dissemination. A paper published by the Upper Midwest 
Rural Health Center (UMRHC) identified pharmacist staffing, finance, 
and access to technology as barriers to medication safety in rural 
hospitals. Through a nationwide survey, the UMRHC found a significant 
positive relationship between pharmacist staffing and the presence and 
quality of medication safety initiatives in rural hospitals. Better 
access to pharmacists in rural hospitals is necessary for reducing 
medication errors and implementing medication safety systems.

                    OFFICE OF TELEHEALTH ADVANCEMENT

    AACP recommends that the subcommittee increase the fiscal year 2008 
appropriation for telehealth to $7 million. AACP further recommends 
that the subcommittee direct the HRSA Office for the Advancement of 
Telehealth to include development of telepharmacy programs as an 
explicit grant funding option.
    Colleges and schools of pharmacy, including North Dakota State 
University College of Pharmacy, Washington State University College of 
Pharmacy, and Texas Tech University have developed successful 
telepharmacy programs that are assisting rural providers and their 
patients improve the management of their medications. The North Dakota 
Telepharmacy Program has restored, retained, or established pharmacy 
services to approximately 40,000 rural citizens in North Dakota and 
Minnesota. The project has not only increased access to medically 
underserved areas, but has also added approximately $12 million in 
economic development to the local rural economies. Duquesne University 
Mylan School of Pharmacy, located in Pittsburgh, Pennsylvania, has 
developed and implemented a telepharmacy program that is assisting 
hospice providers in rural southeastern Pennsylvania, Ohio, West 
Virginia.

                     NATIONAL INSTITUTES OF HEALTH

    AACP, as a member of the Ad Hoc Group for Biomedical Research 
Funding recommends that fiscal year 2008 NIH funding be increased by 
6.7 percent and this same increase be continued for the next 2 years.
    AACP would also ask the Congress to commend the NIH for its 
development of the ``PharmD Gateway to NIH'' and support efforts for 
NIH to create opportunities for the development of new clinical 
pharmacy faculty research.
    Our Nation benefits greatly from both intra and extramural NIH 
research. Our Nation's colleges and schools of pharmacy play an 
important part in that research agenda. Academic pharmacy supports the 
NIH Director's Road Map initiative and is especially pleased with 
recent decisions to allow multiple primary investigators on grants and 
the support of interdisciplinary research. According to 2006 NIH data, 
colleges and schools of pharmacy rank fourth after medicine, public 
health and biomedical engineering in total extramural grant funding. 
AACP is pleased to recognize the committee for its important role in 
doubling the NIH budget, however there is growing concern that without 
continued increases to the NIH budget that work will have been negated. 
In fiscal year 2006 biomedical research conducted by faculty at U.S. 
colleges and schools of pharmacy was supported by $239.7 million. 
Biomedical research is our Nation's best opportunity for finding cures 
for disease and reducing the economic burden of illness and chronic 
illness. The research of academic pharmacy faculty in discovery and 
application is essential at a time when we grow more dependent on 
medications to reduce the impact of chronic and acute illness and 
unexpected threats to our public health.

                      U.S. DEPARTMENT OF EDUCATION

    AACP is pleased that the President continues to recognize the 
importance of higher education to America's global competitiveness. 
What is of growing concern is that the priorities of the administration 
frequently come at the expense of existing programs of importance to 
students attending colleges and schools of pharmacy and the other 
institutions of higher learning they attend in preparation. The ability 
of students to be fully prepared to begin pharmacy studies has been 
heightened through participation in college preparation courses for 
high school students, summer programs for graduated high school 
students, and students entering their professional education through 
programs such as GEAR UP and TRIO. We support the recommendation of the 
Student Aid Alliance that fiscal year 2008 program funding be $350 
million and $1 billion respectively.
    Academic pharmacy is a leader among the health professions 
education community in regard to the development of objective, 
measurable, terminal educational outcomes. Because of growing concern 
about the assessment of student learning and the value-added aspects of 
higher education, faculty at our Nation's colleges and schools of 
pharmacy are ideal resources to work beyond the politics of the 
Spellings Commission on Higher Education. Academic pharmacy is 
committed to improving and demonstrating the value of pharmacy 
education. This commitment led to the creation of AACP's Center for the 
Advancement of Pharmaceutical Education (CAPE). CAPE has established 
and recently redefined and expanded educational outcomes. The CAPE 
outcomes are intended to guide individual institutions in curriculum 
development. The Accrediting Council on Pharmaceutical Education (ACPE) 
has adapted these educational outcomes into its recently revised 
standards and guidelines.
                                 ______
                                 
  Prepared Statement of the American Association for Dental Research 
      (AADR) and the American Dental Education Association (ADEA)

    Discoveries stemming from dental research have reduced the burden 
of oral disease, have led to better oral health for tens of millions of 
Americans, and have uncovered important associations between oral and 
systemic health. Now, dental researchers and educators are poised to 
make new breakthroughs that can result in dramatic progress in medicine 
and health, such as repairing natural form and function to faces 
destroyed by disease, accident, or war injuries; diagnosing systemic 
disease from saliva instead of blood samples; and deciphering the 
complex interactions and causes of oral health care disparities 
involving social, economic, cultural, environmental, racial/ethnic, and 
biological factors. Dental research in large part takes place in 
academic dental institutions where the future oral health workforce 
receives education and training and provides oral health care that 
improves the health of the public. Dental research and education are 
the underpinning of the profession; they enhance the quality of the 
Nation's oral and overall health. This testimony will cover the 
following programs and issues:
    1. Oral Health Research--The National Institutes of Health (NIH) 
and the National Institute of Dental and Craniofacial Research 
(NIDCR)--
    a. Elimination of America's most prevalent infectious disease,
    b. Saliva as a diagnostic tool,
    c. Understanding factors that cause disparities in oral health,
    d. Emerging Possibilities from Dental Researchers,
    2. Dental Education--Title VII General Dentistry and Pediatric 
Dentistry and Workforce Training Programs.
    3. Access to Dental Care--
    a. State Children's Health Insurance Program (SCHIP),
    b. Dental Health Improvement Act,
    c. Centers for Disease Control and Prevention: Division of Oral 
            Health,
    d. and Ryan White CARE Act: Dental Reimbursement and Community-
            based Partnerships Programs

                              INTRODUCTION

    The American Association for Dental Research (AADR) represents the 
oral health research community within the United States, and the 
American Dental Education Association (ADEA) represents over 120 
academic dental institutions as well as all of the educators, 
researchers, residents and students training at these institutions. 
Together our organizations represent over 21,000 members in academic 
dental and dental research institutions throughout the Nation. The 
joint mission of AADR and ADEA is to enhance the quality and scope of 
oral health, advance research and increase knowledge for the 
improvement of oral health, and increase opportunities for scientific 
innovation. Academic dental institutions play an essential role in 
conducting research and educating and training the future oral health 
workforce. Academic dental institutions provide dental care to 
underserved low-income populations, including individuals covered by 
Medicaid and the State Children's Health Insurance Program.
    We thank the committee for this opportunity to submit testimony 
regarding the exciting advances in oral health sciences. There are 
extraordinary opportunities being created through oral health research 
and education. Herein we submit our fiscal year 2008 budget 
recommendations for the National Institute of Dental and Craniofacial 
Research (NIDCR), Title VII Health Professions Education and Training 
Programs administered by the Health Resources and Services 
Administration (HRSA), the Dental Health Improvement Act, the State 
Children's Health Insurance Program (SCHIP), the Centers for Disease 
Control and Prevention's Oral Health Programs, and the Ryan White CARE 
Act, HIV/AIDS Dental Reimbursement Program and the Community Based 
Dental Partnership Program.

                          ORAL HEALTH RESEARCH

    Dental research is concerned with the prevention, causes, 
diagnosis, and treatment of diseases and disorders that affect the 
teeth, mouth, jaws, and related systemic diseases. Dental health is an 
important, vital part of health throughout life, and through dental 
research and education, we can enhance the quality and scope of oral 
health. Dental research has produced tremendous benefits for the health 
and well-being of our Nation and the world. Nonetheless, much remains 
to be done as identified in the Surgeon General's Report of 2000--Oral 
Health in America \1\ and in the 2003--National Call to Action to 
Promote Oral Health.\2\ 
---------------------------------------------------------------------------
    \1\ Oral Health in America: A Report of the Surgeon General, U.S. 
Department of Health and Human Services, 2000.
    \2\ National Call to Action to Promote Oral Health, U.S. Department 
of Health and Humans Services, 2003.
---------------------------------------------------------------------------
    We applaud Congress for demonstrating its overwhelming bipartisan 
support for NIH by passing the NIH Reform Act of 2006. This 
reauthorization legislation is an affirmation of the importance of NIH 
and its vital role in advancing biomedical research to improve the 
health of the Nation. A renewed national commitment to research and 
fighting disease, through increased support for the NIH, will allow us 
to capitalize on new and unprecedented scientific opportunities in oral 
health research.
Eliminating American's most prevalent infectious disease
    America's most prevalent infectious disease is dental decay 
(caries)! It is five times more common than asthma and seven times more 
common than hay fever in school children. Americans spend millions of 
dollars annually in dental caries treatments and tooth restoration. 
Over the past 50 years, discoveries stemming from dental research have 
reduced the burden of dental caries (tooth decay) for many Americans. 
Now, the burden of the disease, in terms of both extent and severity, 
has shifted dramatically to a subset of our population. About a quarter 
of the population now accounts for about 80 percent of the disease 
burden. Dental caries remains a significant problem for vulnerable 
populations of children and people who are economically disadvantaged, 
elderly, chronically ill, or institutionalized.
    Dental caries is a chronic, infectious disease process that occurs 
when a relatively high proportion of bacteria within dental plaque 
begin to damage tooth structure. Most infectious diseases are treated 
through medications, not surgery. But, it has been difficult to treat 
caries this way because our existing diagnostic techniques lack the 
sensitivity to catch it early enough. New strategies for the 
prevention, diagnosis, cure and repair of dental caries are being 
studied and developed by scientists funded through the NIDCR. If caries 
can be diagnosed before irreversible loss of tooth structure occurs, it 
can be reversed using a variety of approaches that ``remineralize'' the 
tooth. In addition to improved diagnostics, some researchers are 
working to develop a vaccine to prevent tooth decay, while others use 
new methods to specifically target and kill the decay-causing bacteria.
Saliva as a Diagnostic Tool
    The development of new diagnostic tests based on the analysis of 
biomarkers in saliva will allow clinicians to more reliably diagnose 
disease and monitor health conditions much earlier than is currently 
possible. Salivary diagnostics is already being used for rapid, non-
invasive HIV screening, and saliva-based tests will soon be available 
for oral cancer screening. Oral cancers and cancer of the larynx are 
diagnosed in 41,000 individuals accounting for 12,500 deaths per year 
in the United States. The death rate associated with this cancer is 
especially high due to delayed diagnosis. Now, scientists funded by the 
NIDCR have taken a major step forward in using saliva to detect oral 
cancer. Elevated levels of distinct, cancer-associated molecules in 
saliva can be used to distinguish between healthy people and those with 
cancer. Soon, with further research, commercial diagnostic tests will 
be developed for oral squamous cell carcinoma with the 99+ percent 
accuracy expected for such tests.
    Using saliva may also be possible for diagnosing and monitoring 
many other systemic health conditions as well as exposure to chemical 
and biological agents. Early diagnosis could potentially save thousands 
of lives.
Understanding Factors that Cause Disparities in Oral Health
    Despite tremendous improvements in the Nation's oral health over 
the past decades, the benefits have not been equally shared by millions 
of low-income and underserved Americans. High-risk populations, 
including poor, inner-city, elderly, rural, and groups with special 
health-care needs, all suffer a disproportionate and debilitating 
amount of oral disease. Research is needed to identify the factors that 
determine disparities in oral health and disease. These factors may 
include proteomic, genetic, environmental, social, and behavioral 
aspects and how they influence oral health singly or in combination. 
Translational and clinical research is underway to analyze the 
prevalence, etiology, and impact of oral conditions on disadvantaged 
and underserved populations and on the systemic health of these 
populations. In addition, community- and practice-based disparities 
research, funded by the NIDCR and the Centers for Disease Control and 
Prevention's Oral Health Programs, can help to identify and reduce 
risks, enhance oral health-promoting behaviors, and help integrate 
research findings directly into oral health care practice.
Other Emerging Exciting Areas in Dental Research
    Looking towards the future--imagine a time when you won't need x-
rays to diagnose tooth decay; instead a molecular or electronic probe 
will do the job. Or imagine teeth being restored to health, not with 
fillings, but with simple mineral rinses or bioengineering techniques. 
This is closer to reality than you might envision!
  --Tissue engineering.--Tissue engineering holds great potential to 
        repair the ravages of orofacial disease, trauma, war injuries, 
        and birth defects, including the bioengineering of complete, 
        fully functional replacement teeth.
  --Stem cells.--Isolating stem cells from the ligament around third 
        molars (wisdom teeth) and from human exfoliated deciduous teeth 
        (baby teeth) holds the distinct possibility that one day--in 
        the near future--we may be able to repair dental and 
        craniofacial defects by growing new tissues.
  --System-oral health linkages.--There is strong evidence of an 
        association between gum (periodontal) disease and systemic 
        events such as cardiovascular disease, diabetes, and adverse 
        pregnancy outcomes. Continued oral health research will provide 
        insight into the prevention and treatment of these and other 
        systemic conditions with links to oral health.
  --Practice Based Research Networks.--By connecting practitioners with 
        experienced clinical investigators, Practice Based Research 
        Networks (PBRNs) can enhance the utility of clinical research 
        funded by NIDCR by developing data and new techniques that may 
        be immediately relevant to practitioners and their patients.

                            DENTAL EDUCATION

Title VII Programs, Public Health Service Act
    Title VII Education and Training Programs are critical. Support for 
these programs is essential to expanding existing or establishing new 
general dentistry and pediatric dentistry residency programs. Title VII 
general and pediatric dental residency training programs have shown to 
be effective in increasing access to care and enhancing dentists' 
expertise and clinical experiences to deliver a wide range of oral 
health services to a broad patient pool, including geriatric, 
pediatric, medically compromised patients, and special needs patients. 
Title VII support increases access to care for Medicaid and SCHIP 
populations. The value of these programs is underscored by reports of 
the Advisory Committee on Training in Primary Care Medicine and 
Dentistry and the Institute of Medicine. Without adequate funding for 
general dentistry and pediatric dentistry training programs it is 
anticipated that access to dental care for underserved populations will 
worsen.
    AADR/ADEA also supports the funding requests advanced by National 
Council for Diversity in the Health Professions for the Health 
Resources and Services Administration's diversity programs, namely the 
Scholarship for Disadvantaged Students, Health Careers Opportunity 
Program, Centers of Excellence, and the Faculty Loan Repayment Program.

                         ACCESS TO DENTAL CARE

State Children's Health Insurance Program
    Reauthorization of the State Children's Health Insurance Program 
(SCHIP) represents a singular opportunity to move closer to the widely-
shared goal of ensuring that all of America's children have health care 
coverage. Congress has taken a significant step in that direction by 
signaling in the House and Senate budget resolutions a willingness to 
provide $50 billion in new funding for SCHIP reauthorization. Now, 
relying on the bipartisan support for SCHIP, Congress must work to 
ensure in a timely manner that SCHIP reauthorization legislation is 
fully funded and that it includes policies that will support States' 
efforts to cover more children.
    Minority, low-income, and geographically isolated children suffer 
disproportionately from dental conditions. Dental care tops the list of 
parent reported unmet needs, with parent reports of unmet dental needs 
three times as often as medical care and four times that of vision 
care. For children with special needs, dental care is the most 
prevalent unmet health care need surpassing mental health, home health, 
hearing aids and all other services. Despite the magnitude of need, 
dental coverage has remained an optional benefit in SCHIP. All States 
have recognized that poor oral health affects children's general health 
and have opted to provide dental coverage. However, dental coverage is 
often the first benefit cut when States seek budgetary savings. SCHIP 
lacks a stable and consistent dental benefit that would provide a 
comprehensive approach to children's health while reducing costly 
treatments caused from advanced dental disease. Congress can help 
stabilize access to oral health care services to underserved children 
by improving funding for the SCHIP program. It is vital that Congress 
deliver on its pledge for children's health coverage of $50 billion in 
new funds for SCHIP and Medicaid as indicated in the congressional 
budget resolutions. This level of funding is the minimum amount needed 
to allow States to sustain their existing SCHIP programs, reach a 
significant share of the uninsured children already eligible for SCHIP 
and Medicaid, and support ongoing State efforts to expand oral health 
care coverage.
Dental Health Improvement Act
    The recent reports of tragic deaths of Deamonte Driver, a 12-year-
old from Maryland, and Alexander Callender, a 6-year-old from 
Mississippi, as a result of unmet dental needs tragically illustrate 
that all children regardless of resources or economic status should 
have access to oral health care.
    Congress provided first-time funding of $2 million in fiscal year 
2006 for the Dental Health Improvement Act, a program established in 
2001, to assist States in developing innovative dental workforce 
programs. The first grants were awarded to States last Fall and are 
being used for a variety of important initiatives including: increasing 
hours of operation at clinics caring for underserved populations, 
recruiting and retaining dentists to work in these clinics, prevention 
programs including water fluoridation, dental sealants, nutritional 
counseling, and augmenting the State dental offices to coordinate oral 
health and access issues.
Centers for Disease Control and Prevention (CDC) Division of Oral 
        Health
    The Centers for Disease Control and Prevention Oral Health Program 
expands the coverage of effective prevention programs by building basic 
capacity of State oral health programs to accurately assess the needs 
in their State, organize and evaluate prevention programs, develop 
coalitions, address oral health in State health plans, and effect 
allocation of resources to the programs. CDC's funding and technical 
assistance to States is essential to help oral health programs build 
capacity.
    An additional $4 million over fiscal year 2007 funding of $11.6 
million is necessary so additional States requesting support to improve 
their capacity to validate, build, and sustain effective preventive 
interventions to reduce health disparities among their citizens can be 
funded. Funding for current grantees expires at the end of fiscal year 
2007. Twenty-four States have previously applied for these grants but 
due to limited funding only 12 States were awarded. Increasing CDC 
funding will help to ensure that all States that apply may be awarded 
an oral health grant.
Dental Reimbursement and Community-based Dental Partnership Program
    Congress designated dental care as a ``core medical service'' when 
it reauthorized the Ryan White program in 2006. The Dental 
Reimbursement Program provides access to quality dental care to people 
living with HIV/AIDS while simultaneously providing educational and 
training opportunities to dental residents, dental students, and dental 
hygiene students who deliver the care. The Dental Reimbursement Program 
is a cost-effective Federal/institutional partnership that provides 
partial reimbursement to academic dental institutions for costs 
incurred in providing dental care to people living with HIV/AIDS. The 
Community-Based Dental Partnership Program fosters partnerships between 
dental schools and communities lacking academic dental institutions to 
ensure access to dental care for HIV/AIDS patients living in those 
areas.

       AADR/ADEA FISCAL YEAR 2008 FUNDING RECOMMENDATIONS SUMMARY

    To maintain support for the biomedical research at the NIH AADR/
ADEA recommends $31.3 billion for the National Institutes of Health 
(NIH) including $425 million for the National Institute of Dental and 
Craniofacial Research (NIDCR).
    Support the development of innovative dental workforce programs 
specific to States' needs and increase access to dental care for 
underserved populations. AADR/ADEA recommends $10 million for the 
Dental Health Improvement Act.
    Help build basic capacity of State oral health programs. AADR/ADEA 
recommends $15.6 million for the CDC Dental Block Grants.
    Support education and training of the dental workforce for the 
future. AADR/ADEA recommends $450.2 million for the full complement of 
Title VII health professions programs including:
  --$89 million for the primary care medicine and dentistry cluster to 
        assure:
    --$10 million for General and Pediatric Dental Residency Training.
  --$118 million for the diversity and student assistance cluster:
    --$33.6 million for Centers of Excellence;
    --$35.6 million for Health Careers Opportunity Program;
    --$1.3 million for the Faculty Loan Repayment Program; and
    --$47.1 million for Scholarships for Disadvantaged Students.
    Help provide access to oral health care services in SCHIP. AADR/
ADEA recommends $50 billion in new funds for SCHIP and Medicaid.
    Assist people with HIV/AIDS, whose immune systems are weakened, to 
have access to quality dental care. AADR/ADEA recommends $19 million 
for of the Ryan White HIV/AIDS Treatment and Modernization Act, the 
Dental Reimbursement Program and the Community-based Dental 
Partnerships Program.
                                 ______
                                 
Prepared Statement of the American Association for Geriatric Psychiatry

    The American Association for Geriatric Psychiatry (AAGP) 
appreciates this opportunity to present its recommendations on issues 
related to fiscal year 2008 appropriations for mental health research 
and services. AAGP is a professional membership organization dedicated 
to promoting the mental health and well being of older Americans and 
improving the care of those with late-life mental disorders. AAGP's 
membership consists of approximately 2,000 geriatric psychiatrists as 
well as other health professionals who focus on the mental health 
problems faced by senior citizens.
    AAGP appreciates the work this subcommittee has done in recent 
years in support of funding for research and services in the area of 
mental health and aging through the National Institutes of Health (NIH) 
and the Substance Abuse and Mental Health Services Administration 
(SAMHSA). Although we generally agree with others in the mental health 
community about the importance of sustained and adequate Federal 
funding for mental health research and treatment, AAGP brings a unique 
perspective to these issues because of the elderly patient population 
served by our members.

       DEMOGRAPHIC PROJECTIONS AND THE MENTAL DISORDERS OF AGING

    With the baby boom generation nearing retirement, the number of 
older Americans with mental disorders is certain to increase in the 
future. By the year 2010, there will be approximately 40 million people 
in the United States over the age of 65. Over 20 percent of those 
people will experience mental health problems.
    Current and projected economic costs of mental disorders alone are 
staggering. It is estimated that total costs associated with the care 
of patients with Alzheimer's disease is over $100 billion per year in 
the United States. Psychiatric symptoms (including depression, 
agitation, and psychotic symptoms) affect 30 to 40 percent of people 
with Alzheimer's and are associated with increased hospitalization, 
nursing home placement, and family burden. These psychiatric symptoms, 
associated with Alzheimer's disease, can increase the cost of treating 
these patients by more than 20 percent.
    Depression is another example of a common problem among older 
persons. Of the approximately 32 million Americans who have attained 
age 65, about 5 million suffer from depression, resulting in increased 
disability, general health care utilization, and increased risk of 
suicide. Depression is associated with poorer health outcomes and 
higher health care costs. Co-morbid depression with other medical 
conditions affects a greater use and cost of medications as well as 
increased use of health services (e.g., medical outpatient visits, 
emergency visits, and hospitalizations). For example, individuals with 
depression are admitted to the emergency room for hypertension, 
arthritis, and ulcers at nearly twice the rate of those without 
depression. Those individuals with depression are more likely to be 
hospitalized for hypertension, arthritis, and ulcers than those without 
depression. Those with depression experience almost twice the number of 
medical visits for hypertension, arthritis and ulcers than those 
without depression. Finally, the cost of prescriptions and number of 
prescriptions for hypertension, arthritis, and ulcers were more than 
twice than those without depression.
    Older adults have the highest rate of suicide compared to any other 
age group. Comprising only 13 percent of the U.S. population, 
individuals age 65 and older account for 19 percent of all suicides. 
The suicide rate for those 85 and older is twice the national average. 
More than half of older persons who commit suicide visited their 
primary care physician in the prior month--a truly stunning statistic.

     THE CHALLENGE OF MEETING THE MENTAL HEALTH NEEDS OF THE AGING 
POPULATION--PROPOSAL FOR IOM STUDY ON MENTAL HEALTH WORKFORCE NEEDS OF 
                            OLDER AMERICANS

    The Institute of Medicine (IOM) of the National Academy of Sciences 
is currently undertaking a study of the readiness of the Nation's 
healthcare workforce to meet the needs of its aging population. IOM has 
recommended in discussions with AAGP that, because this study will not 
delve deeply into the composition of the mental health workforce needed 
to meet future needs of the elderly, a complementary study be 
undertaken to consider specifically this vital area of concern. This 
complementary study will focus on the mental health professional 
workforce that will be needed to meet the demands of the aging 
population in this country. IOM is extremely supportive of this 
proposed study and feel that it would complement their current study on 
broad health needs of older adults. IOM has advised AAGP that $1 
million would be needed to undertake this complementary mental health 
study.
    In discussions with AAGP, the senior staff of IOM suggested the 
following language for inclusion in the fiscal year 2008 Labor HHS 
Appropriations bill:

    ``The committee provides $1,000,000 for a study by the Institute of 
Medicine of the National Academy of Sciences to determine the multi-
disciplinary mental health workforce needed to serve older adults. The 
initiation of this study should be not later than 60 days after the 
date of enactment of this act, whereby the Secretary of Health and 
Human Services shall enter into a contract with the Institute of 
Medicine to conduct a thorough analysis of the forces that shape the 
mental health care workforce for older adults, including education, 
training, modes of practice, and reimbursement.''

    This proposal for funding for an IOM study on mental health 
workforce needs of older Americans is supported by the IOM, and AAGP 
strongly urges its inclusion in the fiscal year 2008 Labor HHS 
Appropriations bill.

                  NATIONAL INSTITUTE OF MENTAL HEALTH

    In his fiscal year 2008 budget, the President again proposed 
decreased funding for the National Institutes of Health (NIH). This 
decline in funding would have a devastating impact on the ability of 
NIH to sustain the ongoing, multi-year research grants that have been 
initiated in recent years.
    AAGP would like to call to the subcommittee's attention the fact 
that, even in the years in which funding was increased for NIH and 
NIMH, these increases did not always translate into comparable 
increases in funding that specifically address problems of older 
adults. Data supplied to AAGP by NIMH indicates that while extramural 
research grants by NIMH increased 59 percent during the 5-year period 
from fiscal year 1995 through fiscal year 2000 (from $485,140,000 in 
fiscal year 1995 to $771,765,000 in fiscal year 2000), NIMH grants for 
aging research increased at less than half that rate: only 27.2 percent 
during the same period (from $46,989,000 to $59,771,000).
    Despite the fact that over the past 6 years Congress, through 
committee report language, has specifically urged NIMH to increase 
research grant funding devoted to older adults, this has not occurred. 
The critical disparity between Federally funded research on mental 
health and aging and the projected mental health needs of older adults 
is continuing. If the mental health research budget for older adults is 
not substantially increased immediately, progress to reduce mental 
illness among the growing elderly population will be severely 
compromised. While many different types of mental and behavioral 
disorders occur in late life, they are not an inevitable part of the 
aging process, and continued and expanded research holds the promise of 
improving the mental health and quality of life for older Americans.

                   CENTER FOR MENTAL HEALTH SERVICES

    It is also critical that there be adequate funding for the mental 
health initiatives under the jurisdiction of the Center for Mental 
Health Services (CMHS) within SAMHSA. While research is of critical 
importance to a better future, the patients of today must also receive 
appropriate treatment for their mental health problems. SAMHSA provides 
funding to State and local mental health departments, which in turn 
provide community-based mental health services to Americans of all 
ages, without regard to the ability to pay. AAGP was pleased that the 
final budgets for the last 5 years have included $5 million for 
evidence-based mental health outreach and treatment to the elderly. 
AAGP worked with members of this subcommittee and its Senate 
counterpart on this initiative, which is a very important program for 
addressing the mental health needs of the Nation's senior citizens. 
However, AAGP is extremely alarmed to see that this program was 
eliminated in President Bush's fiscal year 2008 budget proposal. 
Restoring and increasing this mental health outreach and treatment 
program must be a top priority, as it is the only Federally funded 
services program dedicated specifically to the mental health care of 
older adults.
    The greatest challenge for the future of mental health care for 
older Americans is to bridge the gap between scientific knowledge and 
clinical practice in the community, and to translate research into 
patient care. Adequate funding for this geriatric mental health 
services initiative is essential to disseminate and implement evidence-
based practices in routine clinical settings across the States. 
Consequently, we would urge that the $5 million for mental health 
outreach and treatment for the elderly included in the CMHS budget for 
fiscal year 2007 be increased to $20 million for fiscal year 2008. Of 
that $20 million appropriation, AAGP believes that $10 million should 
be allocated to a National Evidence-Based Practices Program, which will 
disseminate and implement evidence-based mental health practices for 
older persons in usual care settings in the community. This program 
will provide the foundation for a longer-term national effort that will 
have a direct effect on the well-being and mental health of older 
Americans.

              HEALTH RESOURCES AND SERVICES ADMINISTRATION

    Despite growing evidence of the need for more geriatric specialists 
to care for the Nation's elderly population, a critical shortage 
persists. AAGP appreciates the work of this subcommittee in providing 
for the restoration of funding for the geriatric health professions 
programs under Title VII of the Public Health Service Act, which was 
eliminated for fiscal year 2006. The restoration of this programs has 
prevented a devastating impact on physician workforce development over 
the next decade, with would have dangerous consequences for the growing 
population of older adults who will need access to appropriate 
specialized care. The administration has again proposed eliminating 
most Title VII programs, including geriatrics. We urge the subcommittee 
to fund them at the final fiscal year 2007 level. The geriatric health 
professions program supports three important initiatives. The Geriatric 
Faculty Fellowship trains faculty in geriatric medicine, dentistry, and 
psychiatry. The Geriatric Academic Career Award program encourages 
newly trained geriatric specialists to move into academic medicine. The 
Geriatric Education Center (GEC) program provides grants to support 
collaborative arrangements that provide training in the diagnosis, 
treatment, and prevention of disease.

                               CONCLUSION

    Based on AAGP's assessment of the current need and future 
challenges of late life mental disorders, we submit the following 
fiscal year 2008 funding recommendations:
    1. An Institute of Medicine study on the future mental health 
workforce needs for older adults should be funded at $1 million. This 
proposed report is fully supported by IOM.
    2. The current rate of funding for aging grants at NIMH and CMHS is 
inadequate and should be increased to at least three times their 
current funding levels. In addition, the substantial projected increase 
in mental disorders in our aging population should be reflected in the 
budget process in terms of dollar amount of grants and absolute number 
of new grants.
    3. To help the country's elderly access necessary mental health 
care, previous years' funding of $5 million for evidence-based mental 
health outreach and treatment for the elderly within CMHS must be 
increased to $20 million.
    4. Funding for the geriatric health professions program under Title 
VII of the Public Health Service Act should be continued at fiscal year 
2007 levels.
    AAGP looks forward to working with the members of this subcommittee 
and others in Congress to establish geriatric mental health research 
and services as a priority at appropriate agencies within the 
Department of Health and Human Services.
                                 ______
                                 
    Prepared Statement of the American Association of Immunologists

    The American Association of Immunologists (``AAI''), a not-for-
profit professional society representing more than 6,500 of the world's 
leading experts on the immune system, appreciates having this 
opportunity to submit testimony regarding fiscal year 2008 funding for 
the National Institutes of Health (NIH). The NIH budget is of great 
concern to our members--research scientists and physicians who work in 
academia, government, and industry--many of whom depend on NIH funding 
to support their work.\1\ With approximately 83 percent of NIH's $28.9 
billion budget awarded to more than 325,000 scientists throughout the 
United States and around the world, NIH's funding level drives not only 
the advancement of immuno-logical and biomedical research, but also the 
economic activity that fuels local and national economies.\2\
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    \1\ The majority of AAI members are medical school and university 
professors and researchers who receive research grants from NIH, and in 
particular from the National Institute of Allergy and Infectious 
Diseases (NIAID), the National Cancer Institute (NCI), and the National 
Institute on Aging (NIA).
    \2\ NIH funding ``supports peer-reviewed . . . research at more 
than 3,000 universities, medical schools, hospitals, and research 
institutions throughout the 50 States and over-
seas . . . . Additionally, NIH supports 6,000 intramural scientists in 
its own laboratories.'' Fiscal Year 2008 Director's Budget Request 
Statement: Fiscal Year 2008 Budget Request, Witness appearing before 
the House Subcommittee on Labor-HHS-Education Appropriations, Elias A. 
Zerhouni, M.D., Director, National Institutes of Health (March 6, 
2007).
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                            WHY IMMUNOLOGY?

    Basic research on the immune system provides a foundation for the 
discovery of ways to prevent, treat, and cure disease through the 
development of diagnostics, vaccines, and therapeutics.\3\ 
Immunologists use animal models to test theories about immune system 
function and treatments; \4\ if successful, treatments are then tested 
on human subjects through clinical trials before being approved for use 
by the Food and Drug Administration (``FDA'') and made available to the 
general population.
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    \3\ The immune system works by recognizing and attacking ``foreign 
invaders'' (i.e., bacteria and viruses) inside the body and by 
controlling the growth of tumor cells. A healthy immune system can 
protect its human or animal host from illness or disease either 
entirely--by attacking and destroying the virus, bacterium, or tumor 
cell--or partially, resulting in a less serious illness. It will also 
reject transplanted organs and bone marrow. The immune system can 
malfunction, allowing the body to attack itself instead of an invader 
(resulting in an ``autoimmune'' disease like Type 1 diabetes, multiple 
sclerosis, or rheumatoid arthritis).
    \4\ Without animal experimentation, immunologists and other 
researchers would have to use human subjects, an ethically unacceptable 
alternative. Despite the clear necessity for animal research, 
scientists continue to be threatened by people and organizations that 
oppose such research.
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    Immunological research focuses on many of the diseases that most 
threaten life and health: infectious diseases like HIV/AIDS, influenza 
and avian flu, and malaria; and chronic diseases, like diabetes, 
cancer, and autoimmune diseases. In recent years, immunologists have 
also been studying the immune response to natural infectious organisms 
that may be modified for use as agents of bioterrorism, including 
plague, smallpox, and anthrax. As described below, this crucial work is 
already bearing fruit.

          RECENT SCIENTIFIC DISCOVERIES: BLOCKBUSTERS AND HOPE

    The past year has brought tremendous advances in vaccine 
development, with promising results in preliminary clinical trials of a 
vaccine for HIV/AIDS. The vaccine has been shown to be safe and to 
stimulate cellular immune responses against HIV in more than half of 
the subjects. Scientists have also discovered that the chickenpox 
vaccine can be given to adults in order to prevent the occurrence of 
painful shingles in later years. The hallmark of recent vaccine 
research was the final FDA approval of the first vaccine against 
cancer, a vaccine for HPV (Human Papillomavirus). HPV infects over 8 
percent of women aged 15-50 and can cause cervical cancer; the new 
vaccine is efficacious both in preventing primary infection and 
importantly, in reducing the incidence of cervical cancer.
    Immunologists have also made novel insights into understanding 
``innate'' or ``natural'' immune responses (those that do not require 
immunization or prior exposure) and the role of soluble factors in 
inflammation; this has helped scientists discover what appears to have 
made the 1918 influenza strain so deadly. This discovery may lead to 
more effective life-saving treatments for influenza patients and will 
also have broader implications for diseases caused by pandemic 
influenza, other viruses and bacteria. This and other such advances 
depend on substantial, reliable, and sustained public investment in 
basic immunological research.

     BUT THE NIH BUDGET HAS GONE DOWN, THREATENING ONGOING PROGRESS

    AAI is very grateful to this subcommittee and the Congress for its 
successful bipartisan effort to double the NIH budget from fiscal year 
1999 to fiscal year 2003. This unprecedented commitment by the Federal 
Government to biomedical research allowed scientists to grow the 
research enterprise and train new young investigators. Researchers had 
begun to capitalize on many important advances, leading to increased 
translational and clinical applications. Unfortunately, this momentum 
has already been hampered by sub-inflationary budget increases since 
fiscal year 2003.\5\ As a result, although the NIH budget has slightly 
increased (from $27.067 billion in fiscal year 2003 to $28.931 billion 
in fiscal year 2007), NIH has already lost about 8.5 percent in 
purchasing power since fiscal year 2003. This loss in purchasing power, 
which would grow to about 13.3 percent if the President's fiscal year 
2008 budget were approved,\6\ is already having a devastating effect:
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    \5\ NIH funding increases since the doubling period ended [fiscal 
year 2004 (3.03 percent), fiscal year 2005 (2.18 percent) and fiscal 
year 2006 (-.12 percent)] have all been below the ``Biomedical Research 
and Development Price Index (``BRDPI''), a U.S. Department of Commerce 
annual estimate of the cost of inflation for biomedical research. U.S. 
Department of Health and Human Services memo dated February 5, 2007: 
``Biomedical Research and Development Price Index: Fiscal Year 2006 
Update and Projections for Fiscal Year 2007-2012.'' http://
officeofbudget.od.nih.gov/PDF/BRDPI_letter_25_07.pdf http://
officeofbudget.od.nih.gov/BRDPI_2_5_07.pdf
    \6\ The President's fiscal year 2008 budget cuts the NIH budget by 
about $529 million.
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    1. Key NIH Institutes have already had to drop their RO1 paylines 
to 10-14 percent, significantly below the approximately 22 percent 
funded during the doubling. With funding so low, even outstanding grant 
applications are not being funded on their first submission, forcing 
even the most successful senior investigators to spend valuable time on 
revising and resubmitting their applications.
    2. The President's budget would provide no inflationary increases 
for direct, recurring costs in non-competing Research Project Grants 
(RPGs), for the 3rd straight year.
    3. Although the fiscal year 2007 Joint Funding Resolution provides 
$91 million to fund 1,500 first-time investigators, the President's 
fiscal year 2008 budget will either be unable to sustain that promising 
new effort, or will do so at the expense of funding established 
investigators.
    4. The President's budget would not permit increases in already 
inadequate stipends and benefits for post-doctoral fellows, whose work 
is critical to today's established investigators and who will be the 
principal scientists of tomorrow.
    The President's fiscal year 2008 budget would have rapid and long-
term adverse repercussions on Americans' health and the national 
economy: in addition to their terrible human toll, disease and 
disability cost society trillions of dollars annually in medical care, 
lost wages and benefits, and lost productivity.\7\ The President's 
budget would also jeopardize the future of the biomedical research 
enterprise: our brightest young people will be deterred from pursuing 
biomedical research careers if their chances of receiving an NIH grant, 
or of being able to sustain a career as an NIH-funded scientist, do not 
improve. If we are unable to attract and retain the best young minds, 
the United States will lose more of its senior scientists, as well as 
its preeminence in medical research, science, and technology, to 
nations (including India, Singapore, and China) that are already 
investing heavily in this essential economic sector.
---------------------------------------------------------------------------
    \7\ National health expenditures cost $3.28 trillion in 2006 and 
are projected to rise to $4.1 trillion in 2016. U.S. Department of 
Health and Human Services--Centers for Medicare and Medicaid Services 
National Health Expenditure Data http://www.cms.hhs.gov/
NationalHealthExpendData/downloads/proj2006.pdf http://www.cms.hhs.gov/
NationalHealthExpendData/downloads/highlights.pdf
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   aai recommends a 6.7 percent budget increase for fiscal year 2008
    AAI urges the subcommittee to increase the NIH budget by 6.7 
percent ($1.9 billion) in fiscal year 2008, to $30.8 billion. This 
increase, which is only 3 percent above the projected rate of 
biomedical research inflation,\8\ would begin to restore the loss in 
purchasing power that has occurred since the NIH budget doubling ended 
in fiscal year 2003. (Full restoration will require that NIH also 
receive 6.7 percent increases in fiscal year 2009 and fiscal year 
2010.)
---------------------------------------------------------------------------
    \8\ See Footnote 5, supra. The BRDPI for fiscal year 2008 is 
projected to be 3.7 percent.
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         REAL AND IMMEDIATE THREATS: INFLUENZA AND BIOTERRORISM

    Seasonal influenza leads to more than 200,000 hospitalizations and 
about 36,000 deaths nationwide in an average year. Moreover, an 
influenza pandemic as serious as the one that occurred in 1918 could 
result in the illness of almost 90 million Americans and the death of 
more than 2 million, at a projected cost of $683 billion.\9\ And yet, 
while one potential pandemic influenza strain, H5N1 (avian influenza), 
has already killed more than 150 people around the world, the 
President's fiscal year 2008 NIH budget will permit NIAID to devote 
only $223.2 million to influenza ($11.5 million more than fiscal year 
2007). This is an insufficient increase for the agency with primary 
responsibility for both the scientific research and clinical trials 
needed to develop vaccines, antiviral drugs, and diagnostic tools to 
combat both seasonal and pandemic influenza.\10\
---------------------------------------------------------------------------
    \9\ A report issued by Trust for America's Health (``Pandemic Flu 
and the Potential for U.S. Economic Recession'') predicts that a severe 
pandemic flu outbreak could result in the second worst recession in the 
United States since World War II, resulting in a drop in the U.S. Gross 
Domestic Product of over 5.5 percent.
    \10\ The Department of Health and Human Services Pandemic Influenza 
Preparedness and Response Plan gives primary responsibility to NIH, and 
specifically to NIAID.
---------------------------------------------------------------------------
    AAI is also concerned that the President's fiscal year 2008 NIH 
budget leaves inadequate funding for biodefense research; the $1.7 
billion allocated represents a net decrease of 0.4 percent (4.1 percent 
after accounting for projected inflation) from fiscal year 2007. 
Although the availability of non-recurring construction costs will 
allow NIAID to devote an additional $17 million to this research, this 
inadequate increase is restricting research into the human response to 
the many natural and man-made pathogens that could be used for 
nefarious purposes.
    AAI strongly believes that the best preparation for a pandemic or 
bioterrorism is to focus on basic research: for a pandemic, the focus 
should be on seasonal flu, including building capacity, pursuing new 
production methods (cell based), and seeking optimized flu vaccines and 
delivery methods. For bioterrorism, the focus should be on identifying 
new pathogens, understanding the immune response, and developing tools 
(including new and more potent vaccines) to protect against the 
pathogen.\11\
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    \11\ The President's fiscal year 2008 HHS budget requests only $211 
million for the Biomedical Advanced Research and Development Agency 
(``BARDA''), a new agency established to foster the translation of NIH 
research into development of medical and bioterrorism countermeasures. 
AAI is concerned that if BARDA's budget is inadequate to support its 
work, NIH may be forced to assume either duties or costs for BARDA.
---------------------------------------------------------------------------
The new ``National Institutes of Health (NIH) Reform Act of 2006''
    The NIH Reform Act of 2006 calls for the establishment of a 
Division of Portfolio Analysis and Strategic Initiatives to better 
analyze NIH's portfolio, provide leadership and coordination for trans-
NIH research initiatives (including the NIH ``Roadmap for Medical 
Research''), and fund new trans-NIH initiatives through a ``Common 
Fund''. Although AAI supports this effort to improve NIH analysis and 
management, AAI urges (1) that the funds allocated to the Common Fund 
not grow faster than the overall NIH budget, and (2) that all Common 
Fund awards/grants be awarded through a rigorous peer review process.
The NIH effort to require all grantees to give NIH author manuscripts
    AAI strongly opposes any effort to require NIH grantees to submit 
to NIH manuscripts reporting research funded by NIH. Rather, AAI 
believes that NIH should partner with not-for-profit scientific 
publishers to provide public access to NIH-funded research results 
rather than to duplicate, at great cost to NIH and taxpayers, services 
which are already provided cost-effectively and well by the private 
sector. AAI urges the subcommittee to require NIH to work with the not-
for-profit scientific publishing community to develop a plan to enhance 
public access that addresses publishers' concerns, including ensuring 
journals' continued ability to provide high quality, independent peer 
review of NIH-supported research.
Preserving high quality peer review and ensuring the independence of 
        science
    Millions of lives--as well as the prudent use of taxpayer dollars--
depend on the independence of scientists and the willingness of 
government officials to accept the best, most independent scientific 
advice available. AAI urges this subcommittee to ensure that funds 
expended enhance the ability of scientists to provide independent 
scientific advice (particularly on government advisory panels) and to 
ensure the vigor of peer review, whether through the NIH peer review 
system or by supporting the vitality of independent scientific journals 
which provide independent, expert peer review of taxpayer funded 
research.
Ensuring NIH operations and oversight
    AAI is concerned that the President's fiscal year 2008 budget 
proposal for Research, Management and Services (RM&S), which supports 
the management, monitoring, and oversight of all research activities 
(including NIH's peer review process), receives an increase of only $10 
million (89 percent). AAI urges the subcommittee to explore whether 
this sub-inflationary increase will harm NIH's ability to supervise a 
portfolio of increasing size and complexity, and to ensure that NIH 
funds are well and properly spent.

                               CONCLUSION

    AAI greatly appreciates this opportunity to submit testimony and 
thanks the members of the subcommittee for their strong support for 
biomedical research, the NIH, and the scientists who devote their lives 
to preventing, treating, and curing disease.
                                 ______
                                 
       Prepared Statement of the American Association of Museums

    Chairman Harkin, Senator Specter and distinguished members of the 
subcommittee, the American Association of Museums (AAM) appreciates the 
opportunity to submit testimony on the fiscal year 2008 budget for the 
museum program at the Institute of Museum and Library Services (IMLS). 
This agency is the primary Federal entity devoted to assisting museums 
in fulfilling their role as centers for lifelong learning for all 
Americans. We respectfully request your approval of the 
administration's budget request of $39.897 million for grants to 
museums administered through the Office of Museum Services and the 
agency's overall budget request of $271.246 million, which reflects a 
strong endorsement of the vital public service role museums play in 
their communities.
    The American Association of Museums has been bringing museums 
together since 1906, helping to develop standards and best practices, 
gathering and sharing knowledge, and providing advocacy on issues of 
concern to the entire museum community. AAM currently represents more 
than 15,000 individual museum professionals and volunteers, 3,000 
institutions, and 300 corporate members.
    Our Nation's museums are vital community assets. With more than 
17,000 institutions collectively holding our Nation's cultural and 
natural heritage, they serve as a catalyst for our citizens to pursue a 
greater understanding of the world around them. Every day museums save 
the memories of our civilization and help create new memories for our 
visitors. We feed preschoolers' imaginations at children's museums; 
engage elementary school students in learning about art, history and 
science; provide teenagers and college students with opportunities to 
share new found knowledge as tour guides and floor staff; stimulate 
adult learning with lectures on wide array of topics; and offer 
grandparents a place to share memories and stories with their 
grandchildren.
    Within your own State, you could easily name with pride the many 
museums in the communities you serve such as the Dubuque County 
Historical Society's Mississippi River Museum and Aquarium in Iowa or 
the Franklin Institute in Philadelphia. The vast majority of museums 
operate as private nonprofit organizations with nominal government 
funding unlike other community assets such as schools and libraries. 
According to our most recent financial survey, nonprofit museums 
receive approximately 16 percent of their budget from local, State, and 
the Federal Government. The bulk of their income is derived from 
private philanthropy in the form of donations, grants and corporate 
sponsorships and earned income from admission and gift shop sales.
    It is critical, therefore, that the Federal Government continue to 
show leadership by supporting investments to advance America's museums 
in four important areas--caring for and conserving our collections, 
improving museum programs and operations, supporting museum 
professional's development, and conducting research and collecting data 
to help policymakers, museum trustees and leaders make smart decisions.

               CARING FOR AND CONSERVING OUR COLLECTIONS

    The Heritage Health Index, an example of IMLS-supported research, 
documented the condition of America's collections held in our Nation's 
museums, libraries, archives, historical societies and scientific 
research organizations. It is the first comprehensive survey ever 
conducted of the condition and preservation needs of our Nation's 
collections. Through the survey we learned that more than 630 million 
artifacts--works of art, historic objects, photographs, natural science 
specimens, books and periodicals--are at risk and require immediate 
attention and care.
    As a result of this study, IMLS has made a commitment to increase 
public awareness and support for collections care. A national 
conservation summit will be held here in Washington this spring with 
future forums planned in four cities across the country to discuss this 
issue. We are excited at the prospect of increasing attention to this 
issue, as museums are responsible for the care of hundreds of millions 
of works of art, artifacts, and scientific specimens, which continue to 
grow in numbers.
    Information related to collections stewardship continues to be the 
most frequently requested area where AAM members seek guidance on 
professional standards and best practices. Resources for collections 
care are often limited, especially in our small and mid-size 
institutions, due in part to the behind-the-scenes nature of the work. 
It is not well understood by the public and private funders. We are 
hopeful that a renewed commitment to and increased public awareness 
will bring new resources to museums to address the preservation and 
conservation needs that make public exhibitions possible.
    IMLS assists museums with collections issues by providing 
consultation services through the Conservation and Museum Assessment 
Programs and financial assistance through the Conservation Project 
Support program to help ensure some basic safekeeping of museum 
collections. The demand for this support regularly exceeds the funds 
available. In fiscal year 2006, IMLS received 144 grant applications 
and funded only 40 projects. Recipients matched the nearly $2.8 million 
IMLS awarded with an additional $4.6 million. The grants are helping 
these museums examine, document, treat, stabilize, and restore their 
collections. For example, IMLS supported a detailed conservation survey 
by the Putnam Museum of History and Natural Science in Davenport, Iowa 
of its approximately 800 lacquered and wood objects in their Japanese 
and Chinese collections.

                IMPROVING MUSEUM PROGRAMS AND OPERATIONS

    Since its inception, AAM has served as a forum for discussing, 
developing, disseminating, and measuring museum performance standards. 
In 1967, President Lyndon B. Johnson asked the U.S. Federal Council on 
the Arts and Humanities to conduct a study on the status of American 
museums and recommend ways to support and strengthen them. From this 
study, America's Museums: The Belmont Report, the AAM accreditation 
program was born. In 1971 AAM first recognized the achievement of 16 
museums in meeting the highest standards of the profession. The 
Accreditation program continues to evolve. Over the past three decades, 
the program has been a critical tool in advancing the entire museum 
field, insured transparency and good governance to help museums operate 
in the best interest of the public.
    As our partner in helping museums achieve excellence, IMLS has 
supported the Museum Assessment Program (MAP). MAP helps museums 
maintain and improve their operations. Museums participating in the 
program learn their strengths and weaknesses, receive guidance on how 
to improve their operations and set institutional priorities. The 
public benefits by having museums that are striving to improve their 
operations so they are in a better position to serve them through their 
public programs and fulfilling their collections stewardship 
responsibilities.
    IMLS also supports museums in their efforts to continue to improve 
and expand their public service through the Museums for America 
program. In the program's first 3 years, fiscal year 2004-fiscal year 
2006, more than 500 grants totaling $50.2 million have been awarded. 
The flexibility of the program has been invaluable to our museums. It 
allows them to apply for funds to address those high-priority 
activities that advance their institution's strategic plans. Grants 
have helped museums deal with a range of issues such as behind-the-
scenes collections management projects and staff training, investments 
in digital technology to broaden public access, planning new public 
programs, and improving visitor experiences. In fiscal year 2006, the 
agency received 425 eligible grant applications and only 177 awards 
could be made.
    Among those who were successful, the Children's Museum of 
Pittsburgh received support for improving its ``Real Stuff'' exhibits 
which are at the heart of the museum. The museum is seeking to make 
changes to areas which have low levels of visitor engagement. 
Modifications and new exhibits will be based on evaluations from its 
partnership with the University of Pittsburgh Center for Learning in 
Out-of-School Environments.

               SUPPORTING MUSEUM PROFESSIONAL DEVELOPMENT

    While museums have long supported the public pursuit of lifelong 
learning, the staff of museums must also continue to learn. Building 
the 21st century museum workforce is critical to ensure that museums 
have both intellectual leadership and financial stability to carry out 
their mission. The skills required of today's museum directors have 
changed. In the past, trustees sought individuals with a scholarly 
knowledge in the area of the museum's collection. Today museum boards 
are primarily looking for strategic thinkers, excellent communicators, 
and outstanding fundraisers who have energy, creativity, and an 
entrepreneurial focus. Museum operations have grown more complex and 
their leaders need much broader business skills.
    Successful museum directors also need capable professionals who 
have the skills and knowledge to both move the institution forward and 
attend to the daily operations of running a museum. According to AAM's 
most recent financial survey, the median number of employees in a 
museum is 6 full-time and 4 part-time paid staff with 60 volunteers. 
This includes curators, educators, registrars, accountants, marketing 
and development professionals with some wearing more than one hat. 
Unlike our business counterparts, nonprofit museums are not investing 
time and money to develop and train their staff. Unfortunately, 
resources for training and career development are scarce. We see this 
as a looming problem as museums compete with other nonprofits to find 
and hire future leaders from a shrinking pool of qualified applicants.
    In creating the 21st Century Museum Professionals program, IMLS is 
just beginning to help our field identify strategies for addressing 
these challenges. In the first year of the program, IMLS received 55 
applications but only had the resources to award four grants. There is 
much work to be done. We urge you to provide the $2.14 million request 
by the agency and to consider increasing future investment in workforce 
development substantially.

                CONDUCTING RESEARCH AND COLLECTING DATA

    It is critical for IMLS to conduct research that assists museum 
professionals in making critical decisions about their daily 
operations, demonstrating their public value, ensuring their long-term 
viability and most effectively meet the needs of the diverse 
communities they serve. We need basic census data about museums, such 
as how many museums there are in the United States, how many people 
work in museums (both paid, professional staff and volunteers), and how 
many people visit museums annually. A commitment to regular data 
collection is critical to identifying trends that would inform 
decision-making by IMLS and the museum community.
    For example the 2002 IMLS study, ``True Needs, True Partners'', 
about museums serving schools, documented not only the growth in the 
number of schools, students and teachers served, but also the changing 
nature of the services provided by museums. This research has helped 
museum professionals and their school partners understand the evolving 
nature of their work and documented the growing financial commitment 
museums have made to public education and how museums have expanded the 
learning experience for K-12 students.
    A number of other topics should be the subject of future research, 
such as: measuring the social contributions of museums at the national 
level; studying the skills necessary to be a 21st century museum 
professional; supporting field research that collects core data, such 
as financial benchmarks and attendance figures; and examining areas of 
special interest to segments of the museum field. We need this 
information and data so that museum leaders and trustees, policy makers 
at all levels of government and private funders can make informed 
decisions about the future of our Nation's more than 17,000 museums.

                               CONCLUSION

    We recognize that you face difficult choices in allocating 
resources. Our appeal is to ask you to consider what we lose if we do 
not continue to invest in our Nation's museums. The public places a 
great trust in our ability to preserve not only physical artifacts, but 
more importantly the stories and memories of our people and our Nation. 
We need museums where you can learn about the past and dream of the 
future, explore the smallest bugs to the vast expanses of our universe, 
and experience awe and wonder in the beauty of our world. We cannot do 
this alone. Working together we can and will continue to inspire future 
generations of citizens to become thoughtful leaders, creative 
entrepreneurs, scientists, artists and educators.
                                 ______
                                 
  Prepared Statement of the American Association of Nurse Anesthetists

    The AANA is the professional association for more than 36,000 
Certified Registered Nurse Anesthetists (CRNAs) and student nurse 
anesthetists representing over 90 percent of the nurse anesthetists in 
the United States. Today, CRNAs are directly involved in delivering 27 
million anesthetics given to patients each year in the United States. 
CRNA services include administering the anesthetic, monitoring the 
patient's vital signs, staying with the patient throughout the surgery, 
as well as providing acute and chronic pain management services. CRNAs 
provide anesthesia for a wide variety of surgical cases and are the 
sole anesthesia providers in almost 70 percent of rural hospitals, 
affording these medical facilities obstetrical, surgical, and trauma 
stabilization, and pain management capabilities. CRNAs work in every 
setting in which anesthesia is delivered including hospital surgical 
suites and obstetrical delivery rooms, ambulatory surgical centers 
(ASCs), pain management units and the offices of dentists, podiatrists 
and plastic surgeons.
    Nurse anesthetists are experienced and highly trained anesthesia 
professionals whose record of patient safety in the field of anesthesia 
was bolstered by the Institute of Medicine report that found in 2000, 
that anesthesia is 50 times safer than 20 years previous. (Kohn L, 
Corrigan J, Donaldson M, ed. To Err is Human. Institute of Medicine, 
National Academy Press, Washington, DC, 2000.) Nurse anesthetists 
continue to set for themselves the most rigorous continuing education 
and re-certification requirements in the field of anesthesia. Relative 
anesthesia patient safety outcomes are comparable among nurse 
anesthetists and anesthesiologists, with Pine having recently 
concluded, ``the type of anesthesia provider does not affect inpatient 
surgical mortality.'' (Pine, Michael MD et al. Surgical mortality and 
type of anesthesia provider. Journal of American Association of Nurse 
Anesthetists. Vol. 71, No. 2, p. 109-116. April 2003.) Even more 
recently, obstetrical anesthesia, whether provided by Certified 
Registered Nurse Anesthetists (CRNAs) or anesthesiologists, is 
extremely safe, and there is no difference in safety between hospitals 
that use only CRNAs compared with those that use only 
anesthesiologists, according to the results of a new study published in 
the January/February issue of Nursing Research (Vol. 56, No. 1, pp. 9-
17). In addition, a recent AANA workforce study's data showed that 
CRNAs and anesthesiologists are substitutes in the production of 
surgeries. Through continual improvements in research, education, and 
practice, nurse anesthetists are vigilant in their efforts to ensure 
patient safety.
    CRNAs provide the lion's share of the anesthesia care required by 
our U.S. Armed Forces through active duty and the reserves, from here 
at home to the leading edge of the field of battle. In May 2003, at the 
beginning of ``Operation Iraqi Freedom'' 364 CRNAs were deployed to the 
Middle East to ensure military medical readiness capabilities. For 
decades, CRNAs have staffed ships, remote U.S. military bases, and 
forward surgical teams without physician anesthesiologist support.

      IMPORTANCE OF TITLE VIII NURSE ANESTHESIA EDUCATION FUNDING

    The nurse anesthesia profession's chief request of the subcommittee 
is for $4 million to be reserved for nurse anesthesia education and $76 
million for advanced education nursing from the Title VIII program. 
This sustained funding is justified by two facts. First, there is a 
vacancy rate of nurse anesthetists in the United States impacting 
people's healthcare. Second, the Title VIII program, which has been 
strongly supported by members of this subcommittee in the past, is an 
effective means to help address the nurse anesthesia workforce demand. 
This demand for CRNAs is something that the nurse anesthesia profession 
addresses every day with success, and with the critical assistance of 
Federal funding through HHS' Title VIII appropriation.
    The administration's 2008 budget eliminates funding for Advanced 
Education Nursing. We believe that nursing and nursing education 
workforce needs are such that this funding must not be eliminated, but 
preserved and increased for 2008 to meet patient care needs.
    The increase in funding for advanced education nursing from $58 
million to $76 million is necessary to meet the continuing demand for 
nursing faculty and other advanced education nursing services 
throughout the United States. Only a limited number of new programs and 
traineeships can be funded each year at the current funding levels. The 
program provides for competitive grants and contracts to meet the costs 
of projects that support the enhancement of advanced nursing education 
and practice and traineeships for individuals in advanced nursing 
education programs. This funding is critical to the efforts to meet the 
nursing workforce needs of Americans who need healthcare.
    In 2003, the AANA conducted a nurse anesthesia workforce study that 
found a 12 percent vacancy rate in hospitals for CRNAs, and a lower 
vacancy rate in ambulatory surgical centers. The supply has increased 
in recent years, stimulated by increases in the number of CRNAs 
trained. However, there is a reasonable question of whether these 
increases are enough to offset the number of CRNAs intending to retire 
over the next few years. The retirement of baby boomers, both among 
patients and CRNAs alike, requires a continuous growth in the number of 
nurse anesthesia graduates to meet anticipated demand for anesthesia 
services.
    The problem is not that our 105 accredited programs of nurse 
anesthesia are failing to attract qualified applicants. They have to 
turn them away by the hundreds, because the capacity of nurse 
anesthesia educational programs to educate qualified applicants is 
limited by the number of faculty, the number and characteristics of 
clinical practice educational sites, and other factors. A qualified 
applicant to a CRNA program is a bachelor's educated registered nurse 
who has spent at least 1 year serving in an acute care healthcare 
practice environment. Nurse anesthesia educational programs are located 
all across the country including the following:

------------------------------------------------------------------------
                                                              No. of
                                                            Accredited
                          State                                Nurse
                                                            Anesthesia
                                                             Programs
------------------------------------------------------------------------
PA......................................................              12
FL......................................................               8
OH......................................................               5
TX......................................................               5
IL......................................................               5
NY......................................................               4
CA......................................................               3
CT......................................................               3
MD......................................................               3
RI......................................................               2
WI......................................................               1
------------------------------------------------------------------------

    Recognizing the importance of nurse anesthetists to quality 
healthcare, the AANA has been working with the 105 accredited programs 
of nurse anesthesia to increase the number of qualified graduates. In 
addition, the AANA has worked with nursing and allied health deans to 
develop new CRNA programs.
    The Council on Certification of Nurse Anesthetists (CCNA) reports 
that in 1999, our schools produced 948 new graduates. In 2005, that 
number had increased to 1,790, an 89 percent increase in just 5 years. 
This growth is expected to continue. The CCNA projects CRNA programs to 
produce over 2,000 graduates in 2007.
    To truly meet the nurse anesthesia workforce challenge, the 
capacity and number of CRNA schools must continue to expand. With the 
help of competitively awarded grants supported by Title VIII funding, 
the nurse anesthesia profession is making significant progress, 
expanding both the number of clinical practice sites and the number of 
graduates.
    The AANA is pleased to report that this progress is extremely cost-
effective from the standpoint of Federal funding. Anesthesia can be 
provided by nurse anesthetists, physician anesthesiologists, or by 
CRNAs and anesthesiologists working together. As mentioned earlier, the 
study by Pine et al confirms, ``the type of anesthesia provider does 
not affect inpatient surgical mortality.'' Yet, for what it costs to 
educate one anesthesiologist, several CRNAs may be educated to provide 
the same service with the same optimum level of safety. Nurse 
anesthesia education represents a significant educational cost/benefit 
for supporting CRNA educational programs with Federal dollars vs. 
supporting other models of anesthesia education.
    To further demonstrate the effectiveness of the Title VIII 
investment in nurse anesthesia education, the AANA surveyed its CRNA 
program directors in 2003 to gauge the impact of the Title VIII 
funding. Of the eleven schools that had reported receiving competitive 
Title VIII Nurse Education and Practice Grants funding from 1998 to 
2003, the programs indicated an average increase of at least 15 CRNAs 
graduated per year. They also reported on average more than doubling 
their number of graduates, who provide care to patients during and 
following their education. Moreover, they reported producing additional 
CRNAs that went to serve in rural or medically underserved areas. Under 
both of these circumstances, an increased number of student nurse 
anesthetists and CRNAs are providing healthcare to the people of 
medically underserved America.
    We believe it is important for the subcommittee to allocate $4 
million for nurse anesthesia education for several reasons. First, as 
this testimony has documented, the funding is cost-effective and well 
needed. Second, the Title VIII authorization previously providing such 
a reserve expired in September 2002. Third, this particular funding is 
important because nurse anesthesia for rural and medically underserved 
America is not affected by increases in the budget for the National 
Health Service Corps and community health centers, since those 
initiatives are for delivering primary and not surgical healthcare. 
Lastly, this funding meets an overall objective to increase access to 
quality healthcare in medically underserved America.

       TITLE VIII FUNDING FOR STRENGTHENING THE NURSING WORKFORCE

    The AANA joins a growing coalition of nursing organizations, 
including the Americans for Nursing Shortage Relief (ANSR) Alliance and 
representatives of the nursing community, and others in support of the 
subcommittee providing a total of $200 million in fiscal year 2008 for 
nursing shortage relief through Title VIII. This amount is 
approximately $51 million over the fiscal year 2007 level and $95 
million above the President's fiscal year 2008 budget.
    Every district in America is familiar with the importance of 
nursing. The AANA appreciates the support for nurse education funding 
in fiscal year 2007 and past fiscal years from this subcommittee and 
from the Congress.
    The need for strengthening nurse educational funding to strengthen 
our healthcare is clear. According to the Office of the Actuary at the 
Centers for Medicare & Medicaid Services, America spent about $2 
trillion on healthcare in the most recent year for which the agency had 
records, the year 2005. About $342 billion of that was from Medicare 
outlays. Medicaid spending was $313 billion. The Congressional Budget 
Office States that Medicare directs about $8.7 billion of its outlays 
to Graduate Medical Education (GME), of which $2.3 billion was Direct 
GME. Approximately 99 percent of that educational funding helps to 
educate physicians and allied health professionals, and about 1 percent 
is allocated to help educate nurses.
    In the interest of patients past and present, particularly those in 
rural and medically underserved parts of this country, we ask Congress 
to reject cuts from Federal investments in CRNA and nursing educational 
funding programs, and to provide these programs the sustained increases 
required to help ensure Americans get the healthcare that they need and 
deserve. Quality anesthesia care provided by CRNAs saves lives, 
promotes quality of life, and makes fiscal sense. This Federal support 
for nurse education will improve patient access to quality services and 
strengthen the Nation's healthcare delivery system.
    Thank you.
                                 ______
                                 
           Prepared Statement of the American Brain Coalition

                              INTRODUCTION

    The National Institutes of Health (NIH) is the world's leader in 
medical discoveries that improve people's health and save lives. NIH-
funded scientists investigate ways to prevent, treat, and even cure the 
complex diseases of the brain. Because there is much work still to be 
done, the American Brain Coalition writes to ask for your support for 
biomedical research funding at NIH.

                 WHAT IS THE AMERICAN BRAIN COALITION?

    The American Brain Coalition (ABC) is a nonprofit organization that 
seeks to reduce the burden of brain disorders and advance the 
understanding of the functions of the brain. The ABC, made up of nearly 
50 member organizations, brings together afflicted patients, the 
families of those that suffer, the caregivers, and the professionals 
that research and treat diseases of the brain.
    The brain is the center of human existence, and the most complex 
living structure known. As such, there are thousands of brain diseases 
from Rett Syndrome and autism to dystonia and Parkinson's disease. ABC, 
unlike any other organization, brings together people affected by all 
diseases of the brain.
    The ABC is working toward the same level of public awareness and 
support for diseases of the brain that has been achieved by the 
American Heart Association and the American Cancer Society. Fifty 
million Americans--our relatives, friends, neighbors, and your 
constituents--are affected by diseases of the brain. Our goal is to be 
a united voice for these patients, and to work with Congress to 
alleviate the burden of brain disease. A large part of that goal 
involves support for NIH research.

                       THANK YOU FOR PAST SUPPORT

    The American Brain Coalition would like to thank the members of 
this subcommittee for their past support, which resulted in the 
doubling of NIH budget between 1998 and 2003.
    In addition, we are extremely grateful that the fiscal year 2007 
Joint Resolution included an additional $620 million for NIH above the 
fiscal year 2006 funding level. This additional money will allow NIH to 
award an extra 500 research grants. It will also create a new program 
to support innovative, outside-the-box research, as well as to provide 
grants to first-time investigators.
    The doubling of the NIH budget produced advances in the Nation's 
health. Since 2003, however, many policymakers have mistakenly come to 
think that NIH ``has been taken care of.'' As a result, NIH has been 
relatively flat funded since that time.
    Despite the doubling of the budget and the many advances in 
scientific knowledge, there is still much work to be done to uncover 
the mysteries of the brain. The recent start-stop funding approach has 
made efficient research planning extremely difficult, has disrupted 
steady progress, and must be reversed.

                     NIH-FUNDED RESEARCH SUCCESSES

    Today, scientists have a greater understanding of how the brain 
functions due to NIH-funded research. The following are just a few 
areas where research efforts have improved the health of the American 
public:
  --Post Traumatic Stress Disorder (PTSD).--Experiencing or witnessing 
        a crime, terrorist attack, being a victim of sexual abuse, or 
        military combat can lead to a form of stress that can last a 
        life-time. Termed, PTSD, the condition afflicts 5.2 million 
        Americans aged 18 to 54 each year. Its social and economic 
        costs can be devastating. Almost half of the Vietnam veterans 
        with PTSD have been arrested or jailed. With the ongoing wars 
        in Iraq and Afghanistan, the incidence of PTSD is rising.
      For years it was thought that those who survived or witnessed a 
        trauma should be able to tough it out and move on. But NIH-
        funded studies helped reveal that PTSD is a serious brain 
        disorder with biological underpinnings. For example, scientists 
        determined that the part of the brain involved in learning, 
        memory, and emotion appears to be smaller in people with PTSD 
        and that levels of some brain chemicals are altered. These 
        changes are believed to be caused by increased stress hormones 
        from a traumatic event and by the constant reliving of the 
        event.
      New understanding of the disorder paved the way for use selective 
        serotonin reuptake inhibitors in treating PTSD. Studies funded 
        by NIH found that these drugs ease the symptoms of depression 
        and anxiety and improve the memory of patients with PTSD, 
        helping them better deal with traumatic memories. Talking with 
        a counselor or therapist can also help PTSD victims to cope.
  --Multiple Sclerosis.--Multiple sclerosis (MS) strikes people during 
        the prime of their lives, right as they are settling into their 
        careers and families. About 400,000 Americans have multiple 
        sclerosis, and every week an estimated 200 more are diagnosed. 
        Multiple sclerosis costs Americans $9.5 billion in medical care 
        and lost productivity each year.
      In multiple sclerosis, the immune system for unknown reasons 
        mistakenly destroys the protective myelin covering around 
        nerves. Without myelin, electrical signals are transmitted more 
        slowly or not at all from the brain to the body, causing 
        weakness, tremors, pain, and loss of feeling.
      Fortunately, research funded by the NIH and others over the past 
        two decades has led to many advances that allow physicians to 
        diagnose MS earlier and better track its progress so that 
        treatments can be more effective. Imaging techniques such as 
        magnetic resonance imaging and magnetic resonance spectroscopy 
        provide a window on the brain that allows physicians to better 
        predict relapses and thus plan for patients' care.
      In addition to steroids used in the past to reduce the duration 
        and severity of attacks, there are now other drugs like 
        interferon, glatiramer acetate, and mitoxantrone that can 
        decrease disease severity. Studies have shown that these drugs 
        can make relapses less frequent and severe and delay further 
        damage from the disease.
  --Alcoholism.--Excess consumption of alcohol can ruin a person's 
        health, family life, and career. It also makes the world more 
        dangerous for the rest of society. Many accidents, assaults, 
        and robberies involve alcohol use by the offender. Society also 
        pays a high financial price. Alcohol-related problems cost the 
        country an estimated $185 billion per year.
      Until recently, there were not many options to help keep problem 
        drinkers off alcohol. Fortunately, the outlook is improving 
        steadily with the development of new medications and therapies.
      NIH-funded scientists discovered evidence that alcohol acts on 
        several chemical systems in the brain to create its alluring 
        effects. On the basis of these studies, the drug naltrexone--
        which targets one of these systems, called the opioid system--
        was approved as a treatment for alcoholism in the mid-1990s. 
        Alcohol's effect on the opioid system is thought to produce the 
        euphoric feelings that make a person want to drink again. 
        Naltrexone can block this reaction and help cut cravings for 
        alcohol in some alcoholic individuals.
      Congressional investments in research have lead to significant 
        improvements in patient care.

             RESEARCH IMPROVES HEALTH AND FUELS THE ECONOMY

    Diseases of the nervous system pose a significant public health and 
economic challenge, affecting nearly one in three Americans at some 
point in life. Improved health outcomes and positive economic data 
support the assertion that biomedical research is needed today to 
improve public health and save money tomorrow.
    Research drives innovation and productivity, creates jobs, and 
fuels local and regional economies. In fiscal year 2003, the University 
of Wisconsin Madison brought over $228 million into the State from NIH-
funded research.
    Not only does research save lives and fuel today's economy, it is 
also a wise investment in the future. For example, 5 million Americans 
suffer from Alzheimer's disease today, and the cost of caring for these 
people is staggering. Medicare expenditures are $91 billion each year, 
and the cost to American businesses exceeds $60 billion annually, 
including lost productivity of employees who are caregivers. As the 
baby boom generation ages and the cost of medical services increases, 
these figures will only grow. Treatments that could delay the onset and 
progression of the disease by 5 years could save $50 billion in 
healthcare costs each year. Research funded by the NIH is critical for 
the development of such treatments. The cost of investing in NIH today 
is minor compared to both current and future healthcare costs.

             PRESIDENT'S BUDGET NEGATIVELY IMPACTS RESEARCH

    Mr. Chairman, inflation has eaten into the NIH budget. The NIH now 
projects the Biomedical Research and Development Price Index (BRDPI) 
may increase by 3.7 percent for both fiscal year 2007 and fiscal year 
2008; 3.6 percent for fiscal year 2009 and 2010; and 3.5 percent for 
fiscal year 2011 and fiscal year 2012.
    Unfortunately, the President's fiscal year 2008 budget request for 
NIH did not factor in the increases in biomedical research inflation. 
In fact, his budget proposes to cut funding for the National Institutes 
of Health by more than a half billion dollars in fiscal year 2008.

                    FISCAL YEAR 2008 RECOMMENDATION

    The American Brain Coalition supports a 6.7 percent increase in 
funding for the National Institutes of Health in fiscal year 2008. 
Additionally, ABC supports a 6.7 percent increase in funding in per 
year in fiscal years 2009 and 2010.
    This sustained increase is necessary to make-up for lost purchasing 
power that has occurred in the past 3 years. In addition, it will help 
the NIH to achieve its broad research goals and provide hope for those 
people affected with neurological and psychiatric disorders.
    Mr. Chairman, thank you for the opportunity to submit testimony 
before this subcommittee.
                                 ______
                                 
        Prepared Statement of the American College of Cardiology

    The American College of Cardiology (ACC) appreciates the 
opportunity to provide the subcommittee with recommendations for fiscal 
year 2008 funding for life-saving cardiovascular research and public 
education. The ACC is a 34,000 member non-profit professional medical 
society and teaching institution whose mission is to advocate for 
quality cardiovascular care through education, research promotion, 
development and application of standards and guidelines, and to 
influence health care policy.

  THE NEED FOR A FEDERAL INVESTMENT IN CARDIOVASCULAR DISEASE RESEARCH

    Cardiovascular disease continues to be the leading cause of death 
for both women and men in the United States, killing more than 870,000 
Americans each year. While the number of deaths due to cardiovascular 
disease is on the decline, more than one in three Americans lives with 
some form of heart disease. The economic impact of cardiovascular 
disease on the U.S. health care system continues to grow as the 
population ages and as the prevalence of it increases, costing the 
Nation an estimated $430 billion in 2007 alone due to medical expenses 
and lost productivity.\1\
---------------------------------------------------------------------------
    \1\ American Heart Association. Heart Disease and Stroke 
Statistics--2007 Update. Dallas, Texas: American Heart Association; 
2007.
---------------------------------------------------------------------------
    The ACC is extremely concerned that the cuts proposed in the 
administration's fiscal year 2008 budget for many critical health 
agencies, particularly the National Institutes of Health (NIH), will 
negatively impact cardiovascular care. The doubling of the NIH budget 
from 1999 to 2003 resulted in a surge in demand for research grants. In 
recent years, the combination of inflation and stagnant Federal funding 
has threatened the laboratories and continuing research of established 
investigators and, by signaling a lack of Federal commitment to 
consistent funding, will discourage new investigators and new research 
initiatives.
    The ACC encourages Congress to provide a strong Federal investment 
in research and public education that addresses cardiovascular disease. 
Federal research is providing for breakthrough advances that 
fundamentally change our understanding of the prevention and treatment 
of cardiovascular disease, leading to better outcomes, decreased costs, 
and increased quality of life for patients.

              FUTURE CARDIOVASCULAR DISEASE RESEARCH NEEDS

    As the health system continues its move toward using performance 
measurement to foster the delivery of the highest quality of care to 
patients, the need for meaningful clinical guidelines, from which 
performance measures are developed, becomes even more critical.
    The performance measures that will be used to determine whether 
patients are receiving the most effective, efficient, and highest 
quality cardiovascular care are derived from clinical guidelines 
developed by the ACC and the American Heart Association (AHA). The ACC 
strives to produce the preeminent medical specialty practice 
guidelines, with more than 15 guidelines on a range of cardiovascular 
topics. They are developed through a rigorous, evidence-based 
methodology employing multiple layers of review and expert 
interpretation of the evidence on an ongoing, regular basis. Many 
clinical research questions remain unanswered or understudied, however. 
In fact, the percent of guideline recommendations that are based on 
expert opinion rather than clinical data vary by cardiovascular topic 
from only 20 percent for coronary bypass surgery to over 70 percent for 
valvular heart disease.
    To this end, through its clinical policy development process, the 
ACC has identified knowledge gaps for cardiovascular disease. These 
unresolved issues, if addressed, have great potential to impact patient 
outcomes, costs, and the efficiency of care delivery. The ACC strongly 
supports and stands committed to assist the National Heart, Lung and 
Blood Institute (NHLBI) in fulfilling its strategic plan by helping to 
promote the development and speedy implementation of evidence-based 
clinical guidelines in a manner that impacts health outcomes. All 
medicine includes a degree of uncertainty about the ability of a 
particular procedure, device, or therapy to benefit a patient. Yet, an 
investment in answering the following scientific questions through the 
NIH, and in particular the NHLBI, as well as through the Agency for 
Healthcare Research and Quality (AHRQ), will help to better narrow the 
target population who can benefit from treatment and therefore increase 
the efficacy and efficiency of the care delivered.
    1. What is the effect of common cardiovascular therapies on elderly 
populations whose metabolism and kidney function is lower and may not 
respond to medications in the same way as the younger patients 
typically included in clinical trials?
    2. What is the effect of common cardiovascular therapies on 
patients with multiple other diseases/conditions?
    3. What are the best approaches to increasing patient compliance 
with existing therapies?
    4. What screening and risk models (existing or new) could further 
define who will benefit from various therapies?
    5. What are the optimal management strategies for anticoagulation 
and antiplatelet agents in heart attack patients, patients with stents, 
and atrial fibrillation patients to maximize benefit and reduce 
bleeding risks?
    6. What are the best approaches to managing complex but 
understudied cardiovascular topics such as congenital heart disease and 
valvular heart disease? Both congenital heart disease and valvular 
heart disease have become areas of higher research interest as 
techniques have developed to extend the lives of these patients.
    7. What are the risks and benefits of common off-label uses of 
widely used therapies and procedures, such as drug eluting stents?
    8. What are the best catheter-based techniques to increase 
treatment success and reduce complications for both coronary and 
cardiac rhythm procedures?
    The list of topics above is not exhaustive but provides an overview 
of some of the general themes of the evidence gaps that exist across 
the ACC's current guidelines. In addition to specific clinical research 
topics, the ACC recommends funding to help address two structural 
issues that could help identify, prioritize, and interpret research 
findings over the long term:
    1. The NHLBI should work with the clinical cardiology community to 
proactively design clinical trials to address unanswered clinical 
questions and identify methods that allow for greater comparability 
among studies. NHLBI should work with ACC and the AHA to develop an 
evidence model that would drive future research initiatives based on 
current evidence gaps in the guidelines; and
    2. NIH should fund the development of a robust informatics 
infrastructure across Institutes to process research evidence. Studies 
should be designed such that their results could be ``fed'' into a 
computer model that would provide additional insights for developers of 
clinical recommendations.

       COLLABORATING TO IMPROVE CARDIOVASCULAR CARE AND OUTCOMES

    Facilitating the transfer of new knowledge to health care 
professionals, patients and the public is an important aspect of 
Federal research efforts. One example of NHLBI's success in this area 
is the launch last year of the new Peripheral Arterial Disease (P.A.D.) 
national campaign to increase public and health care provider awareness 
of P.A.D. and its association with other cardiovascular diseases. As 
the leader in developing the P.A.D. Guidelines, the ACC is proud to 
collaborate with the NHLBI on the ``Stay in Circulation: Take Steps to 
Learn about P.A.D.'' campaign. The ACC is promoting this important 
campaign through our membership and has formed a P.A.D. Guidelines 
Implementation Task Force that has developed tools--including wall 
charts, webcasts, and slide sets--to help physicians diagnose and treat 
the more than 8 million Americans affected by the disease.
    NHLBI and AHRQ also have been important supporters of the ``D2B: An 
Alliance for Quality'' program. The D2B Alliance is a Guidelines 
Applied in Practice (GAP) program launched by the ACC to save time and 
save lives by reducing the door-to-balloon times in U.S. hospitals 
performing primary percutaneous coronary intervention (PCI) by 
providing hospitals with key evidence-based strategies and supporting 
tools needed to begin reducing their D2B times.
    Through its Centers for Education and Research on Therapeutics 
(CERT), AHRQ has been crucial in helping fund research by ACC on its 
clinical policy development process. The CERT grant provided resources 
to help ACC better understand and adapt how its guidelines and 
performance measures are developed and disseminated. It also provided 
resources to support the development of a framework for ACC to address 
appropriateness of medical technology. This evaluation of ACC processes 
for the development of clinical policy has been an essential part of 
translating research from bench to bedside.
    Recently, ACC leadership met with the NHLBI Director and senior 
staff to discuss opportunities to collaborate on current and future 
efforts. One initiative identified as a unique opportunity to make a 
positive impact on health care quality involves enhancing the NHLBI's 
Center for the Application of Research Discoveries (CARD) through the 
use of health information technology--namely by drawing on the ACC's 
substantial expertise, from the National Cardiovascular Data Registry, 
in developing and operating electronic data registries. Bringing the 
latest discoveries in cardiovascular care to the bedside is a critical 
mission of the NHLBI and is shared by the ACC. Sufficient funding from 
Congress can foster such efforts by the NHLBI and its partners to 
provide patients with effective cutting-edge care that also holds the 
promise of reducing health care costs.

                      ACC FUNDING RECOMMENDATIONS

    As the subcommittee considers its appropriations for programs 
within the Department of Health and Human Services, the ACC urges 
support of the following fiscal year 2008 funding recommendations:
National Institutes of Health
    The ACC, along with the broad medical community, supports an fiscal 
year 2008 NIH budget of $30.869 billion that would help get the NIH 
``back on track.'' Research conducted through the NIH has resulted in 
better diagnosis and treatment of cardiovascular disease, thereby 
improving the quality of life for those living with the disease and 
lowering the number of deaths attributable to it. Adequate funding 
through the NIH is necessary for basic, clinical, and translational 
research that facilitates the delivery of new discoveries to the 
bedside.
National Heart Lung and Blood Institute
    The ACC recommends $3.1 billion for the NHLBI in fiscal year 2008 
for continuing its critical research into the causes, treatment, and 
prevention of cardiovascular disease. Congress must maintain its 
investment in NHLBI to continue the great strides already being made in 
fighting cardiovascular disease. If accepted without an increase, the 
administration's budget request for NHLBI would critically impact the 
institute's ability to fund valuable initiatives and would further harm 
its ability to attract young investigators.
Agency for Healthcare Research and Quality
    The ACC supports $350 million for the AHRQ. At a time when great 
focus is being put on comparative effectiveness research as a means to 
improve health quality, continuing and increasing the Federal 
investment in AHRQ health services research is critical.
Centers for Disease Control and Prevention's (CDC) Division for Heart 
        Disease and Stroke Prevention
    The ACC recommends $55 million for the CDC Division for Heart 
Disease and Stroke Prevention, whose public education efforts are 
making strides in the prevention of and early intervention in treating 
cardiovascular disease--thereby potentially reducing future care costs 
significantly.
Health Resources and Services Administration (HRSA) Rural and Community 
        Access to Emergency Defibrillation (AED) Program
    The ACC supports $8.9 million in fiscal year 2008 for the HRSA 
Rural and Community AED program, an important initiative that saves 
lives by placing external defibrillators in public facilities.
    The ACC urges Congress to provide a strong fiscal year 2008 
investment in the cardiovascular research and education programs 
described above to continue fostering the great strides being made in 
the fight against all cardiovascular disease. If you have any 
questions, please contact Jennifer Brunelle at [email protected] or 
(202) 375-6477.
                                 ______
                                 
    Prepared Statement of the American College of Obstetricians and 
                             Gynecologists

    The American College of Obstetricians and Gynecologists (ACOG), 
representing 51,000 physicians and partners in women's health care, is 
pleased to offer this statement to the Senate Committee on 
Appropriations, Subcommittee on Labor, Health and Human Services, and 
Education. We thank Chairman Harkin, ranking member Specter, and the 
entire subcommittee for their leadership to continually address 
maternal and child health care services.
    The Nation has made important strides to improve women and 
children's health over the past several years, and ACOG is grateful to 
this committee for its commitment to ensure that vital research 
continues to eliminate disease and to ensure valuable new treatment 
discoveries are implemented. The NIH has examined and determined many 
disease pathways, while the Health Resources and Services 
Administration (HRSA) and the Centers for Disease Control and 
Prevention (CDC) have been successful in translating research findings 
into valuable public health policy solutions. This dedicated commitment 
to elevate, promote and implement medical research faces an uncertain 
future at a time when scientists are on the cusp of new cures.
    We urge the committee to support a 6.7 percent increase for the 
National Institutes of Health (NIH), and a 6.7 percent increase for the 
National Institute of Child Health and Human Development (NICHD) in 
fiscal year 2008. We also continue to support efforts to secure 
adequate funds for important public health programs at HRSA ($7.5 
billion) and the CDC ($10.7 billion including funding for the Agency 
for Toxic Substances and Disease Registry, and the Vaccines for 
Children Program).

        NATIONAL INSTITUTES OF HEALTH--RESEARCH LEADING THE WAY

Ob-Gyn Research at the NICHD
    The NICHD conducts research that holds great promise to improve 
maternal and fetal health and safety. With the support of Congress, the 
Institute has initiated research addressing the causes of cerebral 
palsy, gestational diabetes and pre-term birth. However, much more 
needs to be done to reduce the rates of maternal mortality and 
morbidity in the United States. More research is needed on such 
pregnancy-related issues as the impact of chronic conditions during 
pregnancy, racial and ethnic disparities in maternal mortality and 
morbidity, drug safety with respect to pregnancy, and preventing 
unintended pregnancies.
    A commitment to research in women's health sheds light on a breadth 
of issues that save women's lives. Important research examining the 
following issues must continue:
            Reducing High Risk Pregnancies
    NICHD's Maternal Fetal Medicine Unit Network, working at 14 sites 
across the United States (University of Alabama, University of Texas-
Houston, University of Texas-Southwestern, Wake Forest University, 
University of North Carolina, Brown University-Women and Infant's 
Hospital, Columbia University, Drexel University, University of 
Pittsburgh-Magee Women's Hospital, University of Utah, Northwestern 
University, Wayne State University, Case Western University, and Ohio 
State University), will help reduce the risks of cerebral palsy, 
caesarean deliveries, and gestational diabetes. This Network discovered 
that progesterone reduces preterm birth by one-third.
            Reducing the Risk of Perinatal HIV Transmission
    In the last 10 years, NICHD research has helped decrease the rate 
of perinatal HIV transmission from 27 percent to 1.2 percent. This 
advancement signals the near end to mother-to-child transmission of 
this deadly disease.
            Reducing the Effects of Pelvic Floor Disorders
    The Institute has made recent advancements in the area of pelvic 
floor disorders. The NICHD is investigating whether women that have 
undergone cesarean sections have fewer incidences of pelvic floor 
disorder than women who have delivered vaginally.
            Reducing the Prevalence of Premature Births
    NICHD is helping our Nation understand how adverse conditions and 
health disparities increase the risks of premature birth in high-risk 
racial groups.
            Drug Safety During Pregnancy
    The NICHD recently created the Obstetric and Pediatric Pharmacology 
Branch to measure drug metabolism during pregnancy.
            Contraceptive Research
    The United States has one of the highest unintended pregnancy rates 
of the industrialized nations. Of the approximately 6 million 
pregnancies each year, an estimated one half are unintended. It is 
critical that women have access to safe and effective contraceptives, 
to help them time and space their pregnancies. The NICHD conducts 
valuable research on both male and female contraceptives that can help 
reduce the number of unintended pregnancies and improve women's health.
The Challenge of the Future: Attracting New Researchers
    Despite the NICHD's critical advancements, reduced funding has made 
it difficult for research to continue, largely due to the lack of new 
investigators. Congressional programs such as the loan repayment 
program, and the NIH Mentored Research Scientist Development Program 
for reproductive health, all attract new researchers, but low pay lines 
make it difficult for the NICHD to maintain them. We urge the committee 
to significantly increase funding for ob-gyn research at the NICHD to 
maintain a high level of research innovation and excellence, in turn 
reducing the incidence of maternal morbidity and mortality and 
discovering cures for other chronic conditions.
    We encourage the committee, too, to realize and fund ob-gyn 
research possibilities in other Institutes within NIH. While pediatric 
and ob-gyn research are the two main areas of research in NICHD, ob-gyn 
research is very centralized in that Institute, with 56.7 percent of 
all NIH ob-gyn research funding occurring in NICHD in 2005. Pediatrics 
funding, on the other hand, is diversified throughout many Institutes. 
While 21.7 percent of pediatrics funding occurs in NICHD, 19 percent is 
in the National Heart, Lung and Blood Institute (NIHLB), 16 percent is 
in National Institute of Diabetes and Digestive and Kidney, (NIDDK), 
13.5 percent in the National Institute of Aging (NIA), and 7 percent is 
in the National Cancer Institute (NCI). Altogether, pediatrics research 
at NIH totaled $520.7 million in 2005, compared with $156.8 million in 
ob-gyn research.
    The future of women's health, including, reducing preterm labor, 
ensuring drug safety during pregnancy, and reducing the effects of 
pelvic floor disorders, depends on research conducted at the NIH. We 
encourage the committee to increase and expand ob-gyn research funding 
in NICHD and throughout the National Institutes of Health.
      hrsa and cdc: turning research into public health solutions
    It is critical that we rapidly transform women's health research 
findings into public health solutions. The Health Resources and 
Services Administration (HRSA) has created women and children's health 
outreach programs based on research conducted on prematurity, high risk 
pregnancies, gestational diabetes, and a variety of other health 
issues. The National Fetal Infant Mortality Review and the Provider's 
Partnership are two examples of the successful programs under the 
Healthy Start Initiative.
National Fetal Infant Mortality Review
    The Fetal and Infant Mortality Review (FIMR) is a cooperative 
Federal agreement between ACOG and the Maternal Child Health Bureau at 
HRSA. FIMR uses the expertise of ob-gyns and local health departments 
to find solutions to problems related to infant mortality. In light of 
the recent increase in the infant mortality rate for 2002, the FIMR 
program is vital to develop community-specific, culturally appropriate 
interventions. Today 220+ local programs in 42 States are implementing 
FIMR and finding it is a powerful tool to bring communities together to 
address the underlying problems that negatively affect the infant 
mortality rate. We urge this committee to recognize the many positive 
contributions of the FIMR program and ensure it remains a fully funded 
program within HRSA.
Title X Family Planning Program
    Since 1970, the Title X Family Planning program at HRSA has 
provided low income women with timely screenings, education, and 
contraception. Access to these services can be vital to preventing 
breast and cervical cancer, sexually transmitted infections (STIs), and 
unintended pregnancies.
    Title X clinics serve more than 5 million low-income women at 4,500 
clinics nationwide, helping women plan the number and timing of their 
pregnancies and stay healthy. Title X clinics are serving increasing 
numbers of patients without commensurate increases in funding. We urge 
you to increase funding for this vital program to $375 million for 
fiscal year 2008.
The National Breast and Cervical Cancer Early Detection Program 
        (NBCCEDP)
    The National Breast and Cervical Cancer Early Detection Program 
(NBCCEDP) administered by the CDC is an indispensable health program in 
helping underserved women gain access to screening programs for early 
detection of breast and cervical cancers. The NBCCEDP has served over 
2.5 million women and provided 5.8 million screening examinations. 
Early detection and treatment of breast and cervical cancers greatly 
increase a woman's odds of conquering these diseases. We strongly urge 
the committee to continue saving women's lives and to prevent cuts to 
this vital program.
National Center on Birth Defects and Developmental Disabilities 
        (NCBDDD)
    Birth defects affect about one in every 33 babies born in the 
United States each year. Babies born with birth defects have a greater 
chance of illness and long term disability than babies without birth 
defects. According to the CDC, a great opportunity for further 
improvement lies in prevention strategies that, if implemented prior to 
conception, would result in further improvement of pregnancy outcomes. 
A cooperative agreement between the NCBDDD and ACOG has resulted in 
increased provider knowledge of genetic screening and diagnostic tests, 
technical guidance on routine preconception care and prenatal genetic 
screening, and improved access to care for women with disabilities.
    Again, we would like to thank the committee for its continued 
support of interagency cooperation to address the multiple factors that 
affect maternal and child health. We strongly urge this subcommittee to 
support increased ob-gyn research funding for the NICHD and throughout 
NIH, and renewed appropriations for the maternal child health programs 
at the CDC and HRSA. By continuing to translate research done at the 
NICHD into positive outreach programs such as the Title X program and 
the NBCCEDP, we can further improve our Nation's overall health.
                                 ______
                                 
        Prepared Statement of the American Diabetes Association

    Thank you for the opportunity to submit testimony on the importance 
of Federal funding for diabetes programs at the Centers for Disease 
Control and Prevention (CDC) and diabetes research at the National 
Institutes of Health (NIH).
    As the Nation's leading nonprofit health organization providing 
diabetes research, information and advocacy, the American Diabetes 
Association feels strongly that Federal funding for diabetes prevention 
and research efforts is critical not only for the 20.8 million 
Americans who currently have diabetes, but also for the 54 million who 
have a condition known as pre-diabetes.
    Diabetes is a serious disease, and is a contributing cause of many 
of the chronic conditions on which the Federal Government spends the 
most health care dollars. In 2002, the direct and indirect costs spent 
solely on diabetes were $132 billion. In addition, diabetes is a 
significant cause of heart disease, stroke, and a leading cause of 
kidney disease, which combine to cost our Nation $356.7 billion a year. 
Diabetes is also the leading cause of adult-onset blindness and lower 
limb amputations.
    Between 1990 and 2001 diabetes cases increased 60 percent and they 
have continued to increase by 8 percent a year. Every 21 seconds, 
another individual is diagnosed with diabetes. Diabetes is the single 
most prevalent chronic illness among children. Because of the systemic 
havoc that diabetes wreaks throughout the body, it is no surprise that 
the life expectancy of a person with the disease averages 10-15 years 
less than that of the general population.
    As the statistics listed above illustrate, we are facing an 
epidemic of diabetes in this country, which if left unchecked could 
have significant health and economic implications for many future 
generations. Every 24 hours there are: 4,100 individuals diagnosed with 
diabetes, 230 amputations in people with diabetes, 120 people who enter 
end-stage kidney disease programs and 55 people who go blind.\1\  
According to the NIH, approximately 225,000 people died in 2002 from 
diabetes. Nearly a quarter of a million Americans! Please keep these 
numbers in mind as you look at the chart below. It tracks the Federal 
investment in fighting diabetes since fiscal year 2005--a period in 
which the prevalence of diabetes has grown by approximately 32 percent. 
In the case of the CDC budget for their Division of Diabetes 
Translation (DDT), funding has been relatively flat since fiscal year 
2003. A change in formula makes it appear that there was a major 
decrease of 4 percent in fiscal year 2005, when in actuality there was 
a minor increase.
---------------------------------------------------------------------------
    \1\ Frank Vinicor, Associate Director for Public Health Practice at 
the Centers for Disease Control, qtd. in N.R. Kleinfield, ``Diabetes 
and Its Awful Toll Quietly Emerges as a Crisis,'' The New York Times, 9 
January 2006.

----------------------------------------------------------------------------------------------------------------
                                                                                            Percent increase
                                                                Funding     Difference -------------------------
                         DDT at CDC                              Level      from prior   From prior
                                                                               year         year     In diabetes
----------------------------------------------------------------------------------------------------------------
Fiscal year:
    2005....................................................      $63.457        -2.59        -4.09           +8
    2006....................................................       63.119        -9.34         -.54           +8
    2007....................................................       62.806         -.31         -.50           +8
    2008 administration.....................................       62.806  ...........  ...........           +8
----------------------------------------------------------------------------------------------------------------


----------------------------------------------------------------------------------------------------------------
                                                                                            Percent increase
                                                                Funding     Difference -------------------------
                         DDK at NIH                              level      from prior   From prior
                                                                              years         year     In diabetes
----------------------------------------------------------------------------------------------------------------
Fiscal year:
    2005....................................................       $1,864          +43        +2.31           +8
    2006....................................................        1,855           -9         -.49           +8
    2007....................................................        1,854           -1         -.05           +8
    2008 administration.....................................        1,858           +4         +.22           +8
----------------------------------------------------------------------------------------------------------------

    Diabetes has become the greatest public health crisis of the 21st 
century. To stem the tide of this epidemic diabetes prevention and 
outreach efforts must expand, and at the same time scientists and 
researchers must continue their work towards finding a cure. Therefore, 
we are requesting:
  --A $20.8 million increase for the CDC's Division of Diabetes 
        Translation (DDT), only one dollar for each American suffering 
        from diabetes. This program was left at flat funding in the 
        recently-passed joint funding resolution, although it had been 
        slated for an increase in both the House and Senate passed 
        bills.
  --An 8 percent increase over fiscal year 2007 funding at NIH's 
        National Institute for Diabetes, Digestive and Kidney Diseases 
        (NIDDK), the amount included in last year's NIH Reauthorization 
        package. These funds would make up for previous cuts and allow 
        for the ongoing cost of biomedical inflation, which continues 
        to eat into the purchasing power of research funding.

 DIABETES INTERVENTIONS AT THE CENTERS FOR DISEASE CONTROL & PREVENTION

    The CDC's Division of Diabetes Translation is critical to our 
national efforts to prevent and manage diabetes because DDT literally 
translates research into real interventions at the community level. 
Currently, for every dollar that diabetes costs this country, the 
Federal Government invests less than one cent to help Americans prevent 
and manage this deadly disease. This dynamic must be changed. Our 
request of $20.8 million will allow these critical programs to expand 
to more adequately meet the growing demands of the diabetes epidemic.
    In 2006, DDT provided support for more than 50 State, and 
territorial, based Diabetes Prevention and Control Programs (DPCPs) to 
increase outreach and education, and to reduce the complications 
associated with diabetes. However, due to funding constraints, DDT is 
able to provide full support to only 28 States. The remaining 22 
States, 8 territories, and the District of Columbia are given no more 
than partial support. This level of funding, referred to as ``capacity 
building,'' allows a State to do surveillance, but is not enough for 
the State to do much--or in some cases, anything--in the way of 
intervention. Even more alarming, DDT's current funding level only 
allows for prevention activities in five States. While we know from 
clinical trials \2\ that the onset of type 2 diabetes can be delayed or 
prevented in most cases, this dismal funding for primary prevention 
falls far short of the resources needed to address the 54 million 
Americans with pre-diabetes.
---------------------------------------------------------------------------
    \2\ The Diabetes Prevention Program (DPP) was a major clinical 
trial, or research study, aimed at discovering whether either diet and 
exercise or the oral diabetes drug metformin (Glucophage) could prevent 
or delay the onset of type 2 diabetes in people with impaired glucose 
tolerance.
---------------------------------------------------------------------------
    For those 28 States DDT was able to provide a higher level of 
support called basic implementation. At this level, States are able to 
devise and execute community based programs. Without adequately funded 
diabetes programs and projects in all parts of the country, it will be 
exceedingly difficult--if not impossible--to control the escalating 
costs associated with diabetes-associated complications and to stem the 
epidemic rise in diabetes rates. State DPCPs, when provided with enough 
funding, are proven to have been extremely successful in helping 
Americans prevent and manage their diabetes. In the Division of 
Diabetes Translation Program Review fiscal year 2004, the CDC stated, 
``The Basic Implementation DPCPs serve as the backbone for our growing 
primary prevention efforts. These State programs are the key elements 
to our success in meeting the challenges of controlling and preventing 
diabetes.''
    For example, the Pennsylvania DPCP provides funding to support two 
of the Commonwealth's eight community-based Diabetes Nurse Consultants 
which provide information and consultation services to patients and 
their families, health care providers, schools, nursing homes and 
countless others in all 67 counties. These programs have demonstrated 
success in promoting physical activity, weight and blood pressure 
control, and smoking cessation for those with diabetes. Americans in 
every State should have access to such quality programs. Unfortunately, 
States such as Iowa and Mississippi are currently funded at levels that 
don't allow for basic implementation. The Division's fiscal year 2007 
budget of $63 million had no increase from fiscal year 2006 and the 
President has requested flat funding again for fiscal year 2008.
    In addition to DPCP activities, the CDC's Division of Diabetes 
Translation conducts other activities to help people currently living 
with diabetes. To put research into action, CDC works with NIH to 
jointly sponsor the National Diabetes Education Program (NDEP), which 
seeks to improve the treatment and outcomes of people with diabetes, 
promote early detection, and prevent the onset of diabetes. The CDC is 
also currently working to develop a National Public Health Vision Loss 
Prevention Program that will investigate the economic burden and 
strengthen the surveillance and research of this all-to-common 
complication of diabetes. In addition, CDC funds work at the National 
Diabetes Laboratory to support scientific studies that will improve the 
lives of people with diabetes. In fiscal year 2005, the Division of 
Diabetes Translation alone published 53 manuscripts on the care, 
prevention, and science of diabetes, including 17 abstracts.

        DIABETES RESEARCH AT THE NATIONAL INSTITUTES FOR HEALTH

    While there is not yet a cure for diabetes, researchers at NIH are 
working on a variety of projects that represent hope for the millions 
of individuals with type 1 and type 2 diabetes. The list of advances in 
treatment and prevention is thankfully a long one, but it is important 
to understand what has been, and what can be, achieved for Americans 
with diabetes. For example, the Diabetes Control and Complications 
Trial (DCCT), a clinical trial of 1,441 people with type 1 diabetes, 
demonstrated that tight control of blood glucose through intensive 
insulin therapy could significantly reduce or delay many complications 
due to diabetes. This landmark finding spurred a shift in the daily 
management of type 1 diabetes and energized research in the field. 
Subsequent funding has allowed research to continue on topics like risk 
factors, genetics, and complications that provide new approaches to 
improve therapy of diabetes.
    Obesity is a strong risk factor for type 2 diabetes, especially in 
minority populations. Recognizing the growing problem of obesity and 
its increasing prevalence among youth, the NIDDK is focusing on paths 
to prevention. One example of this focus is the HEALTHY study, which is 
led by the NIDDK and co-sponsored by the American Diabetes Association. 
This study is testing a middle school-based intervention to reduce 
students' risk factors for type 2 diabetes, such as obesity.
    Additionally, based on NIH-funded research, scientists have made 
great progress in developing methods that slow the onset and 
progression of kidney disease in people with diabetes, such as 
employing drugs that are typically used to lower blood pressure. These 
antihypertensive drugs can slow the progression of kidney disease 
significantly. Two types of drugs, angiotensin-converting enzyme (ACE) 
inhibitors and angiotensin receptor blockers (ARBs), have proven 
effective in slowing the progression of kidney disease.
    A generation ago, 20 percent of individuals diagnosed with type 1 
diabetes died within 20 years of diagnoses and 30 percent died within 
25 years. Thanks to research at NIDDK, patients now use a variety of 
insulin formulations, including rapid-acting, intermediate acting, 
long-acting insulin, and even insulin pumps, to control their blood 
glucose with much better precision. When it comes to diabetes, real-
life results from research do not merely represent potential advances; 
the advances are happening now and they are improving and saving lives.
    The Association strongly encourages you to provide at least an 8 
percent increase to the NIH to build upon and fulfill this promise of 
scientific research. Unfortunately, while the death rate due to 
diabetes has increased by 45 percent since 1987, diabetes research 
funding has not kept pace. Indeed, from 1987 to 2001, appropriated 
diabetes funding as a share of the overall NIH budget has dropped by 
more than 20 percent (from 3.9 percent to 2.9 percent). While Congress 
had initially begun to address this discrepancy, the fiscal year 2007 
Joint Funding Resolution essentially maintained the cuts of recent 
years, although NIDDK did not have to contribute to the new Common 
Fund. Still, this does not account for even the cost of biomedical 
inflation. The Association believes that NIH research and CDC 
translational programs go hand in hand in the effort to combat the 
diabetes epidemic.
    The Association, and the millions of individuals with diabetes it 
represents, firmly believes that we could rapidly move toward curing, 
preventing, and managing this disease by increasing funding for 
diabetes programs and research at both CDC and NIH. Your leadership is 
essential to accomplishing this goal. As you are considering fiscal 
year 2008 funding, we ask you to remember that chronic diseases, 
including diabetes, account for nearly 70 percent of all health care 
costs as well as 70 percent of American deaths annually. Unfortunately, 
less than $l.25 per person is directed toward public health 
interventions focused on preventing the debilitating effects associated 
with chronic diseases, demonstrating that Federal investment in chronic 
disease prevention remains grossly inadequate. We cannot ignore those 
Americans who are currently living with diabetes and other diseases.
    In closing, the American Diabetes Association strongly urges the 
subcommittee and the Senate to provide a $20.8 million increase for the 
CDC's Division of Diabetes Translation. Providing this funding would be 
an important step towards empowering the effort fight diabetes at the 
community and national levels. Additionally, we urge the subcommittee 
to increase NIH funding by 8 percent, the level that was authorized in 
the bipartisan NIH Reauthorization legislation that passed both the 
House and Senate last year by overwhelming margins. These funding 
levels would allow for an increased commitment to diabetes research.
    An important question has been raised, ``Where will we be in 10 
years?'' For diabetes, the answer to that question is truly in your 
hands. The disease is growing at a rate of 8 percent annually, but the 
government has not increased the resources to prevent, treat or find a 
cure for diabetes in over 4 years. In 2002, the United States spent 
$132 billion in direct and indirect costs for diabetes. If these trends 
continue for the next 10 years, the costs--in human life and 
economics--will be truly unimaginable.
    On behalf of the 20.8 million Americans with diabetes--a disease 
that crosses gender, race, ethnicity and political party; a disease 
that is among the most costly, debilitating, deadly and prevalent in 
our Nation; and a disease that is unnecessarily on the rise--I thank 
you for the opportunity to submit this testimony. The American Diabetes 
Association is prepared to answer any questions you might have on these 
important issues.
                                 ______
                                 
          Prepared Statement of the American Heart Association

    Over the past 50 years, we have made enormous progress against 
heart disease, stroke and other forms of cardiovascular disease (CVD). 
According to the National Institutes of Health, 1.6 million lives have 
been saved since the 1960s that would have been lost to CVD. Americans 
can expect to live 4 years longer from a drop in heart disease deaths.
    In spite of progress, we have not declared victory, and we may be 
losing ground. An estimated 80 million American adults suffer from CVD. 
Despite educational efforts, increased rates of diabetes, obesity and 
other risk factors may undo four decades of declining mortality. And, 
we are often not reaching those at most risk, like those with lower 
socioeconomic status.
    The morbidity and mortality rates still startle. Nearly 2,400 
Americans die from CVD each day--an average of one death every 36 
seconds. Heart disease and stroke remain the No. 1 and No. 3 killers, 
respectively, for both men and women in the United States today and two 
of three men and one of two women will develop CVD during their 
lifetime.
    To make matters worse, a perfect storm is taking shape fueled by 
demographics. As the baby boomers age, the number of Americans 
developing CVD will increase radically. CVD can strike at any age, but 
the odds increase with age. A report estimates that heart disease 
deaths will increase 130 percent from 2000 and 2050.
    Beyond the toll in suffering and death, CVD comes with a steep 
price tag. It costs Americans an estimated $432 billion in medical 
expenses and lost productivity in 2007--more than any other disease. We 
will soon be facing a CVD crisis of staggering proportions and 
implications for health care costs and quality of care. We ignore it at 
our collective peril.

     BUDGET RECOMMENDATIONS: INVESTING IN THE HEALTH OF OUR NATION

    Although progress has been made in the prevention and treatment of 
CVD, there is still no cure and more Americans than ever are at risk. 
The most prudent way to address this looming crisis is to 
simultaneously invest in research, prevention and treatment. 
Regretfully, the funding levels proposed by the administration in its 
fiscal year 2008 budget undermine these efforts.
    Now is not the time to reduce our investment in programs that 
prevent and treat America's leading and most costly killer. Solving a 
problem of this magnitude requires a major public investment. If we 
fail to take aggressive and deliberate action now--we will pay later in 
health care expenditures and lives. The American Heart Association's 
recommendations that follow address this problem in a comprehensive but 
fiscally responsible way.
Increase Funding for the National Institutes of Health (NIH)
    NIH research has revolutionized patient care and holds the key to a 
cure for CVD. NIH research also fuels innovation that generates 
economic growth and preserves our Nation's role as the world leader in 
the pharmaceutical and biotechnology industries. The President's 
request is $511 million below fiscal year 2007 and the gap between the 
levels achieved during the doubling of the NIH budget and the request, 
when adjusted for biomedical research inflation, exceeds 13 percent.
    AHA Recommendation.--AHA advocates for a fiscal year 2008 
appropriation of $30.8 billion for NIH. It represents the first year of 
a 3-year campaign to get NIH funding ``Back on Track.'' A 6.7 percent 
funding increase for each of the next 3 years would restore and protect 
the past investment made by the Congress in doubling the resources of 
the NIH.
Increase Funding for NIH Heart and Stroke Research: A Proven Investment
    From 1994-2004, death rates from cardiovascular diseases, coronary 
heart disease and stroke have fallen respectively by 25 percent, 33 
percent and 20 percent. Much of this progress can be attributed to NIH 
heart and stroke research which has improved health outcomes and in 
some cases, lowered health care costs. Examples of recent NIH research 
accomplishments include:
  --CVD Research a Good Value.--NIH's cumulative investment in CVD 
        research over the past 30 years has resulted in a 63 percent 
        decrease in heart disease deaths at a projected value of $1.5 
        trillion per year from 1970 to 1990 due to increase in life 
        expectancy.
  --Stroke Trials Benefit Economy.--The original NIH tPA trial resulted 
        in a 10-year net reduction in healthcare costs of $6.47 
        billion. The Stroke Prevention in Atrial Fibrillation Trial 1 
        resulted in a 10-year net benefit of $1.27 billion, with a 
        savings of 35,000 quality-adjusted life years.
  --Stroke Rehabilitation.--Constraint-Induced Movement Therapy, a 
        rehabilitative method involving forced use of a paralyzed arm, 
        can help stroke survivors regain arm function.
  --Late Angioplasty No Advantage.--An international study found that 
        stable heart attack survivors who received angioplasty and 
        stenting three to 28 days after the attack did no better than 
        patients receiving, primarily drug treatment. These findings 
        could reduce unnecessary interventions and lower health care 
        costs.
    In spite of these and other successes, NIH heart and stroke 
research budget remains disproportionately under-funded compared to the 
disease burden. CVD meets NIH's priority setting criteria (public 
health needs, scientific quality of research, scientific progress 
potential, portfolio diversification and adequate infrastructure 
support), yet only 7 percent of the NIH budget is invested in heart 
research and a mere 1 percent is devoted to stroke.
Cardiovascular Disease Research
    Relative to the amount needed to keep pace with medical research 
inflation, proposed funding for cardiovascular research will decline by 
15 percent since fiscal year 2003. These limited resources cannot 
adequately support and expand current activities or allow investments 
in promising initiatives to aggressively advance the fight against 
heart disease and stroke--the first and third causes of death among 
Americans. Additional funds could be used in the following areas:
  --Atherosclerosis Prevention Trial.--Atherosclerosis is a main risk 
        factor for heart disease and stroke. With increased funding, 
        the National Heart, Lung, and Blood Institute (NHLBI) could 
        initiate a clinical trial to determine if reducing low-density 
        lipoprotein cholesterol, so-called ``bad'' cholesterol, to a 
        level lower than currently recommended, reduces major CVD 
        events in healthy patients at high risk of heart disease and or 
        stroke.
  --Systolic Blood Pressure Intervention Trial.--High blood pressure is 
        a major risk factor for heart disease, heart failure and 
        stroke. Additional funding would allow the NHLBI to conduct a 
        multi-center clinical trial to determine whether reducing 
        systolic blood pressure to a lower level than currently 
        recommended could prevent heart attacks and strokes.
  --Preventing Weight Gain in Young Adults.--With additional resources, 
        NHLBI could support small-scale studies to develop and evaluate 
        promising, innovative practical, cost-effective ways for young 
        adults to reduce their risk for CVD by preventing weight gain.
Stroke Research
    Stroke is the No. 3 killer of Americans and a major cause of 
permanent disability. In addition to the elderly, stroke also strikes 
newborns, children and young adults. An estimated 700,000 Americans 
will suffer a stroke this year, and nearly 150,000 will die. Many of 
America's 5.7 million stroke survivors face debilitating physical and 
mental impairment, emotional distress and huge medical costs; about 1 
in 4 survivors are permanently disabled.
    As a result of fiscal year 2001 congressional report language, the 
National Institute of Neurological Disorders and Stroke (NINDS) 
convened a Stroke Progress Review Group (PRG). Their report provided a 
long-range strategic plan for stroke research. The PRG was reconvened 
last year and took stock of interim progress and re-evaluated 
recommendations for future research. Since the issuance of the initial 
report, multiple scientific programs have been undertaken; but, more 
funding is needed to fully implement the strategic plan. The fiscal 
year 2008 request for NINDS stroke research falls 56 percent short of 
the strategic plan's target for that year. Additional funding could be 
used to conduct stroke research in the following areas:
  --Stroke Translational Research.--Translational studies are vital to 
        providing cutting-edge stroke treatment and prevention. Due to 
        budget shortfalls, the NINDS has been forced to compress its 
        Specialized Programs of Translational Research in Acute Stroke 
        (SPOTRIAS) from the planned 10 extramural centers to the five 
        currently funded. SPOTRIAS researchers facilitate translation 
        of basic research into patient care and evaluate and treat 
        victims rapidly after the onset of stroke symptoms.
  --Neurological Emergencies Treatment Trials Network.--Limited 
        resources will also force the NINDS to scale back its 
        Neurological Emergencies Treatment Trials Network. This 
        initiative is designed to develop a clinical research network 
        of emergency medicine physicians, neurologists and 
        neurosurgeons to develop through clinical trials more and 
        improved treatments for acute neurological emergencies, such as 
        stroke.
  --Stroke Education.--In partnership with CDC, NINDS launched a 
        grassroots program called ``Know Stroke in the Community.'' It 
        includes enlisting the aid of ``Stroke Champions'' who teach 
        communities about signs and symptoms. The goal is to shift 
        stroke treatment from supportive care to early brain-saving 
        intervention. But, more funding is needed to teach the public 
        and health providers.
    AHA Recommendation.--AHA recommends an fiscal year 2008 
appropriation of $2.2 billion for NIH heart research; $3.1 billion for 
the NHLBI; $362 million for NIH stroke research; and $1.6 billion for 
the NINDS. These figures represent a 6.7 percent increase over fiscal 
year 2007--commensurate with the Association's recommended funding 
increase for the NIH.
Increase Funding for the Centers for Disease Control and Prevention 
        (CDC)
    Basic research must be translated into easy-to-understand guidance 
so people can apply it in their daily lives. Prevention is the best way 
to protect Americans' health and ease the financial burden of disease. 
While literature indicates that increased and improved CVD 
interventions can be highly successful, investigators have also 
concluded that effective strategies for combating CVD are often not 
being implemented. A study suggests that not smoking, maintaining a 
healthy weight, and avoiding diabetes, high blood pressure and high 
cholesterol may add 10 years to life.
    AHA commends Congress for supporting CDC's Division for Heart 
Disease and Stroke Prevention which funds 33 States to create or 
implement programs to prevent first and second instances of heart 
disease and stroke. These state-tailored programs aide collaboration 
among public and private sectors to help people lower blood pressure 
and cholesterol, learn signs and symptoms, call 9-1-1, improve 
emergency response and quality care, and end treatment disparities. 
Many of these programs have reduced risk, like high blood pressure.
    In fiscal year 2007, only 14 States receive funding to implement 
these prevention programs. The remaining 19 receive funds for planning; 
which is now largely complete. Because cardiovascular disease is the 
No. 1 killer in every State, each State needs basic implementation 
money for this program; however, current funding levels are 
insufficient for its expansion.
    AHA Recommendation.--For fiscal year 2008, AHA recommends an 
appropriation of $10.7 billion (including funding for ATSDR, and the 
current funding level for the Vaccines for Children Program) for CDC, 
with increases targeted for programs within the National Center for 
Chronic Disease Prevention and Health Promotion. Within that total, we 
recommend $64.3 million for the Division for Heart Disease and Stroke 
Prevention, allowing CDC to: (1) add up to 12 States to the program to 
conduct state-tailored plans; (2) elevate up to 6 States from planning 
to program implementation; (3) support the Paul Coverdell National 
Acute Stroke Registry; (4) start development of a state-based cardiac 
arrest registry; and (5) explore establishment of a National Heart 
Disease and Stroke Surveillance Unit to monitor data, identify grave 
gaps, and offer modifications to existing components to fill the gaps.
Restore Funding for Rural and Community Access to Emergency Devices 
        (AED) Program
    About 94 percent of cardiac arrest victims die outside of a 
hospital. Immediate CPR and early intervention using AEDs can more than 
double a victim's chance of survival. Small, easy-to-use AEDs can shock 
the heart back into normal rhythm. Placing AEDs in more public settings 
could save thousands of lives each year. Communities with comprehensive 
AED programs that include training of anticipated rescuers have 
achieved survival rates of 40 percent or higher.
    The Rural and Community AED Program provides grants to States to 
train lay rescuers and first responders to use AEDs and buy and place 
them where sudden cardiac arrests are likely to occur. During the first 
year of the program, 6,400 AEDs were purchased and 38,800 individuals 
were trained. AEDs have been placed in schools, faith-based and 
recreation facilities, nursing homes, and other locations in 
communities across our Nation. In spite of this success, the Rural and 
Community AED Program is terminated in the President's fiscal year 2008 
budget.
    AHA Recommendation.--For fiscal year 2008, AHA recommends 
restoration of HRSA's Rural and Community AED Program to its fiscal 
year 2005 level of $8.927 million.
Increase funding for the Agency for Healthcare Research and Quality 
        (AHRQ)
    AHRQ is a key partner of the public and private health care 
sectors. AHRQ helps develop evidence-based information needed by 
consumers, providers, health plans and policymakers to improve health 
care decision making. Through its Effective Health Care Program, AHRQ 
supports research focusing on outcomes, comparative clinical 
effectiveness, and appropriateness of pharmaceuticals, devices and 
health care services for conditions like ischemic heart disease, 
stroke, and high blood pressure. The research and comparative 
effectiveness reviews conducted and funded address issues raised in the 
Institute of Medicine's Crossing the Quality Chasm.
    Their initiative on health information technology is key to our 
Nation's strategy to bring health care into the 21st century. It 
includes more than $166 million in grants. Through these and other 
projects, AHRQ and its partners help identify challenges to HIT 
adoption and use, solutions and best practices, and tools that help 
hospitals and clinicians incorporate HIT.
    AHA Recommendation.--AHA joins with Friends of AHRQ in advocating 
for an appropriation of $350 million for AHRQ, restoring the agency to 
its fiscal year 2005 level to advance health care quality, cut medical 
errors and expand availability of health outcomes information.
    Although heart disease, stroke and other cardiovascular diseases 
are largely preventable, they continue to exact a deadly and costly 
toll. And as baby boomers age, our Nation faces an expanding 
cardiovascular crisis that threatens to overwhelm us unless significant 
and meaningful steps are taken. But, adequate funding of research, 
treatment and prevention programs will save lives and reduce rising 
health care costs. We urge Congress to consider the Association's 
recommendations during its deliberations on the fiscal year 2008 
budget.
                                 ______
                                 
 Prepared Statement of the American Indian Higher Education Consortium

    Summary of Requests.--Summarized below are the fiscal year 2008 
recommendations for the Nation's 34 Tribal Colleges and Universities 
(TCUs), covering three areas within the Department of Education and one 
in the Department of Health and Human Services, Administration for 
children and families' head start program.

                    DEPARTMENT OF EDUCATION PROGRAMS

A. Higher Education Act Programs
    Strengthening Developing Institutions.--Section 316 of Title III 
Part A, specifically supports TCUs through two separate grant programs: 
(a) basic development grants, and (b) facilities/construction grants 
designed to address the critical facilities needs at TCUs. The TCUs 
urge the subcommittee to restore the funding cut proposed in the 
President's fiscal year 2008 Budget and increase funding to $32.0 
million and that report language be restated clarifying that funds in 
excess of those needed to support continuation grants or new planning 
or implementation grants shall be used for facilities, renovation, and 
construction grants.
    Pell Grants.--TCUs urge the subcommittee to fund the Pell Grants 
Program at the highest possible level.
B. Perkins Career and Technical Education Programs
    The TCUs support $8.5 million for Sec. 117 of the Carl D. Perkins 
Career and Technical Education Improvement Act and request language 
reaffirming that this program remains specific to the two Tribally 
Controlled Postsecondary Vocational Institutions: United Tribes 
Technical College and Navajo Technical College. Additionally, TCUs 
strongly support the Native American Career and Technical Education 
Program (NACTEP) authorized under Sec. 116 of the act.
C. Relevant Title IX Elementary and Secondary Education Act (ESEA) 
        Programs
    Adult and Basic Education.--Although Federal funding for tribal 
adult education was eliminated in fiscal year 1996, TCUs continue to 
offer much needed adult education, GED, remediation and literacy 
services for American Indians, yet their efforts cannot meet the 
demand. The TCUs request that the subcommittee direct $5.0 million of 
the Adult Education State Grants appropriated funds to make awards to 
TCUs to support their adult and basic education programs.
    American Indian Teacher and Administrator Corps.--The American 
Indian Teacher Corps and the American Indian Administrator Corps offer 
professional development grants designed to increase the number of 
American Indian teachers and administrators serving their reservation 
communities. The TCUs request that the subcommittee support these 
programs at $10.0 and $5.0 million, respectively.

             DEPARTMENT OF HEALTH & HUMAN SERVICES PROGRAM

D. Tribal Colleges and Universities Head Start Partnership Program 
        (DHHS-ACF)
    Tribal Colleges and Universities are ideal partners to help achieve 
the goals of Head Start in Indian Country. The TCUs are working to meet 
the mandate that Head Start teachers earn degrees in Early Childhood 
Development or a related discipline. The TCUs request that $5.0 million 
be designated for the TCU-Head Start partnership program, to ensure the 
continuation of current TCU programs and the funds necessary for 
additional TCU-Head Start partnership programs.
    Mr. Chairman and members of the subcommittee, on behalf of this 
Nation's 34 Tribal Colleges and Universities (TCUs), which comprise the 
American Indian Higher Education Consortium (AIHEC), thank you for the 
opportunity to share our fiscal year 2008 funding recommendations for 
programs within the U.S. Department of Education and the U.S. 
Department of Health and Human Services--Head Start program.

           I. BACKGROUND ON TRIBAL COLLEGES AND UNIVERSITIES:

    The vast majority of tribal colleges is accredited by independent, 
regional accreditation agencies and like all institutions of higher 
education, must undergo stringent performance reviews on a periodic 
basis to retain their accreditation status. In addition to college 
level programming, TCUs provide much needed high school completion 
(GED), basic remediation, job training, college preparatory courses, 
and adult education. Tribal colleges fulfill additional roles within 
their respective reservation communities functioning as community 
centers, libraries, tribal archives, career and business centers, 
economic development centers, public meeting places, and child care 
centers. Each TCU is committed to improving the lives of its students 
through higher education and to moving American Indians toward self-
sufficiency.
    Tribal Colleges and Universities provide access to higher education 
for American Indians and others living in some of the Nation's most 
rural and economically depressed areas. The average family income for a 
student first entering a TCU is $14,000, which is 27 percent below the 
Federal poverty threshold for a family of four. In addition to serving 
their students, TCUs serve their communities through a variety of 
community outreach programs.
    These institutions, chartered by their respective tribal 
governments, were established in response to the recognition by tribal 
leaders that local, culturally based institutions are best suited to 
help American Indians succeed in higher education. TCUs combine 
traditional teachings with conventional postsecondary curricula. They 
have developed innovative ways to address the needs of tribal 
populations and are overcoming long-standing barriers to success in 
higher education for American Indians. Since the first TCU was 
established on the Navajo Nation, these vital institutions have come to 
represent the most significant development in the history of American 
Indian higher education, providing access to and promoting achievement 
among students who may otherwise never have known postsecondary 
education success.

                           II. JUSTIFICATIONS

A. Higher Education Act
    The Higher Education Act Amendments of 1998 created a separate 
section within Title III, Part A, specifically for the Nation's Tribal 
Colleges and Universities (Section 316). Programs under Titles III and 
V of the act support institutions that enroll large proportions of 
financially disadvantaged students and have low per-student 
expenditures. Although TCUs, which are truly developing institutions, 
are providing access to quality higher education opportunities to some 
of the most rural and impoverished areas of the country, the 
President's fiscal year 2008 budget proposes a 20 percent cut to the 
TCU Title III grants program. A clear goal of the Higher Education Act 
Title III programs is ``to improve the academic quality, institutional 
management, and fiscal stability of eligible institutions, in order to 
increase their self-sufficiency and strengthen their capacity to make a 
substantial contribution to the higher education resources of the 
Nation.'' The TCU Title III program is specifically designed to address 
the critical, unmet needs of their American Indian students and 
communities, in order to effectively prepare them for the workforce of 
the 21st Century. The TCUs urge the subcommittee to reject the 
substantial cut proposed in the President's budget and fund Title III-A 
section 316 at $32.0 million in fiscal year 2008, an increase of $8.2 
million over fiscal year 2007 and $13.5 million over the President's 
request to afford these developing institutions the resources necessary 
to address the needs of their historically underserved students and 
communities. Additionally, we request that report language be restated 
clarifying that funds in excess of those needed to support continuation 
grants or new planning or implementation grants shall be used for 
single year facilities, renovation, and construction grants to ensure 
TCUs will be able to operate in adequate and safe facilities.
    The importance of Pell grants to TCUs students cannot be 
overstated. U.S. Department of Education figures show that the majority 
of TCU students receive Pell grants, primarily because student income 
levels are so low and our students have far less access to other 
sources of aid than students at State funded and other mainstream 
institutions. Within the tribal college system, Pell grants are doing 
exactly what they were intended to do--they are serving the needs of 
the lowest income students by helping them gain access to quality 
higher education, an essential step toward becoming active, productive 
members of the workforce. The TCUs urge the subcommittee to fund this 
critical grants program at the highest possible level.
B. Carl D. Perkins Career and Technical Education Act
    Tribally-Controlled Postsecondary Vocational Institutions.--Section 
117 of the Perkins Act provides basic operating funds for two of our 
member institutions: United Tribes Technical College in Bismarck, North 
Dakota, and Navajo Technical College in Crownpoint, New Mexico. The 
TCUs urge the subcommittee to fund this program at $8.5 million.
    Native American Career and Technical Education Program.--The Native 
American Career and Technical Education Program (NACTEP) under Sec. 116 
of the act reserves 1.25 percent of appropriated funding to support 
Indian vocational programs. The TCUs strongly urge the subcommittee to 
continue to support NACTEP, which is vital to the survival of 
vocational education programs being offered at Tribal Colleges and 
Universities.
C. Greater Support of Indian Education Programs
    American Indian Adult and Basic Education (Office of Vocational and 
Adult Education).--This program supports adult basic education programs 
for American Indians offered by TCUs, State and local education 
agencies, Indian tribes, institutions, and agencies. Despite a lack of 
funding, TCUs must find a way to continue to provide basic adult 
education classes for those American Indians that the present K-12 
Indian education system has failed. Before many individuals can even 
begin the course work needed to learn a productive skill, they first 
must earn a GED or, in some cases, even learn to read. The number of 
students needing remedial educational programs before embarking on 
their degree programs is considerable at TCUs. There is a wide need for 
basic adult educational programs and TCUs need adequate funding to 
support these essential activities. Tribal colleges respectfully 
request that the subcommittee direct $5.0 million of the Adult 
Education State Grants appropriated funds to make awards to TCUs to 
help meet the ever increasing demand for basic adult education and 
remediation program services.
    American Indian Teacher/Administrator Corps (Special Programs for 
Indian Children).--American Indians are severely under represented in 
the teaching and school administrator ranks nationally. These 
competitive programs are designed to produce new American Indian 
teachers and school administrators for schools serving American Indian 
students. These grants support recruitment, training, and in-service 
professional development programs for Indians to become effective 
teachers and school administrators and in doing so become excellent 
role models for Indian children. We believe that the TCUs are the ideal 
catalysts for these two initiatives because of their current work in 
this area and the existing articulation agreements they hold with 4-
year degree awarding institutions. The TCUs request that the 
subcommittee support these two programs at $10.0 million and $5.0 
million, respectively, to increase the number of qualified American 
Indian teachers and school administrators in Indian Country.

DEPARTMENT OF HEALTH AND HUMAN SERVICES/ADMINISTRATION FOR CHILDREN AND 
                          FAMILIES/HEAD START

    Tribal Colleges and Universities (TCU) Head Start Partnership 
Program.--The TCU-Head Start Partnership has made a lasting investment 
in our Indian communities by creating and enhancing associate degree 
programs in Early Childhood Development and related fields. Graduates 
of these programs help meet the degree mandate for all Head Start 
program teachers. More importantly, this program has afforded American 
Indian children Head Start programs of the highest quality. A clear 
impediment to the ongoing success of this partnership program is the 
erratic availability of discretionary funds made available for the TCU-
Head Start Partnership. In fiscal year 1999, the first year of the 
program, some colleges were awarded 3-year grants, others 5-year 
grants. In fiscal year 2002, no new grants were funded at all. In 
fiscal year 2003, funding for eight new TCU grants was made available, 
but in fiscal year 2004, only two new awards could be made because of 
the lack of adequate funds. The President's fiscal year 2008 budget 
includes a total request of $6,788,571,000 for Head Start Programs. The 
TCUs request that the subcommittee direct the Head Start Bureau to 
designate a minimum of $5.0 million of the $6.8 billion recommended for 
the TCU-Head Start Partnership program, to ensure that this critical 
program can continue and expand so that all TCUs have the opportunity 
to participate in the TCU-Head Start Partnership program.

                            III. CONCLUSION

    Tribal Colleges and Universities provide access to higher education 
opportunities to many thousands of American Indians, and essential 
community services and programs to many more. The modest Federal 
investment in TCUs has already paid great dividends in terms of 
employment, education, and economic development, and continuation of 
this investment makes sound moral and fiscal sense. Tribal colleges 
need your help if they are to sustain and grow their programs and 
achieve their missions to serve their students and communities.
    Thank you again for this opportunity to present our funding 
recommendations. We respectfully ask the members of the subcommittee 
for their continued support of the Nation's Tribal Colleges and 
Universities and full consideration of our fiscal year 2008 
appropriations needs and recommendations.
                                 ______
                                 
          Prepared Statement of the American Lung Association

                    SUMMARY: FUNDING RECOMMENDATIONS
                        [In millions of dollars]
------------------------------------------------------------------------
                                                              Amount
------------------------------------------------------------------------
National Institutes of Health...........................          30,537
    National Heart, Lung, and Blood Institute...........           3,114
    National Cancer Institute...........................           5,111
    National Institute of Allergy and Infectious Disease           4,675
    National Institute of Environmental Health Sciences.             683
    National Institute of Nursing Research..............             146
    Fogarty International Center........................              70
Centers for Disease Control and Prevention..............          10,700
    National Institute for Occupational Safety and                   285
     Health.............................................
    Office on Smoking and Health........................             145
    Environmental Health: Asthma Activities.............              70
    Tuberculosis Control Programs.......................             252
Influenza Pandemic......................................           2,652
------------------------------------------------------------------------

    The American Lung Association is pleased to present our 
recommendations to the Labor Health and Human Services and Education 
Appropriations Subcommittee. These programs will make a difference in 
the lives of millions of Americans who suffer from lung disease.
    The American Lung Association is one of the oldest voluntary health 
organizations in the United States, with a National Office and local 
associations around the country. Founded in 1904 to fight tuberculosis, 
the American Lung Association today fights lung disease in all its 
forms.

                        THE TOLL OF LUNG DISEASE

    Each year, close to 400,000 Americans die of lung disease. Lung 
disease is America's number three killer, responsible for one in every 
six deaths. More than 35 million Americans suffer from a chronic lung 
disease. Each year lung disease costs the economy an estimated $157.8 
billion. Lung diseases include: asthma, chronic obstructive pulmonary 
disease, lung cancer, tuberculosis, pneumonia, influenza, sleep 
disordered breathing, pediatric lung disorders, occupational lung 
disease and sarcoidosis.

                 CHRONIC OBSTRUCTIVE PULMONARY DISEASE

    Chronic Obstructive Pulmonary Disease, or COPD, is a growing health 
problem. Yet, it remains relatively unknown to most Americans and much 
of the research community. COPD refers to a group of largely 
preventable diseases, including emphysema and chronic bronchitis that 
generally gradually limit the flow of air in the body. COPD is the 
fourth leading cause of death in the United States and worldwide. In 
2004, the annual cost to the Nation for COPD was $37.2 billion. This 
includes $20.9 billion in direct health care expenditures, $8.9 billion 
in indirect morbidity costs and $7.4 billion in indirect mortality 
costs. Medicare expenses for COPD beneficiaries were nearly 2.5 times 
that of the expenditures for all other patients.
    It has been estimated that 11.4 million patients have been 
diagnosed with some form of COPD and as many as 24 million adults may 
suffer from its consequences. In 2004, 120,104 people in the United 
States died of COPD. Women have exceeded men in the number of deaths 
attributable to COPD since 2000. Over the past 30 years, the death rate 
due to COPD has doubled while the death rates for heart disease, cancer 
and stroke have decreased by over 50 percent.
    Today, COPD is treatable but not curable. Fortunately, promising 
research is on the horizon for COPD patients. Research on the genetic 
susceptibility underlying COPD is making progress. Research is also 
showing promise for reversing the damage to lung tissue caused by COPD. 
Despite these promising research leads, the American Lung Association 
believes that research resources committed to COPD are not commensurate 
with the impact COPD has on the United States and the world.
    The American Lung Association strongly recommends that the NIH and 
other Federal research programs commit additional resources to COPD 
research programs. We support increasing the National Heart, Lung and 
Blood Institute budget to $3,114 billion. The Lung Association supports 
the CDC in gathering more information about COPD as part of the 
National Health and Nutrition Examination Survey, the Behavioral Risk 
Factor Surveillance System and other health surveys. This information 
will help public health professionals and researchers understand the 
disease better and lead to possible control of the disease.

                              TOBACCO USE

    Tobacco use is the leading preventable cause of death in the United 
States, killing more than 438,000 people every year. Smoking is 
responsible for one in five U.S. deaths. The direct health care and 
lost productivity costs of tobacco-caused disease and disability are 
also staggering, an estimated $167 billion each year.
    The CDC's Office on Smoking and Health provides significant 
technical assistance to States to develop comprehensive and effective 
tobacco prevention programs, in addition to providing a small, yet 
essential, amount of Federal assistance directly to State tobacco 
control and prevention programs. Funds for tobacco prevention at CDC 
also are used to maintain comprehensive information on smoking and 
health and to support ongoing research on tobacco-related issues.
    We believe Congress should fund the type of youth tobacco 
prevention programs that science tells us are essential to counter the 
impact of tobacco company marketing to our kids. The American Lung 
Association strongly supports a minimum level of $145 million in fiscal 
year 2008 funding for the Office on Smoking and Health.

                                 ASTHMA

    Asthma is a chronic lung disease in which the bronchial tubes 
become swollen and narrowed, preventing air from getting into or out of 
the lung. An estimated 32.6 million Americans have ever been diagnosed 
with asthma by a health professional. Approximately 22.2 million 
Americans currently have asthma, of which 12.2 million had an asthma 
attack in 2005. Asthma prevalence rates are almost 12 percent higher 
among African Americans than whites. Studies also suggest that Puerto 
Ricans have higher asthma prevalence rates and age-adjusted death rates 
than all other Hispanic subgroups.
    Asthma is expensive. Asthma incurs an estimated annual economic 
cost of $16.1 billion to our Nation. Asthma is the third leading cause 
of hospitalization among children under the age of 15. It is also the 
number one cause of school absences attributed to chronic conditions. 
The Federal response to asthma has three components: research, programs 
and planning. We are making progress on all three fronts but more must 
be done:
Asthma Research
    Researchers are developing better ways to treat and manage chronic 
asthma. The NHLBI has shown that using corticosteroids to treat 
children with mild to moderate asthma is safe and effective. Genetic 
research is also providing insights into asthma. Researchers in the 
NHLBI-supported Asthma Clinical Research Network have discovered that a 
genetic variation determines how well asthma patients will respond to 
the most common asthma medication, inhaled beta-agonists. This 
discovery will help physicians better target the drugs they proscribe.
Asthma Programs
    Last year, Congress provided approximately $31.9 million for the 
CDC to conduct asthma programs. The American Lung Association 
recommends that CDC be provided $70 million in fiscal year 2008 to 
expand its asthma programs. This funding includes State asthma planning 
grants, which leverage small amounts of funding into more comprehensive 
State programs.
Asthma Surveillance
    In addition to public education programs, the CDC has been piloting 
programs to determine how to establish a nationwide health-tracking 
system. Congress needs to increase funding to create a nationwide 
health-tracking system, based on the localized pilots that are underway 
now.

                              LUNG CANCER

    An estimated 351,344 Americans are living with lung cancer. During 
2007, an estimated 213,380 new cases of lung cancer will be diagnosed. 
Also, 160,390 Americans will die from lung cancer. Survival rates for 
lung cancer tend to be much lower than those of most other cancers. Men 
have higher rates of lung cancer than women. However, over the past 30 
years, the lung cancer age-adjusted incidence rate has decreased 9 
percent in males compared to an increase of 143 percent in females. 
Further, African Americans are more likely to develop and die from lung 
cancer than persons of any other racial group.
    Given the magnitude of lung cancer and the enormity of the death 
toll, the American Lung Association strongly recommends that the NIH 
and other Federal research programs commit additional resources to lung 
cancer research programs. We support increasing the National Cancer 
Institute budget to $5.111 billion.

                               INFLUENZA

    Influenza is a highly contagious viral infection and one of the 
most severe illnesses of the winter season. It is responsible for an 
average of 200,000 hospitalizations and 36,000 deaths each year. 
Further, the emerging threat of a pandemic influenza is looming. Public 
health experts warn that over half a million Americans could die and 
over 2.3 million could be hospitalized if a moderately severe strain of 
a pandemic flu virus hits the United States. To prepare for a potential 
pandemic, the American Lung Association supports funding the Federal 
Pandemic Influenza Plan at the recommended level of $2.652 billion.

                              TUBERCULOSIS

    Tuberculosis primarily affects the lungs but can also affect other 
parts of the body. There are an estimated 10 million to 15 million 
Americans who carry latent TB infection. Each has the potential to 
develop active TB in the future. About 10 percent of these individuals 
will develop active TB disease at some point in their lives. In 2005, 
there were 14,097 cases of active TB reported in the United States. 
While declining overall TB rates are good news, the emergence and 
spread of multi-drug resistant TB pose a significant threat to the 
public health of our Nation. Continued support is needed if the United 
States is going to continue progress toward the elimination of TB. We 
request that Congress increase funding for tuberculosis programs to 
$252 million for fiscal year 2008.
    The NIH also has a prominent role to play in the elimination of TB. 
Currently there is no highly effective vaccine to prevent TB 
transmission. However, the recent sequencing of the TB genome and other 
research advances has put the goal of an effective TB vaccine within 
reach. In addition, the American Lung Association encourages the 
subcommittee to fully fund the TB vaccine blueprint development effort 
at the NIAID.
Fogarty International Center TB Training Programs
    The Fogarty International Center at NIH provides training grants to 
U.S. universities to teach AIDS treatment and research techniques to 
international physicians and researchers. Because of the link between 
AIDS and TB infection, FIC has created supplemental TB training grants 
for these institutions to train international health care professionals 
in the area of TB treatment and research. However, we believe TB 
training grants should not be offered exclusively to institutions that 
have received AIDS training grants. The TB grants program should be 
expanded and open to competition from all institutions. The American 
Lung Association recommends Congress provide $70 million for FIC to 
expand the TB training grant program from a supplemental grant to an 
open competition grant.

                          ENVIRONMENTAL HEALTH

    The National Institute of Environmental Health Sciences funds vital 
research on the impact of environmental influence on disease. The 
American Lung Association supports increasing the appropriation from 
this subcommittee to $680 million.
          researching and preventing occupational lung disease
    The American Lung Association recommends that the subcommittee 
provide $285 million for the National Institute for Occupational Safety 
and Health (NIOSH) at the CDC.

                               CONCLUSION

    In conclusion, Mr. Chairman, lung disease is a continuing, growing 
problem in the United States. It is America's number three killer, 
responsible for one in seven deaths. The lung disease death rate 
continues to climb. Mr. Chairman, the level of support this committee 
approves for lung disease programs should reflect the urgency 
illustrated by these numbers.
                                 ______
                                 
 Prepared Statement of the American National Red Cross and the United 
                           Nations Foundation

    Chairman Harkin, Senator Specter, and members of the subcommittee, 
the American Red Cross and the United Nations Foundation appreciate the 
opportunity to submit testimony in support of measles control 
activities of the U.S. Centers for Disease Control and Prevention 
(CDC). The American Red Cross and the United Nations Foundation 
recognize the leadership that Congress has shown in funding CDC for 
these essential activities.
    In 2001, CDC--along with the American Red Cross, the United Nations 
Foundation, the World Health Organization, and UNICEF--became one of 
the spearheading partners of the Measles Initiative, a partnership 
committed to reducing measles deaths globally. When the Initiative 
began, the United Nations had set the goal of reducing measles deaths 
by 50 percent by 2005 compared with 1999 figures. Measles is one of the 
leading causes of vaccine-preventable death worldwide, and at its 
outset this partnership committed to meeting that global goal.
    Thanks to your leadership in appropriating funds, the international 
effort to reduce measles deaths has made tremendous progress. In 
January 2007, in an article published in ``The Lancet,'' WHO announced 
that this goal was not only reached, but surpassed: global measles 
deaths had dropped from 873,000 in 1999 to 345,000 in 2005, a reduction 
of 60 percent. In sub-Saharan Africa, the success was even greater 
during those years, with measles deaths dropping by 75 percent, from 
506,000 to 126,000.
    How was this remarkable international public health success 
achieved? Working closely with host governments, the Measles Initiative 
has been the main international supporter of mass measles immunization 
campaigns since 2001. The Initiative mobilized more than $300 million 
and provided technical support to host governments in 48 developing 
countries conducting these vaccination campaigns and improving routine 
vaccination services. As a result, almost 400 million children in 
Africa and Asia received measles immunizations, preventing an estimated 
2.3 million child deaths.
    Nearly all the measles vaccination campaigns have been able to 
reach more than 90 percent of their target populations. Countries 
recognize the opportunities that measles vaccination campaigns provide 
in accessing mothers and young children, and have begun increasingly 
``integrating'' the campaigns with other life-saving health 
interventions. In addition to measles vaccine, Vitamin A (crucial for 
preventing blindness in under nourished children), de-worming medicine, 
and insecticide-treated bed nets (ITNs) for malaria prevention are 
distributed during vaccination campaigns. The scale of these 
distributions is immense. For example, more than 18 million ITNs were 
distributed in vaccination campaigns in the last few years saving more 
than 378,000 lives. Thus, these campaigns protect young children from 
both measles and malaria, which kills an African child every 30 
seconds. The delivery of multiple child health interventions during a 
single campaign is far less expensive than delivering the interventions 
separately, and this strategy increases the potential positive impact 
on children's health from a single campaign.
    Based on the success in reaching the 2005 measles mortality 
reduction goal, a bold new global goal has been set: to reduce measles 
deaths by 90 percent by 2010 compared with 2000 figures. In addition to 
sustaining the reduction of measles cases and deaths in sub-Saharan 
Africa, the Initiative will provide funds and technical support to 
South Asia, where countries with the largest measles burdens are now 
found. Countries such as Pakistan and India have not yet mounted 
national measles vaccination campaigns due to competing health 
priorities and the challenges and costs of vaccinating tens of millions 
of children. Achieving this new goal will require the continued and 
expanded support of CDC for the purchase of vaccine and the provision 
of technical expertise in Africa and Asia.
    By controlling measles cases in other countries, U.S. children are 
also being protected from the disease. A major resurgence of measles 
occurred in the United States between 1989 and 1991, with more than 
55,000 cases reported. This resurgence was particularly severe, 
accounting for more than 11,000 hospitalizations and 123 deaths. Since 
then, measles control measures in the United States have been 
strengthened and endemic transmission of measles cases have been 
eliminated here since 2000. However, importations of measles cases into 
this country continue to occur each year.

           ROLE OF CDC IN GLOBAL MEASLES MORTALITY REDUCTION

    From fiscal year 2001-2007, Congress provided more than $250 
million in funding to CDC for global measles control activities. These 
funds were used for the purchase of over 200 million doses of measles 
vaccine for use in large-scale measles vaccination campaigns in 42 
countries in Africa and 6 countries in Asia, and for the provision of 
technical support to Ministries of Health in those countries. 
Specifically, this technical support includes:
  --Planning, monitoring, and evaluating large-scale measles 
        vaccination campaigns;
  --Conducting epidemiological investigations and laboratory 
        surveillance of measles outbreaks; and
  --Conducting operations research to guide cost-effective and high 
        quality measles control programs.
    In addition, CDC epidemiologists and public health specialists have 
worked closely with WHO, UNICEF, the United Nations Foundation, and the 
American Red Cross to strengthen measles control programs at global and 
regional levels.
    While it is not possible to precisely quantify the impact of CDC's 
financial and technical support to the Measles Initiative, there is no 
doubt that CDC's support--made possible by the funding appropriated by 
Congress--was essential in helping achieve the sharp reduction in 
measles deaths in just 6 years.
    The American Red Cross and the United Nations Foundation would like 
to acknowledge the leadership and work provided by CDC and recognize 
that CDC brings much more to the table than just financial resources. 
The Measles Initiative is fortunate in having a partner that provides 
critical personnel and technical support for vaccination campaigns and 
in response to disease outbreaks. CDC personnel have routinely 
demonstrated their ability to work well with other organizations and 
provide solutions to complex problems that help critical work get done 
faster and more efficiently.
    In fiscal year 2007, Congress has appropriated approximately $43 
million to fund CDC for global measles control activities. The American 
Red Cross and the United Nations Foundation thank Congress for the 
financial support that has been provided to CDC in the past and this 
year. We respectfully request an additional $10 million increase in the 
fiscal year 2008 funding for CDC's measles control activities so that 
the gains made to date can continue and the 2010 goal of a 90 percent 
reduction in measles deaths can be achieved.
    The additional funds we are seeking for CDC are critical for:
  --Sustaining the great progress in measles mortality reduction in 
        Africa by strengthening measles surveillance and strengthening 
        the delivery of measles vaccine through routine immunization 
        services to protect new birth cohorts;
  --Conducting large-scale measles vaccination campaigns in South Asia, 
        thus protecting million of children;
  --Conducting nationwide measles vaccination campaigns in countries, 
        such as the Philippines, lacking access to traditional and new 
        funding sources.
    Your commitment has brought us unprecedented victories in reducing 
measles mortality around the world. Measles can cause severe 
complications and death. Your continued support for this initiative 
helps prevent children from needlessly suffering from this debilitating 
disease in the United States and abroad.
    Thank you for the opportunity to submit testimony.
                                 ______
                                 
   Prepared Statement of the American Nephrology Nurses' Association

                              INTRODUCTION

    On behalf of the American Nephrology Nurses' Association (ANNA), I 
appreciate having the opportunity to submit written testimony to the 
Senate Labor, Health, and Human Services (LHHS) Subcommittee regarding 
funding for nursing and nephrology related programs in fiscal year 
2008. ANNA is a professional nursing organization of more than 12,000 
registered nurses practicing in nephrology, transplantation, and 
related therapies. Nephrology nurses use the nursing process to care 
for patients of all ages who are experiencing, or are at risk for, 
kidney disease.
    ANNA understands that Congress has many concerns and limited 
resources, but believes kidney disease is a heavy burden on our society 
that must be addressed. The United States has the highest incidence 
rate of late stage kidney disease in the world.\1\ The direct economic 
cost for treating kidney failure is $20 billion a year in the United 
States and the number of people diagnosed with kidney failure has 
doubled each decade for the last 20 years. Because kidney disease 
imposes such a heavy burden in the United States, we must provide 
adequate funding for research and prevention programs.
---------------------------------------------------------------------------
    \1\ Sources: National Kidney Disease Education Program, American 
Nephrology Nurses' Association.
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                 KIDNEY DISEASE AND NEPHROLOGY NURSING

    Chronic kidney disease (CKD) is the slow, progressive loss of 
kidney function as a result of abnormalities of the kidney. The 
National Kidney Foundation estimates that around 20 million Americans 
have CKD, and another 20 million are at risk. When CKD patients lose 85 
percent of kidney function, it is known as end stage renal disease 
(ESRD).\2\ When patients reach ESRD, they must receive replacement 
therapy either in the form of dialysis or kidney transplant in order to 
survive. While kidney transplant is a treatment option for many ESRD 
patients, unfortunately the need for donor organs exceeds the supply, 
resulting in long waiting times for those who do not have a living 
donor.
---------------------------------------------------------------------------
    \2\ American Nephrology Nurses' Association. (2006). Chronic Kidney 
Disease Fact Sheet [Brochure]. ANNA Chronic Kidney Disease Special 
Interest Group: Author.
---------------------------------------------------------------------------
    CKD is often undiagnosed until the signs and symptoms related to 
the loss of kidney function materialize. Risk factors for developing 
CKD include increasing age, family history and diabetes. The disease is 
more prevalent in men and people of African American, American Indian, 
Hispanic, Asian, or Pacific Islander descent.
    Since treatment of kidney patients often spans the duration of 
their lifetime, nephrology nurses must be skilled in offering care for 
all stages of life and disease progression. Nephrology nurses work in 
dialysis clinics, hospitals, physician practices, transplant programs, 
and many other settings.
    To ensure that patients receive the best quality care possible, 
ANNA supports Federal programs and research institutions that address 
the national nursing shortage and conduct biomedical research into 
kidney disease and related health problems. Therefore, ANNA 
respectfully requests the Senate LHHS Appropriations Subcommittee 
provide increased funding for the following programs:

NURSING WORKFORCE AND DEVELOPMENT PROGRAMS AT THE HEALTH RESOURCES AND 
                     SERVICES ADMINISTRATION (HRSA)

    ANNA supports efforts to resolve the national nursing shortage, 
including appropriate funding to address the shortage of qualified 
nursing teaching faculty. Nephrology nursing requires a high level of 
education and technical expertise, and ANNA is committed to assuring 
and protecting access to professional nursing care delivered by highly 
educated, well-trained, and experienced registered nurses for 
individuals with kidney disease or other disease processes that require 
replacement therapies.
    According to the Department of Health and Human Services, the 
Nursing Workforce Development programs at HRSA have supported the 
recruitment, education, and retention of an estimated 36,750 nurses. A 
report issued by HRSA, Projected Supply, Demand, and Shortages of 
Registered Nurses: 2000-2020, predicts that the nursing shortage is 
expected to grow by 29 percent by 2020. The HRSA Nursing Workforce 
Development Programs provide the largest source of Federal funding to 
address the national nursing shortage, therefore:
    ANNA strongly supports the national nursing community's request of 
$200 million in fiscal year 2008 funding for Nursing Workforce 
Development programs at HRSA.

   NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES 
                                (NIDDK)

    As the primary professional caretakers of patients with CKD and 
ESRD, ANNA members support legislative, regulatory, and programmatic 
efforts that promote prevention and management of chronic kidney 
disease, including early diagnosis, education and proactive creation of 
native fistulae for dialysis.
    NIDDK supports and conducts research on many serious diseases, 
including chronic kidney disease and ESRD. Specifically, the National 
Kidney Disease Education Program (NKDEP) at NIDDK is focused on 
reducing the overall mortality and morbidity from kidney disease. The 
programs at NKDEP were created to increase awareness about the 
seriousness of kidney disease, and the importance of prevention, early 
diagnosis, and appropriate management of kidney disease.
    ANNA encourages Congress to support funding for research into and 
prevention of kidney disease by providing the maximum possible funding 
level for NIDDK in fiscal year 2008.

             NATIONAL INSTITUTE OF NURSING RESEARCH (NINR)

    ANNA understands that research is essential for the advancement of 
nursing science, and believes new concepts must be developed and tested 
to sustain the continued growth of the nephrology nursing profession. 
NINR works to create cost-effective and high-quality health care by 
testing new nursing science concepts and investigating how to best 
integrate them into daily practice. NINR has a broad mandate that 
includes seeking to prevent and delay disease and to ease the symptoms 
associated with both chronic and acute illnesses. NINR's recent areas 
of research focus include the following:
  --End of life and palliative care in rural areas;
  --Research in multi-cultural societies;
  --Bio-behavioral methods to improve outcomes research; and
  --Increasing health promotion through comprehensive studies.
    ANNA respectfully requests $150 million in funding for NINR in 
fiscal year 2008 to continue their efforts to address issues related to 
nursing care for chronic and acute illnesses.

                               CONCLUSION

    I appreciate the opportunity to share ANNA's fiscal year 2008 
funding priorities for programs designed to address issues relating to 
kidney disease and provide for a sustainable nursing workforce. 
Providing $200 million in fiscal year 2008 funding to the HRSA Nursing 
Workforce Development programs, $150 million to NINR and the largest 
allocation possible for NIDDK will ensure we are providing adequate 
resources for this fight. ANNA thanks the Senate LHHS Appropriations 
Subcommittee for their consideration and is happy to serve as a 
resource regarding these programs or other kidney disease or nursing 
related issues.
                                 ______
                                 
       Prepared Statement of the American Optometric Association

    The American Optometric Association appreciates the opportunity to 
submit written testimony to the file of the hearing of the Labor, 
Health and Human Services, Education and Related Agencies Subcommittee 
of the Senate Appropriations Committee in support of increased funding 
the National Eye Institute (NEI), of the National Institutes of Health 
(NIH).
    The American Optometric Association represents over 35,000 
practicing Doctors of Optometry across the Nation. As a profession 
devoted to improving the vision care and health of the public, doctors 
of optometry examine eyes and the visual system, treat ocular diseases 
and disorders, and diagnose related systemic conditions.
    Doctors of optometry (ODs) are the primary health care 
professionals for the eye. Optometrists examine, diagnose, treat, and 
manage diseases, injuries, and disorders of the visual system, the eye, 
and associated structures, as well as identify related systemic 
conditions affecting the eye.
  --ODs prescribe medications, low vision rehabilitation, vision 
        therapy, spectacle lenses, contact lenses, and perform certain 
        surgical procedures.
  --Optometrists counsel their patients regarding surgical and non-
        surgical options that meet their visual needs related to their 
        occupations, avocations, and lifestyle.
  --An optometrist has completed pre-professional undergraduate 
        education in a college or university and 4 years of 
        professional education at a college of optometry, leading to 
        the doctor of optometry (O.D.) degree. Some optometrists 
        complete an optional residency in a specific area of practice.
  --Optometrists are eye health care professionals state-licensed to 
        diagnose and treat diseases and disorders of the eye and visual 
        system.
    The American Optometric Association (AOA) requests fiscal year 2008 
National Institutes of Health (NIH) funding at $31 billion, or a 6.7 
percent increase over fiscal year 2007, to balance the biomedical 
inflation rate of 3.7 percent and to maintain the momentum of 
discovery. Although AOA commends the leadership's actions in the 110th 
Congress to increase fiscal year 2007 NIH funding by $620 million, this 
was just an initial step in restoring the NIH's purchasing power, which 
had declined by more than 13 percent since fiscal year 2005. That power 
would be eroded even further under the administration's fiscal year 
2008 budget proposal. Funding would also be eroded even further under 
the administration's fiscal year 2008 budget proposal. AOA commends NIH 
Director, Dr. Elias Zerhouni, who has articulately described his agenda 
to foster collaborative, cost-effective research and to transform the 
health care research and delivery paradigm into one that is predictive, 
preemptive, preventive, and personalized. NIH is the world's premier 
institution and must be adequately funded so that its research can 
reduce health care costs, increase productivity, improve quality of 
life, and ensure our Nation's global competitiveness.
    AOA requests that Congress make eye and vision health a top 
priority by funding the National Eye Institute (NEI) at $711 million in 
fiscal year 2008, or a 6.7 percent increase over fiscal year 2007. This 
level is necessary to fully advance the breakthroughs resulting from 
NEI's basic and clinical research that are resulting in treatments and 
therapies to prevent eye disease and restore vision. Vision impairment/
eye disease is a major public health problem that is growing and that 
disproportionately affects the aged and minority populations, costing 
the United States at least $68 billion annually in direct and societal 
costs, let alone the indirect costs of reduced independence and 
decreased quality of life. Adequately funding the NEI is a cost-
effective investment in our Nation's health, as it can delay, save, and 
prevent expenditures, especially to the Medicare and Medicaid programs.
funding the nei at $711 million in fiscal year 2008 would enable it to 

     LEAD TRANS-INSTITUTE VISION RESEARCH THAT MEETS NIH'S GOAL OF 
    PREEMPTIVE, PREDICTIVE, PREVENTIVE, AND PERSONALIZED HEALTH CARE

    Funding NEI at $711 million in fiscal year 2008 represents the 
judgment of the AOA and its partners in the eye and vision research 
community as the level necessary to fully advance breakthroughs 
resulting from NEI's basic and clinical research that are resulting in 
treatments and therapies to prevent eye disease and restore vision.
  --NEI research responds to the NIH's overall major health challenges, 
        as set forth by NIH Director Dr. Zerhouni: an aging population; 
        health disparities; the shift from acute to chronic diseases; 
        and the co-morbid conditions associated with chronic diseases 
        (e.g., diabetic retinopathy as a result of the epidemic of 
        diabetes). In describing the predictive, preemptive, 
        preventive, and personalized approach to health care research, 
        Dr. Zerhouni has also frequently cited NEI-funded research as a 
        tangible example of the value of our Nation's past and future 
        investment in the NIH.
    Although NEI's breakthroughs came directly from the past doubling 
of the NIH budget, their long-term potential to preempt, predict, 
prevent, and treat disease relies on adequately funding NEI's follow-up 
research. Unless its funding is increased, the NEI's ability to 
capitalize on the findings cited above will be seriously jeopardized, 
resulting in missed opportunities that include:
  --Following up on the Age-related Macular Degeneration (AMD) gene 
        discovery by developing diagnostics for early detection and 
        developing promising therapies, as well as to further study the 
        impact of the body's inflammatory response on other 
        degenerative eye diseases.
  --Fully investigating the impact of additional, cost-effective 
        dietary supplements in the Age-Related Eye Disease Study 
        (AREDS) study, singly and in combination, to determine if they 
        can demonstrate enhanced protective effects against progression 
        to advanced AMD.
    In addition, NEI research into other significant eye disease 
programs, such as glaucoma and cataract, will be threatened, along with 
quality of life research programs into low vision and chronic dry eye. 
This comes at a time when the U.S. Census and NEI-funded 
epidemiological research (also threatened without adequate funding) 
both cite significant demographic trends that will increase the public 
health problem of vision impairment and eye disease.
vision impairment/eye disease is a major public health problem that is 

  INCREASING HEALTH CARE COSTS, REDUCING PRODUCTIVITY AND DIMINISHING 
                            QUALITY OF LIFE

    The 2000 U.S. Census reported that more than 119 million people in 
the United States were age 40 years or older, which is the population 
most at risk for age-related eye disease. The NEI estimates that, 
currently, more than 38 million Americans age 40 years and older 
experience blindness, low vision or an age-related eye disease such as 
AMD, glaucoma, diabetic retinopathy, or cataracts. This is expected to 
grow to more than 50 million Americans by 2020. The economic and 
societal impact of eye disease is increasing not only due to the aging 
population, but to its disproportionate incidence in minority 
populations and as a co-morbid condition of other chronic, common 
disease, such as diabetes.
    Although the NEI estimates that the current annual cost of vision 
impairment and eye disease to the United States is $68 billion, this 
number does not fully quantify the impact of direct health care costs, 
lost productivity, reduced independence, diminished quality of life, 
increased depression, and accelerated mortality. The continuum of 
vision loss presents a major public health problem and financial 
challenge to both the public and private sectors.
    In public opinion polls over the past 40 years, Americans have 
consistently identified fear of vision loss as second only to fear of 
cancer. As a result, Federal funding for the NEI is a vital investment 
in the health, and vision health, of our Nation, especially our 
seniors, as the treatments and therapies emerging from research can 
preserve and restore vision. Adequately funding the NEI can delay, 
save, and prevent expenditures, especially those associated with the 
Medicare and Medicaid programs, and is, therefore, a cost-effective 
investment.
AOA urges fiscal year 2008 NIH and NEI funding at $31 billion and $711 
        million, respectively
    Of course, vision impairment and eye disease are not limited to the 
middle-aged and the elderly. Public health experts recommend that 
children visit an eye care professional in the first year of life--one 
of the most critical stages of visual development--to identify the 
potential for eye and vision problems.
    In fact, current research shows us that:
  --One in 10 children is at risk from undiagnosed eye and vision 
        problems, which, if undetected, could lead to permanent vision 
        impairment, and in rare cases, life-threatening health risks.
  --Only 14 percent of children from infancy to age 6 have had a 
        comprehensive eye assessment from an eye care professional.
    The NEI has funded several clinical trials in the area of 
children's vision. The VIP Study (Vision in Preschoolers) evaluated the 
best screening tests to identify preschool children in need of vision 
care for amblyopia (``lazy'' eye), strabismus (crossed eyes) and 
significant refractive errors (e.g., nearsightedness or 
farsightedness). The CLEER Study (Collaborative Longitudinal Evaluation 
of Ethnicity and Refractive Error) evaluated the role of ethnicity in 
children's vision conditions. The CITT Study (Convergence Insufficiency 
Treatment Trial) is studying the success rates of treatments for 
convergence insufficiency (eye turns in). The NEI budget should be 
sufficient to permit funding of grants at a high level in the areas of 
strabismus, amblyopia and refractive error. Since about 60 percent of 
Americans have refractive errors requiring eyeglasses or contact 
lenses, research in the cause and prevention of refractive error should 
continue.
    The value of clinical trials to the public cannot be overestimated. 
NEI has a remarkable record of scientific breakthroughs attributed to 
clinical trial research, beginning with studies of diabetic retinopathy 
in the 1970s. NEI clinical trials involve collaboration with many 
institutions, health professionals and thousands of patients. Although 
significant progress has been made, further clinical trial research is 
needed to determine the causes of refractive error and amblyopia in 
children and subsequent prevention of visual impairment.
    In an effort to encourage early detection and treatment, the 
American Optometric Association launched in 2005 a national public 
health initiative to provide no-cost vision assessments for infants. 
The program is called InfantSEE, and it's achieving remarkable results 
for children and their families. Thanks to the more than 7,500 of my 
colleagues from across the country who have volunteered their time and 
expertise to make this optometry's most successful vision saving and 
lifesaving public health initiative, more than 80,000 babies have 
received a vision assessment at no cost from their local optometrist.
                                 ______
                                 
      Prepared Statement of the American Public Health Association

    The American Public Health Association (APHA) is the Nation's 
oldest, largest and most diverse organization of public health 
professionals in the world, dedicated to protecting all Americans and 
their communities from preventable, serious health threats and assuring 
community-based health promotion and disease prevention activities and 
preventive health services are universally accessible in the United 
States. We are pleased to submit our views on Federal funding for 
public health activities in fiscal year 2008.

         RECOMMENDATIONS FOR FUNDING THE PUBLIC HEALTH SERVICE

    APHA's budget recommendation for overall funding for the Public 
Health Service includes funding for the Centers for Disease Control and 
Prevention (CDC), the Health Resources and Services Administration 
(HRSA), the Substance Abuse and Mental Health Services Administration 
(SAMHSA), the Agency for Healthcare Research and Quality (AHRQ), and 
the National Institutes of Health (NIH), as well as agencies outside 
the subcommittee's jurisdiction--the Food and Drug Administration (FDA) 
and the Indian Health Service (IHS).

            CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

    APHA believes that Congress should support CDC as an agency--not 
just the individual programs that it funds. We support a funding level 
for CDC that enables it to carry out its mission to protect and promote 
good health and to assure that research findings are translated into 
effective State and local programs.
    In the best professional judgment of APHA, in conjunction with the 
CDC Coalition--given the challenges and burdens of chronic disease, a 
potential influenza pandemic, terrorism, disaster preparedness, new and 
reemerging infectious diseases, increasing drug resistance to 
critically important antimicrobial drugs and our many unmet public 
health needs and missed prevention opportunities--we believe the agency 
will require funding of at least $10.7 billion including sufficient 
funding to prepare the Nation against a potential influenza pandemic, 
funding for the Agency for Toxic Substances and Disease Registry and to 
maintain the current funding level for the Vaccines for Children (VFC) 
program. This request does not include any additional funding that may 
be required to expand the mandatory VFC in fiscal year 2008.
    APHA appreciates the subcommittee's work over the years, including 
your recognition of the need to fund chronic disease prevention, 
infectious disease prevention and treatment, programs to combat racial, 
ethnic and geographic disparities in health and health care and 
environmental health programs at CDC. Federal funding through CDC 
provides the foundation for our State and local public health 
departments, supporting a trained workforce, laboratory capacity and 
public health education communications systems.
    CDC also serves as the command center for our Nation's public 
health defense system against emerging and reemerging infectious 
diseases. With the for an potential onset of an influenza pandemic, in 
addition to the many other natural and man-made threats, CDC is the 
Nation's--and the world's--expert resource and response center, 
coordinating communications and action and serving as the laboratory 
reference center.
    CDC's budget has actually shrunk since 2005 in terms of real 
dollars--by almost 4 percent. If you add inflation, the cuts are even 
worse--and these are cuts to the core programs of the agency. The 
current administration request for fiscal year 2008 is inadequate, with 
a total cut to core budget categories from fiscal year 2005 to fiscal 
year 2008 of half a billion dollars. We are moving in the wrong 
direction, especially in these challenging times when public health is 
being asked to do more, not less. Funding public health outbreak by 
outbreak is not an effective way to ensure either preparedness or 
accountability. Until we are committed to a strong public health 
system, every crisis will force trade offs.
    CDC serves as the lead agency for bioterrorism preparedness and 
must receive sustained support for its preparedness programs in order 
for our Nation to meet future challenges. APHA supports the proposed 
increase for anti-terrorism activities at CDC, including the increases 
for the Strategic National Stockpile. However, we strongly oppose the 
President's proposed $125 million cut to the State and local capacity 
grants. We ask the subcommittee to restore these cuts to ensure that 
our States and local communities can be prepared in the event of an act 
of terrorism.
    Unfortunately, the President's budget proposes the elimination of 
some very important CDC programs, like the Preventive Health and Health 
Services (PHHS) Block Grant. Within an otherwise-categorical funding 
construct, the PHHS Block Grant is the only source of flexible dollars 
for States and localities to address their unique public health needs. 
The track record of positive public health outcomes from PHHS Block 
Grant programs is strong, yet so many requests go unfunded. We 
encourage the subcommittee to restore the cuts and fund the Prevention 
Block Grant at $131 million.
    We must address the growing disparity in the health of racial and 
ethnic minorities. CDC's Racial and Ethnic Approaches to Community 
Health (REACH), helps States address these serious disparities in 
infant mortality, breast and cervical cancer, cardiovascular disease, 
diabetes, HIV/AIDS and immunizations. Please provide adequate funds for 
this program.
    We encourage the subcommittee to provide adequate funding for CDC's 
Environmental Public Health Services Branch to revitalize environmental 
public health services at the national, State and local level. As with 
the public health workforce, the environmental health workforce is 
declining. Furthermore, the agencies that carry out these services are 
fragmented and their resources are stretched. These services are the 
backbone of public health and are essential to protecting and ensuring 
the health and well being of the American public from threats 
associated with West Nile virus, terrorism, E. coli and lead in 
drinking water. We encourage the committee to provide at least $50 
million for CDC's Environmental Health Tracking Network.
    We also encourage the subcommittee to provide $50 million to CDC 
Environmental Health Activities to develop and enhance CDC's capacity 
to help the Nation prepare for and adapt to the potential health 
effects of global climate change. This new request for funding would 
help prepare State and local health department to prepare for the 
public health impacts of global climate change, allow CDC to fund 
academic and other institutions in their efforts to research the 
impacts of climate change on public health and to create a Center of 
Excellence at CDC to serve as a national resource for health 
professionals, government leaders and the public on climate change 
science.

          HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)

    HRSA programs are designed to give all Americans access to the best 
available health care services. Through its programs in thousands of 
communities across the country, HRSA provides a health safety net for 
medically underserved individuals and families, including more than 45 
million Americans who lack health insurance; 50 million Americans who 
live in neighborhoods where primary health care services are scarce; 
African American infants, whose infant mortality rate is more than 
double that of whites; and the estimated 1 to 1.2 million people living 
with HIV/AIDS. Programs to support the underserved place HRSA on the 
front lines in erasing our Nation's racial/ethnic and rural/urban 
disparities in health status. HRSA funding goes where needs exists, in 
communities all over America. In the best professional judgment of 
APHA, to respond to this challenge, the agency will require an overall 
funding level of at least $7.5 billion for fiscal year 2008.
    APHA is gravely concerned about a number of programs that are 
slated for deep cuts or elimination under the administration's budget 
proposal. Building on the HRSA programs that were cut or eliminated in 
the fiscal years 2006 and 2007 appropriations bills, we strongly 
suggest that this trend is moving our Nation in the wrong direction. We 
urge the subcommittee to restore funding to HRSA programs that were cut 
last year, as well as ensure adequate funding for fiscal year 2008 by 
rejecting the proposed cuts contained in the President's budget.
    We express our dismay at the eroding support from the 
administration for some of HRSA's programs. On top of the $250 million 
cut to the agency for fiscal year 2006, the President has proposed 
another $321 million overall cut from last year's appropriated level. 
Under the proposal, total cuts to HRSA since fiscal year 2005 would 
reach more than $570 million, a devastating 8 percent cut in 2 years, 
which has been even more severe for HRSA's core programs from which 
funding has been diverted to fund other administration priorities. We 
urge the subcommittee to restore the cuts delivered to these programs 
in fiscal years 2006 and 2007, and reject the President's proposed cuts 
for fiscal year 2008. We are again concerned that the HRSA health 
professions programs under Title VII and VIII of the Public Health 
Service Act have landed on the chopping block. Today our Nation faces a 
widening gap between challenges to improve the health of Americans and 
the capacity of the public health workforce to meet those challenges. 
These programs help meet the health care delivery needs of the areas in 
this country with severe health professions shortages, at times serving 
as the only source of health care in many rural and disadvantaged 
communities.
    We believe the elimination of the Healthy Community Access Program, 
the Traumatic Brain Injury program, universal newborn hearing screening 
programs, and the Emergency Medical Services for Children Program, will 
further undermine the availability of basic health services for those 
most in need-especially children. The Healthy Community Access Program 
is an example of communities building partnerships among health care 
providers to deliver a broader range of health services to their 
neediest residents. Elimination of the universal newborn hearing 
screening programs in the administration's budget will leave hearing 
impairments in infants undetected, negatively impacting speech and 
language acquisition, academic achievement, and social and emotional 
development. The proposed elimination of EMSC jeopardizes improvements 
made to pediatric emergency care, disproportionately affecting children 
eligible for Medicaid and SCHIP, but not enrolled due to State 
enrollment limits and budgetary pressures, and therefore frequently use 
emergency health services.
    The Maternal and Child Health Block Grant is also operating for a 
third year with less funds than in fiscal year 2005, yet with greater 
needs among pregnant women, infants, and children, particularly those 
with special health care needs.
    We are pleased with the increases proposed by the President for 
programs under the Ryan White CARE Act, administered by HRSA's HIV/AIDS 
Bureau. The CARE Act programs are an important safety net, providing an 
estimated 571,000 people access to services and treatments each year. 
At a time when the number of new domestic HIV/AIDS cases is increasing, 
we support increased funding for these programs.
    Through its many programs, HRSA helps countless individuals live 
healthier lives. APHA believes that with adequate resources, HRSA is 
well positioned to meet these challenges as it continues to provide 
needed health care to the Nation's most vulnerable citizens. Please 
restore funds to these important public health programs.

           AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)

    We request a funding level of $350 million for the AHRQ for fiscal 
year 2008. This level of funding is needed for the agency to fully 
carry out its congressional mandate to improve health care quality, 
including eliminating racial and ethnic disparities in health, reducing 
medical errors, and improving access and quality of care for children 
and persons with disabilities. The cuts proposed in the administration 
budget will severely hamper these efforts.

   SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION (SAMHSA)

    APHA supports a funding level of $3.532 billion for SAMHSA for 
fiscal year 2008. This funding level would provide support for 
substance abuse prevention and treatment programs, as well as continued 
efforts to address emerging substance abuse problems in adolescents, 
the nexus of substance abuse and mental health, and other serious 
threats to the mental health of Americans.

                  NATIONAL INSTITUTES OF HEALTH (NIH)

    APHA supports a funding level of $30.869 billion for the NIH for 
fiscal year 2008. The translation of fundamental research conducted at 
NIH provides some of the basis for community based public health 
programs that help to prevent and treat disease.
    In closing, we emphasize that the public health system requires 
financial investments at every stage. Successes in biomedical research 
must be translated into tangible prevention opportunities, screening 
programs, lifestyle and behavior changes, and other interventions that 
are effective and available for everyone. We ask you to think in a 
broad and balanced way, leveraging funding whenever possible to provide 
public health benefits as a matter of routine, rather than emergency.
    We thank the subcommittee for the opportunity to present our views 
on the fiscal year 2008 appropriations for public health service 
programs.
                                 ______
                                 
        Prepared Statement of the American Society of Nephrology

                              INTRODUCTION

    The American Society of Nephrology (ASN) is pleased to submit this 
statement for the record to the Senate Appropriations Subcommittee on 
Labor, Health and Human Services and Education.
    The ASN is a professional society of more than 10,000 researchers, 
physicians, and practitioners committed to the treatment, prevention, 
and cure of kidney disease. Specifically, the ASN strives to enhance 
and assist the study and practice of nephrology, to provide a forum for 
the promulgation of research, and to meet the professional and 
continuing education needs of its members.
    This ASN statement focuses on those issues and programs that most 
immediately fall under the committee's jurisdiction and assist our 
members to fulfill their missions. We want to express our strong 
support for advancing programs supported by the National Institutes of 
Health (NTH) and Agency for Healthcare Research and Quality (AHRQ). The 
ASN thanks the subcommittee for its commitment and steadfast support of 
these programs.

            KIDNEY DISEASE: A GROWING PUBLIC HEALTH CONCERN

    Kidney disease is the ninth leading cause of death in the United 
States. It is estimated that at least 15 million people have lost 50 
percent of their kidney function. Another 20 million more Americans are 
at increased risk of developing kidney disease. The culmination of 
unimpeded progression is end stage renal disease (ESRD), a condition in 
which patients have permanent kidney failure, affects almost 400,000 
Americans and directly causes 50,000 deaths annually. In the past 10 
years, the number of patients in the United States with ESRD has almost 
doubled and it is expected to reach 700,000 by 2015, according to the 
United States Renal Data System (USRDS). ESRD disproportionately 
affects minorities. For example, although they constitute approximately 
12 percent of the U.S. Population, African Americans comprise 32 
percent of the prevalent ESRD population and are nearly four times more 
likely to develop kidney disease than Caucasians. Native Americans are 
twice as likely. The elderly are also disproportionately affected. One 
in four new ESRD patients was 75 or older in 2004. The two major 
therapies for ESRD are dialysis and kidney transplantation. The number 
of patients waiting for a kidney transplant increased from 9,452 in 
1988 to 60,393 in 2004. Almost 50 percent of kidney transplants are 
received by people aged 45-64.

                             ECONOMIC COSTS

    Although no dollar amount can be affixed to human suffering or the 
loss of human life, economic data can help to identify and quantify the 
current and projected future financial costs associated with ESRD. The 
2000 report of the USRDS indicates that the total Medicare ESRD program 
cost will more than double, surpassing $28 billion, by 2010, as the 
prevalence of kidney failure is projected to double. Currently, the 
total Medicare cost for ESRD is nearly $20.1 billion. The annual 
average cost per ESRD patient is approximately $58,000. These 
escalating costs serve to magnify the need to investigate new, and 
better apply, recently proven strategies for preventing progressive 
kidney disease.
    In short, we can treat and maintain patients who have lost their 
kidney function but the critical need is to prevent the loss of kidney 
function and its complications in the first place. Meeting this vital 
goal can only be accomplished through more concerted research and 
education.

                MAJOR CAUSES OF END STAGE RENAL DISEASE

    Diabetes, a disease that affects 18 million Americans, is the most 
common cause of ESRD in the United States, accounting for 44 percent of 
new cases in 2002. The time from the onset of diabetes-related kidney 
disease to kidney failure is 5-7 years. With current projections that 
the epidemic of obesity-related diabetes mellitus will continue to 
soar, a dramatic increase in kidney disease is anticipated in the next 
10 years.
    Hypertension, or high blood pressure, is the next leading cause of 
ESRD, accounting for 27 percent of ESRD patients. Higher rates of 
hypertension can be found among certain age and ethnic groups. For 
example, 35 percent of African Americans have hypertension. Among new 
patients whose kidney failure was caused by high blood pressure, more 
than half (51.2 percent) were African American. It is also a disease of 
the aged and accounts for 37 percent of new ESRD cases in those 65 
years old and above.
    Despite recent progress and discoveries regarding the major causes 
of ESRD, it is among many areas of disease research that remain under-
investigated. Researchers agree that significant inroads in previously 
understudied sub-fields need to be made. Significant among them, more 
focus and direction need to be introduced into the general field of 
renal research and patient and physician education.

                        LACK OF PUBLIC AWARENESS

    A major problem with kidney disease is that it is largely a 
``Silent Disease''. In fact, of the 15 million Americans who have lost 
at least half of their kidney function, the vast majority have no 
knowledge of their condition. While people with chronic kidney disease 
may not show any symptoms, this does not mean that they are not going 
to have long-term damage to their kidney function, requiring dialysis 
or a transplant. These people may also be especially vulnerable to 
cardiovascular disease. If these 15 million people were identified 
early, there are new therapies, particularly special blood pressure 
drugs known as ACE inhibitors, which could be prescribed with 
potentially significant benefits. In addition, vigorous treatment of 
hypertension and other complications that cause illnesses and loss of 
productivity could be administered to the patients.
    Given the cost to human life and to the Federal Government caused 
by the growing public health issues of CKD and ESRD, we urge this 
subcommittee to provide funding increases for kidney disease research.

                        KIDNEY DISEASE RESEARCH

National Institutes of Health (NIH)
    The ASN applauds Congress and members of the subcommittee for 
leading the bipartisan effort to double our investment in promising 
biomedical research supported and conducted by the NIH. NIH has served 
as a vital component in improving the Nation's health through research, 
both on and off the NIH campus, and in the training of research 
investigators, including nephrology researchers. Strides in biomedical 
discovery have had an impact on the quality of life for people with 
kidney disease. If we are to sustain this momentum and translate the 
promise of biomedical research into the reality of better health, this 
Nation must maintain its commitment to medical research. Unfortunately, 
since the doubling ended in 2003, funding for NIH has failed to keep 
pace with biomedical inflation and as a result, the NIH has lost more 
than 13 percent of its purchasing power. We support the recommendation 
of the Ad-Hoc Group for Medical Research Funding to add 6.7 percent to 
the NIH budget for a total of $30.869 in fiscal year 2008.
National Institute of Diabetes, Digestive, and Kidney Diseases (NIDDK)
    Many recent advances have been made in our understanding into the 
causes and progression of renal failure, such as: how diabetes and 
hypertension affect the kidney and the mechanisms responsible for acute 
renal failure. Despite these advances, the number of people with renal 
failure and the numbers who die of renal failure continue to increase 
each year. Most alarming is the significant increase in diabetes, the 
most common cause of chronic kidney failure, and its relationship to 
kidney disease. The ASN believes the rising incidence and prevalence of 
diabetes-related kidney disease warrants additional recourses to 
improve our understanding of the relationship between kidney disease 
and diabetes.
    The NIDDK sponsors a number of activities that researchers hope 
will lead to improved detection, treatment and prevention of kidney 
disease and chronic kidney failure. To ensure ongoing kidney disease 
and kidney disease related research and important clinical trials 
infrastructure development we recommend a 6.7 percent increase for the 
NIDDK over fiscal year 2007 levels.

        ASN RESEARCH GOALS & RECOMMENDATIONS FOR KIDNEY DISEASE

    The ASN continues to evaluate its priorities for future kidney 
disease research. In the fall of 2004, the ASN conducted a series of 
research retreats to develop priorities to combat the growing 
prevalence of kidney disease in the United States. The ASN joined 
experts, both within and outside the renal community, and identified 
five areas requiring attention: acute renal failure, diabetic 
nephropathy, hypertension, transplantation, and kidney-associated 
cardiovascular disease.
    The final research retreat report(s) highlighted priorities and 
contained three overriding recommendations. Theses include:
Development of Core Centers for kidney disease research
    Expansion of the kidney research infrastructure in the United 
States can be achieved by vigorous funding of a program of kidney 
research core centers. Specifically, we propose that the number of 
kidney centers be increased with the goal of providing core facilities 
to support collaborative research on a local, regional and national 
level. It should be emphasized that such a program of competitively 
reviewed kidney core centers would facilitate investigator-initiated 
research in both laboratory and patient-oriented investigation. This 
approach is highly compatible with the collaborative research 
enterprise conceived in the NIH Road Map Initiative.
Support programs/research initiatives that impact the understanding of 

        THE RELATIONSHIP BETWEEN RENAL AND CARDIOVASCULAR DISEASE

    It is now well recognized that chronic kidney dysfunction is an 
important risk factor for the development of cardiovascular disease. It 
is recommended that the NIDDK and NHLBI work cooperatively to support 
both basic and clinical science projects that will shed light on the 
pathogenesis of this relationship and to support the exploration of 
interventions that can decrease cardiovascular events in patients with 
CM). Thus, we specifically propose that NHLBI should support 
investigator-initiated research grants in areas of kidney research with 
a direct relationship to cardiovascular disease. Similarly, NHLBI 
should work collaboratively with NIDDK to support the proposed program 
of kidney core research centers.
Continued support and expansion of investigator initiated research 
        projects
    In each of the five subjects there are areas of fundamental 
investigation that require the support of investigator initiated 
projects, if ultimately progress is to be made in the understanding of 
the basic mechanisms that underlie the diseases processes. It is 
recommended that there should be an expansion of support for research 
in the areas that lend themselves to this mechanism of funding, by 
encouraging applications with appropriate program announcements and 
requests for proposals. In addition to vigorous support for RO1 grants, 
continued funding of Concept Development and R2 1/R33 grants is 
essential to support development of investigator-initiated clinical 
studies in these areas of high priority. Such funding is critical to 
accelerate the transfer of new knowledge from the bench to the bedside.
Agency for Health Care Research and Quality (AHRO)
    Complementing the medical research conducted at NIH, the AHRQ 
sponsors health services research designed to improve the quality of 
health care, decrease health care costs, and provide access to 
essential health care services by translating research into measurable 
improvements in the health care system. The AHRQ supports emerging 
critical issues in health care delivery and addresses the particular 
needs of priority populations, such as people with chronic diseases. 
The ASN firmly believes in the value of AHRQ's research and quality 
agenda, which continues to provide health care providers, policymakers, 
and patients with critical information needed to improve health care 
and treatment of chronic conditions such as kidney disease. The ASN 
supports the Friends of AHRQ recommendation of $350 million for AHRO in 
fiscal year 2008.

                               CONCLUSION

    Currently, there is no cure for kidney disease. The progression of 
chronic renal failure can be slowed, but never reversed. Meanwhile, 
millions of Americans face a gradual decline in their quality of life 
because of kidney disease. In many cases, abnormalities associated with 
early stage chronic renal failure remain undetected and are not 
diagnosed until the late stages. In sum, chronic renal failure requires 
our serious and immediate attention.
    As practicing nephrologists, ASN members know firsthand the 
devastating effects of renal disease. ASN respectfully requests the 
subcommittees' continued support to enable the nephrology community to 
continue with its efforts to find better ways to treat and prevent 
kidney disease.
    Thank you for your continued support for medical research and 
kidney disease research. To obtain further information about ASN, 
please go to http://www.asn-online.org or contact Paul Smedberg, ASN 
Director of Policy & Public Affairs at 202-416-0646.
                                 ______
                                 
    Prepared Statement of the American Society for Pharmacology and 
                       Experimental Therapeutics

    The American Society for Pharmacology and Experimental Therapeutics 
(ASPET) is pleased to submit written testimony in support of the 
National Institutes of Health fiscal year 2008 budget. ASPET is a 4,500 
member scientific society whose members conduct basic and clinical 
pharmacological research within the academic, industrial and government 
sectors. Our members discover and develop new medicines and therapeutic 
agents that fight existing and emerging diseases as well as increasing 
our knowledge regarding how these therapeutics work.
    ASPET members are grateful for the U.S. Congress' historic support 
of the NIH. However, appropriations in recent years have failed to 
adequately fund the NIH to meet the scientific opportunities and 
challenges to our public health. For the fourth year in a row, the NIH 
research portfolio will not keep pace with the Biomedical Research and 
Development Price Index. After a 5 year bipartisan plan to double the 
NIH budget that ended in 2003, the budget in now going backwards. The 
administration's recommended fiscal year 2008 budget, if enacted would 
mean that the NIH's ability to conduct biomedical research would be cut 
by more than 13 percent in inflation adjusted dollars since fiscal year 
2003.
    To prevent this erosion and sustain the biomedical research 
enterprise, ASPET recommends that the NIH receive $30.8 billion in 
fiscal year 2008. This would represent an increase of 6.7 percent ($1.9 
billion) over the fiscal year 2007 Joint Funding Resolution passed by 
Congress. ASPET joins other biomedical research organizations and 
professional societies, including the Ad Hoc Group for Medical 
Research, the Federation of American Societies for Experimental biology 
(FASEB), and Research!America, in advocating for a 6.7 percent increase 
in each of the next 3 years to help regain the momentum of discovery 
and pre-eminent research, and to help increase NIH's purchasing power 
and recover the losses caused by biomedical research inflation.

          NIH IMPROVES HUMAN HEALTH AND IS AN ECONOMIC ENGINE

    Recent budget levels for the NIH constitute a retraction in the 
budget, sending the wrong signal to the best and brightest of American 
students who will not be able to or have chosen not to pursue a career 
in biomedical research. A diminished NIH research enterprise will mean 
a continued reduction in research grants and the resulting phasing-out 
of research programs and declining morale, an increasing loss of 
scientific opportunities such as the discovery of new therapeutic 
targets to develop, fewer discoveries that produce spin-off companies 
that employ individuals in districts around the country. In contrast, 
the requested funding level would provide the institutes with an 
opportunity to raise or at least maintain their paylines, fund more 
high quality and innovative research, and provide an incentive for 
young scientists to continue their research careers.
    Many important drugs have been developed as a direct result of the 
basic knowledge gained from federally funded research, such as new 
therapies for breast cancer, the prevention of kidney transplant 
rejection, improved treatments for glaucoma, new drugs for depression, 
and the cholesterol lowering drugs known as statins that prevent 
125,000 deaths from heart attack each year. AIDS related deaths have 
fallen by 73 percent since 1995 and the 5-year survival rate for 
childhood cancers rose to almost 80 percent in 2000 from under 60 
percent in the 1970s. And for the first time in 70 years, the number of 
deaths from cancer has fallen. The link between basic research, drug 
discovery and clinical applications was vividly illustrated when three 
pharmacologists were awarded the 1998 Nobel Prize in Physiology or 
Medicine for their research on nitric oxide. More recently, NIH funded 
research for the 2005 Nobel Prize winners in chemistry. These 
scientists developed metal-containing molecules that are now being used 
by the pharmaceutical industry to aid in the drug discovery process. 
Historically, our past investment in basic biological research has led 
to innovative medicines that have virtually eliminated diphtheria, 
whooping cough, measles and polio in the United States 8 out of 10 
children now survive leukemia. Death rates from heart disease and 
stroke have been reduced by half in the past 30 years. Molecularly 
targeted drugs such as GleevecTM to treat adult leukemia do 
not harm normal tissue and dramatically improve survival rates. NIH 
research has developed a class of drugs that slow the progression of 
symptoms of Alzheimer's disease. The robust past investment in the NIH 
has provided major gains in our knowledge of the human genome, 
resulting in the promise of pharmacogenetics and a reduction in adverse 
drug reactions that currently represent a major, worldwide health 
concern. But unless more robust funding is restored, such scientific 
opportunities from the human genome investment and others will be 
delayed, lost, or forfeited to biomedical research opportunities in 
other countries.
    The human cost of not adequately investing in the NIH impact us 
all. The total economic cost to our Nation is also staggering: cancer, 
$190 billion; obesity, $99 billion; heart disease, $255 billion; 
diabetes, $131 billion; and arthritis, $125 billion.
    Scientific inquiry leads to better medicine but there remain 
challenges and opportunities that need to be addressed, including:
  --The need to increase support for training and research in 
        integrative/whole organ science to see how drugs act not just 
        at the molecular level--but also in whole animals, including 
        human beings.
  --The need to meet public health concerns over growing consumer use 
        of botanical therapies and dietary supplements. These products 
        have unsubstantiated scientific efficacy and may adversely 
        impact the treatment of chronic diseases, create dangerous 
        interactions with prescription drugs, and may cause serious 
        side effects including death among some users.

              SUPPORT FOR INTEGRATIVE ORGAN SYSTEM SCIENCE

    ASPET supports efforts to increase funding for training and 
research in integrative organ system science (IOSS). IOSS is the study 
of responses in organs and organisms, including intact animals. 
Identification of isolated cellular and molecular components of drugs 
in vitro are important for identifying mechanisms of actions but are 
inadequate in determining all the complex interactions that happen in 
vivo in the actual organs of species. Because of the great advances in 
cellular and molecular biology over the past two decades, there has 
been much less emphasis in whole organ biology such that academic 
infrastructure in this area has eroded and there remain few faculty and 
institutions that can provide the appropriate scientific training in 
this important area of research. Too few individuals have opportunities 
to be trained beyond cellular and molecular techniques. As a 
consequence, the pool of talent with expertise in whole organs has 
greatly diminished and the biotechnology and pharmaceutical industry 
are having great difficulty finding well-trained whole organ scientists 
to fill critical positions in their drug discovery departments. As a 
result of this training and research deficit, a more thorough and 
comprehensive examination of new therapeutic approaches may be 
compromised before clinical trials begin.
    The lack of training and research opportunities to develop 
scientists well rounded in cellular, molecular and in vivo whole organ 
biology impacts progress in medicine and the training of future 
physicians. Development of preventive approaches and effective 
therapeutic strategies for many disorders with devastating health 
consequences and increasing incidence in an aging population will 
require intensive study at all levels from molecular to whole organ. 
For instance, obesity is not just a metabolic disorder. Obesity impacts 
many organ functions, including the heart, circulatory system, and 
brain. Similarly, clinical depression should not be viewed as just a 
neurological disorder because depression affects multiple organs in a 
variety of ways. And the discovery of new drugs to treat 
neurodegenerative diseases such as Alzheimer's and Parkinson's will 
ultimately need to look at complex whole animal systems. For these 
reasons, scientists must be trained to look broadly at complex medical 
problems afflicting humans. Medical progress in the post-genomic era 
needs scientists or teams of scientists who can integrate the results 
of studies in gene function at the molecular, cellular, organ system, 
whole animal and behavioral levels to fully understand the actions of 
current drugs and to facilitate the development of safe new drugs and 
treatment strategies.
    To reverse the decline and adequately support training and research 
in integrative organ systems, integrative biology, program project 
grants, and pre and post-doctoral training programs should be 
implemented that support integrative training and research activities. 
Multi-disciplinary institutional and individual training and research 
grants on whole systems and integrative biology should be funded to 
investigate disease processes. ASPET is pleased that the National 
Institute of General Medical Sciences has recognized this training and 
research deficit and has funded four summer workshops to train students 
in integrative whole organ sciences. ASPET encourages other institutes 
to explore available mechanisms to begin developing a pool of talented 
scientists with the appropriate skills in integrative, whole organ 
systems biology. While many industrial concerns provide limited support 
for training and research at the post-doctoral level, their efforts 
remain necessarily focused on drug discovery and development. It is the 
role of the NIH and academic institutions to provide adequate training 
opportunities to develop the next generation of integrative scientists.
    Support for training and research in integrative whole organ 
sciences has been affirmed in the fiscal year 2002 U.S. Senate Labor/
Health and Human Services & Related Agencies Appropriations Report 
(107-84). The Senate report supports ASPET recommendation that 
``Increased support for research and training in whole systems 
pharmacology, physiology, toxicology, and other integrative biological 
systems that help to define the effects of therapy on disease and the 
overall function of the human body.'' These principles and 
recommendations are also affirmed in the FASEB Annual Consensus 
Conference Report on Federal Funding for Biomedical and Related Life 
Sciences Research for Fiscal Year 2002.

SUPPORT FOR RESEARCH ON BOTANICALS AND HERBAL THERAPIES TO MEET PUBLIC 
                              HEALTH NEEDS

    ASPET has for years supported peer-reviewed pharmacological 
examination of the mechanisms of actions of medicinal plants and is 
pleased that the NIH's National Center for Complementary and 
Alternative Medicine (NCCAM) continues rigorous investigations into the 
basic biology of various botanical agents. ASPET continues to recommend 
increased support to study the interaction of botanical remedies and 
dietary supplements with prescription medications. This support is 
critical to the promotion and funding of the highest quality research 
in botanical medicine, will help meet urgent needs of this neglected 
area of biological research, and will address a growing public health 
problem. Support for highly innovative research on botanicals should be 
encouraged among all institutes and centers.
    The increased use of botanical and dietary supplements by consumers 
to treat various ailments and diseases is a major public health 
concern. One national survey reported that in 1997 an estimated 15 
million adults (18.4 percent of all prescription users) took herbal 
remedies concurrently with prescription medicines. Between 1990 and 
1997, the use of herbal products grew by 380 percent. Although there is 
little solid scientific evidence to support the therapeutic efficacy of 
many botanical and dietary supplement products, the industry records 
over $19 billion in annual sales. Botanical products were once 
regulated as drugs and the FDA had authority to prevent the sale of 
unproven herbal ingredients. However, legislative reforms in 1994 
eliminated the FDA's authority to test or approve herbal products prior 
to marketing. Thus, at a time when many more consumers are using more 
herbal products, there is little research on either their clinical 
efficacy or basic mechanisms of action. The growing use of herbal 
products by consumers, their interactions with prescription drugs--and 
mechanisms of such interactions--represent a serious and growing public 
health problem that demands scientific attention and redress by 
regulatory and legislative action.
    Through the NIH, research into the safety and efficacy of botanical 
products can be conducted in a rigorous and high quality manner. Sound 
pharmacological studies will help determine the value of botanical 
preparations and the potential for their interactions with prescription 
drugs as well as chronic disease processes. This research will allow 
the FDA to review the available pharmacology and review valid evidence-
based reviews to form a valid scientific foundation for regulating 
these products.

                               CONCLUSION

    The biomedical research enterprise is facing a critical moment as 
funding stagnates. Reversing this trend and helping to sustain the 
extraordinary scientific progress that has been made at the NIH and at 
the academic institutions funded by the NIH over the past years is a 
major challenge facing this subcommittee. A 6.7 percent increase for 
the NIH in fiscal year 2008 will allow the NIH to make greater strides 
to prevent, diagnose and treat disease, improving the health of our 
Nation. A 6.7 percent increase in the fiscal year 2008 NIH budget will 
begin to restore NIH's role as a national treasure that attracts and 
retains the best and brightest scientists to biomedical research.
                                 ______
                                 
  Prepared Statement of the American Society of Tropical Medicine and 
                                Hygiene

                                OVERVIEW

    The American Society of Tropical Medicine and Hygiene appreciates 
the opportunity to submit written testimony to the House Labor, Health 
and Human, Services, and Education Appropriations Subcommittee. With 
more than 3,300 members, ASTMH is the world's largest professional 
membership organization dedicated to the prevention and control of 
tropical diseases. We represent, educate, and support tropical medicine 
scientists, physicians, clinicians, researchers, epidemiologists, and 
other health professionals from this field.
    We respectfully request that the subcommittee provide the following 
allocations in the fiscal year 2008 Labor, Health and Human, Services, 
and Education Appropriations bill to support a comprehensive effort to 
eradicate malaria:
  --$18 million to the Centers for Disease and Control and Prevention 
        (CDC) for malaria research, control, and program evaluation 
        efforts with a $6 million set-aside for program monitoring and 
        evaluation;
  --$30.8 billion to National Institutes of Health (NIH);
  --$4.7 billion to the National Institute of Allergy and Infectious 
        Diseases (NIAID); and
  --$70.8 million to the Fogarty International Center (FIC).
    We very much appreciate the subcommittee's consideration our views, 
and we stand ready to work with the subcommittee members and staff on 
these and other important global health matters.

                                 ASTMH

    ASTMH plays an integral and unique role in the advancement of the 
field of tropical medicine. Its mission is to promote world health by 
preventing and controlling tropical diseases through research and 
education. As such, the Society is the principal membership 
organization representing, educating, and supporting tropical medicine 
scientists, physicians, researchers, and other health professionals 
dedicated to the prevention and control of tropical diseases. Our 
members reside in 46 States and the District of Columbia and work in a 
myriad of public, private, and non-profit environments, including 
academia, the U.S. military, public institutions, Federal agencies, 
private practice, and industry.
    ASTMH aims to advance policies and programs that prevent and 
control those tropical diseases which particularly impact the global 
poor.

                TROPICAL MEDICINE AND TROPICAL DISEASES

    The term ``tropical medicine'' refers to the wide-ranging clinical 
work, research, and educational efforts of clinicians, scientists, and 
public health officials with a focus on the diagnosis, mitigation, 
prevention, and treatment of diseases prevalent in the areas of the 
world with a tropical climate. Most tropical diseases are located in 
either sub-Saharan Africa, parts of Asia (including the Indian 
subcontinent), or Central and South America. Many of the world's 
developing nations are located in these areas; thus tropical medicine 
tends to focus on diseases that impact the world's most impoverished 
individuals.
    The field of tropical medicine encompasses clinical work treating 
tropical diseases, work in public health and public policy to prevent 
and control tropical diseases, basic and applied research related to 
tropical diseases, and education of health professionals and the public 
regarding tropical diseases.
    Tropical diseases are illnesses that are caused by pathogens that 
are prevalent in areas of the world with a tropical climate. These 
diseases are caused by viruses, bacteria, and parasites which are 
spread through various mechanisms, including airborne routes, sexual 
contact, contaminated water and food, or an intermediary or 
``vector''--frequently an insect (e.g. a mosquito)--that transmits a 
disease between humans in the process of feeding.

                                MALARIA

    Malaria is a global emergency affecting mostly poor women and 
children; it is an acute and sometimes fatal disease caused by the 
single-celled Plasmodium parasite that is transmitted to humans by the 
female Anopheles mosquito.
    Malaria is highly treatable and preventable. The tragedy is that 
despite this, malaria is one of the leading causes of death and disease 
worldwide. According to the CDC, as many as 2.7 million individuals die 
from malaria each year, with 75 percent of those deaths occurring in 
African children. In 2002, malaria was the fourth leading cause of 
death in children in developing countries, causing 10.7 percent of all 
such deaths. Malaria-related illness and mortality extract a 
significant human toll as well as cost Africa's economy $12 billion per 
year perpetuating a cycle of poverty and illness. Nearly 40 percent of 
the world's population lives in an area that is at high risk for the 
transmission of malaria.
    Fortunately, malaria can be both prevented and treated using four 
types of relatively low-cost interventions: (1) the indoor residual 
spraying of insecticide on the walls of homes; (2) long-lasting 
insecticide-treated nets; (3) Artemisinin-based combination therapies; 
and (4) intermittent preventive therapy for pregnant women. However, 
limited resources preclude the provision of these interventions and 
treatments to all individuals and communities in need.

        REQUESTED MALARIA-RELATED ACTIVITIES AND FUNDING LEVELS

CDC Malaria Efforts
    ASTMH calls upon Congress to fund a comprehensive approach to 
malaria control, including public health infrastructure improvements, 
increased availability of existing anti-malarial drugs, development of 
new anti-malarial drugs and better diagnostics, and research to 
identify an effective malaria vaccine. Much of this important work 
currently is underway; however, additional funds and a sustaining 
commitment from the Federal Government are necessary to make progress 
in malaria prevention, treatment, and control.
    The CDC conducts research to address pertinent questions regarding 
issues related to malaria as well as engages in prevention and control 
efforts, especially as a lead collaborator on the President's Malaria 
Initiative. To maximize CDC's efforts and expertise, we request $18 
million for the CDC for malaria research, control, and program 
evaluation efforts with a $6 million set-aside for program monitoring 
and evaluation. The CDC maintains several domestic activities, 
international activities, and research activities, including:
  --Surveillance of malaria
  --Investigations of locally transmitted malaria
  --Advice and consultations such as a toll-free information service
  --Diagnostic assistance to State health departments on malaria 
        diagnosis
  --Research to improve understanding of malaria
  --International Activities including the President's Malaria 
        Initiative (PMI), the Amazon Malaria Initiative (AMI), the West 
        Africa Network against Malaria during Pregnancy
    CDC collaborations support treatment and prevention policy change 
based on scientific findings; formulation of international 
recommendations through membership on World Health Organization (WHO) 
technical committees; and work with Ministries of Health and other 
local partners in malaria-endemic countries and regions to develop, 
implement, and evaluate malaria programs. In addition, CDC has provided 
direct staff support to WHO; UNICEF; the Global Fund to Fight AIDS, 
Tuberculosis, and Malaria; and the World Bank--all stakeholders in the 
Roll Back Malaria (RBM) Partnership.
NIH Malaria Efforts
    As the Nation's and world's premier biomedical research agency, the 
NIH and its Institutes and Centers play an essential role in the 
development of new anti-malarial drugs, better diagnostics, and an 
effective malaria vaccine. NIH estimates that its fiscal year 2007 
spending on malaria research will total $101 million while malaria 
vaccine efforts will receive $45 million. ASTMH urges that NIH malaria 
research portfolio and budget be increased by at least 6.7 percent in 
fiscal year 2008. To support a comprehensive effort to eradicate 
malaria, ASTMH respectfully requests the following funding:
  --$30.8 billion to NIH;
  --$4.7 billion NIAID; and
  --$70.8 million to the Fogarty International Center to support 
        training in biomedical research on behalf of the developing 
        nations of the world.
National Institute of Allergy and Infectious Diseases (NIAID)
    NIH estimates that in fiscal year 2007 it will spend approximately 
$101 million for malaria research and $45 million for research related 
specifically to creating a malaria vaccine. NIAID, the lead institute 
for this research, has developed an Implementation Plan for Global 
Research on Malaria, which is focused on five research areas: vaccine 
development, drug development, diagnostics, vector control, and 
infrastructure and research capability strengthening.
  --Vaccine Development.--No malaria vaccine currently exists. NIAID 
        introduced a research agenda for malaria vaccine development in 
        1997, the aim of which is to support discovery and 
        characterization of new vaccine candidates, production of pilot 
        lots, and clinical evaluation of promising candidate vaccines.
  --Drug Development.--Drug-resistant malaria increasingly is being 
        reported around the world. NIAID is involved in improving the 
        monitoring of drug resistance and developing new drugs.
  --Diagnostics.--Improved diagnostic tools are essential in making 
        early diagnosis and providing rapid treatment.
  --Vector Control.--NIAID is working to create next-generation, 
        environmentally-friendly insecticides for public health use.
  --Strengthening Infrastructure and Research Capability.--NIAID is 
        working with partners to strengthen research capabilities of 
        scientists in their own countries.
    ASTMH encourages the subcommittee to increase funding for NIAID to 
ensure that we do not lose ground in the fight against malaria.
Fogarty International Center (FIC)
    The FIC addresses global health challenges and supports the NIH 
mission through myriad activities, including: collaborative research 
and capacity building projects relevant to low- and middle-income 
nations; institutional training grants designed to enhance research 
capacity in the developing world; the Forum for International Health, 
through which NIH staff share ideas and information on relevant 
programs and develop input from an international perspective on cross-
cutting NIH initiatives; the Multilateral Initiative on Malaria, which 
fosters international collaboration and co-operation in scientific 
research against malaria; and the Disease Control Priorities Project, 
which is a partnership to develop recommendations on effective health 
care interventions for resource-poor settings. ASTMH urges the 
subcommittee to allocate additional resources to the FIC in fiscal year 
2008 to increase these efforts, particularly as they apply to abatement 
and treatment of malaria.

                               CONCLUSION

    Thank you for your attention to these important global health 
matters. We know that you face many challenges in choosing funding 
priorities and we hope that you will provide the requested fiscal year 
2008 resources to those agencies programs identified above. ASTMH 
appreciates the opportunity to share its views, and we thank you for 
your consideration of our requests.
                                 ______
                                 
          Prepared Statement of the American Thoracic Society

                    SUMMARY.--FUNDING RECOMMENDATIONS
                        [In millions of dollars]
------------------------------------------------------------------------
                                                               Amount
------------------------------------------------------------------------
National Institutes of Health.............................      30,537
    National Heart, Lung and Blood Institute..............       3,114
    National Institute of Allergy and Infectious Disease..       4,675
    National Institute of Environmental Health Sciences...         683
    Fogarty International Center..........................          70
    National Institute of Nursing Research................         146
Centers for Disease Control and Prevention................      10,700
    National Institute for Occupational Safety and Health.         253
    Environmental Health: Asthma Activities...............          70
    Tuberculosis Control Programs.........................         252.4
------------------------------------------------------------------------

    The American Thoracic Society (ATS) is pleased to submit our 
recommendations for programs in the Labor Health and Human Services and 
Education Appropriations Subcommittee purview.
    The American Thoracic Society, founded in 1905, is an independently 
incorporated, international education and scientific society that 
focuses on respiratory and critical care medicine. For 100 years, the 
ATS has continued to play a leadership role in scientific and clinical 
expertise in diagnosis, treatment, cure and prevention of respiratory 
diseases. With approximately 18,000 members who help prevent and fight 
respiratory disease around the globe, through research, education, 
patient care and advocacy, the Society's long-range goal is to decrease 
morbidity and mortality from respiratory disorders and life-threatening 
acute illnesses.

                        LUNG DISEASE IN AMERICA

    Lung disease is a serious health problem in the United States. Each 
year, close to 400,000 Americans die of lung disease. Lung disease is 
responsible for one in every seven deaths, making it America's number 
three cause of death. More than 35 million Americans suffer from a 
chronic lung disease. In 2005, lung diseases cost the U.S. economy an 
estimated $157.8 billion in direct and indirect costs.
    Lung diseases represent a spectrum of chronic and acute conditions 
that interfere with the lung's ability to extract oxygen from the 
atmosphere, protect against environmental or biological challenges and 
regulate a number of metabolic processes. Lung diseases include chronic 
obstructive pulmonary disease, lung cancer, tuberculosis, influenza, 
sleep disordered breathing, pediatric lung disorders, occupational lung 
disease, sarcoidosis, asthma and severe acute respiratory syndrome 
(SARS).
    The ATS is pleased that the subcommittee provided increases in the 
National Institutes of Health (NIH) budget last fiscal year. However, 
we are extremely concerned that the President's fiscal year 2008 budget 
proposes a 1.7 percent cut for NIH and significant cuts for the Centers 
for Disease Control and Prevention (CDC). We ask that this subcommittee 
recommend a 6.7 percent increase for NIH so that the NIH can respond to 
biomedical research opportunities and public health needs. In order to 
stem the devastating effects of lung disease, research funding must 
continue to grow to sustain the medical breakthroughs made in recent 
years. We also ask that the CDC budget be adjusted to reflect increased 
needs in chronic disease prevention, infectious disease control, 
including strengthened TB control to prevent the spread of extensively 
drug-resistant (XDR)-TB, and occupational safety and health research 
and training. There are three lung diseases that illustrate the need 
for further investment in research and public health programs: Chronic 
Obstructive Pulmonary Disease, pediatric lung disease, asthma and 
tuberculosis.

                                  COPD

    Chronic Obstructive Pulmonary Disease (COPD) is the fourth leading 
cause of death in the United States and the third leading cause of 
death worldwide. Yet, COPD remains relatively unknown to most 
Americans. COPD is the term used to describe the airflow obstruction 
associated mainly with emphysema and chronic bronchitis and is a 
growing health problem.
    While the exact prevalence of COPD is not well defined, it affects 
tens of millions of Americans and can be an extremely debilitating 
condition. It is estimated that 11.2 million patients have COPD while 
an additional 12 million Americans are unaware that they have this life 
threatening disease.
    According to the National Heart, Lung and Blood Institute (NHLBI), 
COPD cost the U.S. economy an estimated $37 billion per year. We 
recommend the subcommittee encourage NHLBI to devote additional 
resources to finding improved treatments and a cure for COPD.
    Medical treatments exist to relieve symptoms and slow the 
progression of the disease. Today, COPD is treatable but not curable. 
Fortunately, promising research is on the horizon for COPD patients. 
Despite these leads, the ATS feels that research resources committed to 
COPD are not commensurate with the impact the disease has on the United 
States and that more needs to be done to make Americans aware of COPD, 
its causes and symptoms. The ATS commends the NHLBI for its leadership 
on educating the public about COPD through the National COPD Education 
and Prevention Program. As this initiative continues, we encourage the 
NHLBI to maintain its partnership with the patient and physician 
community.
    While additional resources are needed at NIH to conduct COPD 
research, CDC has a role to play as well. The ATS encourages the CDC to 
add COPD-based questions to future CDC health surveys, including the 
National Health and Nutrition Evaluation Survey (NHANES), the National 
Health Information Survey (NHIS) and the Behavioral Risk Factor 
Surveillance Survey (BRFSS). By collecting information on the 
prevalence of COPD, researchers and public health professionals will be 
better able to understand and control the disease.

                         PEDIATRIC LUNG DISEASE

    Lung disease affects people of all ages. The ATS is pleased to 
report that infant death rates for various lung diseases have declined 
for the past 10 years. However, of the seven leading causes of infant 
mortality, four are lung diseases or have a lung disease component. In 
2003, lung diseases accounted for 18 percent of all deaths under 1 year 
of age. It is also widely believed that many of the precursors of adult 
respiratory disease start in childhood. The ATS encourages the NHLBI to 
continue with its research efforts to study lung development and 
pediatric lung diseases.
    The pediatric origins of chronic lung disease extend back to early 
childhood factors. For example, many children with respiratory illness 
are growing into adults with COPD. In addition, it is estimated that 
close to 20.5 million people suffer from asthma, including an estimated 
6.2 million children. While some children appear to outgrow their 
asthma when they reach adulthood, 75 percent will require life-long 
treatment and monitoring of their condition. Asthma is the third 
leading cause of hospitalization among children under the age of 15 and 
is the leading cause of chronic illness among children.

                                 ASTHMA

    The ATS believes that the NIH and the CDC must play a leadership 
role in assisting individuals with asthma. National statistical 
estimates show that asthma is a growing problem in the United States. 
Approximately 22.2 million Americans currently have asthma, of which 
12.2 million had an asthma attack in 2005. African Americans have the 
highest asthma prevalence of any racial/ethnic group. The age-adjusted 
death rate for asthma in the African-American population is three times 
the rate in whites.

                          ASTHMA SURVEILLANCE

    There is a need for more data on regional and local asthma 
prevalence. In order to develop a targeted public health strategy to 
respond intelligently to asthma, we need locality-specific data. CDC 
should take the lead in collecting and analyzing this data and Congress 
should provide increased funding to build this these tracking systems.
    In fiscal year 2007, Congress provided approximately $31.9 million 
for CDC's National Asthma Control Program. The goals of this program 
are to reduce the number of deaths, hospitalizations, emergency 
department visits, school or work days missed, and limitations on 
activity due to asthma. We recommend that CDC be provided with $70 
million in fiscal year 2008 to expand the program and establish grants 
to community organizations for screening, treatment, education and 
prevention of childhood asthma.

                                 SLEEP

    Sleep is an essential element of life, but we are only now 
beginning to understand its impact on human health. Several research 
studies demonstrate that sleep illnesses and sleep disordered breathing 
affect over 50 million Americans. The public health impact of sleep 
illnesses and sleep disordered breathing is still being determined, but 
is known to include traffic accidents, lost work and school 
productivity, cardiovascular disease, obesity, mental health disorders, 
and other sleep-related comorbidities. We cannot appropriately address 
these problems if we do not consider how chronic sleep loss contributes 
to them. Despite the increased need for study in this area, research on 
sleep and sleep-related disorders has been underfunded. The ATS 
recommends increased funding to support activities related to sleep and 
sleep disorders at the CDC, including for the National Sleep Awareness 
Roundtable (NSART), and research on sleep disorders at the Nation 
Center for Sleep Disordered Research (NCSDR) at the NHLBI.

                              TUBERCULOSIS

    Tuberculosis (TB) is a global public health crisis that remains a 
concern for the United States. Tuberculosis is an airborne infection 
caused by a bacterium, Mycobacterium tuberculosis. Tuberculosis 
primarily affects the lungs but can also affect other parts of the 
body, such as the brain, kidneys or spine. The statistics for TB are 
alarming. Globally, one-third of the world's population is infected 
with the TB germ, 8.8 million active cases develop each year and 1.6 
million people die of tuberculosis annually. It is estimated that 9-14 
million Americans have latent tuberculosis. Tuberculosis is the leading 
cause of death for people with HIV/AIDS.
    According to the CDC, although the overall rate of new TB cases is 
declining in the United States, the annual rate of decrease in TB cases 
has slowed significantly, from about 7.3 percent (1993 to 2000) to 3.8 
percent currently (2000-2006). This rate represents one of the smallest 
declines since 1992, when over $1 billion was spent in New York City 
alone to regain control of TB. The ATS is concerned that TB rates in 
African Americans remain high and that TB rates in foreign-born 
Americans are growing.
    The emergence of extensively drug-resistant XDR-TB has created a 
global health emergency. Because it is resistant to most of the drugs 
used to treat TB, XDR-TB is virtually untreatable and has an extremely 
high fatality rate. In one of the latest outbreaks in South Africa from 
late 2005 until early 2006, XDR-TB killed 52 out of 53 infected 
patients. According to data released by the CDC in March, between 1993 
and 2006, there were 49 reported XDR-TB cases in the United States. 
Because of the ease with which TB can spread, XDR TB will continue to 
pose a serious risk to the United States as long as it exists anywhere 
else in the world.
    While we urge immediate action in response to the XDR-TB emergency, 
we also recognize the best way to prevent the future development of 
other resistant strains of tuberculosis is through supporting effective 
tuberculosis control programs in the United States and throughout the 
globe. We ask the subcommittee to take the first steps to eliminating 
TB in the United States and prevent further outbreaks of drug resistant 
forms of TB. The ATS, in collaboration with the National Coalition for 
Elimination of Tuberculosis, recommends an increase of $120 million in 
fiscal year 2008 for CDC's National Program for the Elimination of 
Tuberculosis.
    The NIH also has a prominent role to play in the elimination of 
tuberculosis. Currently there is no highly effective vaccine to prevent 
TB transmission. However, the recent sequencing of the TB genome and 
other research advances have put the goal of an effective TB vaccine 
within reach. The National Institute of Allergy and Infectious Disease 
has developed a Blueprint for Tuberculosis Vaccine Development. We 
encourage the subcommittee to fully fund the TB vaccine blueprint. We 
also encourage the NIH to continue efforts to develop drugs to combat 
multi-drug resistant tuberculosis a serious emerging public health 
threat.
Fogarty International Center TB Training Programs
    The Fogarty International Center (FIC) at NIH provides training 
grants to U.S. universities to teach AIDS treatment and research 
techniques to international physicians and researchers. Because of the 
link between AIDS and TB infection, FIC has created supplemental TB 
training grants for these institutions to train international health 
care professionals in the area of TB treatment and research. These 
training grants should be expanded and offered to all institutions. The 
ATS recommends Congress provide $70 million for FIC to expand the TB 
training grant program from a supplemental grant to an open competition 
grant.

          RESEARCHING AND PREVENTING OCCUPATIONAL LUNG DISEASE

    The National Institute of Occupational Safety and Health (NIOSH) is 
the sole Federal agency responsible for conducting research and making 
recommendations for the prevention of work-related diseases and injury. 
In addition to conducting research, NIOSH investigates potentially 
hazardous working conditions, makes recommendations and disseminates 
information on preventing workplace disease, injury, and disability; 
and provides training to occupational safety and health professionals. 
The ATS recommends that Congress provide $253 million for NIOSH to 
expand or establish the following activities: the National Occupational 
Research Agenda (NORA); tracking systems for identifying and responding 
to hazardous exposures and risks in the workplace; emergency 
preparedness and response activities; and training medical 
professionals in the diagnosis and treatment of occupational illness 
and injury.

                               CONCLUSION

    Lung disease is a growing problem in the United States. It is this 
country's third leading cause of death. The lung disease death rate 
continues to climb. Overall, lung disease and breathing problems 
constitute the number one killer of babies under the age of 1 year. 
Worldwide, tuberculosis is one of the leading infectious disease 
killers. The level of support this subcommittee approves for lung 
disease programs should reflect the urgency illustrated by these 
numbers. The ATS appreciates the opportunity to submit this statement 
to the subcommittee.
                                 ______
                                 
              Prepared Statement of Americans for the Arts

    Americans for the Arts and the Los Angeles County Arts Commission 
respectfully request the subcommittee to adopt an appropriation of $53 
million for the Arts in Education programs of the U.S. Department of 
Education. We also ask that it require the U.S. Department of Education 
to conduct much-needed research on the status of arts education, 
including the Fast Response Statistical Survey (FRSS) and the National 
Assessment of Educational Progress (NAEP).
    Before considering funding levels, members of the subcommittee need 
to be aware of a simple but breathtaking fact: Students with an 
education rich in the arts have better grade point averages in core 
academic subjects, score better on standardized tests, and have lower 
drop-out rates than students without arts education. This fact is 
demonstrated by an increasing amount of compelling research. It is not 
seriously contested. Further, research confirms that these results 
occur across the socio-economic range.
    Artists believe that the arts are important for their own sake. 
Educators know they are rigorous and standards-based, and they are 
essential for supporting the learning styles of all students while 
providing them with the unique opportunity to develop problem solving 
skills, to develop critical thinking skills and to foster their 
creativity. In essence, the arts help students develop skills that are 
needed for the 21st century workforce. In fact, CEOs have stated that 
the MFA (Masters in Fine Arts) is the new MBA and seek employees that 
have had a solid arts education. You can agree or disagree with us, of 
course. But you can't ignore the research, which shows that the arts 
help kids do better in school And for that reason, we believe that the 
Federal Government has an essential role in ensuring that all children 
have access to excellent arts education.
    For several decades, the U.S. Department of Education's Arts in 
Education programs have provided funding for the national programs of 
the John F. Kennedy Center for the Performing Arts and VSA arts 
(formerly Very Special Arts). Since 2001 they have also run two 
important competitive grant programs:
  --The Model Development and Dissemination program identifies, 
        develops, documents, and disseminates models of excellence in 
        arts education that impact schools and communities nationwide. 
        These projects strengthen student learning through standards-
        based arts education and integration of arts instruction into 
        other subject areas.
  --The Professional Development grants program supports projects that 
        serve as national models for effective professional development 
        that improve instruction for arts specialists and classroom 
        teachers. State and local education agencies can adapt these 
        models to provide rigorous arts instruction for all students.
    A recent Model Development grant was given to the Los Angeles 
Unified School District, in partnership with Inner-City Arts, a non-
profit organization providing arts learning services to students in the 
district, and the University of California, Los Angeles (UCLA) Graduate 
School of Education and Information Sciences. The three-year Arts in 
the Middle (AIM) Project will expand and rigorously evaluate an 
innovative, cohesive model for delivery of arts-based instruction to 
remedial grade six English learners. The Project's strategy will extend 
community resources to under-resourced urban middle schools in order to 
improve academic performance among English learners by integrating 
standards-based arts education within the core Language Arts curricula 
of grade six students. The Project's target population is remedial 
grade six students who are at extreme high risk of academic failure due 
to low levels of English Language Development. Assuming it is 
successful, the goal is to replicate it within other Los Angeles 
schools. This project directly supports the school district's 10-year 
plan for arts education.
    With increased funding, the Arts in Education programs will be able 
to support additional such models that improve arts learning in high-
poverty schools, and findings from the model projects may be more 
widely disseminated.
    With regard to another aspect of our request: despite research 
showing the positive effects of arts education, there is a serious lack 
of empirical data on how much arts education is being delivered in our 
Nation's schools. We do not have comprehensive, reliable information 
about student access to arts instruction or student performance in the 
arts. The last Fast Response Survey report was for the 1999-2000 school 
year, and the next round is long overdue.
    Congress has repeatedly urged the Department of Education to 
implement the Fast Response Survey in the arts to no avail. In public 
statements, U.S. Secretary of Education Margaret Spellings has said, 
``Art, dance, music, and theater are as much a part of education as 
reading, math, and science.'' And yet, the Department has told Congress 
that among the ``many tough choices'' made in the area of research, the 
arts survey did not rate as a priority.
    The Senate included report language in the fiscal year 2007 
appropriations bill that explicitly directed the Department of 
Education to conduct the FRSS, and it also provided funding for that 
purpose. As you know, however, the bill did not become law, and 
therefore the Department of Education has been able to delay 
implementing the FRSS for yet another year. We thank this subcommittee 
for taking this step last year and urge you to adopt similar language 
in your fiscal year 2008 bill.
    Good data does exist in some localities, but only data that is 
national in scope will allow Congress to make national policy. We would 
like to tell you about data was gathered and used to affect policy in 
Los Angeles County. The task was an essential step in helping the 
County and community stakeholders such as school districts, arts 
organizations, elected officials, business leaders, foundations, and 
corporations strategically organize their efforts to restore K-12 arts 
education. We hope the story of how the information was collected, and 
the way it was used, will convince you of the need to compel the 
Department of Education to collect national data.
    In 2000, the Arts Commission commissioned the Arts in Focus survey, 
which detailed the status of arts education for 1.7 million students in 
82 school districts. These students represent 27 percent of all public 
school students in the State, and 3.4 percent of all public school 
students in the country. With 80 of the 82 superintendents in the 
County participating, it was found that:
  --54 percent of school leaders reported no adopted arts policy and 37 
        percent reported no defined sequential arts education in any 
        discipline, at any school level.
  --64 percent reported no district level arts coordinator, and the 
        current average ratio of credentialed arts teachers to students 
        was 1:1,200.
  --Nearly 50 percent reported ``lack of instructional time in 
        students' schedules'' as their most significant challenge.
  --Many districts would not have arts programs without the support of 
        parents and partnerships with non-profit arts organizations. 
        Seventy-eight percent of districts allocated less than 2 
        percent of their budget to arts education and 82.3 percent used 
        partnerships with non-profit organizations to provide arts 
        education.
    One hundred percent of superintendents who were interviewed stated 
that they believe in the importance of the arts. However, what the data 
revealed was the lack of an infrastructure to support arts education 
and, given the three decades without sequential arts education, limited 
capacity of school districts to incorporate it back into the school 
day.
    In response to the findings of Arts in Focus, Los Angeles County 
(the Arts Commission in partnership with the Los Angeles County Office 
of Education) embarked on a year-long, community-based planning 
process. In 2002, the County Board of Supervisors, the County Board of 
Education and the County Arts Commission unanimously adopted Arts for 
All: Los Angeles County Regional Blueprint for Arts Education, which 
presents a series of policy changes, educational initiatives, and 
establishment of a new infrastructure to ensure all 1.7 million 
students receive a high-quality K-12 arts education.
    The first goal of the Blueprint is to help school districts create 
a sustainable infrastructure for arts education by conducting a needs 
assessment and utilizing district data to develop and adopt an arts 
education policy and long-range budgeted plan with benchmarks. To date, 
20 school districts are at various stages of receiving technical 
assistance from a coach to strategically, and thoughtfully, identify 
and implement key budgeted priorities for arts education in the areas 
of standards-based curriculum, instruction and methodology, assessment, 
professional development, program administration and personnel, 
partnerships and collaborations, funding, resources and facilities, and 
evaluation.
    As a key strategy in the Blueprint, the County created the Arts 
Education Performance Indicators report, or AEPI, to collect pertinent 
school district data to track the status of an arts education 
infrastructure based on five critical factors: an arts education policy 
adopted by the school board; an arts education plan adopted by the 
school board; a district level arts coordinator; an arts education 
budget of at least 5 percent of the district's total budget; and a 
student to credentialed arts teacher ratio of no higher than 400:1. 
With these pieces in place, school districts can deliver sustainable 
arts education.
    The AEPI is released every other year. It is interesting to note 
that for the 2005 report, those districts making the greatest progress 
in achieving the five critical success factors received technical 
assistance while those showing little to no improvement did not. AEPI 
is an invaluable tool in providing a county-wide picture of the status 
of an arts education infrastructure, target technical assistance to 
help school districts plan, keep arts education visible and at the 
forefront of policy discussions, provide a mechanism for school 
districts to self-evaluate and reflect on their progress in providing 
equal access to a quality arts education and to compare themselves to 
other districts, and encourage County-wide dialogue on arts education 
among diverse stakeholders in the community--from elected officials, to 
educators, to parents and students.
    Access to up-to-date, accurate data is imperative to drive 
strategic planning and policy change. In addition, Arts for All 
illustrates the importance of providing customized assistance to help 
school districts effectively plan for the implementation of arts 
education based on identified needs and priorities. Without this help, 
we have found that it is difficult for school districts to use 
available funds effectively--including, for example, Federal Title I 
funds.
    You may be aware that the fiscal year 2006-2007 budget for the 
State of California includes $500 million in one-time funding for arts 
education and physical education equipment, supplies and professional 
development and $105 million in on-going funding especially for arts 
education personnel, supplies, materials, and professional development. 
As it turns out, the districts that have received technical assistance 
and that have established policies and plans are able to effectively 
and strategically utilize this funding. Seventeen County school 
districts have expressed an interest in receiving arts education 
planning assistance through Arts for All in light of the new State 
money. With these additional school districts, 37 districts in Los 
Angeles County will be planning for and implementing standards-based 
arts education--close to 50 percent of County school districts--with 
more school districts joining Arts for All each year.
    Each level of government has its part to play, in concert with 
stakeholders at each level. We have described the massive commitment of 
Los Angeles County government to providing excellent arts education, 
and we have touched on the increased recognition by the State of 
California of its responsibility to help. The Federal Government needs 
to step up as well. It has a unique role in collecting and publishing 
data, and an essential role in supporting, researching and 
disseminating locally developed projects. Both of these roles are the 
focus of this testimony.
    We would also like to ask you to encourage local districts to use 
Federal education funds, such as Title I, to institute data collection 
and technical assistance programs similar to what was done in Los 
Angeles County. They should also use Federal funds to hire local 
district-wide arts education coordinators.
    Finally, we would like to mention that the NAEP--the national arts 
``report card''--is scheduled to be administered in 2008, and must stay 
on track. It is designed to measure students' knowledge and skills in 
dance, music, theatre, and visual arts, and it provides critical 
information about the arts skills and knowledge of our Nation's 
students. The last arts NAEP was performed in 1997. Like the FRSS, the 
next round is long overdue.
    Thank you very much for the opportunity to submit this testimony.
                                 ______
                                 
Prepared Statement of the Americans for Nursing Shortage Relief (ANSR) 
                                Alliance

    The undersigned organizations of the ANSR Alliance greatly 
appreciate the opportunity to submit written testimony regarding fiscal 
year 2008 appropriations for Title VIII--Nursing Workforce Development 
Programs. The ANSR Alliance is comprised of 52 national nursing 
organizations that united in 2001 to identify and promote creative 
strategies for addressing the nursing and nurse faculty shortages, 
including passage of the Nurse Reinvestment Act of 2002.
    The ANSR Alliance stands ready to work with lawmakers to advance 
programs and policy that will sustain and strengthen our Nation's 
nursing workforce. To ensure that our Nation has a sufficient and 
adequately prepared nursing workforce to provide quality care to all 
well into the 21st century, ANSR urges Congress to:
  --Appropriate at least $200 million in funding for Nursing Workforce 
        Development Programs under Title VIII of the Public Health 
        Service Act at the Health Resources and Services Administration 
        (HRSA) in fiscal year 2008.
  --Restore the Advanced Education Nursing program (Sec. 811) and fund 
        it at a level on par with the proposed fiscal year 2008 
        increase for the other Title VIII programs.

                            NURSING SHORTAGE

    Nurses play a critical role in our Nation's health care system. An 
estimated 2.9 million licensed registered and advanced practice 
registered nurses (RNs and APRNs) represent the largest professional 
occupation of all health care workers providing patient care in 
virtually all locations in which health care is delivered. The 
diversity of practice settings and differing scopes of practice makes 
the nursing shortage an even more complex challenge. Some facts to 
consider:
  --The nursing workforce is aging. In 1980, 26 percent of RNs were 
        under the age of 30. Today, approximately 8 percent of RNs are 
        under the age of 30 with the average nurse being 46.8 years of 
        age;
  --Approximately half of the RN workforce is expected to reach 
        retirement age within the next 10 to 15 years. The average age 
        of new RN graduates is almost 30 years old;
  --A December 2005 Bureau of Labor Statistics report projected that 
        registered nursing would create the second largest number of 
        new jobs among all occupations within 9 years. In addition, 
        employment of RNs is expected to grow much faster than average 
        for all occupations through 2014. It is anticipated that 
        approximately 703,000 additional jobs, for a total of 
        3,096,000, will be available for RNs by that date;
  --The national nursing shortage also is affecting our Nation's 7.6 
        million veterans who receive care through the 1,300 Department 
        of Veterans Affairs (VA) health care facilities. The VA, the 
        largest sole employer of RNs in the United States, has a 10 
        percent RN vacancy rate;
  --The nurse faculty vacancies in the United States continued to grow 
        even as the numbers of full- and part-time educators increased 
        during the 2005-2006 academic year. According to the National 
        League for Nursing's 2006 Nurse Faculty Census, the estimated 
        number of budgeted, unfilled, full-time positions in 2006 was 
        1,390. This number represents a 7.9 percent vacancy rate in 
        baccalaureate and higher degree programs, which is an increase 
        of 32 percent since 2002; and a 5.6 percent vacancy rate in 
        associate degree programs, which translates to a 10 percent 
        rise in the same period.
        nursing supply impacts america's emergency preparedness
    The National Center for Health Workforce Analysis at the Bureau of 
Health Professions in HRSA reports that the nursing shortage makes it 
challenging for the health care sector to meet current service needs. 
Nursing shortfalls exacerbating capacity insufficiencies throughout the 
health care system have ripple effects, for example, seen in the 
problems encountered by most communities' day-to-day emergency care 
services. Facing a pandemic flu or other natural or man-made disaster 
of significant proportions makes the nursing shortage an even greater 
national concern, as well as an essential part of national preparedness 
and response planning
    Nurses play a critical role as front-line, first-responders. When 
word of the devastation caused by Hurricanes Katrina and Rita reached 
nurses across the country, they immediately volunteered in American Red 
Cross shelters, medical clinics, and hospitals throughout that 
widespread region. Nurses and advanced practice registered nurses 
(e.g., nurse midwives, nurse practitioners, clinical nurse specialists 
and certified registered nurse anesthetists) are particularly critical 
national resources in an emergency, able to provide clinical nursing 
care as well as primary care. During Katrina and Rita, nurse midwives 
delivered babies in airplane hangars, and nurses trained in geriatric 
care assisted in caring for those traumatized by their evacuation from 
the comforts of their homes, assisted living facilities or nursing 
homes. Nurse practitioners diligently staffed temporary and permanent 
health care clinics to provide needed primary care to hurricane 
victims. Many nurses contributed not just through their clinical 
expertise, but also by offering psychological support as they listened 
to survivors recount their stories of pain and tragedy.
    These stories seem particularly relevant in demonstrating the 
essential assistance nurses provide during tragedies, and reinforce the 
need to ensure an adequate supply of all types of nurses. Unless steps 
are taken now, the Nation's ability to respond to disasters will be 
further hindered by the growing nursing shortage. An investment in the 
nursing workforce is a reasonable and cost-effective investment toward 
rebuilding the public health infrastructure and increasing our Nation's 
health care readiness and emergency response capabilities.

                    DESPERATE NEED FOR NURSE FACULTY

    After years of declining interest, the nursing profession is seeing 
a resurgence of interest in the profession. Many people in America have 
come to find nursing an attractive career because of job openings, 
salary levels, and the opportunity to help others. However, the common 
theme among prospective nursing students is that due to a lack of 
enrollment openings, owing to faculty shortages, they can face waiting 
periods of up to 3 years before matriculating. When all nursing 
programs are considered, the number of qualified applications turned 
away during the 2004-2005 academic year was estimated to be nearly 
147,000 by the National League for Nursing. Without sufficient support 
for current nurse faculty and adequate incentives to encourage more 
nurses to become faculty, nursing schools will fail to have the 
teaching infrastructure necessary to educate and train the next 
generation of nurses that the Nation so desperately need.
    The current and deepening nurse faculty shortfall is the critical 
reason that the Advanced Education Nursing line item in the Title VIII 
programs must be fully funded. This program supported 11,949 graduate 
nursing students in fiscal year 2005. The students that are supported 
by this funding are the pool of future faculty for the nursing 
profession. Whether supporting students in clinical education or as 
faculty in schools of nursing, it is essential that advanced education 
nursing funding be restored.

                            FUNDING REALITY

    Enacted in 2002, the Nurse Reinvestment Act (Public Law 107-205) 
addressed new and expanded initiatives, including loan forgiveness, 
scholarships, career ladder opportunities, and public service 
announcements to advance nursing as a career. Despite the enactment of 
this critical measure, HRSA fails to have the resources necessary to 
meet the current and growing demands for our Nation's nursing 
workforce. For example:
  --Fiscal Year 2005 Nursing Education Loan Repayment Program.--Of the 
        4,465 applicants, 803 awards were made (599 initial 2-year 
        awards and 204 amendment awards) with 18 percent of applicants 
        receiving awards.
  --Fiscal Year 2006 Nursing Education Loan Repayment Program.--Of the 
        4,222 applicants, 615 awards were made (373 initial 2-year 
        awards and 242 amendment awards). This translates to 14.6 
        percent of applicants receiving awards.
  --Fiscal Year 2005 Nursing Scholarship Program.--This program 
        received 3,482 applicants and was able to provide 212 awards or 
        6.1 percent of the applicants received scholarships.
  --Fiscal Year 2006 Nursing Scholarship Program.--3,320 applicants 
        were received and 218 awards made or 6.6 percent of the 
        applicants received scholarships.
    The ANSR Alliance requests that the subcommittee provide a minimum 
of $200 million in fiscal year 2008 to fund the Title VIII--Nursing 
Workforce Development Programs. We also urge the restoration of the 
Advanced Education Nursing program (sec. 811) funded at a level on par 
with the proposed fiscal year 2008 increase for the other Title VIII 
programs.
    This funding can be used to restore the Advanced Education Nursing 
program and fund a higher rate of Nurse Education Loan Repayment and 
Nursing Scholarship applications, as well as implement other essential 
endeavors to sustain and boost our Nation's nursing workforce. We thank 
you for consideration of our request.
                                summary

----------------------------------------------------------------------------------------------------------------
                                                                               President's
                   Programmatic area                     Final fiscal year    budget fiscal      ANSR Alliance
                                                                2007            year 2008           request
----------------------------------------------------------------------------------------------------------------
Title VIII--Nursing Workforce Development Programs at         $149,679,000       $105,263,000       $200,000,000
 HRSA..................................................
----------------------------------------------------------------------------------------------------------------

                      ANSR ALLIANCE ORGANIZATIONS

    Academy of Medical-Surgical Nurses; American Academy of Ambulatory 
Care Nursing; American Academy of Nurse Practitioners; American 
Association of Critical-Care Nurses; American Association of Nurse 
Anesthetists; American Association of Nurse Assessment Coordinators; 
American Association of Occupational Health Nurses; American College of 
Nurse Practitioners; American Organization of Nurse Executives; 
American Radiological Nurses Association; American Society for Pain 
Management Nursing; American Society of PeriAnesthesia Nurses; American 
Society of Plastic Surgical Nurses; Association of periOperative 
Registered Nurses; Association of Rehabilitation Nurses; Asociation of 
State and Territorial Directors of Nursing; Association of Women's 
Health, Obstetric and Neonatal Nurses; Emergency Nurses Association; 
Infusion Nurses Society; National Association of Clinical Nurse 
Specialists; National Association of Neonatal Nurses; National 
Association of Nurse Practitioners in Women's Health; National 
Association of Orthopaedic Nurses; National Association of Pediatric 
Nurse Practitioners; National Conference of Gerontological Nurse 
Practitioners; National Council of State Boards of Nursing, Inc.; 
National Gerontological Nursing Association; National League for 
Nursing; National Nursing Centers Consortium; National Nursing Staff 
Development Organization; National Organization for Associate Degree 
Nursing; National Organization of Nurse Practitioner Faculties; 
National Student Nurses' Association, Inc.; Society for Vascular 
Nursing; Society of Pediatric Nurses; Society of Trauma Nurses; and 
Society of Urologic Nurses and Associates.
                                 ______
                                 
   Prepared Statement of the Association of Academic Health Sciences 
             Libraries and the Medical Library Association

            SUMMARY OF RECOMMENDATIONS FOR FISCAL YEAR 2008

    (1) A 6.7 percent increase for the NationaL Library of Medicine at 
the National Institutes of Health and support for the National Library 
of Medicine's Urgent Facility construction needs.
    (2) Continued support for the Medical Library community's role in 
the National Library of Medicine's Outreach, Telemedicine, Disaster 
Preparedness and Health Information Technology Initiatives.
    Mr. Chairman, thank you for the opportunity to testify today on 
behalf of the Medical Library Association (MLA) and the Association of 
Academic Health Sciences Libraries (AAHSL) regarding the fiscal year 
2008 budget for the National Library of Medicine (NLM). I am Marianne 
Comegys, Director of the Louisiana State University (LSU) Health 
Sciences Center Library in Shreveport, Louisiana.
    MLA is a nonprofit, educational organization with more than 4,500 
health sciences information professional members worldwide. Founded in 
1898, MLA provides lifelong educational opportunities, supports a 
knowledgebase of health information research and works with a global 
network of partners to promote the importance of quality information 
for improved health to the healthcare community and the public.
    AAHSL is comprised of the directors of the libraries of 142 
accredited American and Canadian medical schools belonging to the 
Association of American Medical Colleges (AAMC). AAHSL's goals are to 
promote excellence in academic health sciences libraries and to ensure 
that the next generation of health professionals is trained in 
information-seeking skills that enhance the quality of healthcare 
delivery.
    Together, MLA and AAHSL address health information issues and 
legislative matters of importance through a joint task force.
    With respect to NLM's budget for the upcoming year, I would like to 
touch briefly on five issues: (1) the growing demand for NLM's basic 
services, (2) NLM's outreach and education services, (3) NLM's role in 
emergency preparedness and response, (4) NLM's health information 
technology initiatives and (5) NLM's facility needs.

            THE GROWING DEMAND FOR THE NLM'S BASIC SERVICES

    Mr. Chairman, it is a tribute to NLM that the demand for its 
services and expertise continues to grow. As the world's foremost 
digital library and knowledge repository in the health sciences, NLM 
provides the critical infrastructure in the form of data repositories 
and integrated services such as GenBank and PubMed that are helping to 
revolutionize medicine and advance science to the next important era--
individualized medicine based on an individual's unique genetic 
differences.
    As the world's largest and most comprehensive medical library, 
services based on NLM's traditional and electronic collections continue 
to steadily increase each year. These collections stand at more than 
8.5 million items--books, journals, technical reports, manuscripts, 
microfilms, photographs, and images. By selecting, organizing and 
ensuring permanent access to health science information in all formats, 
NLM is ensuring the availability of this information for future 
generations, making it accessible to all Americans, irrespective of 
geography or ability to pay, and ensuring that each citizen can make 
the best, most informed decisions about their healthcare.
    Mr. Chairman, simply stated NLM is a national treasure and support 
for its programs and services could not be more important at the 
present time. I can tell you that without NLM our Nation's medical 
libraries would be unable to provide the quality information services 
that our Nation's health professionals, educators, researchers and 
patients have all come to expect.
    Recognizing the invaluable role that NLM plays in our healthcare 
delivery system, MLA and AAHSL join with the Ad Hoc Group for Medical 
Research in asking for a 6.7 percent increase for NLM, and the NIH 
overall, in fiscal year 2008.

                         OUTREACH AND EDUCATION

    NLM's outreach programs are of particular interest to both MLA and 
AAHSL. These activities are designed to educate medical librarians, 
health professionals and the general public about NLM's services.
    NLM has taken a leadership role in promoting educational outreach 
aimed at public libraries, secondary schools, senior centers and other 
consumer-based settings. Furthermore, NLM's emphasis on outreach to 
underserved populations assists the effort to reduce health disparities 
among large sections of the American public.
    We applaud the success of NLM's outreach initiatives, particularly 
those initiatives that reach out to medical libraries and health 
consumers. We ask the committee to encourage NLM to continue to 
coordinate its outreach activities with the medical library community 
in fiscal year 2008.
Partners in Information Access
    NLM's ``Partners in Information Access'' program is designed to 
improve the access of local public health officials to information 
needed to prevent, identify and respond to public health threats. With 
nearly 6,000 members in communities across the country, the National 
Network of Libraries of Medicine (NNLM) is well-positioned to ensure 
that every public health worker has electronic health information 
services that can protect the public's health. My own facility, the LSU 
Health Sciences Center in Shreveport, Louisiana, participates in this 
program. Through it, we are able to train public health workers on how 
to access health information online.
PubMed/Medline
    NLM's PubMed/Medline is the Nation's premier online bibliographic 
database. PubMed/Medline makes accessing important medical information 
easier and quicker, which in turn lowers healthcare costs while 
improving care. For more than 10 years, PubMed/Medline has afforded 
anyone with access to the Internet the opportunity to tap into the vast 
resources of NLM.
    The NIH Public Access policy makes use of NLM's PubMed Central 
electronic archive of full-text journal articles and manuscripts. This 
policy supports NLM's mission to archive and enhance access to 
healthcare information. We are concerned however that the current rate 
of participation in the voluntary policy is low. Even with an 
increasing number of journals depositing their complete contents in 
PubMed Central less than 15 percent of NIH-funded articles are 
available to the public there.
    We concur with the NLM Board of Regents that the NIH Public Access 
policy cannot achieve its stated goals unless the deposit of 
manuscripts becomes mandatory. An informal survey conducted by AAHSL of 
faculty and research administrators at 19 universities illustrated that 
NIH-funded researchers are aware of the NIH Public Access policy. This 
finding has been confirmed by NIH focus groups. Hence, lack of 
awareness does not appear to be the primary reason for the low 
submission rate; rather lack of incentive is impeding the success of 
this policy.
    In September, NLM, NIH and the Friends of NIH, launched NIH 
MedlinePlus Magazine. This new publication will be distributed in 
doctors' waiting rooms, and will provide the public with access to high 
quality, easily understood health information.
    NLM also continues to work with medical librarians and health 
professionals to encourage doctors to provide MedlinePlus ``information 
prescriptions'' to their patients. This initiative has been expanded to 
encourage genetics counselors to prescribe the use of NLM's Genetics 
Home Reference website. ``Go Local'' is another new exciting feature of 
MedlinePlus that enables local and State agencies and others to 
participate by creating sites that link the MedlinePlus information 
seeker to local pharmacies, doctors and other health and social 
services. This service further enhances the value of NLM and 
MedlinePlus, not just for medical librarians and health professionals, 
but also for health consumers. It also provides a platform for 
enhancing public access to the information needed to prepare for and 
respond to disasters and emergencies.
Clinical Trials
    NLM's clinical trials database was launched in February 2000 and 
lists more than 38,000 United States and international trials for a 
wide range of diseases. The clinical trials database is a free and 
invaluable resource to patients and families who are interested in 
participating in cutting-edge treatments for serious illnesses. MLA and 
AAHSL thank NLM for its leadership in creating ClinicalTrials.gov and 
looks forward to assisting NLM in advancing this important initiative.
    We are aware of current proposals to mandate the submission of 
clinical trial results to this or a related database. We strongly 
endorse the notion of improving public access to information about the 
results of clinical trials, but are concerned about the possibility of 
results being posted without having been subject to some form of 
external review. If such information is to be used by patients and 
their physicians to make informed decisions, the information must be 
trustworthy and should be held to the same standard as other publicly 
available information made available on the NLM web sites.

                  EMERGENCY PREPAREDNESS AND RESPONSE

    MLA and AAHSL support the recommendation of the NLM Board of 
Regents Long Range Plan for 2006-2016 that NLM establish a Disaster 
Information Management Research Center to expand NLM's capacity to 
support disaster response and management initiatives. Following 
Hurricane Katrina, NLM provided health professionals and the public 
with access to needed health and environmental information by: (1) 
quickly compiling Web pages on toxic chemicals and environmental 
concerns, (2) rapidly providing funds, computers and communication 
services to assist librarians in the field who were restoring health 
information services to displaced clinicians and patients, and (3) 
rerouting interlibrary loan requests from the afflicted regions through 
the NNLM.

            HEALTH INFORMATION TECHNOLOGY AND BIOINFORMATICS

    Mr. Chairman, NLM has played a pivotal role in creating and 
nurturing the field of medical informatics, most notably through the 
creation of GenBank and a wide array of related scientific data and 
analysis tools which provide critical infrastructure for the Nation's 
researchers. This critical infrastructure will be key to advances in 
medicine in the future.
    For nearly 35 years, NLM has supported informatics research and 
training and the application of advanced computing and informatics to 
biomedical research and healthcare delivery including a variety of 
telemedicine projects. Many of today's informatics leaders are 
graduates of NLM-funded informatics research programs at universities 
across the country, and many of the country's exemplary electronic 
health record systems benefited from NLM grant support.
    A leader in supporting, licensing, developing and disseminating 
standard clinical terminologies for free United States-wide use (e.g., 
SNOWMED), NLM works closely with the Office of the National Coordinator 
for Health Information Technology (ONCHIT) to promote the adoption of 
interoperable electronic records.
    MLA and AAHSL encourage Congress to continue their strong support 
of NLM's medical informatics and genomic science initiatives, at a 
point when the linking of clinical and genetic data holds increasing 
promise for enhancing the diagnosis and treatment of disease. MLA and 
AAHSL also support Health Information Technology initiatives at
    ONCHIT and the Agency for Healthcare Research and Quality (AHRQ) 
that build upon initiatives housed at NLM.

                         NLM'S FACILITIES NEEDS

    Mr. Chairman, over the past two decades NLM has assumed many new 
responsibilities, particularly in the areas of biotechnology, health 
services research, high performance computing and consumer health. As a 
result, NLM has had tremendous growth in its basic functions related to 
the acquisition, organization and preservation of an ever-expanding 
collection of biomedical literature an expanded staff. NLM now houses 
1,100 staff in a facility built to accommodate only 650. This increase 
in the volume of biomedical information and in the number of personnel 
has led to a serious space shortage. Digital archiving--once thought to 
be a solution to the problem of housing physical collections--has only 
added to the challenge, as materials must often be stored in multiple 
formats and as new digital resources consume increasing amounts of 
storage space. As a result, the space needed for computing facilities 
has also grown, further squeezing out staff. In order for NLM to 
continue its mission as the world's premier biomedical library, a new 
facility is urgently needed. The NLM Board of Regents has assigned the 
highest priority to supporting the acquisition of a new facility. 
Further, Senate Report 108-345 that accompanied the fiscal year 2005 
appropriations bill acknowledged that the design for the new research 
facility at NLM had been completed and the committee urged the NIH to 
assign a high priority to this construction project so that NLM's 
information-handling capabilities are not jeopardized.
    We encourage the subcommittee to provide the resources necessary to 
construct a new facility.
    Mr. Chairman, thank you again for the opportunity to present the 
views of the medical library community.
                                 ______
                                 
  Prepared Statement of the Association of American Cancer Institutes

    The Association of American Cancer Institutes (AACI), representing 
89 of the Nation's premier academic and free-standing cancer centers, 
appreciates the opportunity to submit this statement for consideration 
as the Labor, Health and Human Services Appropriations Subcommittee 
plans the fiscal year 2008 appropriations for the National Institutes 
of Health (NIH) and the National Cancer Institute (NCI).

                             CANCER BURDEN

    In 2007, there will be approximately 1.44 million new cases of 
cancer in the United States.\1\ Today, lifetime cancer risk in the 
United States is one in two for men and one in three for women.\2\ This 
number will continue to climb as the population ages, with an estimated 
18.2 million cancer survivors (those undergoing treatment, as well as 
those who have completed treatment) alive in 2020. By comparison, 11.7 
million survivors were living in the United States in 2005.\3\
---------------------------------------------------------------------------
    \1\ Cancer Statistics, 2007. CA: Cancer Journal for Clinicians 
2007; 57: 43-66.
    \2\ The Nations' Investment in Cancer Research; A Plan and Budget 
Proposal for Fiscal Year 2008, National Cancer Institute, 2007.
    \3\ Future Supply and Demand for Oncologists, Journal of Oncology 
Practice 2007; 3(2): 79-86.
---------------------------------------------------------------------------
                          RESEARCH IN JEOPARDY

    A recent analysis published in the Journal of Oncology Practice 
suggested that the increase in the number of cancer patients and 
survivors over the next decade will be coupled with a shortage of 
clinical oncologists.\3\ And there is another shortage that is all too 
real now, the implications of which will be felt for generations to 
come if our government's policymakers do not address the problem 
immediately. Because of continuing decreases to the budgets of the NIH 
and NCI (in actual dollars and as a result of biomedical inflation), 
grants to support cancer researchers as they discover new treatments 
for cancer and strategies to prevent and detect the disease continue to 
be cut. Without these grants, fewer and fewer cancer researchers will 
be able to maintain their commitment to science--a dearth of cancer 
researchers is on the horizon.

               CANCER RESEARCH: BENEFITING ALL AMERICANS

    The cancer research enterprise in the United States is second-to-
none. Cancer research, conducted in academic laboratories across the 
country saves money by reducing healthcare costs associated with the 
disease, enhances the United States' global competitiveness, and has a 
positive economic impact on localities that house a major research 
center. While these aspects of cancer research are important, what 
cannot be overstated is the impact cancer research has had on 
individuals' lives--lives that have been lengthened and even saved by 
virtue of discoveries made in cancer research laboratories across the 
United States.
    Our Nation's cancer researchers are making advances against this 
disease--for the second year in a row, statistics show that the number 
of people dying of cancer has declined.\2\ And for the first time ever, 
coming generations may be able to prevent some cancers from occurring 
at all. For instance, with the recent FDA approval of the HPV (human 
papillomavirus) vaccine Gardasil, young women will be protected against 
the virus that causes up to 70 percent of cervical cancer cases 
worldwide.\4\ In 2007 11,150 women will develop cervical cancer and 
3,670 will die as a result of the disease.\5\ Gardasil is expected to 
significantly reduce the number of cases of cervical cancer as young 
women begin receiving the vaccine. Also, the HPV infection may play 
some role in the development of other diseases such as head and neck 
cancer, suggesting that the vaccine may have wider applicability in the 
future.
---------------------------------------------------------------------------
    \4\ Taking Pride in an Important Achievement, The NCI Cancer 
Bulletin, 2006; 3(24): 1-2.
    \5\ American Cancer Society. Cancer Facts & Figures 2007, 2007, 20-
21.
---------------------------------------------------------------------------
    Recent headlines have linked dropping breast cancer rates with a 
decrease in the use of hormone replacement therapy among millions of 
older women. An NCI-funded study conducted at The University of Texas 
M.D. Anderson Cancer Center explored factors that may be involved in 
the 7 percent age-adjusted decline--or 14,000 fewer cases--in breast 
cancer incidence between 2002 and 2003.\6\ The researchers, led by Dr. 
Donald Berry, concluded that ``only the potential impact of hormone 
replacement therapy was strong enough to explain the effect.'' \2\ 
Without a strong research infrastructure to examine this relationship, 
health professionals might still routinely prescribe menopausal 
hormones without knowing that the hormones may increase their patients' 
risk of developing breast cancer.
---------------------------------------------------------------------------
    \6\ Decline in Breast Cancer Cases Likely Linked to Reduced Use of 
Hormone Replacement. M.D. Anderson Cancer Center News Release, December 
14, 2006.
---------------------------------------------------------------------------
    This and other success stories are positive news in the war on 
cancer, but are only one small part of the battle. Research advances 
that have led to increased cancer survivorship, prevention efforts, and 
enhanced treatment and understanding of the disease are at stake with 
research funding becoming more and more limited. Now is the time to 
provide funding to NIH and NCI to fully capitalize on the accelerated 
pace of research that was fostered by the doubling of the NIH budget 
from 1998 through 2003, not to risk losing out on lifesaving 
opportunities by cutting funding to the Nation's biomedical 
infrastructure.

            EFFECTS OF THE ``UNDOUBLING'' OF THE NIH BUDGET

    During the period from 1998 through 2003 the budget of the NIH was 
doubled. This doubling provided resources that allowed a greater number 
of promising young investigators to enter the field of cancer research, 
and also supported research into the ideas of established 
investigators. In 2007, however, funding for NIH is in the process of 
being ``undoubled'' through actual budget cuts and because of the 
effects of biomedical inflation. This year, NIH's budget is 
approximately $28.9 billion--an impressive sum to be sure. However, if 
NIH's 2003 budget (the last year of the doubling period) had been 
increased each year only to account for biomedical inflation, its 2007 
budget would be $31.6 billion.
    While the doubling of the NIH budget was an ambitious undertaking, 
the effort has ultimately resulted in inconsistent funding for the 
institutes that make up the NIH. The budget of the NCI alone has lost 
approximately 12 percent of its purchasing power due to the effects of 
biomedical inflation.\7\ The Biomedical Research and Development Price 
Index (BRDPI) is calculated each year to determine how NIH expenditures 
must increase to compensate for inflation. In 2005 BRDPI was estimated 
at 3.9 percent, meaning that each research dollar lost 3.9 percent of 
its value for the year.\8\ The NIH budget also decreased 0.5 percent 
from 2005 to 2006, which caused a net loss of 4.4 percent purchasing 
power for 2006. NCI Director Dr. John E. Niederhuber estimates that 
because of actual cuts in funding and the effects of BRDPI, in fiscal 
year 2006 NCI was unable to fund 180 grants that would otherwise have 
been deemed worthy of funding.\7\ These projects would have built upon 
progress made during the doubling period--progress that will now be 
unrealized.
---------------------------------------------------------------------------
    \7\ Cancer Research Budget Cuts Cause ``Missed Opportunities,'' NCI 
Director Tells Advisors, The Cancer Letter; 33(9), 5-8.
    \8\ Biomedical Research and Development Price Index (BRDPI), BRDPI 
Table of Annual Values Index. Office of Budget, National Institutes of 
Health, 2007. http://officeofbudget.od.nih.gov/ui/GDP_FromGenBudget.htm
---------------------------------------------------------------------------
    In 2007, NCI's Clinical Trials Cooperative Group Program will have 
to cut as much as 60 percent of its members' new clinical trials. This 
will result in an 11 percent decrease in the number of patients accrued 
into clinical trials, or approximately 3,000 eligible patients who will 
be unable to enroll in a cooperative group trial.\7\ These trials would 
answer questions that help lead to more effective therapies and other 
interventions for cancer, as well as methods for screening and 
prevention. Not only will these patients be unable to benefit from the 
cutting-edge treatments available only through clinical trials, 
patients for generations to come will not benefit from the results of 
this research.
    Additionally, NCI's Specialized Programs of Research Excellence 
(SPOREs) program that promotes interdisciplinary research to move basic 
research findings from the laboratory to clinical settings was cut by 8 
percent, or $8 million, in fiscal year 2006, with more cuts expected 
this year. NCI's Tobacco Control Research Branch has been cut by $6.5 
million between fiscal year 2004 and fiscal year 2007 and its Cancer 
Survivorship Program by $1 million. Patient accrual for clinical trials 
at NCI's Center for Cancer Research (CCR) was at 4,210 in fiscal year 
2004, but in fiscal year 2006 that number was down to 3,795.\7\

                      THE NATION'S CANCER CENTERS

    The nexus of cancer research in the United States is the Nation's 
network of cancer centers, both with and without NCI designation, that 
are represented by AACI. These cancer centers are highly integrated, 
multidisciplinary hubs of scientific excellence and exceptional patient 
care. They are uniquely patient oriented, research intensive, 
translationally adept, and clinically superb. In 2005, these academic 
based institutions received 86 percent of the grant dollars available 
for 2005, or 59 percent of NCI's budget as a whole. Because these 
centers are networked nationally, opportunities for collaborations are 
many--assuring wise and non-duplicative investment of scarce Federal 
dollars.
    In addition to conducting basic, clinical, and population research, 
the cancer centers are largely responsible for training the cancer 
workforce that will practice in the United States in the years to come. 
Much of this training is dependent on Federal dollars, via training 
grants and other funding from NCI. Decreasing Federal support will 
significantly undermine the centers' ability to continue to train the 
next generation of cancer specialists--both researchers and providers 
of cancer care.
    Success stories at the cancer centers are common--but are in danger 
of becoming less so as research dollars are lost. For instance, a 
patient at a major academic cancer center had been told he had 6 months 
to live after being diagnosed with an aggressive form of brain cancer. 
But through an innovative clinical trial at the center, this patient 
was tumor-free 6 years later.\9\ Without the Federal funding that 
supported his treatment, he may not have been so fortunate.
---------------------------------------------------------------------------
    \9\ Road to Nowhere, Frontiers Magazine, Winter 2006.
---------------------------------------------------------------------------
                   FINANCIAL IMPACT ON CANCER CENTERS

    The cancer center network in the United States forms the country's 
cancer research infrastructure. As the nationwide hubs of cancer-
related scientific inquiry, the negative impact of reduced Federal 
funding for cancer research on these centers is enormous. The rapid 
pace of cancer research at AACI centers requires that investigators and 
clinicians from diverse disciplines work together to share information, 
expertise and resources. These interactions yield many insights into 
the cancer problem. Reduced, or--even worse--no support for even one 
member of this multidisciplinary team affects the collective progress 
and productivity of the entire program.
    Furthermore, the grants that comprise the core funding for the NCI-
designated cancer centers have been flat for the past 3 years.\7\ This 
core funding helps support academic and research institutions to 
sustain coordinated interdisciplinary programs in cancer research. With 
no annual adjustment for inflation, the actual purchasing power over 
the course of a typical multi-year grant has decreased, essentially 
resulting in a cut to funding. Stagnant funding prevents expansion at 
existing centers, but also--and perhaps more importantly--prevents new 
centers from achieving NCI designation. While most major metropolitan 
areas in the United States have easy access to an NCI-designated cancer 
center, several States and many underserved areas do not.

                              SOCIAL VALUE

    Though cancer statistics can seem daunting, even small steps 
forward will have tremendous results. Dr. Kevin M. Murphy, the George 
J. Stigler Distinguished Service Professor of Economics at the 
University of Chicago Graduate School of Business, estimates that even 
a 1 percent reduction in cancer deaths would result in almost $500 
billion in social value to the United States. Social value is 
calculated in terms of improved health and longevity. Curing the 
disease would be worth as much as $50 trillion in social value.\10\
---------------------------------------------------------------------------
    \10\ AACR Meeting: Increase Research Funding that Cuts U.S. Cancer 
Mortality by 1 percent Could Provide Payback of Nearly $500 Billion, 
Oncology Times, May 10, 2006.
---------------------------------------------------------------------------
                               CONCLUSION

    These are very exciting times in science and, particularly, in 
cancer research. Recent discoveries in the molecular biology of cancer 
have led to important advances and new approaches to the prevention and 
treatment of the disease. Drug discovery often is now based on the 
understanding of molecular targets unique to cancer cells compared with 
normal cells. Because of the Nation's investment in this research, we 
are learning how to target and treat cancer specifically, while sparing 
healthy tissues, and we are helping survivors lead more vibrant lives. 
Reduced or flat funding will have a grave impact on progress in 
targeted therapies and other promising research endeavors that could 
lead to increased cancer survivorship.
    Simply put, cancer research is a marathon, not a sprint. While the 
period of NIH doubling briefly helped speed the pace of cancer 
research, the potential legacy of this doubling will be squandered if 
the NCI and NIH budgets are not funded--at a minimum--to account for 
the effects of biomedical inflation. AACI and its members urge Congress 
to support an NIH budget increase for fiscal year 2008 of at least 6.7 
percent to make up for recent annual inflationary shortfalls. AACI and 
its members also urge Congress to appropriate $5.1 billion for NCI's 
fiscal year 2008 budget, which reflects a 6.7 percent increase over 
fiscal year 2007, consistent with our overall NIH request.
    We must, as a Nation, commit to fully funding the budget of the NCI 
and the NIH. Our generation has been fortunate--a diagnosis of cancer 
is no longer the certain death sentence it was for our parents and 
grandparents. We owe the same to our children and grandchildren, and we 
urge your support to increase this critical funding.
                                 ______
                                 
      Prepared Statement of the Association of American Publishers

    I am pleased to submit the following statement for the record on 
behalf of the Professional and Scholarly Publishing Division of the 
Association of American Publishers (PSP/AAP) in conjunction with the 
subcommittee's hearing on the fiscal year 2008 Budget for the National 
Institutes of Health (NIH). The AAP represents commercial and non-
profit entities who publish scientific, technical and medical journals. 
Scholarly publishers are committed to working with NIH to successfully 
implement NIH's Public Access Policy and ensure that articles based on 
NIH-funded research are deposited with NIH. Publishers believe that 
such a proactive public-private partnership between NIH and journal 
publishers is critical to the success of the NIH policy. As a result of 
the voluntary efforts by publishers, the number of articles deposited 
with NIH has increased significantly.
    The number of articles deposited with NIH has increased well beyond 
the low figures referenced by NIH. The voluntary effort initiated by 
publishers to deposit manuscripts on behalf of authors has resulted in 
an increase in deposits from 4 percent to over 20 percent. This 
significant increase is just the beginning. We will be able to do more 
as additional publishers join this effort. However, we need NIH's help 
to make that happen. To date, NIH has been slow to work with publishers 
to resolve key implementation issues necessary to bring on additional 
publishers.
    We strongly oppose any move to a mandatory policy and feel that NIH 
should instead engage publishers more broadly so we may achieve our 
mutual objectives. This is important to attain the maximum article 
deposition rate without adversely affecting the valuable peer review 
process or the stability of important scientific journals and their 
publishers. Considering the immense stakes, it is prudent to work 
through the outstanding issues under the voluntary policy in a way that 
optimizes participation by all players to ensure the greatest benefit 
to the public interest and scientific progress.
    We are confident that through a cooperative approach involving the 
publishing community, deposition rates for manuscripts reporting on 
NIH-funded research can reach optimum levels within a period of month, 
not years. We encourage Congress to direct NIH to work together with 
publishers to improve the implementation of the voluntary Public Access 
Policy and further increase deposit rates. We stand ready to work with 
NIH to achieve this important goal.
    Publishers remain committed to working with NIH to ensure the 
successful implementation of the current voluntary program, while 
protecting the peer review process that helps ensure the quality and 
integrity of scientific and medical research. On behalf of the AAP, I 
appreciate this opportunity to submit this statement and look forward 
to enhanced collaboration with NIH.
                                 ______
                                 
  Prepared Statement of the Association for Clinical Research Training

              SUMMARY OF FISCAL YEAR 2008 RECOMMENDATIONS

    A 6.7 percent increase for the National Institutes of Health, 
including the National Center for Research Resources.
    $462 million for the Clinical and Translational Science Awards.
    $350 million for the agency for Healthcare Research and Quality.
    $750 million for a Center for Comparative Effectiveness at the 
agency for Healthcare Research and Quality. Of this $750 million, a 
substantial portion should be for research training.
    The Association for Clinical Research Training (ACRT) is committed 
to improving the Nation's health by increasing the amount and quality 
of clinical research through the expansion and improvement of clinical 
research training. This training is funded by both the National 
Institutes of Health (NIH) and the Agency for Healthcare Research and 
Quality (AHRQ).

                     NATIONAL INSTITUTES OF HEALTH

    The NIH's Clinical and Translational Science Awards (CTSAs) aim to 
meet one of the profound challenges of 21st Century medicine, namely 
that the ever increasing complexities involved in conducting clinical 
research are making it more difficult to translate new knowledge from 
the bench to the bedside. As Dr. Elias Zerhouni, the Director of the 
NIH, wrote in the October 13, 2005 edition of the New England Journal 
of Medicine, ``it is the responsibility of those of us involved in 
today's biomedical research enterprise to translate the remarkable 
scientific innovations we are witnessing into health gains for the 
Nation.''
    The CTSAs assist institutions in creating a home for clinical and 
translational science that has the resources necessary to train and 
advance a cadre of investigators. The CTSAs transform basic research 
into clinical practice, advance information technology, integrate 
research networks and improve workforce training.
    The ACRT supports the fiscal year 2008 President's budget request 
of $462 million for the CTSAs, and joins the Ad Hoc Group for Medical 
Research in asking for a 6.7 percent increase in fiscal year 2008 for 
the NCRR and the NIH overall.

               AGENCY FOR HEALTHCARE RESEARCH AND QUALITY

    AHRQ is the lead Federal agency charged with supporting research to 
improve healthcare quality, reduce costs, advance patient safety, 
decrease medical errors, eliminate disparities and broaden access to 
essential services. AHRQ supports health services research that will 
improve the quality of healthcare and improve evidence-based decision 
making. The agency also transforms research into in practice in order 
to facilitate wider access to effective healthcare services.
    By providing funds to train clinical researchers, AHRQ ensures that 
there continues to be researchers who are able to provide the Nation 
with high quality, unbiased information about healthcare. Once 
consumers have this information, they will then be able to make 
effective, evidence based healthcare choices. A Center for Comparative 
Effectiveness would help to leverage AHRQ's expertise in providing this 
information to consumers. But in order to continue AHRQ's mission of 
training clinical researchers, there must be ample funding for training 
the investigators who will move this center forward.
    The ACRT joins the Friends of AHRQ in requesting $350 million for 
AHRQ in fiscal year 2008. The ACRT also joints the Society of General 
Internal Medicine (SGIM) and other organizations in advocating for a 
Center for Comparative Effectiveness at AHRQ. This center should have 
an initial investment of $750 million, including a substantial portion 
for research training.
                                 ______
                                 
  Prepared Statement of the Association of Maternal and Child Health 
                                Programs

    Mr. Chairman and members of the subcommittee, I am pleased to 
submit testimony on behalf of the Association of Maternal and Child 
Health Programs (AMCHP) regarding the critical need for increased 
funding of the Maternal and Child Health Services Block Grant, Title V 
of the Social Security Act. The Maternal and Child Health Services 
Block Grant is the only Federal program devoted to improving the health 
of all women, children and families. The program provides funding to 
State maternal and child health programs, which serve 33 million women 
and children in the United States.
    When our children are healthy, they are more likely to succeed. 
Maternal and child health (MCH) programs help promote our children's 
success by identifying emerging and urgent health needs, while 
continuing to assure services like prenatal care, universal newborn 
screening, immunizations and access to health services. In fact, 80 
percent of all American children access or connect with one or more 
programs funded by the Title V MCH Block Grant, making this program a 
vital resource for families--especially those with special health care 
needs.

                INCREASE THE BLOCK GRANT TO $750 MILLION

    The MCH Block Grant ``Works.''--The Office of Management and Budget 
reported that the block grant-funded programs helped to decrease the 
infant mortality rate, prevent disabling conditions, increase the 
number of children immunized, increase access to care for uninsured 
mothers and children, and improve the overall health of all mothers and 
children. Funding for the program has decreased since fiscal year 2002, 
yet participation has increased. These funding shortages have 
threatened the MCH programs' ability to continue achieving successful 
outcomes. As health care costs rise and the number of under- or un-
insured women and children continue to grow, block grant programs will 
face a critical erosion of their successes. This erosion will impact 
the health and well-being of hundreds of thousands of women and 
children.
    The Need for Programs for Families and Children With Special Health 
Care Needs Continues to Grow.--As States face economic hardships and 
limit their enrollment and benefit packages in Medicaid and State 
Children's Health Insurance Programs (SCHIP), more women and children 
seek and receive services through MCH programs. This is especially true 
for children with special health care needs who require services that 
are not covered in most health insurance plans. Block grant funds also 
are used to reduce infant mortality, provide mental health care, 
improve oral health, provide care coordination to children with special 
health care needs and reduce racial disparities in health care.
    The Block Grant Funds Improvements to Vital Health Care Systems.--
State MCH programs establish health care standards that promote 
preventive health care; provide outreach and health care education to 
assure that children receive services through insurance programs; and, 
measure the impact of health care practices. The block grant allows 
States to fund efforts to increase the quality health care, collect 
data and conduct analyses. MCH programs identify factors associated 
with infant mortality, inadequate immunizations, and late prenatal care 
so that strategies can be developed to address these needs. Every 
funding cut means the provision of fewer direct services and limits the 
development of health care system improvements.
maternal and child block grant-funded programs have far-reaching impact 

               AND USE MONIES EFFICIENTLY AND EFFECTIVELY

Working with Efficiency and Agility, Spending Limited Resources Wisely
    The care coordination of MCH programs ensures that all mothers and 
children, insured, under- and un-insured, utilize available health care 
coverage to receive all possible benefits. All payment sources (private 
insurance, State or federally funded health care) are integrated to 
deliver quality care.
    Dollars invested in MCH programs yield a high return on investment.
      The State of Iowa was awarded an Early Hearing Detection and 
        Intervention grant through 2008 to focus on reducing the number 
        of infants who are ``lost'' in the system, delaying the 
        provision of early intervention services. The States' Child 
        Health Specialty Clinics use the funds to screen all newborns 
        and enroll eligible children into early intervention programs.
      The Pennsylvania Department of Health currently funds the 
        Pennsylvania Shaken Baby Syndrome Prevention and Awareness 
        Program in the amount of approximately $100,000 annually. This 
        program seeks to increase awareness of new parents on the 
        dangers of shaking a baby. Medical care over the lifetime of a 
        single child that suffers from Shaken Baby Syndrome can easily 
        surpass the million dollar mark.
      In Florida, for every dollar spent on newborn screening, $17 are 
        saved. Newborn screening detects diseases and disorders that, 
        without intervention, are debilitating, costly and potentially 
        deadly.
Focusing on Those with the Greatest Need
    Nationally, the incidence of low birth weight babies and infant 
mortality for African Americans is twice the rate for whites. MCH 
programs share strategies and tactics to reduce these racial and ethnic 
disparities.
      Nevada contracts with local agencies to serve uninsured pregnant 
        women with prenatal care including screening and referral for 
        depression during and post-pregnancy.
    Many young people are at risk for serious chronic diseases and 
premature death. Among 5- to 24-year-olds, nearly 75 percent of deaths 
are behavior-related, as are many illness and social problems, such as 
substance abuse. State MCH programs work to build the capacity of 
adolescent health coordinators and child health professionals at the 
State level to address adolescent health and make it a priority.
    State technical assistance programs funded by the Title V MCH Block 
Grant help prevent HIV transmission from mothers to babies, help women 
quit smoking during pregnancy and promote safe motherhood.
    A recent survey of State MCH program adolescent health coordinators 
identified teen pregnancy prevention as the number one priority related 
to adolescent health. State MCH programs work to raise the visibility 
of teen pregnancy prevention efforts to increase State capacity to 
address teen pregnancy and develop sustained and effective prevention 
efforts.
Serving America's Families
    MCH State programs serve more than 33 million people, striving to 
improve the health of all women, infants, children and adolescents 
including those with special health care needs by delivering critical 
screening services, and supporting preventive, primary and specialty 
care.
      Montana's MCH funding was the financial basis for public health 
        services, especially in many small counties until recent 
        bioterrorism funding. Federal and State MCH funding enables 
        local public health to leverage small amounts of match funding 
        at the county level.
    Eighty percent of America's children utilize one or more maternal 
and child health program.
      California's MCH program is collaborating with the Children's 
        Hospital of Los Angeles and State Epilepsy Foundation on a HRSA 
        grant called Improving Access to Care for Children and Youth 
        with Epilepsy. The overall goal is to improve access to health 
        and other services and supports related to epilepsy by 
        facilitating the development of state-wide community-based 
        interagency models of comprehensive, family-centered and 
        culturally effective statewide standards of care. The program 
        collaborates with Family Voices and the Children's Regional 
        Integrated Service Systems which comprises 14 MCH county 
        programs to implement integrated community systems of care for 
        children and youth with special health care needs.
    More families are turning to MCH services. Over the last 5 years, 
the number of individuals served increased by 18 percent.
      The number of families served through Regional Genetics Clinics 
        in Washington State grew from 2,736 families to 4,406 families 
        in 5 years.
Touching the Lives of Women and Children from Every Walk of Life
    MCH clients are as diverse as the country itself. MCH programs 
serve families in urban, suburban, rural, and frontier settings.
    Many MCH clients are ``special populations,'' those that face 
severe health problems and access issues to needed health care. They 
include children with complex health care needs, the under- and 
uninsured, American Indian and Alaska Natives, migrant and seasonal 
workers, immigrants, and racial and ethnic minorities.
      Pennsylvania's MCH program has partnered with the Pennsylvania 
        Chapter of the American Academy of Pediatrics on the Educating 
        Practices in Community Integrated Care (EPIC-IC) Medical Home 
        Training Program. Between Oct. 2006 to Feb. 2007, the EPIC IC 
        program has prevented over 200 hospitalizations and almost 700 
        emergency doctor visits from. Future cost benefit modeling with 
        parent and insurance data can translate this savings into real 
        time dollars. In addition, care coordination and the EPIC IC 
        program has favorably impacted the quality of life of both 
        parents and children and youth with special health care needs 
        by preventing almost 400 missed school days and over 250 
        parental work days missed.
maternal and child health programs work hand in hand with medicaid and 
  schip. the health and continuity of our programs are vital to their 

                        CONTINUED EFFECTIVENESS

    AMCHP represents the State public health leaders and others working 
to assure that all women, children and families receive quality health 
care. MCH programs provide services and supports that augment Medicaid 
and SCHIP coverage and ensure eligible women and children access to 
needed services. MCH programs work with other programs such as WIC, 
community health providers, Head Start and schools to make referrals to 
Medicaid and SCHIP programs. They also train public health workers who 
inform families about the availability of Medicaid and SCHIP and how to 
apply. These programs participate in the development of Medicaid and 
SCHIP policies and practice standards that help providers work with 
special populations, such as children and youth with special health 
care needs.
    Changes to Medicaid and SCHIP often have a great effect on MCH 
programs and the people they serve. As some States restrict eligibility 
for Medicaid and SCHIP, people in need look to MCH-funded services to 
meet their health care needs. This puts an increased demand on MCH 
programs to offer more services without additional funding. With the 
increasing cost of health care and tighter State budgets, States are 
examining ways to offer health care services with decreasing resources. 
It is more important than ever to maintain the necessary services for 
pregnant women, children and adolescents by using the expertise, 
creativity and resources of Medicaid, SCHIP and Title V in joint 
program planning and development.

                               CONCLUSION

    After its creation, the Title V Maternal and Child Health Block 
Grant grew from a $2.7 million program in fiscal year 1936 to a $731 
million program in fiscal year 2002 to address the developing needs of 
America's women and children. However, since then, as maternal and 
child health related needs have increased, the Block Grant funding has 
decreased. Title V remains vital as a source of flexible funding that 
allows States to meet the needs of their most vulnerable populations 
through effective, efficient and integrated programs. Increased funding 
is crucial to sustain and expand these efforts to assure quality health 
care for families and children with special health care needs.
    Please provide $750 million for the Block Grant in fiscal year 
2008. Thank you for this opportunity to provide testimony.
                                 ______
                                 
 Prepared Statement of the Association of Minority Health Professions 
                                Schools

              SUMMARY OF FISCAL YEAR 2008 RECOMMENDATIONS

    $300 million for the Title VII Health Professions Training 
Programs, including:
  --$33.6 million for the minority centers of excellence.
  --$35.6 million for the health careers opportunity program.
    $250 million for the National Institutes of Health's National 
Center on Minority Health and Health Disparities.
    Support for the National Center for Research Resources Extramural 
Facilities Construction program.
  --$6.7 percent increase for Research Centers for Minority 
        Institutions.
  --$119 million for extramural facilities construction.
    $65 million for the Department of Health and Human Services' Office 
of Minority Health.
    $65 million for the Department of Education's Strengthening 
Historically Black Graduate Institutions program.
    Mr. Chairman and members of the subcommittee, thank you for the 
opportunity to present my views before you today. I am Dr. Barbara 
Hayes, president of the Association of Minority Health Professions 
Schools (AMHPS) and the dean of the school of pharmacy at Texas 
Southern University. AMHPS, established in 1976, is a consortium of our 
Nation's 12 historically black medical, dental, pharmacy, and 
veterinary schools. The members are two dental schools at Howard 
University and Meharry Medical College; four schools of medicine at The 
Charles Drew University, Howard University, Meharry Medical College, 
and Morehouse School of Medicine; five schools of pharmacy at Florida 
A&M University, Hampton University, Howard University, Texas Southern 
University, and Xavier University; and one school of veterinary 
medicine at Tuskegee University. In all of these roles, I have seen 
firsthand the importance of minority health professions institutions 
and the Title VII Health Professions Training programs.
    Mr. Chairman, time and time again, you have encouraged your 
colleagues and the rest of us to take a look at our Nation and evaluate 
our needs over the next 10 years. I want to say that minority health 
professional institutions and the Title VII Health Professionals 
Training programs address a critical national need. Persistent and 
sever staffing shortages exist in a number of the health professions, 
and chronic shortages exist for all of the health professions in our 
Nation's most medically underserved communities. Furthermore, our 
Nation's health professions workforce does not accurately reflect the 
racial composition of our population. For example while blacks 
represent approximately 15 percent of the U.S. population, only 2-3 
percent of the Nation's health professions workforce is black. Mr. 
Chairman, I would like to share with you how your committee can help 
AMHPS continue our efforts to help provide quality health professionals 
and close our Nation's health disparity gap.
    There is a well established link between health disparities and a 
lack of access to competent healthcare in medically underserved areas. 
As a result, it is imperative that the Federal Government continue its 
commitment to minority health profession institutions and minority 
health professional training programs to continue to produce healthcare 
professionals committed to addressing this unmet need.
    An October 2006 study by the Health Resources and Services 
Administration (HRSA), entitled ``The Rationale for Diversity in the 
Health Professions: A Review of the Evidence'' found that minority 
health professionals serve minority and other medically underserved 
populations at higher rates than non-minority professionals. The report 
also showed that; minority populations tend to receive better care from 
practitioners who represent their own race or ethnicity, and non-
English speaking patients experience better care, greater 
comprehension, and greater likelihood of keeping follow-up appointments 
when they see a practitioner who speaks their language. Studies have 
also demonstrated that when minorities are trained in minority health 
profession institutions, they are significantly more likely to: (1) 
serve in rural and urban medically underserved areas, (2) provide care 
for minorities and (3) treat low-income patients.
    As you are aware, Title VII Health Professions Training programs 
are focused on improving the quality, geographic distribution and 
diversity of the healthcare workforce in order to continue eliminating 
disparities in our Nation's healthcare system. These programs provide 
training for students to practice in underserved areas, cultivate 
interactions with faculty role models who serve in underserved areas, 
and provide placement and recruitment services to encourage students to 
work in these areas. Health professionals who spend part of their 
training providing care for the underserved are up to 10 times more 
likely to practice in underserved areas after graduation or program 
completion.
    Institutions that cultivate minority health professionals, like the 
AMHPS members, have been particularly hard-hit as a result of the cuts 
to the Title VII Health Profession Training programs in fiscal year 
2006 and fiscal year 2007 Funding Resolution passed earlier this 
Congress. Given their historic mission to provide academic 
opportunities for minority and financially disadvantaged students, and 
healthcare to minority and financially disadvantaged patients, minority 
health professions institutions operate on narrow margins. The cuts to 
the Title VII Health Professions Training programs amount to a loss of 
core funding at these institutions and have been financially 
devastating.
    In fiscal year 2008, funding for the Title VII Health Professions 
Training programs must be restored to the fiscal year 2005 level of 
$300 million, with two programs--the Minority Centers of Excellence 
(COEs) and Health Careers Opportunity Program (HCOPs)--in particular 
need of a funding restoration. In addition, the National Institutes of 
Health (NIH)'s National Center on Minority Health and Health 
Disparities (NCMHD), as well as the Department of Health and Human 
Services (HHS)'s Office of Minority Health (OMH), are both in need of a 
funding increase.
Minority Centers of Excellence
    COEs focus on improving student recruitment and performance, 
improving curricula in cultural competence, facilitating research on 
minority health issues and training students to provide health services 
to minority individuals. COEs were first established in recognition of 
the contribution made by four historically black health professions 
institutions (the Medical and Dental Institutions at Meharry Medical 
College; The College of Pharmacy at Xavier University; and the School 
of Veterinary Medicine at Tuskegee University) to the training of 
minorities in the health professions. Congress later went on to 
authorize the establishment of ``Hispanic'', ``Native American'' and 
``Other'' Historically black COEs.
    Presently the statute is configured in such a way that the 
``original four'' institutions compete for the first $12 million in 
funding, ``Hispanic and Native American'' institutions compete for the 
next $12 million, and ``Other'' institutions can compete for grants 
when the overall funding is above $24 million. For funding above $30 
million all eligible institutions can compete for funding.
    However, as a consequence of limited funding for COEs in fiscal 
year 2006 and fiscal year 2007, ``Hispanic and Native American'' and 
``Other'' COEs have lost their support. Out of 34 total COEs in fiscal 
year 2005, only 4 now remain due to the cuts in funding. Many AMHPS 
institutions lost its COE funding as well, which was a devastating blow 
to our institutions.
    For fiscal year 2008, I recommend a funding level of $33.6 million 
for COEs.
Health Careers Opportunity Program (HCOP)
    HCOPs provide grants for minority and non-minority health 
profession institutions to support pipeline, preparatory and recruiting 
activities that encourage minority and economically disadvantaged 
students to pursue careers in the health professions. Many HCOPs 
partner with colleges, high schools, and even elementary schools in 
order to identify and nurture promising students who demonstrate that 
they have the talent and potential to become a health professional.
    Collectively, the absence of HCOPs will substantially erode the 
number of minority students who enter the health professions. Over the 
last three decades, HCOPs have trained approximately 30,000 health 
professionals including 20,000 doctors, 5,000 dentists and 3,000 public 
health workers. If HCOPs continue to lose Federal support, then these 
numbers will drastically decrease. It is estimated that the number of 
minority students admitted to health professional schools will drop by 
25-50 percent without HCOPs. A reduction of just 25 percent in the 
number of minority students admitted to medical school will produce 
approximately 600 fewer minority medical students nationwide.
    As a result of cuts in the fiscal year 2006 and fiscal year 2007 
Labor-HHS Appropriations process, only 4 out of 74 total HCOPs 
currently receive Federal funding.
    For fiscal year 2008, I recommend a funding level of $35.6 million 
for HCOPs.
national institutes of health (nih): extramural facilities construction
    Mr. Chairman, if we are to take full advantage of the recent 
funding increases for biomedical research that Congress has provided to 
NIH over the past decade, it is critical that our Nation's research 
infrastructure remain strong. The current authorization level for the 
Extramural Facility Construction program at the National Center for 
Research Resources is $250 million. The law also includes a 25 percent 
set-aside for ``Institutions of Emerging Excellence'' (many of which 
are minority institutions) for funding up to $50 million. Finally, the 
law allows the NCRR Director to waive the matching requirement for 
institutions participating in the program. We strongly support all of 
these provisions of the authorizing legislation because they are 
necessary for our minority health professions training schools.
    Unfortunately, funding for NCRR's Extramural Facility Construction 
program was completely eliminated in the fiscal year 2006 Labor-HHS 
bill, and no funding was restored in the funding resolution for fiscal 
year 2007. In fiscal year 2008, please restore funding for this program 
to its fiscal year 2004 level of $119 million, or at a minimum, provide 
funding equal to the fiscal year 2005 appropriation of $40 million.

               RESEARCH CENTERS IN MINORITY INSTITUTIONS

    The Research Centers at Minority Institutions program (RCMI) at the 
National Center for Research Resources has a long and distinguished 
record of helping our institutions develop the research infrastructure 
necessary to be leaders in the area of health disparities research. 
Although NIH has received unprecedented budget increases in recent 
years, funding for the RCMI program has not increased by the same rate. 
Therefore, the funding for this important program grow at the same rate 
as NIH overall in fiscal year 2008.

 STRENGTHENING HISTORICALLY BLACK GRADUATE INSTITUTIONS--DEPARTMENT OF 
                               EDUCATION

    The Department of Education's Strengthening Historically Black 
Graduate Institutions program (Title III, Part B, section 326) is 
extremely important to AMHPS. The funding from this program is used to 
enhance educational capabilities, establish and strengthen program 
development offices, initiate endowment campaigns, and support numerous 
other institutional development activities. In fiscal year 2008, an 
appropriation of $65 million (an increase of $7 million over fiscal 
year 2007) is suggested to continue the vital support that this program 
provides to historically black graduate institutions.
National Center on Minority Health and Health Disparities
    The National Center on Minority Health and Health Disparities 
(NCMHD) is charged with addressing the longstanding health status gap 
between minority and nonminority populations. The NCMHD helps health 
professional institutions to narrow the health status gap by improving 
research capabilities through the continued development of faculty, 
labs, and other learning resources. The NCMHD also supports biomedical 
research focused on eliminating health disparities and develops a 
comprehensive plan for research on minority health at the NIH. 
Furthermore, the NCMHD provides financial support to health professions 
institutions that have a history and mission of serving minority and 
medically underserved communities through the Minority Centers of 
Excellence program.
    For fiscal year 2008, I recommend a funding level of $250 million 
for the NCMHD.
Department of Health and Human Services' Office of Minority Health
    Specific programs at OMH include:
    (1) Assisting medically underserved communities with the greatest 
need in solving health disparities and attracting and retaining health 
professionals,
    (2) Assisting minority institutions in acquiring real property to 
expand their campuses and increase their capacity to train minorities 
for medical careers,
    (3) Supporting conferences for high school and undergraduate 
students to interest them in health careers, and
    (4) Supporting cooperative agreements with minority institutions 
for the purpose of strengthening their capacity to train more 
minorities in the health professions.
    The OMH has the potential to play a critical role in addressing 
health disparities. Unfortunately, the OMH does not yet have the 
authority or resources necessary to support activities that will truly 
make a difference in closing the health gap between minority and 
majority populations.
    For fiscal year 2008, I recommend a funding level of $65 million 
for the OMH.
    Mr. Chairman, please allow me to express my appreciation to you and 
the members of this subcommittee. With your continued help and support, 
AMHPS's member institutions and the Title VII Health Professions 
Training programs can help this country to overcome health and 
healthcare disparities. Congress must be careful not to eliminate, 
paralyze or stifle the institutions and programs that have been proven 
to work. The Association seeks to close the ever widening health 
disparity gap. If this subcommittee will give us the tools, we will 
continue to work towards the goal of eliminating that disparity 
everyday.
    Thank you, Mr. Chairman, and I welcome every opportunity to answer 
questions for your records.
                                 ______
                                 
    Prepared Statement of the Association for Psychological Science

                       SUMMARY OF RECOMMENDATIONS

    As a member of the Ad Hoc Group for Medical Research Funding, APS 
recommends $30.8 billion for NIH in fiscal year 2008, a 6.7 percent 
increase.
    APS requests committee support for establishing behavioral and 
social science research and training as a core priority at NIH in order 
to: better meet the Nation's health needs, many of which are behavioral 
in nature; realize the exciting scientific opportunities in behavioral 
and social science research, and; accommodate the changing nature of 
science, in which new fields and new frontiers of inquiry are rapidly 
emerging.
    Given the critical role of basic behavioral science research and 
training in addressing many of the Nation's most pressing public health 
needs, we ask the committee to (1) require NIMH to coordinate its 
efforts with other Institutes to ensure that these and related areas 
are adequately supported at NIH; and (2) request a report from NIH 
outlining a structure for basic behavioral science within NIGMS.
    APS encourages the committee to review behavioral science 
activities at a number of individual institutes. Examples are provided 
in this testimony to illustrate the exciting and important behavioral 
and social science work being supported at NIH.
    Mr. Chairman, members of the committee: As our organization's name 
indicates, APS is dedicated to all areas of scientific psychology, in 
research, application, teaching, and the improvement of human welfare. 
Our 18,000 members are scientists and educators at the Nation's 
universities and colleges, conducting NIH-supported basic and applied, 
theoretical and clinical research. They look at such things as: the 
connections between emotion, stress, and biology and the impact of 
stress on health; they look at how children grow, learn, and develop; 
they use brain imaging to explore thinking and memory and other aspects 
of cognition; they develop ways to manage debilitating chronic 
conditions such as diabetes and arthritis as well as depression and 
other mental disorders; and they address the behavioral aspects of 
smoking and drug and alcohol abuse. Still others look at how genes and 
the environment influence behavioral traits such as aggression and 
anxiety; the development of a normative model of vision to understand 
how it is used in behavior; and the study of the behavioral and neural 
mechanisms of sound localization.
    As a member of the Ad Hoc Group for Medical Research Funding, APS 
recommends $30.8 billion for NIH in fiscal year 2008, an increase of 
6.7 percent over the fiscal year 2007 Joint Funding Resolution level. 
This increase would halt the erosion of the Nation's public health 
research enterprise, and help restore momentum to our efforts to 
improve the health and quality of life of all Americans.
    Within the NIH budget, APS is particularly focused on behavioral 
and social science research and the central role of behavior in health. 
The remainder of this testimony concerns the status of those areas of 
research at NIH.

       BASIC AND APPLIED PSYCHOLOGICAL RESEARCH RELATED TO HEALTH

    Behavior is an indelible part of health. Many leading health 
conditions--heart disease; stroke; lung disease and certain cancers; 
obesity; AIDS, suicide; teen pregnancy, drug abuse and addiction, 
depression and other mental illnesses; neurological disorders; 
alcoholism; violence; injuries and accidents--originate in behavior and 
can be prevented or controlled through behavior. As just one example, 
stress is something we all feel in our daily lives, and we now have a 
growing body of research that illustrates the direct link between 
stress and health: chronic stress accelerates not only the size but 
also the strength of cancer tumors; mounting evidence indicates that 
chronic stressors weaken the immune system to the point where the heart 
is damaged, paving the way for cardiac disease; children who are 
genetically vulnerable to anxiety and who are raised by stressed 
parents are more likely to experience more anxiety and stress later in 
life; animal research has shown that stress interferes with working 
memory; and stressful interactions may contribute to systemic 
inflammation in older adults which in turn may maintain negative 
emotion and pain over time.
    None of the conditions or diseases described above can be fully 
understood without an awareness of the behavioral and psychological 
factors involved in causing, treating and preventing them. Just as 
there exists a layered understanding, from basic to applied, of how 
molecules affect brain cancer, there is a similar spectrum for 
behavioral research. For example, before you address how to change 
attitudes and behaviors around AIDS, you need to know how attitudes 
develop and change in the first place. Or, to design targeted therapies 
for bipolar disorder, you need to know how to understand how circadian 
rhythms work as disruptions in sleeping patterns have been shown to 
worsen symptoms in bipolar patients.
    Despite the clear central role of behavior in health, behavioral 
research has not received the recognition or support needed to reverse 
the effects of behavior-based health problems in this Nation. APS asks 
that you continue to help make behavioral research more of a priority 
at NIH, both by providing maximum funding for those institutes where 
behavioral science is a core activity, by encouraging NIH to advance a 
model of health that includes behavior in its scientific priorities, 
and by encouraging stable support for basic behavioral science research 
at NIH.

    BASIC BEHAVIORAL SCIENCE RESEARCH NEEDS A STABLE INFRASTRUCTURE

    Broadly defined, behavioral research explores and explains the 
psychological, physiological, and environmental mechanisms involved in 
functions such as memory, learning, emotion, language, perception, 
personality, motivation, social attachments, and attitudes. Within 
this, basic behavioral research aims to understand the fundamental 
nature of these processes in their own right, which provides the 
foundation for applied behavioral research that connects this knowledge 
to real-world concerns such as disease, health, and life stages. We are 
sorry to have to tell you that basic behavioral research is not faring 
well at NIH, a circumstance that jeopardizes the success of the entire 
behavioral research enterprise. Let us describe the current situation:
    Traditionally, the National Institute of Mental Health (NIMH) has 
been the home for far more basic behavioral science than any other 
institute. Many basic behavioral and social questions were being 
supported by NIMH, even if their answers could also be applied to other 
institutes. Recently, NIMH has begun to aggressively reduce its support 
for many areas of the most basic behavioral research, in favor of 
translational and clinical research. This means that previously funded 
areas now are not being supported.
    NIMH's abrupt decision to narrow its portfolio came without 
adequate planning and is happening at the expense of critical basic 
behavioral research. We favor a broader spectrum of support for basic 
behavioral science across NIH as appropriate and necessary for a vital 
research enterprise. But until other Institutes have the capacity to 
support more basic behavioral science research connected to their 
missions, programs of research in fundamental behavioral phenomena such 
as cognition, emotion, psychopathology, perception, and development, 
will continue to languish. The existing conditions for basic behavioral 
science research undermine the scientific community's efforts to 
address many of the Nation's most pressing public health needs. We ask 
the committee to require NIMH to coordinate its efforts with other 
Institutes to ensure that these areas are adequately supported at NIH.

         NIGMS SHOULD SUPPORT BASIC BEHAVIORAL SCIENCE RESEARCH

    The situation at NIMH underscores the need for a dependable 
``home'' for basic behavioral science research and training at NIH. In 
fact, that is the recommendation of the NIH Director's own Working 
Group on Research Opportunities in the Basic Behavioral and Social 
Sciences, which also recommended the National Institute of General 
Medical Sciences (NIGMS), known as NIH's ``basic research institute.'' 
Congress has given NIGMS a statutory mandate [TITLE 42, CHAPTER 6A, 
SUBCHAPTER III, Part C, subpart 11, Sec. 285k] to support basic 
behavioral research and training, but that mandate has not been 
fulfilled.
    As early as fiscal year 2000, this committee, along with your 
colleagues in the House, has repeatedly issued report language urging 
NIGMS to fund basic behavioral research and training, saying, for 
example: ``There is a range of basic behavioral research and training 
that the institute could support, such as the fundamental relationships 
between the brain and behavior, basic cognitive processes such as 
motivation, learning, and information processing, and the connections 
between mental processes and health. The committee encourages NIGMS to 
support basic behavioral research and training and to consult with the 
behavioral science research community and other Institutes to identify 
priority research and training areas.'' [House Fiscal Year 2000 
Appropriations Report 106-370]
    As a result of meetings between NIH Deputy Director Raynard Kington 
and Representatives Kennedy and Baird, the NIH Director commissioned a 
panel of outside experts in 2004 to study the matter. This Working 
Group, which was convened under the auspices of the NIH Director's 
Advisory Council, spent a year assessing the state of basic behavioral 
research throughout NIH. In its final report to NIH, the Working Group 
formally recommended the establishment of a secure and stable home for 
basic behavioral science research and training at NIH. In particular, 
it suggested that an Institute such as NIGMS should be that home, as 
this committee, the Institute of Medicine, and the National Academy of 
Sciences have recommended. NIH has deflected this request, made by 
multiple entities, time and time again. In view of the fact that 8 of 
the 10 leading causes of death have a significant behavioral component 
and that basic research is the underpinning of advances in applied 
behavioral research, the continued lack of focus of scientific 
leadership at NIH for this important field of science is counter to the 
interests of the Nation's health needs.
    Basic behavioral research in the cognitive, psychological, and 
social processes underlying substance abuse and addiction (significance 
for NIDA, NIAAA, NCI and NHLBI), obesity (significance for NIDDK, 
NHLBI, and NICHD) and the connections between the brain and behavior 
(significance for NIMH, NINDS, and NHGRI) just to name a few, all are 
within the NIGMS mission. Greater involvement between the behavioral 
science community and NIGMS is an alliance that can reap enormous 
benefits for NIGMS, for behavioral science, for medical science, and 
for the public welfare. It is our feeling that the time is ripe for 
NIGMS to provide a supportive home for the kinds of basic behavioral 
science research that will be critical to fulfilling the NIGMS mission 
in the coming years. Given the statutory mandate, the recommendations 
of a recent Director's advisory council's task force, the strong 
congressional interest, the recommendations of the National Academy of 
Sciences and the Institute of Medicine, the scientific imperative, and 
most important, the health needs of the Nation, APS asks the committee 
to request the Office of the Director to submit to the committee a 
report indicating the structure for scientific leadership for this 
important field within the appropriate grant making institute, by 
November 16, 2007.

                  BEHAVIORAL SCIENCE AT KEY INSTITUTES

    In the remainder of this testimony, we highlight examples of 
cutting-edge behavioral science research being supported by individual 
institutes.
    National Institute of Mental Health (NIMH).--In addition to our 
earlier discussion of NIMH, we would like to give special recognition 
to the Institute's support of the emerging field of Social 
Neuroscience, which investigates the interaction of biological 
mechanisms and social processes and behavior. We commend NIMH for 
making this a priority. Elucidating the complex interplay between brain 
and social behavior will help us better understand and treat mental 
disorders such as autism and schizophrenia, and will lead to cognitive 
therapies for treating the emotion dysregulation associated with post-
traumatic stress, depression, and cardiovascular disease.
    National Institute on Drug Abuse (NIDA).--By supporting a 
comprehensive research portfolio that stretches across basic 
neuroscience, behavior, and genetics, NIDA is leading the Nation to a 
better understanding and treatment of drug abuse. Risky Decision-Making 
and HIV/AIDS-NIDA-funded research is examining every aspect of the 
transmission of HIV/AIDS through drug abuse and addiction, including 
risk-taking behaviors associated with both injection and non-injection 
drug abuse, how drugs of abuse alter brain function and impair decision 
making, and HIV prevention and treatment strategies for diverse groups. 
The goal is to achieve a broad understanding of the multiple ways that 
drug abuse and addiction affect HIV/AIDS and how research can inform 
public health policy. APS asks this committee to support this and other 
critical behavioral science research at NIDA, and to increase NIDA's 
budget in proportion to the overall increase at NIH in order to reduce 
the health, social and economic burden resulting from drug abuse and 
addiction in this Nation.
    It's not possible to highlight all of the worthy behavioral science 
research programs at NIH. In addition to those reviewed in this 
statement, many other institutes play a key role in NIH behavioral 
science research enterprise. These include the National Institute on 
Alcohol Abuse and Alcoholism, the National Cancer Institute, the 
National Institute for Child Health and Human Development, the National 
Institute on Aging, the National Heart, Lung, and Blood Institute, and 
the National Institute of Diabetes and Digestive and Kidney Diseases. 
Behavioral science is a central part of the mission of these 
institutes, and their behavioral science programs deserve the 
committee's strongest possible support.
    This concludes our testimony. Again, thank you for the opportunity 
to discuss NIH appropriations for fiscal year 2008 and specifically, 
the importance of behavioral science research in addressing the 
Nation's public health concerns. We would be pleased to answer any 
questions.
                                 ______
                                 
   Prepared Statement of the Association for Research in Vision and 
                          Ophthalmology (ARVO)

                           EXECUTIVE SUMMARY

    ARVO requests fiscal year 2008 NIH funding at $31 billion, or a 6.7 
percent increase over fiscal year 2007, to balance the biomedical 
inflation rate of 3.7 percent and to maintain the momentum of 
discovery. Although ARVO commends the leadership's actions in the 110th 
Congress to increase fiscal year 2007 NIH funding by $620 million, this 
was just an initial step in restoring the NIH's purchasing power, which 
has declined by more than 13 percent since the budget doubling ended in 
fiscal year 2003. That power would be eroded even further under the 
President's proposed fiscal year 2008 budget. ARVO commends NIH 
Director Dr. Zerhouni, who has articulately described his agenda to 
foster collaborative, cost-effective research and to transform the 
healthcare research and delivery paradigm into one that is predictive, 
preemptive, preventive, and personalized. NIH is the world's premier 
institution and must be adequately funded so that its research can 
reduce healthcare costs, increase productivity, improve quality of 
life, and ensure our Nation's global competitiveness.
    ARVO requests that Congress make vision health a top priority by 
funding the NEI at $711 million in fiscal year 2008, or a 6.7 percent 
increase over fiscal year 2007. This level is necessary to fully 
advance the breakthroughs resulting from NEI's basic and clinical 
research that are resulting in treatments and therapies to prevent eye 
disease and restore vision. Vision impairment/eye disease is a major 
public health problem that is growing and which disproportionately 
affects aging and minority populations, costing the United States $68 
billion annually in direct/societal costs, reduced independence, and 
quality of life. NEI funding is a cost-effective investment in our 
Nation's health, as it can delay and prevent expenditures, especially 
to the Medicare and Medicaid programs.
    Adequate NEI funding is also essential to a strong and vibrant 
research community, which risks losing established investigators. The 
flat funding in recent years may cause young investigators to pursue 
other careers and thus fail to keep the research pipeline strong. ARVO 
is especially concerned about the impact on clinician scientists who 
have been so instrumental to the NEI's successful track record of the 
translations of basic research into clinical applications that directly 
benefit the American people.

                               ABOUT ARVO

    ARVO is the world's largest association of physicians and 
scientists who study diseases and disorders affecting vision and the 
eye. ARVO has more than 11,700 members from the United States and 70 
countries, and some 80 percent of U.S. members have grants from the 
National Eye Institute. It is in that regard that ARVO submits these 
comments in support of increased fiscal year 2008 NIH and NEI funding.
funding the nei at $711 million in fiscal year 2008 enables it to lead 

 TRANS-INSTITUTE VISION RESEARCH THAT MEETS NIH'S GOAL OF PREEMPTIVE, 
          PREDICTIVE, PREVENTIVE, AND PERSONALIZED HEALTHCARE

    Funding NEI at $711 million in fiscal year 2008 represents the eye 
and vision research community's judgment as that necessary to fully 
advance breakthroughs resulting from NEI's basic and clinical research 
that are resulting in treatments and therapies to prevent eye disease 
and restore vision.
    NEI research responds to the NIH's overall major health challenges, 
as set forth by Dr. Zerhouni: an aging population; health disparities; 
the shift from acute to chronic diseases; and the co-morbid conditions 
associated with chronic diseases (e.g., diabetic retinopathy). In 
describing the predictive, preemptive, preventive, and personalized 
approach to healthcare research, Dr. Zerhouni has frequently cited NEI-
funded research as tangible examples of the value of our Nation's past 
and future investment in the NIH. These include:
  --Dr. Zerhouni has cited as a breakthrough the collaborative Human 
        Genome Project/NEI-funded discovery of gene variants strongly 
        associated with an individual's risk of developing age-related 
        macular degeneration (AMD), the leading cause of blindness 
        (affecting more than 10 million Americans) which increasingly 
        robs seniors of their independence and quality of life. These 
        variants, which are responsible for about 60 percent of the 
        cases of AMD, are associated with the body's inflammatory 
        response and may relate to other inflammation-associated 
        diseases, such as Alzheimer's and Parkinson's disease. As NEI 
        Director Dr. Paul Sieving has stated, ``One of the important 
        stories during the next decade will be how Alzheimer's disease 
        and macular degeneration fit together.''
  --Dr. Zerhouni has cited the NEI-funded Age-Related Eye Disease Study 
        (AREDS) as a cost-effective preventive measure. In 2006, NEI 
        began the second phase of the AREDS study, which will follow up 
        on initial study findings that high levels of dietary zinc and 
        antioxidant vitamins (Vitamins C, E and beta-carotene) are 
        effective in reducing vision loss in people at high risk for 
        developing advanced AMD--by a magnitude of 25 percent.
  --NEI has funded research, along with the National Cancer Institute 
        (NCI) and the National Heart, Lung, and Blood Institute 
        (NHLBI), into factors that promote new blood vessel growth 
        (such as Vascular Endothelial Growth Factor, or VEGF). This has 
        resulted in anti-VEGF factors that have been translated into 
        the first generation of ophthalmic drugs approved by the Food 
        and Drug Administration (FDA) to inhibit abnormal blood vessel 
        growth in ``wet'' AMD, thereby stabilizing vision loss. Current 
        research is focused on using treatments singly and in 
        combination to improve vision or prevent further vision loss 
        due to AMD. As part of its Diabetic Retinopathy Clinical 
        Research Network, NEI is also evaluating these drugs for 
        treatment of macular edema associated with diabetic 
        retinopathy.
    Although these breakthroughs came directly from the past doubling 
of the NIH budget, their long-term potential to preempt, predict, 
prevent, and treat disease relies on adequately funding NEI's follow-up 
research. Unless its funding is increased, the NEI's ability to 
capitalize on the findings cited above will be seriously jeopardized, 
resulting in ``missed opportunities'' that could include:
  --Following up on the AMD gene discovery by developing diagnostics 
        for early detection and promising therapies, as well as to 
        further study the impact of the body's inflammatory response on 
        other degenerative eye diseases.
  --Fully investigating the impact of additional, cost-effective 
        dietary supplements in the AREDS study, singly and in 
        combination, to determine if they can demonstrate enhanced 
        protective effects against progression to advanced AMD.
  --Following up with further clinical trials on patients with the 
        ``wet'' form of AMD, as well as patients with diabetic 
        retinopathy, using the new anti-angiogenic ophthalmic drugs 
        singly and in combination to halt disease progression and 
        potentially restore vision.
    In addition, NEI research into other significant eye disease 
programs, such as glaucoma and cataract, will be threatened, along with 
quality of life research programs into low vision and chronic dry eye. 
This comes at a time when the U.S. Census and NEI-funded 
epidemiological research (also threatened without adequate funding) 
both cite significant demographic trends that will increase the public 
health problem of vision impairment and eye disease.
    Adequate NEI funding is also essential to a strong and vibrant 
research community, which risks losing established investigators. The 
flat funding in recent years may cause young investigators to pursue 
other careers and thus fail to keep the research pipeline strong. ARVO 
is especially concerned about the impact on clinician scientists who 
have been so instrumental to the NEI's successful track record of the 
translations of basic research into clinical applications that directly 
benefit the American people.
vision impairment/eye disease is a major public health problem that is 

  INCREASING HEALTHCARE COSTS, REDUCING PRODUCTIVITY, AND DIMINISHING 
                            QUALITY OF LIFE

    The 2000 U.S. Census reported that more than 119 million people in 
the United States were age 40 or older, which is the population most at 
risk for an age-related eye disease. The NEI estimates that, currently, 
more than 38 million Americans age 40 and older experience blindness, 
low vision or an age-related eye disease such as AMD, glaucoma, 
diabetic retinopathy, or cataracts. This is expected to grow to more 
than 50 million Americans by year 2020. The economic and societal 
impact of eye disease is increasing not only due to the aging 
population, but to its disproportionate incidence in minority 
populations and as a co-morbid condition of other chronic disease, such 
as diabetes.
    Although the NEI estimates that the current annual cost of vision 
impairment and eye disease to the United States is $68 billion, this 
number does not fully quantify the impact of direct healthcare costs, 
lost productivity, reduced independence, diminished quality of life, 
increased depression, and accelerated mortality. The continuum of 
vision loss presents a major public health problem and financial 
challenge to both the public and private sectors.
    In public opinion polls over the past 40 years, Americans have 
consistently identified fear of vision loss as second only to fear of 
cancer. As a result, Federal funding for the NEI is a vital investment 
in the health, and vision health, of our Nation, especially our 
seniors, as the treatments and therapies emerging from research can 
preserve and restore vision. Adequately funding the NEI can delay and 
prevent expenditures, especially those associated with the Medicare and 
Medicaid programs, and is, therefore, a cost-effective investment.
    ARVO urges fiscal year 2008 NIH and NEI funding at $31 billion and 
$711 million, respectively.
                                 ______
                                 
Prepared Statement of the Association of Women's Health, Obstetric and 
                            Neonatal Nurses

    The Association of Women's Health, Obstetric and Neonatal Nurses 
(AWHONN) appreciates the opportunity to provide comments on the fiscal 
year 2008 appropriations for nursing education, research, and workforce 
development programs as well as programs designed to improve maternal 
and child health. AWHONN is a membership organization of 22,000 nurses, 
and our mission is to promote the health and well-being of all women 
and newborns. AWHONN members are registered nurses, nurse 
practitioners, certified nurse-midwives, and clinical nurse specialists 
who work in hospitals and health systems, physicians' practices, 
universities, and community clinics throughout the United States.

             DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS)

AWHONN recommends $1 million in fiscal year 2008 funding to convene a 
        Surgeon General's conference on preterm birth
    Premature birth is the leading cause of neonatal death. Each year, 
an estimated 1 in 8 births is premature. A 2006 report by the Institute 
of Medicine found that the annual economic burden associated with 
preterm birth is at least $26.2 billion. This translates to $51,600 per 
preterm infant. The PREEMIE Act (Public Law 109-450) authorized funding 
to convene a Surgeon General's conference to establish a public-private 
research and education agenda to accelerate the development of new 
strategies for preventing preterm birth. This Surgeon General's 
conference is a critical step in reducing this growing challenge.

          HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)

AWHONN recommends a minimum of $7.5 billion in funding for HRSA
    AWHONN is deeply concerned by the President's budget request, which 
eliminates 12 programs and cuts over $200 million from the Federal 
funds HRSA received in 2007. Through its many programs and new 
initiatives, HRSA provides for the Nation's most vulnerable citizens. 
Rapid advances in research and technology promise unparalleled change 
in the Nation's health care delivery system. In order to take 
reasonable advantage of these opportunities, HRSA will require an 
overall funding level of at least $7.5 billion for fiscal year 2008.

     TITLE VIII--NURSING WORKFORCE DEVELOPMENT PROGRAMS UNDER HRSA

AWHONN recommends a minimum of $200 million in funding for Title VIII
    Nursing workforce development programs authorized under Title VIII 
of the Public Health Service Act, are an essential component of the 
American health care safety net. Title VIII programs are the only 
comprehensive Federal programs that provide annual funds for nursing 
education. These funds help nursing schools and students prepare to 
meet changing patient needs and provide clinical education to promote 
practice in medically underserved communities and Health Professional 
Shortage Areas.
    The President's budget recommends a 30 percent reduction in funding 
at $105 million for fiscal year 2008, despite the worsening nursing 
shortage. AWHONN believes a minimum of $200 million is needed to 
adequately fund in funding for Title VIII Nursing Workforce 
Development. In addition, AWHONN supports funding the Advanced 
Education Nursing Training Program (sec. 811) at an increased level on 
par with other Title VIII programs in fiscal year 2008.
    In 2002, Congress enacted the Nurse Reinvestment Act, which 
provides funding for programs such as the Nurse Education Loan 
Repayment Program (NELRP), internships and residencies, retention 
programs, and faculty loans designed to encourage students to consider 
nursing, retain nurses, and increase nurse educators. These new 
programs received an initial appropriation of $20 million in fiscal 
year 2003, in addition to $93 million provided for existing Title VIII 
programming. Inadequate funding stunted the potential of loan and 
scholarship programs and limited the support to nursing students. For 
example, NELRP is a competitive program that repays 60 percent of the 
qualifying loan balance of registered nurses selected for funding in 
exchange for 2 years of service at a critical shortage facility. In 
fiscal year 2005, the NELRP received 4,465 applications and dispersed 
803 awards; an 18 percent award rate. In fiscal year 2006, NELRP 
assessed 4,222 applications and gave 615 awards; only a 14 percent 
award rate. The award trend is going in the wrong direction.
    Increased Funding for Title VIII Will Make a Positive Impact on the 
Nursing Shortage.--Recent data from the Bureau of Health Professions, 
Division of Nursing's The Registered Nurse Population: National Sample 
Survey of Registered Nurses, Preliminary Findings--March 2007, confirm 
that of the approximately 2.9 million registered nurses in the Nation 
only 83 percent of these nurses work full-time or part-time in nursing. 
A dominant factor in this shortage is the impending retirement of up to 
40 percent of the workforce by 2010. The average age of a nurse 
according to a 2004 sample survey is 46.8 compared to 45.2 in the 2000 
survey. This anticipated wave of retirement will occur as the needs of 
the aging baby boomer population will markedly increase demand for 
health care services and registered nurses. Also, the 2007 U.S. Bureau 
of Labor and Statistics report projected that registered nurses will 
have the largest 10-year job growth; about 1 million new job openings 
by 2010.
    The shortage of registered nurses and its effect on staffing 
levels, patient safety, and quality care demands attention and a 
significant increase in funding to bolster and improve these programs. 
Nursing is the largest health profession, yet only .2 percent of 
Federal health funding is devoted to nursing education. A significant 
increase in funding for these programs can help lay the groundwork for 
expanding the nursing workforce, through education, clinical training 
and retention programs.
    Increased Funding for Title VIII Will Help Fill the Nursing Faculty 
Gap.--AWHONN supports efforts to recruit new faculty and increase 
nursing faculty available to teach in nursing schools. Currently, 
according to the National League for Nursing, there are fewer than 
17,000 full-time faculty members. The estimated number of nurse faculty 
required to meet current demand is estimated to be 40,000 nurse 
educators. The Advanced Nurse Education funding in fiscal year 2005 
produced 11,949 graduate nursing students, who are the primary pool for 
future faculty.
    Nursing faculty continues to decrease in number as nursing school 
applications have surged more than 59 percent over the past decade. In 
a NLN survey of the 2004-2005 academic year, nursing programs at all 
degree levels turned away an estimated 147,000 qualified applications 
because of the lack of faculty. This number represents a 17.6 percent 
increase from last year's figures. Without sufficient support for 
current nursing faculty and adequate incentives to attract future 
faculty, nursing schools will fail to have the teaching infrastructure 
necessary to educate and train our next generation of nurses.
    While the capacity to implement faculty development is currently 
available through section 811 and section 831, adequate funding and 
direction is needed to ensure that these programs are fully 
operational. Options to provide support for full-time doctoral study 
are essential to rapidly prepare future nurse educators. AWHONN 
recommends that a portion of the funds be allocated for faculty 
development and mentoring.
    Funding Advanced Practice Nurses Provides Needed Faculty and 
Primary Care Providers.--Advanced Practice nurses such as nurse 
practitioners, clinical nurse specialists, certified registered nurse 
anesthetists and certified nurse midwives are essential to eliminating 
the nursing shortage. As in other professions, the advanced degree has 
become a necessary achievement for career advancement. Registered 
nurses who pursue MSN and PhD degrees often go on to become faculty and 
essential health care providers. The nursing shortage encompasses both 
advanced practice and basic nursing; each must receive additional 
funding but not at the expense of one another. In addition, advanced 
practice nurses are critical and sometimes the only available primary 
care providers, and often serve in inner city, rural and frontier 
health care settings.
    The entire nursing workforce needs strengthening. As a result, it 
will take long-term planning and innovative initiatives at the local, 
State and Federal levels to ensure an adequate supply of a qualified 
nurse workforce for the Nation. Federal investment in nursing education 
and retention programs is critical for meeting the health care needs of 
our Nation.

      TITLE V--MATERNAL AND CHILD HEALTH BUREAU (MCHB) UNDER HRSA

AWHONN recommends $731 million in funding for MCHB
    The Maternal and Child Health Bureau incorporates valuable programs 
like the Traumatic Brain Injury program, Universal Newborn Hearing 
Screening, Emergency Medical Services for Children, and Healthy Start, 
which were zeroed out, and the Maternal and Child Health Block Grant 
(MCH) that saw no funding growth from the previous year. These programs 
provide comprehensive, preventive care for mothers and young children, 
and an array of coordinated services for children with special needs. 
In fact, MCH serves over 80 percent of all infants, half of all 
pregnant women and 20 percent of all children in the United States.

                  NATIONAL INSTITUTES OF HEALTH (NIH)

AWHONN recommends a 6.7 percent increase in appropriation funding for 
        NIH
    Multiple institutes housed under the National Institutes of Health 
(NIH) serve valuable roles in helping promote the importance of nursing 
in the health care industry along with the health and well-being of 
women and newborns. AWHONN calls on Congress to implement a 6.7 percent 
increase in funding for NIH in each of the next 3 years. This funding 
will allow scientists, including nurse scientists, to continue making 
life-saving research breakthroughs and discoveries. This funding also 
is the estimated amount needed to sustain the current model of NIH 
research funding.

        NATIONAL INSTITUTE OF NURSING RESEARCH (NINR) UNDER NIH

AWHONN recommends $150 million in funding for NINR
    The National Institute of Nursing Research (NINR) engages in 
significant research affecting areas such as health disparities among 
ethnic groups, training opportunities for management of patient care 
and recovery, and telehealth interventions in rural/underserved 
populations. This research allows nurses to refine their practice and 
provide quality patient care. For example, NINR research is invaluable 
in contributing to improved health outcomes for women. Recent public 
awareness campaigns target differences in the manifestation of 
cardiovascular disease between men and women. The differing symptoms 
are the source of many missed diagnostic opportunities among women 
suffering from the disease, which is the primary killer of American 
women. Because of the emphasis on biomedical research in this country, 
there are few sources of funds for high-quality behavioral research for 
nursing other than NINR. It is critical that we increase funding in 
this area in an effort to optimize patient outcomes and decrease the 
need for extended hospitalization. While the President's budget 
recommended a decrease at $138 million, AWHONN requests $150 million 
for fiscal year 2008, consistent with the overall increase for all 
National Institutes of Health.

NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD) UNDER 
                                  NIH

AWHONN recommends $1.34 billion in funding for NICHD
    The National Institute of Child Health and Human Development 
(NICHD) seeks to ensure that every baby is born healthy, that women 
suffer no adverse consequences from pregnancy, and that all children 
have the opportunity for a healthy and productive life unhampered by 
disease or disability. For example, with increased funding, NICHD could 
expand its use of the NICHD Maternal-Fetal Medicine Network to study 
ways to reduce the incidence of low birth weight. Prematurity/low birth 
weight is the second leading cause of infant mortality and the leading 
cause of death among African American infants. AWHONN is directly 
involved in programs to improve the health of women and newborns and 
looks to NICHD to provide national initiatives that assist with the 
care of pregnant women and babies. AWHONN suggests a 6.7 percent 
increase in NICHD funding to $1.34 billion.

 NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES (NIEHS) UNDER NIH

AWHONN recommends $673 million for NIEHS
    Research conducted by NIEHS plays a critical role in what we know 
about the relationship between environmental exposures and the onset of 
diseases. Through their research, we know that Parkinson's disease, 
breast cancer, birth defects, miscarriage, delayed or diminished 
cognitive function, infertility, asthma and many other diseases have 
confirmed environmental triggers. Our expanded knowledge, allows 
policymakers and the public to make important decisions about how to 
reduce toxin exposure, the risk of disease and other negative health 
outcomes. As the prevalence of infertility and related reproductive 
challenges continues to increase according to the CDC, the investment 
in improving our understanding of environmental impacts should be 
increased to $673 million.

 INDIAN HEALTH SERVICE (IHS) UNDER THE DEPARTMENT OF HEALTH AND HUMANS 
                             SERVICES (HHS)

AWHONN recommends $3.5 billion in funding for IHS
    The Indian Health Service (IHS) is the principal Federal health 
care provider and health advocate for the American Indian and Alaska 
Native populations. The President's budget recognizes this importance 
by requesting a 6.9 percent increase of $211 million to the IHS budget, 
bringing the fiscal year 2008 total to $3.27 billion. While AWHONN 
applauds this increase, we recommend that a total of $3.5 billion is 
needed for IHS to fully achieve its legitimate goals. A recent study of 
Federal health care spending per capita found that the United States 
spends $5,065 per year for the general population, $3,803 per year for 
a Federal prisoner, and only $1,914 for a Native American. Where health 
needs continue at unprecedented levels ad the average age of nurses 
(48) is higher than for the general public. The nursing shortage has 
disproportionately affected Indian Health Services. Further, the 
average reported vacancy rate for RNs in 2006 was 18 percent. IHS 
administers three severely under-funded interrelated scholarship 
programs designed to meet the health professional staffing needs of IHS 
and other health programs serving Indian people. Targeted resources 
need to be invested in the IHS health professions programs to recruit 
and retain registered nurses.

       CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) UNDER HHS

AWHONN recommends $52 million for Safe Motherhood/Infant Health to fund 
        activities authorized by the PREEMIE Act
    This would include epidemiological studies on preterm birth, 
including the relationship between prematurity, birth defects and 
developmental disabilities.
    AWHONN thanks you for your consideration and greatly appreciates 
this opportunity to submit testimony on these critical funding areas.
                                 ______
                                 
          Prepared Statement of the Autism Society of America

    My name is Ruth Elaine Hane. I live in Minneapolis, Minnesota, 
where I facilitate a social group, the Aspie Get-Together, for adults 
with Aspergers and autism. It is a privilege to testifying on behalf of 
my self and other adults on the spectrum of autism. I appreciate 
sharing my story with strong advocates for autism, Senators Harkin, 
Specter and Durbin. Thank you, for all you do, to improve the lives of 
those affected by autism.
    Several others have given testimony to this subcommittee, 
emphasizing the needs of children with autism who are waiting for 
essential services, and I do not deny that this is a critical issue, 
but, there are others who are also waiting, adults who have aged out of 
the system after 21, and are now left without support. A portion of 
these adults benefited from the various programs for early intervention 
in the past two decades, but are lacking employment and life skills to 
live independently. Many are sitting at home in front of their parent's 
computer or television screen without the quality of life they were 
promised.
    I was born with autism, sometimes referred to as a ``Rubella 
baby,'' since my mother had a severe case of Rubella Measles during her 
pregnancy with me. A delivery using forceps injured and distorted my 
head. I screamed for continuously, could not swallow or tolerate touch. 
My mother was advised by her doctor, not to become attached to her baby 
girl, because there was little hope of my survival, and, even if I did, 
I would never be normal. But, I did live, because of a community of 
neighbors who problem solved, volunteered, and taught my mother how to 
care for me. The bases of their practical advice came from sheep 
ranching, and the methods they used to nurture baby lambs who were born 
with neurological problems like mine . . . to wrap me tightly in a warm 
blanket, place me in a box set on the slightly warmed oven door and to 
drip goat's milk into my mouth. Since the sound of ticking clock calmed 
me, it was placed near the box. I was not to be clothed, or disturbed 
for 3 hours at a time. Over time, I began to grow, however I did not 
acclimate to touch, or learn to coo, or respond to others.
    I identified with cats and not people, and did not talk until I was 
4 years old. The small town where we lived accepted me as an 
``unusual'' child who was stubborn, independent, and overly active, 
skipping, twirling, and singing to herself. Autism was not well-known 
by the doctors at that time. My grandmother, who was a school teacher, 
stepped in to give me love, taught me manners and structured learning. 
I graduated with honors from college, married and had two children, who 
are now grown. My second husband and I are grandparents. Presently, I 
volunteer in the community and serve as First vice Chair on the 
national board, of the Autism Society of America. I consult with 
sensitive people, many of whom are on the spectrum of autism.
    My message is that most adults with autism are greatly underserved. 
Autism is sometimes called hidden, because many people like me look 
normal. Some, have learned to accommodate, to pretend to be normal, 
but, others have odd social communication and behaviors especially when 
there are stressful situations, such as loud noise, flashing emergency 
lights, florescent lighting, confusing verbal directions and poor signs 
in public places. Since our brains are unable to processes the incoming 
information in a timely way, we are put a risk socially, sometimes 
hurt, bullied, raped or even killed. Depression is common with little 
hope of living a productive independent life, even though many are 
educated, with college degrees, and some with graduate and doctoral 
degrees.
    After I was diagnosed, as an adult, with High Functioning autism, I 
became active in the local Autism Society of America, Minnesota State 
Chapter. In 1999, several young adults on the spectrum asked if I would 
organize and facilitate a group for people diagnosed with Aspergers and 
autism. They wanted a place to socialize and meet friends. I formed the 
Aspic Get-Together.
    The Aspic Get-Together is an all voluntary group of mostly young 
adults, run and governed by the participants. Since most of our members 
are unemployed or under employed, the nominal membership dues are often 
waived. We are limited in the activities that we can do because of this 
lack of funding. However it is a demonstration of how people who are 
often marginalized and at times, ostracized, because of a difference in 
social skills, can become, productive members of a group, and, of 
society at large if given structure, guidance and the opportunity to be 
themselves.
    Those with autism, who are living with their parents, are under a 
cloud of uncertainty with parents who are aging, anguishing about the 
future of their dependent adult with autism. With our population 
shifting toward a nuclear family unit, we can no longer depend on the 
extended family to fill in this gap. We need appropriations to fund 
services to change this grave situation in America. With applied 
research, job and life skills training, community building and mentors, 
who could provide several hours of weekly planning and guidance, so 
that the underserved people with autism could work, lead productive 
lives and contribute to society in unique and beneficial ways. In 
addition, there are those who are profoundly affected by autism, who 
need 24 hours a day of assistance and supervision. The best and most 
successful programs today, are based on empowering the individual to 
make personal choices, allowing for, as much independence as is 
possible. Without exception, these providers are under funded.
    Although those of us with autism diagnoses are directly affected by 
choices others make about and for us, our voice is seldom heard.
    I dream of a society that embraces difference of all kinds, 
including autism, and a society that listens to those with autism--who 
can speak.
    Please remember to include us so that there is . . . Nothing about 
us . . . without us.
    Thank you.
                                 ______
                                 
 Prepared Statement of the Centers for Disease Control and Prevention 
                               Coalition

    The CDC Coalition is a nonpartisan coalition of more than 100 
groups committed to strengthening our Nation's prevention programs. Our 
mission is to ensure that health promotion and disease prevention are 
given top priority in Federal funding, to support a funding level for 
the Centers for Disease Control and Prevention (CDC) that enables it to 
carry out its prevention mission, and to assure an adequate translation 
of new research into effective State and local programs. Coalition 
member groups represent millions of public health workers, researchers, 
educators, and citizens served by CDC programs.
    The CDC Coalition believes that Congress should support CDC as an 
agency--not just the individual programs that it funds. In the best 
judgment of the CDC Coalition--given the challenges and burdens of 
chronic disease, a potential influenza pandemic, terrorism, disaster 
preparedness, new and reemerging infectious diseases, increasing drug 
resistance to critically important antimicrobial drugs and our many 
unmet public health needs and missed prevention opportunities--we 
believe the agency will require funding of at least $10.7 billion 
including sufficient funding to prepare the Nation against a potential 
influenza pandemic, funding for the Agency for Toxic Substances and 
Disease Registry and to maintain the current funding level for the 
Vaccines for Children (VFC) program. This request does not include any 
additional funding that may be required to expand the mandatory VFC in 
fiscal year 2008.
    The CDC Coalition appreciates the subcommittee's work over the 
years, including your recognition of the need to fund chronic disease 
prevention, infectious disease prevention and treatment, and 
environmental health programs at CDC. Federal funding through CDC 
provides the foundation for our State and local public health 
departments, supporting a trained workforce, laboratory capacity and 
public health education communications systems.
    CDC also serves as the command center for our Nation's public 
health defense system against emerging and reemerging infectious 
diseases. With the potential onset of a worldwide influenza pandemic, 
in addition to the many other natural and man-made threats that exist 
in the modern world, the CDC has become the Nation's--and the world's--
expert resource and response center, coordinating communications and 
action and serving as the laboratory reference center. States and 
communities rely on CDC for accurate information and direction in a 
crisis or outbreak.
    CDC's budget has actually shrunk since 2005 in terms of real 
dollars--by almost 4 percent. If you add inflation, the cuts are even 
worse--and these are cuts to the core programs of the agency. The 
current administration request for fiscal year 2008 is inadequate, with 
a total cut to core budget categories from fiscal year 2005 to fiscal 
year 2008 of half a billion dollars. We are moving in the wrong 
direction, especially in these challenging times when public health is 
being asked to do more, not less. It simply does not make any sense to 
cut the budget for CDC core public health programs at a time when the 
threats to public health are so great. Funding public health outbreak 
by outbreak is not an effective way to ensure either preparedness or 
accountability. Until we are committed to a strong public health 
system, every crisis will force trade offs.
    CDC serves as the lead agency for bioterrorism preparedness and 
must receive sustained support for its preparedness programs in order 
for our Nation to meet future challenges. In the best judgment of CDC 
Coalition members, given the challenges of terrorism and disaster 
preparedness, and our many unmet public health needs and missed 
prevention opportunities, we support the proposed increase for anti-
terrorism activities at CDC, including the increases for the Strategic 
National Stockpile. However, we strongly oppose the President's 
proposed $125 million cut to the State and local capacity grants. We 
ask the subcommittee to restore these cuts to ensure that our States 
and local communities can be prepared in the event of an act of 
terrorism or other public health threat.
    Public health programs delivered at the State and local level 
should be flexible to respond to State and local needs. Within an 
otherwise-categorical funding construct, the Preventive Health and 
Health Services (PHHS) Block Grant is the only source of flexible 
dollars for States and localities to address their unique public health 
needs. The track record of positive public health outcomes from PHHS 
Block Grant programs is strong, yet so many requests go unfunded. 
However, the President's budget once again proposes the elimination of 
the PHHS Block Grant. We greatly appreciate the work of the 
subcommittee to at least partially restore the fiscal year 2007 
elimination of the Block Grant. Nevertheless, the cut to the Block 
Grant in fiscal year 2006 reduces the States' ability to tailor Federal 
public health dollars to their specific needs.

                      ADDRESSING URGENT REALITIES

    Heart disease remains the Nation's No. 1 killer. In 2004, more than 
650,000 people died from heart disease, accounting for 27 percent of 
all U.S. deaths. In 1998, the U.S. Congress provided funding for CDC to 
initiate a national, state-based Heart Disease and Stroke Prevention 
Program with funding for eight States. Now, 32 States and the District 
of Columbia are funded, 19 as capacity building and 14 as basic 
implementation. We must expand these efforts to continue the gains we 
have made in combating heart disease and stroke.
    The CDC funds proven programs addressing cancer prevention, early 
detection, and care. In 2006, about 1.4 million new cases of cancer 
will be diagnosed, and about 564,830 Americans--more than 1,500 people 
a day--are expected to die of the disease. The financial cost of cancer 
is also significant. According to the National Institutes of Health, in 
2005, the overall cost for cancer in the United States was nearly $210 
billion: $74 billion for direct medical costs, $17.5 billion for lost 
worker productivity due to illness, and $118.4 billion for lost worker 
productivity due to premature death.
    Among the ways the CDC is fighting cancer, is through funding the 
National Breast and Cervical Cancer Early Detection Program that helps 
low-income, uninsured and medically underserved women gain access to 
lifesaving breast and cervical cancer screenings and provides a gateway 
to treatment upon diagnosis. CDC also funds programs to raise awareness 
about colorectal, prostate, lung, ovarian and skin cancers, and the 
National Program of Cancer Registries, a critical registry for tracking 
cancer trends in all 50 States.
    Although more than 20 million Americans have diabetes, 6.2 million 
cases are undiagnosed. From 1980-2002, the number of people with 
diabetes in the United States more than doubled, from 5.8 million to 
13.3 million. Unfortunately funding for diabetes, along with many other 
core CDC programs, has either been cut or flat funded for the past 
several years. Without additional funds, most States will not be able 
to create programs based on these new data. States also will continue 
to need CDC funding for diabetes control programs that seek to reduce 
the complications associated with diabetes.
    Over the last 25 years, obesity rates have doubled among adults and 
children, and tripled in teens. Obesity, diet and inactivity are cross-
cutting risk factors that contribute significantly to heart disease, 
cancer, stroke and diabetes. The CDC funds programs to encourage the 
consumption of fruits and vegetables, to get sufficient exercise, and 
to develop other habits of healthy nutrition and activity. In order to 
fully support these activities, we urge the subcommittee to provide at 
least $43 million for the Steps to a Healthier U.S. program and $65 
million for CDC's Division of Nutrition and Physical Activity.
    Childhood immunizations provide one of the best returns on 
investment of any public health program. Despite the incredible success 
of the program, it faces serious financial challenges. In the past 10 
years, the number of recommended childhood vaccines has jumped from 10 
to 16. Even more striking, the cost of fully vaccinating an adolescent 
female has increased from $285 to over $1,200 in past 8 years alone. 
Despite these challenges funding for vaccine purchases under section 
317 has remained stagnant. The consequence of this disconnect, is that 
while 747,000 children and adolescents could potentially receive their 
full series of vaccinations with 317 funds in 1999, that number has 
plummeted by over 70 percent to just 218,000 in 2007.
    More than 400,000 people die prematurely every year due to tobacco 
use. CDC's tobacco control efforts seek to prevent tobacco addition in 
the first place, as well as help those who want to quit. We must 
continue to support these vital programs and reduce tobacco use in the 
United States.
    Almost 80 percent of young people do not eat the recommended number 
of servings of fruits and vegetables, while nearly 30 percent of young 
people are overweight or at risk of becoming overweight. And every 
year, almost 800,000 adolescents become pregnant and about 3 million 
become infected with a sexually transmitted disease. School health 
programs are one of the most efficient means of correcting these 
problems, shaping our Nation's future health, education, and social 
well-being.
    Much of CDC's work in chronic disease prevention and health 
promotion is guided by its prevention research activities. Healthy 
Passages is a longitudinal study that is following a cohort of children 
will have to be discontinued without $6 million in additional 
appropriations. If allowed to continue, the study would follow children 
from birth through adulthood in order to discover critical links 
between risks and protective factors and health outcomes.
    CDC provides national leadership in helping control the HIV 
epidemic by working with community, State, national, and international 
partners in surveillance, research, prevention and evaluation 
activities. CDC estimates that up to 1,185,000 Americans are living 
with HIV, one-quarter of who are unaware of their infection. Prevention 
of HIV transmission is our best defense against the AIDS epidemic that 
has already killed over 500,000 U.S. citizens and is devastating the 
populations of nations around the globe, and CDC's HIV prevention 
efforts must be expanded.
    The United States has the highest sexually transmitted diseases 
(STD) rates in the industrialized world. More than 18 million people 
contract STDs each year. Untreated STDs contribute to infant mortality, 
infertility, and cervical cancer. State and local STD control programs 
depend heavily on CDC funding for their operational support.
    CDC conducts several surveys that help track health risks and 
provide information for priority setting at the State and local levels. 
The Behavioral Risk Factor Surveillance System, Youth Risk Behavior 
Survey, Youth Tobacco Survey, and National Health and Nutrition 
Examination Survey (NHANES) are important national sources of objective 
health data. NHANES is a unique collaboration between CDC, the National 
Institutes of Health (NIH), and others to obtain data for biomedical 
research, public health, tracking of health indicators, and policy 
development. Ensuring adequate funding for this survey is essential for 
determining rates of major diseases and health conditions and 
developing public health policies and prevention interventions.
    We must address the growing disparity in the health of racial and 
ethnic minorities. CDC's Racial and Ethnic Approaches to Community 
Health (REACH), helps States address these serious disparities in 
infant mortality, breast and cervical cancer, cardiovascular disease, 
diabetes, HIV/AIDS and immunizations. We encourage the subcommittee to 
provide adequate funds for CDC's REACH program.
    CDC oversees immunization programs for children, adolescents and 
adults, and is a global partner in the ongoing effort to eradicate 
polio worldwide. The value of adult immunization programs to improve 
length and quality of life, and to save health care costs, is realized 
through a number of CDC programs, but there is much work to be done and 
a need for sound funding to achieve our goals. Influenza vaccination 
levels remain low for adults. Levels are substantially lower for 
pneumococcal vaccination and significant racial and ethnic disparities 
in vaccination levels persist among the elderly.
    Injuries are the leading cause of death in the United States for 
people ages 1-34. Of all injuries, those to the brain are most likely 
to result in death or permanent disability. Traumatic brain injury 
(TBI) is widely recognized as the signature wound of the Iraq war with 
estimates of the numbers of injured service members as high as 150,000. 
Each year, however, more than 50,000 civilians die and 90,000 civilians 
are left with a long-term disability as a result of TBI. The Traumatic 
Brain Injury Act is the Nation's only law that specifically responds to 
this growing public health crisis. The Institute of Medicine found that 
this law has been effective in addressing a wide variety of gaps in 
service system development.
    Injury at work remains a leading cause of death and disability 
among U.S. workers. During the period from 1980 through 1995, at least 
93,338 workers in the United States died as a result of injuries 
suffered on the job, for an average of about 16 deaths per day. The 
injury prevention and workforce protection initiatives of NIOSH need 
continued support.
    Created by the Children's Health Act of 2000 (Public Law 106-310), 
the National Center on Birth Defects and Developmental Disabilities 
(NCBDDD) at CDC conducts programs to protect and improve the health of 
children and adults by preventing birth defects and developmental 
disabilities; promoting optimal child development and health and 
wellness among children and adults with disabilities. We must ensure 
adequate funding for this important Center.
    We also encourage the subcommittee to provide adequate funding for 
CDC's Environmental Public Health Services Branch to revitalize 
environmental public health services at the national, State and local. 
These services are essential to protecting and ensuring the health and 
well being of the American public from threats associated with West 
Nile virus, terrorism, E. coli and lead in drinking water. We encourage 
the committee to provide at least $50 million for CDC's Environmental 
Health Tracking Network and to provide $50 million in new funding to 
CDC Environmental Health Activities to develop and enhance CDC's 
capacity to help the Nation prepare for and adapt to the potential 
health effects of global climate change. This new request for funding 
would help prepare State and local health department to prepare for the 
public health impacts of global climate change, allow CDC to fund 
academic and other institutions in their efforts to research the 
impacts of climate change on public health and to create a Center of 
Excellence at CDC to serve as a national resource for health 
professionals, government leaders and the public on climate change 
science.
    We appreciate the subcommittee's hard work in advocating for CDC 
programs in a climate of competing priorities. We encourage you to 
consider our request for $10.7 billion, plus sufficient funding to 
prepare for a possible influenza pandemic, for CDC in fiscal year 2008.

                      MEMBERS OF THE CDC COALITION

    Advocates for Youth; AIDS Action; AIDS Alliance for Children, Youth 
and Families; AIDS Foundation Chicago; Alliance to End Childhood Lead 
Poisoning; American Academy of Ophthalmology; American Academy of 
Pediatrics; American Association for Health Education; American 
Association of Orthopedic Surgeons; American Cancer Society; American 
College of Obstetricians and Gynecologists; American College of 
Preventive Medicine; American College of Rheumatology; American 
Dietetic Association; American Foundation for AIDS Research; American 
Heart Association; American Indian Higher Education Consortium; 
American Lung Association; American Medical Women's Association; 
American Optometric Association; American Podiatric Medical 
Association; American Psychological Association; American Psychological 
Society; American Public Health Association; American Red Cross; 
American School Health Association; American Society for Clinical 
Pathology; American Society for Gastrointestinal Endoscopy; American 
Society for Microbiology; American Society for Reproductive Health; 
American Thoracic Society; American Urological Association c/o MARC 
Assoc.; Arthritis Foundation; Assn. for Professionals in Infection 
Control & Epidemiology; Association of American Medical Colleges; 
Association of Maternal & Child Health Programs; Association of 
Minority Health Professions Schools; Association of Public Health 
Laboratories; Association of Reproductive Health Professionals; 
Association of Schools of Public Health; Association of State and 
Territorial Health Officials; Association of Teachers of Preventive 
Medicine; Barbara Levine & Associates; Brain Injury Association; Bread 
for the World Institute; Campaign for Tobacco-Free Kids; CDC 
Foundation; Center for Science in the Public Interest; Coalition for 
Health Funding; Coalition for Health Services Research; Commissioned 
Officers Association of the U.S. Public Health Service; Consortium for 
Citizens with Disabilities; Consortium of Social Science Associations; 
Council of Professional Association on Federal Statistics; Council of 
State and Territorial Epidemiologist; Crohn's and Colitis Foundation of 
America; Environmental Defense; ESA, Inc.; Every Child By Two; GLMA; 
Health and Medicine Counsel of Washington; Hepatitis Foundation 
International; Immune Deficiency Foundation; Infectious Diseases 
Society of America; Latino Council on Alcohol & Tobacco; Legal Action 
Center; March of Dimes; NASEMSD; National Alliance of State and 
Territorial AIDS Directors; National Association of Children's 
Hospitals; National Association of County and City Health Officials; 
National Association of Councils on Developmental Disabilities; 
National Association of Local Boards of Health; National Association of 
School Nurses; National Black Nurses Association; National Coalition 
for the Homeless; National Coalition of STD Directors; National Council 
of La Raza; National Episcopal AIDS Coalition; National Family Planning 
and Reproductive Health Association; National Health Care for the 
Homeless Council; National Hemophilia Foundation c/o MARC Assoc.; 
National Medical Association; National Osteoporosis Foundation; 
National Partnership for Immunization; National Rural Health 
Association; National Safe Kids Campaign; National Association for 
Public Health Statistics & Information Systems & Information Systems; 
Partnership for Prevention; Planned Parenthood Federation of America; 
Powers, Pyles, Sutter and Verville; Research!America; Society for 
Maternal Fetal-Medicine c/o CRD Associates; Society for Public Health 
Education; Society of General Internal Medicine (SGIM); Spina Bifida 
Association of America; The Alan Guttmacher Institute; Trust for 
America's Health; U.S. Conference of Mayors; United Cerebral Palsy; 
YMCA of the USA; and YWCA of the USA/Office of Women's Health 
Initiative.
                                 ______
                                 
 Prepared Statement of the Charles R. Drew University of Medicine and 
                                Science

              SUMMARY OF FISCAL YEAR 2008 RECOMMENDATIONS

    $300 million for the Health Resources and Services Administration 
Title VII Health Professisons Training programs, including:
  --$33.6 million for the Minority Centers of Excellence, and
  --$35.6 million for the Health Careers Opportunity program.
    Provide a 6.7 percent increase for fiscal year 2008 to the National 
Institutes of Health (NIH), specifically:
  --A proportional increast to the National Cancer Institute (NCI),
  --$250 million for the National Center on Minority Health and Health 
        Disparities (NCMHD),
  --Support the National Center for research resources:
    --Proportional increase for Research Centers for Minority 
            Institutions and Institutional Development Award (IDeA) 
            program institutions, and
    --$119 million for extramural facilities construction.
    Continue to urge NCI to support the Establishment of a 
Collaborative Minority Health Comprehensive Research Center at a 
Historically Minority Institution in collaboration with the existing 
NCI cancer centers. continue to urge NCRR and NCMHD to collaborate on 
the Establishment of a Minority Health Comprehensive Research Center.
    $65 million for the Department of Health and Human Services' Office 
of Minority Health, and
  --Urge support for the Health Professions Leadership Development and 
        Support program at the Charles Drew University.
    $65 million for the Department of Education's Strengthening 
Historically Black Graduate Institutions program.
    Mr. Chairman and members of the subcommittee, thank you for the 
opportunity to present you with testimony. The Charles Drew University 
is distinctive in being the only dually designated Historically Black 
Graduate Institution and Hispanic Serving Institution in the Nation. We 
would like to thank you and your predecessors,
    Mr. Chairman, for the support that this subcommittee has given to 
the National Institutes of Health (NIH) and its various institutes and 
centers over the years, NIH has been and continues to be invaluable to 
our university and especially our community.
    The Charles Drew University is located in the Watts-Willowbrook 
area of South Los Angeles. Its mission is to prepare predominantly 
minority doctors and other health professionals to care for underserved 
communities with compassion and excellence through education, clinical 
care, outreach, pipeline programs and advanced research that makes a 
rapid difference in clinical practice. In our over 35 years of 
enrolling students, the university has become a significant source of 
Latino and African American doctors and health professionals. We have 
made a measurable contribution to improving health care in this Nation 
by graduating over 400 physicians, 2,000 physician assistants, 2,500 
physician specialists, and numerous other health professionals--almost 
all from diverse communities. Even more importantly, our graduates go 
on to serve underserved communities and 10 years later, over 70 percent 
of them are still working with people who are in most need and who have 
the poorest access to decent health care.
    The Charles Drew University has established a national reputation 
for translational research that addresses the health disparities and 
social issues that strike hardest and deepest among urban and minority 
populations. As you can see, we are a unique institution, and we serve 
a very important constituency, which regrettably, represents a growing 
segment of the overall U.S. population.
    Currently, The Charles Drew University is experiencing a period of 
positive, dynamic growth. Though our former affiliate hospital, Martin 
Luther King-Harbor, is experiencing difficulties, our institution is 
transforming and continues to make an expanding contribution to the 
health work force, by graduating the highest caliber of health 
professionals--particularly, significant number of Latinos and African 
Americans, who are highly sought after for employment and further 
training positions. Many serve in our community where recent 
circumstances and public health budget cuts have reduced the number of 
beds and physicians back to the low level that existed in 1965, when 
the voiceless community of South Los Angeles was forced to rebel in 
order to get the health and social resources it deserves.
    Our university continues to flourish and garner respect and support 
from our colleagues, community partners and those we serve. After 30 
years, in partnership with the University of California, we are 
establishing our own 4-year medical school and a new School of Nursing 
to prepare nurses as well as nursing faculty--particularly from 
minority populations. The Charles Drew University remains a beacon of 
hope for our students and our community as we have been since we began 
when we rose out of the ashes of the 1965 Watts civil unrest.

              HEALTH RESOURCES AND SERVICES ADMINISTRATION

Title VII Health Professions Training Programs
    The health professions training programs administered by the Health 
Resources and Services Administration (HRSA) are the only Federal 
initiatives designed to address the longstanding under representation 
of minorities in health careers. HRSA's own report, ``The Rationale for 
Diversity in the Health Professions: A Review of the Evidence,'' found 
that minority health professionals disproportionately serve minority 
and other medically underserved populations, minority populations tend 
to receive better care from practitioners of their own race or 
ethnicity, and non-English speaking patients experience better care, 
greater comprehension and greater likelihood of keeping follow-up 
appointments when they see a practitioner who speaks their language. 
Studies have also demonstrated that when minorities are trained in 
minority health professions institutions, they are significantly more 
likely to: (1) serve in medically underserved areas, (2) provide care 
for minorities, and (3) treat low-income patients.
    HRSA's Minority Centers of Excellence (COE) and Health Careers 
Opportunity Program (HCOP) support health professions institutions with 
a historic mission and commitment to increasing the number of 
minorities in the health professions.
    Mr. Chairman, in fiscal year 2006 these programs were cut by over 
50 percent. Unfortunately, those cuts were sustained in the funding 
resolution passed earlier in this Congress. Looking ahead a decade, as 
you have encouraged your colleagues and us to do, the cuts of recent 
years to these programs will seriously hamper our ability to provide 
the desperately needed healthcare advances for our citizens. Those cuts 
will widen the health disparities gap that is already far too wide, and 
they will exacerbate the already present national physician shortage, 
particularly in urban areas.
Minority Centers of Excellence
    The purpose of the Minority Centers of Excellence (COE) program is 
to assist schools, like Charles Drew University, that train minority 
health professionals, by supporting programs of excellence. The COE 
program focuses on improving student recruitment and performance; 
improving curricula and cultural competence of graduates; facilitating 
faculty and student research on minority health issues; and training 
students to provide health services to minority individuals by 
providing clinical teaching at community-based health facilities. For 
fiscal year 2008, the funding level for Minority Centers of Excellence 
should be $33.6 million (an increase of $21.8 million over fiscal year 
2007).
Health Careers Opportunity Program
    Grants made to health professions schools and educational entities 
under Health Careers Opportunity Program (HCOP) enhance the ability of 
individuals from disadvantaged backgrounds to improve their 
competitiveness to enter and graduate from health professions schools. 
HCOP funds activities that are designed to develop a more competitive 
applicant pool through partnerships with institutions of higher 
education, school districts, and other community based entities. HCOP 
also provides for mentoring, counseling, primary care exposure 
activities, and information regarding careers in a primary care 
discipline. Sources of financial aid are provided to students as well 
as assistance in entering into health professions schools. For fiscal 
year 2008, the HCOP funding level of $35.6 million is suggested (an 
increase of $31.6 million).

    NATIONAL INSTITUTES OF HEALTH'S CONTRIBUTION TO FIGHTING HEALTH 
                              DISPARITIES

    Racial and ethnic disparities in health outcomes for a multitude of 
major diseases in minority and underserved communities continue to 
plague a Nation that was built on the premise of equality. As 
articulated in the Institute of Medicine report entitled ``Unequal 
Treatment: Confronting Racial and Ethnic Disparities in Health Care,'' 
this problem is not getting better on its own. For example, African 
American males develop cancer 15 percent more frequently than their 
white counterparts. While African American women are not as likely as 
white women to develop breast cancer, they are much more likely to die 
from breast cancer once it is detected. In fact, according to the 
American Cancer Society, those who are poor, lack health insurance, or 
otherwise have inadequate access to high-quality cancer care, typically 
experience high cancer incidence and mortality rates. Similarly to 
African American populations, Latino communities uffer much higher 
incidences of heart disease, diabetes, obesity and some cancers than 
white populations. These devastating statistics beg for more research 
dollars and better access to quality clinical resources to address the 
deep-seated problems.
    In response to these and similar findings in our own community and 
across the Nation, The Charles Drew University has been working to 
build a new Life Sciences Research Facility on its campus. The Center 
will specialize in providing not only cutting-edge research but 
associated medical treatments for the community that focus on 
prevention and the development of new strategies in the fight against 
cancer. These strategies will be disseminated locally and nationally to 
communities at risk, as well as to others engaged in comprehensive 
cancer prevention programs everywhere.
    Mr. Chairman, as I mentioned earlier, the support that the 
subcommittee has given to the National Institutes of Health (NIH) and 
its various institutes and centers has been and continues to be 
critical to the effectiveness of our university and our community. The 
dream of a state-of-the-art research facility to aid in the fight 
against cancer and other diseases in our underserved community would be 
infeasible in our disadvantaged location without the resources of NIH.
    To help establish the Life Sciences Research Building and expand 
our innovative translational research activities that focus on 
improving the health of underserved communities, The Charles Drew 
University is requesting increased congressional support for the 
National Center for Research Resources (NCRR), the National Center for 
Minority Health and Health Disparities (NCMHD), the National Cancer 
Institute (NCI), Health Resources and Services Administration (HRSA) 
and the Department of Health and Human Services' Office of Minority 
Health.
National Center for Minority Health and Health Disparities
    The National Center on Minority Health and Health Disparities 
(NCMHD) is charged with addressing the longstanding health status gap 
between under-represented minority and non minority populations. The 
NCMHD helps health professional institutions to narrow the health 
status gap by improving research capabilities through the continued 
development of faculty, labs, telemedicine technology and other 
learning resources. The NCMHD also supports biomedical research focused 
on eliminating health disparities and developed a comprehensive plan 
for research on minority health at NIH. Furthermore, the NCMHD provides 
financial support to health professions institutions that have a 
history and mission of serving minority and medically underserved 
communities through the COE program and HCOP.
    For fiscal year 2008, $250 million is recommended for NCMHD to 
support these critical activities.
Research Centers At Minority Institutions
    The Research Centers at Minority Institutions program (RCMI) at the 
National Center for Research Resources (NCRR) has a long and 
distinguished record of helping institutions like The Charles Drew 
University develop the research infrastructure necessary to be leaders 
in the area of translational research focused on reducing health 
disparities research. Although NIH has received some budget increases 
over the last 5 years, funding for the RCMI program has not increased 
by the same rate. The new Clinical and Translational Research 
Applications (CTSA) essentially preclude smaller institutions such as 
RCMI and IDeA schools to compete and link to the CTSA roadmap. We 
request an additional $40 million to support a CTSA-like roadmap 
mechanism for RCMI and IDeA schools, and $9.5 million to support the 
RCMI Translational Research Network, and alsosmall grant mechanisms to 
fund pilot studies linked to the NIH Roadmap, the newly developed 
Global Alliance for HIV/AIDS, and community centers of health research 
and education excellence. This is a total of an additional $49.5 
million in fiscal year 2008.
Extramural Facilities Construction
    Mr. Chairman, one issue that sets The Charles Drew University and 
many minority-dedicated institutions apart from the major universities 
of this country is the facilities where research takes place. The need 
for research infrastructure at our Nation's minority serving 
institutions must also remain strong to maximize efforts to reduce 
health disparities. The current authorization level for the Extramural 
Facility Construction program at the National Center for Research 
Resources (NCRR) is $250 million. The law also includes a 25 percent 
set-aside for ``Institutions of Emerging Excellence'' (many of which 
are minority institutions) for funding up to $50 million. Also, the law 
allows the NCRR director to waive the matching requirement for 
institutions participating in the program. We strongly support all of 
these provisions of the authorizing legislation in order to ensure the 
continued growth of relevant research from our minority health 
professions training schools.
    Unfortunately, funding for NCRR's Extramural Facility Construction 
program was completely eliminated in the fiscal year 2006 Labor-HHS 
bill, and funding was not restored in the fiscal year 2007 funding 
resolution. In fiscal year 2008, we respectfully request the 
restoration of funding for this program to the fiscal year 2004 level 
of $119 million.
   department of health and human services' office of minority health
    Specific programs at OMH include:
    Assisting medically underserved communities,
    Supporting conferences for high school and undergraduate students 
to interest them in health careers, and
    Supporting cooperative agreements with minority institutions for 
the purpose of strengthening their capacity to train more minorities in 
the health professions.
    OMH has the potential to play a critical role in addressing health 
disparities. Unfortunately, OMH does not yet have the authority or 
resources necessary to support activities that will truly make a 
difference in closing the health gap between minority and majority 
populations.
    One recent OMH pilot project is the Health Professions Leadership 
Development and Support Program, which is designed to enhance faculty 
recruitment and retention support for academicians providing for the 
supervision, instruction, and guidance of resident physicians-in-
training in underserved communities. This is a critical program for 
improving the minority pipeline filling a gap outlined in the report by 
a committee chaired by former Secretary of the Department of Health and 
Human Services (HHS),
    Dr. Louis Sullivan titled ``Missing Persons: Minorities in the 
Health Professions September 20, 2004.'' This report highlights the 
critical role played by institutions such as The Charles Drew 
University as a major training site for minority health care 
professions and biomedical scientists.
    For fiscal year 2008, I recommend a funding level of $65 million 
for OMH to support these critical activities.

 STRENGTHENING HISTORICALLY BLACK GRADUATE INSTITUTIONS--DEPARTMENT OF 
                               EDUCATION

    The Department of Education's Strengthening Historically Black 
Graduate Institutions program (Title III, Part B, section 326) is 
extremely important to MMC and other minority serving health 
professions institutions. The funding from this program is used to 
enhance educational capabilities, establish and strengthen program 
development offices, initiate endowment campaigns, and support numerous 
other institutional development activities. In fiscal year 2008, an 
appropriation of $65 million (an increase of $7 million over fiscal 
year 2007) is suggested to continue the vital support that this program 
provides to historically black graduate institutions.

                               CONCLUSION

    Despite all the knowledge that exists about racial/ethnic, socio-
cultural and gender-based disparities in health outcomes, the gap 
continues to widen. Not only are minority and underserved communities 
burdened by higher disease rates, they are less likely to have access 
to quality care upon diagnosis. As you are aware, in many minority and 
underserved communities preventative care and research are inaccessible 
either due to distance or lack of facilities and expertise. As noted 
earlier, in just one underserved area, South Los Angeles, the number 
and distribution of beds, doctors, nurses and other health 
professionals are as parlous as they were at the time of the Watts 
Rebellion, after which the McCone Commission attributed the so-named 
``Los Angeles Riots'' to poor services--particularly access to 
affordable, quality healthcare. The Charles Drew University has proven 
that it can produce excellent health professionals who ``get'' the 
mission--years after graduation they remain committed to serving people 
in the most need. But, the university needs investment and committed 
increased support from Federal, State, and local governments and is 
actively seeking foundation, philanthropic and corporate support.
    Even though institutions like The Charles Drew University are 
ideally situated (by location, population, community linkages and 
mission) to study conditions in which health disparities have been well 
documented, research is limited by the paucity of appropriate research 
facilities. With your help, the Life Sciences Research Facility will 
translate insight gained through research into greater understanding of 
disparities and improved clinical outcomes. Additionally, programs like 
Title VII Health Professions Training programs will help strengthen and 
staff facilities like our Life Sciences Research Facility.
    We look forward to working with you to lessen the huge negative 
impact of health disparities on our Nation's increasingly diverse 
populations, the economy and the whole American community.
    Mr. Chairman, thank you again for the opportunity to present 
testimony on behalf of The Charles Drew University. It is indeed an 
honor.
                                 ______
                                 
   Prepared Statement of the Coalition for the Advancement of Health 
             Through Behavioral and Social Science Research

    Mr. Chairman and members of the subcommittee, the Coalition for the 
Advancement of Health Through Behavioral and Social Science Research 
(CAHT-BSSR) appreciates and welcomes the opportunity to comment on the 
fiscal year 2008 appropriations for the National Institutes of Health 
(NIH). CAHT-BSSR includes 16 professional organizations, scientific 
societies, coalitions, and research institutions concerned with the 
promotion of and funding for research in the social and behavioral 
sciences. Collectively, we represent more than 120 professional 
associations, scientific societies, universities, and research 
institutions.
    The behavioral and social sciences regularly make important 
contributions to the well-being of this Nation. Due in large part to 
the behavioral and social science research sponsored by the NIH, we are 
now aware of the enormous contribution behavior makes to our health. At 
a time when genetic control over diseases is tantalizingly close but 
not yet possible, knowledge of the behavioral influences on health is a 
crucial component in the Nation's battles against the leading causes of 
morbidity and mortality: obesity, heart disease, cancer, AIDS, 
diabetes, age-related illnesses, accidents, substance abuse, and mental 
illness. As a result of the strong congressional commitment to the NIH 
in years past, our knowledge of the social and behavioral factors 
surrounding chronic disease health outcomes is steadily increasing. The 
NIH's behavioral and social science portfolio has emphasized the 
development of effective and sustainable interventions and prevention 
programs targeting those very illnesses that are the greatest threats 
to our health, but the work is just beginning.
    To ensure that progress is sustained, the Coalition joins the Ad 
Hoc Group for Medical Research in supporting a fiscal year 2008 
appropriation of $30.8 billion for the NIH, a 6.7 percent increase over 
fiscal year 2007. This level of funding will provide adequate resources 
to sustain the momentum of the recently completed campaign to double 
the Nation's investment in the promising research supported and 
conducted by the NIH. Unfortunately, the President's request does not 
allow us to fully reap the research opportunities that the doubling 
campaign have made available.
    Nearly 125 million Americans are living with one or more chronic 
conditions, like heart disease, cancer, diabetes, kidney disease, 
arthritis, asthma, mental illness and Alzheimer's disease. The Centers 
for Medicare and Medicaid Services (CMS) recently reported that health 
care spending in the United States rose to $1.6 trillion in 2002, up 
from $1.4 trillion in 2001 and $1.3 trillion in 2000. Health 
expenditures per person averaged $5,440 in 2002, up from $5,021 in 2001 
and $4,670 in 2000. Today, it is even more. Significant factors driving 
this increase are the aging of the U.S. population, and the rapid rise 
in chronic diseases, many caused or exacerbated by behavioral factors: 
for example, obesity, caused by sedentary behavior and poor diet; 
addictions and resulting health problems caused by tobacco and other 
drug use.
    Behavioral and social sciences research supported by NIH is 
increasing our knowledge about the factors that underlie positive and 
harmful behaviors, and the context in which those behaviors occur. NIH 
supports behavioral and social science research throughout most of its 
27 institutes and centers. Numerous reports by the National Academy of 
Sciences (e.g. The Aging Mind, New Horizons in Health: An Integrative 
Approach, and Health and Behavior) have presented cutting edge research 
agendas and made eloquent cases for the applicability of the social and 
behavioral scientific disciplines to the myriad, complex problems of 
prevention, treatment and cure of diseases as well as the enhancement 
of quality of life.
    CAHT-BSSR supports an appropriation of $27.8 million for NIH Office 
of Behavioral and Social Sciences Research, an increase of 6.7 percent, 
commensurate with an overall increase of 6.7 percent for the NIH. 
OBSSR's purpose is to serve a convening and coordinating role among the 
institutes and centers at NIH. The Office was authorized by Congress in 
the NIH Revitalization Act of 1993 and established in 1995.
    As highlighted by NIH Director Elias Zerhouni on the occasion of 
OBSSR's 10th anniversary in June 2006, ``the OBSSR has been a 
tremendous asset to NIH throughout its first 10 years . . . we are 
faced with an enormous and evolving national burden of disease and 
disability, much of which has roots in personal behavior or 
socioeconomic influences. The need for behavioral and social research 
and intervention has never been greater, and its impact has never been 
clearer. We need but look at recent decreases in rates of cancer, 
largely due to dramatic decreases in tobacco use. We can point to a 
remarkable demonstration of the pronounced benefits of diet and 
exercise--more effective than drug therapy--in preventing the onset of 
type 2 diabetes among high-risk individuals. These are but two among 
many shining examples of the widespread benefits to public health 
realized through our investment in basic and applied behavioral and 
social science research, so critical to our understanding of health and 
disease.
    OBSSR focuses on cross-cutting behavioral and social research 
issues (e.g. ``Long-term Maintenance of Behavior Change'') using its 
modest budget to seed cross-institute research initiatives. OBSSR has 
spurred cutting edge research in areas such as measures of community 
health, socioeconomic status, and new methodology development. The 
Office has been able to leverage substantive funding initiatives with a 
small budget.
    In fiscal year 2008, OBSSR plans to work with the 27 NIH Institutes 
and Centers (ICs) to initiate two new programs. The first program is in 
the area of health disparities. The Behavioral and Social Science 
Contributions to Understanding and Reducing Health Disparities will be 
designed to support trans-disciplinary research involving teams of 
behavioral, social, and biomedical scientists, on prevention, policy, 
and health care. The research program will emphasize both basic 
research on the behavioral, social, and biomedical pathways, giving 
rise to disparities in health and applied research on the development, 
testing, and delivery of interventions to reduce disparities in the 
areas of policy, prevention, and health care.
    The second initiative planned by OBSSR is in the area of Genes, 
Behavior and the Social Environment. OBSSR plans to work across the 
institutes and centers to consider the recommendations from the 
Institute of Medicine's report, Genes, Behavior, and the Social 
Environment, Moving Beyond the Nature/Nurture Debate, commissioned by 
OBSSR, along with the National Institute of General Medical Sciences 
(NIGMS) and the National Human Genome Research Institute (NHGRI). The 
report identifies gaps in knowledge and barriers that hamper the 
integration of social, behavioral, and genetic research.
    The IOM panel recognized ``that understanding the association 
between health and interactions among social, behavioral, and genetic 
factors require research that embraces the systems view and includes an 
examination of the interactive pathways through which these fields 
operate to affect health.'' Such research requires the participation of 
scientific investigators from a variety of fields and a shift in focus 
from efforts that are dominated by single disciplines to research that 
involves collaborative participation of scientists from various 
expertise at all stages of the research process. Below are the IOM's 14 
recommendations.
    1. Conduct Trans-disciplinary, Collaborative Research.--The NIH 
should develop Requests for Applications (RFAs) to study the impact on 
health of interactions among social, behavioral, and genetic factors 
and their interactive pathways (i.e., physiological).
    2. Measure Key Variables Over the Life Course and Within the 
Context of Culture.--NIH should develop RFAs for studies of 
interactions that incorporate measurement, over the life course and 
within the context of culture, of key variables in the important 
domains of social, behavioral, and genetic factors.
    3. Develop and Implement New Modeling Strategies to Build More 
Comprehensive, Predictive Models of Etiologically Heterogeneous 
Disease.--NIH should emphasize research aimed at developing and 
implementing such models (e.g., pattern recognition, multivariate 
statistics, and systems-oriented approaches) for incorporating social, 
behavioral, and genetic factors, and their interactive pathways in 
testable models within populations, clinical settings, or animal 
studies.
    4. Investigate Biological Signatures.--Researchers should use 
genomic, transcriptomic, proteomic, metabonomic, and other high 
dimensional molecular approaches to discover new constellations of 
genetic factors, biomarkers, and mediating systems through which 
interactions with social environment and behavior influence health.
    5. Conduct Research in Diverse Groups and Settings.--NIH should 
encourage research on the impact of interactions among social, 
behavioral, and genetic factors and their interactive pathways on 
health that emphasizes diversity in groups and settings. NIH should 
also support efforts to ensure that the findings of such research is 
validated by replication in independent studies, translated to patient-
oriented research, conducted and applied in the context of public 
health, and used to design preventive and therapeutic approaches.
    6. Use Animal Models to Study Gene-Social Environment 
Interaction.--NIH should develop RFAs that use carefully selected 
animal models for research on the impact on the impact of interactions 
among social, behavioral, and genetic factors and their interactive 
pathways.
    7. Advance the Science of Study of Interactions.--Researchers 
should base testing for interaction on a conceptual framework rather 
than simply the testing of a statistical model, and they must specify 
the scale (e.g., additive or multiplicative) used to evaluate whether 
or not interactions are present. NIH should develop RFAs for research 
on developing study designs that are efficient at testing interactions, 
including variation in interactions over time and development.
    8. Expand and Enhance Training for Trans-disciplinary 
Researchers.--NIH should use existing and modified training tools both 
to reach the next generation of researchers and to enhance the training 
of current researchers. Approaches include individual fellowships and 
senior fellowships, trans-disciplinary institutional grants, and short 
courses.
    9. Enhance Existing and Develop New Datasets.--NIH should support 
datasets that can be used by investigators to address complex levels of 
social, behavioral, and genetic variables and their interactive 
pathways. This should include enhancement of existing datasets that 
already provide many, but not all of the needed measures and the 
encouragement of their use. NIH should also develop new datasets that 
address specific topics that have high potential for showing genetic 
contribution, social variability, and behavioral contributions--topics 
such as obesity, diabetes, and smoking.
    10. Create Incentives to Foster Trans-disciplinary Research.--NIH 
and universities should explore ways to create incentives for the kinds 
of team science needed to support trans-disciplinary research.
    11. Communicate with Policymakers and the Public.--Researchers 
should (1) be mindful of public and policymakers' concerns; (2) develop 
mechanisms to involve and inform these constituencies; (3) avoid 
overstating their scientific findings; and (4) give careful 
consideration to the appropriate level of community involvement and the 
level of community oversight needed for such studies.
    12. Expand the Research Focus.--NIH should develop RFAs for 
research that elucidates how best to encourage people to engage in 
health--promoting behaviors that are informed by a greater 
understanding of these interactions; how best to effectively 
communicate research results to the public and other stakeholders; and 
how best to inform research participants about the nature of the 
investigation (gene-environment interactions) and the uses of data 
following the study.
    13. Establish Data-Sharing Policies That Ensure Privacy.--
Institutional Review Boards and investigators should establish policies 
regarding the collection, sharing, and use of data that include 
information about: (1) whether and to what extent data will be shared; 
(2) the level of security to be provided by all members of the research 
team as well as the research and administrative process; (3) the use of 
state-of-the-art security data in ways that are consistent with those 
agreed to by the research participants.
    14. Improve Informed Consent Process.--Researchers should ensure 
that informed consent includes the following: (1) descriptions of the 
individual and social risks and benefits of the research; (2) the 
identification of which individual results participants will and will 
not receive; (3) the definition of the procedural protections that will 
be provided, including access policies and scientific oversight; and 
(4) specific security, privacy, and confidentiality protections to 
protect the data and samples of research participants.
    Implementing the IOM's recommendations would go a long ways towards 
helping to realize the ultimate goal of personalized health care, one 
of Secretary Michael Leavitt's priorities. Personalization needs to 
reflect genes, behaviors, and environments. Assessing behavior is 
critical to helping individuals see how they can improve their health. 
It is also critical to helping health care see where it needs to put 
resources for behavior change. As noted by Dr. Zerhouni, ``Right now, 
everyone is focused on finding the magic answer. But health care is 
different from region to region across the country.'' Full 
personalization needs to consider the environmental, community, and 
neighborhood circumstances that govern how individuals' genes and 
behavior will influence their health. For personalized health to be 
realized, we need a sophisticated understanding of the interplay 
between genetics and the environment, broadly defined.
    CAHT-BSSR would be pleased to provide any additional information on 
these issues. We have attached a list of coalition member societies to 
the end of the testimony. We thank the subcommittee for its generous 
support of the National Institutes of Health and for the opportunity to 
present our views.

                           CAHT-BSSR MEMBERS

    American Educational Research Association; American Psychological 
Association; American Sociological Association; Association of 
Population Centers; Center for the Advancement of Health; Consortium of 
Social Science Associations; Gerontological Society of America; 
Institute for the Advancement of Social Work Research; National 
Association of Social Workers; National Council on Family Relations; 
National Mental Health Association; Population Association of America; 
Sex Information and Education Council of the United States; Society for 
Public Health Information; Society for Research in Child Development; 
and The Alan Guttmacher Institute.
                                 ______
                                 
      Prepared Statement of the Coalition for American Trauma Care

    The Coalition for American Trauma Care is pleased to provide its 
recommendations for fiscal year 2008 appropriations for public health 
programs that support trauma care, trauma care research, and injury 
prevention.
    The Coalition for American Trauma Care is a nonprofit association 
of national health and professional organizations that seeks to improve 
care for the seriously injured patient through improved delivery of 
trauma care services, research and rehabilitation activities. The 
Coalition also supports efforts to prevent injury from occurring.
    Injury is one of the most important public health problems facing 
the United States today. It is the leading cause of death for Americans 
from age 1 through age 34. More than 145,000 people die each year from 
injury, 88,000 from unintentional injury such as car crashes, fires, 
and falls, and 56,000 from violence-related causes. Over 85 children 
and young adults die from injuries in the United States every day 
translating into 30,000 deaths annually. Injury is also the most 
frequent cause of disability. Millions of Americans are non-fatally 
injured each year leaving many temporarily disabled and some 
permanently disabled with severe head, spinal cord, and extremity 
injuries. Because injury so often strikes the young, injury is also the 
leading cause of years of lost work productivity and, at an estimated 
$224 billion in lifetime costs each year, trauma is our Nation's most 
costly disease.
    Trauma Care Systems.--The Coalition is extremely disappointed that 
Congress failed to appropriate any funding for the Health Resources and 
Services administration's Trauma-EMS program in fiscal year 2007 and 
urges the subcommittee to provide $12 million in funding for fiscal 
year 2008. Congress is in the process of re-authorizing the program 
(H.R. 727; S. 657) at a level of $12 million for fiscal year 2008. In 
recent days both the House Energy and Commerce Committee and the Senate 
Health, Education, Labor and Pensions Committees approved their 
respective bills unanimously. The Trauma-EMS program, administered by 
HRSA for 5 years, from fiscal year 2001-2005, provided critical 
national leadership which leveraged additional scarce State dollars to 
strengthen trauma systems so that seriously injured individuals, 
wherever they live, receive prompt emergency transport to the nearest 
appropriate trauma center within the ``golden hour.'' Receiving 
appropriate, quality trauma care within 1 hour of injury saves lives 
and provides the best chance for a good recovery. Achieving this result 
takes coordination, commitment of staff, development and implementation 
of standards of care, a process for designating trauma centers, and 
evaluation.
    No other program in the Federal Government addresses this critical 
aspect of the Nation's emergency response infrastructure. According to 
the Trauma-EMS Systems Program Assessment Rating Tool (PART) released 
by the OMB, ``the Trauma Care program has demonstrated success in 
assisting States in adopting statewide standardized triage protocols 
and designating trauma centers. Studies indicate with some consistency 
that improving organized systems of trauma care, specifically States 
designating trauma centers and adopting standardized triage protocols, 
leads to measurable decreases in mortality due to trauma.''
    Despite this progress, only 8 States have fully developed trauma 
systems; 12 States do not even have the authority to designate trauma 
centers. In a recent Harris Poll, large majorities of the American 
public said they valued trauma centers and systems as highly as having 
a police or fire department in their community. We therefore request 
that you reinstate funding for this vital, life saving program.
    National Center for Injury Prevention and Control.--The Coalition 
supports $168 million in funding in fiscal year 2008 for the National 
Center for Injury Prevention and Control which is currently funded at 
$138 million. The Coalition is exceedingly pleased with the support CDC 
has provided for the National Evaluation of the Effect of Trauma Center 
Care on Mortality. The results of this study, published in the January 
26, 2006 New England Journal of Medicine, were that care at a trauma 
center lowers by 25 percent the risk of death for injured patients 
compared to treatment received at non-trauma centers. The NCIPC 
supports a range of injury prevention activities and through evaluation 
has proven their effectiveness in many areas. Just two examples of 
these: reduction of the more than 20,000 head injuries that occur every 
year by encouraging the use of bicycle helmets and reduction of burn-
related injuries through smoke detector implementation programs.
    Traumatic Brain Injury (TBI).--Traumatic brain injury is a leading 
cause of trauma-related disability. Brain injury is a silent epidemic 
that compounds every year, but about which still little is known. The 
Coalition is opposed to the proposed elimination of this important 
program in the President's fiscal year 2008 budget request and urges 
you to provide a total of $30 million for the Traumatic Brain Injury 
(TBI) Act, as follows: $9 million for CDC to strengthen State and local 
data collection activities, improve linkage of persons with TBI to 
services, increase public education and awareness, and conduct public 
health research related to TBI. Within the $30 million, the Coalition 
also supports $15 million for the HRSA TBI State Grant Program to 
ensure that every State, territory and American Indian Consortia can 
coordinate and maximize resources to serve their TBI population and 
provide training and technical assistance to grantees. Also within the 
$30 million total, $6 million is needed for the HRSA Protection and 
Advocacy Program for population-based allotments to all States to 
ensure adequate and appropriate assistance to individuals with brain 
injury in exercisng their rights and accessing public service systems.
    Children's EMS.--The Coalition is opposed to the proposed 
elimination of this program in the President's fiscal year 2008 budget 
request and urges you to provide $25 million in fiscal year 2008. While 
this amount represents a 25 percent increase for this program, it has 
been flat-funded for 6 years causing an erosion in available resources 
due to inflation. Children currently account for up to 30 percent of 
all emergency department visits and 10 percent of ambulance runs 
annually, but many facilities lack the specialized equipment needed to 
care for them. Moreover, many emergency personnel do not have the 
necessary education or training to provide optimal care to children. In 
order to assist local communities in providing the best emergency care 
to children the Children's EMS program needs to continue and continue 
at a level that allows resources to keep pace with inflation.
    Preventive Health/Health Services Block Grant (PHHS).--The 
Coalition is deeply disappointed that Congress cut funding in fiscal 
year 2006 for this program by $32 million, or 24 percent, and that the 
President has proposed to eliminate funding in fiscal year 2008. The 
Coalition urges you to restore funding to the fiscal year 2005 of $131 
million when the subcommittee marks up its fiscal year 2008 bill. The 
PHHS Block Grant provides flexible funding to States to allow them to 
address specific health problems identified under the Healthy People 
2010 assessment process. The funding allows States to take innovative 
approaches to address significant health issues and complements, not 
duplicates, some of CDC's other program activities. In addition, the 
PHHS Block Grant is the largest single source of Federal funding for 
support of basic State Emergency Medical Services' (EMS) 
infrastructure--the first line of defense against death and disability 
resulting from severe injury.
    Rural EMS Training and Equipment Program.--The Coalition urges you 
to provide $900,000 in funding for the Rural EMS Training and Equipment 
Program. This program was eliminated in fiscal year 2006 and needs not 
only restoration, but expansion in fiscal year 2008. Rural areas are in 
critical need of emergency medical services training and equipment. 
Recent national events have continued to draw attention to the need for 
communities to have strong emergency medical systems in place. 
Unfortunately, while the need for effective emergency medical care may 
have increased, the number of individuals able to provide these 
services has declined. This is a particular problem in rural areas 
where the majority of EMS personnel are unpaid volunteers. As rural 
economies continue to suffer, it has become progressively more 
difficult for rural EMS providers to recruit and retain these 
personnel. As a consequence, emergency medical squads are becoming 
smaller. The rural EMS training and equipment program awards 
competitive grants to State EMS Offices, State Offices of Rural Health, 
local government, and State or local ambulance providers to improve 
emergency medical services in rural areas.
    The funds can be used to:
  --Recruit emergency and volunteer medical service personnel;
  --Train emergency medical service personnel in emergency response, 
        injury prevention, safety awareness, and other topics relevant 
        to the delivery of emergency medical services;
  --Fund specific training to meet Federal or State certification 
        requirements;
  --Develop new ways to educate emergency health care providers through 
        the use of technology enhance educational methods (such as 
        distance learning);
  --Acquire emergency medical services equipment including cardiac 
        defibrillators;
  --Acquire personal protective equipment for emergency medical 
        services personnel; and
  --Educate the public concerning cardiopulmonary resuscitation, first 
        aid, injury prevention, safety awareness, illness prevention, 
        and other related emergency preparedness topics.
    The Coalition for American Trauma Care is both deeply disappointed 
and alarmed by the President's fiscal year 2008 budget which proposes 
elimination of all funding for four programs specifically designed to 
build infrastructure to ensure that trauma and emergency medical 
services are available and appropriate to need: HRSA's Trauma-EMS 
systems program; HRSA's Traumatic Brain Injury program; HRSA's 
Children's EMS program and CDC's Preventive Health and Health Services 
Block Grant. If these cuts are enacted, the results would be 
devastating for emergency care in the United States for everyone and 
particularly for children and those who have suffered head injury. The 
burden of injury in America has been well documented by numerous IOM 
reports and injury facts speak for themselves: injury is the leading 
cause of death and disability for children and adults up to age 44. 
While much more can and needs to be done to prevent injury from 
occurring at all, we will never be able to eliminate it entirely. 
Cutting these programs will not lessen the injury burden in America; on 
the contrary, it will significantly increase the burden of death, 
disability and direct and indirect health care costs. We need to 
increase our investment in these program areas, not reduce our 
commitment.
    The Coalition greatly appreciates the support the subcommittee has 
provided to trauma related programs in the past and looks forward to 
working with the subcommittee in the coming weeks and months.
                                 ______
                                 
       Prepared Statement of the Coalition of EPSCoR/IDeA States

    Thank you for the opportunity to submit this testimony in support 
of fiscal year 2008 funding for the National Institutes of Health's 
Institutional Development Award or ``IDeA'' Program. The IDeA program 
is funded by NIH's National Center for Research Resources (NCRR), and 
was authorized by the 1993 NIH Revitalization Act (Public Law 103-43).
    My name is Dr. Peter Alfonso and I am the Vice Provost for 
Research, Graduate Studies and Outreach and Dean of the Graduate School 
at the University of Rhode Island. I submit this testimony on behalf of 
the Coalition of EPSCoR/IDeA States.\1\ EPSCoR is the ``Experimental 
Program to Stimulate Competitive Research,'' and IDeA, as previously 
stated, is the NIH's Institutional Development Award program.
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    \1\ Alabama, Alaska, Arkansas, Delaware, Hawaii, Idaho, Kansas, 
Kentucky, Louisiana, Maine, Mississippi, Montana, Nebraska, Nevada, New 
Hampshire, New Mexico, North Dakota, Oklahoma, Puerto Rico, Rhode 
Island, South Carolina, South Dakota, Vermont, Virgin Islands, West 
Virginia, and Wyoming. (States in italic letters are eligible for the 
IDeA program. All of the States listed above are also eligible for the 
EPSCoR program.)
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    IDeA is an important program because it increases our Nation's 
biomedical research capability by improving research in States that 
have historically been less successful in obtaining biomedical research 
funds. Twenty-three States and Puerto Rico are eligible.
    IDeA funds only merit-based, peer-reviewed research that meets NIH 
research objectives.
    As previously mentioned, IDeA was authorized by the 1993 NIH 
Revitalization Act (Public Law 103-43), but the program was funded at 
very low levels during its early years. However, between fiscal year 
2000 and fiscal year 2003, IDeA grew rapidly, due in large part to the 
thoughtful actions of this subcommittee. This funding permitted the 
initiation of two new program elements:
    The first was COBRE or ``Centers of Biomedical Research 
Excellence;'' which are research clusters targeting specific biomedical 
research problems. The COBRE program is designed to increase the pool 
of well-trained investigators in the IDeA States by expanding research 
facilities, equipping laboratories with the latest research equipment, 
providing mentoring for promising candidates, and developing research 
faculty through support of a multi-disciplinary center, led by an 
established, senior investigator with expertise in the research focus 
area of the center.
    The second was BRIN or ``Biomedical Research Infrastructure 
Networks;'' which targeted key areas such as bioinformatics and 
genomics and facilitated the development of cooperative networks 
between research-intensive and primarily undergraduate colleges. The 
BRIN grants underwent competitive renewals in 2004 under the new name 
of IDeA Networks of Biomedical Research Excellence (INBRE). The INBRE 
program prepares students for graduate and professional schools as well 
as careers in the biomedical sciences, supports research and mentoring 
of young investigators, and enhances research infrastructure at 
participating institutions.
    Although IDeA is relatively new, there is already objective 
evidence of its success. In fiscal year 1999, the year before COBRE 
grants were initiated, IDeA States received a total of $595 million 
from NIH. In fiscal year 2005, NIH funding for the IDeA States had 
increased to $1.556 billion, representing an increase of 162 percent in 
6 years. It is important to note, however, that in the following year 
as the IDeA budget started to decrease, NIH funding for the IDeA States 
fell to $1.458 billion, the same level as in fiscal year 2003.
    I would like to describe a few examples of how both COBRE and INBRE 
(formerly BRIN) grants have changed the biomedical research landscape 
of Rhode Island. The first COBRE award in Rhode Island was made to 
Brown University in 2000. Prior to this award the biomedical research 
infrastructure of the University was severely lacking and the 
interactions between researchers at Brown and at other institutions 
within the State were minimal at best.
    The COBRE award allowed the PI to fund five promising junior 
investigators, all of whom won subsequent major NIH grants by the end 
of the award period. State-of-the-art core facilities in microscopy, 
genomics, and transgenics were established and staffed with Ph.D. level 
directors. Seminar series and workshops were initiated with COBRE 
funding, and served as the basis for developing collaborative ties with 
researchers throughout the State. COBRE funding also was directly 
translated into the establishment of a ``Center for Genomics and 
Proteomics'' at Brown that included the purchase and renovation of 
significant new research space in an old industrial section of the 
city. This area of the city has now been filled with new businesses and 
is prospering.
    The 2000 COBRE award was renewed for another 5 years and the focus 
is now on signaling and cancer, with the long term goal of establishing 
a cancer center. Since the first COBRE award to Brown University in 
2000, three other COBREs have been awarded to three separate 
institutions: Rhode Island Hospital, Roger Williams Hospital, and Women 
and Infants Hospital. In all three cases, the awarded funds have 
directly led to the establishment of critical Core Facilities that 
provide new faculty with valuable access to state-of-the-art 
instrumentation that they would not be able to acquire through standard 
grant award mechanisms For all of these reasons, COBRE is a critical 
mechanism of support for States with limited budgets for research 
support.
    The 3-year BRIN grant, awarded to Rhode Island in 2001 and 
competitively renewed as INBRE for 5 years in 2004, provided another 
mechanism for addressing both the lack of critical mass of biomedical 
researchers at the University of Rhode Island and other primarily 
undergraduate institutions in the States, and the lack of high-end 
state-of-the-art equipment for biomedical research at these 
institutions. Lack of critical mass and the necessary infrastructure to 
support biomedical research meant that existing researchers were unable 
to perform cutting edge research and effectively compete for research 
dollars from Federal agencies such as the National Institutes of 
Health. Meager startup funds available for hiring new faculty hampered 
efforts to recruit quality research-oriented faculty. There were 
limited opportunities for student training in faculty laboratories, and 
finally, there was a lack of the type of interinstitutional cooperation 
needed to create a network of biomedical researchers.
    Through funding received as a result of the BRIN/INBRE awards, more 
than $2 million in biomedical research equipment for genomics, 
proteomics and drug development studies has been purchased and housed 
in a renovated laboratory. This equipment is accessible to all 
researchers from the participating institutions: University of Rhode 
Island; Rhode Island College; Providence College; Roger Williams 
University; Salve Regina University; and Brown University Through BRIN/
INBRE funding, the Center for Molecular Toxicology at the University of 
Rhode Island was established. The Center has allowed us to leverage the 
creation of new faculty positions at all participating institutions in 
the related thematic areas of toxicology, cell biology and 
environmental health, and helped provide competitive new faculty 
startup packages. New faculty research, coupled with regularly 
scheduled seminars and workshops, is generating increased student 
interest in research and also greater training opportunities for 
students in faculty laboratories. Greater student training in turn 
translates into workforce development in the biomedical and 
biotechnological fields.
    The Rhode Island BRIN/INBRE awards have led to the creation of an 
effective state-wide collaborative network of biomedical researchers, 
which is essential for implementing an environment that will foster 
collaborative research. Finally, and most importantly, this funding has 
helped biomedical researchers in our State to achieve greater success 
in competing for Federal research dollars. This is the ultimate goal of 
the IDeA program.
    Despite these successes, our task is far from complete. Funding 
disparities between the States remain and may have a detrimental impact 
on our national self-interest. And that is why the IDeA program is so 
important. It is helping to ensure that all regions of the country 
participate in biomedical research. Citizens from all States should 
have the opportunity to benefit from the latest innovations in health 
care, which are most readily available in centers of biomedical 
research excellence.
    For this reason, I am deeply concerned by the fiscal year 2008 
Budget Request for the IDeA program. The fiscal year 2008 Budget 
Request for the IDeA program is $210,963,000, which is a $9,023,000 
decrease from the fiscal year 2006 level of funding for the program. 
This is the second year in a row that the IDeA program has been cut in 
the President's Budget. The fiscal year 2007 budget request was the 
first time since 1993 that the budget request for IDeA was below the 
previous year's appropriated level for the program.
    I applaud the efforts your subcommittee has made over the years to 
provide increased funding for IDeA, and hope that you will continue to 
invest in this program, which is so important to almost half of our 
States. The cut proposed in the fiscal year 2008 budget request will 
have a crippling effect on the biomedical research centers, researchers 
and students in IDeA States. The IDeA program is important to so many 
in our States, but especially to the junior investigators who are 
starting to become competitive for NIH funding. I think we send these 
young investigators the wrong message by cutting or even possibly 
eliminating funding for their research projects after encouraging them 
to pursue a career in biomedical research.
    For this reason, the Coalition of EPSCoR/IDeA States believe the 
program should be funded at $250 million in fiscal year 2008. This 
level of funding would restore and continue funding for COBRE and 
INBRE, provide funding for information technoIogy (IT) infrastructure 
upgrades through IDeANet, and also, some funding would be used for a 
co-funding program, which would allow researchers and institutions to 
merge with the overall national biomedical research community.
    By any reasonable standard, an already proven ``IDeA'' for 
increasing biomedical research capacity in a cohort of States which 
comprise one-sixth of our population and yet still receive barely one-
twentieth of the NIH budget, deserves increased support. I am sensitive 
to the tough budget environment that NIH has faced over the past 4 
years. Yet, when I consider that in 2005, the top 7 States that were 
recipients of NIH funding received over a $1 billion each, California 
alone received over $3 billion, $250 million for 23 States and Puerto 
Rico seems more than reasonable. Every region of the country has talent 
and expertise to contribute to our Nation's biomedical research 
efforts--and every region of the country must participate if we are to 
increase our Nation's biomedical research capacity substantially. On 
behalf of the Coalition of EPSCoR/IDeA States, I thank the subcommittee 
for the opportunity to submit this testimony.
                                 ______
                                 
         Prepared Statement of the Coalition for Health Funding

    The Coalition for Health Funding is pleased to provide the 
subcommittee with its testimony recommending fiscal year 2008 funding 
levels for the agencies and programs of the U.S. Public Health Service. 
Since 1970, the Coalition's member organizations, representing 40 
million health care professionals, researchers, patients and families, 
have been advocating for sufficient resources for PHS agencies and 
programs to meet the changing health challenges confronting the 
American people. One of the important principles that unites the 
Coalition's members is that the health needs of the Nation's population 
must be addressed by strong, sustained support for a continuum of 
activities that includes biomedical, behavioral and health services 
research; community-based disease prevention and health promotion; 
health care services for vulnerable and medically underserved 
populations; ensuring a safe and effective food and drug supply; and 
education of a health professions workforce in adequate numbers to 
address the breadth of need.
    The Coalition for Health Funding believes the Bush administration, 
and Congress, have undermined progress that has been made and also 
missed an important opportunity to improve the health of all Americans 
by reducing rather than investing more resources in the agencies and 
programs of the U.S. Public Health Service. Federal spending for public 
health has always been low compared to other health spending, amounting 
to 3 percent of total health care spending according to the Centers for 
Medicare and Medicaid, and yet an investment in public health has the 
potential to slow unsustainable growth in mandatory costs, reduce lost 
productivity at work, school and home, and strengthen every citizen's 
contribution for a healthy, economically strong America.
    Instead of investing in these proven approaches, in recent years we 
have seen serious erosion of resources. Last year, through the strong 
efforts of a few House and Senate Members of Congress working with the 
advocacy community, the bleeding was staunched somewhat through the 
addition of $7 billion in funding for the agencies and programs under 
the jurisdiction of the Labor-HHS-Education Appropriations 
Subcommittees. However, as the table below shows, health agencies did 
not benefit across the board, with CDC, HRSA and SAMHSA funded in the 
final fiscal year 2007 Joint Resolution below fiscal year 2005 by a 
total of $837 million. In addition, all of the health agencies still 
face shortfalls when compared with fiscal year 2005 when inflation is 
accounted for. The President's fiscal year 2008 budget request cuts 
even more deeply--another $1.1 billion below fiscal year 2007 and a 
full $1.6 billion below fiscal year 2005.
    The Coalition for Health Funding urges the subcommittee to reject 
the President's proposal to reduce the Nation's investment in public 
health and instead join over 400 health organizations that, in letter 
dated February 26, urged Congress to make an investment in public 
health of $4 billion over fiscal year 2007 levels. As that letter 
states:

    ``The investment in disease prevention and health promotion for all 
Americans needs to grow, as our Nation struggles with escalating health 
care costs, growing numbers of uninsured, and the prospect of declining 
health measured by overall morbidity and mortality. Over the past 4 
years we have seen a decrease in that investment. The President's 
budget for fiscal year 2008 continues to seriously underfund and 
undermine an important part of the solution: public health activities 
and programs.
    While the final fiscal year 2007 funding resolution provided needed 
increases to selected programs, most public health programs were held 
at fiscal year 2006 funding levels. The undersigned organizations urge 
you to increase funding for public health through the Function 550/
discretionary budget allocation in fiscal year 2008 by an amount that 
will restore funding cuts to public health programs enacted in fiscal 
year 2006, and restore lost purchasing power. It is estimated that an 
additional $4 billion, 7.8 percent, will be needed in fiscal year 2008 
to meet that goal and reverse the erosion of support for the continuum 
of biomedical, behavioral and health services research, community-based 
disease prevention and health promotion, basic and targeted services 
for the medically uninsured and those with disabilities, health 
professions education, and robust regulation of the Nation's food and 
drug supply.''

    The following is a partial list of the Coalition's fiscal year 2008 
recommendations for specific U.S. Public Health Service agencies. The 
Coalition developed these recommendations working with eight other 
health coalitions with a more targeted focus on one agency.

                  NATIONAL INSTITUTES OF HEALTH (NIH)

    The Coalition supports $30.869 billion in fiscal year 2008 for the 
National Institutes of Health, a 6.7 percent increase over the fiscal 
year 2007 funding level. This recommendation begins a 3 year process 
for restoring NIH's purchasing power following 4 years of flat funding 
at the end of the doubling in fiscal year 2003. The President's fiscal 
year 2008 budget request, by contrast, cuts NIH $310 million below 
fiscal year 2007. Enactment of the administration's proposal would mean 
about a 13 percent cut in inflation-adjusted dollars in the biomedical 
research capacity of our Nation. The result is NIH is funding fewer 
research projects, slowing our progress against disease and disability 
and discouraging talented young people from pursuing careers in medical 
research. Scientific discoveries are the result of a series of 
incremental steps that pave the way for future breakthroughs. This 
process needs sustained support.

            CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

    The Coalition for Health Funding recommends a level of $7.7 billion 
for CDC's core programs in fiscal year 2008. This amount is $1.6 
billion more than the fiscal year 2007 funding level and $1.8 billion 
more than the President's request for fiscal year 2008. This amount 
reflects CDC's professional judgment for core CDC programs that address 
prevention of chronic diseases, infectious diseases including adult and 
child immunization, and support for basic public health infrastructure. 
CDC is the Nation's primary investment in disease prevention and health 
promotion. Since fiscal year 2005, the agency's core programs have lost 
$500 million in funding. It is astounding this decline has been allowed 
to occur when the Nation faces the challenge of galloping obesity and 
its ensuing costly chronic disease; new and emerging infectious 
diseases like West Nile virus and those caused by antimicrobial 
resistant bacteria; vaccine-preventable diseases that occur every day; 
still growing numbers of Americans with HIV, with an estimated 250,000 
who do not know they are infected; and a public health infrastructure 
that still needs shoring up after decades of neglect and that is facing 
massive loss of its trained workforce. One example that summarizes the 
shocking condition of core CDC programs is the National Center for 
Health Statistics (NCHS). Due to a shortfall of a mere $3 million in 
fiscal year 2007, NCHS does not have the funding it needs to collect 
vital birth and death statistics from States for the last 3 months of 
this calendar year. If this is not addressed, the United States will be 
the first industrialized Nation in the world unable to collect this 
information, and as Rep. Rosa DeLauro, a member of the House Labor-HHS-
Education Subcommittee on Appropriations commented, ``. . . [this will] 
compromise our ability not only to target our own public health 
interventions and evaluate our health standing on the international 
stage, but also monitor causes of death, including infectious diseases 
like influenza. As you know, death records are the first line of 
defense in our preparedness system, serving as the warning bell for a 
pandemic outbreak.''

          HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)

    The Coalition for Health Funding recommends an overall funding 
level of $7.5 billion for HRSA in fiscal year 2008. This amount is $617 
million, or 8.9 percent, more than the fiscal year 2007 funding level, 
and is $1.7 billion more than the President's request. This is the 
amount that the Coalition believes is needed to provide adequate 
resources for the important programs that HRSA administers.
    The Coalition is extremely concerned about recent deep cuts in 
funding to HRSA, the Federal agency whose central stated mission is to 
achieve 100 percent access to health care services with zero 
disparities. This is simply not achievable with a cut of over 6 percent 
in fiscal year 2006 and a proposed additional cut of 8.5 percent in the 
President's fiscal year 2008 budget. Chief among the cuts enacted in 
fiscal year 2006, and proposed for complete elimination in the 
President's budget request, are the Title VII Health Professions 
education programs. In addition, the President's fiscal year 2008 
budget cuts the Title VIII nursing education programs by $44 million, 
or nearly 30 percent. The Title VII and the Title VIII nursing 
education programs are the only Federal programs designed to train 
providers in multidisciplinary settings to meet the needs of special 
and underserved populations, as well as increase the minority 
representation in the health care workforce. Cuts imposed in fiscal 
year 2006 of 51.5 percent, including elimination of 7 Title VII 
programs, will only exacerbate racial and geographic disparities. 
Graduates of these programs are 3-10 times more likely to practice in 
underserved areas and are 2-5 times more likely to be minorities. The 
Coalition urges the subcommittee to restore funding levels for Title 
VII to the fiscal year 2005 level, and not only reject proposed cuts 
for Title VIII, but increase funding for this program addressing well-
documented nursing shortages.
    The Coalition also rejects the proposed 63 percent cut in 
Children's Hospitals Graduate Medical Education. Children's hospitals 
do not have access to Medicare funds to help train physicians that care 
for sick children.
    The Coalition deplores the elimination of several other HRSA 
programs in fiscal year 2006 including the Trauma-EMS Systems program, 
which supports States in the development of systems to ensure severely 
injured individuals receive quality trauma care in a timeframe that 
ensures optimal outcomes, and the Healthy Community Access program and 
State planning grants designed to close gaps in access to health care 
for uninsured individuals. Proposed elimination in the President's 
fiscal year 2008 budget of the Children's EMS program, the Traumatic 
Brain Injury program, the Universal Newborn Screening program, the 
Rural and Community Access to Emergency Devices program to train lay 
rescuers and first responders to us Automated External Defibrillators, 
and a 90 percent cut for the Office of Rural Health Policy diminish 
both targeted prevention activities and health care access. Further, a 
cut of $31 million in fiscal year 2006 to the Maternal and Child Health 
program, followed by a hard freeze in fiscal year 2007 and a proposed 
freeze in the President's fiscal year 2008 budget request, has reduced 
services across the Nation to the more than 26 million pregnant women, 
infants and special needs children served by the MCH Block Grant. MCH 
programs increase immunizations, newborn screening, reduce infant 
mortality and developmentally handicapping conditions, prevent 
childhood accidents and injuries, and reduce adolescent pregnancy.

       SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION

    The Coalition for Health Funding recommends an overall funding 
level of $3.532 billion for SAMHSA in fiscal year 2008. This amount is 
$207 million, or 6.2 percent, more than the fiscal year 2007 funding 
level, and $364 million more than the President's budget request, which 
includes a $157 million cut for SAMHSA programs.
    Despite the recent release of the Federal ``Action Agenda'' to 
ensure that people with mental illness have every opportunity for 
recovery, the President's fiscal year 2008 budget proposes to cut 
mental health services by $77 million, or 8.7 percent, following a cut 
in fiscal year 2006 of $17 million. This means that the charge from the 
President's New Freedom Commission on Mental Health for transforming 
the mental health system cannot occur if SAMHSA funding continually 
erodes. The need to make mental health a national priority is nowhere 
better illustrated than in the shocking rates of suicide and suicide 
attempts in the United States despite the Commission's finding that 
suicides are ``a largely preventable public health problem.'' According 
to CDC, the suicide rate among U.S. residents younger than age 20 
increased by 18 percent from 2003-2004, the only cause of death for 
teens that increased. Up to 35,000 children displaced by Hurricane 
Katrina in 2005 are having emotional, behavioral or school problems 
with a fourfold increase in those diagnosed with clinical depression or 
anxiety and a doubling of behavioral, or conduct problems after the 
hurricane. A proposed fiscal year 2008 mental health budget that is 
less than it was in fiscal year 2003 does not allow SAMHSA to meet 
existing needs, let alone respond to the consequences following a 
disaster.
    The Coalition is disappointed that the President's fiscal year 2008 
budget proposes cuts in funding for substance abuse programs by $84 
million and recommends a $100 million increase for the Substance Abuse 
Treatment and Prevention Block Grant and a $15 million increase for 
discretionary treatment programs and a $17 million increase for 
discretionary prevention programs. Substance abuse is a significant and 
very costly national problem involving an estimated 21.6 million 
Americans--over 9 percent of the population--and needs investment in 
both treatment and prevention. Currently only 18 percent of all 
Americans over the age of 12 who need treatment receive it. Emerging 
trends also need specific attention: returning veterans with mental 
health and substance abuse problems that are not eligible for VA 
services, or will not use them due to stigma; and growing 
methamphetamine addiction. Clearly, a stronger investment for this 
problem, which is estimated to cost the Nation $346 billion, is needed.
    The Coalition appreciates this opportunity to provide its fiscal 
year 2008 recommendations and looks forward to working with the 
subcommittee in the coming weeks and months.
                                 ______
                                 
    Prepared Statement of the Coalition for International Education

    Mr. Chairman and members of the subcommittee: We are pleased to 
have the opportunity to present the views of the Coalition for 
International Education on fiscal year 2008 funding for the Higher 
Education Act, Title VI and the Mutual Educational and Cultural 
Exchange Act, section 102(b)(6), commonly known as Fulbright-Hays. The 
Coalition for International Education is an ad hoc group of over 30 
national higher education organizations with interest in the Department 
of Education's international and foreign language education programs. 
Together the Coalition represents the Nation's 3,300 colleges and 
universities, and organizations encompassing various academic 
disciplines, as well as the international exchange and foreign language 
communities. The urgency about United States shortfalls in 
international expertise against a backdrop of enormous global 
challenges is so strong within the higher education community that it 
draws our different perspectives into a single consensus position.
    We express our deep appreciation for the subcommittee's long-time 
support for these programs. We believe that global challenges to our 
Nation and its leadership continue to underscore the importance of 
training specialists in foreign languages, cultures and international 
business who can offer their skills to the government, the private 
sector, educational institutions and the media, and who can communicate 
across cultures on our behalf.

                  PROGRAM OVERVIEW AND FUNDING HISTORY

    In 1958 at the height of the cold war, Congress created these 
programs out of a sense of crisis about United States ignorance of 
other countries and cultures. They have served as the lynchpin for 
producing international specialists for nearly five decades. Expanding 
over time to meet new global challenges, fourteen Title VI/Fulbright-
Hays programs support activities to improve our educational 
capabilities, from K-12 through the graduate levels and advanced 
research, with emphasis on the less commonly-taught languages and areas 
of the world. Title VI largely supports the domestic side of training 
and research, while Fulbright-Hays supports the overseas component. The 
programs leverage a large amount of additional non-Federal resources 
and are relied upon by other Federal and non-Federal programs. Outside 
resources are essential incentives to develop and sustain these 
interdisciplinary programs, underwrite high cost programs in the less 
commonly-taught languages and areas, and provide extensive outreach and 
collaboration among educational institutions, government agencies, and 
corporations.
    Developing the international expertise the Nation will need in the 
21st Century requires educational reform and sustained financing. 
International expertise cannot be produced quickly. Just as the Federal 
Government maintains military reserves to be called upon when needed, 
it should invest steadily in an educational infrastructure that trains 
sufficient numbers and diversity of American students. Unfortunately, 
historical under-funding of Title VI and Fulbright-Hays combined with 
expanding needs and rising costs have contributed to the Nation's 
shortfall in specialists today. A March 2007 report by the National 
Research Council concludes: ``Title VI/FH funding, including staff 
resources, has not kept pace with the expansion in the mission of the 
programs.'' Funding for key Title VI/Fulbright-Hays programs is more 
than 30 percent below the high point in fiscal year 1967. For example, 
only 1,561 or 33 percent fewer Foreign Language and Area Studies 
fellowships were awarded in fiscal year 2007 compared to 2,344 in 
fiscal year 1967. Four years of level funding combined with across-the-
board cuts since fiscal year 2003 eroded by 10 percent in real terms 
the fiscal year 2002-2003 funding increases. Our statement today speaks 
to the urgent need to resume the infusion of new funds into Title VI/
Fulbright-Hays, to ensure that this expertise is readily available when 
needed.

         WHY INVESTING IN TITLE VI/FULBRIGHT-HAYS IS IMPORTANT

    Our national security, stability and economic vitality depend, in 
part, on American experts who have sophisticated language skills and 
cultural knowledge about the various areas of the world.
    Government Needs.--The quantity, level of expertise, and 
availability of U.S. personnel with high-level expertise in foreign 
languages, cultures, political, economic and social systems throughout 
the world do not match our national strategic needs at home or abroad.
  --``All of our efforts in Iraq, military and civilian, are 
        handicapped by Americans' lack of language and cultural 
        understanding. Our embassy of 1,000 has 33 Arabic speakers, 
        just six of whom are at the level of fluency. In a conflict 
        that demands effective and efficient communication with Iraqis, 
        we are often at a disadvantage. There are still far too few 
        Arab language--proficient military and civilian officers in 
        Iraq, to the detriment of the U.S. mission.'' The Iraq Study 
        Group: The Way Forward--A New Approach, December 2006.
  --``We have begun the process to imbed language and regional 
        expertise as a core military skill. The need for language and 
        regional expertise has long been a core requirement for Special 
        Forces Command, but as the type of conflicts and wars in which 
        we engage change, and irregular operations and 
        counterinsurgency and stability operations increase, language 
        and regional expertise and cultural awareness become key skills 
        needed by every Soldier, Marine, Sailor, and Airman for this 
        century's global and ever-changing mission.'' David S.C. Chu, 
        Under Secretary of Defense for Personnel and Readiness, before 
        the Senate Armed Services Personnel Subcommittee, March 2006.
  --``It is a mark of how far the FBI still has to go to remake itself 
        into a first-rate counter-terrorism force that 5 years after 
        Sept. 11, 2001, it has only 33 special agents, with one more on 
        the way, who speak Arabic. Most of them don't speak it very 
        well. Only six have a rating of ``advanced professional'' in 
        the language_one twentieth of 1 percent of the bureau's 12,000 
        agents.'' Washington Post Editorial, October 2006.
    Workforce Needs.--National security is increasingly linked to 
commerce, and U.S. business is widely engaged around the world with 
joint ventures, partnerships, and economic linkages that require its 
employees to have international expertise both at home and abroad.
  --``Most of the growth potential for U.S. businesses lies in overseas 
        markets. Already, one in five U.S. manufacturing jobs is tied 
        to exports. In 2004, 58 percent of growth in the earnings of 
        U.S. businesses came from overseas. Foreign consumers, the 
        majority of whom primarily speak languages other than English, 
        represent significant business opportunities for American 
        producers, as the United States is home to less than 5 percent 
        of the world's population.'' Education for Global Leadership, 
        Committee for Economic Development, 2006.
  --``A study on the internationalization of American business 
        education found that knowledge of other cultures, cross-
        cultural communications skills, experience in international 
        business, and fluency in a foreign language ranked among the 
        top skills sought by corporations (especially small and mid-
        size) involved in global business. Despite new efforts to 
        internationalize business education in the last decade, U.S. 
        business schools still fall short of fulfilling the need of 
        businesses for personnel who can think and act in a global 
        context.'' U.S. Business Needs for Employees with International 
        Expertise, Ben L. Kedia and Shirley Daniel, January 2003.
  --The war on terrorism threatens U.S. economic prosperity--and 
        economic stability worldwide--in ways that are not yet entirely 
        understood. Businesses are re-evaluating the risks they face 
        for their employees, their products and services, and their 
        investments in domestic and global markets. The Title VI 
        Centers for International Business Education and Research are 
        mobilizing the intellectual resources of U.S. universities to 
        focus on homeland security and risks in global markets for 
        American business. See: Homeland Security & U.S. International 
        Competitiveness, CIBERWeb.msu.edu.
    Improving our Image Abroad.--More Americans with understanding of 
other cultures and proficiency in foreign languages helps to improve 
the Nation's tarnished image abroad.
  --Undersecretary of State for Public Diplomacy and Public Affairs 
        Karen Hughes in an interview with Parade magazine places some 
        of the responsibility for America's image abroad on the United 
        States. The article states: ``She talks about how--before 9/
        11--people abroad perceived the United States as being 
        uninterested in the rest of the world. Our military, cultural 
        and economic power `buy resentment around the world,' she says. 
        `It will take all of us to address that. Any American who 
        travels abroad is an ambassador for our country, and I hope 
        you'll demonstrate the respect America has for different 
        countries and cultures.' She'd like more U.S. students to study 
        abroad and more Americans to learn a foreign language.'' 
        Interview with Karen Hughes in PARADE MAGAZINE: ``Can the U.S. 
        Rebuild Its Image?'' January 28, 2007.
    Language and Area Training.--Title VI/Fulbright-Hays programs 
expand foreign language and area studies enrollments, train K-16 
foreign language teachers, and build the training infrastructure in the 
less commonly-taught languages and areas most needed by the national 
security agencies, such as Chinese, Russian, Arabic, Korean, Hindi, 
Urdu, among many others.
  --Title VI institutions account for 3 percent of all colleges and 
        universities that offer language instruction, but 21 percent of 
        undergraduate enrollment and 56 percent of graduate enrollment 
        in the less commonly taught languages. For the rare languages, 
        Title VI institutions account for 49 percent of undergraduate 
        and 78 percent of graduate enrollments.
  --Title VI institutions provide instruction in roughly over 130 
        languages and in 19 world areas, and have the capacity to teach 
        over 200 languages. Because of the high cost per student, many 
        of these languages would not be taught on a regular basis at 
        all but for Title VI and Fulbright-Hays support.
  --The decline in foreign language enrollments in higher education 
        from 16 percent of total student enrollments in 1960 to just 
        8.7 percent today must be reversed to meet the increasing 
        demand for globally competent personnel, and to address 
        national needs.
  --Only 5 percent of all higher education students taking foreign 
        languages study non-European languages spoken by roughly 85 
        percent of the world's population.
  --U.S. educational institutions from K-16 face a shortage of teachers 
        with global competence, especially foreign language teachers of 
        the less commonly taught languages. Faculty in professional 
        disciplines require greater international expertise.

   PRESIDENT'S FISCAL YEAR 2008 REQUEST AND THE COALITION'S RESPONSE

    The President's fiscal year 2008 budget recommends $105.75 million 
for Title VI and Fulbright-Hays. This represents the same level as 
fiscal year 2006 for these programs. As part of the National Strategic 
Language Initiative (NSLI), a $1 million E-learning clearinghouse for 
critical need languages is proposed at the expense of existing Title VI 
programs that also serve foreign language needs. The Coalition proposes 
$132.6 million for fiscal year 2008. We support the creation of the E-
learning clearinghouse only if new funds are made available and a 
broader spectrum of less commonly taught languages than the 
administration is recommending is included.

    WHAT ADDITIONAL FUNDING OF $26.9 MILLION OVER THE REQUEST WOULD 
                               ACCOMPLISH

    Strengthen foreign language, area and international business 
education and research: $114 million for Title VI, Parts A&B--a $22.5 
million increase.
  --Fund an Additional 350 Academic Year and 200 Summer Title VI 
        Foreign Language (FLAS) Fellowships--35 Percent More Than the 
        Request.--This would restore the number of foreign language 
        academic year fellowships to about 85 percent of the number 
        funded in fiscal year 1967, and 100 percent of the number of 
        summer fellowships funded in that year. Cuts or level funding 
        since fiscal year 2003 have resulted in a cumulative loss of 
        over 340 academic year fellowships in the last 4 years. ($10.75 
        million)
  --Increase the Center Grants for the National Resource Centers (NRC), 
        Language Resource Centers (LRCs), and Centers for International 
        Business Education and Research (CIBERs) to Their Fiscal Year 
        2003 Levels Adjusted for Inflation.--Cuts, inflation, and an 
        increase in the number of centers in last year's competition 
        have caused a 15-20 percent reduction (adjusted for inflation) 
        in the average grant for these vital centers. This would 
        restore center awards that have eroded over the last 4 years to 
        about 100 percent of their fiscal year 2003 levels in real 
        terms. The additional funding will: (1) accelerate efforts to 
        begin training a new generation of international/language 
        specialists and faculty, especially for the less commonly 
        taught languages, who will be needed to replace those expected 
        to retire over the next decade; (2) expand professional 
        development for teachers of critical languages at both the K-12 
        and higher education levels, as well as the development of 
        widely accessible critical language teaching materials and 
        assessments for students of critical languages; and (3) step up 
        programs in the critical languages in business education, as 
        well as expand research and education on homeland security and 
        risk management. ($8.5 million)
  --Sustain and strengthen other Title VI activities, including the 
        undergraduate foreign language and international studies, 
        international research and studies, business and international 
        education programs, American Overseas Research Centers, and 
        information technology innovation. Additional funds would build 
        and strengthen programs in critical languages, including 
        advanced language training at home and abroad. It would also 
        increase resources for the development of curriculum materials, 
        assessment instruments and research, as well as obtaining from 
        abroad and disseminating educational information about world 
        regions. ($3.25 million)
    Increase the diversity of U.S. students who major in international 
fields: $3 million for the Institute for International Public Policy, 
TVI-C--a $1.4 million increase. The Institute for International Public 
Policy responds to the national need for a diverse pool of well-
trained, language-proficient professionals to enter the Foreign Service 
and related careers. The additional funds would raise the number of 
entering fellows by 50 percent and extend the pipeline to recruit 
graduate students and those working in international affairs to focus 
on strategic languages and issues. It also would restore and expand the 
capacity building grants for minority serving institutions to 
strengthen foreign language instruction on campus and in local 
secondary schools, including collaborative efforts with other Title VI 
grantee institutions.
    Strengthen the overseas component of research and training of 
Americans in foreign languages and international studies: $15.6 million 
for Fulbright-Hays--a $3 million increase. Fulbright-Hays provides an 
essential overseas component for research and training of Americans in 
foreign languages and international studies. Overseas immersion is 
critical to achieving high levels of foreign language proficiency. All 
of the Fulbright-Hays programs require strengthening, with emphasis on 
increasing the number of research abroad fellowships and group projects 
abroad in intermediate and advanced language training in strategic 
world areas, and expanding curriculum development and summer seminars 
abroad for K-12 teachers.

                      APPROPRIATIONS BILL LANGUAGE

    In the last 6 years, Congress has enacted language in the 
appropriations bill to provide these programs with more flexibility for 
overseas immersion opportunities for foreign language training, and to 
permit use of Fulbright-Hays funds, in addition to teaching, in fields 
including government, professional fields or international development. 
It also provides a 1 percent set aside for the Department of Education 
to carry out evaluation, outreach and dissemination activities. The 
Coalition recommends a continuation of the following language, but with 
the insert noted in bold to provide the Secretary with more flexibility 
in using the 1 percent set-aside.

    ``Provided further, That notwithstanding any other provision of 
law, funds made available in this act to carry out title VI of the 
Higher Education Act of 1965, as amended, and section 102(b)(6) of the 
Mutual Educational and Cultural Exchange Act of 1961 may be used to 
support visits and study in foreign countries by individuals who are 
participating in advanced foreign language training and international 
studies in areas that are vital to United States national security and 
who plan to apply their language skills and knowledge of these 
countries in the fields of government, the professions, or 
international development: Provided further, That up to 1 percent of 
the funds referred to in the preceding proviso may be used for program 
evaluation, national outreach, and information dissemination activities 
[insert: that may be carried out by the Secretary or through grants and 
contracts to institutions of higher education or public and private 
nonprofit agencies and organizations]''

    Finally, the Coalition is eager to work with the subcommittee on 
several recommendations in the just released March 2007 National 
Research Council's report on these programs entitled, ``International 
Education and Foreign Languages: Keys to Securing America's Future.''
    We consider our request to be a modest one for programs vital to 
our Nation's long-term security and economic well-being. Thank you for 
your consideration of our views.
                                 ______
                                 
     Prepared Statement of the Coalition of Northeastern Governors

    The Coalition of Northeastern Governors (CONEG) is pleased to 
provide this testimony for the record to the Senate Subcommittee on 
Labor, Health and Human Services, Education, and Related Agencies 
regarding fiscal year 2008 appropriations for the Low Income Home 
Energy Assistance Program (LIHEAP). The Governors appreciate the 
subcommittee's continued support for the LIHEAP program and recognize 
the difficult challenges facing the subcommittee in this time of severe 
fiscal constraints. In light of the continuously increasing cost of 
home energy, the Governors request that Congress provide the authorized 
level of $5.1 billion in regular fiscal year 2008 funding as well as 
contingency funds to address energy emergency situations. Funding at 
the authorized level will restore some of the program's purchasing 
power and also provide States across the country with additional 
resources to help our most vulnerable citizens afford to heat their 
homes.
    Home energy prices--for heating oil, natural gas, propane and 
electricity--have dramatically increased in recent years. According to 
the Energy Information Administration, the average cost for home 
heating has risen from $550 during the winter of 2001-2002 to a 
projected $862 this year--a 56 percent increase. Low-income households, 
whose growth in income is far below the rise in energy prices, face the 
prospect of keeping their homes at unhealthy or unsafe temperatures, 
using unsafe alternative heating options, or accumulating high levels 
of home energy debt and the possibility of utility service shut-off. 
LIHEAP is a vital safety net for the most vulnerable of these low-
income households--the elderly and disabled living on fixed incomes, 
and families with small children. A recent survey by the National 
Energy Assistance Directors' Association (NEADA) found that LIHEAP 
eligible low-income households spent an average of 14 percent of their 
annual income on residential energy before LIHEAP assistance, but 11 
percent after LIHEAP benefits.
    The need for home heating assistance far exceeds available Federal 
and State resources. LIHEAP was able to assist 5.6 million households 
in fiscal year 2006--the highest level in over a decade, but more than 
80 percent of eligible households received no assistance. States across 
the country in recent years have seen significant increases in their 
regular LIHEAP caseloads, as well as in requests for emergency crisis 
from those households in imminent danger of a utility or fuel service 
cut-off. At the same time, recent price increases have caused the 
purchasing power of the LIHEAP dollar to plummet, defraying only a 
modest amount of a low-income household's total heating bill.
    Congress provided much-appreciated additional LIHEAP funds in 
fiscal year 2006, but most of these funds have already been obligated, 
will be used for crisis cases this year, or are reserved for cooling 
assistance for the upcoming summer. As energy prices continue to 
increase the need for home energy assistance, the reduced LIHEAP 
Federal funding level in fiscal year 2007 is forcing many States across 
the country to reduce benefits, limit crisis assistance, or consider 
closing the program early--even as winter moratoriums on utility shut-
off expire this spring.
    Without additional Federal resources, the States have limited 
options to assist these households in need. A continued reduction in 
benefits could result in limited assistance if recipient households are 
unable to purchase the required minimum delivery of home heating oil or 
make the necessary payment on utility arrearages. Many States have used 
State resources to supplement available LIHEAP funds. Limited 
opportunities exist to squeeze more assistance dollars from the 
program, since LIHEAP administrative costs are already among the lowest 
of human service programs. In order to deliver maximum program dollars 
to households in need, States in the Northeast have incorporated 
various strategies to minimize the program's administrative costs 
including using uniform application forms to determine program 
eligibility, establishing a one-stop shopping approach for the delivery 
of LIHEAP and related programs, sharing administrative costs with other 
programs, and using mail recertification.
    In spite of these State efforts to stretch Federal and State LIHEAP 
dollars, the need for the program is far too great. Increased Federal 
funding is vital for LIHEAP to assist the Nation's vulnerable, low-
income households faced with unaffordable home energy bills. An 
increase in the regular LIHEAP appropriation to $5.1 billion for fiscal 
year 2008 in addition to contingency funds will enable States across 
the Nation to help mitigate the potential life-threatening emergencies 
and economic hardship that confront the Nation's most vulnerable 
citizens. With these additional funds, States can provide assistance to 
more households in need, offer benefit levels that provide meaningful 
assistance, lessen the need for emergency crisis relief, plan and 
operate a more efficient program, and again make optimal use of 
leveraging and other cost-effective programs.
    We thank the subcommittee for this opportunity to share the views 
of the Coalition of Northeastern Governors, and we stand ready to 
provide you with any additional information on the importance of the 
Low Income Home Energy Assistance Program to the Northeast and the 
Nation.
                                 ______
                                 
                Prepared Statement of the College Board

                              INTRODUCTION

    The College Board is a national not-for-profit association of more 
than 5,000 member schools, colleges, and universities. Its mission is 
challenging: To connect students to college success and opportunity. 
One of the College Board's most ambitious and important teaching and 
learning programs is the Advanced Placement Program (AP). Comprised of 
37 college-level courses taught in high school, AP represents the 
highest standard of academic excellence in our Nation's schools and has 
become the most influential general education program in the country. A 
collaborative effort between motivated students, dedicated teachers, 
expert college professors, and committed high schools, colleges, and 
universities, the AP Program has allowed millions of students to take 
college-level courses and exams and to earn college credit or placement 
while still in high school since its inception in 1955. Ninety percent 
of the colleges and universities in the United States, as well as 
colleges and universities in 30 other countries, have an AP policy 
granting incoming students credit, placement, or both on the basis of 
their AP Exam grades. Many of these institutions grant up to a full 
year of college credit (sophomore standing) to students who earn a 
sufficient number of qualifying AP scores.
    President Bush's request for $122 million in support for AP--
including $90 million in new funding to train AP math, science, and 
world language teachers--will dramatically improve the quality of 
instruction in our Nation's schools. The ultimate outcome will be a 
substantial increase in the number of high school graduates who enter 
college with the desire and ability to succeed in science, technology, 
engineering, and mathematics (STEM) fields and compete in a global 
marketplace. Moreover, increased support for an expanded AP Program 
will contribute to the goal of raising standards and achievement in all 
of our Nation's high schools. The AP Program benefits both the students 
who take AP courses and those who do not take AP by promoting higher 
standards and better teaching in all classes. As such, a significant 
investment in the expansion of AP math, science, and world language 
programs will have a profound effect on the overall quality of 
education in our Nation's schools.

                       ADVANCED PLACEMENT PROGRAM

    AP is a time-tested program with an existing infrastructure of tens 
of thousands of teachers and a network of hundreds of training sites 
across the country. Funds invested in this program will not need to be 
dedicated to creating a new system for teacher professional 
development, course development, or the administration and scoring of 
assessments. That system already exists as a result of our efforts over 
the past 50 years, and as a result of the involvement of thousands of 
schools, colleges and universities in the operation of the AP Program. 
Thus, new Federal dollars invested in AP can go directly into teacher 
training and student preparation and support.
    The principles and values of the AP Program can be stated quite 
simply:
  --AP supports academic excellence. AP represents a commitment to high 
        standards, hard work, and enriched academic experiences for 
        students, teachers, and schools.
  --AP is about equity. The AP Program should be open to all students, 
        and we believe that every student should have access to AP 
        courses and should be given the support he or she needs to 
        succeed in these challenging courses.
  --AP can drive school-wide academic reform. Schools that use AP as an 
        anchor for setting high standards and raising expectations for 
        all students see significant returns not just in terms of AP 
        participation but in terms of increasing the overall quality 
        and intensity of their academic programs.
    Across the Nation, every State, and most school districts are 
exploring ways to raise standards and ensure that all students take 
challenging courses that prepare them for success in college and work. 
AP is recognized as a powerful tool for increasing academic rigor, 
improving teacher quality, and creating a culture of excellence in high 
schools. Students who take AP courses assume the intellectual 
responsibility of thinking for themselves, and they learn how to engage 
the world critically and analytically--both inside and outside of the 
classroom. This is an invaluable experience for students as they 
prepare for college or work upon graduation from high school. Moreover, 
schools in which AP is widely offered--and accessible to all students--
experience the diffusion of higher standards throughout the entire 
school curriculum.

                   AP MATHEMATICS AND SCIENCE COURSES

    Increasing rigorous math and science education in the United States 
will significantly boost our high school graduates' math and science 
proficiency, which will increase the number of students who enter 
college ready to succeed in programs of study leading to science, 
technology, engineering, and mathematics (STEM) careers. We urgently 
need to create those opportunities for our students. Today, only 32 
percent of American undergraduates earn degrees in science and 
engineering, compared to 66 percent of undergraduates in Japan, 59 
percent in China, and 36 percent in Germany. In 2004, China graduated 
600,000 engineers, India graduated 350,000, and the United States 
graduated 70,000.\1\
---------------------------------------------------------------------------
    \1\ Committee on Science, Engineering and Public Policy. Rising 
Above the Gathering Storm: Energizing and Employing America for a 
Brighter Economic Future. National Academies Press, 2006. This report 
notes that America appears to be on a ``losing path'' today with regard 
to our future competitiveness and standard of living.
---------------------------------------------------------------------------
    The AP Program is an important tool in this Nation's efforts to 
increase its economic competitiveness. AP math and science students are 
much more likely than other students to major in STEM disciplines than 
students whose first exposure to college-level math and science courses 
is in college. For example:
  --Sixteen percent of students who take AP Chemistry go on to major in 
        chemistry in college. By way of contrast, only 3-4 percent of 
        students who take general chemistry instead of AP chemistry 
        major in that field in college.
  --More than 25 percent of students who take AP Calculus go on to 
        major in a STEM field in college, and 40 percent of students 
        who take AP Physics major in physics in college.
    Furthermore, research indicates that AP math and science courses 
prepare American students to achieve a level of proficiency that 
exceeds that of students from all other nations. For example, in the 
most recent TIMSS assessments, U.S. Calculus students ranked No. 15 
(out of 16 countries) in the international advanced mathematics 
assessment. But AP Calculus students who scored a 3 or better on the AP 
Calculus Exam ranked first in the world. Even AP Calculus students who 
scored a 1 or 2 on the AP Calculus Exam--below ``passing''--were ranked 
second in the world. AP Physics students, as compared to other U.S. 
physics students and physics students internationally, were also at the 
top of the ranking.
    Most significantly, there are many more U.S. students who could 
succeed in AP math and science courses--if given the chance. By 
utilizing an existing, diagnostic tool called AP Potential, more 
students could be identified as individuals who have the potential to 
succeed in Advanced Placement classes but may not currently have the 
opportunity to do so. This year we anticipate that more than 100,000 
U.S. students will earn a 3 or above on the AP Calculus Exam--the score 
typically required for college credit. But in a national analysis of 
the math proficiency of students enrolled in U.S. high schools during 
the 2005-2006 academic year, we can identify, by name and school, an 
additional 500,000 students who have the same academic background and 
likelihood of success in AP Calculus as the 100,000 students who 
currently are fortunate enough to have an AP Calculus course available 
to them.
    If we look at Biology, we see an even larger gap; we expect that 
about 74,000 students will earn exam grades of 3 or higher on the AP 
Biology Exam this year, whereas we know that at least 640,000 
additional U.S. students have the academic skills that would enable 
them to succeed in AP Biology if they only had a course available to 
them and the encouragement to take on this challenge. There are 
hundreds of thousands of high school students in the United States who 
are prepared and ready to succeed in rigorous high school courses such 
as AP Calculus, AP Biology, AP Physics, and AP Chemistry. In many 
cases, the only thing preventing them from learning at this higher 
level is the lack of an AP teacher in their school or the lack of 
adequate encouragement and support to take the AP course.

                               CONCLUSION

    AP is not for the elite, it is for the prepared. The tremendous 
potential of AP to drive reform in a powerful way in all of our 
Nation's schools is well established, and no other program has as 
strong an impact on overall student and teacher quality as AP. The 
committee's support for expanded AP math, science, and world language 
courses and exams will prepare many more students for the opportunity 
to compete in a global environment and succeed in STEM fields in 
college and work. We respectfully urge that you fully fund the 
administration's AP expansion request.
                                 ______
                                 
          Prepared Statement of the Cooley's Anemia Foundation

    Mr. Chairman and members of the subcommittee: Thank you for the 
opportunity to present this testimony to the subcommittee today. My 
name is Frank Somma. I live in Holmdel, New Jersey and I am honored to 
serve as the National President of the Cooley's Anemia Foundation. As 
many members of this subcommittee know, Cooley's anemia, or 
thalassemia, is a fatal genetic blood disorder.
    I could bog you down in a detailed scientific explanation of what 
happens physiologically when the human body cannot produce red blood 
cells in adequate numbers and of adequate quality to sustain life. I am 
not going to do that. The important thing for members of this 
subcommittee to remember about Cooley's anemia is that it is a fatal 
genetic blood disorder. Period.
    I also understand that I can present you with five pages of 
detailed single-spaced testimony. I am not going to do that either. 
Instead, I am respectfully going to address the following three issues 
in a clear and succinct manner.
  --The first is the immediate need to retain $1.94 million in the 
        CDC's Division of Blood Disorders to fund the thalassemia blood 
        safety surveillance network. This program works for thalassemia 
        patients, and for all Americans, by providing a mechanism to 
        take immediate actions to keep the blood supply safe when a 
        threat emerges.
  --The second issue is the equally critical need for this subcommittee 
        to commit our government through the NIH--and more specifically 
        through NHLBI--to the development of a vigorous, ethical, 
        progressive and focused gene therapy program that is designed 
        to cure gene disorders in the shortest possible time.
  --The third issue is the urgent need to increase funding for the NIH 
        by 6.7 percent a year for the next 3 years to assure the 
        continuation of desperately needed research at NIDDK for the 
        Thalassemia Clinical Research Network at NHLBI.

                       BLOOD SAFETY SURVEILLANCE

    Mr. Chairman, when a baby is diagnosed with Cooley's anemia, or 
thalassemia major, the standard of treatment is to begin that child on 
blood transfusions. I want to be very clear here that the treatment is 
not to give the child a blood transfusion; it is to begin a lifetime 
treatment regimen of this most invasive and dangerous intervention. 
Once diagnosed, our patients will receive a blood transfusion every 2 
weeks for the rest of their lives.
    Because Cooley's anemia patients are transfused so regularly, they 
represent an ``early warning system'' for problems in the blood supply. 
If there is an emerging infection or other problem with the blood 
supply, it is our patients that will get it first and, because of their 
fragile health, will likely suffer more greatly from this secondary 
complications.
    Please understand that nearly every patient over the age of 18 
today who has thalassemia major also has HIV or hepatitis C as a result 
of their transfusions--or did have it while they were still alive.
    Blood safety is a major national issue. Surgical and trauma 
patients often have no choice but to be transfused. And, it is done on 
an emergency basis many times. Nothing is more important to the patient 
at the time of transfusion than that they can be confident that the 
blood being pumped into their veins is free from infectious agents--
HIV, HCV, or something that none of us have yet heard and doctors have 
yet to identify.
    The blood safety surveillance program is currently operating very 
effectively through the Division of Blood Disorders in the National 
Center for Birth Defects and Developmental Disability (NCBDDD) with 
about $1.94 million in funding. While the funding is currently in 
place, this subcommittee and its staff are painfully aware that CDC 
management attempted to eliminate it following the passage of the 
fiscal year 2007 Continuing Resolution.
    We are respectfully urging that the subcommittee retain this 
funding at the $1.94 million level that currently exists in order to 
continue to protect Americans from unnecessary infections and diseases 
that may occur in the blood supply. Also, we are requesting that the 
subcommittee and its staff remain vigilant in protecting this program 
from unjustified and unjustifiable assaults.

                              GENE THERAPY

    Mr. Chairman, as you know, in the last year or 2 we have begun to 
see evidence of some very good news about gene therapy. After decades 
of overblown promises and false starts, we can now see a pathway for 
scientists to follow to help make the promise of gene therapy become 
the reality of cures. The problem to this point in the long saga that 
is gene therapy has not been one of science; it has been one of 
expectations. As a society, we all forgot that science requires trial 
and error and that experiments are just that--experiments. Sometimes 
they succeed, but often they fail. And, when they fail, we need to 
analyze what happened and identify how to correct it . . . and then try 
again.
    Today, gene therapy is advancing at a rapid pace in the rest of the 
world. Exciting work is being undertaken in Japan and China, in the UK 
and in France. Unfortunately, it is showing less progress the United 
States of America . . . and that is not right. We are the international 
leaders in scientific research and, in a field like this--fraught with 
financial, scientific and ethical minefields--it is essential that 
America demonstrate its continued leadership to the world. We set the 
highest ethical and moral standards on every one of these issues. We 
protect human subjects best. The future of gene therapy as a means of 
curing disease is simply too important to leave it to anyone else.
    For persons with a single cell mutation disorder like thalassemia 
or sickle cell disease or severe combined immune deficiency (SCID), 
gene therapy holds tremendous promise for a cure. In fact, the CAF has 
recently launched the CURE Campaign: Citizens United for Research 
Excellence. The theme of the campaign is ``It is Time to Cure 
Something.'' We are now learning so much about how to deliver healthy 
genes to unhealthy cells that we cannot turn back--nor can we as a 
Nation afford to let down the scientists in this country who have such 
a depth of knowledge and experience. Our friends in Europe and Asia are 
leaping ahead of us in this critical area of biomedical research and 
gene therapy.
    We hope that this Congress--speaking through this subcommittee--
will do what we have done and dare the NIH and its grantees to ``cure 
something.'' You are investing nearly $29 billion of taxpayer money in 
this agency that houses the ``best and the brightest'' and that funds 
``the best and the brightest.'' We as Americans must never stop 
striving to reach previously unimaginable heights. If that means that 
we have to shake up the status quo and create a new funding mechanism, 
let's do it. But let's not continue to follow the slow going 
incremental, some might say ``glacial'' path of the past.
    We need to spend our tax dollars in a coordinated and focused 
manner that will maximize the chances that we will unlock the secrets 
of how to correct single gene defects. We are gaining direct knowledge 
of how to safely proceed, with an experiment currently being 
conducted--in France--that may be a breakthrough. It is time for the 
United States to step up and lead the world in this life-saving area of 
research.

           NIH AND THE THALASSEMIA CLINICAL RESEARCH NETWORK

    Mr. Chairman, 6 years ago, working closely with members of this 
subcommittee from both sides of the aisle, the CAF convinced the NHLBI 
of the need to create a Thalassemia Clinical Research Network. The 
purpose of the Network is to create an infrastructure that would enable 
the top researchers in the field to collaborate on desperately needed 
research projects using common protocols. Today, the Network is up and 
running and is the focal point for thalassemia research, most of which 
takes place in academic medical centers, literally spread from coast to 
coast.
    However, there remains a cloud hanging over this, and all other, 
research at NIH. As the Biomedical Research and Development Price Index 
continues to escalate, the buying power of an NIH that has been flat-
funded for 4 years continues to decrease. There would be nothing wrong 
with this if we had cured thalassemia, and hemophilia, and cystic 
fibrosis, and all other genetic and non-genetic diseases. But that is 
not the case.
    There is an enormous amount of work to be done, treatments to be 
developed and cures to be found. And there is no one else to do it but 
our National Institutes of Health, with the support of our Congress and 
President.
    I urge the subcommittee to make a commitment this year in this bill 
to a 6.7 percent increase per year for NIH for the next 3 years. This 
level of funding will simply bring us back to where were in fiscal year 
2003 at the end of the 5 year doubling. It is time to commit to undo 
the damage that has been done in the last 4 years.

                               CONCLUSION

    As I indicated at the outset, Mr. Chairman, the Cooley's Anemia 
Foundation has three priorities this year:
  --Funding the blood safety surveillance program at CDC at $1.94 
        million;
  --An enhanced focus on gene therapy designed to cure something; and,
  --A 6.7 percent increase in NIH funding per year for 3 years.
    Mr. Chairman, every night when I watch my beautiful, smart, 
talented 22 year old daughter Alicia suffer from the complications of 
thalassemia such as osteoporosis and as I watch her endure daily 8-10 
hours of painful drug infusions to remove the excess iron in her system 
from her bi-weekly blood transfusions, I know we can do better than 
what we are doing now.
    Please excuse my passion, but this is the United States of America. 
I know we can prevent this disease from happening in newborns. I know 
we can improve the lives of those who currently have it. And, most 
importantly, I know that we can cure it once and for all.
    You don't need four pages of testimony from me to do that. You just 
need to demand the very best from the very best--our scientists, our 
government, and ourselves.
    Thank you for your very kind attention and for all the support this 
committee has shown to our patients and their families over the years.
                                 ______
                                 
  Prepared Statement of the Consortium of Social Sciences Associations

    Mr. Chairman and members of the subcommittee, the Consortium of 
Social Science Associations (COSSA) appreciates and welcomes the 
opportunity to comment on the fiscal year 2008 appropriations for a 
number of agencies in the Department of Health and Human Services and 
the Department of Education. COSSA is an advocacy group promoting 
attention to and funding for social and behavioral science research. It 
is supported by more than 110 professional associations, scientific 
societies, universities, centers and research institutes. A list of our 
members is attached.

           AGENCY FOR HEALTHCARE RESEARCH AND QUALITY (AHRQ)

    The mission of AHRQ is to promote health care quality improvement 
by conducting and supporting health services research that improves the 
outcomes, quality, access to, cost, and utilization of health care 
services. As the lead Federal agency charged with supporting research 
designed to improve healthcare, AHRQ-sponsored research provides 
evidence-based information that empowers healthcare decisionmakers--
patients, clinicians, health system leaders, and policymakers--to make 
informed decisions that impact the quality of healthcare services 
delivered.
    Health services research also addresses issues of organization, 
financing, utilization, patient and provider behavior, quality, 
outcomes, effectiveness, and costs. Since fiscal year 2005, AHRQ has 
lost nearly $20 million in purchasing power due flat funding from 
Congress and inflation. As a member of Friends of AHRQ, COSSA supports 
the Friends' recommendation for a funding increase of at least $30 
million--just .0015 percent of the $2 trillion we spent on health care 
annually.
    This funding level would allow AHRQ to support ongoing efforts to 
improve the quality, safety, outcomes, access to and cost and 
utilization of health care services. In addition, AHRQ will be able to 
expand its efforts to improve patient safety, modernize health care 
through health information technology, develop the next generation of 
researchers, and evaluate the relative value of alternative 
technologies.

            CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

    The CDC is the lead Federal agency for promoting health and safety 
and providing credible health information through strong partnerships, 
both nationally and internationally. As the command center for our 
Nation's public health defense system against emerging and reemerging 
infectious diseases, the CDC faces unprecedented challenges and 
responsibilities, ranging from chronic disease prevention, eliminating 
health disparities, bioterrorism preparedness, to combating the obesity 
epidemic. COSSA commends the CDC for acknowledging that as human 
behavior and demographics create new public health challenges, the 
expertise within the social and behavioral sciences will be critical in 
keeping the American public healthy. These behavioral factors--tobacco 
use, poor diet, physical inactivity, risky sexual behavior and illicit 
drug use--are, according to the CDC, ``the underlying causes for nearly 
half of all deaths in the United States.''
    As a member of the CDC Coalition, a nonpartisan coalition of more 
than 100 groups committed to strengthening our Nation's prevention and 
health promotion programs, COSSA supports the Coalition's 
recommendation of a $10.7 billion appropriation for CDC (including 
funding for the Agency for Toxic Substances and Disease Registry, and 
the Vaccines for Children Program). This funding enables the agency to 
carry out its mission to protect and promote good health and to assure 
that research findings are translated into effective State and local 
programs. CDC's programs are crucial to the health of millions of 
Americans, a key to maintaining a strong public health infrastructure, 
and essential in protecting us from threats to our health.
    The National Center for Health Statistics (NCHS), housed within 
CDC, provides critical information to guide actions and policies to 
improve the health of the American people. NCHS data document the 
health status of the U.S. population and identify disparities in health 
status and the use of health care by race/ethnicity, socioeconomic 
status, region, and other population characteristics. New demands for 
health information exceed the capacity of our current data systems. At 
few points in recent history has the need for information been greater.
    Stagnant and reduced funding throughout most of the last decade has 
forced significant reduction in some of the NCHS' most important 
monitoring tools. Since fiscal year 2005, NCHS has lost $13 million in 
purchasing power due to a combination of flat funding and inflation. As 
a result, key NCHS programs are in jeopardy. For example, NCHS lacks 
resources to collect a full year's worth of vital statistics from 
States. Without at least $3 million in additional funding, we will 
become the first industrialized Nation unable to continuously collect 
birth, death, and other vital information. Funding shortfalls are also 
preventing the collection of data on many other key health care issues.
    As a member of the Friends of NCHS, COSSA supports the Friends 
recommendation of a fiscal year 2008 funding level of $117 million for 
the agency, an increase of just $8 million over fiscal year 2007.

               THE INSTITUTE OF EDUCATION SCIENCES (IES)

    Improving the education of our children may be the most widely 
shared priority in the United States today. Support for other issues 
may come and go, but recognition of the importance of education and the 
government's opportunity to improve the state of education in our 
Nation seems only to grow. Indeed, through No Child Left Behind (NCLB), 
the President has made education his top domestic priority. Members 
from both sides of the aisle have offered legislation to reform and 
improve the educational system. Yet after the legislation passes, what 
will guide the policies that underlie the education our children 
receive? Most people, including the current administration, would agree 
that what should guide education policy is what works best. We can 
accomplish finding what works best through impartial, scientific 
research that evaluates the efficacy of programs in an objective, 
systematic way and subjects findings to public scrutiny and scientific 
peer review.
    The Education Sciences Reform Act of 2002 reauthorized the 
Department's educational research, statistics, and assessment 
activities and placed them in the newly created IES. A cornerstone of 
the administration's NCLB initiative is investment in research to 
identify effective instructional and program practices, as well as data 
collection needed to track student achievement and measure education 
reform. The new structural and management reforms underway at IES 
insure that the Federal investment in education research is well 
managed and relevant to the needs of educators and policymakers.
    The $162.5 million request for research, development, and 
dissemination would support IES-sponsored education research, 
development, and dissemination, and the funding of discretionary grants 
and contracts that support directed and field-initiated research. The 
request would also include funding for the What Works Clearinghouse, 
which provides evidence-based information for policymakers, 
researchers, and educators on promising approaches and interventions, 
the National Library of Education, and the Education Research 
Information Clearinghouse (ERIC). COSSA supports increasing this amount 
to $180 million. This funding increase would enable IES to continue to 
support a diverse portfolio of directed and field-initiated research, 
including its eight national research and development centers. To 
strengthen the education research enterprise, new opportunities are 
needed for investigator-initiated studies that move the field forward 
with innovative methods and research ideas.
    The $29 million increase for the National Center for Education 
Statistics (NCES), which COSSA strongly supports, would allow it to 
conduct a pilot study on the development of a postsecondary student 
level data system that is essential for computing postsecondary 
completion rates and measuring the true costs of higher education. 
Funds also would support a new secondary school longitudinal study, 
scheduled to begin in 2007, which will follow a ninth grade cohort 
through high school and college.
    Assessment is a critical part of the President's education plan No 
Child Left Behind (NCLB). The fiscal year 2008 budget request includes 
funding NAEP and the National Assessment Governing Board. The $23.5 
million increase, which COSSA supports, will allow the Department to 
complete preparations for implementing State-level assessments at the 
12th grade level in 2009.
    Part of the NCLB mission is closing the achievement gap. To this 
end, the President's budget would provide awards to enhance States' 
capacity for accurate reporting of high school graduation and dropout 
data, and to increase the capability of States to comply with Federal 
reporting requirements. The Statewide Data Systems program supports 
competitive awards to State educational agencies to foster the design, 
development, and implementation of longitudinal data systems that would 
enable States to use individual student data to enhance the provision 
of education and close achievement gaps. COSSA supports the proposed 
increase of $30 million for this activity in fiscal year 2008.

                      TITLE VI AND FULBRIGHT-HAYS

    The importance of knowing about foreign cultures, economies, 
histories, and politics, and the ability to speak other languages 
besides English is critical to functioning in today's world. On March 
27, the National Academies' released its report: International 
Education and Foreign Languages: Keys to Securing America's Future. The 
report concluded that the programs supported by the Department of 
Education--Title VI and Fulbright-Hays--were successful and useful and 
indicated that the country was getting internationally educated people 
at a small cost, because the universities are able to leverage the 
money from the Education Department. However, the report also proclaims 
that the funding for the Title VI and Fulbright-Hays programs has not 
kept up with the expanding pace of their mission as world conditions 
have changed dramatically.
    The historical under-funding of Title VI and Fulbright-Hays 
combined with expanding needs and rising costs have contributed to the 
Nation's shortfall in specialists today. As the Coalition for 
International Education (CIE), of which COSSA is a member, has pointed 
out funding for key Title VI/Fulbright-Hays programs is more than 30 
percent below the high point in fiscal year 1967. For example, only 
1,561 or 33 percent fewer Foreign Language and Area Studies fellowships 
were awarded in fiscal year 2007 compared to 2,344 in fiscal year 1967. 
Four years of level funding combined with across-the-board cuts since 
fiscal year 2003 have begun to erode the earlier gains. There is an 
urgent need to increase funding for these programs. COSSA supports the 
CIE's recommendation of a $132.6 million appropriation for fiscal year 
2008.

   JAVITS FELLOWSHIPS AND THURGOOD MARSHALL LEGAL OPPORTUNITY GRANTS

    COSSA supports increasing the funding for the Jacob Javits 
Fellowship Program, which provides graduate students with the funds to 
pursue advanced degrees in the social sciences, arts, and humanities. 
For many years the budget of this program has stagnated and in recent 
years across-the-board cuts have reduced a rather small budget even 
further. COSSA recommends funding at $12 million in fiscal year 2008. 
Providing student support for those pursuing degrees in these fields is 
important to the future of this country. America does not compete in a 
rapidly changing global environment by only supporting physicists and 
engineers!
    COSSA also supports the restoration of funding for the Thurgood 
Marshall Legal Opportunity Grants to help members of underrepresented 
groups prepare for a legal education. It is imperative that the legal 
profession look like the American we have become and are becoming. That 
means offering opportunities to those who need a leg up to obtain a 
legal education. COSSA recommends funding at $3 million in fiscal year 
2008.
    In conclusion, COSSA acknowledges the subcommittee's history of 
support for these critical programs that promote health, prevent 
disease, and help educate a new generation of students. We hope that 
support will continue in fiscal year 2008.
    Thank you for the opportunity to present our views.
                                 ______
                                 
               Prepared Statement of the COPD Foundation

                         AGENCY RECOMMENDATIONS

Department of Labor--Employment and Training Administration
    Training Demonstration to Employ Disabled Americans.--The 
Foundation recommends that the Department provide increased emphasis 
and support for training disabled Americans. The Chronic Obstructive 
Pulmonary Disease (COPD) Foundation initiative that trains COPD 
patients to work on a hotline that provides counseling and health 
referral information to COPD patients across the country is a project 
that uses technology based training, helps SSI and SDI recipients find 
employment, and helps meets documented job market demand. The 
Foundation urges favorable consideration of this and similar 
initiatives to train disabled Americans.

Center for Disease Control and Prevention--National Center for Chronic 
        Disease Prevention
    COPD Self Management Demonstration.--Chronic Obstructive Pulmonary 
Disease (COPD) is the fourth leading cause of death and is a chronic 
condition similar to diabetes that requires an aggressive self-
management in order to prevent continued deterioration, 
hospitalization, and costly medical interventions. In view of the 
increasing mortality, morbidity, and cost to the Nation's health care 
system, the Foundation urges CDC to demonstrate and validate 
intervention and training protocols that are needed to improve health 
outcomes and reduce health care costs for COPD patients. The Foundation 
urges CDC to work with leading health care organizations to develop and 
validate self management protocols.

Center for Disease Control and Prevention--National Center for Public 
        Health Informatics
    Increasing Awareness, Early Diagnoses, and Treatment for COPD.--The 
National Institutes of Health launched an information campaign in 
January, 2007 designed to increase awareness, diagnoses, and treatment 
for Chronic Obstructive Pulmonary Disease (COPD). COPD is a growing 
epidemic, the fourth leading cause of U.S. deaths, and affects 1 in 4 
Americans over the age of 45. More that 12 million people are currently 
diagnosed with COPD and it is estimated that another 12 million have it 
but remain undiagnosed despite recognizable symptoms and treatments 
that can control symptoms and prolong life. CDC is urged to collaborate 
with leading COPD health care organizations to support the effort to 
increase public awareness, early diagnosis, and treatment for COPD.

National Institutes of Health--National Heart, Lung, and Blood 
        Institute--Division of Lung Diseases
    Chronic Obstruction Pulmonary Disease.--Chronic Obstructive 
Pulmonary Disease (COPD) is a growing epidemic, the fourth leading 
cause of U.S. deaths, and affects one in four Americans over the age of 
45. In view of these trends, it is noted that only 10 percent of the 
Division of Lung Disease research portfolio is focused on COPD. The 
Foundation commends the Division of Lung Diseases for sponsoring 
several COPD workshops that have recommended additional research 
focused on the disease process, pathogenesis, and therapy and other 
recommendations. The Foundation recommends that the NHLBI aggressively 
pursue COPD research as recommended by these expert panels and convene 
a panel of leading researchers from across the country to create a COPD 
Research Action Plan to identify opportunities and to accelerate the 
pace of research.
    Mr. Chairman and members of the subcommittee thank you for the 
opportunity to submit testimony for the record on behalf of the COPD 
Foundation.

                          THE COPD FOUNDATION

    Established in 2004, the COPD Foundation has a clear mission: to 
develop and support programs, which improve the quality of life through 
research, education, early diagnosis, and enhanced therapy for persons 
whose lives are impacted by Chronic Obstructive Pulmonary Disease. 
Chronic obstructive pulmonary disease (COPD) is an umbrella term for a 
group of lung disorders that result in obstruction to airflow in the 
lung causing breathlessness. The four diseases classified under COPD 
are emphysema, chronic bronchitis, refractory asthma, and severe 
bronchiectasis. The COPD Foundation was established to speed 
innovations which will make treatments more effective and affordable. 
It also undertakes initiatives that result in expanded services for 
COPD patients and improves the lives of patients with COPD through 
research and education that will lead to prevention and someday a cure 
for this disease.
    The COPD Foundation is led by a diverse Board of Directors that 
includes patients with COPD, as well as some of the most recognized 
professionals involved in COPD clinical practice, research and patient 
care. Under the board's direction, the COPD Foundation has established 
policies based on industry best practices from the Better Business 
Bureau's Wise Giving Alliance and the National Health Council in areas 
of governance, accountability and transparency. The first of the COPD 
Foundation's research initiatives is a partnership with the Scarborough 
family for the Richard H. Scarborough Bronchiectasis Research Fund, 
aimed to support translational research to halt or reverse the airways 
destruction of bronchiectasis.

             COPD: FOURTH LEADING CAUSE OF DEATH AND RISING

    Chronic Obstructive Pulmonary Disease (COPD) was the fourth leading 
cause of death in 2003 based on the Centers for Disease Control and 
Prevention's final data, which attributes 126,382 deaths to COPD for 
the year. Given that figure, a person dies of COPD every 4 minutes, and 
because of the mechanisms of this devastating disease, he or she slowly 
suffocates to death over several years as airway obstruction and 
breathlessness increase. No one knows exactly how many people in the 
United States have this terrible disease, but estimates range from 12 
million diagnosed with another 12 million symptomatic, undiagnosed and 
at risk.
    The decreased ability to breathe causes severe physical and mental 
disability in afflicted individuals. In a 2004 survey, over 50 percent 
of patients said that their disease limited the amount or type of work 
they were able to do, and of those patients nearly 80 percent were 
unable to work at all due to their breathlessness. Many of these 
individuals would otherwise have the ability to continue working for 
many years.
    COPD cost the U.S. economy $32 billion in 2002 and it is estimated 
that 600 million people worldwide have the disease.

        THE MEDICAL NEEDS OF THE COPD COMMUNITY HAVE GONE UNMET

    While smoking is a predominant cause of COPD it is not the only 
cause. Other significant factors are second hand smoke, occupational 
dusts and chemicals, air pollution, and a genetic cause called alpha-1 
antitrypsin deficiency.
    The other leading causes of death have seen great improvements over 
the past several decades. While the mortality of COPD rose by 163 
percent from 1965-1998, the mortality of coronary heart disease 
decreased by 59 percent and the mortality of stroke decreased by 64 
percent.
    Yet this fourth leading cause of death is a hidden, silent killer. 
There is a lack of awareness among the public that coughing and 
breathlessness is not a normal sign of aging. Those diagnosed with this 
disease are quick to blame themselves and are ashamed of their disease 
because of the current societal stigma. Many lack the information for 
proper disease self-management, which could easily prevent 
exacerbations and thusly, many hospital and emergency room visits.
    Currently, the only therapy shown to improve survival is 
supplemental oxygen. There are other therapies that can improve 
symptoms but they do not alter the natural history of the disease.

                               DETECTION

    COPD is fairly easy to detect: in addition to symptoms of 
breathlessness, cough and sputum production, spirometry is a 
quantitative test that measures air volume and air flow in the lung and 
is relatively easy and inexpensive to administer.

                             COPD RESEARCH

    The COPD Foundation believes that significant Federal investment in 
medical research is critical to improving the health of the American 
people and specifically those affected with COPD. The support of this 
subcommittee has made a substantial difference in improving the 
public's health and well-being. While this is by no means an exhaustive 
list, the Foundation wishes to recognize and appreciate the efforts of 
the National Institutes of Health in creating the COPD Clinical 
Research Network, for conducting a COPD state of the science 
conference, and commends NHLBI for the national launch of the COPD 
Awareness and Education Campaign titled ``COPD Learn More Breathe 
Better''.
    Chronic diseases have a profound human and economic toll on our 
Nation. Nearly 125 million Americans today are living with some form of 
chronic condition. The Foundation recognizes that the Centers for 
Disease Control and Prevention understands that COPD is one of the only 
top 10 causes of death that is on the increase, however, COPD has not 
been designated the resources to be a major focus of the CDC. The 
Foundation urges the subcommittee to encourage the CDC to expand its 
data collection efforts and to expand programs aimed at education and 
prevention of the general public and health care providers.
    NIH and CDC: The Foundation requests that the National Institutes 
of Health in fiscal year 2008 receive an increase of 6.7 percent over 
fiscal year 2007 Joint Resolution Funding Levels. The COPD Foundation 
joins the Ad Hoc Group for Medical Research Funding, a coalition of 
some 300 patient and voluntary health groups, medical and scientific 
societies, academic research organizations and industry in making this 
recommendation. The fiscal year 2008 administration budget request for 
NIH is a $511 million cut (1.7 percent) below the final fiscal year 
2007 levels. If implemented, this funding level would mean NIH's 
ability to conduct and support life-saving research will be cut by more 
than 13 percent in inflation-adjusted dollars since fiscal year 2003. 
The NIH, National Heart Lung, and Blood Institute, National Institute 
of Allergy and Infectious Diseases and National Institute on Aging, 
should increase the investment in Chronic Obstructive Pulmonary Disease 
and the Centers for Disease Control and Prevention should initiate a 
Federal partnership with the COPD community to achieve the following 
goals:
  --Promotion of basic science and clinical research related to COPD;
  --Programs to attract and train the best young clinicians for the 
        care of individuals with COPD;
  --Support for outstanding established scientists to work on problems 
        within the field of COPD research;
  --Development of effective new therapies to prevent progression of 
        the disease and control symptoms of COPD;
  --Expansion of public awareness and targeted detection to promote 
        early diagnosis and treatment.
                                 ______
                                 
                Prepared Statement of the Corps Network

    The Corps Network (formerly the National Association of Service and 
Conservation Corps or NASCC) appreciates the opportunity to submit 
testimony to the subcommittee about the critical need for funding 
AmeriCorps and other national service programs in fiscal year 2008.
    We urge you to make much needed, and long overdue, investments in 
AmeriCorps and other national service programs supported by the 
Corporation for National and Community Service (CNCS).
    Specifically, we recommend that the subcommittee fund:
  --AmeriCorps State and National Grants at $312 million;
  --The National Service Trust at $143 million;
  --The National Civilian Community Corps (NCCC) at $26.7 million; and
  --AmeriCorps VISTA at $95 million.
    We believe that these funding levels would adequately support 
75,000 AmeriCorps members ands retain the historic balance between 
full- and part-time service.
    Established in 1985, The Corps Network is the voice of the Nation's 
113 Service and Conservation Corps. Currently operating in 41 States 
and the District of Columbia, Corps annually enroll more than 23,000 
young men and women who contribute 13 million hours of service every 
year. Corps annually mobilize approximately 125,000 community 
volunteers who contributed more than 2.4 million additional hours of 
service.
    Service and Conservation Corps are a direct descendent of the 
Civilian Conservation Corps (CCC) that built parks and other public 
facilities still in use today. Like the legendary CCC of the 1930s, 
today's Corps are a proven strategy for giving young men and women the 
chance to change their communities, their own lives and those of their 
families. Service and Conservation Corps provide a wealth of valuable 
conservation, infrastructure improvement and human service projects. 
Some Corps tutor and some fight forest fires. Others complete a wide 
range of projects on public lands. Still others improve the quality of 
life in low-income communities by renovating deteriorated housing, 
engaging in environmental restoration, creating parks and gardens and 
staffing after-school programs.
    Service and Conservation Corps serve young people who are most in 
need. Since 1985, approximately 600,000 young people have completed 
service in our Nation's Service and Conservation Corps. Approximately 
57 percent of our Corpsmembers are young people of color, 64 percent 
come from families with income below the poverty line, at least 30 
percent have had previous court involvement and at least 10 percent 
have been in foster care. More than half of all Corpsmembers enroll 
without a high school diploma.
    Today's Corps are a proven strategy for giving young men and women, 
many of whom are economically or otherwise disadvantaged and out-of-
work or out-of-school, the chance to change their own lives and those 
of their families, as well as improve their communities. Corps 
represent the country's largest full-time, non-federal system for youth 
development.
    I would like to share with you three examples of why AmeriCorps 
funds are so important to our Nation. The Corps Network administers 
three AmeriCorps programs, the Gulf Coast Recovery Corps, the Civic 
Justice Corps and RuralResponse that address important societal 
problems through service.
    The AmeriCorps Gulf Coast Recovery Corps:
  --Assists residents impacted by the devastation of Hurricane Katrina 
        and Rita in the long-term recovery efforts along the Gulf Coast 
        of Mississippi.
  --Deploys crews of young people (ages 18-25) from the Nation's 113 
        Service and Conservation Corps for 4-week projects that include 
        rebuilding homes and structures, chopping down damaged trees 
        near homes, removing debris, restoring trails, replanting marsh 
        grass and trees, performing environmental restoration and other 
        projects.
  --Brings a total of 300 trained and semi-skilled volunteers to the 
        region through the summer of 2007.
  --Partners with the Hancock County Long-Term Recovery Committee, 
        Mississippi Commission for Volunteer Service, St. Rose Delima 
        Catholic Church in Bay St. Louis, Mississippi State Parks, U.S. 
        Fish and Wildlife Service and other local and national 
        organizations working in the region.
  --Builds on the tradition of Corps helping communities recover from 
        natural disasters, including the San Francisco earthquake in 
        1989, Hurricane Andrew in 1992, the Mississippi River floods in 
        1993 and the aftermath of other major hurricanes, floods, 
        tornadoes, and wildfires.
  --Will pave the way for a permanent Mississippi Corps, funded in part 
        by the Mississippi Commission for Volunteer Service, to engage 
        local young people in the recovery efforts.
  --Is funded by the Corporation for National and Community Service's 
        Federal AmeriCorps program.
    The Civic Justice Corps (funded by AmeriCorps and the Department of 
Labor):
  --Re-engages court-involved youth and young adults, not less than 50 
        percent who have been incarcerated, in their communities, the 
        workforce, education and society as a whole, with the goal of 
        reducing recidivism by at least 20 percent.
  --Empowers Corpsmembers through a variety of service projects that 
        meet critical community needs.
  --Creates a support system that begins in the corrections facility, 
        continues through the time in the Corps and extends 12 months 
        after the Corps experience.
  --Formalizes effective working relationships with justice agencies, 
        employers and other partners.
  --Enables Corpsmembers to earn a high school diploma or GED while 
        preparing for careers in high-growth industries or 
        opportunities in post-secondary education.
  --Draws on the experience of Corps which enroll nearly 5,000 court-
        involved youth each year.
  --Represents a partnership between the Cascade Center for Community 
        Governance, the Open Society Institute, the JEHT Foundation and 
        The Corps Network.
  --Is funded by AmeriCorps in the following sites: Bend, OR; 
        Charleston, SC; Washington, DC.
  --Is funded by the U.S. Department of Labor in the following sites: 
        Austin, TX; Camden, NJ; Denver, CO; Fremont, OH; Fresno, CA; 
        Madison, WI; Miami, FL; Oakland, CA; Sacramento, CA; San Diego, 
        CA and Wheaton, MD.
    The RuralResponse AmeriCorps Program:
  --Enables Service and Conservation Corps to bolster homeland security 
        and disaster response capacity in underserved rural communities 
        by filling gaps in rural emergency response networks.
  --Engages young people (ages 16-25) each year in disaster response as 
        well as traditional service and conservation projects to meet 
        the needs of rural communities.
  --Trains Corpsmembers in specific disaster preparedness and response 
        activities such as first aid, adult and child CPR, mass care, 
        use of global positioning systems (GPS), shelter operations, 
        hazardous materials removal, chain saw safety and use and 
        wildfire suppression.
  --Prepares Service and Conservation Corps for long-term engagement 
        with existing disaster response and preparedness efforts in 
        rural communities.
  --Provides a minimum wage based living allowance and an AmeriCorps 
        Education Award (scholarship) of up to $4,725 per Corpsmember.
  --Requires a 33 percent non-federal match by Service and Conservation 
        Corps.
  --Is funded by AmeriCorps at $3.6 million over 3 years in the 
        following sites: Minnesota Conservation Corps, Quilter Civilian 
        Conservation Corps (Fremont, OH), Vermont Youth Conservation 
        Corps and Youth Conservation Corps, Inc. (Waukegan, IL).
    Our work in the Gulf Coast Recovery Corps, the Civic Justice Corps 
and Rural Response embodies many of AmeriCorps' core principles 
including:
  --Using service in creative ways to meet needs that would otherwise 
        go unmet;
  --Relying on public-private partnerships and using public dollars to 
        attract private funds;
  --A bottom-up structure in which the local community determines the 
        projects on which we work;
  --Communities demonstrate their support for projects by helping Corps 
        meet AmeriCorps' matching requirements;
  --Partnering with local government, State, and Federal land 
        management agencies and local nonprofit organizations, 
        including faith-based groups;
  --Providing an opportunity for all Americans to serve and 
        reconnecting disconnected youth to their communities by 
        insuring that Corpsmembers learn life skills and job skills 
        that enhance their employability; and
  --Using the AmeriCorps Education Award to make higher education 
        accessible to thousands of young people for whom it would 
        otherwise be too costly.
    While it is difficult to describe the ``typical'' Corps, successful 
Corps share common core elements. They:
  --Rely on a model in which adult leaders serve as mentors, role 
        models, technical trainers and supervisors for crews of 8-12 
        Corpsmembers;
  --Provide Corpsmembers with a minimum-wage based living allowance;
  --Offer classroom training to improve basic competencies, a chance to 
        earn a GED or high school diploma, experiential and 
        environmental service-learning-based education, generic and 
        technical skills training, a wide range of support services, 
        and, in many cases, an AmeriCorps post-service educational 
        award of up to $4,725.
  --Build on Corpsmembers' strengths to provide an environment in which 
        every Corpsmember can experience success. They offer consistent 
        contact with a caring adult, stress leadership development, 
        creative problem-solving, and the ability to work as a member 
        of a team; and
  --Provide Corpsmembers a ``second chance'' to succeed in life and 
        focus youth on the future.
    A 1997 Abt Associates/Brandeis University random assignment study 
concluded that Youth Service and Conservation Corps are an invaluable 
resource for young people. According to the study, Corps generate a 
positive return on investment and the youth involved were positively 
affected by joining a Corps. The report documents that:
  --Significant employment and earnings accrue to young people who join 
        a Corps;
  --Positive outcomes are particularly striking for African-American 
        men;
  --Arrest rates drop by one third among all Corpsmembers; and
  --Out-of-wedlock pregnancy rates drop among female Corpsmembers.
    Abt Associates documents several factors to which the effectiveness 
of Corps is attributed including:
  --Comprehensiveness of services;
  --Supportive and dedicated program staff;
  --Quality of the service projects;
  --Intensity of the service experience; and
  --Corpsmembers have access to an expanded social network.
    It is critical for CNCS to have sufficient resources to ensure that 
participants in national service programs are able to continue their 
crucial work. Restoring our investment in AmeriCorps State and 
National, the National Service Trust, AmeriCorps*NCCC and 
AmeriCorps*VISTA, will allow more Americans of all ages and backgrounds 
to serve and create greater capacity to meet critical community needs.
    Thank you for your consideration of these requests. If you have any 
questions, please do not hesitate to contact me at (202) 737-6272 or at 
[email protected].
                                 ______
                                 
      Prepared Statement of the Council of State and Territorial 
                            Epidemiologists

 PUBLIC HEALTH WORKFORCE: INCREASING STATE AND LOCAL EPIDEMIOLOGY AND 
                          LABORATORY CAPACITY

Recommendations
  --$5 million for the Office of Workforce and Career Development to 
        support 65 CDC/Council of State and Territorial Epidemiology 
        (CSTE) first year applied epidemiology fellows.
  --$2 million increase for the National Center for Infectious Diseases 
        to support 35 CDC/Association of Public Health Laboratories 
        (APHL) applied research training fellows.
    Building a strong public health infrastructure, particularly a 
trained public health workforce with sufficient epidemiologists and 
public health laboratory scientists--core public health professionals, 
will take a sustained commitment of resources over a long period of 
time.
    The disciplines of epidemiology and laboratory science are the 
pillars of public health practice. States and local communities have 
come to rely on public health epidemiologists and laboratory scientists 
to investigate, monitor, and respond aggressively to public health 
threats. Every State's residents have become familiar with the 
``disease detectives'' who communicate risks and provide preventive 
recommendations during incidents such as the recent outbreak of E. coli 
in spinach, seasonal influenza, West Nile virus, and epidemics of 
obesity, diabetes, HIV/AIDS and a host of other serious threats the 
public has experienced during recent years. The 2006 CSTE National 
Assessment of Epidemiologic Capacity shows the number and the level of 
training of epidemiologists is perceived as seriously deficient in most 
States. Federal funding has increased the number of epidemiologists 
engaged in bioterrorism preparedness since 2002, but has done so at the 
expense of State environmental health, injury and occupational health 
activities--shifting epidemiologists from these activities to Federal 
bioterrorism preparedness priorities. Those engaged in chronic disease 
activities have increased since 2002, but are still viewed as too low 
in number and training. According to the 2003 Institute Of Medicine 
report, Microbial Threats to Health: Emergence, Detection, and 
Response, rebuilding domestic public health capacity was among its 
highest recommendations for addressing both diseases occurring 
naturally and intentional release of microbial agents.
    Efforts under the leadership of CDC have been made to begin 
addressing these gaps. CDC is supporting training fellowship programs 
for epidemiologists and laboratory scientists who are expected to 
increase State capacity and provide future leadership in these 
professions. CSTE applauds these efforts and proposes aggressive 
expansion of existing state-focused programs to increase the number of 
epidemiologists and public health laboratory scientists at State and 
local health departments. The proposed fiscal year 2008 increase will 
provide CSTE and APHL with the resources to accelerate much needed 
expansion of the State and local workforce in these critical 
disciplines.
    States and localities will benefit through increased numbers of 
highly trained epidemiologists and laboratory scientists entering 
employment through training programs that include the following 
characteristics:
  --national recruiting through a partnership between CSTE and the 
        Association of Schools of Public Health;
  --orientation and training course with CDC, CSTE, and APHL faculty;
  --applicant pool for State and local positions with adequate time to 
        evaluate job performance;
  --a structured, individualized training curriculum for each fellow; 
        and
  --technical and administrative support for fellows and State mentors.
    The capacity and leadership legacy of these state-based programs is 
intended to be modeled on the success of the Epidemic Intelligence 
Service and provide States and localities with epidemiology and 
laboratory leadership for the future.

  STRENGTHENING CAPACITY IN FOUR CRITICAL PUBLIC HEALTH PROGRAM AREAS

Preparing for an Influenza Pandemic
    Fiscal year 2006 State and Local pandemic influenza preparedness 
funding is being used to: (1) create and implement, including 
exercising, emergency pandemic plans; (2) conduct integrated disease 
surveillance; (3) fund laboratory testing of influenza strains; (4) 
inform the public; (5) manage distribution of vaccine and antiviral 
medications; (6) plan for alternative facilities in the event of 
hospital capacity excess; (7) track vaccine and antiviral use; (8) 
document adverse outcomes from influenza-related medications. Continued 
funding at the level of $250 million in fiscal year 2008 will support 
these activities and help ensure that our health system is ready for 
the seasonal influenza epidemics and a potentially catastrophic 
influenza pandemic.
Epidemiologic-Laboratory Capacity (ELC Cooperative Grant Program)
    CSTE strongly supports a $53 million increase for the 
Epidemiologic-Laboratory Capacity program at the CDC for fiscal year 
2008. This increase will be instrumental in implementing the CDC plan 
Preventing Emerging Infectious Diseases: A Strategy for the 21st 
Century. This program, which supports health departments in 50 States 
and 6 highly populated cities/counties, was developed to repair the 
deteriorated surveillance and response capacity for emerging infectious 
diseases in health departments nationwide. Funds build capability to 
detect, diagnose, and prevent diseases caused by food, water and vector 
borne infections, vaccine preventable disease, and drug resistant 
infections. The early detection and prompt response to West Nile virus 
(WNV) in 2000 can be attributed to the foundations laid by this 
cooperative grant program. Funding reductions, beginning in 1998, have 
compromised the mission of this program and may contribute to a 
weakened ability to detect and respond to future disease threats. CSTE 
is very disappointed that the President's fiscal year 2008 budget cuts 
WNV funding by 45 percent. In an effort to maintain and build public 
health capacity, CSTE supports full funding ($110 million) for the ELC 
cooperative grant program in fiscal year 2008.
Terrorism Preparedness
    State and Local CDC Terrorism Preparedness Grants are used to 
fortify health department ability to detect and investigate disease 
occurrence, evaluate infectious outbreaks, and rapidly access, exchange 
and disseminate relevant information. Funding also provides surge 
capacity for personnel and supplies that will be needed in the event of 
a terrorist attack. In fiscal year 2006, funding was cut by $100 
million and remained at that level for fiscal year 2007. The 
President's fiscal year 2008 budget cuts funding further by $125 
million. While health departments nationwide have made good progress in 
emergency preparedness, these funding cuts have led to a decreased 
epidemiology and laboratory capacity due to downsized personnel that 
were paid with these funds. Further staff reduction, and concomitant 
reduction in surveillance performed, will leave our Nation's public 
health system unable to provide bioterrorism threat surveillance and 
response. CSTE recommends full funding at the fiscal year 2005 level--
$919.1 million.
Preventive Health--Health Services (PHHS) Block Grant
    CSTE is disappointed that the President's fiscal year 2008 budget, 
once again, eliminates all funding for the PHHS Block Grant and urges 
restoration of funding to the fiscal year 2005 level of $131 million. 
This grant program was developed to allow States flexible use of funds 
to support objectives identified at the local level. For example, a 
city with increasing incidence of whooping cough (Bordatella pertussis) 
would be able to use funds to intensively track cases and prevent 
spread of the disease. Other cities or States may use funds to address 
their region-specific disease trends, such as injection drug related 
morbidity, sexually transmitted disease, mother-to-child diseases, or 
hantavirus. Because of the variation in disease prevalence across our 
diverse Nation, flexible funding with local allocation capacity is 
necessary to achieve detection, prevention, and community outreach 
tasks for Americans. CSTE recommends restoration of the PHHS block 
grant to $131 million to limit the extent of local disease epidemics 
spreading to becoming national disease threats.

               SURVEILLANCE ISSUES: FIVE CSTE PRIORITIES

    Epidemiologists working in public health agencies are responsible 
for monitoring trends in health and health problems, and devising 
prevention programs that support healthy communities. Surveillance is 
the foundation for developing a public health response to any disease 
threat--be it infectious, chronic, environmental, occupational, or 
injury. Surveillance is useful in (1) determining which segments of the 
population are at highest risk; (2) identifying changes in disease 
incidence rates; (3) determining modes of transmission; and (4) 
planning and evaluating disease prevention and control programs. For 
fiscal year 2008, CSTE urges Congress to provide the following 
increased resources for expanding surveillance of key diseases, injury 
and environmental health areas:
    Behavioral Risk Factor Surveillance Survey (BRFSS).--Administered 
by CDC's Center for Chronic Disease Prevention, Health Promotion, and 
Genomics, the BRFSS is a primary source of information used to guide 
intervention, policy decisions, and budget direction at the local, 
State, and Federal level for multiple health conditions and chronic 
diseases. An increase in funding by $10 million, to $18 million, is 
needed to fully implement the survey. BRFSS is the primary source of 
information for leading health indicators for 6 areas in Health People 
2010. As our Nation moves towards evidence based medicine and funding, 
our data source needs to be comprehensive enough to accurately reflect 
the health of our population. Further congressional support will 
improve data collection infrastructure, timely reporting, and 
sophisticated analysis to provide data in meaningful ways to end users 
nationwide.
    HIV/AIDS Surveillance.--Cooperative Agreement funding to State and 
Local health departments for HIV/AIDS surveillance is critical to 
prevent new HIV infections, thereby saving an estimated $195,000 in 
lifetime treatment costs per individual. HIV/AIDS incidence is 
increasing without commensurate increases in Federal spending for 
surveillance. CSTE urges an increase of $35 million, to $101.3 million, 
for the surveillance cooperative agreements in CDC's HIV/AIDS 
Prevention budget (total recommendation $1,049.2 million) to address 
increasing HIV/AIDS incidence.
    National Violent Death Reporting System (NVDRS).--Fifty thousand 
deaths per year in the United States are attributable to violence. The 
National Center for Injury Prevention and Control (NCIPC) has developed 
the NVDRS to collect data related to these deaths for use in 
development of targeted prevention and early intervention programs. 
Seventeen States currently are equipped with NVDRS, however increased 
funding will help distribute the program and personnel to all States 
and strengthen our Nation's ability to collect the data that will 
ultimately result in reduction in violent deaths. CSTE urges an 
increase in funding from $3.4 million to $10 million for NVDRS, 
administered by CDC's NCICP (total $168 fiscal year 2008 request).
    Occupational Safety and Health State-Based Surveillance (NIOSH 
Program Announcement PAR 04-106).--In fiscal year 2005 NIOSH funded 12 
States to establish Occupational Safety and Health programs that use 13 
occupational health indicators to measure the burden of workplace 
injury and illness and make recommendations for prevention. This 
successful program should be expanded to all 50 States to establish a 
nationwide system to prevent major injuries and illnesses caused by 
hazardous work conditions. An increase in funding to $12.5 million, 
within the $300 million NIOSH budget request, will allow the expansion 
of this occupational surveillance to all States.
    Environmental Health Tracking Grants.--There is no national 
surveillance system to investigate possible links between environmental 
exposures and a number of diseases and health conditions, as noted in 
the PEW Environmental Health Commission's report, America's 
Environmental Health Gap: Why the Country Needs a Nationwide Health 
Tracking Network. Most States have little capacity for tracking 
environmental health. Since fiscal year 2002, Congress has recognized 
the need for increased environmental health capacity with funding, 
however a significant increase is needed to ensure that all States have 
the ability to track disease occurrence and adverse health conditions 
and their possible linkages to environmental toxins and hazards (such 
as the link between asbestos and mesothelioma). Funding at the $100 
million level will strengthen our nations resolve to identify harmful 
environmental exposures and eliminate the disease burden caused by 
them.
                                 ______
                                 
          Prepared Statement of the Cystic Fibrosis Foundation

    On behalf of the Cystic Fibrosis Foundation, and the 30,000 people 
with cystic fibrosis (CF), I am pleased to submit the following 
testimony regarding fiscal year 2008 appropriations for cystic 
fibrosis-related research at the National Institutes of Health (NIH) 
and other agencies.

                         ABOUT CYSTIC FIBROSIS

    Cystic fibrosis is a life-threatening genetic disease for which 
there is currently no cure. People with CF have two copies of a 
defective gene that causes the body to produce abnormally thick, sticky 
mucus, which clogs the lungs and result in fatal lung infections. The 
thick mucus in those with CF also obstructs the pancreas, causing 
patients difficulty in absorbing nutrients in food.
    The common symptoms of CF include chronic cough, wheezing or 
shortness of breath, excessive appetite but poor weight gain, and 
greasy, bulky stools. CF symptoms vary from patient to patient, due to 
the fact that there are more than 1,000 mutations of the CF gene.
    Since its founding, the Cystic Fibrosis Foundation has maintained 
its focus on promoting research and improving treatments for CF. CF has 
been significantly transformed from a childhood death sentence into a 
chronic disease, which requires a rigorous daily regimen of therapy. 
Treatments for individuals with CF include enzymes that aid digestion, 
antibiotics to treat lung infections, and daily therapy to loosen the 
mucus in the lungs. Strict adherence to CF treatments improves the 
health status and quality of life for those with CF, but the regimen 
can be a daily challenge for patients and their families.
    Through the research leadership of the Cystic Fibrosis Foundation, 
the life expectancy of individuals with CF has been boosted from less 
than 6 years in 1955 to nearly 37 years in 2005. Today, 43 percent of 
people with CF are 18 or older. This improvement in the life expectancy 
for those with CF can be attributed to research advances, which I will 
discuss in some detail later, and to the teams of CF caregivers who 
offer specialized care of the highest quality. This improvement in life 
expectancy is important, but we continue to loose young lives to this 
disease. Our progress is not nearly sufficient for those living with CF 
and their families, friends, and caregivers.
    The promise for those with CF is in research. In the past 5 years, 
the Cystic Fibrosis Foundation has invested over $595 million in its 
medical programs of drug discovery, drug development, research, care 
and drug delivery aimed at life-sustaining treatments and a cure for 
cystic fibrosis. But a greater investment is necessary to accelerate 
the pace of discovery of CF therapies. This statement focuses on the 
investment that will be required to develop new CF treatments rapidly 
and efficiently and to encourage research on a cure.

        SUSTAINING THE FEDERAL INVESTMENT IN BIOMEDICAL RESEARCH

    This subcommittee and Congress are to be commended for their 
steadfast support for biomedical research, and their commitment to the 
National Institutes of Health (NIH), including the effort to double the 
NIH budget between fiscal year 1999 and fiscal year 2003. This 
impressive increase in funding resulted in a revolution in medical 
research, fueling discoveries that benefit all Americans.
    However, we risk losing the research momentum the doubling 
generated if we fail to adequately fund the NIH so that they can 
capitalize on scientific advances. The Cystic Fibrosis Foundation joins 
the Ad Hoc Group for Medical Research to recommend increasing the NIH 
budget by at least 6.7 percent in fiscal year 2008. This investment 
will help maintain the NIH's ability to fund essential biomedical 
research today that will provide tomorrow's care and cures.

                STRENGTHEING OUR RESEARCH INFRASTRUCTURE

    It is now vital to assess our ability to translate the basic 
research advances of the last decade into treatment advances. The 
Cystic Fibrosis Foundation has been recognized for its own research 
approach to encompass many types of research, from basic research 
through Phase III clinical trials, and has created the infrastructure 
required to accelerate the development of new CF therapies. As a 
result, we now have a pipeline of more than 25 potential therapies that 
are being examined to treat people with CF. Several drugs in this 
pipeline treat the basic defect of CF, while others attack the symptoms 
of the disease.
    The NIH Roadmap for Medical Research provides the opportunity for 
the NIH to translate research into treatments for people with disease. 
We applaud Congress for its leadership and support for the NIH's 
Roadmap, which mirrors the Cystic Fibrosis Foundation's own approach to 
support and rewards innovation throughout the research process.
    Cystic fibrosis is a disease which impacts multiple systems in the 
body, and as a result, several different institutes at NIH share 
responsibility for CF research. Having multiple responsible institutes 
presents roadblocks to CF research in that there can be imperfect 
communication among the institutes regarding research in the field. 
This can limit our ability to capitalize on all research opportunities. 
Moreover, multidisciplinary research approaches, of the sort we believe 
are most promising in CF, may be disadvantaged in the NIH system of 
review and funding.
    The Cystic Fibrosis Foundation applauds NIH leaders for encouraging 
multidisciplinary research and Congress for directing resources to the 
Common Fund to finance multidisciplinary research projects. Funding 
pioneering multidisciplinary research is critical, but the Common Fund 
is also important in intangible ways, such as encouraging communication 
among researchers, placing a high value on trans-institute research, 
and breaking down barriers to communication and collaboration between 
institutes. We urge sufficient funding for such a multidisciplinary 
approach, which is most responsive to the research needs of complex 
diseases like CF.

                     FACILITATING CLINICAL RESEARCH

    The Cystic Fibrosis Foundation applauds the efforts of NIH to 
encourage greater efficiency in clinical research. The Foundation has 
been a pioneer in creating a clinical trials network to achieve greater 
efficiency in clinical investigation. Our pioneering effort in clinical 
trials emerged from the necessity of a small patient population for the 
number of trials we are undertaking and because our patients literally 
cannot tolerate research delays. Yet we believe that our model should 
be adopted and adapted by others. We have a permanent network of 
clinical trial sites and have centralized and coordinated data 
management and analysis functions and data safety monitoring. Among the 
results of this outstanding network--called the Therapeutics 
Development Network--are the ability to achieve rapid accrual to trials 
and the ability to conduct multiple trials simultaneously, even in a 
population of 30,000 CF patients. Since the TDN's inception, it has 
conducted over 40 trials. Of course, the ultimate goal of a centralized 
clinical trials system is the acceleration of the therapeutic 
development process.
    Although we have achieved significant efficiencies in our clinical 
trials system, we still encounter substantial slowdowns in the review 
of our multi-institutional trials by the institutional review boards 
(IRBs) of each of the institutions participating in the trials. We 
encourage Congress to urge the Department of Health and Human Services 
to demonstrate more aggressive leadership in persuading academic 
institutions to accept review by a central IRB--without insisting on 
parallel and often duplicative review by their own IRB--at least in the 
case of multi-institutional trials in rare diseases.
Pursuing New Therapies: The Cystic Fibrosis Therapeutics Development 
        Network
    The Cystic Fibrosis Foundation requests the committee allocate $3 
million in Federal funding in fiscal year 2008 to support much-needed 
expansion of our clinical research program, the Therapeutics 
Development Network (TDN), through the Coordinating Center at 
Children's Hospital & Regional Medical Center in Seattle, Washington. 
This will provide a significant investment in the Cystic Fibrosis 
Foundation's ongoing efforts to meet the demand for testing of all the 
promising new therapies for cystic fibrosis.
    Designating Federal funding for the Cystic Fibrosis Therapeutics 
Development Network will accelerate testing of new therapies for CF. 
The TDN plays a pivotal role in accelerating the development of new 
treatments to improve the length and quality of life for cystic 
fibrosis patients. Since the Cystic Fibrosis Foundation established 
this program in 1998, the TDN has evaluated 12 new products, with seven 
more products now in clinical trials. Opportunities exist to pursue 10 
additional trials on drug candidates in the next 18 months.
    The CF Foundation has adopted an innovative business approach to 
drug discovery and development that is emulated by other nonprofits. 
Lessons learned from centralization of data management and analysis and 
data safety monitoring in the TDN will be useful in designing clinical 
trial networks in other diseases. Federal funding to support the TDN 
will provide special insights regarding the most efficient means of 
conducting clinical trials on orphan diseases.
National Center for Research Resources
    The Institutional Clinical and Translational Science Awards program 
is an initiative of particular importance to cystic fibrosis. This NIH 
Roadmap program administered by the National Center for Research 
Resources (NCRR) encourages novel approaches to clinical and 
translational research, enhances the utilization of informatics and 
strengthens the training of young investigators. The Cystic Fibrosis 
Foundation has enjoyed a productive relationship with the NCRR to 
support our vision for improving clinical trials capacity through its 
early financial support of the TDN.

                  SUPPORTING ADDITIONAL RESEARCH AREAS

    While much of this testimony has focused on clinical research, 
these new therapies rely on solid basic research. Although the 
discovery of the CF gene in 1989 was an important step forward, there 
is still much to be learned about the disease. As a result, the CF 
Foundation continues to invest in basic research on the disease to 
deepen our knowledge of CF and to better understand how we may 
intervene in the disease course. There are several research projects at 
NIH that are essential to this work, and for which we express our 
strong support.
Protein Misfolding and Mistrafficking
    The Cystic Fibrosis Foundation urges the NIH to devote special 
focus to research in protein misfolding and mistrafficking, an area 
which may yield significant benefits for CF and other diseases where 
misfolding is an issue. We applaud both the National Heart, Lung and 
Blood Institute (NHLBI), and the National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK) for their initiatives that target 
research on protein misfolding, and urge an aggressive commitment to 
facilitate continue exploration in this area to build upon promising 
discoveries. Additionally, we urge funding by the National Institute of 
General Medical Sciences (NIGMS) for the creation of tools and reagents 
and advances in techniques for precision monitoring of folding and 
trafficking events and for the sharing of resulting data that would 
complement the efforts of NIDDK- and NHLBI-funded investigations in 
this area.
    On behalf of the Cystic Fibrosis Foundation, I thank the committee 
for its consideration. Congress has reason to be proud of its role in 
supporting NIH, which is the world's leader in biomedical research. The 
NIH has strong leadership to move into the new century, when we will 
see the translation of basic research into new treatments for many 
diseases. We believe the experience of the CF Foundation in clinical 
research can serve as a model for research on other orphan diseases, 
and we stand ready to work with NIH and congressional leaders.
                                 ______
                                 
              Prepared Statement of the Endocrine Society

    The Endocrine Society would like to submit the following testimony 
regarding fiscal year 2008 Federal appropriations for biomedical 
research, with emphasis on appropriations for the National Institutes 
of Health. The Endocrine Society is the world's largest and most active 
professional organization of endocrinologists representing over 14,000 
members worldwide. Our organization is dedicated to promoting 
excellence in research, education, and clinical practice in the field 
of endocrinology. The Society is comprises thousands of researchers who 
depend on Federal support for their careers and their scientific 
advances.
    In April 2004 the Endocrine Society testified before the House 
Appropriations Committee. During this testimony the Society provided 
the committee with a grim picture of what might happen to NIH-funded 
research if the financial commitment made during the doubling period 
(1998-2003) was not sustained. Our testimony indicated that 
breakthroughs in areas of endocrine research--such as diabetes and 
obesity--were on the horizon after the doubling period, but that the 
breakthroughs were in jeopardy of being abandoned due to sharp 
decreases in NIH funding from Congress. Unfortunately, it seems our 
prognostication was correct.
    Included as an addendum (Addendum A) to this testimony is an 
excerpt from a compelling article that appeared in the April issue of 
Men's Health magazine. Highlighted within this article is the story of 
Endocrine Society member, Alan Schneyer, Ph.D. This article examines 
the real life impact that reduced funding for NIH has on the Nation's 
researchers and their potential breakthroughs. Dr. Schneyer has been 
working in the field of endocrine research and has made promising 
discoveries that could lead to future diabetes treatments. But as of 
April 2007 his lab, his research, and his employees have been shut down 
because his grant will no longer be funded. The great promise hoped for 
in 1997, at the beginning of the doubling period, has led to closed 
labs and unemployed scientists in 2007.
    A simple glance at NIH funding trends over the last few years will 
show how this great promise led to great disappointment. Under the 
President's proposed fiscal year 2008 budget most NIH institutes and 
centers would see their budgets remain flat for the fourth year in a 
row. The proposed fiscal year 2008 NIH budget of $28.7 billion would be 
down $230 million from the recently finalized fiscal year 2007 budget. 
Worse yet, the NIH budget would fall 12 percent from 2004 to 2008 when 
adjusted for biomedical research inflation.
    This funding downturn not only has a drastic impact on existing 
researchers such as Dr. Schneyer, but it is having a profound effect on 
future researchers as well. NIH projects the success rate for new 
renewal grant applications will stabilize at 20 percent in 2007 and 
2008, down steeply from a high of 32 percent in fiscal year 2001. 
According to the American Association for the Advancement of Science, 
NIH expects to fund 1 in 5 applicants who apply for research funding in 
2008. During the height of the doubling period NIH funded 1 in 3 
applicants. As you can imagine, these trends send a chilling message to 
young researchers who were drawn to biomedical research during the 
doubling period. After years of steady support for biomedical research 
over the last decade, many young people were drawn into research labs, 
but now Federal funds are declining. As the funding declines, so too 
does the opportunity for young researchers. NIH is trying to address 
this issue with its Pathways to Independence program. This program 
would provide up to 5 years of support for scientists just beginning 
their research careers. We would encourage the committee to fully-fund 
the Pathways to Independence program in fiscal year 2008.
    The Endocrine Society recommends that the National Institutes of 
Health receive $30.8 billion in fiscal year 2008. This increase of 6.7 
percent will set NIH, and the researchers who depend on it for funding, 
on a 3-year track to recoup the losses caused by biomedical research 
inflation over the last 4 years.
    While researchers will never guarantee cures from ongoing research, 
we do know that without adequate sustained Federal support the chances 
for breakthroughs are diminished. In fact very significant advances 
have been made; for example for the first time in our history death 
rates from cancer have started to decrease, which can be attributed to 
NIH funded research in previous decades. We ask that Congress stop the 
boom and bust funding cycles that have plagued NIH over the last 10 
years and commit to a steady funding stream to keep the research of 
today on track to become the breakthroughs of tomorrow.

             Addendum A--Men's Health--Tons of Useful Stuff

                       THE BATTLE FOR YOUR HEALTH

    As American soldiers fight terrorists overseas, another war is 
being lost at home: The one to cure disease and, ultimately, save your 
life.
    Boston, MA.--The last thing Alan Schneyer, Ph.D., expected to find 
when he began manipulating the reproductive genes in mice was a 
possible cure for diabetes.
    ``We made these mice and thought they would be infertile, but they 
weren't,'' Schneyer tells me as we pace his sparse laboratory at 
Massachusetts General Hospital. ``So we started looking at their other 
organs. Turns out, they have improved glucose tolerance and very little 
visceral fat. Boom! I thought, This is great. We can address a real 
disease.''
    Schneyer eyes the empty beakers, vials, and tubes, the dust 
beginning to gather on microscopes, tissue-holding minifridges, 
computer terminals. The mood is so grim I expect Edgar Allan Poe's 
valet to walk through the door. ``Then we lost our grant. Normally 
you'd see six people working here. Now my fellows are gone. My 
technician is leaving at the end of the month. My associate works for 
someone else now.'' He looks at me and musters a half-hearted smile. 
``I'm out in April,'' he says.
    Schneyer's is a familiar tale. Since a doubling of the National 
Institutes of Health (NIH) budget between 1997 and 2003--an increase, 
incidentally, that contributed to the discovery and mapping of the 
human genome--the agency's budget has flatlined at about $28 billion 
for the past 3 years, outpaced by 9 percent inflation. When funds were 
cut by $33 million in 2006, it marked the first time in more than 35 
years that NIH appropriations actually decreased.
    Schneyer, 52, is quick to note that his discovery might well have 
``come to a dead end.'' Still, with 73 million Americans either having 
diabetes or a high risk of it--and with the number of overweight 
children in America at 9 million and growing--it's frustrating to let 
any possible cure go unexplored. ``We'll never know where my research 
might have led, will we?'' Schneyer says, adding that since the NIH 
started issuing research grants after World War II, ``a good 75 
percent'' of discovered cures have come from government-funded programs 
like his--and not from drug-company labs. In fact, thanks to NIH-
sanctioned research, we know that exercise promotes weight loss, high 
LDL cholesterol raises the risk of heart disease, chemotherapy kills 
cancer, and fluoride prevents tooth decay.
    Now, Schneyer is left hoping for a last-minute reprieve. This is 
unlikely. The 2007 budget for the Department of Health and Human 
Services, under which both the CDC and NIH operate, shows that grant 
monies for ``Preventive Health and Health Services,'' ``Public Health 
Improvement,'' and ``Children's Hospitals'' have been slashed by almost 
$375 million. ``Bioterrorism'' funding, on the other hand, has 
increased to $1.7 billion, up nearly tenfold in the past 5 years.
    Like many medical researchers and physicians, Schneyer is angry 
with the Federal Government for shifting funds away from medical 
research and--``ostensibly,'' he says--into the war on terror at home 
and abroad. It has not gone unnoticed in America's medical community 
that as Federal grants stagnate or plunge, Washington politicos have, 
as of January, authorized more than $315 billion--that's $6.5 billion a 
month, $9 million an hour--to be spent in Iraq alone.
    Then there are the seemingly insane items, recently reported by 
Newsday, in the Department of Homeland Security's budget: $18,000 to 
equip the Santa Clara, California, bomb squad with Segways; $30,000 to 
ensure a defibrillator is on hand for every Lake County, Tennessee, 
high-school basketball game; $500,000 worth of security gear to the 
town of North Pole, Alaska, population 1,778; Kevlar vests for the 
police dogs of Columbus, Ohio; the list goes on.
    Sitting in Schneyer's office, I motion toward the window. What 
would happen, I ask, if I walked into the tavern across the street and 
queried the first five patrons about whether Federal dollars would be 
better spent on body armor for soldiers, or research on the 
reproductive organs of mice?
    ``You're not framing the question correctly,'' he says. 
``Statistics indicate that two of the five men in the bar have already 
developed some form of cardiovascular disease. So you ask them how they 
feel about genetic research that might find a cure, so that their 
children don't die of heart disease.
    ``It's easy to ask why we're funding work on a mouse organ, or on a 
worm. Well, you take that same gene and look for a similar one in a 
human, and suddenly, `Hey, it's responsible for diabetes!' It's not a 
question of a cure for diabetes versus body armor for soldiers. This 
isn't about medical science versus armor or, for that matter, school 
lunches, fire departments, or red lights at dangerous intersections. A 
smart government can fund it all.''
    ``Where will that money come from?'' I ask.
    Schneyer's cheeks burn as he speaks of cost overruns in Iraq and 
the recent tax cuts. ``Every medical-research experiment that is not 
done is an opportunity lost,'' he says. ``You don't know which one is 
going to bring the eureka moment.''
    He smiles, rueful. ``Our country--the president, Congress--has to 
decide if it's worth doing research that will lead to better health in 
the long run and lower costs for the next generation of Americans.
    ``The catchall excuse for the funding cuts is the war on terror. 
But al-Qaeda could attack New York, and that wouldn't reduce the number 
of children with diabetes in Chicago and Miami and Detroit. Researchers 
who are on the verge of finding cures for Alzheimer's, Parkinson's, all 
kinds of cancers . . . their funding is all being cut.
    ``That's a strange way to protect America.''
                                 ______
                                 
   Prepared Statement of the Fair Allocations in Research Foundation

    The death rate in our country from AIDS has plummeted as evidenced 
in 2006 by the 99 percent drop in California's newly infected AIDS 
patients \1\ from just under 10,000 to 130 (as of 2/28/07) and the 93 
percent drop to 100 in all of Illinois's HIV/AIDS patients for 2004.\2\ 
In addition, we respectfully bring to Chairman Byrd's attention that 
this great success includes West Virginia where AIDS deaths have 
dropped to 23 for their latest reporting period (2005).\3\ This success 
against AIDS is being repeated throughout America, yet AIDS still 
receives 10 percent of the entire National Institutes of Health (NIH) 
disease research budget.
---------------------------------------------------------------------------
    \1\ http://www.dhs.ca.gov/aids/Statistics/pdf/Stats2007/
Feb07AIDSMerged.pdf Page 2, CA Office of AIDS--patients infected in 
2006 who died in 2006.
    \2\ http://fairfoundation.org/states/illinois_AIDS_deaths.htm
    \3\ WVA Dept of Health, Tom Light, 304-558-1748 or http://
fairfoundation.org/states/west_virginia.htm
---------------------------------------------------------------------------
    Such exorbitant funding for AIDS has resulted in unfair allocations 
for all non-AIDS diseases, including the sixteen \4\ that kill a 
million more Americans than AIDS annually. For example, cardiovascular 
disease kills almost a million Americans compared to 16,316 (2005) \5\ 
for AIDS, yet the NIH is spending only $40 on each CVD patient versus 
$3,052 on each AIDS patient in research.\6\ Diabetes kills more 
citizens than AIDS and breast cancer combined, yet only $50 is spent on 
each diabetic in research. More AIDS patients are now dying of 
hepatitis C than they are of AIDS,\7\ and hepatitis C (HCV) affects 4-5 
times as many as AIDS yet only $25 is allocated for each HCV patient.
---------------------------------------------------------------------------
    \4\ http://www.fairfoundation.org/thesixteen.htm
    \5\ http://fairfoundation.org/CDC_AIDS_death_estimates_2001-
2005.pdf
    \6\ http://www.fairfoundation.org/factslinks.htm
    \7\ http://fairfoundation.org/specter_letter_hcv_in_aids_pts.pdf

----------------------------------------------------------------------------------------------------------------
                                                     2005 NIH
                                                     research       Deaths per      Dollars per     Dollars per
                     Disease                        [Dollars in       disease     patient  death      patient
                                                     billions]
----------------------------------------------------------------------------------------------------------------
HIV/AIDS........................................          $2.930          16,316        $178,046          $3,052
Cardiovascular Dis..............................           2.300         930,000           2,523              40
Diabetes........................................           1.000          73,965          14,236              50
Alzheimer's Dis.................................            .642          63,343          10,182             143
Prostate Cancer.................................            .373          27,350          13,638             192
Parkinson's Dis.................................            .205          17,898          12,403             148
Hepatitis C.....................................            .121          12,000          10,166              25
Hepatitis B.....................................            .036           5,000           6,600              32
COPD............................................            .066         126,128             500               5
West Nile Virus.................................            .063             161         390,304          14,932
----------------------------------------------------------------------------------------------------------------

    Regardless if the funding comparison is measured utilizing 
``allocation per patient,'' ``allocation per death'' or ``total 
allocation'' per disease, the great success of AIDS researchers has 
resulted in funding for AIDS now being disproportionate and 
inequitable.
    In addition, hundreds of millions of dollars are raised for AIDS by 
celebrities and non-profit organizations (amfAR, etc.) while similar 
efforts do not exist for many other diseases. With the recent $37 
billion stock pledge by Warren Buffett to the $29 billion Bill and 
Melinda Gates Foundation and Mr. Buffett's support for the Gates's bias 
in funding to combat HIV disease, the favoritism afforded this disease 
has reached excessive proportions. Indeed, Melinda Gates has stated 
that her fondest goal is a vaccine for HIV disease and to date the 
total funding by the Gates's Foundation for all HIV programs is $6.5 
billion. It is anticipated that much more of the Gates Foundation will 
go towards combating HIV disease in the future.
    When one reflects that the total NIH bio-medical research budget 
for every disease known to man is only $28.4 billion and 10 percent of 
that also goes to HIV research, one can only be dismayed at the 
continual favoritism afforded this illness.
    The NIH has responded to The FAIR Foundation's requests to cease 
the favoritism afforded HIV/AIDS and to reallocate some of the present 
AIDS dollars to other diseases by referencing global AIDS and the fact 
that AIDS is communicable and destructive to the young.\8\
---------------------------------------------------------------------------
    \8\ http://www.fairfoundation.org/nihletter.htm
---------------------------------------------------------------------------
    What are the solutions for global AIDS--more research? No, the 
answers to global AIDS are the same that have dropped the death rate 
throughout America, and they have been expressed by Presidents Clinton, 
Bush and the Director of the NIAID, Dr. Fauci, namely: preventive 
education, the drugs which converted AIDS from an acute illness into a 
chronic illness (HAART or Highly Active Anti-retroviral Therapy) and 
setting up health infrastructures.
    Indeed, Dr. Fauci himself recently admitted the great success in 
HIV research when he stated on CNN, ``. . . the scientific advancements 
that have been made in HIV [research] are breathtaking [with] highly 
effective drugs to suppress HIV to the point where what was a death 
sentence in the early eighties to now having patients who look and feel 
well, who are leading very productive, very gratifying lives . . .''
    Regarding the ``communicable'' nature of AIDS, Congress must force 
realization upon the NIH that simply because an illness is 
``infectious'' does not warrant disproportionate research funding. 
Patients suffering from non-communicable illnesses such as prostate 
disease, Alzheimer's disease, etc. should not be discriminated against 
because they cannot transmit their disease to others or because its 
etiology is congenital or acquired by environmental causes.
    In America's youth, the CDC's 2005 report States seven deaths in 
patients age <13, 63 under age of 19 and 677 deaths under age 30. The 
estimated deaths from SIDS each year is 3,000. Clearly, HIV disease is 
not a major factor killing our youth.
    An unrecognized factor negatively impacting all non-AIDS diseases 
is the ``compounding effect'' of present NIH policy. The present 
funding total of each disease may be viewed as their ``principal 
balance'' for this analogy. If the present effort by 100 Members of the 
House to increase NIH funding by 6.7 percent is successful, the 
increase in AIDS funding will be approximately $194 million whereas 
Alzheimer's disease will receive only $43 million and Chronic 
Obstructive Pulmonary Disease (COPD) $4.4 million even though those two 
diseases kill, respectively, three and nine times more Americans than 
AIDS. Each year the additional increases in the ``principle balance,'' 
or total funding, results in the ``compounding interest effect'' that 
increases the disproportionate funding for AIDS. Consequently, the gap 
in funding between AIDS and all other diseases grows even larger. 
Supplying greater funding to the NIH without redistribution of present 
inequities is unfair for non-AIDS illnesses.
    The issue of AIDS favoritism is rapidly becoming a political issue. 
Before billions more dollars are spent on yet another preventive 
measure (HIV vaccine), we urge you to publicly call for a partial 
redistribution of the HIV excess funding to other illnesses that do not 
presently have effective treatments, including the 16 maladies [iii] 
that are killing a million more Americans than HIV disease annually.
    Indeed, with the budgetary limitations resulting from our 
government's commitments, including supporting the war in Iraq and 
restoring the areas ravaged by hurricanes Katrina and Rita, necessary 
increases for bio-medical research funding have been non-existent. As 
with the common citizen whose budget is pinched, it is appropriate to 
reallocate existing funds, in this case some of HIV/AIDS funding to 
other illnesses.
    Sixty-one million voters with cardiovascular disease, 21 million 
diabetics and millions of other constituents with non-AIDS illnesses 
will applaud your courageous declaration, while approximately 1 million 
with HIV/AIDS may be dismayed at such an announcement.
    The FAIR Foundation (FAIR is an acronym for ``Fair Allocations In 
Research) is a national organization representing thousands of members 
and supporters--concerned citizens--who want the success of AIDS 
advocates and AIDS researchers recognized with a corresponding change 
in the allocation priorities of the NIH with our taxpayer dollars that 
fund bio-medical research. Gay members of our country are present on 
our Board, including Ray Hill, who used to be one of this country's 
most strident HIV activists. Because of their great success, Ray, who 
has been named Houston's gay hero by that community 7 years in a row, 
now advocates for hepatitis C.
    On behalf of our national membership we are respectfully requesting 
that a portion of AIDS research allocations be reevaluated and 
redistributed now that the existing medications and extensive 
prevention programs for this illness have significantly mitigated its 
threat.
                                 ______
                                 
   Prepared Statement of the Families USA Global Health Initiative's

    Families USA Global Health Initiative appreciates the opportunity 
to submit this written testimony to the Senate Appropriations 
Subcommittee on Labor, Health and Human Services, and Education 
concerning Federal funding for the National Institutes of Health (NIH) 
and the Centers for Disease Control and Prevention (CDC). Our statement 
today speaks to the important role that NIH and CDC play in protecting 
and improving health in the United States and the world.
    For more than 20 years, Families USA has advocated for changes in 
U.S. policies to increase access to affordable health care, especially 
for low-income individuals. The Global Health Initiative was launched 
in 2006 to advocate for increased U.S. investment in research and 
development of medical interventions targeting infectious diseases that 
disproportionately affect populations in low-income countries (``global 
health'' research).
    The government must step in to support global health research and 
development because there is little private industry interest in 
filling the current void, an overwhelming human need, a long history of 
underfunding, and it's in our Nation's self-interest to do so.

           OVERWHELMING HUMAN NEED AND HISTORIC UNDERFUNDING

    Research addressing global health crises has been historically 
underfunded. More than 500 million people contract malaria each year. 
NIH spends just 0.3 percent of its budget on malaria research. CDC's 
malaria extramural research program was cut.
    Nine million people develop active tuberculosis (TB) each year, 2 
million die from TB, and extensively drug-resistant strains poses a 
substantial domestic and worldwide health threat. NIH spends just 0.5 
percent of its budget on tuberculosis. The Global Health section of 
CDC's Proposed fiscal year 2008 Budget, submitted to the Congress, 
contains no mention of work on TB.
    More than 1 billion people living in tropical and subtropical 
climates around the world are stricken with devastating, debilitating 
parasitic diseases that receive so little research funding that the 
World Health Organization and others in the medical community refers to 
these conditions as ``neglected'' tropical diseases.
    Almost 40 million people around the world are currently infected 
with HIV. Only 2.5 percent of NIH's budget is devoted to research on 
preventative medical interventions, including vaccines and 
microbicides. CDC's global HIV/AIDS activities are limited primarily to 
support of the President's Emergency Plan for AIDS Relief (PEPFAR). 
Although PEPFAR is expanding access to existing HIV/AIDS treatments for 
many in need, PEPFAR alone will not curb the global AIDS pandemic. More 
than 4 million people become newly infected each year and existing 
treatments are becoming increasingly ineffective due to drug 
resistance. Vaccines and microbicides, along with improved treatments, 
are needed to curtail the global AIDS pandemic.

                         OUR NATIONAL INTEREST

    When NIH and CDC are insufficiently funded, as has consistently 
been the case in recent years, they are forced to fight global health 
crises with one hand tied behind their back. This has serious health, 
economic, and political implications--not just internationally, but 
also domestically. There are also compelling diplomatic and 
humanitarian reasons for funding NIH's and CDC's global health work.
    First, we have a national health interest in ensuring that NIH and 
CDC have all the resources that they need. Diseases can easily spread 
across international borders; epidemics abroad, including lethal 
strains of extremely drug-resistant TB, can lead to cases here at home. 
Americans who travel abroad, including our troops, are also at risk of 
contracting infectious diseases that are endemic in other countries.
    Second, we have a national economic interest in providing NIH and 
CDC with all the resources that they require. In regions where HIV/
AIDS, malaria, and TB prevalence are greatest, countries' entire 
workforces suffer from substantially reduced productivity and economic 
growth is hindered. With globalization, countries' economic health is 
intertwined. The economic toll of diseases hurts world economic growth 
and limits trade, and it reduces markets for U.S. goods.
    Third, we have a national political interest in giving NIH and CDC 
the funding needed to combat infectious diseases with a massive global 
burden. In areas of the world where the infectious disease burden is 
greatest, enormous numbers of people are getting sick and dying. 
Populations are being decimated. The social structures of entire 
countries has been unraveling, paving the way for political unrest and 
the undermining of democracy in entire regions of the world.
    Fourth, we have a national diplomatic interest, and there are 
strong humanitarian reasons as well, for funding NIH's and CDC's work 
in preventing and controlling diseases that burden millions of people 
around the world. As the wealthiest country on earth, we have the means 
to advance health and alleviate human suffering. Using our wealth to 
improve global health improves America's image and serves as a very 
effective foreign policy tool.

                        FUNDING RECOMMENDATIONS

All NIH Institutes and Centers
    Families USA Global Health Initiative recommends 6.7 percent annual 
increases to NIH's total budget from fiscal year 2008 to fiscal year 
2010 (including 3.7 percent adjustments each year for annual rises in 
biomedical inflation, plus an additional 3.0 percent each year to start 
to correct for the failure in recent years to keep up with inflation).
    In recent years, NIH funding has fallen further and further behind 
the rising costs of biomedical research. This means that less research 
gets funded and medical progress is delayed. Only 16.7 percent of new 
grant applications were funded in 2006--an 83 percent failure rate. 
Many scientists are sitting on the sidelines, unable to develop 
promising ideas that could lead to an effective AIDS vaccine, improved 
tuberculosis treatments, and other medical interventions that could 
improve the lives of millions worldwide.
    A 6.7 percent annual increase for all NIH Institutes and Centers, 
for each year from fiscal year 2008 to fiscal year 2010, would adjust 
NIH funding for anticipated annual rises in inflation and add a modest 
3.0 percent rise to help make up for losses in inflation-adjusted 
funding experienced by all of NIH in recent years.
Additional Increase for NIH Global Health Programs
    Families USA Global Health Initiative recommends that Congress 
begin to rectify, over a 7 year period, historic underfunding of global 
health programs by increasing the National Institute of Allergy and 
Infectious Diseases and Fogarty International Center budgets annually 
by 2.9 percent for each year from fiscal year 2008 to fiscal year 2014.
    This increased annual 2.9 percent investment in global health would 
be apart from, and in addition to, the 6.7 percent increases over the 
next 3 years for all NIH Institutes and Centers, and annual 
inflationary adjustments provided thereafter.
    The National Institute of Allergy and Infectious Diseases (NIAID) 
has taken a leadership role in the bulk of global health research and 
development activities undertaken at NIH. Robust funding for NIAID is 
essential for addressing infectious disease crises around the globe and 
in the United States.
    The John E. Fogarty International Center (FIC) also plays a crucial 
role in addressing global health challenges by facilitating 
collaboration between United States and international researchers 
through its international training and global health research capacity 
building programs. FIC's programs facilitate the development of medical 
discoveries worldwide.
    Malaria and tuberculosis research, combined, comprise less than 1 
percent of the National Institutes of Health's total budget. Last year, 
cuts to the NIH budget resulted in funding being completely cut to 11 
HIV/AIDS clinical trials in the United States. FIC's fiscal year 2006 
funding constituted a miniscule 0.23 percent of NIH's total budget.
    A 2.9 percent additional increase for NIAID and FIC, for each year 
from fiscal year 2008 to fiscal year 2014--apart from and on top of the 
6.7 percent annual increases for all of NIH from fiscal year 2008 to 
fiscal year 2010, and inflationary increases thereafter--is badly 
needed to make up for historic underfunding for global health research 
and to achieve progress in the development of new interventions for 
diseases devastating millions worldwide.
Centers for Disease Control and Prevention
    Families USA Global Health Initiative supports the CDC Coalition's 
recommendation of increasing CDC's total budget to $10.7 billion in 
fiscal year 2008 and further recommends that Congress appropriate $512 
million in fiscal year 2008 for CDC's global health work (4.8 percent 
of CDC's $10.7 billion total budget).
    CDC's global health programs are vitally important to protecting 
Americans and people around the world from disease. Cuts to CDC's 
budget undermine both the United States and the global public health 
infrastructures that are crucial to rapidly responding to new disease 
outbreaks and combating existing global pandemics.
    Yet, some of CDC's global health programs have been flat-funded for 
years; other global health programs can no longer carry out their 
critical mission due to limited funds. For instance, CDC currently has 
no appropriated budget for global tuberculosis activities and the 
malaria extramural research program had to be phased out due to 
insufficient funds. Moreover, failure to adequately fund CDC's global 
health work has broader implications for the success of other United 
States funded initiatives, including PEPFAR and the President's Malaria 
Initiative (PMI).
    At a global health funding level of $512 million in fiscal year 
2008, CDC would be able to support crucial global disease surveillance 
and control programs; perform research to improve existing medical 
interventions; and develop new interventions for diseases where 
interventions are currently lacking.

                            CALL FOR ACTION

    Americans across the country, and people from around the world, are 
looking to NIH and CDC for new medical advances that will lead to a 
healthier tomorrow. Shortchanging NIH and CDC places America's--and the 
world's--health at risk. We urge the subcommittee to fund NIH and CDC 
at the levels specified above.
    For additional information, please contact Janet Goldberg at 202-
628-3030 or [email protected].
                                 ______
                                 
           Prepared Statement of Fight Crime: Invest in Kids

    Mr. Chairman and members of the subcommittee: Thank you for the 
opportunity to submit this written testimony. My name is Dennis Conard 
and I am the Sheriff in Scott County, IA (Davenport), where I have 
served in law enforcement for almost 35 years. I am also a graduate of 
the FBI National Academy, the National Sheriffs' Institute and the Iowa 
Law Enforcement Academy and a member of the National Sheriffs' 
Association. I am also one of the 3,000 police chiefs, sheriffs, 
prosecutors, and victims of violence of FIGHT CRIME: INVEST IN KIDS--a 
non-profit anti-crime organization that has come together to take a 
hard-nosed look at the research about what really works to keep kids 
from becoming criminals.
    The law enforcement leaders of FIGHT CRIME: INVEST IN KIDS know 
that dangerous criminals must be prosecuted and put behind bars. But we 
also know better than anyone that we cannot arrest and imprison our way 
out of the crime problem. No prison can bring back a murdered wife, 
mother or child, and no punishment can undo a crime victim's anguish. 
Fortunately, research--and our experiences on the front lines in the 
fight against crime--show that targeted investments can help kids get a 
good start in life. We could be saving thousands of lives and 
preventing thousands of crimes by increasing our investments in cost-
effective, proven crime-prevention programs.
    Four types of proven crime-prevention approaches are outlined in 
FIGHT CRIME: INVEST IN KIDS' ``School and Youth Violence Prevention 
Plan'':
  --quality early childhood education;
  --child abuse and neglect prevention programs;
  --quality after-school; and
  --prevention and intervention programs to get troubled kids back on 
        track.
    As you know, the first three areas fall within your Appropriations 
Subcommittee's jurisdiction. Since both the research and my years of 
experience on the front lines in the fight against crime show that 
these approaches help stop crime in its tracks, I urge you to increase 
our Nation's investments in these proven strategies for saving lives 
and taxpayer dollars.

                   EARLY CHILDHOOD EDUCATION AND CARE

    By now, most people know that Head Start and quality child care 
help close the achievement gap. But few people are aware of the amazing 
impact of early education programs on later criminality. A Journal of 
the American Medical Association-published study of Chicago's 
government-funded Child Parent Centers, which have served more than 
100,000 3- and 4-year-olds, showed that children who did not 
participate in the program were 67 percent more likely to have been 
retained a grade in school and 71 percent more likely to have been 
placed in special education. But equally impressive, the study showed 
that kids who did not participate were 70 percent more likely to be 
arrested for a violent crime by age 18. Similarly, at-risk kids who 
were left out of the high-quality High/Scope Perry preschool program 
were five times more likely to be chronic offenders (more than four 
arrests) by age 27 than those who participated.
    By improving outcomes for kids, quality early childhood education 
also saves money. The High/Scope Perry Preschool program saved $17 for 
every $1 spent. An analysis by Arthur Rolnick of the Federal Reserve 
Bank of Minneapolis shows that the program's annual return on 
investment is 16 percent after adjusting for inflation. Seventy-five 
percent of that return goes to taxpayers in the form of decreased 
special education expenditures, crime costs and welfare payments. In 
comparison, the long-term average return on U.S. stocks is 7 percent 
after adjusting for inflation. Thus, an initial investment of $1,000 in 
a program like Perry Preschool is likely to return more than $19,000 in 
20 years, while the same initial investment in the stock market is 
likely to return less than $4,000.
    However, due to lack of State and Federal financial resources, 
there remains significant unmet need with only about half of eligible 
poor kids nationally served by Head Start and less than 5 percent of 
eligible infants and toddlers in Early Head Start. Only one in seven 
kids in eligible, low-income families receives help from the Child Care 
and Development Block Grant to pay for the quality child care that can 
help ensure they are on the path toward being a productive, taxpaying 
adult rather than a burden on taxpayers and part of our criminal 
justice system. Funding has been stagnant over the last several years. 
By the administration's own estimates, 150,000 fewer children receive 
child care assistance now than in 2000.
    I urge Congress to:
  --Increase funding for Head Start by at least $750 million to restore 
        funding for services to kids to the fiscal year 2002 level.
  --Increase discretionary funding for the Child Care and Development 
        Block Grant by $720 million to restore funding for services to 
        kids to the fiscal year 2002 level.
    This is the first step toward meeting the unmet need and further 
strengthening the quality of early childhood care and education.

              CHILD ABUSE AND NEGLECT PREVENTION PROGRAMS

    The best available research indicates that, based on confirmed 
cases of abuse and neglect in just 1 year, an additional 35,000 violent 
criminals and more than 250 murderers will emerge as adults who would 
never have become violent criminals if not for the abuse or neglect 
they endured as kids.
    Fortunately, quality, voluntary in-home parent coaching can help 
stop this cycle of violence. Voluntary, in-home parent coaching (or 
``home visiting'') programs help new parents get the information, 
skills and support they need to be better parents and promote healthy 
child development. One program, the Nurse Family Partnership (NFP), has 
been shown to cut child abuse and neglect of at-risk children in half 
and reduce kids' and moms' later arrests by about 60 percent--saving an 
average of $28,000 (net) for each family in the program.
    As a first step toward meeting this need, I urge Congress to 
provide:
  --$100 million to expand and improve in-home coaching programs like 
        those that would be supported under the Education Begins as 
        Home Act (S. 667), which is expected to be enacted this year.
  --$545 million (the combined mandatory and discretionary authorized 
        level) for the Promoting Safe and Stable Families program to 
        help communities run in-home parent coaching programs, 
        parenting-education programs, family-strengthening services for 
        troubled families, adoption services, and other child abuse and 
        neglect prevention programs.
  --$200 million (the authorized level) for the Child Abuse Prevention 
        and Treatment Act to help improve State child protection 
        services and community-based prevention services.
  --$1.7 billion (rejecting the administration's proposed cuts) for the 
        Social Services Block Grant (SSBG), the Federal Government's 
        single largest support for child welfare services.

                         AFTER-SCHOOL PROGRAMS

    In the hour after the school bell rings, violent juvenile crime 
soars and the prime time for juvenile crime begins. The peak hours for 
such crime are from 3:00 p.m. to 6:00 p.m. These are also the hours 
when children are most likely to become victims of crime, be in an 
automobile accident, smoke, drink alcohol, or use drugs. After-school 
programs that connect children to caring adults and provide 
constructive activities during these critical hours are among our most 
powerful tools for preventing crime. For example, a study compared five 
housing projects without Boys & Girls Clubs to five receiving new 
clubs. At the beginning, drug activity and vandalism were the same. But 
by the time the study ended, the projects without the programs had 50 
percent more vandalism and scored 37 percent worse on drug activity. 
Despite these proven benefits, more than 14 million children nationwide 
still lack adult supervision after school.
    The 21st Century Community Learning Centers program (21st CCLC) 
awards grants to communities to establish after-school programs that 
provide constructive activities for kids. Since being funded at $1 
billion in fiscal year 2002, there have been no real funding increases 
for 21st CCLC. In fiscal year 2007, the program received $981 million--
far below the program's $2.5 billion authorization under the No Child 
Left Behind Act. I urge Congress to:
  --Substantially increase funding for the 21st Century Community 
        Learning Centers to support and expand after-school programs 
        that offer kids constructive activities during the peak hours 
        of violent juvenile crime, 3:00 pm to 6:00 pm. Also, I urge you 
        to authorize at least an additional $500 million for programs 
        for at-risk middle and high school students who now experience 
        the greatest unmet need--and are at greatest risk of 
        perpetrating or being victims of crime.

                   LAW ENFORCEMENT LEADERS ARE UNITED

    The members of FIGHT CRIME: INVEST IN KIDS, along with major 
national law enforcement associations, have adopted forceful calls for 
public officials to ensure access to quality early care and education, 
provide adequate funding to prevent child abuse and neglect, and ensure 
access to after-school programs. If we do not invest in research-proven 
crime-prevention programs for America's most vulnerable kids, many of 
them will grow up to become America's most wanted adults. By failing to 
adequately invest in proven crime-prevention strategies, Congress is 
not only failing to promote the well-being of millions of kids but is 
also permitting the cultivation of criminals--jeopardizing the safety 
of all Americans for years to come.
    Thank you for this opportunity to present our views on how your 
subcommittee can help to reduce crime and make us all safer.
                                 ______
                                 
          Prepared Statement of the Foster Grandparent Program

    Mr. Chairman and members of the subcommittee, thank you for the 
opportunity to submit this testimony in support of fiscal year 2008 
funding for the Foster Grandparent Program (FGP), the oldest and 
largest of the three programs known collectively as the National Senior 
Volunteer Corps, which are authorized by Title II of the Domestic 
Volunteer Service Act (DVSA) of 1973, as amended and administered by 
the Corporation for National and Community Service (CNS). NAFGPD is a 
membership-supported professional organization whose roster includes 
the majority of more than 350 directors, who administer Foster 
Grandparent Programs nationwide, as well as local sponsoring agencies 
and others who value and support the work of FGP.
    Mr. Chairman, I would like to begin by thanking you and the 
distinguished members of the subcommittee for your steadfast support of 
the Foster Grandparent Program. No matter what the circumstances, this 
subcommittee has always been there to protect the integrity and mission 
of our programs. Our volunteers and the children they serve across the 
country are the beneficiaries of your commitment to FGP, and for that 
we thank you. I also want to acknowledge your outstanding staff for 
their tireless work and very difficult job they have to ``make the 
numbers fit''--an increasingly difficult task in this budget 
environment.

                    ADMINISTRATION'S REQUEST FOR FGP

    Although the number of older people in America eligible to serve as 
Foster Grandparent volunteers is increasing by leaps and bounds as the 
``Baby Boomer'' cohort ages, we were extremely disappointed to learn 
that--instead of seeking an increase for FGP to enable FGP to engage 
more low-income seniors in service--the administration has proposed 
slashing funding for FGP by $13.387 million--a 12.1 percent cut.

           IMPACT OF THE ADMINSTRATION'S PROPOSED FUNDING CUT

    FGP is the only program in existence today that actively seeks out, 
trains, enables, places and supports the elderly poor in contributing 
to their communities by changing the lives of children who desperately 
need one-on-one attention. If enacted, this request will have a 
devastating effect on FGP programs nationwide:
  --3,150 low-income Foster Grandparent volunteers--over 10 percent of 
        the current volunteer complement--will be cut permanently, 
        slashing the total number of Foster Grandparent volunteers from 
        30,550 to 27,400. This will happen at a time when the number of 
        FGP volunteers has not increased appreciably in 10 years!
  --Local communities will lose over 3.3 million hours of volunteer 
        service annually.
  --Approximately 35,000 fewer children with special needs will receive 
        the critical services provided by Foster Grandparents.
  --FGP will permanently lose 3,000 Volunteer Service Years (VSYs, or 
        volunteer ``slots''). For each volunteer ``slot'' that is cut 
        from a Foster Grandparent Program, that program will lose 
        approximately $4,500 from its Federal grant. In addition, at 
        least $500 in valuable non-federal resources contributed by 
        communities will also be lost for every volunteer position that 
        is eliminated.
  --Low-income Baby Boomers will be excluded from serving as Foster 
        Grandparents, because there will be no funds available to hire 
        and place new volunteers as they reach the age of 60. According 
        to the administration on Aging, there are currently 6,000,000 
        low-income seniors eligible for FGP; in 20 years, there will be 
        13,000,000!
    This cut will take FGP back 7 years, to a funding level that is 
more than $1 million less than its funding level in fiscal year 2001. 
In addition, the cut will take effect at a time when the average 
Federal grant for FGP has increased a miniscule $2,898--or .875 percent 
(seven-eighths of 1 percent!)--since fiscal year 2003. After 4 years of 
flat funding, this 12.1 percent cut will not only cut volunteer 
numbers, it will also dig deeply into funds needed to sustain quality 
staff and quality programs. As a result, some FGPs may actually close, 
and local sponsoring agencies--short of funds themselves and unable to 
contribute the funds needed to make up the cut--may simply relinquish 
their sponsorship.
    The Corporation for National and Community Service's Budget 
Justification states that this cut can be absorbed merely through 
volunteer attrition. The reality is that the majority of FGPs 
nationwide will be forced to cut precious volunteers from their 
volunteer rosters. Whether a volunteer leaves through attrition or 
because there is no funding for his/her position, the fact is that this 
budget proposal will result in 3,150 fewer low income elders serving as 
Foster Grandparents.
    NAFGPD respectfully requests three things of the subcommittee:
    (1) to provide $115.937 million for the Foster Grandparent Program 
in fiscal year 2008, an increase of $5.000 million over the fiscal year 
2006 and fiscal year 2007 levels of funding for the program and an 
$18.387 million increase over the administration's fiscal year 2008 
Budget Request for FGP. This critical funding will ensure the continued 
viability of the Foster Grandparent Program, and allow for important 
expansion of this unique program. Specifically, this proposal would 
fund a 3 percent cost of living increase for every Foster Grandparent 
Program as well as expansion grants to existing programs that would add 
370 new low-income senior volunteers to serve 3000 additional children;
    (2) to maintain current appropriations statutory language that 
prohibits CNCS from using funds in the bill to pay non-taxable stipend 
to volunteers whose incomes exceed 125 percent of the national poverty 
level. Congress has repeatedly over the last 7 years re-affirmed that 
the non-taxable stipend must be reserved for low-income volunteers. We 
ask that you again protect the mission of the Foster Grandparent and 
Senior Companion Programs--to enable low-income older people to serve 
their communities--by maintaining this important statutory language.
    (3) to oppose administration proposals that would consolidate 
National and Community Service Act and DVSA accounts and set aside 
provisions of section 412 of the DVSA as they apply to the RSVP program 
(Title II, Part A), and, instead, direct that the changes proposed 
shall not be implemented prior to passage of a bill by the authorizing 
committees of jurisdiction specifying such changes.

                            FGP: AN OVERVIEW

    Established in 1965, the Foster Grandparent Program was the first 
federally funded, organized program to engage older volunteers in 
significant service to others. It remains today the only volunteer 
program in existence that enables seniors living on very low incomes to 
serve as community volunteers by providing a small non-taxable stipend 
that allows volunteers to serve at little or no cost to themselves. 
From the 20 original programs based totally in institutions for 
children with severe mental and physical disabilities, FGP now 
comprises nearly 350 programs in every State and the District of 
Columbia, Puerto Rico, and the Virgin Islands. These programs are now 
primarily in community-based child caring agencies or organizations--
where most special needs children can be found today--and are 
administered locally through a non-profit organization or agency and 
Advisory Council comprised of community citizens dedicated to FGP and 
its mission. FGP represents the best in Federal partnerships with local 
communities, with Federal dollars flowing directly to local sponsoring 
agencies, which in turn determine how the funds are used. Through this 
partnership and the flexibility of the program, FGP is able to meet the 
immediate needs of the local communities. This was demonstrated by 
Foster Grandparent Programs in communities that were impacted by the 
influx of Hurricane Katrina evacuees. Foster Grandparents rallied to 
provide services to children in shelters, child care centers, and 
schools.

                          FGP: THE VOLUNTEERS

    There are currently 30,500 Foster Grandparent volunteers who give 
31 million hours annually to more than 264,000 children, including 
6,300 children of prisoners through 10,200 local agencies. FGP is a 
versatile, dynamic, and uniquely multi-purpose program. The program 
gives Americans 60 years of age or older who are living on incomes at 
or less than 125 percent of the poverty level the opportunity to serve 
15 to 40 hours every week and use the talents, skills and wisdom they 
have accumulated over a lifetime to give back to the communities which 
nurtured them throughout their lives. FGP provides intensive pre-
service orientation and at least 48 hours of ongoing training every 
year to keep volunteers current and informed on how to work with 
children who have special needs.

                           FGP: THE CHILDREN

    Through our volunteers, FGP also provides person-to-person service 
to children and youth under the age of 21 who have special or 
exceptional needs, many of whom face serious, often life-threatening 
challenges. The Foster Grandparent is very often the only person in a 
child's life who is there every day, who accepts the child, encourages 
him no matter how many mistakes the child makes, and focuses on the 
child's successes.
    Special needs of children served by Foster Grandparents include 
AIDS or addiction to crack or other drugs; abuse or neglect; physical, 
mental, or learning disabilities; speech, or other sensory 
disabilities; incarceration and terminal illness. Of the children 
served, 7 percent are abused or neglected, 25 percent have learning 
disabilities, and 10 percent have developmental delays. FGP focuses its 
resources in areas where they will have the most impact: early 
intervention services and literacy activities. Nationally, 90 percent 
of the children served by Foster Grandparents are under the age of 12, 
with 39 percent of these children age 5 or under. Foster Grandparents 
work intensively with these very young children to address their 
problems at as early an age as possible, before they enter school. 
Nearly one-half of FGP volunteers serve nearly 12 million hours 
annually addressing literacy and emergent-literacy problems with 
special needs children.
    Activities of the FGP volunteers with their assigned children 
include teaching parenting skills to teen parents; providing physical 
and emotional support to babies abandoned in hospitals; helping 
children with developmental, speech, or physical disabilities develop 
self-help skills; reinforcing reading and mathematics skills; and 
giving guidance and serving as mentors to incarcerated or other youth.

                        FGP: THE VOLUNTEER SITES

    The Foster Grandparent Program provides child-caring agencies and 
organizations offering services to special-needs children with a 
consistent, reliable, invaluable extra pair of hands 15 to 40 hours 
every week to assist in providing these services. Seventy-one percent 
of FGP volunteers serve in public and private schools as well as sites 
that provide early childhood pre-literacy services to very young 
children, including Head Start.

                      FGP: COST-EFFECTIVE SERVICE

    Using the Independent Sector's 2005 valuation for 1 hour of 
volunteer service ($18.03/hour), the value of the service given by 
Foster Grandparents annually is over $503 million, and represents a 4-
fold return on the Federal dollars invested in FGP. The annual Federal 
cost for one Foster Grandparent is $3,960--less than $4.00 per hour. 
FGP's fiscal year 2006 Federal allocation was matched with $37.4 
million in non-federal donations from States and local communities in 
which Foster Grandparents volunteer. This represents a non-federal 
match of 34 percent, or $.34 for every $1.00 in Federal funds 
invested--well over the 10 percent local match required by law.

                NAFGPD'S FISCAL YEAR 2008 BUDGET REQUEST

    Given the dramatically expanding number of low-income seniors 
eligible to serve and the staggering number of troubled and challenged 
children in America today, we respectfully request that the 
subcommittee provide $115.937 million for the Foster Grandparent 
Program in fiscal year 2008, an increase of $5.000 million over fiscal 
year 2006 and fiscal year 2007 funding levels. This critical funding 
will ensure the continued viability of the Foster Grandparent program, 
and allow for an expansion of this important program. It will generate 
opportunities for approximately 370 new low-income senior volunteers to 
contribute 390,000 hours of service annually to nearly 3,000 additional 
children with special needs through Program of National Significance 
(PNS) grants to existing FGPs. The requested increase would be 
allocated for the following purposes, in order of priority: 1st: in 
accordance with the Domestic Volunteer Service Act (DVSA), designate 
one-third of the increase over the fiscal year 2006 and fiscal year 
2007 level to fund Program of National Significance (PNS) expansion 
grants to allow existing FGP programs to expand the number of 
volunteers serving in areas of critical need as identified by Congress 
in the DVSA.2nd: use all remaining funds to award an administrative 
cost increase of at least 3 percent to each existing Foster Grandparent 
Program in order to maintain quality, enable recruitment and sustain 
the work already being done by programs. The last time FGPs in the 
field realized any increases at all to cover the increased costs of 
doing business--especially in the area of transportation costs--was in 
fiscal year 2005; that increase amounted to a very small .84 percent, 
when inflationary price increases have been averaging 2-3 percent 
annually.
    We request that no funds be provided for Senior Demonstration, and 
that language that expressly prohibits the payment of a non-taxable 
stipend to individuals whose incomes exceed 125 percent of the national 
poverty level continue to be included in the appropriations statute as 
it has been since fiscal year 2000. This important language protects 
the purpose of FGP: to enable low-income elders to serve their 
communities at little or no cost to themselves.
    The message is clear: (1) the population of low-income seniors 
available to volunteer 15 to 40 hours every week is increasing; (2) 
communities need and want more Foster Grandparent volunteers and more 
Foster Grandparent Programs. The subcommittee's continued investment in 
FGP now will pay off in savings realized later, as more seniors stay 
healthy and independent through volunteer service, as communities save 
tax dollars, and as children with special needs are helped to become 
contributing members of society.
    Mr. Chairman, in closing I would like to again thank you for the 
subcommittee's support and leadership for FGP over the years. NAFGPD 
believes that you and your colleagues in Congress appreciate what our 
low-income senior volunteers accomplish every day in communities across 
the country.
                                 ______
                                 
                   Letter From the FSH Society, Inc.
                                                  January 24, 2007.
Senator Tom Harkin,
Chairman, Subcommittee on Labor, HHS, Education and Related Agencies 
        U.S. Senate, Washington, DC.
    Dear Hon. Tom Harkin: I request the opportunity to testify in 
writing or in person before your Subcommittee on Labor, Health and 
Human Services, Education and Related Agencies regarding the fiscal 
year 2008 appropriations to the National Institutes of Health (NIH) for 
research on FSH muscular dystrophy.
    The FSH Society requests the opportunity to update your committee 
on the progress made by the NIH over the past several years in FSH 
muscular dystrophy. Despite a growth in funding from $7 million to $75 
million between 1991 and 2007 for research in muscular dystrophy across 
all Federal agencies, funding for our dystrophy is still anemic. The 
NIH now has perhaps a half dozen grants for FSH Dystrophy out of some 
200 grants for muscular dystrophy in the NIH portfolio. FSHD is the 
third most common disease of muscle.
    The NIH still needs encouragement and funding to develop a 
comprehensive research portfolio for FSHD. We are most appreciative of 
your support in this area and for the gains made thus far. It has 
always been an honor to participate in the hearing process.
    The FSH Society, Inc. and the tens of thousands of patients it 
represents hope you will enable us by affording us the opportunity to 
present testimony to your subcommittee. It is most important to speak 
this year and to provide constructive input on this issue.
            Sincerely,
                                         Daniel Paul Perez,
                                 President & CEO, FSH Society, Inc.
                                 ______
                                 
Prepared Statement of the Friends of the Health Resources and Services 
                             Administration

    The Friends of the Health Resources and Services Administration 
(HRSA) is an advocacy coalition of more than 100 national 
organizations, collectively representing millions of public health and 
health care professionals, academicians and consumers. Our member 
organizations strongly support the programs at HRSA designed to ensure 
access to health services for each person in the United States.
    Through its programs in thousands of communities across the 
country, HRSA provides a health safety net for medically underserved 
individuals and families, including 45 million Americans who lack 
health insurance; 49 million Americans who live in neighborhoods where 
primary health care services are scarce; African American infants, 
whose infant mortality rate is more than double that of whites; and the 
estimated 850,000 to 950,000 people living with HIV/AIDS. Programs to 
support the underserved place HRSA on the front lines in responding to 
our Nation's racial/ethnic and rural/urban disparities in health 
status. HRSA funding goes where the need exists, in communities all 
over America. We support a growing trend in HRSA programs to increase 
flexibility of service delivery at the local level, necessary to tailor 
programs to the unique needs of America's many varied communities. The 
agency's overriding goal is to achieve 100 percent access to health 
care, with zero disparities. In the best professional judgment of the 
members of the Friends of HRSA, to respond to this challenge, the 
agency will require an overall funding level of at least $7.5 billion 
for fiscal year 2008.
    The Friends of HRSA are gravely concerned about the president's 
budget recommendation of devastating cuts for fiscal year 2008, 
including over 12 program eliminations. This is in addition to the 
programs that were eliminated in the fiscal year 2006 and 2007 budget 
cycles and other programs that received deep cuts in both years.
    Through its many programs and initiatives, HRSA helps countless 
individuals live healthier, more productive lives. In the 21st century, 
rapid advances in research and technology promise unparalleled change 
in the Nation's health care delivery system. HRSA could be well 
positioned to meet these new challenges as it continues to provide 
needed health care to the Nation's most vulnerable citizens.
    The Primary Care Bureau received a $207 million increase over the 
fiscal year 2007 current funding level, all of which is designated for 
the Community Health Centers adding 342 new or expanded health center 
service sites and bringing the number of patients served annually to 
16.3 million. Community health centers, often in partnership with 
National Health Service Corps clinicians, form the backbone of the 
Nation's safety net. More than 4,000 of these sites across the Nation 
provide needed primary and preventive care to over 15 million poor and 
near-poor Americans. HRSA primary care centers include community health 
centers, migrant health centers, health care for the homeless programs, 
public housing primary care programs and school-based health centers. 
Health centers provide access to high-quality, family-oriented, 
culturally and linguistically competent primary care and preventive 
services, including mental and behavioral health, dental and support 
services. Nearly three-fourths of health center patients are uninsured 
or on Medicaid, approximately two-thirds are people of color, and more 
than 85 percent live below 200 percent of the poverty level. 2,700 
clinicians in the National Health Service Corps deliver a significant 
portion of the primary care services provided at health centers. Corps 
members work in communities with a shortage of health professionals in 
exchange for scholarships and loan repayments. While recent growth in 
the health centers program has been substantial, a significant need 
remains in underserved communities across the country--we encourage the 
committee to continue its support of existing health centers and 
efforts to expand the reach and scope of health centers into new 
communities.
    Health professions and nursing education programs, authorized under 
Titles VII and VIII of the Public Health Service Act, are essential 
components of America's health care safety net, filling the gaps in the 
health professions' supply not met by traditional market forces. 
Through loans, loan guarantees, scholarships to students, and grants 
and contracts to academic institutions and non-profit organizations, 
the Title VII and VIII health professions programs are the only Federal 
programs designed to train providers in interdisciplinary settings to 
meet the needs of special and underserved populations, as well as 
increase minority representation in the health care workforce. The 
programs provide support for the training of physicians, nurses, 
dentists, physician assistants, nurse practitioners, public health 
personnel, psychologists, and other allied health providers. The final 
budget for fiscal year 2006 included a 51.5 percent cut to Title VII; 
the $40 million increase in the recently enacted fiscal year 2007 joint 
funding resolution does not fully recover the funding lost as a result 
of this devastating cut. Moreover, the President's fiscal year 2008 
budget proposes an additional 94.6 percent cut to Title VII and a 29.7 
percent cut to Title VIII. We are concerned that cuts to the health 
professions programs will exacerbate existing provider shortages in 
rural, medically underserved, and federally designated health 
professions shortage areas and impede recruitment of underrepresented 
minorities and students of disadvantaged backgrounds into the health 
professions. Adequate funding for HRSA Health Professions Programs 
under Title VII and VIII will help to create a prepared national 
workforce by working to reverse projected nationwide shortages of 
physicians, nurses, pharmacists, and other professionals. We strongly 
encourage the subcommittee to restore funding to these vital Health 
Professions programs.
    The Maternal and Child Health Block Grant is a source of flexible 
funding for States and territories to address their unique needs, and 
remains in great need of increased funding. The Title V Maternal and 
Child Health Block (MCH) Grant received a $31 million cut in the fiscal 
year 2006 budget and stagnant funding for fiscal year 2007. The 
President's budget for fiscal year 2008 proposed level funding for the 
block grant at the fiscal year 2006 level. Greater needs among pregnant 
women, infants, and children, particularly those with special health 
care needs present daunting challenges to the State maternal and child 
health programs. Furthermore, if programs like the Traumatic Brain 
Injury program, Universal Newborn Hearing Screening, and Emergency 
Medical Services for Children program are eliminated, those costs will 
be borne by the MCH Block Grant. Of the nearly 4 million mothers who 
give birth annually, almost half receive some prenatal or postnatal 
service from a MCH-funded program. MCH programs increase immunizations 
and newborn screening, reduce infant mortality and developmentally 
handicapping conditions, prevent childhood accidents and injuries, and 
reduce adolescent pregnancy.
    Research indicates that 50,000 individuals die as a result of 
Traumatic Brain Injury (TBI) each year in the United States and an 
additional 80,000 survive with residual long-term impairments. Today 
over 5.3 million Americans are living with a TBI-related disability. 
TBI can strike at anyone at any time--from falls, vehicle crashes, 
sports injuries, violence, and other causes. HRSA's Traumatic Brain 
Injury program makes grants to States to coordinate, expand and enhance 
service delivery systems in order to improve access to services and 
support for persons with TBI and their families. Despite increasing 
numbers of soldiers returning from war with head injuries, increasing 
numbers of children being identified as disabled due to head injuries, 
and the release of an Institute of Medicine Report stating the 
importance of the program to brain injury survivors and their families, 
the administration's fiscal year 2008 budget eliminates the TBI State 
Grant program. We encourage the subcommittee to restore funds that were 
cut from the TBI State Grant program. Individuals with traumatic brain 
injury have an array of protection and advocacy needs, including 
assistance with returning to work; finding a place to live; accessing 
needed supports and services, such as attendant care and assistive 
technology; and obtaining appropriate mental health, substance abuse, 
and rehabilitation services.
    The Children's Health Act of 2000 authorized funding for grants and 
programs to improve state-based newborn screening. Newborn screening is 
a vital public health activity used to identify and treat genetic, 
metabolic, hormonal and functional conditions in newborns. Screening 
detects disorders in newborns that, if left untreated, can cause death, 
disability, mental retardation and other serious illnesses. Parents are 
often unaware that while nearly all babies born in the United States 
undergo newborn screening for genetic birth defects, the number and 
quality of these tests vary from State to State. The March of Dimes, 
the American Academy of Pediatrics and the American College of Medical 
Genetics recommend that at a minimum, every baby born in the United 
States be screened for a core group of 29 treatable conditions 
regardless of the State in which the infant is born. Currently, Federal 
support for State newborn screening activities is provided through the 
Maternal and Child Health Block Grant, Special Projects of Regional and 
National Significance (SPRANS). We encourage the subcommittee to 
increase funding for newborn screening to assist States in improving 
their newborn screening programs and override the administration's 
proposed elimination of the universal newborn hearing screening 
program.
    The proposed elimination of the Emergency Medical Services for 
Children (EMSC) program, a national initiative designed to reduce child 
and youth disability and death due to severe illness and injury, is 
also of great concern, especially in light of the recent Institute of 
Medicine report that highlighted significant shortcomings in pediatric 
emergency care. EMSC grants fund improvements to existing emergency 
medical services systems and to develop and evaluate improved 
procedures and protocols for treating children. Children are not merely 
small adults; they have unique and specific concerns that this programs 
works to address. We request that the EMSC program be funded at $25 
million in fiscal year 2008.
    Although the administration proposes level funding for the hospital 
preparedness program, we are concerned with the $13 million cut the 
program took in fiscal year 2007. All responders, providers and 
facilities must be ready to detect and respond to complex disasters, 
including terrorism, and HRSA must continue to support these vital 
hospital preparedness programs. Furthermore, HRSA's Trauma-EMS Systems 
Program, which is critical to ensure that our response to local, State 
and Federal emergencies is effective and reflects the best clinical 
practice in trauma and emergency medicine, was also proposed to be 
eliminated in fiscal year 2008. We request that the $3.5 million 
funding level be restored.
    The Office of Rural Health Policy, which serves more than 61 
million people, was cut by 89 percent in the President's budget. 
Although almost a quarter of the U.S. population lives in rural areas, 
only an eighth of our doctors work there. Because rural families 
generally earn less than urban families, many health problems 
associated with poverty are more serious, including high rates of 
chronic disease and infant mortality. We encourage the subcommittee to 
restore funding for rural health programs. Additionally, the HRSA Rural 
and Community Access to Emergency Devices Program provides grants to 
States to train lay rescuers and first responders to use AEDs and 
purchase and place these devices in public areas where cardiac arrests 
are likely to occur. We encourage the subcommittee to restore funding 
for this program to the fiscal year 2005 level of $8.927 million.
    The HIV/AIDS Bureau received a $21 million increase in the 
President's 2008 request over fiscal year 2007 levels for a total of 
$2.1 billion. The Ryan White CARE Act programs are the largest single 
source of Federal discretionary funding for HIV/AIDS health care for 
low-income, uninsured and underinsured Americans. While we are pleased 
with the additional funds for HIV related drug therapies, it is 
insufficient to meet the needs of those seeking services. We are 
concerned that the cuts across the programs since fiscal year 2003 is 
diminishing the availability of services. These cuts have forced State, 
local and public health clinics' HIV/AIDS programs to stretch already 
thin dollars to treat existing clients while trying to provide care and 
treatment to those newly diagnosed. We request an increase of $682 
million for Ryan White programs in fiscal year 2008. In fiscal year 
2006 the AIDS Drug Assistance Programs (ADAP) received a $2 million 
increase. Unfortunately, by the end of fiscal year 2007 it is expected 
that hundreds more individuals will be added to ADAP waiting lists and 
that States will have had to institute other cost-containment measures 
such as reduced formularies, increased cost-sharing for ADAP clients 
and lowered eligibility requirements for enrollment.
    Title X of the Public Health Service Act was enacted to provide 
high-quality, subsidized contraceptive care to those who cannot afford 
such services, to improve women's health, reduce unintended 
pregnancies, and decrease infant mortality and morbidity. Title X 
programs provide comprehensive, voluntary and affordable family 
planning services to millions--many of whom are uninsured--at more than 
4,600 clinics nationwide. People who visit Title X funded clinics 
receive a broad package of preventive health services, including breast 
and cervical cancer screening, blood pressure checks, anemia testing, 
and STD/HIV screening.
    A major source of HRSA's strength is its many linkages and 
partnerships with other Federal agencies, State, national and local 
organizations. For example, HRSA and the Centers for Medicare and 
Medicaid Services (CMS) are jointly implementing outreach on the new 
State Children's Health Insurance Program in addition to working 
together to improve data sharing and coordination, particularly on 
Medicaid. Work also is ongoing with the Substance Abuse and Mental 
Health Services Administration (SAMHSA) to integrate behavioral health 
and substance abuse screening, early intervention, referral and follow-
up into primary health care settings funded through HRSA grants. HRSA 
and the Centers for Disease Control and Prevention (CDC) cooperate on a 
variety of disease prevention and health promotion activities.
    We urge the members of the subcommittee to restore the allocations 
that were cut and fund the agency at a level that allows HRSA to 
effectively implement these important programs. The members of the 
Friends of HRSA are grateful for this opportunity to present our views 
to the subcommittee.
                                 ______
                                 
        Prepared Statement of the Friends of the NIDA Coalition

    Mr. Chairman and members of the subcommittee: The Friends of the 
National Institute on Drug Abuse (FoN), a burgeoning coalition of over 
165 scientific and professional societies, patient groups, and other 
organizations committed to preventing and treating substance use 
disorders as well as understanding the causes and public health 
consequences of addiction, is pleased to provide testimony in support 
of the NIDA's extraordinary work. Pursuant to clause 2(g)4 of House 
Rule XI, the Coalition does not receive any Federal funds.
    Drug abuse is costly--to individuals and to our society as a whole. 
Smoking, alcohol abuse and illegal drugs cost this country more than 
$500 billion a year, with illicit drug use alone accounting for about 
$180 billion in health care, crime, productivity loss, incarceration, 
and drug enforcement. Beyond its monetary impact, drug and alcohol 
abuse tear at the very fabric of our society, often spreading 
infectious diseases and bringing about family disintegration, loss of 
employment, failure in school, domestic violence, child abuse, and 
other crimes. The good news is that treatment for drug abuse is 
effective and recovery from addiction is real for millions of Americans 
across the country. Preventing drug abuse and addiction and reducing 
these myriad adverse consequences is the ultimate aim of our Nation's 
investment in drug abuse research. Over the past three decades, 
scientific advances resulting from research have revolutionized our 
understanding of and approach to drug abuse and addiction.
    Because of the critical importance of drug abuse research for the 
health and economy of our Nation, we write to you today to request your 
support for a 6.7 percent increase for NIDA in the fiscal year 2008 
Labor, Health and Human Services, Education and Related Agencies 
Appropriations bill. That would bring total funding for NIDA in fiscal 
year 2008 to $1,067,389,455. Recognizing that so many health research 
issues are inter-related, we also support a 6.7 percent increase for 
the National Institutes of Health overall, which would bring its total 
to $30.8 billion for fiscal year 2008. This work deserves continuing, 
strong support from Congress. Below is a short list of significant NIDA 
accomplishments, challenges, and successes.
    Reducing Prescription Drug Abuse.--NIDA research has documented a 
continued increase in the number of people, especially young people, 
who use prescription drugs for non-medical purposes. Particular concern 
revolves around the inappropriate use of opioid analgesics--very 
powerful pain medications. Research targeting a reduction in 
prescription drug abuse, particularly among our Nation's youth, should 
continue to be a priority for NIDA.
    Pain Medications and Addiction.--FoN commends NIDA for taking a 
leadership role in addressing issues around pain medications and 
addiction. The most powerful treatments available for most forms of 
pain are opioids. However, opioid treatment can produce negative health 
consequences, such as intoxication and physical dependence, and may 
result in opioid abuse and addiction. The prevalence of and process of 
how to prevent, reduce, and treat, these negative health consequences 
in the context of pain are not well understood. FoN is pleased that 
NIDA brought a focus to this important issue, in collaboration with the 
American Medical Association and in conjunction with the NIH Pain 
Consortium, via its Spring 2007 conference ``Pain, Opioids, and 
Addiction: An Urgent Problem for Doctors and Patients.''
    Genes, Environment, and Development.--FoN recognizes and commends 
NIDA for its leadership role in launching the Genes, Environment, and 
Development Initiative (GEDI) with the National Cancer Institute. This 
initiative will support research and add to our understanding of the 
contribution of genetic, environmental, and developmental factors to 
the etiology of substance abuse and related phenotypes, and will 
hopefully lead to improved and tailored drug abuse and addiction 
prevention and treatment interventions. FoN applauds this important, 
cutting-edge research.
    Social Neuroscience.--Research-based knowledge about the dynamic 
interactions of genes with environment confirms addiction as a complex 
and chronic disease of the brain with many contributors to its 
expression in individuals. FoN applauds NIDA's involvement in last 
year's ``social neuroscience'' request for applications, and this 
year's ``genes, environment, and development initiative'' request for 
applications.
    Centers of Excellence for Physician Information.--FoN is very 
pleased that NIDA has created Centers of Excellence for Physician 
Information, and understands that these Centers will serve as national 
models to support the advancement of addiction awareness, prevention, 
and treatment in primary care practices. The NIDA Centers of Excellence 
will target physicians-in-training, including medical students and 
resident physicians in primary care specialties (e.g., internal 
medicine, family practice, and pediatrics). FoN also applauds NIDA for 
developing these centers in collaboration with the American Medical 
Association's Research Education Consortium.
    Drug Abuse and HIV/AIDS.--NIDA understands that drug abuse and 
addiction continue to fuel the spread of HIV/AIDS in the United States 
and abroad, and that drug abuse prevention and treatment interventions 
can be very effective in reducing HIV risk. Research should continue to 
examine every aspect of HIV/AIDS, drug abuse, and addiction, including 
risk behaviors associated with both injection and non-injection drug 
abuse, how drugs of abuse alter brain function and impair decision 
making, and HIV prevention and treatment strategies for diverse groups. 
FoN applauds the Institute for holding a Spring 2007 conference titled 
``Drug Abuse and Risky Behaviors: The Evolving Dynamics of HIV/AIDS.''
    Medications Development.--FoN commends NIDA for its continued 
leadership in working with private industry to develop anti-addiction 
medications and is pleased this collaboration resulted in an effective 
medication for opiate addiction. FoN encourages NIDA to continue its 
efforts to engage the private sector in the development of anti-
addiction medications, particularly for cocaine, methamphetamine, and 
marijuana.
    Co-Occurring Disorders.--NIDA recognizes that substance abuse is a 
disorder that can affect the course of many other diseases. To 
adequately address co-occurring health problems, FoN encourages the 
Institute to work with other agencies to stimulate new research to 
develop effective strategies and to ensure the timely adoption and 
implementation of evidence-based practices for the prevention and 
treatment of co-occurring disorders.
    Adolescent Brain Development--How Understanding the Brain Can 
Impact Prevention Efforts.--FoN notes neuroimaging research by NIDA and 
others showing that the human brain does not fully develop until about 
age 25. This adds to the rationale for referring to addiction as a 
``developmental disease.'' FoN encourages NIDA to continue its emphasis 
on adolescent brain development to better understand how developmental 
processes and outcomes are affected by drug exposure, the environment, 
and genetics.
    Translating Research Into Practice.--FoN commends NIDA for its 
outreach and work with State substance abuse authorities to reduce the 
current 15- to 20-year lag between the discovery of an effective 
treatment intervention and its availability at the community level. In 
particular, FoN applauds NIDA for continuing its work with SAMHSA to 
strengthen State agencies' capacity to support and engage in research 
that will foster statewide adoption of meritorious science-based 
policies and practices. FoN encourages NIDA to continue this 
collaboration.
    Translational Research.--Ensuring Research is Adaptable and 
Useable. FoN commends NIDA for its broad and varied information 
dissemination programs. FoN also understands that the Institute 
continues its focus on stimulating and supporting innovative research 
to determine the components necessary for adopting, adapting, 
delivering, and maintaining effective research-supported policies, 
programs, and practices. As evidence-based strategies are developed, 
FoN urges NIDA to support research to determine how these practices can 
be best implemented at the community level.
    Primary Care Settings and Youth.--NIDA recognizes that primary care 
settings are potential key points of access to prevent and treat 
problem drug use among young people. FoN encourages NIDA to continue to 
support health services research on effective ways to educate primary 
care providers about drug abuse and develop brief behavioral 
interventions for preventing and treating drug use and related health 
problems; and develop methods to integrate drug abuse screening, 
assessment, prevention and treatment into primary health care settings.
    Utilizing Knowledge of Genetics and New Technological Advances to 
Curtail Addiction.--NIDA recognizes that not everyone who takes drugs 
becomes addicted. Research has shown that genetics plays a critical 
role in addiction, and that the interplay between genetics and 
environment is crucial. FoN applauds the Institute's efforts to find 
new and important uses for brain imaging technologies and urges the 
Institute to continue work in this area.
    Reducing Health Disparities.--NIDA research notes that the 
consequences of drug abuse disproportionately impact minorities, 
especially African American populations. FoN is pleased to learn that 
NIDA continues to encourage researchers to conduct more studies in this 
population and to target their studies in geographic areas where HIV/
AIDS is high and or growing among African Americans, including in 
criminal justice settings.
    The Clinical Trials Network--Using Infrastructure to Improve 
Health.--FoN is pleased with the continued success and progress of 
NIDA's National Drug Abuse Treatment Clinical Trials Network (CTN). The 
CTN provides an infrastructure to test the effectiveness of new and 
improved interventions in real-life community settings with diverse 
populations, enabling an expansion of treatment options for providers 
and patients.
    Drug Treatment in Criminal Justice Settings.--NIDA is very 
concerned about the well-known connections between drug use and crime. 
Research continues to demonstrate that providing treatment to 
individuals involved in the criminal justice system significantly 
decreases future drug use and criminal behavior, while improving social 
functioning. FoN strongly supports NIDA's efforts in this area, 
particularly the Criminal Justice Drug Abuse Treatment Studies (CJ-
DATS).
    Emerging Drug Problems.--FoN recognizes that drug use patterns are 
constantly changing and is pleased with NIDA's efforts to monitor drug 
use trends and to rapidly inform the public of emerging drug problems. 
FoN especially encourages NIDA to continue supporting research that 
provides reliable data on emerging drug trends, particularly among 
youth and in major U.S. cities.
    Reducing Methamphetamine Abuse.--NIDA is very concerned about the 
continued abuse of methamphetamine across the United States. NIDA notes 
the advances in understanding methamphetamine abuse and addiction, and 
is encouraged by the growing evidence of treatment effectiveness in 
these populations. FoN urges NIDA to continue supporting research to 
address the broad medical consequences of methamphetamine abuse.
    Reducing Inhalant Abuse.--NIDA understands and is alarmed that 
inhalant use continues to be a significant problem among our youth. FoN 
urges the Institute to continue its support of research on prevention 
and treatment of inhalant abuse, and to enhance public awareness on 
this issue.
    Long-Term Consequences of Marijuana Use.--NIDA is concerned with 
the continuing widespread use of marijuana. FoN urges NIDA to continue 
support for efforts to assess the long-term consequences of marijuana 
use on cognitive abilities, achievement, and mental and physical 
health, as well as work with the private sector to develop medications 
focusing on marijuana addiction.
    Blending Research and Practice.--NIDA notes that it takes far too 
long for clinical research results to be implemented as part of routine 
patient care, and that this lag in diffusion of innovation is costly 
for society, devastating for individuals and families, and wasteful of 
knowledge and investments made to improve the health and quality of 
people's lives. FoN applauds NIDA's collaborative approach aimed at 
proactively involving all entities invested in changing the system and 
making it work better.
    Disseminating Drug Abuse and Addiction Research Information to the 
General Public.--FoN congratulates NIDA for its collaboration with HBO 
and other partners on the production of a groundbreaking documentary 
film on addiction. This film details the latest scientific knowledge on 
addiction and presents it in a compelling way for the lay public, 
helping people to understand addiction as a brain disease that can be 
successfully treated. FoN recognizes the importance of this documentary 
because it shows that substance abuse happens to ordinary, every day 
people, and that treatment can be very successful. The documentary 
should encourage support of those who suffer from this disease, and 
will reduce the stigma that so often accompanies it.
    Support for Young Investigators.--NIDA recognizes the importance 
of, over time, replenishing the ``pipeline'' of researchers in the 
addiction field. FoN congratulates NIDA for its focus on supporting 
young investigators, especially in the area of clinical research. Such 
support is crucial to the future of this field, and the Institute 
should continue its efforts in this area.
    Thank you, Mr. Chairman, and the subcommittee, for your support for 
the National Institute on Drug Abuse.
                                 ______
                                 
               Prepared Statement of Gallaudet University

    Mr. Chairman and members of the committee: I would like to express 
my appreciation to you and to Congress for the generous support that we 
received in fiscal year 2007 during what I know are difficult times for 
Federal funding. I am especially grateful that Congress continues to 
support us during these challenging times, and I am writing in support 
of our appropriation request for fiscal year 2008. As I enter the first 
months of my presidency, I would like to introduce myself to you and 
discuss briefly the challenges that Gallaudet has faced during the past 
year and those that it will face in the near future.
    In December, 2006, I was appointed interim president of Gallaudet 
following a lengthy protest, involving a broad segment of the Gallaudet 
community, against the installation of the individual appointed by 
Gallaudet's Board of Trustees to succeed Dr. I. King Jordan. I recently 
informed the University community that the 2 months since I took office 
on January 2, 2007 have been the most difficult and challenging of my 
50 year career in education and government service (I have come out of 
retirement for a second time to accept this challenge). At the same 
time, this may be the most energized I have ever felt, as well. I do 
not want to minimize the seriousness of the issues that were at the 
heart of the protest, but I also want to assure you that I believe the 
Gallaudet community has never been more unified in its purpose to work 
together toward a future that will be worthy of Gallaudet's 
distinguished past.
    First though, I think it is important for you to know something 
about the qualifications I bring to this task. I am a proud graduate of 
Gallaudet, having received my bachelor's degree in 1953. As I have told 
everyone willing to listen to my story, it was Gallaudet that prepared 
me to take advantage of the opportunities that eventually became open 
to me--Gallaudet made me what I am, and like many other deaf people I 
will always be grateful for that. When I left Gallaudet, I became a 
mathematics teacher at the New York School for the Deaf in White 
Plains. After earning a Master's degree from Hunter College and a Ph.D. 
in educational technology from Syracuse University, I was appointed 
director of the Kendall Demonstration Elementary School and then vice 
president for Pre-College Programs at Gallaudet.
    Following 11 years as a Gallaudet vice president, I was appointed 
by President George H. W. Bush and approved by the Senate as Assistant 
Secretary of Education for Special Education and Rehabilitative 
Services, where I served as the chief oversight officer for Gallaudet 
and the National Technical Institute for the Deaf (NTID) until 1993. 
Since then, I have served for 3 years as headmaster of the New York 
School and, finally, for 8 years as vice president of the Rochester 
Institute of Technology and director of NTID. I think my career 
experiences have given me a unique perspective on the needs of 
Gallaudet University and on its relationship with the Federal 
Government.
    I would like to address those needs briefly. Because of Congress's 
support for Gallaudet during recent years, we have been able to 
maintain a competitive pay structure for our employees while retaining 
the flexibility to meet the needs of a changing student body. Given the 
unique student population we serve and the communication skills our 
employees are expected to possess, retaining skilled employees is 
critical to our mission. Gallaudet employees received general pay 
increases of 2 percent in fiscal year 2003, 3 percent in fiscal year 
2004, 2 percent in fiscal year 2005, and 2 percent again in fiscal year 
2006 and 2007, increases that are below what Federal employees in the 
region received during the same timeframe, and somewhat below increases 
in the Consumer Price Index (CPI). During the most recent 12 month 
period, the national CPI-U increased by 2.1 percent and that for the 
Washington, DC locality increased by 2.9 percent. Given these current 
rates of inflation and a small erosion in the purchasing power or our 
employee salaries in recent years, I am projecting the need for a 3 
percent general pay increase in fiscal year 2008. We are also 
requesting support for inflationary increases in non-salary areas, 
especially in the cost of utilities and benefits. In this regard, I 
need to point out that our benefits costs during the past several years 
have increased by more than 2 percent of base salaries, and we have had 
to fund those increases as part of our total payroll package.
    The administration budget for fiscal year 2008 includes $106.998 
million for Gallaudet, the same as our fiscal year 2007 and 2006 
appropriations, and it would, thus, represent a second year of no 
funding increase. Moreover, the administration budget proposes that 
$600,000 of that base budget be used by the Department of Education for 
a major evaluation of Gallaudet's programs. As a former Federal 
oversight officer for Gallaudet, I understand the importance of 
evaluation studies, and I would welcome working in this way with the 
Federal Government, but I need to point out that taking these funds 
from our existing budget would further erode our financial base. I have 
carefully analyzed our fiscal year 2008 funding needs and have 
determined that in order to provide a 3 percent salary increase to our 
faculty and staff, and to meet other inflation-driven increases, we 
need an increase of at least 3 percent, or $3.2 million, in our 
appropriation for operations. I have announced a set of priorities to 
the Gallaudet community that are student centered and that are designed 
to restore Gallaudet's traditional reputation for excellence in the 
education of deaf students. This modest increase in our appropriation 
would provide substantial support for the achievement of this agenda.
    In addition, I want to bring to your attention a major a problem 
for Gallaudet's infrastructure. During the past several years, there 
has been damage to dormitories serving the students of the Model 
Secondary School for the Deaf (MSSD) as a result of instability in the 
hillside site of the school's facilities. This instability is due to 
the construction of the facilities on an area underlain by a layer of 
marine clay, a problem that has been identified throughout the 
Washington region only during the past 20 to 30 years, following the 
construction of the MSSD facilities. We have discussed this problem 
with officials from the Department of Education in the past, but only 
with respect to the dormitories. During the past year, it has become 
evident that the main MSSD academic building is now being affected and 
there are threats to other buildings in the vicinity, including the 
Kendall Demonstration Elementary School (KDES). We have retained soil 
and structural engineers to assist us in assessing the current damage 
and the future threat, and to help us estimate costs for stabilizing 
the site and repairing the structural damage that has already occurred. 
Because of the urgent nature of the situation we have sought the 
support of the Department and are requesting funding to begin site 
stabilization from Congress in fiscal year 2008. Current estimates for 
stabilizing the site and repairing the existing damage are in the range 
of $15 to $20 million. I am requesting $7.5 million in fiscal year 2008 
to support the cost of stabilizing the site. I will be making further 
requests to repair the damage to facilities in fiscal year 2009.
    In making this request, I want to point out that Gallaudet has not 
asked for special funding for construction for many years. The 
buildings most recently constructed on the campus, the Kellogg 
Conference Center and the Jordan Student Academic Center were 
constructed with privately raised funds, as will be the Sorenson Center 
for Language and Communication that is currently under construction. 
So, I do not make this request lightly. The Model Secondary School is 
operated as a public school, without charging tuition and with the full 
support of the Federal Government. Therefore, I believe this request 
for support is both prudent and appropriate.

                  FUNDING REQUEST FOR FISCAL YEAR 2008

    In our budget request to the Department of Education for fiscal 
year 2008, we addressed the need for inflationary increases as well as 
support for program development. Given the funding issues currently 
facing Congress, I am requesting support at this time only for our most 
pressing inflationary needs and the need to address the infrastructure 
issues I described above. Funding of our need to cover inflationary 
costs will provide us some budget stability, but we will continue to 
face the need for development and enhancement of our programs. Our 
strategy will be to seek alternative sources of funding for some of 
these program priorities and to defer development of others. We will 
continue to seek support for program growth from both Federal and 
private sources in the future.
  --Inflationary costs at 3 percent--$3.2 million.
  --MSSD site stabilization--$7.5 million.
    My total request for fiscal year 2008 is, thus, $117.7 million; 
$110.2 million for operations and $7.5 million for site stabilization 
of the MSSD facilities.
    I appreciate the challenges that Congress faces in making 
appropriations decisions for fiscal year 2008, but I believe experience 
has shown that Gallaudet provides an outstanding return on Federal 
dollars that are invested here, in terms of the educated and productive 
deaf community that the Nation enjoys as a result. Thank you.
                                 ______
                                 
  Prepared Statement of the Health Professions and Nursing Education 
                               Coalition

    The members of the Health Professions and Nursing Education 
Coalition (HPNEC) are pleased to submit this statement for the record 
in support of the health professions education programs authorized 
under Titles VII and VIII of the Public Health Service Act. HPNEC is an 
informal alliance of more than 60 national organizations representing 
schools, programs, health professionals, and others dedicated to 
ensuring that Title VII and VIII programs continue to help educate the 
Nation's health care and public health personnel. HPNEC members are 
thankful for the support the subcommittee has provided to the programs, 
which are essential to building a well-educated, diverse health care 
workforce.
    The Title VII and VIII health professions and nursing programs are 
essential components of the Nation's health care safety net, bringing 
health care services to underserved communities. These programs support 
the training and education of health care providers with the aim of 
enhancing the supply, diversity, and distribution of the workforce, 
filling the gaps in the health professions' supply not met by 
traditional market forces. The Title VII and VIII health professions 
programs are the only Federal programs designed to train providers in 
interdisciplinary settings to meet the needs of special and underserved 
populations, as well as increase minority representation in the health 
care workforce.
    The final fiscal year 2006 Labor-HHS-Education Appropriations bill 
cut Title VII & VIII programs by 34.5 percent, including a 51.5 percent 
cut to Title VII programs. The $40 million increase provided for Title 
VII in the recently enacted fiscal year 2007 joint funding resolution 
does not restore these devastating cuts. Moreover, the President's 
fiscal year 2008 budget proposes an additional 94.6 percent cut to 
Title VII and a 29.7 percent cut to Title VIII.
    HPNEC members recommend that the Title VII and VIII programs 
receive an appropriation of at least $550 million for fiscal year 2008. 
This recommendation would ensure the programs have sufficient funds to 
continue fulfilling their mission of educating and training a health 
care workforce that meets the public's health care needs.
    During their 40-year existence, the Title VII and VIII programs 
have created a network of initiatives across the country that supports 
the training of many disciplines of health providers. Together, the 
programs work in concert with the National Health Service Corps and 
Community Health Centers (CHCs) to strengthen the health safety net for 
rural and medically underserved communities. A March 2006 study 
published in the Journal of the American Medical Association (JAMA) 
found that CHCs report high percentages of provider vacancies, 
including an insufficient supply of dentists, pharmacists, 
pediatricians, family physicians, and registered nurses; these 
shortages are especially pronounced in rural areas. Because Title VII 
and VIII programs have a successful record of training providers who 
serve underserved areas, the study recommends increased support for the 
programs as its primary means of alleviating the shortages. Further, 
the study serves as an important reminder that the success of CHCs is 
highly dependent upon a well-trained clinical staff to provide care.
    HPNEC members urge the subcommittee to consider the vital need for 
these health professions education programs as demonstrated by the 
passage of the Health Professions Education Partnerships Act of 1998 
(Public Law 105-392), which reauthorized the programs. The 
reauthorization consolidated the programs into seven general 
categories:
  --The purpose of the Minority and Disadvantaged Health Professionals 
        Training programs is to improve health care access in 
        underserved areas and the representation of minority and 
        disadvantaged health care providers in the health professions. 
        Minority Centers of Excellence support programs that seek to 
        increase the number of minority health professionals through 
        increased research on minority health issues, establishment of 
        an educational pipeline, and the provision of clinical 
        opportunities in community-based health facilities. The Health 
        Career Opportunity Program seeks to improve the development of 
        a competitive applicant pool through partnerships with local 
        educational and community organizations. The Faculty Loan 
        Repayment and Faculty Fellowship programs provide incentives 
        for schools to recruit underrepresented minority faculty. The 
        Scholarships for Disadvantaged Students (SDS) make funds 
        available to eligible students from disadvantaged backgrounds 
        who are enrolled as full-time health professions students.
  --The Primary Care Training category, including General Pediatrics, 
        General Internal Medicine, Family Medicine, General Dentistry, 
        Pediatric Dentistry, and Physician Assistants, provides for the 
        education and training of primary care physicians, dentists, 
        and physician assistants to improve access and quality of 
        health care in underserved areas. The General Pediatrics, 
        General Internal Medicine, and Family Medicine programs provide 
        critical funding for primary care training in community-based 
        settings and have been successful in directing more primary 
        care physicians to work in underserved areas. They support a 
        range of initiatives, including medical student training, 
        residency training, faculty development and the development of 
        academic administrative units. The General Dentistry and 
        Pediatric Dentistry programs provide grants to dental schools 
        and hospitals to create or expand primary care dental residency 
        training programs. Recognizing that all primary care is not 
        only provided by physicians, the primary care cluster also 
        provides grants for Physician Assistant programs to encourage 
        and prepare students for primary care practice in rural and 
        urban Health Professional Shortage Areas. Additionally, these 
        programs enhance the efforts of osteopathic medical schools to 
        continue to emphasize primary care medicine, health promotion, 
        and disease prevention, and the practice of ambulatory medicine 
        in community-based settings.
  --Because much of the Nation's health care is delivered in areas far 
        removed from health professions schools, the Interdisciplinary, 
        Community-Based Linkages cluster provides support for 
        community-based training of various health professionals. These 
        programs are designed to provide greater flexibility in 
        training and to encourage collaboration between two or more 
        disciplines. These training programs also serve to encourage 
        health professionals to return to such settings after 
        completing their training. The Area Health Education Centers 
        (AHECs) provide clinical training opportunities to health 
        professions and nursing students in rural and other underserved 
        communities by extending the resources of academic health 
        centers to these areas. Health Education and Training Centers 
        (HETCs) were created to improve the supply of health 
        professionals along the U.S.-Mexico border. They incorporate a 
        strong emphasis on wellness through public health education 
        activities for disadvantaged populations. Geriatric Health 
        Professions programs support geriatric faculty fellowships, the 
        Geriatric Academic Career Award, and Geriatric Education 
        Centers, which are all designed to bolster the number and 
        quality of health care providers caring for our older 
        generations. The Quentin N. Burdick Program for Rural Health 
        Interdisciplinary Training places an emphasis on long-term 
        collaboration between academic institutions, rural health care 
        agencies and providers to improve the recruitment and retention 
        of health professionals in rural areas. The Allied Health 
        Project Grants program represents the only Federal effort aimed 
        at supporting new and innovative education programs designed to 
        reduce shortages of allied health professionals and create 
        opportunities in medically underserved and minority areas. The 
        Graduate Psychology Education Program provides grants to 
        doctoral, internship and postdoctoral programs in support of 
        interdisciplinary training of psychology students with other 
        health professionals for the provision of mental and behavioral 
        health services to underserved populations, especially in rural 
        and urban communities.
  --The Health Professions Workforce and Analysis program provides 
        grants to institutions to collect and analyze data on the 
        health professions workforce to advise future decision-making 
        on the direction of health professions and nursing programs. 
        The Health Professions Research and Health Professions Data 
        programs have developed a number of valuable, policy-relevant 
        studies on the distribution and training of health 
        professionals, including the Eighth National Sample Survey of 
        Registered Nurses (NSSRN), the Nation's most extensive and 
        comprehensive source of statistics on registered nurses.
  --The Public Health Workforce Development programs are designed to 
        increase the number of individuals trained in public health, to 
        identify the causes of health problems, and respond to such 
        issues as managed care, new disease strains, food supply, and 
        bioterrorism. The Public Health Traineeships and Public Health 
        Training Centers seek to alleviate the critical shortage of 
        public health professionals by providing up-to-date training 
        for current and future public health workers, particularly in 
        underserved areas. Preventive Medicine Residencies provide 
        training in the only medical specialty that teaches both 
        clinical and population medicine to improve community health. 
        Dental Public Health Residency programs are vital to the 
        Nation's dental public health infrastructure. The Health 
        Administration Traineeships and Special Projects grants are the 
        only Federal funding provided to train the managers of our 
        health care system, with a special emphasis on those who serve 
        in underserved areas.
  --The Nursing Workforce Development programs under Title VIII provide 
        training for entry-level and advanced degree nurses to improve 
        the access to, and quality of, health care in underserved 
        areas. Health care entities across the Nation are experiencing 
        a crisis in nurse staffing, caused in part by an aging 
        workforce and capacity limitations within the educational 
        system. Each year, nursing schools turn away between 42,000 and 
        92,000 qualified applicants at all degree levels due to an 
        insufficient number of faculty, clinical sites, classroom 
        space, clinical preceptors, and budget constraints. Congress 
        responded to this dire national need by passing the Nurse 
        Reinvestment Act (Public Law 107-205) in 2002, which increases 
        nursing education, retention, and recruitment. The Advanced 
        Education Nursing program awards grants to train a variety of 
        advanced practice nurses, including nurse practitioners, 
        certified nurse-midwives, nurse anesthetists, public health 
        nurses, nurse educators, and nurse administrators. Workforce 
        Diversity grants support opportunities for nursing education 
        for disadvantaged students through scholarships, stipends, and 
        retention activities. Nurse Education, Practice, and Retention 
        grants are awarded to help schools of nursing, academic health 
        centers, nurse managed health centers, State, and local 
        governments, and other health care facilities to develop 
        programs that provide nursing education, promote best 
        practices, and enhance nurse retention. The Loan Repayment and 
        Scholarship Program repays up to 85 percent of nursing student 
        loans and offers full-time and part-time nursing students the 
        opportunity to apply for scholarship funds. In return these 
        students are required to work for at least 2 years of practice 
        in a designated nursing shortage area. The Comprehensive 
        Geriatric Education grants are used to train RNs who will 
        provide direct care to older Americans, develop and disseminate 
        geriatric curriculum, train faculty members, and provide 
        continuing education. The Nurse Faculty Loan program provides a 
        student loan fund administered by schools of nursing to 
        increase the number of qualified nurse faculty. The Title VIII 
        nursing programs also support the National Advisory Council on 
        Nurse Education and Practice, which is charged with advising 
        the Secretary of Health and Human Services and Congress on 
        nursing workforce, education, and practice improvement issues.
  --The loan programs in the Student Financial Assistance support needy 
        and disadvantaged medical and nursing school students in 
        covering the costs of their education. The Nursing Student Loan 
        (NSL) program provides loans to undergraduate and graduate 
        nursing students with a preference for those with the greatest 
        financial need. The Primary Care Loan (PCL) program provides 
        loans covering the cost of attendance in return for dedicated 
        service in primary care. The Health Professional Student Loan 
        (HPSL) program provides loans covering the cost of attendance 
        for financially needy health professions students based on 
        institutional determination. The NSL, PCL, and HPSL programs 
        are funded out of each institution's revolving fund and do not 
        receive Federal appropriations. The Loans for Disadvantaged 
        Students (LDS) program provides grants to health professions 
        institutions to make loans to health professions students from 
        disadvantaged backgrounds.
    These programs work collectively to fulfill their unique, three-
pronged mission:
Title VII & VIII programs enhance the supply of the health professions 
        workforce
    A network of 50 Geriatric Education Centers has trained over 
500,000 health practitioners in 35 health-related disciplines to better 
serve the burgeoning elderly population.
    As the largest source of Federal funding for nursing education, the 
Nursing Workforce Development programs provided loan, scholarship, and 
programmatic support to 48,698 student nurses and nurses in fiscal year 
2006.
Title VII & VIII programs improve the distribution of health care 
        providers
    A study published in the Winter 2006 issue of the Journal of Rural 
Health reports that up to 83 percent of family medicine residents and 
80 percent of nurse practitioners who went through a program with Title 
VII or VIII funding chose to practice in areas with health professions 
shortages or medically underserved practice locations.
    A study from the University of California, San Francisco shows that 
medical schools that receive primary care training dollars produce more 
physicians who work in CHCs and serve in the National Health Service 
Corps compared to schools without Title VII primary care funding.
Title VII & VIII programs increase the representation of minority and 

        DISADVANTAGED STUDENTS IN THE HEALTH PROFESSIONS

    A study published in the September 2006 issue of the JAMA finds 
that post-baccalaureate programs, which rely on Title VII among other 
sources of funding, are highly effective in increasing minority 
representation in medical school. The study concludes that enacted 
reductions in funding for Title VII may have negative consequences for 
these effective programs.
    A review of physician assistant graduates from 1990-2004 reveals 
that graduates of Title VII supported programs were 67 percent more 
likely to be from underrepresented minority backgrounds than graduates 
of non-Title VII supported programs.
    HPNEC members respectfully urge support for funding of at least 
$550 million for the Title VII and VIII programs, an investment 
essential not only to the development and training of tomorrow's health 
care professions but also to our Nation's efforts to provide needed 
health care services to underserved and minority communities. We 
greatly appreciate the support of the subcommittee and look forward to 
working with Members of Congress to achieve these goals in fiscal year 
2008 and into the future.
                                 ______
                                 
             Prepared Statement of the Heart Rhythm Society

    The Heart Rhythm Society (HRS) thanks you and the Subcommittee on 
Labor, Health and Human Services and Education for your past and 
continued support of the National Institute of Health, and specifically 
the National Heart, Lung and Blood Institute (NHLBI).
    The Heart Rhythm Society, founded in 1979 to address the scarcity 
of information about the diagnosis and treatment of cardiac 
arrhythmias, is the international leader in science, education and 
advocacy for cardiac arrhythmia professionals and patients, and the 
primary information resource on heart rhythm disorders. The Heart 
Rhythm Society serves as an advocate for millions of American citizens 
from all 50 States, since arrhythmias are the leading cause of heart-
disease related deaths. Other, less lethal forms of arrhythmias are 
even more prevalent, account for 14 percent of all hospitalizations of 
Medicare beneficiaries.\1\ A Our mission is to improve the care of 
patients by promoting research, education and optimal health care 
policies and standards. We are the preeminent professional group, 
representing more than 4,200 specialists in cardiac pacing and 
electrophysiology.
---------------------------------------------------------------------------
    \1\ Heart Rhythm Foundation, Arrhythmia Key Facts, 2004 http://
www.heartrhythmfoundation.org/facts/arrhythmia.asp
---------------------------------------------------------------------------
    The Heart Rhythm Society recommends the subcommittee renew its 
commitment to supporting biomedical research in the United States and 
recommends Congress provide NIH with a 6.7 percent increase for fiscal 
year 2008. This increase will enable NIH and NHLBI to sustain the level 
of research that leads to research breakthroughs and improved health 
outcomes. In particular, the Heart Rhythm Society recommends Congress 
support research into abnormal rhythms of the heart.
    HRS appreciates the actions of Congress to double the budget of the 
NIH in recent years. The doubling has directly promoted innovations 
that have improved treatments and cures for a myriad of medical 
problems facing our Nation. Medical research is a long-term process and 
in order to continue to meet the evolving challenges of improving human 
health we must not let our commitment wane. Furthermore, NIH research 
fuels innovation that generates economic growth and preserves our 
Nation's role as a world leader in the biomedical and biotech 
industries. Healthier citizens are the key to robust economic growth 
and greater productivity. Economists estimate that improvements in 
health from 1970 to 2000 were worth $95 trillion. During the same time 
period, the United States invested $200 billion in the NIH. If only 10 
percent of the overall health savings resulted from NIH-funded 
research, our investment in medical research has provided a 50-fold 
return to the economy.\2\
---------------------------------------------------------------------------
    \2\ Murphy, KM and Topel, RH, The Value of Health and Longevity, 
National Bureau of Economic Research Working Paper Series, Working 
Paper 11405, June 2005.
---------------------------------------------------------------------------
    Unfortunately, since the end of the doubling in 2003, funding for 
NIH has failed to keep pace with biomedical inflation. As a result 13 
percent of NIH's purchasing power has been lost. Because of this NIH 
has been unable to fully fund existing multi-year grants, thus stalling 
life-saving discoveries. If these vacillations in funding continue, 
future generations of researchers will become discouraged from pursuing 
a career in basic science and laboratories' resources could be strained 
to the point of forcing lay-offs and even closure.

                        RESEARCH ACCOMPLISHMENTS

    In the field of cardiac arrhythmias, NIH-funded research has 
advanced our ability to treat atrial fibrillation and thus prevent the 
devastating complications of stroke. Atrial fibrillation is found in 
about 2.2 million Americans and increases the risk for stroke about 5-
fold. About 15-20 percent of strokes occur in people with atrial 
fibrillation. Stroke is a leading cause of serious, long-term 
disability in the United States and people who have strokes caused by 
AF have been reported as 2-3 times more likely to be bedridden compared 
to those who have strokes from other causes. Each year about 700,000 
people experience a new or recurrent stroke and in 2002 stroke 
accounted for more than 1 of every 15 deaths in the United States. 
Ablation therapy however is providing a cure for individuals whose 
rapid heart rates had previously incapacitated them, giving them a new 
lease on life.\3\
---------------------------------------------------------------------------
    \3\ American Stroke Association and American Heart Association, 
Heart Disease and Stroke Statistics_2005 Update, 2005 http://
www.americanheart.org/downloadable/heart/
1105390918119HDSStats2005Update.pdf
---------------------------------------------------------------------------
    Important advances have also been made in identifying patients with 
heart failure and those who have suffered a heart attack and are at 
risk for sudden death. The development, through initial NIH-sponsored 
research, and implantation of sophisticated internal cardioverter 
defibrillators (ICD's) in such patients has saved the lives of hundreds 
of thousands and provides peace of mind for families everywhere, 
including that of Vice-President Cheney's. A new generation of 
pacemakers and ICDs is restoring the beat of the heart as we grow 
older, permitting us to lead more normal and productive lives, reducing 
the burden on our families, communities and the healthcare system. 
Arrhythmias and sudden death affect all age groups and are not solely 
diseases of the elderly.
    Research advances in molecular genetics have provided us the root 
basis for life-threatening abnormal rhythms of the heart associated 
with of wide range of inherited syndromes including long and short QT, 
Brugada syndromes, and hypertrophic cardiomyopathies. Inroads have been 
achieved in the identification of cardiac arrhythmias as a cause of 
Sudden Infant Death Syndrome (SIDS) and the genetic basis for a new 
clinical entity associated with sudden death of young adults was 
uncovered earlier this year. This knowledge has provided guidance to 
physicians for better detection and treatment of these sudden death 
syndromes reducing mortality and disability of infants, children and 
young adults. Individuals who survive an instance of sudden death often 
remain in vegetative states, resulting in a devastating burden on their 
families and an enormous economic burden on society. These advances 
have translated into sizeable savings to the health care system in the 
United States. Researchers are also developing a noninvasive imaging 
modality for cardiac arrhythmias. Despite the fact that more than 
325,000 Americans die every year from heart rhythm disorders, a 
noninvasive imaging approach to diagnosis and guided therapy of 
arrhythmias, the equivalent of CT or MRI, has previously not been 
available.
    The NIH-funded Public Access Defibrillation (PAD) Trial was also 
able to determine that trained community volunteers increase survival 
for victims of cardiac arrest. It had already been known that 
defibrillation, utilizing an automated external defibrillator (AED), by 
trained public safety and emergency medical services personnel is a 
highly effective live-saving treatment for cardiac arrest. A NIH-funded 
trial however was able to conclude that placing AED's in public places 
and training lay persons to use them can prevent additional deaths and 
disabilities.\4\
---------------------------------------------------------------------------
    \4\ National Heart Lung and Blood Institute, NIH, Public Access 
Defibrillation by Trained Community Volunteers Increases Survival for 
Victims of Cardiac Arrest, November 2003 http://www.nhlbi.nih.gov/new/
press/03-11-11.htm
---------------------------------------------------------------------------
    Without NIH support, these life-saving findings may have taken a 
decade to unravel. The highly focused approach utilizing basic and 
clinical expertise, funded through Federal programs made these advances 
a reality in a much shorter time-period.

                          BUDGET JUSTIFICATION

    These impressive strides notwithstanding, cardiac arrhythmias 
continue to plague our society and take the lives of loved ones at all 
ages, nearly one every minute of every day, as well as straining an 
already burdened health system. Sudden Cardiac Arrest is a leading 
cause of death in the United States, claiming an estimated 325,000 
lives every year, or one life every 2 minutes.\5\ The burden of 
morbidity and mortality due to cardiac arrhythmias is predicted to grow 
dramatically as the baby boomers age. Atrial fibrillation strikes 3-5 
percent of people over the age of 65,\6\ Apresenting a skyrocketing 
economic burden to our society in the form of healthcare treatment and 
delivery. Cardiac diseases of all forms increase with advancing age, 
ultimately leading to the development of arrhythmias. Effective drug 
therapy for the management of atrial fibrillation is one of the 
greatest unmet needs in our society today and additional research is 
needed to address this problem. NIH research provides the basis for the 
medical advances that hold the key to lowering health care costs.
---------------------------------------------------------------------------
    \5\ Heart Rhythm Foundation, The Facts on Sudden Cardiac Arrest, 
2004 http://www.heartrhythmfoundation.org/itsabouttime/pdf/
providerfactsheet.pdf
    \6\ Heart Rhythm Society, Atrial Fibrillation & Flutter, 2005 
http://www.hrspatients.org/patients/heart disorders/atrial 
fibrillation/default.asp
---------------------------------------------------------------------------
    The above progress we have witnessed in recent years will provide 
treatments for this illness, only if the resources continue to be 
available to the academic scientific and medical community. However, 
the budgets appropriated by Congress to the NIH in the past 3 years 
were far below the level of scientific inflation. These vacillations in 
funding cycles threaten the continuity of the research and the momentum 
that has been gained over the years. While HRS recognizes that Congress 
must balance other priorities, sustaining multi-year growth for the 
biomedical research enterprise is critical. A central objective of the 
doubling of the NIH budget was to accelerate solutions to human disease 
and disability. NIH is now engaging in the next generation of 
biomedical research to translate basic research and clinical evidence 
into new cures. Our ability to bring together uniquely qualified and 
devoted investigators and collaborators both at the basic science level 
and in the clinical arena is a vital key to our to this success. 
Funding models however show that a threshold exists, below which NIH 
will not be able to maintain its current scope and number of grants, 
let alone expand its programs to address new concerns and emerging 
opportunities. Furthermore, the United States is in danger of losing 
its leadership role in science and technology. The United States faces 
growing competition from other nations, such as China and India, which 
are working to invest more of their GDP's into building state-of-the 
art research institutes and universities to foster innovation and 
compete directly for the world's top students and researchers.\7\
---------------------------------------------------------------------------
    \7\ Task Force on the Future of American Innovation, The Knowledge 
Economy: Is the United States Losing it's Competitive Edge?, February 
16, 2005.
---------------------------------------------------------------------------
    It is for this reason that we are asking for your support to 
increase NIH appropriations by 6.7 percent for fiscal year 2008. The 
Heart Rhythm Society recommends Congress specifically acknowledge the 
need for cardiac arrhythmia research to prevent sudden cardiac arrest 
and other life threatening conditions such as sudden infant death 
syndrome, definitive therapeutic approaches for atrial fibrillation and 
the prevention of stroke, and other genetic arrhythmia conditions. 
Thank you very much for your consideration of our request.
    If you have any questions or need additional information, please 
contact Nevena Minor, Coordinator, Health Policy at the Heart Rhythm 
Society ([email protected] or 202-464-3431).
    Thank you again for the opportunity to submit testimony.
                                 ______
                                 
      Prepared Statement of the Hepatitis Foundation International

              SUMMARY OF FISCAL YEAR 2007 RECOMMENDATIONS

    Continue the great strides in research at the National Institutes 
of Health (NIH) by providing a 6.7 percent budget increase for fiscal 
year 2008. Increase funding for the National Institute for Allergy and 
Infectious Diseases (NIAID), the National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK), the National Institute on 
Alcohol Abuse and Alcoholism (NIAAA), and the National Institute on 
Drug Abuse (NIDA) by 6.7 percent.
    Continued support for the hepatitis B vaccination program for 
adults at the Centers for Disease Control and Prevention (CDC) as well 
as CDC's Prevention Research Centers by providing an 8 percent increase 
for CDC.
    Support for the Substance Abuse and Mental Health Services 
Administration (SAMHSA) by providing an 8 percent increase in fiscal 
year 2007.
    Urge CDC, NIAID, NIDDK, NIAAA, NIDA, and SAMHSA to work with 
voluntary health organizations to promote liver wellness, education, 
and prevention of both hepatitis and substance abuse.
    Mr. Chairman and members of the subcommittee, thank you for your 
continued leadership in promoting better research, prevention, 
education, and control of diseases affecting the health of our Nation. 
I am Thelma King Thiel, Chairman and Chief Executive Officer of the 
Hepatitis Foundation International (HFI).
    Currently, five types of viral hepatitis have been identified, 
ranging from type A to type E. All of these viruses cause acute, or 
short-term, viral hepatitis. Hepatitis B, C, and D viruses can also 
cause chronic hepatitis, in which the infection is prolonged, sometimes 
lifelong. While treatment options are available for many patients, 
individuals with chronic viral hepatitis B and C represent a 
significant number of the patients that require a liver transplant. 
Current treatments have limited success and there is no vaccine 
available for hepatitis C, the most prevalent of these diseases.

                              HEPATITIS B

    Hepatitis B (HBV) claims an estimated 5,000 lives every year in the 
United States, even though therapies exist that slow the progression of 
liver damage. Vaccines are available to prevent hepatitis B. This 
disease is spread through contact with the blood and body fluids of an 
infected individual and from an HBV infected mother to child at birth. 
Unfortunately, due to both a lack in funding to vaccinate adults and 
the absence of an integrated preventive education strategy, 
transmission of hepatitis B continues to be problematic. Additionally, 
there are significant disparities in the occurrence of chronic HBV-
infections. For example, Asian Americans represent 4 percent of the 
population; however, they account for more than half of the 1.3 million 
chronic hepatitis B cases in the United States. Current treatments do 
not cure hepatitis B, but appropriate treatment can help to reduce the 
progression to liver cancer and liver failure. Yet, many are not 
treated. Preventive education and universal vaccination are the best 
defenses against hepatitis B.
    HFI supports the recommendation to increase funding by $50 million 
for the cost of vaccines for adults offered by the Institute of 
Medicine in their report, entitled ``Calling the Shots: Immunization 
Finance Policies and Practices.''

                              HEPATITIS C

    Infection rates for hepatitis C (HCV) are at epidemic proportions. 
Unfortunately, many individuals are not aware of their infection until 
many years after they are infected. This creates a dangerous situation, 
as individuals who are infected unknowingly continue to spread the 
disease. The Center for Disease Control and Prevention estimates that 
there are over 4 million Americans who have been infected with 
hepatitis C, of which over 2.7 million remain chronically infected, 
with 8,000-10,000 deaths each year. Additionally, the death rate is 
expected to triple by 2010 unless additional steps are taken to improve 
outreach and education on the prevention of hepatitis C and scientists 
identify more effective treatments and cures. As there is no vaccine 
for HCV, prevention education and treatment of those who are infected 
serve as the most effective approach in halting the spread of this 
disease.

                         PREVENTION IS THE KEY

    The absence of information about the liver and hepatitis in 
education programs over the years has been a major factor in the spread 
of viral hepatitis through unknowing participation in liver damaging 
activities. Adults and children need to understand the importance of 
the liver and how viruses and drugs can damage its ability to keep them 
alive and healthy. Many who are currently infected are unaware of the 
risks they are taking that expose them to viral infections and 
ultimately liver damage.
    Knowledge is the key to prevention. Preventive education is 
essential to motivate individuals to protect themselves and avoid 
behaviors that can cause life-threatening diseases. Primary prevention 
that encourages individuals to adopt healthful lifestyle behaviors must 
begin in elementary schools when children are receptive to learning 
about their bodies. In addition to educating individuals at a critical 
age, schools provide access to one-fifth of the American population.
    Individuals need to be motivated to assess their own risk 
behaviors, to seek testing, to accept vaccination, to avoid spreading 
their disease to others, and to understand the importance of 
participating in their own health care and disease management. The NIH 
needs to support education programs to train teachers and healthcare 
providers in effective communication techniques, and to evaluate the 
impact preventive education has on reducing the incidence of hepatitis 
and substance abuse.
    Therefore, HFI recommends that CDC, NIAID, NIDDK, NIAAA, NIDA, and 
SAMHSA be urged to work with voluntary health organizations to promote 
liver wellness, education, and prevention of viral hepatitis, sexually 
transmitted diseases and substance abuse.
    Only a major investment in immunization and preventive education 
will bring these diseases under control. All newborns, young children, 
young adults, and especially those who participate in high-risk 
behaviors must be a priority for immunization, outreach initiatives, 
and preventive education. We recommend that the following activities be 
undertaken to prevent the further spread of all types of hepatitis:
  --Provide effective preventive education in our elementary and 
        secondary schools so children can avoid the serious health 
        consequences of risky behaviors that can lead to viral 
        hepatitis.
  --Train educators, health care professionals, and substance abuse 
        counselors in effective communication and counseling 
        techniques.
  --Promote public awareness campaigns to alert individuals to assess 
        their own risk behaviors, motivate them to seek medical advice, 
        encourage immunization against hepatitis A and B, and to stop 
        the consumption of any alcohol if they have participated in 
        risky behaviors that may have exposed them to hepatitis C.
  --Expand screening, referral services, medical management, 
        counseling, and prevention education for individuals who have 
        HCV, many of whom may be co-infected with HIV and Hepatitis C 
        and/or Hepatitis B.

            CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

    HFI recommends an increase of $12 million in fiscal year 2008 for 
further implementation of CDC's Hepatitis C Prevention Strategy. Such 
an increase would bring the total funding level for the Hepatitis C 
Prevention Strategy to $30 million in fiscal year 2008. This increase 
will support and expand the development of state-based prevention 
programs by increasing the number of State health departments with CDC 
funded hepatitis coordinators. The Strategy will use the most cost-
effective way to implement demonstration projects evaluating how to 
integrate hepatitis C and hepatitis B prevention efforts into existing 
public health programs.
    CDC's Prevention Research Centers, an extramural research program, 
plays a critical role in reducing the human and economic costs of 
disease. Currently, CDC funds 26 prevention research centers at schools 
of public health and schools of medicine across the country. HFI 
encourages the subcommittee to increase core funding for these 
prevention centers, as it has been decreasing since this program was 
first funded in 1986. We recommend the subcommittee provide an 8 
percent increase for the Prevention Research Centers program in fiscal 
year 2008.
    Also, HFI recommends that the CDC, particularly the Division of 
Adolescent and School Health (DASH), work with voluntary health 
organizations to promote liver wellness with increased attention toward 
childhood education and prevention, especially through partnerships 
between school districts and non-governmental organizations.

                        INVESTMENTS IN RESEARCH

    Investment in the NIH has led to an explosion of knowledge that has 
advanced understanding of the biological basis of disease and 
development of strategies for disease prevention, diagnosis, treatment, 
and cures. Countless medical advances have directly benefited the lives 
of all Americans. NIH-supported scientists remain our best hope for 
sustaining momentum in pursuit of scientific opportunities and new 
health challenges. For example, research into why some HCV infected 
individuals resolve their infection spontaneously may prove to be life 
saving information for others currently infected. Other areas that need 
to be addressed are:
  --Reasons why African Americans do not respond as well as Caucasians 
        and Hispanics to antiviral agents in the treatment of chronic 
        hepatitis C.
  --Pediatric liver diseases, including viral hepatitis.
  --The outcomes and treatment of renal dialysis patients who are 
        infected with HCV and HBV.
  --Co-infections of HIV/HCV and HIV/HBV positive patients.
  --Hemophilia patients who are co-infected with HIV/HCV and HIV/HBV.
  --The development of effective treatment programs to prevent 
        recurrence of HCV infection following liver transplantation.
  --The development of effective vaccines to prevent HCV infection.
    HFI supports a 6.7 percent increase for NIH in fiscal year 2008. 
HFI also recommends a comparable increase of 6.7 percent in hepatitis 
research funding at NIAID, NIDDK, NIAAA, and NIDA.
    HFI is dedicated to the eradication of viral hepatitis, which 
affects over 500 million people around the world. We seek to raise 
awareness of this enormous worldwide problem and to motivate people to 
support this important--and winnable--battle. Thank you for providing 
this opportunity to present testimony.
                                 ______
                                 
           Prepared Statement of the HIV Medicine Association

    The HIV Medicine Association (HIVMA) of the Infectious Diseases 
Society of America represents more than 3,600 physicians, scientists 
and other health care professionals who practice on the frontline of 
the HIV/AIDS pandemic. Our members treat people with HIV/AIDS 
throughout the United States and the world, develop and implement 
effective prevention interventions, and conduct research to develop 
effective prevention technologies, effective vaccines and less complex 
and less toxic treatment regimens for use in the United States and 
abroad. They are medical providers that specialize in HIV medicine and 
work in communities across the country and in more than 150 countries 
outside of the United States.
    The United States must sustain our three-pronged response to the 
AIDS pandemic--conducting research to effectively prevent and treat HIV 
disease; supporting programs that identify persons infected with HIV 
and prevent or reduce HIV transmission; and providing access to 
lifesaving HIV treatment to people without a reliable source of health 
coverage. Our past commitments resulted in our ability to develop, and 
provide access to, remarkable treatments that effectively suppress HIV 
and allow people to live healthier, more productive lives here at home 
and abroad. In recent years, we have been deeply concerned by our 
country's failure to prioritize support for domestic discretionary 
programs outside of defense and homeland security. The impact of our 
failure to invest in health care programs is already being felt and 
will be far-reaching and long lasting as our communities' public health 
infrastructures weaken and our capacity to lead the world in 
discovering new therapies for controlling deadly diseases such as HIV 
erodes.
    The funding requests in our testimony largely represent the 
consensus of the Federal AIDS Policy Partnership (FAPP), a coalition of 
HIV/AIDS organizations from across the country, and are estimated to be 
the amounts necessary to sustain and strengthen our investment in 
effectively combating HIV disease.

       CDC'S NATIONAL CENTER FOR HIV, STD, TB PREVENTION (NCHSTP)

    HIVMA strongly supports substantial increases in funding for the 
National Center for HIV/AIDS, STD and TB Prevention programs at the 
CDC. Programs supported by NCHSTP play a critical role in reducing the 
40,000 new HIV infections that still occur annually in the United 
States. Sufficient resources must be devoted to supporting efforts to 
identify people with HIV earlier in the disease so that they can be 
effectively linked to the medical care and treatment that prevents or 
delays progression to AIDS. Tuberculosis is the major cause of AIDS-
related mortality worldwide. It is critical that we shore up our 
ability as a Nation to address tuberculosis, especially drug-resistant 
tuberculosis here in the United States and in the developing world. 
With regard to these programs, we urge at least an increase of $93 
million for domestic HIV prevention programs and a funding level of 
$252.4 million for CDC's Division of Tuberculosis Elimination.
    In the absence of an HIV vaccine, preventing new HIV transmissions 
is our best weapon in reducing the number of people newly infected with 
HIV disease each year. We strongly support the CDC guidance 
recommending routine HIV testing for adults in healthcare settings, but 
are gravely concerned about the absence of Federal resources to assist 
State health departments and healthcare institutions in implementing 
this guidance. According to the CDC, at least 25 percent of people with 
HIV infection in the United States do not know it and more than 39 
percent of people with HIV infection progress to AIDS within 1 year of 
diagnosis. The expansion of HIV testing to identify individuals who are 
infected with HIV, but not yet aware of their status, is vital so that 
they can be optimally treated early in disease progression, and can 
reduce risky behaviors that put others at risk for HIV transmission.
    An even more robust HIV prevention budget is necessary to conduct 
effective surveillance, and to target uninfected individuals who engage 
in high-risk behaviors if we are to dramatically reduce the 40,000 new 
HIV infections that occur each year in the United States. We also must 
continue to support science-based, comprehensive programs that target 
people who are not HIV positive but who are at high risk for HIV 
infection. We are seriously concerned that the resources committed to 
supporting a broad-based prevention agenda have diminished while 
funding for unproven and unscientific abstinence-only programs has 
increased. We strongly encourage Congress to halt this troubling trend. 
Adequate resources are needed to address the high prevalence rates 
among vulnerable populations, e.g., men and women of color and men who 
have sex with men. It is short sighted to compromise these programs in 
order to support newer initiatives.
    Funding for HIV prevention activities at the CDC should be 
increased by at least the $93 million recommended in the President's 
2008 budget. These resources should be utilized to restore the $26 
million cut in HIV prevention cooperative agreements with State and 
local health departments, to enhance core surveillance cooperative 
agreements with health departments and to expand HIV testing in 
critical health care venues by funding testing infrastructure, the 
purchase of approved testing devices, including rapid tests and 
confirmatory testing.
    Funding for tuberculosis prevention and control must increase 
substantially in order to address the emerging new threat of XDR-TB. 
HIVMA supports the recommendation of the Advisory Council for the 
Elimination of Tuberculosis (ACET) for a funding level of $252.4 
million for CDC's Division of Tuberculosis Elimination.
  hiv/aids bureau of the health resources and services administration
    HIVMA supports a total commitment of $2.79 billion, an increase of 
$682 million for the Ryan White CARE Act program. This recommendation 
includes a $233 million increase for the AIDS Drug Assistance Program 
(ADAP) and at least an increase of $35 million for Title III (Part C).
    The Health Resources and Services Administration (HRSA) oversees 
programs that are vital to our communities' health care safety nets--
and to the ability of our clinician members to provide state-of-the-art 
treatment and care to patients living with HIV/AIDS. Through grants to 
States, cities and community clinics, CARE Act funding helps us to meet 
the serious and complex needs of people with HIV/AIDS who are un- or 
under-insured by supporting the delivery of primary medical care, 
prescription drugs, diagnostic tests, mental health services, substance 
abuse treatment, and dental services in our communities.
    We strongly support a substantial increase in CARE Act funding and 
would propose that the majority of new funding be targeted to HIV 
medical care under Title III (Part C) and to the AIDS Drug Assistance 
Program (ADAP) to ensure that uninsured and underinsured individuals 
with HIV/AIDS have access to a base line of lifesaving medical care and 
prescription drugs regardless of where they live. Funding increases are 
urgently needed for Title III programs. After years of flat funding or 
decreases in grant awards, we estimate that these programs require an 
increase of $83.3 million in Federal funds. At a minimum, we urge you 
to include a $35 million increase for Title III, Part C programs, with 
this additional funding targeted to current Title III grantees with the 
highest demonstrated increases in patient caseloads.
    Many HIV clinical programs depend on funding from multiple parts of 
the CARE Act to create the comprehensive services that our patients 
need. We strongly encourage you to support funding increases of $65 
million for Title I, and $57 million for the Title II base. Resources 
for domestic HIV care and treatment have eroded dramatically and this 
trend must be reversed or AIDS mortality in the United States could 
increase dramatically.

                  NATIONAL INSTITUTES OF HEALTH (NIH)

    HIVMA strongly supports at least a 6.7 percent increase for all 
research programs at the National Institutes of Health (NIH) including 
a 6.7 percent for the NIH Office of AIDS research for fiscal year 2007. 
This level of increase, if sustained over several years, would halt the 
erosion in the Nation's medical research effort, and accelerate the 
pace of research that could improve the health and quality of life for 
millions of Americans.
    The failure in recent years to adequately invest in biomedical 
research is taking its toll in deep cuts to clinical trials networks 
and significant reductions in the numbers of high quality, 
investigator-initiated grants that are approved. In the arena of AIDS 
research, virtual flat funding leads to reductions in critical research 
efforts to develop new therapeutics, to support the development of 
effective prevention technologies, and to finance vaccine development. 
A robust and comprehensive portfolio has been largely responsible for 
the dramatic gains that have been made in our knowledge about and 
response to the HIV virus, gains that have resulted in reductions in 
mortality from AIDS in the United States and other developing countries 
of nearly 80 percent. A continuing robust AIDS research effort is 
essential if we are to continue to make progress in preventing new 
infections, offering potent treatments with minimal toxicity, and 
developing a vaccine that may ultimately end the deadliest pandemic in 
human history. Our failure to make an adequate investment in this 
lifesaving research will compromise our ability to compare and evaluate 
optimum treatment and prevention strategies in resource-poor countries, 
and limit our ability to understand the appropriate role of new classes 
of antiretrovirals that are currently in development here at home for 
treatment and prevention.
    The sheer magnitude of the number of people still living with HIV/
AIDS in the United States and around the world--1,039,000 to 1,185,000 
in the United States; 40 million globally--demands an increased 
investment in AIDS research if we are going to truly eradicate this 
devastating disease.
    We also strongly support the NIH's Fogarty International Center 
(FIC), and believe that its programs and funding should be expanded. 
The FIC training programs play a critical role in developing self-
sustaining health care infrastructures in resource-limited countries. 
By training local physicians in these countries, they are able to 
develop effective research programs that best address the health care, 
cultural and resource needs of residents in their respective countries.
    Our Nation has made significant strides in responding to the HIV/
AIDS pandemic here at home and around the world, but we have lost 
ground in recent years, particularly domestically, as funding 
priorities have shifted away from public health and research programs. 
This retreat on our past investments in AIDS research through NIH, 
surveillance and prevention programs through the CDC, and care and 
treatment through the Ryan White CARE Act program place the remarkable 
advancements of the past two decades in serious jeopardy. We have an 
opportunity to reverse this trend and to move forward with a budget 
that prioritizes funding for scientific discovery, public health, and 
care and treatment for those without resources or adequate insurance. 
With the support of this Congress, we have the opportunity to further 
limit the toll of this deadly infectious disease on our planet and to 
save the lives of millions who are infected or at risk of infection 
here in the United States and around the world.
                                 ______
                                 
    Prepared Statement of the Infectious Diseases Society of America

    The Infectious Diseases Society of America (IDSA) appreciates the 
opportunity to provide this statement to the Senate Appropriations 
Subcommittee on Labor, Health and Human Services, Education and Related 
Agencies concerning fiscal year 2008 Federal funding for the Centers 
for Disease Control and Prevention (CDC) and the National Institutes of 
Health (NIH). IDSA's statement speaks to the value of U.S. public 
health and infectious diseases research programs to the health of 
people in the United States and globally as well as the need to provide 
sufficient funding in fiscal year 2008 to sustain and improve these 
programs. While IDSA's leadership recognizes that current fiscal 
budgets are constrained due to the war in Iraq and the Federal budget 
deficit, we urge the subcommittee to support appropriate investments to 
protect all of us against the scourges wrought by infectious pathogens.
    IDSA represents 8,400 infectious diseases physicians and scientists 
devoted to patient care, education, research, prevention, and public 
health. Our members care for patients of all ages with serious 
infections, including antibiotic-resistant bacterial infections, 
meningitis, pneumonia, tuberculosis, and those with cancer or 
transplants who have life-threatening infections caused by unusual 
microorganisms, food poisoning, and HIV/AIDS, as well as emerging 
infections like severe acute respiratory syndrome (SARS). Housed within 
IDSA is the HIV Medicine Association (HIVMA), which represents more 
than 3,600 physicians working on the frontline of the HIV/AIDS 
pandemic. HIVMA members conduct research, implement prevention 
programs, and provide clinical services to individuals who are infected 
with HIV/AIDS. IDSA and HIVMA are the principal organizations 
representing infectious diseases and HIV physicians in the United 
States.
    Over the past several decades, the United States has made many 
significant advances in the fight against infectious diseases. For 
example, CDC's public health prevention and control strategies have 
reduced infectious diseases morbidity and mortality rates in the United 
States and globally. NIH-funded research and training has led to 
critical new discoveries while at the same time supporting economic 
growth in incubator sites across the country, fostering innovation and 
competition, and making the United States the leader in global 
biomedical research. Needless to say, much work remains to be done as 
infectious diseases remain the second leading cause of death worldwide 
and the third leading cause of death in the United States. Of greatest 
concern:
  --Avian flu is an imminent threat to the United States. Despite the 
        increased attention and progress that has been made in 
        preparing for an influenza pandemic, the Institute of Medicine 
        and virtually all experts conclude that the United States is 
        woefully unprepared to sufficiently respond to pandemic flu and 
        many gaps and challenges remain.
  --Antimicrobial resistant infections have created a ``silent 
        epidemic'' in communities and hospitals across the country--
        methicillin-resistant Staphylococcus aureus (MRSA), for 
        example, is crippling and killing a growing number of 
        previously healthy people including children, athletes, and 
        military recruits as well as many elderly people; and
  --On a global scale, infectious diseases annually cause 15 million 
        deaths--HIV/AIDS, tuberculosis, and malaria alone account for 
        one third of these deaths.

PANDEMIC AND SEASONAL INFLUENZA FISCAL YEAR 2008 FUNDING RECOMMENDATION

    IDSA is deeply appreciative to the committee members for your 
support of increased funding for pandemic and seasonal influenza 
preparedness efforts as well as for the inclusion of additional 
pandemic influenza funding in the pending emergency supplemental 
appropriations bill. IDSA also applauds Congress and the administration 
for enacting this past December the Pandemic and All-Hazards 
Preparedness Act and establishing the Biomedical Advanced Research 
Development Authority (BARDA) within the Department of Health and Human 
Services. We request that Congress ensure significantly increased and 
sustained long-term funding to support critical activities authorized 
by the act. We are deeply concerned that the Federal, State, and local 
preparedness and response goals outlined in the act cannot be achieved 
without significantly increased, long-term, sustainable funding.
    In addition, experts and Federal Government officials agree that 
the development of a pandemic vaccine is the strategy most critically 
needed to protect U.S. citizens from a pandemic. IDSA has proposed the 
establishment of a multinational Pandemic Influenza Vaccine Master 
Program led by the United States to outline a comprehensive approach 
that will systematize, coordinate, and strengthen vaccine research and 
development (R&D), increase production capacity, accelerate licensure, 
guarantee equitable global distribution, and monitor vaccine 
performance and safety. IDSA has proposed that a U.S. commitment of 
$2.8 billion is needed in fiscal year 2008 to initiate the master 
program and to serve as a catalyst for additional financial support 
from international partners. Included within our fiscal year 2008 
master program proposal is a $750 million commitment for the new BARDA 
program. BARDA will enhance and accelerate the R&D activities necessary 
to produce new medical countermeasures that will protect U.S. citizens 
from pandemic influenza.

             OTHER FISCAL YEAR 2008 FUNDING RECOMMENDATIONS

Centers for Disease Control and Prevention
    IDSA recommends a total budget level of $8.7 billion for CDC's 
discretionary programs in fiscal year 2008 including an increase of at 
least $686.4 million for CDC's Infectious Diseases Program.
    As part of our proposed increase in CDC's total ID Program funding, 
IDSA supports:
            An increase of at least $50 million for CDC's Antimicrobial 
                    Resistance Program
    Antimicrobial resistance is a priority funding area for IDSA in 
fiscal year 2008. Microbes' ability to become resistant to 
antimicrobial drugs not only impacts individual patients, but also can 
have a devastating impact on the general population as resistant 
microbes pass from one individual to another. A multi-pronged approach 
is essential to limit the impact of antibiotic resistance on patients 
and public health. Our proposed increase in antimicrobial resistance 
funding will enable CDC to strengthen programs such as the National 
Healthcare Safety Network (NHSN), which generates national prevalence 
data to track the spread of multi-drug-resistant organisms in health 
care settings; expand its surveillance of clinical and prescribing data 
that are associated with drug-resistant infections; gather morbidity 
and mortality data due to resistance; educate physicians and parents 
about the need to protect the long-term effectiveness of antibiotics; 
and strengthen infection control activities across the United States. 
Broadening the number of CDC's extramural grants in applied research at 
academic-based centers also would harness the brainpower of our 
Nation's researchers.
            An increase of at least $281 million for CDC's Immunization 
                    Program
    Vaccines are one of the greatest public health successes ever 
achieved, helping to reduce, and in some cases eliminate, the spread of 
infectious diseases in the United States and abroad. In the United 
States, immunization of a birth cohort, or a year's worth of children 
born, saves 33,000 lives and $42 billion in costs. Important new 
vaccines have been licensed for rotavirus, pertussis, zoster, and human 
papillomavirus (HPV). The HPV vaccine could prevent the majority of 
cases of cervical cancer. Yet these new vaccines add new costs. Without 
additional funding of CDC's 317 Program, these vaccines will not be 
available to under-insured children and the infrastructure to 
administer vaccines and track their safety will be compromised. IDSA 
also is very concerned that adult immunization rates are much too low. 
Vaccines can be cost-saving, but new efforts are needed to make sure 
that access is available for all age groups. We cannot afford, however, 
to take scarce funds from childhood immunization to fund adult 
immunization--a significant new investment is required.
    For these reasons, we support a total fiscal year 2008 
appropriation level of $802.4 million for CDC's discretionary 
immunization program. This amount includes $387 million for the 
purchase of childhood vaccines, and $200 million for childhood 
immunization operations/infrastructure grants to States. In parallel 
fashion, as a first step toward meeting extensive needs in the adult 
arena, it includes $88 million for purchase of adult vaccines and $45 
million for adult operations and infrastructure grants to States. 
Finally this amount includes $82.4 million for prevention, safety, and 
administrative activities.
            An increase of at least $93 million for CDC's HIV 
                    Prevention Program
    These additional resources should be utilized to restore cuts in 
HIV prevention cooperative agreements with State and local health 
departments, to enhance core surveillance cooperative agreements with 
health departments, and to expand HIV testing in critical health care 
venues by funding testing infrastructure and the purchase of approved 
testing devices, including rapid tests and confirmatory testing.
            An increase of at least $252.4 million for CDC's TB 
                    Elimination Program
    Recent cuts of 14 percent have eroded national tuberculosis (TB) 
control at a time of increased threat posed by extensively-drug 
resistant TB and multi-drug resistant TB. Additionally, a total of $350 
million is needed across CDC as well as at the NIH to support research 
on TB vaccines, diagnostics, drugs, and related clinical research.
  --An increase of $10 million for CDC's Public Health and Human 
        Services Block Grant
    We are concerned that the President's proposed budget once again 
proposes to eliminate CDC's Public Health and Human Services Block 
Grants, which provide States the flexibility to respond to infectious 
diseases outbreaks, among other events. IDSA opposes the termination of 
this program and instead supports a healthy increase of $10 million.

                     NATIONAL INSTITUTES OF HEALTH

    IDSA recommends that Congress support at least a 6.7 percent 
increase for NIH research programs and particularly for the National 
Institute of Allergy and Infectious Diseases' (NIAID) AIDS research; 
non-AIDS, non-bioterrorism infectious diseases research, particularly 
antimicrobial resistance, antimicrobial therapy, and pandemic influenza 
research; and biodefense research. IDSA also supports a doubling of the 
Fogarty International Center's (FIC) budget to $134 million in fiscal 
year 2007.
    Advancing biomedical research and maintaining the U.S. leadership 
in this arena requires a consistent, long-term strategy and continued 
strong investments. We must not be short-sighted in our approach. In 
light of the rise in emerging and re-emerging diseases, and 
particularly, the trend of previously treatable organisms evading our 
best drugs, IDSA urges more aggressive, sustained scientific effort and 
funding dedicated not only to understanding the fundamental mechanisms 
of these diseases, but also support for clinical studies and 
translational research as a stepping stone to the development of new 
therapies. In addition, little research has been devoted to defining 
optimal antimicrobial dosing regimens, particularly related to the 
minimal duration of therapy necessary to cure many types of infections. 
Such studies require a long-term commitment and are not likely to be 
funded by pharmaceutical manufacturers. The consensus of many experts 
is that infections are frequently treated for longer periods of time 
than are necessary, needlessly increasing antimicrobial resistance. For 
this reason, IDSA urges the establishment of a Clinical Trials Network 
at NIH, similar to the AIDS Clinical Trials Group, devoted to defining 
optimal antibacterial therapy. Well-designed, multi-center randomized 
controlled trials that define the necessary length of therapy would 
create an excellent basis of evidence from which coherent and 
defensible recommendations could be developed.
    IDSA also is concerned that NIH research project grant funding has 
steadily declined after peaking in 2004--the average award would be 8.4 
percent smaller in 2008 than in 2004. IDSA fears that we are 
discouraging and potentially sacrificing an entire generation of young 
scientists if they conclude that NIH grants are unattainable. 
Sustainable and predictable funding is needed in this area. Finally, 
IDSA supports a doubling of FIC's budget. FIC oversees vital programs 
which train health professionals in resource-limited countries about 
how best to attack AIDS, tuberculosis, malaria, and other infectious 
diseases.

                               CONCLUSION

    Today's investment in infectious disease research, prevention, and 
treatments will pay significant dividends in the future by dramatically 
reducing health care costs and improving the quality of life for 
millions of Americans. In addition, U.S. leadership in infectious 
diseases research and prevention will translate into worldwide health 
benefits. We urge the subcommittee to continue to demonstrate 
leadership and foresight in this area by appropriating the much-needed 
resources outlined above in recognition of the lives and dollars that 
ultimately will be saved.
                                 ______
                                 
   Prepared Statement of the International Foundation for Functional 
                       Gastrointestinal Disorders

              SUMMARY OF FISCAL YEAR 2008 RECOMMENDATIONS

    Provide a 6.7 percent increase for fiscal year 2008 to the National 
Institutes of Health (NIH) budget. Within NIH, provide proportional 
increases of 6.7 percent to the various institutes and centers, 
specifically, the National Institute of Diabetes and Digestive and 
Kidney Diseases (NIDDK) and the Office of Research on Women's Health 
(ORWH).
    Accelerate funding for extramural clinical and basic functional 
gastrointestinal disorders (FGID) and motility disorders research at 
NIDDK.
    Continue to urge NIDDK to develop a strategic plan on irritable 
bowel syndrome (IBS) with the purpose of setting research goals, 
determining improved treatment options for IBS sufferers, and assisting 
in recruitment of new investigators to conduct IBS research.
    Urge the National Institute of Child Health and Human Development 
(NICHD) and NIDDK to continue to support research into fecal and 
urinary incontinence, including the development of a standardization of 
scales to measure incontinence severity and quality of life and to 
develop strategies for primary prevention of fecal incontinence 
associated with childbirth.
    Provide funding to NIDDK and the National Cancer Institute (NCI) 
for increased research on the causes of esophageal cancer.
    Thank you for the opportunity to present this written statement 
regarding the importance of functional gastrointestinal and motility 
disorders research. IFFGD has been serving the digestive disease 
community for 15 years. We work to broaden the understanding of 
functional gastrointestinal and motility disorders in adults and 
children. IFFGD raises awareness on disorders and diseases that many 
people are uncomfortable and embarrassed to discuss. The prevalence of 
fecal incontinence and irritable bowel syndrome or IBS, as well as a 
host of other gastrointestinal disorders affecting both adults and 
children, is underestimated in the United States. These conditions 
continue to remain hidden in our society. Not only are they 
misunderstood, but the burden of illness and human toll has not been 
fully recognized.
    Since its establishment, IFFGD has been dedicated to increasing 
awareness of functional gastrointestinal and motility disorders, among 
the public, health professionals, and researchers. While maintaining a 
high level of public education efforts, IFFGD has also become 
recognized for our professional symposia. We consistently bring 
together a unique group of international multidisciplinary 
investigators to communicate new knowledge in the field of 
gastroenterology. Next month IFFGD will be hosting our Seventh 
International Symposium on Functional Gastrointestinal Disorders, 
bringing scientists, researchers, and clinicians from across the world 
together to discuss the current science and opportunities on IBS and 
other functional gastrointestinal and motility disorders. Also, in 
November 2002, we hosted a conference on fecal and urinary 
incontinence, the proceedings of which were published in 
Gastroenterology, the official journal of the American 
Gastroenterological Association (AGA). The IFFGD has also been working 
with the National Institute of Child Health and Human Development 
(NICHD), the National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK), and the Office of Medical Applications of Research 
(OMAR) in the NIH Office of the Director on the NIH State of the 
Science Conference on Fecal and Urinary Incontinence to beheld in 
December 2007.
    The majority of the diseases and disorders we address have no cure. 
We have yet to completely understand the pathophysiology of the 
underlying conditions. Patients face a life of learning to manage a 
chronic illness that is accompanied by pain and an unrelenting myriad 
of gastrointestinal symptoms. The costs associated with these diseases 
are enormous; estimates range from $25-$30 billion annually. The human 
toll is not only on the individual but also on the family. Economic 
costs spill over into the workplace. In essence, these diseases reflect 
lost potential for the individual and society. The IFFGD is a resource 
that provides hope for hundreds of thousands of people as they try to 
regain as normal a life as possible.

                     IRRITABLE BOWEL SYNDROME (IBS)

    IBS strikes people from all walks of life. It affects 25 to 45 
million Americans and results in significant human suffering and 
disability. This chronic disease is characterized by a group of 
symptoms, which include abdominal pain or discomfort associated with a 
change in bowel pattern, such as loose or more frequent bowel 
movements, diarrhea, and/or constipation. Although the cause of IBS is 
unknown, we do know that this disease needs a multidisciplinary 
approach in research and often treatment.
    IBS can be emotionally and physically debilitating. Due to 
persistent bowel unpredictability, individuals who suffer from this 
disorder may distance themselves from social events, work, and even may 
fear leaving their home.
    In the House and Senate fiscal years 2004, 2005, 2006, and 2007 
Labor, Health and Human Services, and Education Appropriations bills, 
Congress recommended that NIDDK develop an IBS strategic plan. The 
development of a strategic plan on IBS would greatly increase the 
institute's progress toward the needed research on this functional 
gastrointestinal disorder, as well as serve to advance our 
understanding of this disease, determine improved treatment options for 
IBS sufferers, and assist in recruiting new investigators to conduct 
IBS research. NIDDK is formulating an action plan for digestive 
diseases through the National Commission on Digestive Diseases and has 
indicated that IBS will be included as a component of this overall 
plan. IBS must be given sufficient attention, however, in order to 
increase the functional gastrointestinal disorders (FGID) and motility 
disorders research portfolio at NIDDK.

                           FECAL INCONTINENCE

    At least 6.5 million Americans suffer from fecal incontinence. 
Incontinence is neither part of the aging process nor is it something 
that affects only the elderly. Incontinence crosses all age groups from 
children to older adults, but is more common among women and in the 
elderly of both sexes. Often it is a symptom associated with various 
neurological diseases and many cancer treatments. Yet, as a society, we 
rarely hear or talk about the bowel disorders associated with spinal 
cord injuries, multiple sclerosis, diabetes, prostate cancer, colon 
cancer, uterine cancer, and a host of other diseases.
    Damage to the anal sphincter muscles; damage to the nerves of the 
anal sphincter muscles or the rectum; loss of storage capacity in the 
rectum; diarrhea; or pelvic floor dysfunction can cause fecal 
incontinence. People who have fecal incontinence may feel ashamed, 
embarrassed, or humiliated. Some don't want to leave the house out of 
fear they might have an accident in public. Most attempt to hide the 
problem for as long as possible. They withdraw from friends and family, 
and often limit work or education efforts. Incontinence in the elderly 
burdens families and is the primary reason for nursing home admissions, 
an already huge social and economic burden in our increasingly aged 
population.
    In November 2002, the IFFGD sponsored a consensus conference--
``Advancing the Treatment of Fecal and Urinary Incontinence Through 
Research: Trial Design, Outcome Measures, and Research Priorities.'' 
Among other outcomes, the conference resulted in six key research 
recommendations:
  --More comprehensive identification of quality of life issues 
        associated with fecal incontinence and improved assessment and 
        communication of treatment outcomes related to quality of life.
  --Standardization of scales to measure incontinence severity and 
        quality of life.
  --Assessment of the utility of diagnostic tests for affecting 
        management strategies and treatment outcomes.
  --Development of new drug compounds offering new treatment approaches 
        to fecal incontinence.
  --Development and testing of strategies for primary prevention of 
        fecal incontinence associated with childbirth.
  --Further understanding of the process of stigmatization as it 
        applies to the experience of individuals with fecal 
        incontinence.
    The IFFGD has been working with the NICHD, NIDDK, and OMAR on a NIH 
State of the Science Conference on Fecal and Urinary Incontinence that 
is scheduled to take place in December 2007. The goal of this 
conference will be to assess the state of the science and outline 
future priorities for research on both fecal and urinary incontinence; 
including, the prevalence and incidence of fecal and urinary 
incontinence, risk factors and potential prevention, pathophysiology, 
economic and quality of life impact, current tools available to measure 
symptom severity and burden, and the effectiveness of both short- and 
long-term treatment. Once the conference is completed, NIH must 
prioritize implementation of the recommendations of this important 
conference.

                 GASTROESOPHAGEAL REFLUX DISEASE (GERD)

    Gastroesophageal reflux disease, or GERD, is a common disorder 
affecting both adults and children, which results from the back-flow of 
acidic stomach contents into the esophagus. GERD is often accompanied 
by persistent symptoms, such as chronic heartburn and regurgitation of 
acid. But sometimes there are no apparent symptoms, and the presence of 
GERD is revealed when complications become evident. One uncommon 
complication is Barrett's esophagus, a potentially pre-cancerous 
condition associated with esophageal cancer. Symptoms of GERD vary from 
person to person. The majority of people with GERD have mild symptoms, 
with no visible evidence of tissue damage and little risk of developing 
complications. There are several treatment options available for 
individuals suffering from GERD.
    Gastroesophageal reflux (GER) affects as many as one-third of all 
full term infants born in America each year. GER results from an 
immature upper gastrointestinal motor development. The prevalence of 
GER is increased in premature infants. Many infants require medical 
therapy in order for their symptoms to be controlled. Up to 25 percent 
of older children and adolescents will have GER or GERD due to lower 
esophageal sphincter dysfunction. In this population, the natural 
history of GER is similar to that of adult patients, in whom GER tends 
to be persistent and may require long-term treatment.

                             GASTROPARESIS

    Gastroparesis, or paralysis of the stomach, refers to a stomach 
that empties slowly. Gastroparesis is characterized by symptoms from 
the delayed emptying of food, namely: bloating, nausea, vomiting or 
feeling full after eating only a small amount of food. Gastroparesis 
can occur as a result of several conditions, including being present in 
30 percent to 50 percent of patients with diabetes mellitus. A person 
with diabetic gastroparesis may have episodes of high and low blood 
sugar levels due to the unpredictable emptying of food from the 
stomach, leading to diabetic complications. Other causes of 
gastroparesis include Parkinson's disease and some medications, 
especially narcotic pain medications. In many patients the cause of the 
gastroparesis cannot be found and the disorder is termed idiopathic 
gastroparesis. Over the last several years, as more is being found out 
about gastroparesis, it has become clear this condition affects many 
people and the condition can cause a wide range of symptoms of 
differing severity.

  FUNCTIONAL GASTROINTESTINAL AND MOTILITY DISORDERS AND THE NATIONAL 
                          INSTITUTES OF HEALTH

    The International Foundation for Functional Gastrointestinal 
Disorders recommends an increase of 6.7 percent to the budget of NIH, 
and a 6.7 percent increase for NIDDK and NICHD. However, we request 
that this increase for NIH does not come at the expense of other Public 
Health Service agencies.
    We urge the subcommittee to provide the necessary funding for the 
expansion of the NIDDK's research program on FGID and motility 
disorders. This increased funding will allow for the growth of new 
research on FGID and motility disorders at NIDDK, a strategic plan on 
IBS, and increased public and professional awareness of FGID and 
motility disorders. In addition, we urge the subcommittee to continue 
to support and provide adequate funding to the Office of Research on 
Women's Health (ORWH) under the NIH Office of the Director, 
particularly for their Specialized Centers of Research on Sex and 
Gender Factors Affecting Women's Health (SCORs) program and the 
Building Interdisciplinary Research Careers in Women's Health (BIRCWH) 
program. The ORWH supports important research into IBS.
    A primary tenant of IFFGD's mission is to ensure that clinical 
advancements concerning GI disorders result in improvements in the 
quality of life for those affected. By working together, this goal will 
be realized and the suffering and pain millions of people face daily 
will end. Thank you.
                                 ______
                                 
          Prepared Statement of the Jeffrey Modell Foundation

    Mr. Chairman and members of the subcommittee: Thank you for the 
opportunity to testify before you today. I am Vicki Modell and, along 
with my husband Fred, we created the Jeffrey Modell Foundation in 1987 
in memory of our son, who died at the age of 15 as a result of a life 
long battle against one of the estimated 140 primary immunodeficiency 
(PI) diseases.
    Today I wish to discuss with you two important initiatives for the 
Congress, the CDC, and the Jeffrey Modell Foundation to collaborate on 
that will achieve the following:
  --Continue to educate and raise awareness about primary 
        immunodeficiency diseases among physicians, other health care 
        providers, and the public through a highly successful program 
        that has, to date, generated $10 private for every $1 public 
        invested; and
  --Launch a pilot program that will extend newborn screening to Severe 
        Combined Immune Deficiency, the most lethal of all PI diseases, 
        saving lives and saving money.
    The Jeffrey Modell Foundation is an international organization 
located in New York City. In its 21 years of existence, the Foundation 
has grown into the premier advocacy and service organization on behalf 
of people afflicted with primary immunodeficiency diseases. As a 
demonstration of the extent to which the JMF leads in the field, please 
consider the following:
  --The Foundation has established Jeffrey Modell Research and 
        Diagnostic Centers at 34 academic and teaching hospitals in the 
        United States and abroad.
  --The Foundation conducts a national physician education and public 
        awareness campaign, currently funded with approximately $2.5 
        million appropriated by this committee to the Centers for 
        Disease Control and Prevention (CDC) and awarded to the JMF. To 
        date, the Foundation has leveraged the Federal money to 
        generate in excess of $75 million in donated media and 
        corporate contributions with almost 250,000 placements/airings 
        on television, radio, print, and other public media, as well as 
        a 30-minute program produced for PBS. CME physician symposia 
        have been held at leading academic teaching hospitals 
        throughout the Nation. It has also included mailings to 
        physicians in a variety of specialist and generalist fields, 
        including pediatrics and several pediatric specialties, family 
        practice, and internal medicine, as well as to school nurses, 
        clinical and registered nurses and daycare centers throughout 
        the United States.
  --In addition, the Foundation has long been a provider of direct 
        patient services such as KIDS Days that give young people a 
        chance to meet and share experiences with others similarly 
        situated in their communities in a fun atmosphere that 
        encourages a feeling of normalcy in patients.
    First and foremost, Mr. Chairman, I am here today to thank you and 
all the members of this committee. Over the last 10 years that we have 
been coming to Washington, we have been given the opportunity to build 
a partnership with the Congress, the Centers for Disease Control and 
Prevention, the National Institutes of Health, the Health Resources and 
Services Administration, as well as with our own supporters in the 
private sector, including the pharmaceutical and biotechnology 
industries, and other concerned donors. We believe that we have 
maximized the benefits for patients from the support that this 
subcommittee has afforded the Foundation.

               CENTERS FOR DISEASE CONTROL AND PREVENTION

    This subcommittee is currently funding CDC with $2.5 million for 
physician education and public awareness of primary immune 
deficiencies. The Jeffrey Modell Foundation operates the program under 
a contract with CDC. Since the campaign's inception, it has generated 
more than $75 million in donated media, including television and radio 
spots, magazine ads, billboards, airport signs and other print media, 
as well as other corporate support. Every $1 provided by the committee 
has been leveraged into more than $10 of private money for this 
education and awareness program.
    In a national survey conducted on behalf of the Foundation, funded 
by a grant from the CDC, one in three Americans state that they have 
heard of Primary Immunodeficiency. When 502 pediatricians and family 
practice physicians were asked about PI, 85 percent of physicians 
consider PI to be rare or extremely rare (1 in 5,000-10,000 patients). 
However, the National Institutes of Health cites the prevalence of 1 in 
500. This disparity shows how much education the medical community 
still needs.
    The progress being made by the campaign is significant. As reported 
by the Foundation's Centers for Primary Immunodeficiencies, there has 
been a 79 percent increase in the number of diagnosed patients, a 58 
percent increase in the number of patients receiving treatment, and a 
57 percent increase in patients referred to JMF specialized centers. 
These increases are reflected on an annual basis for each year of the 
campaign. The most meaningful statistic is that there has been an 
annual 256 percent increase in the number of diagnostic tests 
performed, showing that the campaign is raising patients' and 
physicians' awareness of PI. The campaign has generated over 6 million 
hits to the JMF website annually, 500,000 unique visits to the JMF 
website annually and over 12,000 calls to the JMF hotline, further 
evidence of the campaign's effectiveness.
    Two years ago the subcommittee increased the CDC funding for the 
campaign by approximately $500,000 in order to expand the campaign to 
target the underserved minority population. Research shows that the 
incidence of PI does not vary between races or among ethnic groups. To 
reach its intended audience, the minority campaign must run ads on 
different radio stations and television networks and have space in 
different print media. Since the program's launch, the campaign has 
leveraged the $1 million in Federal funds to generate over $17 million 
in donated media and has had almost 60,000 airings/placements.
    We respectfully request that this subcommittee continue to fund 
this program at $2.5 million in fiscal year 2008 (the level requested 
in the President's budget), allowing the Foundation to continue both 
the original education and awareness program and the targeted minority 
campaign.

               QUALITY OF LIFE AND ECONOMIC IMPACT STUDY

    In 2006, the Foundation set out to examine the impact of early 
diagnosis in a rigorous manner. Physician experts at the 118 Jeffrey 
Modell Diagnostic and Referral Centers were contacted. Each of the 
Centers was asked to examine patient records 1 year prior to diagnosis 
and for the year following diagnosis and treatment. The data, which 
included 532 patient records, was collected by the Foundation and 
reviewed by members of the Foundation's Medical Advisory Board.
    The results of the study clearly demonstrate that the quality of 
life of undiagnosed patients is significantly lower than that of 
diagnosed patients. Undiagnosed patients suffer from chronic infections 
an average of 44.7 days per year compared to 12.6 days for diagnosed 
patients. On average, undiagnosed patients are treated with antibiotics 
166.2 days per year compared to 72.9 days per year. Undiagnosed 
patients spend 14.1 more days of the year in hospitals than diagnosed 
patients. Also, the study found that undiagnosed patients missed 33.9 
days of work or school compared to only 8.9 days missed by diagnosed 
patients.
    Besides being sicker, requiring more care, and more time out of the 
workforce, ultimately, an undiagnosed patient costs the healthcare 
system $102,552 per year compared to $22,610; diagnosing a patient with 
PI saves $79,942 per year. According to NIH, there are as many as 
500,000 undiagnosed patients in this country; these undiagnosed 
patients cost the healthcare system approximately $40 billion annually. 
These costs underscore the important of early identification and 
treatment for PI patients.

                       NEWBORN SCREENING PROGRAM

    Mr. Chairman, our dedication to the importance of early diagnosis 
has led us to field of newborn screening. And here we have an 
opportunity for the action of this subcommittee to save lives, 
literally. Severe combined immune deficiency (SCID) is the most severe 
form of PI and is fatal, if an infant is not diagnosed and treated 
within the first year of life. Within the first few months of life, the 
infant will suffer from one or more serious infections, including 
pneumonia, meningitis or bloodstream infections.
    Newborn screening is the solution to this life-threatening 
condition. Last fall the Foundation sponsored a meeting in conjunction 
with the CDC Foundation to examine the state of the science regarding 
newborn screening for SCID. We learned at that meeting that doctors can 
diagnose SCID with 99 percent accuracy; and we learned that they can 
treat it with a 95 percent success rate using bone marrow 
transplantation to restore the immune system before the infant develops 
any serious infections. If a diagnosis of SCID is made within the 
infant's first 2 months of life, treating SCID costs under $10,000. 
However, by the 9th or 10th month of life, if the infant survives that 
long, the costs of transplantation and other medical complications are 
over $1 million and the success rate falls dramatically.
    Based on discussions at last fall's meeting at the CDC, both 
Wisconsin and New York are prepared to begin a pilot program to screen 
newborns for SCID. In Wisconsin, a collaboration between the Children's 
Hospital of Wisconsin, the Medical College of Wisconsin and the 
Wisconsin State Laboratory of Hygiene has been established to begin the 
program by replicating the State's current screening model for cystic 
fibrosis. The Wisconsin State Laboratory of Hygiene currently runs 300-
500 tests per day, 6 days a week, easily accommodating all the newborns 
in the State. Screening tests are conducted between the 3rd and 7th day 
of life, and a report is delivered by the lab to the pediatrician 
within 7 days. New York State health officials are going to monitor 
Wisconsin's program to determine how the screen needs to be altered to 
handle New York's 250,000 live births a year.
    To start this pilot, both the Children's Hospital of Wisconsin and 
the Foundation each contributed to this effort. The Foundation has 
estimated that it will cost approximately $560,000 per State to begin 
screening for SCID. Once the pilot program demonstrates efficacy, SCID 
screening will cost a maximum of between $6.50 and $7 per child.
    To support the efforts of Wisconsin and New York, we respectfully 
request that this subcommittee increase funding for CDC's Environmental 
Health Laboratory program by $750,000, specifically to fund the pilot 
program to screen newborns for SCID in Wisconsin and New York. We 
anticipate that this will be a one-time cost. Once the pilot is 
evaluated and methods are proven, States will be able to add this test 
to their screening panel.

                               CONCLUSION

    With the support the Jeffrey Modell Foundation has received from 
this subcommittee, we have been able to increase significantly the 
public's awareness of PI and most importantly, thanks to your support, 
we have been able to save lives. The Federal Government's investment in 
this campaign is producing results far beyond anything that even we had 
anticipated. Many more children are being tested and treated; lives are 
being saved.
    We understand that the subcommittee must make difficult decisions 
in this fiscal environment. However, the Foundation's education and 
awareness campaign has been recognized as a model collaborative program 
that has successfully leveraged Federal dollars in a manner rarely 
seen. We now know the financial burden an undiagnosed patient places on 
the healthcare system; there is no reason to spend $40 billion annually 
on the treatment of undiagnosed patients. For every Federal dollar 
spent on the campaign and research, the potential to save lives 
increases exponentially. This is precisely the kind of public-private 
partnership that should be encouraged. It works. It saves lives. And, 
it is the best example of bringing scientific advances to every citizen 
regardless of their station in life.
    After 5 years of funding for the campaign, we believe it is time 
for this subcommittee to take the next step with us and financially 
support newborn screening for SCID. The science shows the screening is 
accurate and the treatment is successful and cost effective. 
Diagnosing, transplanting and curing just one baby will make the all of 
our efforts worthwhile; but, there is no reason to stop at one. We will 
continue to advocate for the expansion of this pilot program and 
eventually the inclusion of the screen for SCID on every State's list 
of required newborn screening.
    Thank you, Mr. Chairman, for the opportunity to present this 
testimony to the subcommittee.
                                 ______
                                 
         Prepared Statement of the Lupus Foundation of America

                                SUMMARY

    The Lupus Foundation of America (LFA) is the Nation's leading non-
profit voluntary health organization dedicated to improving the 
diagnosis and treatment of lupus, supporting individuals and families 
affected by the disease, increasing awareness of lupus among health 
professionals and the public, and finding the causes and cure. LFA 
respectfully calls upon Congress to provide the following allocations 
in the fiscal year 2008 Labor-Health and Human Services-Education 
(LHHS) appropriations measure to reduce and prevent suffering from 
lupus:
  --$3.25 million for the National Lupus Patient Registry (NLPR) at the 
        National Center for Chronic Disease Prevention and Health 
        Promotion within the Centers for Disease Control and Prevention 
        (CDC) to sustain current epidemiological efforts and expand the 
        registry to seven sites. Such an expansion would ensure that 
        the registry includes all forms of lupus and all affected 
        populations, particularly African Americans, Hispanics, and 
        Asian Americans, who are disproportionately at-risk for--and 
        have worse outcomes associated with--lupus.
  --$30.8 billion (a 6.7 percent increase) for the National Institutes 
        of Health (NIH) to support lupus research. Specifically, we 
        urge the subcommittee to provide a 6.7 percent increase to each 
        of the following institutes and centers, which play an integral 
        role in lupus research: NCMHD, NHGRI, NHLBI, NIAID, NIAMS, 
        NIDDK, NIEHS, and NINDS. Moreover, we respectfully call on 
        Congress to move to provide a 33 percent increase for lupus 
        research for each of the next three fiscal years.
  --$1 million in new funding for the HHS Office on Women's Health to 
        support a sustained national lupus education and awareness 
        campaign. These educational efforts would be directed toward 
        healthcare professionals who diagnose and treat people with 
        lupus, with an emphasis on reaching those individuals at 
        highest risk--women of color--a health disparity that remains 
        unexplained.

                          BACKGROUND ON LUPUS

    As you may know, lupus--a debilitating, chronic autoimmune disease 
that causes inflammation and tissue damage to virtually any organ 
system--affects as many as 2 million Americans. Since lupus is a 
systemic disease, it can cause significant disability and even death. 
Lupus can be particularly difficult to diagnose because its symptoms 
are similar to those of many other diseases, and major gaps exist in 
understanding the causes and consequences of the disease. Lupus affects 
women nine times more often than men and disproportionately impacts 
women of color. Our scientific advisors note that lupus is the 
prototypical autoimmune disease and indicate that finding answers to 
questions about lupus also may provide understanding about other 
autoimmune diseases affecting 22 million Americans. Tragically, there 
have been no new drugs approved by the Food and Drug Administration 
specifically for lupus in nearly 40 years. Currently, there is no cure 
for lupus; available treatments can lead to damaging side effects and 
can adversely impact quality of life. LFA maintains that the Nation 
must significantly increase its attention to--and investment in--lupus 
research, education, and awareness to help ensure that much-needed 
progress is made in lupus diagnosis and treatment--eventually achieving 
a cure.

                  CDC NATIONAL LUPUS PATIENT REGISTRY

    LFA respectfully requests that the subcommittee provide $3.25 
million in fiscal year 2008 to the CDC National Lupus Patient Registry 
(NLPR). The NLPR plays an integral role in lupus epidemiological 
studies which provide important insight into the disease. The 
establishment of the NLPR was the first nationwide step in the CDC's 
effort to assess the prevalence and incidence of lupus. The NLPR serves 
as a conduit for the collection of valid and reliable data for 
epidemiological studies to better understand and measure the burden of 
illness, assess the social and economic impact of the disease, and 
stimulate additional private investment by industry in the development 
of new, safe, and effective therapies--and hopefully a cure--for lupus.
    Currently, the NLPR involves two study sites--in Georgia and 
Michigan. The information collected through the Emory University School 
of Medicine and the Michigan Department of Community Health (in 
collaboration with the University of Michigan) stems from a multi-
pronged approach using data from laboratory tests, interviews with 
physicians who treat lupus patients, hospital data, and other sources. 
While the data gleaned from the current sites are important and useful, 
unfortunately--due to limited resources--the NLPR does not include 
information on all forms of lupus and all populations affected by the 
disease. This constrained scope, depth, and breadth of the NLPR limits 
its utility to researchers and does not allow for adequate exploration 
of the health disparities apparent among those diagnosed with lupus.
    Existing epidemiological data on lupus are decades old and no 
longer reliable. Population-based epidemiological studies of lupus must 
be conducted at strategically-located sites throughout the Nation that 
will provide accurate data on all forms of lupus (i.e. systemic lupus, 
primary discoid lupus, drug-induced lupus, neonatal lupus, 
antiphospholipid antibodies) and the disparity among the various racial 
and ethnic populations. The LFA and its scientific and medical advisors 
recommend that the NLPR be expanded to an additional five sites, which 
should represent the populations that are disproportionately affected 
by lupus--principally African Americans, Hispanics, Asian Americans, 
and Native Americans. To that end, LFA urges the subcommittee to 
provide $3.25 million in fiscal year 2008 and to include language in 
the report accompanying the fiscal year 2008 LHHS measure that 
encourages the CDC to create a common data entry and management system 
across all study sites, to collaborate with a consortium of academic 
health centers with an expertise in lupus epidemiology, and ensure 
adequate numbers and locations of study sites and sufficient numbers of 
individuals of all racial and ethnic backgrounds.

               RESEARCH FOR BETTER TREATMENTS AND A CURE

    The LFA has long been concerned about the inadequate levels of 
Federal investment in lupus research. Unfortunately, during the 
doubling of NIH funding, lupus did not receive its proportional 
increase; now that NIH funding has flattened, lupus research is in 
danger of falling even further behind. However, after a tragic 40 year 
dearth of specific new treatments to manage this debilitating and 
devastating disease, lupus researchers are on the brink of major 
discoveries that could substantially advance lupus research, leading to 
better treatments, and possibly a cure.
    To achieve these much-needed breakthroughs, LFA maintains that 
Federal research funding must be increased significantly. It is 
important to note that level or decreased NIH funding could bring to a 
standstill clinical trials and large observational studies, and could 
curtail research on those at highest risk for lupus, women of color. 
Furthermore, insufficient Federal funding also could slow much-needed 
genetic research, when we are just discovering the critical components 
that may contribute to lupus and its adverse effects. Therefore, it is 
critical that biomedical researchers be provided the necessary 
resources to continue seeking answers to the questions that will lead 
to safer and more effective lupus treatments. To that end, LFA has 
joined with the broader public health and research communities in 
supporting an overall 6.7 percent increase for the NIH in fiscal year 
2008. LFA has identified a number of NIH institutes and centers whose 
research activities are critical to identifying improved treatments and 
a cure for lupus, and as noted above, we urge that each of these 
entities receive a 6.7 percent increase in fiscal year 2008: NCMHD, 
NHGRI, NHLBI, NIAID, NIAMS, NIDDK, NIEHS, NIDDK and NINDS. We urge 
Congress to move to provide a 33 percent increase for lupus research 
for each of the next 3 fiscal years.
    NIAMS.--Lupus affects the skin, bones, joints, and connective 
tissue. NIAMS is integral to making gains in lupus treatment and 
identifying a cure. LFA asks that the subcommittee encourage NIAMS to 
significantly expand research related to lupus, with a particular focus 
on understanding the underlying mechanisms of disease, gene-gene and 
gene-environmental interactions, lupus and kidney disease, biomarkers, 
pediatric research, environmental factors, and factors related to 
health disparities and comorbidities associated with lupus.
    NIAID.--Lupus is a dysfunction of the immune system which warrants 
greater examination. LFA's scientific and medical advisors maintain 
that NIAID has an integral and more significant role to play in lupus 
research. To that end, LFA respectfully requests that the subcommittee 
urge NIAID to take a leadership role in lupus research and expand and 
intensify genetic, clinical, and basic research related to lupus, with 
a particular focus on gene-gene and gene-environmental interactions, 
biomarkers, pediatric research, environmental factors, and factors 
related to health disparities and comorbidities associated with lupus.
    NCMHD.--Nine out of 10 people with lupus are women; lupus is two to 
three times more common among women of color than Caucasian women. 
Lupus mortality has increased over the past 3 years and is higher among 
older African American women. We urge the subcommittee to encourage 
NCMHD to collaborate with extra-mural researchers and LFA to ensure 
that these terrible disparities receive the attention--and 
interventions--they deserve.
    NHGRI.--Lupus likely is a polygenetic disease. As such, LFA asks 
the subcommittee to encourage NGHRI to undertake efforts to help 
identify the gene(s) associated with lupus.
    NHLBI.--Lupus attacks the heart, lungs, blood, and blood vessels. 
LFA encourages the subcommittee to urge NHLBI to expand and intensity 
research on lupus, with a special emphasis on lupus and early onset of 
cardiovascular disease.
    NIEHS.--Lupus disease activity can be triggered by certain 
environmental factors. LFA encourages the subcommittee to urge NIEHS to 
undertake additional lupus related research activities to help identify 
environmental factors, biomarkers, and gene-environmental interactions 
associated with the disease.
    NIDDK.--Lupus causes lupus nephritis--inflammation of the kidneys. 
LFA asks the subcommittee to urge NIDDK to undertake studies into this 
condition, which is one of the most serious manifestations of lupus.
    NINDS.--Lupus attacks the blood vessels in the brain, causing 
seizures, psychosis, and stroke. LFA urges the subcommittee to 
encourage NINDS to expand its research related to lupus.

         INCREASED AWARENESS AND EDUCATION FOR BETTER OUTCOMES

    Too many affected individuals and their health professionals remain 
unaware of the signs and symptoms of lupus, delaying correct diagnoses 
and often leading to poorer outcomes. Therefore, the LFA's medical 
advisors recommend a sustained national lupus education campaign to 
improve awareness and education of the public and health professionals 
to reduce and prevent suffering from lupus. LFA respectfully requests 
the subcommittee provide $1 million in new fiscal year 2008 funding to 
the Office on Women's Health to support this important endeavor. LFA 
welcomes the opportunity to work with HHS staff and others to ensure 
the campaign's success.

                                SUMMARY

    LFA very much appreciates the opportunity to submit written 
testimony on fiscal year 2008 funding for lupus research, 
epidemiological studies, education and awareness efforts. We understand 
that the Nation faces unprecedented fiscal challenges; however, LFA has 
serious concerns that without new Federal investments, we will not make 
the necessary progress in lupus-related biomedical research and 
epidemiology at such a promising time. LFA stands ready to work with 
the subcommittee and others in Congress to reduce and prevent suffering 
from lupus.
                                 ______
                                 
         Prepared Statement of the Lymphoma Research Foundation

    I am Melanie Smith, director of Public Policy and Advocacy for the 
Lymphoma Research Foundation (LRF). On behalf of the lymphoma 
survivors, researchers, and caregivers who are represented by LRF, I 
would like to express our appreciation for the opportunity to submit a 
statement to the House Appropriations Subcommittee for Labor, Health 
and Human Services, and Education. We will focus our remarks on the 
opportunities and challenges in lymphoma research and the potential for 
extending and improving the lives of those who are diagnosed with 
lymphoma.
    LRF is the Nation's largest lymphoma-focused voluntary health 
organization devoted exclusively to funding lymphoma research and 
providing patients and healthcare professionals with critical 
information on this disease. LRF's mission is to eradicate lymphoma and 
serve those touched by this disease. To that end, we have developed a 
research program through which we fund leading lymphoma researchers at 
outstanding academic institutions. LRF-funded research focuses on 
understanding the basic mechanisms of lymphoma as well as enhancing the 
available treatments for the disease. To date, LRF has funded more than 
$34.7 million in lymphoma research.
    LRF is especially proud of its 3-year initiative to provide more 
than $21 million for a special mantle cell lymphoma program comprised 
of eighteen clinical and/or laboratory-based projects in North America 
and Europe. The program is aimed at identifying curative therapies for 
mantle cell lymphoma. Because mantle cell lymphoma is a form of 
lymphoma for which treatment options have been limited and survival 
much too short, this intensive and aggressive research effort is 
critically important.

           THE BURDEN OF LYMPHOMA AND NEED FOR NEW TREATMENTS

    Lymphoma is the most commonly diagnosed hematologic cancer and the 
third most common childhood cancer. Although lymphoma experts hail the 
lymphoma therapeutic advances of the last decade for dramatically 
changing lymphoma treatment and care, these new treatments do not 
eliminate the pressing need for additional therapeutic research. The 
numbers underscore the need for a continued commitment to lymphoma 
research. In 2007, approximately 71,380 Americans will be diagnosed 
with lymphoma. It is estimated that 63,190 will be diagnosed with non-
Hodgkin lymphoma (NHL), and that 18,660 will die from NHL. Also in 
2007, it is expected that 8,190 cases of Hodgkin lymphoma will be 
diagnosed, and 1,070 Americans will die from the disease. Nearly half a 
million Americans are living with lymphoma.
    The treatment advances of recent years have not boosted the 
survival rate for NHL as dramatically as we had hoped. The 5-year 
survival rate is 63 percent and the 10-year survival rate is only 49 
percent. The 5-year survival rate for Hodgkin lymphoma is 86 percent 
and the 10-year survival rate is 81 percent.
    Still another issue must be remembered when we are evaluating the 
progress that has been made in the fight against Hodgkin lymphoma and 
NHL. There is an increasing body of knowledge about the long-term 
effects of treatment for cancer, but there is a need for additional 
research to understand the effects of cancer therapies, develop 
strategies to minimize or address these effects, and develop therapies 
that are accompanied by fewer side effects. A study published in a 
recent edition of the Journal of the National Cancer Institute 
underscored the challenges facing Hodgkin lymphoma patients; according 
to the report of a British research team, Hodgkin lymphoma patients may 
have an increased rate of myocardial infarction for up to 25 years 
after undergoing treatment. The cardiotoxicity can be attributed to the 
radiotherapy, anthracyclines, and vincristine used in Hodgkin lymphoma 
therapy.

                     ADVANCES IN LYMPHOMA RESEARCH

    In the last decade, there have been a number of significant 
advances in lymphoma research that have contributed to deeper 
understanding of the disease and its progression and fostered the 
development of new treatments. Knowledge about the diversity of 
lymphoma has contributed to the effort to target treatment regimens to 
specific forms of the disease. In addition, we are learning more about 
the link between environmental factors and infections--chemicals, 
toxins, drugs, infectious agents such as hepatitis C and Epstein Barr 
virus, and the gastric pathogen Helicobacter pylori--and many forms of 
lymphoma.
    Recent lymphoma treatment advances are a monoclonal antibody 
(rituximab) that blocks a specific protein on B lymphocytes and a 
radioactively labeled monocolonal antibody (tositumomab) that may 
prolong remission in follicular lymphoma patients. Studies suggest that 
bortezomib, which inhibits an enzyme complex that plays a role in 
regulating cell function and growth, will shrink tumors in patients 
with mantle cell lymphoma. Finally, research is underway on additional 
immunotherapies, including therapeutic vaccines for lymphoma.
    One of the key areas of inquiry is the identification of the best 
combinations of treatments, including rituximab. Investigators are also 
considering whether to treat low-grade follicular lymphoma immediately 
or to continue the current approach of ``watch and wait.'' Stem cell 
transplantation remains an important part of lymphoma treatment, but 
additional research may contribute to refinements in the procedure and 
better results for lymphoma patients.
    There are a number of new therapies in development with the hope of 
prolonging life and providing a better quality of life. In addition, 
long-term and late effects of treatment are a concern. Lymphoma 
patients may be at risk for developing second cancers, and 
investigation of these risks is critical and may contribute to better 
management of currently available therapies.

                    ROLE OF LRF IN LYMPHOMA RESEARCH

    By supporting outstanding investigators considering a wide range of 
topics in lymphoma research, LRF contributes significantly to progress 
in the field. In 2003, LRF made a determination that it would tackle 
one of the most challenging forms of non-Hodgkin lymphoma, mantle cell 
lymphoma, with an aggressive and well-coordinated research program that 
focuses on this rare form of non-Hodgkin lymphoma (NHL) affecting only 
6-10 percent of NHL patients.
    Since 2003, LRF has dedicated more than $21 million to the Mantle 
Cell Lymphoma Research Initiative, and with those funds has supported a 
range of critical research efforts, including:
  --Hosting the preeminent scientific meeting focused exclusively on 
        mantle cell lymphoma.
  --Formation of the Mantle Cell Lymphoma Consortium to stimulate 
        collaboration among its members to accelerate the pace of 
        finding cures for the disease.
  --Launching of an MCL web site and awarding the first set of 
        correlative clinical trials grants.
  --Inclusion of nearly 100 scientists in the network of mantle cell 
        researchers.
    The Mantle Cell Lymphoma Consortium may serve as a research model 
for focusing on other forms of lymphoma, and LRF is moving ahead with 
additional targeted initiatives.

                    ROLE OF NIH IN LYMPHOMA RESEARCH

    LRF will continue to play a strong and creative role in funding 
lymphoma research, fostering cutting edge initiatives that hold the 
promise of making a meaningful and positive change in the lives of 
those living with lymphoma. Although the Foundation's efforts will 
continue and even expand, its work must be undertaken in collaboration 
with NIH. This is not only because of the magnitude of the NIH cancer 
research budget but also because of the potential for NIH to provide 
leadership among all elements of the research and development 
community, including NIH intramural researchers, academic researchers, 
private foundations, industry, and the Food and Drug Administration 
(FDA).
    We understand that the substantial increases in NIH funding that 
Congress approved between 1999 and 2003 will not be replicated in the 
foreseeable future. However, we urge that Congress provide an increase 
of 6.7 percent for NIH in fiscal year 2008, an increase that will 
simply protect the recent investment in NIH and permit additional 
research progress. Advances in cancer research have contributed to 
improvements in survival, but these advances have generally been 
incremental and have required a sustained funding commitment.
    We urge that Congress protect NIH funding and strive to provide an 
increase in funding to allow researchers to pursue promising avenues of 
research. LRF recommends that NIH strengthen its lymphoma research 
program by several actions:
  --The National Cancer Institute (NCI) should boost its support for 
        translational and clinical lymphoma research. NCI should 
        support research efforts aimed at evaluating the most 
        appropriate utilization of new therapies, including the best 
        possible combinations of therapies.
  --NCI should also enhance its support for correlative studies of 
        tumor biology and treatment response, as well as its investment 
        in research on the late and long-term effects of lymphoma 
        treatments.
  --NCI should expand its research effort focused on understanding the 
        complex interaction among environmental, viral, and 
        immunogenetic factors that are involved in the initiation and 
        promotion of lymphoma.
  --Although NCI has historically been the lead institute in funding 
        lymphoma research, other institutes, including the National 
        Heart, Lung, and Blood Institute (NHLBI), National Institute on 
        Aging (NIA), and National Institute of Environmental Health 
        Sciences (NIEHS), should also evaluate and improve their 
        lymphoma research programs. A lymphoma-focused initiative to 
        investigate environmental/viral links is warranted.
    NCI is developing a plan for the implementation of the 
recommendations of its Clinical Trials Working Group. To date, most 
implementation efforts have concentrated on the planning and management 
of NCI-sponsored clinical trials. We urge NCI to act on recommendations 
of the Working Group that focused on strengthening patient 
participation in clinical trials. Increasing the rate of participation 
in clinical trials is a key element in accelerating the pace of cancer 
clinical research and the development of new treatments.
    We also recommend that NCI consider actions that would encourage 
the utilization of a centralized institutional review board (IRB), an 
effort that could contribute to a streamlining of the review of new 
clinical trials and minimize delays in the clinical trials process. NCI 
has tested a central IRB, and that IRB or another might be utilized by 
cancer researchers for review and approval of their protocols. 
Encouragement from NCI regarding the utilization of a centralized IRB 
could contribute to a more rapid acceptance among researchers.
    We have detailed some impressive advances in lymphoma treatment, 
but the research task is far from complete. Much more research must be 
undertaken to ensure proper utilization of existing therapies, and new 
therapies are needed for a number of different forms of lymphoma. We 
look forward to the continued commitment of Congress to lymphoma 
research. As we seek to strengthen our private sector investment in 
research, we hope that the public-private lymphoma research partnership 
will continue.
                                 ______
                                 
          Prepared Statement of the March of Dimes Foundation

    The 3 million volunteers and 1,400 staff members of the March of 
Dimes Foundation appreciate the opportunity to submit the Foundation's 
Federal funding recommendations for fiscal year 2008. The March of 
Dimes is a national voluntary health agency working to improve the 
health of mothers, infants and children by preventing birth defects, 
premature birth and infant mortality through research, community 
services, education, and advocacy.
    The volunteers and staff of the March of Dimes urge the 
subcommittee to provide the funding increases recommended below. Of 
particular note, one of the last actions of the 109th Congress was 
unanimous approval of the PREEMIE Act (Public Law 109-450). The March 
of Dimes commends Congress for recognizing the growing health crisis of 
preterm birth and calls on the subcommittee to fund two major 
provisions of the act: (1) expansion of CDC activities related to 
preterm birth, which are outlined in the CDC section of this testimony 
and (2) a Surgeon General's Conference and report on preterm birth. In 
order to convene a Surgeon General's conference on preterm birth and 
produce a widely disseminated report, $1,000,000 in fiscal year 2008 
funding is needed. The conference and report will establish a public-
private research and education agenda to accelerate the development of 
new strategies for preventing preterm birth.

                  NATIONAL INSTITUTES OF HEALTH (NIH)

    The March of Dimes joins the larger research community in 
recommending a 6.7 percent increase in funding for the NIH bringing 
total Federal support to just over $30 billion. The 6.7 percent 
increase was calculated by the biomedical inflator of 3.7 percent and 
lost purchasing power which is 3 percent. Since the doubling of NIH's 
budget was completed in 2003, the agency has lost 13 percent of its 
purchasing power. With all the threats to children's health it is 
imperative to increase the overall investment in medical research.
Office of the Director
    The March of Dimes was extremely pleased that Congress included $69 
million for the National Children's Study (NCS) in the fiscal year 2007 
Joint Funding Resolution, allowing for implementation of the next phase 
of the study. The Foundation urges the subcommittee to include within 
the Office of the Director $111 million ($42 million in new funding) 
for the NCS in fiscal year 2008. While the amount may seem substantial, 
it is dwarfed by the cost of treating the diseases and conditions the 
study is designed to address. Approximately 1 year after the full study 
is underway researchers will begin a thorough review of data pertaining 
to premature birth and pregnancy outcomes and, using this data, will 
focus on an array of serious pediatric health problems. This landmark 
study holds the potential to dramatically enhance understanding of the 
causes of preterm birth, birth defects, and infant mortality as well as 
numerous other childhood diseases and conditions.
National Institute of Child Health and Human Development (NICHD)
    The March of Dimes recommends a 6.7 percent increase for NICHD in 
fiscal year 2008 and an increase of at least $100 million over the next 
5 years to boost prematurity-related research. In recent years, the 
NICHD has made a major commitment to enhance our understanding of the 
factors that result in premature birth and to develop strategies to 
prolong pregnancy so that infants are not born too soon. But additional 
research is needed.
    Since 1981, the preterm birth rate has increased 30 percent 
resulting in more than half a million premature births in 2005--or 1 in 
8. Preterm birth is the leading cause of death in the first month of 
life and, for those babies who do survive, 1 in 5 experience life long 
health problems including cerebral palsy, mental retardation, chronic 
lung disease, and vision and hearing loss. Preterm labor can happen to 
any pregnant woman, and the causes of nearly half of all premature 
births are not yet known.
    This growing problem of preterm births was brought into sharp focus 
by the 2006 Institute of Medicine (IOM) report entitled, ``Preterm 
Birth: Causes, Consequences and Prevention.'' The IOM found that the 
annual economic burden associated with preterm birth in the United 
States was at least $26.2 billion, or $51,600 per infant born preterm. 
In 2003, the national hospital bill alone for the care of these babies 
exceeded $18 billion, half of which was borne by Medicaid and other 
public programs and the remainder was charged to employers and 
families.

            CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)

Safe Motherhood/Infant Health
    The National Center for Chronic Disease Prevention and Health 
Promotion, Division of Reproductive Health works to promote optimal 
reproductive and infant health. The March of Dimes recommends an $8 
million increase, as authorized in the PREEMIE Act, for CDC to increase 
epidemiological research on preterm labor and delivery, which is vital 
to ultimately preventing preterm birth.
    Specifically, these additional funds will enable CDC to conduct 
additional epidemiological studies on preterm birth, including the 
relationship between prematurity, birth defects and developmental 
disabilities. These new funds will also make possible the establishment 
of systems for the collection of maternal-infant clinical and 
biomedical information that is linked with the Pregnancy Risk 
Assessment Monitoring System (PRAMS). Increasing CDC's research 
activities related to preterm birth will bring the Nation closer to 
improving screening and early detection and finding new interventions 
for women at risk for preterm labor.
National Center on Birth Defects and Developmental Disabilities 
        (NCBDDD)
    Of particular interest to the March of Dimes is NCBDDD's birth 
defects program that includes surveillance, research and prevention 
activities. For fiscal year 2008, the March of Dimes requests an 
increase of $10 million to support surveillance and research and an 
additional $2 million for folic acid education. In the March of Dimes 
professional judgment, these modest increases are vital to making 
progress in reducing the incidence of birth defects.
    In the United States, about 3 percent of all babies are born with a 
major birth defect. Birth defects are the leading cause of infant 
mortality accounting for more than 20 percent of all infant deaths 
every year. Children with birth defects who survive may experience 
lifelong physical and mental disabilities, and are at increased risk 
for developing other health problems. In fact, birth defects contribute 
substantially to the Nation's health care costs. According to CDC, the 
lifetime economic cost of caring for infants born each year with 1 of 
the 18 most common birth defects exceeds $8 billion.
    The causes of nearly 70 percent of birth defects are unknown and it 
is therefore critical that the subcommittee increase funding for the 
National Birth Defects Prevention Study. This groundbreaking CDC 
initiative is being carried out by 9 regional Centers for Birth Defects 
Research and Prevention located in Arkansas, California, Georgia, Iowa, 
Massachusetts, New York, North Carolina, Texas, and Utah. Each of these 
centers identify infants with major birth defects; interview mothers 
about medical history, environmental exposures, and lifestyle before 
and during pregnancy; and collect DNA samples to study gene-environment 
interactions. This study has nearly 11 years worth of data and DNA 
samples collected. Due to funding limitations, CDC has yet to be able 
to analyze the DNA samples to identify genetic risk factors. In 
addition, without increased funding the CDC will be forced to decrease 
the number of centers participating in the study.
    NCBDDD also provides funding to assist States with community-based 
birth defects tracking systems, programs to prevent birth defects and 
improve access to health services for children with birth defects. 
Surveillance forms the backbone of a vital, functional and responsive 
public health network. Additional resources are sorely needed to help 
States seeking assistance.
    Finally, NCBDDD is conducting a national public and health 
professions education campaign designed to increase the number of women 
taking folic acid. CDC estimates that up to 70 percent of neural tube 
defects (NTDs), serious birth defects of the brain and spinal cord 
including anencephaly and spina bifida could be prevented if all women 
of childbearing age consume 400 micrograms of folic acid daily, 
beginning before pregnancy. Since 1996, the rate of NTDs in the United 
States has decreased by 26 percent. Unfortunately, according to a 
recent analysis conducted by CDC folate concentrations among non-
pregnant women of child bearing age decreased by 16 percent from 1999-
2000 through 2003-2004. Clearly, women are still not receiving an 
adequate level of folic acid and increased resources to CDC for the 
expansion of its folic acid education campaign is needed.
National Center for Health Statistics
    The National Center for Health Statistics (NCHS) provides data 
essential for both public and private research and programmatic 
initiatives. The National Vital Statistics System and the National 
Survey on Family Growth, for example, is the principal source of 
information on the utilization of prenatal care and on birth outcomes, 
including preterm delivery, low birthweight and infant mortality. The 
current funding level threatens the collection of vital information and 
more specifically NCHS lacks the resources to collect a full year's 
worth of vital statistics from States. Without at least $3 million in 
additional funding we will become the first industrialized Nation 
unable to collect birth, death and other vital statistics. The March of 
Dimes supports a funding level of $117 million, an increase of $8 
million over fiscal year 2007, to ensure that NCHS continues its role 
in monitoring our Nation's health.

          HEALTH RESOURCES AND SERVICES ADMINISTRATION (HRSA)

Newborn Screening
    Newborn screening is a vital public health activity used to 
identify and treat genetic, metabolic, hormonal and functional 
conditions in newborns. Screening detects disorders in newborns that, 
if left untreated, can cause death, disability, mental retardation and 
other serious illnesses. Parents are often unaware that while nearly 
all babies born in the United States undergo newborn screening for 
genetic birth defects, the number and quality of these tests vary from 
State to State. The March of Dimes, the American Academy of Pediatrics 
and the American College of Medical Genetics recommend that at a 
minimum, every baby born in the United States be screened for a core 
group of 29 treatable conditions regardless of the State in which the 
infant is born. Only 11 States and the District of Columbia currently 
screen for all 29 of these conditions.
    Currently, Federal support for State newborn screening activities 
is provided through the Maternal and Child Health Block Grant, Special 
Projects of Regional and National Significance (SPRANS). The March of 
Dimes recommends full funding of the MCH Block Grant at the authorized 
level of $850 million. In addition, the Foundation urges that $9 
million of SPRANS funding be set-aside for newborn screening activities 
(an increase of $3 million over fiscal year 2007). In the March of 
Dimes professional judgment, this funding will allow for the 
continuation of the Regional Genetic Service and Newborn Screening 
Collaboratives that focus on the maldistribution of genetic services 
and resources and bring services closer to local communities. It would 
also enable HRSA to improve the capacity of States to: (1) provide 
screening, counseling, testing, and special services for newborns and 
children at risk for heritable disorders; (2) educate health 
professionals and parents on the availability and importance of newborn 
screening; and (3) support States with technical assistance on the 
acquisition and use of new technologies and newborn screening services.

            FISCAL YEAR 2008 FEDERAL FUNDING RECOMMENDATIONS
                        [In millions of dollars]
------------------------------------------------------------------------
                                                          March of Dimes
                                             Fiscal year    fiscal year
                  Program                        2007          2008
                                               funding    recommendation
------------------------------------------------------------------------
National Institutes of Health (Total)......       28,879       30,813
National Children's Study..................           69          111
National Institute of Child Health & Human         1,253        1,337
 Development...............................
National Human Genome Research Institute...          486          519
National Center on Minority Health and               199          212
 Disparities...............................
Center for Disease Control and Prevention          6,095        7,800
 (CDC).....................................
Save Motherhood/Infant Health (NCCDPHP)....           44           52
Birth Defects Research & Surveillance......           15           25
Folic Acid Education Campaign..............            2            4
Immunization...............................          520          802.4
Polio Eradication..........................          101          101
National Center for Health Statistics......          109          117
Health Resources and Services                      6,884        7,500
 Administration (Total)....................
Maternal and Child Health Block Grant......          693          850
Newborn Screening..........................            6            9
Newborn Hearing Screening..................           10           10
Consolidated (Community) Health Centers....        1,988        2,188
Healthy Start..............................          102          102
Agency for Healthcare Research and Quality.          319          350
------------------------------------------------------------------------

                                 ______
                                 
             Prepared Statement of Meharry Medical College

              SUMMARY OF FISCAL YEAR 2008 RECOMMENDATIONS

    $300 million for the Title VII Health Professions Training 
programs, including:
  --$33.6 million for the Minority Centers of Excellence.
  --$35.6 million for the Health Careers Opportunity program.
    $250 million for the National Institutes of Health's National 
Center on Minority Health and Health Disparities.
    $169 million for the National Center for Research Resources 
Extramural Facilities Construction program.
  --$6.7 percent increase for Research Centers for Minority 
        Institutions.
  --$119 million for Extramural Facilities construction.
    $65 million for the Department of Health and Human Services' Office 
of Minority Health.
    $65 million for the Department of Education's Strengthening 
Historically Black Graduate Institutions program.
    Mr. Chairman and members of the subcommittee, thank you for the 
opportunity to present my views before you today. I am Dr. Wayne J. 
Riley, president and CEO of Meharry Medical College in Nashville, 
Tennessee. I have previously served as vice-president and vice dean for 
health affairs and governmental relations and associate professor of 
medicine at Baylor College of Medicine in Houston, Texas and as 
assistant chief of medicine and a practicing general internist at 
Houston's Ben Taub General Hospital. In all of these roles, I have seen 
firsthand the importance of minority health professions institutions 
and the Title VII Health Professions Training programs.
    Mr. Chairman, time and time again, you have encouraged your 
colleagues and the rest of us to take a look at our Nation and evaluate 
our needs over the next 10 years. I want to say that minority health 
professional institutions and the Title VII Health Professionals 
Training programs address a critical national need. Persistent and 
sever staffing shortages exist in a number of the health professions, 
and chronic shortages exist for all of the health professions in our 
Nation's most medically underserved communities. Furthermore, our 
Nation's health professions workforce does not accurately reflect the 
racial composition of our population. For example while blacks 
represent approximately 15 percent of the U.S. population, only 2-3 
percent of the Nation's health professions workforce is black. If you 
take minorities as a whole, Minority health professional institutions 
and the Title VII Health Professions Training programs address this 
critical national need. Persistent and severe staffing shortages exist 
in a number of the health professions, and chronic shortages exist for 
all of the health professions in our Nation's most medically 
underserved communities. Our Nation's health professions workforce does 
not accurately reflect the racial composition of our population. For 
example, African Americans represent approximately 15 percent of the 
U.S. population while only 2-3 percent of the Nation's healthcare 
workforce is African American.
    There is a well established link between health disparities and a 
lack of access to competent healthcare in medically underserved areas. 
As a result, it is imperative that the Federal Government continue its 
commitment to minority health profession institutions and minority 
health professional training programs to continue to produce healthcare 
professionals committed to addressing this unmet need.
    An October 2006 study by the Health Resources and Services 
Administration (HRSA), entitled ``The Rationale for Diversity in the 
Health Professions: A Review of the Evidence'' found that minority 
health professionals serve minority and other medically underserved 
populations at higher rates than non-minority professionals. The report 
also showed that; minority populations tend to receive better care from 
practitioners who represent their own race or ethnicity, and non-
English speaking patients experience better care, greater 
comprehension, and greater likelihood of keeping follow-up appointments 
when they see a practitioner who speaks their language. Studies have 
also demonstrated that when minorities are trained in minority health 
profession institutions, they are significantly more likely to: (1) 
serve in rural and urban medically underserved areas, (2) provide care 
for minorities and (3) treat low-income patients.
    As you are aware, Title VII Health Professions Training programs 
are focused on improving the quality, geographic distribution and 
diversity of the healthcare workforce in order to continue eliminating 
disparities in our Nation's healthcare system. These programs provide 
training for students to practice in underserved areas, cultivate 
interactions with faculty role models who serve in underserved areas, 
and provide placement and recruitment services to encourage students to 
work in these areas. Health professionals who spend part of their 
training providing care for the underserved are up to 10 times more 
likely to practice in underserved areas after graduation or program 
completion.
    Institutions that cultivate minority health professionals have been 
particularly hard-hit as a result of the cuts to the Title VII Health 
Profession Training programs in fiscal year 2006 and fiscal year 2007 
Funding Resolution passed earlier this Congress. Given their historic 
mission to provide academic opportunities for minority and financially 
disadvantaged students, and healthcare to minority and financially 
disadvantaged patients, minority health professions institutions 
operate on narrow margins. The cuts to the Title VII Health Professions 
Training programs amount to a loss of core funding at these 
institutions and have been financially devastating.
    Mr. Chairman, I feel like I can speak authoritatively on this issue 
because I received my medical degree from Morehouse School of Medicine, 
a historically black medical school in Atlanta. I give credit to my 
career in academia, and my being here today, to Title VII Health 
Profession Training programs' Faculty Loan Repayment Program. Without 
that program, I would not be the president of my father's alma mater, 
Meharry Medical College, another historically black medical school 
dedicated to eliminating healthcare disparities through education, 
research and culturally relevant patient care.
    In fiscal year 2008, funding for the Title VII Health Professions 
Training programs must be restored to the fiscal year 2005 level of 
$300 million, with two programs--the Minority Centers of Excellence 
(COEs) and Health Careers Opportunity Program (HCOPs)--in particular 
need of a funding restoration. In addition, the National Institutes of 
Health (NIH)'s National Center on Minority Health and Health 
Disparities (NCMHD), as well as the Department of Health and Human 
Services (HHS)'s Office of Minority Health (OMH), are both in need of a 
funding increase.

                     MINORITY CENTERS OF EXCELLENCE

    COEs focus on improving student recruitment and performance, 
improving curricula in cultural competence, facilitating research on 
minority health issues and training students to provide health services 
to minority individuals. COEs were first established in recognition of 
the contribution made by four historically black health professions 
institutions (the Medical and Dental Institutions at Meharry Medical 
College; The College of Pharmacy at Xavier University; and the School 
of Veterinary Medicine at Tuskegee University) to the training of 
minorities in the health professions. Congress later went on to 
authorize the establishment of ``Hispanic'', ``Native American'' and 
``Other'' Historically black COEs.
    Presently the statute is configured in such a way that the 
``original four'' institutions compete for the first $12 million in 
funding, ``Hispanic and Native American'' institutions compete for the 
next $12 million, and ``Other'' institutions can compete for grants 
when the overall funding is above $24 million. For funding above $30 
million all eligible institutions can compete for funding.
    However, as a consequence of limited funding for COEs in fiscal 
year 2006 and fiscal year 2007, ``Hispanic and Native American'' and 
``Other'' COEs have lost their support. Out of 34 total COEs in fiscal 
year 2005, only 4 now remain due to the cuts in funding.
    For fiscal year 2008, I recommend a funding level of $33.6 million 
for COEs.

               HEALTH CAREERS OPPORTUNITY PROGRAM (HCOP)

    HCOPs provide grants for minority and non-minority health 
profession institutions to support pipeline, preparatory and recruiting 
activities that encourage minority and economically disadvantaged 
students to pursue careers in the health professions. Many HCOPs 
partner with colleges, high schools, and even elementary schools in 
order to identify and nurture promising students who demonstrate that 
they have the talent and potential to become a health professional.
    Collectively, the absence of HCOPs will substantially erode the 
number of minority students who enter the health professions. Over the 
last three decades, HCOPs have trained approximately 30,000 health 
professionals including 20,000 doctors, 5,000 dentists and 3,000 public 
health workers. If HCOPs continue to lose Federal support, then these 
numbers will drastically decrease. It is estimated that the number of 
minority students admitted to health professional schools will drop by 
25-50 percent without HCOPs. A reduction of just 25 percent in the 
number of minority students admitted to medical school will produce 
approximately 600 fewer minority medical students nationwide.
    As a result of cuts in the fiscal year 2006 and fiscal year 2007 
Labor-HHS Appropriations process, only 4 out of 74 total HCOPs 
currently receive Federal funding. As president of Meharry, I feel this 
loss as we were one of the 70 institutions who lost their HCOP grants.
    For fiscal year 2008, I recommend a funding level of $35.6 million 
for HCOPs.
national institutes of health (nih): extramural facilities construction
    Mr. Chairman, if we are to take full advantage of the recent 
funding increases for biomedical research that Congress has provided to 
NIH over the past decade, it is critical that our Nation's research 
infrastructure remain strong. The current authorization level for the 
Extramural Facility Construction program at the National Center for 
Research Resources is $250 million. The law also includes a 25 percent 
set-aside for ``Institutions of Emerging Excellence'' (many of which 
are minority institutions) for funding up to $50 million. Finally, the 
law allows the NCRR Director to waive the matching requirement for 
institutions participating in the program. We strongly support all of 
these provisions of the authorizing legislation because they are 
necessary for our minority health professions training schools.
    Unfortunately, funding for NCRR's Extramural Facility Construction 
program was completely eliminated in the fiscal year 2006 Labor-HHS 
bill, and no funding was restored in the funding resolution for fiscal 
year 2007. In fiscal year 2008, please restore funding for this program 
to its fiscal year 2004 level of $119 million, or at a minimum, provide 
funding equal to the fiscal year 2005 appropriation of $40 million.

               RESEARCH CENTERS IN MINORITY INSTITUTIONS

    The Research Centers at Minority Institutions program (RCMI) at the 
National Center for Research Resources has a long and distinguished 
record of helping our institutions develop the research infrastructure 
necessary to be leaders in the area of health disparities research. 
Although NIH has received unprecedented budget increases in recent 
years, funding for the RCMI program has not increased by the same rate. 
Therefore, the funding for this important program grow at the same rate 
as NIH overall in fiscal year 2008.

 STRENGTHENING HISTORICALLY BLACK GRADUATE INSTITUTIONS--DEPARTMENT OF 
                               EDUCATION

    The Department of Education's Strengthening Historically Black 
Graduate Institutions program (Title III, Part B, section 326) is 
extremely important to MMC and other minority serving health 
professions institutions. The funding from this program is used to 
enhance educational capabilities, establish and strengthen program 
development offices, initiate endowment campaigns, and support numerous 
other institutional development activities. In fiscal year 2008, an 
appropriation of $65 million (an increase of $7 million over fiscal 
year 2007) is suggested to continue the vital support that this program 
provides to historically black graduate institutions.
National Center on Minority Health and Health Disparities
    The National Center on Minority Health and Health Disparities 
(NCMHD) is charged with addressing the longstanding health status gap 
between minority and nonminority populations. The NCMHD helps health 
professional institutions to narrow the health status gap by improving 
research capabilities through the continued development of faculty, 
labs, and other learning resources. The NCMHD also supports biomedical 
research focused on eliminating health disparities and develops a 
comprehensive plan for research on minority health at the NIH. 
Furthermore, the NCMHD provides financial support to health professions 
institutions that have a history and mission of serving minority and 
medically underserved communities through the Minority Centers of 
Excellence program.
    For fiscal year 2008, I recommend a funding level of $250 million 
for the NCMHD.
Department of Health and Human Services' Office of Minority Health 
        (OMH)
    Specific programs at OMH include:
    (1) Assisting medically underserved communities with the greatest 
need in solving health disparities and attracting and retaining health 
professionals,
    (2) Assisting minority institutions in acquiring real property to 
expand their campuses and increase their capacity to train minorities 
for medical careers,
    (3) Supporting conferences for high school and undergraduate 
students to interest them in health careers, and
    (4) Supporting cooperative agreements with minority institutions 
for the purpose of strengthening their capacity to train more 
minorities in the health professions.
    The OMH has the potential to play a critical role in addressing 
health disparities. Unfortunately, the OMH does not yet have the 
authority or resources necessary to support activities that will truly 
make a difference in closing the health gap between minority and 
majority populations.
    For fiscal year 2008, I recommend a funding level of $65 million 
for the OMH.
    Mr. Chairman, please allow me to express my appreciation to you and 
the members of this subcommittee. With your continued help and support, 
Meharry Medical College along with other minority health professions 
institutions and the Title VII Health Professions Training programs can 
help this country to overcome health and healthcare disparities. 
Congress must be careful not to eliminate, paralyze or stifle the 
institutions and programs that have been proven to work. Meharry and 
other minority health professions schools seek to close the ever 
widening health disparity gap. If this subcommittee will give us the 
tools, we will continue to work towards the goal of eliminating that 
disparity as we have done for 1,876.
    Thank you, Mr. Chairman, for this opportunity.
                                 ______
                                 
         Prepared Statement of the Morehouse School of Medicine

              SUMMARY OF FISCAL YEAR 2008 RECOMMENDATIONS

    $300 million for the Title VII Health Professions Training 
programs, including:
  --$33.6 million for the Minority Centers of Excellence.
  --$35.6 million for the Health Careers Opportunity program.
    $250 million for the National Institutes of Health's National 
Center on Minority Health and Health Disparities.
    Support for the National Center for Research Resources Extramural 
Facilities Construction program.
  --$6.7 percent increase for Research Centers for Minority 
        Institutions.
  --$119 million for Extramural Facilities Construction.
    $65 million for the Department of Health and Human Services' Office 
of Minority Health.
    $65 million for the Department of Education's Strengthening 
Historically Black Graduate Institutions program.
    Mr. Chairman and members of the subcommittee, thank you for the 
opportunity to present my views before you today. I am Dr. John E. 
Maupin, president of Morehouse School of Medicine (MSM) in Atlanta, 
Georgia. I have previously served as President of Meharry Medical 
College, executive vice-president at Morehouse School of Medicine, as 
director of a community health center in Atlanta, and deputy director 
of health in Baltimore, Maryland. In all of these roles, I have seen 
firsthand the importance of minority health professions institutions 
and the Title VII Health Professions Training programs.
    Mr. Chairman, time and time again, you have encouraged your 
colleagues and the rest of us to take a look at our Nation and evaluate 
our needs over the next 10 years. I want to say that minority health 
professional institutions and the Title VII Health Professionals 
Training programs address a critical national need. Persistent and 
sever staffing shortages exist in a number of the health professions, 
and chronic shortages exist for all of the health professions in our 
Nation's most medically underserved communities. Furthermore, our 
Nation's health professions workforce does not accurately reflect the 
racial composition of our population. For example while blacks 
represent approximately 15 percent of the U.S. population, only 2-3 
percent of the Nation's health professions workforce is black. 
Morehouse is a private school with a very public mission of educating 
students from traditionally underserved communities so that they will 
care for the underserved. Mr. Chairman, I would like to share with you 
how your committee can help us continue our efforts to help provide 
quality health professionals and close our Nation's health disparity 
gap.
    There is a well established link between health disparities and a 
lack of access to competent healthcare in medically underserved areas. 
As a result, it is imperative that the Federal Government continue its 
commitment to minority health profession institutions and minority 
health professional training programs to continue to produce healthcare 
professionals committed to addressing this unmet need.
    An October 2006 study by the Health Resources and Services 
Administration (HRSA), entitled ``The Rationale for Diversity in the 
Health Professions: A Review of the Evidence'' found that minority 
health professionals serve minority and other medically underserved 
populations at higher rates than non-minority professionals. The report 
also showed that; minority populations tend to receive better care from 
practitioners who represent their own race or ethnicity, and non-
English speaking patients experience better care, greater 
comprehension, and greater likelihood of keeping follow-up appointments 
when they see a practitioner who speaks their language. Studies have 
also demonstrated that when minorities are trained in minority health 
profession institutions, they are significantly more likely to: (1) 
serve in rural and urban medically underserved areas, (2) provide care 
for minorities and (3) treat low-income patients.
    As you are aware, Title VII Health Professions Training programs 
are focused on improving the quality, geographic distribution and 
diversity of the healthcare workforce in order to continue eliminating 
disparities in our Nation's healthcare system. These programs provide 
training for students to practice in underserved areas, cultivate 
interactions with faculty role models who serve in underserved areas, 
and provide placement and recruitment services to encourage students to 
work in these areas. Health professionals who spend part of their 
training providing care for the underserved are up to 10 times more 
likely to practice in underserved areas after graduation or program 
completion.
    Institutions that cultivate minority health professionals, like 
MSM, have been particularly hard-hit as a result of the cuts to the 
Title VII Health Profession Training programs in fiscal year 2006 and 
fiscal year 2007 Funding Resolution passed earlier this Congress. Given 
their historic mission to provide academic opportunities for minority 
and financially disadvantaged students, and healthcare to minority and 
financially disadvantaged patients, minority health professions 
institutions operate on narrow margins. The cuts to the Title VII 
Health Professions Training programs amount to a loss of core funding 
at these institutions and have been financially devastating.
    Mr. Chairman, I feel like I can speak authoritatively on this issue 
because I received my medical degree from Meharry Medical College, a 
historically black medical and dental school in Nashville, Tennessee. I 
have seen first hand what Title VII funds have done to minority serving 
institutions like Morehouse and Meharry. I compare my days as a student 
to my days as president, without that Title VII, our institutions would 
not be here today. However, Mr. Chairman, since those funds have been 
cut in the last 2 fiscal years, we are standing at a cross roads. This 
committee has the power to decide if our institutions will go forward 
and thrive, or if we will continue to try to just survive. We want to 
work with you to eliminate health disparities and produce world class 
professionals, but we need your assistance.
    In fiscal year 2008, funding for the Title VII Health Professions 
Training programs must be restored to the fiscal year 2005 level of 
$300 million, with two programs--the Minority Centers of Excellence 
(COEs) and Health Careers Opportunity Program (HCOPs)--in particular 
need of a funding restoration. In addition, the National Institutes of 
Health (NIH)'s National Center on Minority Health and Health 
Disparities (NCMHD), as well as the Department of Health and Human 
Services (HHS)'s Office of Minority Health (OMH), are both in need of a 
funding increase.

                     MINORITY CENTERS OF EXCELLENCE

    COEs focus on improving student recruitment and performance, 
improving curricula in cultural competence, facilitating research on 
minority health issues and training students to provide health services 
to minority individuals. COEs were first established in recognition of 
the contribution made by four historically black health professions 
institutions (the Medical and Dental Institutions at Meharry Medical 
College; The College of Pharmacy at Xavier University; and the School 
of Veterinary Medicine at Tuskegee University) to the training of 
minorities in the health professions. Congress later went on to 
authorize the establishment of ``Hispanic'', ``Native American'' and 
``Other'' Historically black COEs.
    Presently the statute is configured in such a way that the 
``original four'' institutions compete for the first $12 million in 
funding, ``Hispanic and Native American'' institutions compete for the 
next $12 million, and ``Other'' institutions can compete for grants 
when the overall funding is above $24 million. For funding above $30 
million all eligible institutions can compete for funding.
    However, as a consequence of limited funding for COEs in fiscal 
year 2006 and fiscal year 2007, ``Hispanic and Native American'' and 
``Other'' COEs have lost their support. Out of 34 total COEs in fiscal 
year 2005, only 4 now remain due to the cuts in funding. MSM lost its 
COE funding as well, which was a devastating blow to our School.
    For fiscal year 2008, I recommend a funding level of $33.6 million 
for COEs.

               HEALTH CAREERS OPPORTUNITY PROGRAM (HCOP)

    HCOPs provide grants for minority and non-minority health 
profession institutions to support pipeline, preparatory and recruiting 
activities that encourage minority and economically disadvantaged 
students to pursue careers in the health professions. Many HCOPs 
partner with colleges, high schools, and even elementary schools in 
order to identify and nurture promising students who demonstrate that 
they have the talent and potential to become a health professional.
    Collectively, the absence of HCOPs will substantially erode the 
number of minority students who enter the health professions. Over the 
last three decades, HCOPs have trained approximately 30,000 health 
professionals including 20,000 doctors, 5,000 dentists and 3,000 public 
health workers. If HCOPs continue to lose Federal support, then these 
numbers will drastically decrease. It is estimated that the number of 
minority students admitted to health professional schools will drop by 
25-50 percent without HCOPs. A reduction of just 25 percent in the 
number of minority students admitted to medical school will produce 
approximately 600 fewer minority medical students nationwide.
    As a result of cuts in the fiscal year 2006 and fiscal year 2007 
Labor-HHS Appropriations process, only 4 out of 74 total HCOPs 
currently receive Federal funding. As president of MSM, I am proud to 
say we competed well enough to be one of those four; however, those who 
have the same mission as ours must have this funding as well.
    For fiscal year 2008, I recommend a funding level of $35.6 million 
for HCOPs.
national institutes of health (nih): extramural facilities construction
    Mr. Chairman, if we are to take full advantage of the recent 
funding increases for biomedical research that Congress has provided to 
NIH over the past decade, it is critical that our Nation's research 
infrastructure remain strong. The current authorization level for the 
Extramural Facility Construction program at the National Center for 
Research Resources is $250 million. The law also includes a 25 percent 
set-aside for ``Institutions of Emerging Excellence'' (many of which 
are minority institutions) for funding up to $50 million. Finally, the 
law allows the NCRR Director to waive the matching requirement for 
institutions participating in the program. We strongly support all of 
these provisions of the authorizing legislation because they are 
necessary for our minority health professions training schools.
    Unfortunately, funding for NCRR's Extramural Facility Construction 
program was completely eliminated in the fiscal year 2006 Labor-HHS 
bill, and no funding was restored in the funding resolution for fiscal 
year 2007. In fiscal year 2008, please restore funding for this program 
to its fiscal year 2004 level of $119 million, or at a minimum, provide 
funding equal to the fiscal year 2005 appropriation of $40 million.

               RESEARCH CENTERS IN MINORITY INSTITUTIONS

    The Research Centers at Minority Institutions program (RCMI) at the 
National Center for Research Resources has a long and distinguished 
record of helping our institutions develop the research infrastructure 
necessary to be leaders in the area of health disparities research. 
Although NIH has received unprecedented budget increases in recent 
years, funding for the RCMI program has not increased by the same rate. 
Therefore, the funding for this important program grow at the same rate 
as NIH overall in fiscal year 2008.

 STRENGTHENING HISTORICALLY BLACK GRADUATE INSTITUTIONS--DEPARTMENT OF 
                               EDUCATION

    The Department of Education's Strengthening Historically Black 
Graduate Institutions program (Title III, Part B, Section 326) is 
extremely important to MMC and other minority serving health 
professions institutions. The funding from this program is used to 
enhance educational capabilities, establish and strengthen program 
development offices, initiate endowment campaigns, and support numerous 
other institutional development activities. In fiscal year 2008, an 
appropriation of $65 million (an increase of $7 million over fiscal 
year 2007) is suggested to continue the vital support that this program 
provides to historically black graduate institutions.
National Center on Minority Health and Health Disparities
    The National Center on Minority Health and Health Disparities 
(NCMHD) is charged with addressing the longstanding health status gap 
between minority and nonminority populations. The NCMHD helps health 
professional institutions to narrow the health status gap by improving 
research capabilities through the continued development of faculty, 
labs, and other learning resources. The NCMHD also supports biomedical 
research focused on eliminating health disparities and develops a 
comprehensive plan for research on minority health at the NIH. 
Furthermore, the NCMHD provides financial support to health professions 
institutions that have a history and mission of serving minority and 
medically underserved communities through the Minority Centers of 
Excellence program.
    For fiscal year 2008, I recommend a funding level of $250 million 
for the NCMHD.
Department of Health and Human Services' Office of Minority Health 
        (OMH)
    Specific programs at OMH include:
    (1) Assisting medically underserved communities with the greatest 
need in solving health disparities and attracting and retaining health 
professionals,
    (2) Assisting minority institutions in acquiring real property to 
expand their campuses and increase their capacity to train minorities 
for medical careers,
    (3) Supporting conferences for high school and undergraduate 
students to interest them in health careers, and
    (4) Supporting cooperative agreements with minority institutions 
for the purpose of strengthening their capacity to train more 
minorities in the health professions.
    The OMH has the potential to play a critical role in addressing 
health disparities. Unfortunately, the OMH does not yet have the 
authority or resources necessary to support activities that will truly 
make a difference in closing the health gap between minority and 
majority populations.
    For fiscal year 2008, I recommend a funding level of $65 million 
for the OMH.
    Mr. Chairman, please allow me to express my appreciation to you and 
the members of this subcommittee. With your continued help and support, 
Morehouse School of Medicine along with other minority health 
professions institutions and the Title VII Health Professions Training 
programs can help this country to overcome health and healthcare 
disparities. Congress must be careful not to eliminate, paralyze or 
stifle the institutions and programs that have been proven to work. MSM 
and other minority health professions schools seek to close the ever 
widening health disparity gap. If this subcommittee will give us the 
tools, we will continue to work towards the goal of eliminating that 
disparity as we have since our founding day.
    Thank you, Mr. Chairman, and I welcome every opportunity to answer 
questions for your records.
                                 ______
                                 
    Prepared Statement of the National Alliance to End Homelessness

    The National Alliance to End Homelessness (the Alliance) is a 
nonpartisan, nonprofit organization that has several thousand partner 
agencies and organizations across the country. These partners are local 
faith-based and community-based nonprofit organizations and public 
sector agencies that provide homeless people with shelter, transitional 
and permanent housing, and services such as substance abuse treatment, 
job training, and physical health and mental health care. In addition, 
we have supported over 160 State and local entities who have completed 
10 year plans to end homelessness. The Alliance represents a united 
effort to address the root causes of homelessness and challenge 
society's acceptance of homelessness as an inevitable by-product of 
American life.
    Overview--Our recent research report, Homelessness Counts, 
estimates that 744,313 people are homeless on any given night. This 
includes 98,452 families. Fifty-six percent of the total were living in 
shelters or transitional housing and 44 percent were unsheltered. This 
report illustrates that far too many people are homeless and many are 
not being reached by existing programs. This is inexcusable given that 
we know what interventions work and several communities are making 
progress toward ending homelessness. These interventions, such as 
housing first for families and permanent supportive housing, couple 
housing with an appropriate level of services for the family or 
individual. Therefore, not only does the Department of Housing and 
Urban Development play a role in ending homelessness, so do the 
Departments of Labor, Health and Human Services, and Education. We call 
on Congress and all Federal agencies to adequately fund the programs 
that assist States and local entities in developing permanent housing 
and the necessary social services to once and for all end homelessness 
for all Americans.

                                 GOALS

    1. Moving Forward to End Homelessness.--Communities across America 
are working toward ending homelessness. Communities are using Federal, 
State, and local funds to help homeless persons maintain housing. It is 
important that this progress not be undermined. To this end, the 
Alliance recommends the following:
  --Allocate an additional $80 million for services in permanent 
        supportive housing within SAMHSA's Center for Mental Health 
        Services.
  --Increase funding to Projects for Assistance in Transition from 
        Homelessness (PATH) to $58.3 million.
  --Increase the Runaway and Homeless Youth Act Programs to $140 
        million.
  --Provide a $200 million increase in the Community Health Center 
        program within Health Resource Services Administration. This 
        would result in the Health Care for the Homeless programs 
        receiving $190 million.
  --Fund Education for Homeless Children and Youth services at its full 
        authorized level of $70 million.
  --Increase funding for the Homeless Veterans Reintegration Program to 
        $50 million.
    2. Connecting Homeless Families, Individuals, and Youth to 
Mainstream Services.--People experiencing homelessness also depend on 
mainstream programs such as the ones below to live day to day and once 
housed, remain housed. The Alliance recommends the following to meet 
this goal:
  --Fund the Social Services Block Grant at $1.7 billion, the same 
        funding level as fiscal year 2006.
  --Reject cuts and fund the Community Services Block Grant at $700 
        million
  --Appropriate $60 million in education and training vouchers for 
        youth exiting foster care under the Safe and Stable Families 
        Program.

               GOAL 1--MOVING FORWARD TO END HOMELESSNESS

Support Services for Permanent Supportive Housing Projects
    The Alliance recommends allocating an additional $80 million for 
services in permanent supportive housing within SAMHSA's Center for 
Mental Health Services. The administration has set a goal of ending 
chronic homelessness by 2012 and joined with Congress to set a goal of 
creating 150,000 additional units of permanent supportive housing. 
According to the Alliance's report, Homelessness Counts, 23 percent of 
those who are homeless on any given night meet the chronic homelessness 
definition of being homeless for long periods of time or repeatedly. 
These people need access to housing and support services. The Alliance 
and our partners believe the Department of Health and Human Services 
needs to raise its commitment to provide the services necessary to end 
homelessness. Therefore, we are proposing this increase in SAMHSA 
funding to help communities provide services to 16,000 new units of 
permanent supportive housing.

      PROJECTS FOR TRANSITION ASSISTANCE FROM HOMELESSNESS (PATH)

    The Alliance recommends that Congress increase PATH funding to 
$58.3 million and adjust the funding formula to increase allocation for 
small States and territories.
    The PATH program provides access to mental health services for 
homeless people with serious mental illnesses. PATH focuses on outreach 
to eligible consumers, followed by help in ensuring that those 
consumers are connected with mainstream services, such as Supplemental 
Security Income (SSI), Medicaid and welfare programs. Under the PATH 
formula grant, approximately 30 States share in the program's annual 
appropriations increases. The remaining States and territories receive 
the minimum grant of $300,000 for States and $50,000 for territories. 
These amounts have not been raised since the program was authorized in 
1991. To account for inflation, the minimum allocation should be raised 
to $600,000 for States and $100,000 for territories. Amending the 
minimum allocation requires a legislative change. If the authorizing 
committees do not address this issue, we hope that appropriators will 
explore ways to make the change through appropriations bill language.

                  RUNAWAY AND HOMELESS YOUTH PROGRAMS

    The Alliance recommends funding the Runaway and Homeless Youth Act 
(RHYA) programs at $140 million. RHYA programs support cost-effective, 
community and faith-based organizations that protect youth from the 
harms of life on the streets. The problems of homeless and runaway 
youth are addressed by the Administration for Children and Families 
within HHS, which operates coordinated competitive grant programs like 
RHYA. The RHYA programs can either reunify youth safely with family or 
find alternative living arrangements. RHYA programs end homelessness 
by: engaging youth living on the street with Street Outreach Programs, 
quickly providing emergency shelter and family crisis counseling 
through the Basic Centers, or providing supportive housing that helps 
young people develop lifelong independent living skills through 
Transitional Living Programs. Recently, the Congressional Research 
Service issued a report complimenting the good work of RHYA programs 
but detailing the gaps in services due to limited funding. It is 
essential that Congress increase this program.

    COMMUNITY HEALTH CENTERS AND HEALTH CARE FOR THE HOMELESS (HCH) 
                                PROGRAMS

    The Alliance recommends a $200 million increase to the Community 
Health Centers Program which would result in funding the HCH programs 
at $190 million.
    Persons living on the street suffer from health problems resulting 
from or exacerbated by the condition of being homeless, such as 
hypothermia, frostbite, and heatstroke. In addition, they often have 
infections of the respiratory and gastrointestinal systems, 
tuberculosis, vascular diseases such as leg ulcers, and 
hypertension.\1\ Health care for the homeless programs are vital to 
prevent these conditions from becoming fatal. Congress allocates 8.7 
percent of the Consolidated Health Centers account for Health Care for 
the Homeless (HCH) projects. The HCH program has achieved significant 
success since its inception in 1987, but the health care needs of 
Americans experiencing homelessness each year far exceed the service 
capacity of Health Care for the Homeless grantees.
---------------------------------------------------------------------------
    \1\ Harris, Shirley N, Carol T. Mowbray and Andrea Solarz. Physical 
Health, Mental Health and Substance Abuse Problems of Shelter Users. 
Health and Social Work, Vol. 19, 1994.
---------------------------------------------------------------------------
               EDUCATION FOR HOMELESS CHILDREN AND YOUTH

    The Alliance recommends funding Education for Homeless Children and 
Youth (EHCY) at its full authorized level of $70 million. The most 
important potential source of stability for homeless children is 
school. The mission of the Education for Homeless Children and Youth 
program is to ensure that these children can continue to attend school 
and thrive. The Education for Homeless Children and Youth program, 
within the Department of Education's Office of Elementary and Secondary 
Education, removes obstacles to enrollment and retention by 
establishing liaisons between schools and shelters and providing 
funding for transportation, tutoring, school supplies, and the 
coordination of statewide efforts to remove barriers.

             HOMELESS VETERANS REINTEGRATION PROGRAM (HVRP)

    The Alliance recommends that Congress increase HVRP funding to $50 
million.
    HVRP, within the Department of Labor's Veterans Employment and 
Training Service (VETS), provides competitive grants to community-
based, faith-based, and public organizations to offer outreach, job 
placement, and supportive services to homeless veterans. HVRP is the 
primary employment services program accessible by homeless veterans and 
the only targeted employment program for any homeless subpopulation. It 
is estimated that this program only reaches about two percent of the 
overall homeless veteran population. An appropriation at the authorized 
level of $50 million would enable HVRP grantees to reach approximately 
19,866 homeless veterans.

    GOAL 2--CONNECTING HOMELESS FAMILIES, INDIVIDUALS AND YOUTH TO 
                          MAINSTREAM SERVICES

Social Services Block Grant (SSBG)
    The Alliance recommends that Congress fully restore SSBG funding to 
its fiscal year 2006 level of $1.7 billion. SSBG funds are essential 
for programs dedicated to ending homelessness. In particular, youth 
housing programs and permanent supportive housing providers often 
receive State, county, and local funds which originate from the SSBG. 
As the U.S. Department of Housing and Urban Development has focused its 
funding on housing, programs that provide both housing and social 
services have struggled to fund the service component of their 
programs. This gap is often closed using Federal programs such as SSBG.
Community Services Block Grant (CSBG)
    The Alliance recommends that Congress fully restore CSBG funding to 
its fiscal year 2006 level of $630 million. Funding cuts for the CSBG 
will destabilize the progress communities have made toward ending 
homelessness by not only ending services directly provided by CSBG 
funds but limiting a community's ability to access other Federal 
dollars such as those provided by HUD. Community Action Agencies (CAAs) 
are directly involved in housing and homelessness services. In several 
communities, CAAs lead the Continuum of Care (CoC). CoCs coordinate 
local homeless service providers and the community's McKinney-Vento 
Homeless Assistance Grant application process with the Department of 
Housing and Urban Development.
    In the fiscal year 2004 Community Services Block Grant Information 
Systems report published by the U.S. Department of Health and Human 
Services, CAAs reported administering $207.4 million in section 8 
vouchers, $30 million in section 202 services \2\ and $271.1 million in 
other Department of Housing and Urban Development (HUD) programs which 
includes homeless program funding.\3\
---------------------------------------------------------------------------
    \2\ Section 202 is dedicated to housing from elderly and disabled 
individuals and families.
    \3\ U.S. Department of Health and Human Services, Administration of 
Children and Families. The Community Services Block Grant fiscal year 
2004 Statistical Report. Prepared by the National Association for State 
Community Services Programs.
---------------------------------------------------------------------------
Foster Youth Education and Training Vouchers
    The Alliance recommends that Congress appropriate $60 million in 
education and training vouchers for youth exiting foster care under the 
Safe and Stable Families Program. The Education and Training Voucher 
Program offers funds to foster youth and former foster youth to enable 
them to attend colleges, universities and vocational training 
institutions. Students may receive up to $5,000 a year for college or 
vocational training education. The funds may be used for tuition, 
books, housing, or other qualified living expenses. Given the large 
number of people experiencing homelessness who have a foster care 
history, it is important to provide assistance such as these education 
and training vouchers to stabilize youth, prevent economic crisis, and 
prevent possible homelessness.

                               CONCLUSION

    Homelessness is not inevitable. As communities implement plans to 
end homelessness, they are struggling to find funding for the services 
homeless and formerly homeless clients need to maintain housing. The 
Federal investments in mental health services, substance abuse 
treatment, employment training, youth housing, and case management 
discussed above will help communities create stable housing programs 
and change social systems which will end homelessness for millions of 
Americans.
                                 ______
                                 
Prepared Statement of the National Alliance for Eye and Vision Research 
                                (NAEVR)

                           EXECUTIVE SUMMARY

    NAEVR requests fiscal year 2008 NIH funding at $31 billion, or a 
6.7 percent increase over fiscal year 2007, to balance the biomedical 
inflation rate of 3.7 percent and to maintain the momentum of 
discovery. Although NAEVR commends the leadership's actions in the 
110th Congress to increase fiscal year 2007 NIH funding by $620 
million, this was just an initial step in restoring the NIH's 
purchasing power, which has declined by more than 13 percent since 
fiscal year 2005. That power would be eroded even further under the 
President's proposed fiscal year 2008 budget. NAEVR commends NIH 
Director Dr. Zerhouni who has articulately described his agenda to 
foster collaborative, cost-effective research and to transform the 
healthcare research and delivery paradigm into one that is predictive, 
preemptive, preventive, and personalized. NIH is the world's premier 
institution and must be adequately funded so that its research can 
reduce healthcare costs, increase productivity, improve quality of 
life, and ensure our Nation's global competitiveness.
    NAEVR requests that Congress make vision health a top priority by 
funding the NEI at $711 million in fiscal year 2008, or a 6.7 percent 
increase over fiscal year 2007. This level is necessary to fully 
advance the breakthroughs resulting from NEI's basic and clinical 
research that are resulting in treatments and therapies to prevent eye 
disease and restore vision. Vision impairment/eye disease is a major 
public health problem that is growing and which disproportionately 
affects the aging and minority populations, costing the United States 
$68 billion annually in direct and societal costs, let alone reduced 
independence and quality of life. Adequately funding the NEI is a cost-
effective investment in our Nation's health, as it can delay, save, and 
prevent expenditures, especially to the Medicare and Medicaid programs.

FUNDING THE NEI AT $711 MILLION IN FISCAL YEAR 2008 ENABLES IT TO LEAD 
 TRANS-INSTITUTE VISION RESEARCH THAT MEETS NIH'S GOAL OF PREEMPTIVE, 
          PREDICTIVE, PREVENTIVE, AND PERSONALIZED HEALTHCARE

    Funding NEI at $711 million in fiscal year 2008 represents the eye 
and vision research community's judgment as that necessary to fully 
advance breakthroughs resulting from NEI's basic and clinical research 
that are resulting in treatments and therapies to prevent eye disease 
and restore vision.
    NEI research responds to the NIH's overall major health challenges, 
as set forth by Dr. Zerhouni: an aging population; health disparities; 
the shift from acute to chronic diseases; and the co-morbid conditions 
associated with chronic diseases (e.g., diabetic retinopathy as a 
result of the epidemic of diabetes). In describing the predictive, 
preemptive, preventive, and personalized approach to healthcare 
research, Dr. Zerhouni has frequently cited NEI-funded research as 
tangible examples of the value of our Nation's past and future 
investment in the NIH. These include:
  --Dr. Zerhouni has cited as a breakthrough the collaborative Human 
        Genome Project/NEI-funded discovery of gene variants strongly 
        associated with an individual's risk of developing age-related 
        macular degeneration (AMD), the leading cause of blindness 
        (affecting more than 10 million Americans) which increasingly 
        robs seniors of their independence and quality of life. These 
        variants, which are responsible for about 60 percent of the 
        cases of AMD, are associated with the body's inflammatory 
        response and may relate to other inflammation-associated 
        diseases, such as Alzheimer's and Parkinson's disease. As NEI 
        Director Dr. Paul Sieving has stated, ``One of the important 
        stories during the next decade will be how Alzheimer's disease 
        and macular degeneration fit together.''
  --Dr. Zerhouni has cited the NEI-funded Age-Related Eye Disease Study 
        (AREDS) as a cost-effective preventive measure. In 2006, NEI 
        began the second phase of the AREDS study, which will follow up 
        on initial study findings that high levels of dietary zinc and 
        antioxidant vitamins (Vitamins C, E and beta-carotene) are 
        effective in reducing vision loss in people at high risk for 
        developing advanced AMD--by a magnitude of 25 percent.
  --NEI has funded research, along with the National Cancer Institute 
        (NCI) and the National Heart, Lung, and Blood Institute 
        (NHLBI), into factors that promote new blood vessel growth 
        (such as Vascular Endothelial Growth Factor, or VEGF). This has 
        resulted in anti-VEGF factors that have been translated into 
        the first generation of ophthalmic drugs approved by the Food 
        and Drug Administration (FDA) to inhibit abnormal blood vessel 
        growth in ``wet'' AMD, thereby stabilizing vision loss. Current 
        research is focused on using treatments singly and in 
        combination to improve vision or prevent further vision loss 
        due to AMD. As part of its Diabetic Retinopathy Clinical 
        Research Network, NEI is also evaluating these drugs for 
        treatment of macular edema associated with diabetic 
        retinopathy.
    Although these breakthroughs came directly from the past doubling 
of the NIH budget, their long-term potential to preempt, predict, 
prevent, and treat disease relies on adequately funding NEI's follow-up 
research. Unless its funding is increased, the NEI's ability to 
capitalize on the findings cited above will be seriously jeopardized, 
resulting in ``missed opportunities'' that could include:
  --Following up on the AMD gene discovery by developing diagnostics 
        for early detection and promising therapies, as well as to 
        further study the impact of the body's inflammatory response on 
        other degenerative eye diseases.
  --Fully investigating the impact of additional, cost-effective 
        dietary supplements in the AREDS study, singly and in 
        combination, to determine if they can demonstrate enhanced 
        protective effects against progression to advanced AMD.
  --Following up with further clinical trials on patients with the 
        ``wet'' form of AMD, as well as patients with diabetic 
        retinopathy, using the new anti-angiogenic ophthalmic drugs 
        singly and in combination to halt disease progression and 
        potentially restore vision.
    In addition, NEI research into other significant eye disease 
programs, such as glaucoma and cataract, will be threatened, along with 
quality of life research programs into low vision and chronic dry eye. 
This comes at a time when the U.S. Census and NEI-funded 
epidemiological research (also threatened without adequate funding) 
both cite significant demographic trends that will increase the public 
health problem of vision impairment and eye disease.

VISION IMPAIRMENT/EYE DISEASE IS A MAJOR PUBLIC HEALTH PROBLEM THAT IS 
  INCREASING HEALTHCARE COSTS, REDUCING PRODUCTIVITY, AND DIMINISHING 
                            QUALITY OF LIFE

    The 2000 U.S. Census reported that more than 119 million people in 
the United States were age 40 or older, which is the population most at 
risk for an age-related eye disease. The NEI estimates that, currently, 
more than 38 million Americans age 40 and older experience blindness, 
low vision or an age-related eye disease such as AMD, glaucoma, 
diabetic retinopathy, or cataracts. This is expected to grow to more 
than 50 million Americans by year 2020. The economic and societal 
impact of eye disease is increasing not only due to the aging 
population, but to its disproportionate incidence in minority 
populations and as a co-morbid condition of other chronic disease, such 
as diabetes.
    Although the NEI estimates that the current annual cost of vision 
impairment and eye disease to the United States is $68 billion, this 
number does not fully quantify the impact of direct healthcare costs, 
lost productivity, reduced independence, diminished quality of life, 
increased depression, and accelerated mortality. The continuum of 
vision loss presents a major public health problem and financial 
challenge to both the public and private sectors.
    In public opinion polls over the past 40 years, Americans have 
consistently identified fear of vision loss as second only to fear of 
cancer. As a result, Federal funding for the NEI is a vital investment 
in the health, and vision health, of our Nation, especially our 
seniors, as the treatments and therapies emerging from research can 
preserve and restore vision. Adequately funding the NEI can delay, 
save, and prevent expenditures, especially those associated with the 
Medicare and Medicaid programs, and is, therefore, a cost-effective 
investment.
    NAEVR urges fiscal year 2008 NIH and NEI funding at $31 billion and 
$711 million, respectively.

                              ABOUT NAEVR

    Founded in 1997, NAEVR is a non-profit advocacy organization 
comprised of a coalition of 55 professional, consumer, and industry 
organizations (see list below) involved in eye and vision research. 
NAEVR's goal is to achieve the best vision for all Americans through 
advocacy and public education about the value and cost-effectiveness of 
eye and vision research sponsored by the NIH, NEI, and other Federal 
research entities.
  Advanced Medical Optics; Alcon Laboratories, Inc.; Allergan, Inc.; 
        AMD Alliance International; American Academy of Ophthalmology; 
        American Academy of Optometry; American Association for 
        Pediatric Ophthalmology and Strabismus; American Assoc. of 
        Ophthalmic Pathologists; American Diabetes Association; 
        American Glaucoma Society; American Ophthalmological Society; 
        American Society of Retina Specialists; American Optometric 
        Association; American Society of Cataract and Refractive 
        Surgery; American Uveitis Society; Association for Research in 
        Vision and Ophthalmology; Association of Schools and Colleges 
        of Optometry; Association of University Professors of 
        Ophthalmology; Association of Vision Science Librarians; Bausch 
        & Lomb; Blinded Veterans Association; Discovery Eye Foundation; 
        Eli Lilly & Company; Eye Bank Association of America; EyeSight 
        Foundation of Alabama; Fight for Sight; Foundation Fighting 
        Blindness; Genentech, Inc.; Glaucoma Research Foundation; 
        Inspire Pharmaceuticals, Inc.; ISTA Pharmaceuticals, Inc.; 
        Juvenile Diabetes Research Foundation Intl.; Lighthouse 
        International; Lions Clubs Intl. Foundation; Macular 
        Degeneration Partnership; Natl. Vision Rehabilitation Assoc.; 
        Novartis; Ocular Microbiology and Immunology Group; Pfizer 
        Inc.; Prevent Blindness America; Prevention of Blindness 
        Society of Metropolitan Washington; Research to Prevent 
        Blindness; Santen, Inc.; Second Sight; Sjogren's Syndrome 
        Foundation; Tear Film and Ocular Surface Society; The Cornea 
        Society; The Glaucoma Foundation; The Macula Society; The 
        Retina Society; Vision Council of America; Vision Share, The 
        Consortium of Eye Banks; Vistakon, Johnson & Johnson Vision 
        Care, Inc.; Women in Ophthalmology; and Women's Eye Health Task 
        Force.
                                 ______
                                 
   Prepared Statement of the National Area Health Education Centers 
                              Organization

              SUMMARY OF FISCAL YEAR 2008 RECOMMENDATIONS

    $300 million for the Title VII Health Professions Training 
programs.
    $33 million for area Health Education Centers.
    $4.371 million for Health Education and Training Centers.
    The National Area Health Education Centers Organization (NAO) is 
the professional organization representing Area Health Education 
Centers (AHECs) and Health Education and Training Centers (HETCs).
    AHECs and HETCs are two of the Title VII Health Professions 
Training programs. The Title VII Health Professions Training programs 
are focused on improving the quality, geographic distribution and 
diversity of the healthcare workforce and eliminating the disparities 
in our Nation's healthcare system. These programs help address 
healthcare disparities by employing strategies such as providing 
training for students in rural and underserved areas, interaction with 
faculty role models who serve in rural and underserved areas and 
placement services to foster and encourage students to work in these 
areas.
    AHECs develop and support the community based training of health 
professions students, particularly in rural and underserved areas. They 
also provide continuing education and other services that improve the 
quality of community-based healthcare. HETCs use the infrastructure of 
AHECs to address the needs of diverse populations with persistent and 
severe unmet health needs. In 5 border and 6 non-border States, HETCs 
train and support Community Health Workers (CHWs) to provide healthcare 
services and information to their communities.
    Nationwide, AHECs and HETCs support health professional training in 
almost 25,000 community based practice settings, and over 47,000 health 
professional students receive training at these sites. Furthermore, 
over 339,000 health professionals receive continuing education through 
AHECs and HETCs. AHECs and HETCs perform these education and training 
services through collaborative partnerships with Community Health 
Centers (CHCs) and the National Health Service Corps (NHSC).

     COMMUNITY HEALTH CENTERS AND THE NATIONAL HEALTH SERVICE CORPS

    CHCs are dedicated to providing preventative and ambulatory 
healthcare to uninsured and underinsured populations. A March 2006 
study published in the Journal of the American Medical Association 
(JAMA) found that CHCs report high percentages of provider vacancies, 
including an insufficient supply of dentists, pharmacists, 
pediatricians, family physicians and registered nurses. These shortages 
are particularly pronounced in CHCs that serve rural areas. Because the 
Title VII Health Professions Training programs (including AHECs and 
HETCs) have a successful record of training providers to work in 
underserved areas, the study recommends increased support for the Title 
VII Health Professions Training programs as the primary means of 
alleviating the health professions shortage in rural CHCs. The study 
serves as an important reminder that the success of CHCs is highly 
dependent upon a well-trained clinical staff to provide care. Thirty-
eight percent of AHEC training sites are CHCs, and 26 percent of the 
health professionals who receive continuing education through HETCs are 
employed at CHCs. Another 36 percent are employed at NHSC sites.
    AHECs and HETCs also undertake a variety of programs related to the 
placement and support of NHSC scholars and loan repayment recipients. 
NHSC scholars and loan repayment recipients commit to practicing in an 
underserved area, and are focused on improving health by providing 
comprehensive team-based healthcare that bridges geographic, financial 
and cultural barriers. As contractors of the NHSC Student/Resident 
Experiences and Rotations in Community Health (SEARCH) program, AHECs 
and HETCs help to expand the NHSC by placing students and residents in 
rotations in rural areas. These students and residents are then far 
more likely to return to the rural area as a NHSC scholar or loan 
repayment recipient. This is because health professionals who spend 
part of their training providing care for rural and underserved 
populations are 3 to 10 times more likely to practice in rural and 
underserved areas after graduation or program completion.

                        COMMUNITY HEALTH WORKERS

    Like NHSC scholars and loan repayment recipients, CHWs aim to 
respond to local health problems with effective and culturally 
sensitive strategies. They provide health services in their communities 
and specifically address healthcare disparities by working to improve 
health literacy. CHWs are uniquely suited to these tasks because they 
come from, and live in, the same communities as their patients. They 
also speak the same language as their non-English speaking patients.
    An October 2006 study by the Health Resources and Services 
Administration (HRSA) entitled ``The Rationale for Diversity in the 
Health Professions: A Review of the Evidence'' shows the importance of 
the CHWs. This study found that minority health professionals 
disproportionately serve minority and other medically underserved 
populations, minority populations tend to receive better care from 
practitioners of their own race or ethnicity, and non-English speaking 
patients experience better care, greater comprehension and greater 
likelihood of keeping follow-up appointments when they see a 
practitioner who speaks their own language.
    HETCs are the only Federal program mandated to recruit, train and 
support CHWs. In 2004-2005 HETCs provided the initial training and 
continuing education for over 5,000 CHWs. But the Fiscal Year 2006 and 
Fiscal Year 2007 Labor-Health and Human Services (HHS)-Education 
Appropriations bills zeroed out the funding for HETCs. Unless funding 
is restored, HETCs will no longer be able to recruit, train or support 
CHWs.

               JUSTIFICATION FOR FUNDING RECOMMENDATIONS

    By improving the quality, geographic diversity and diversity of the 
healthcare workforce, the United States can eliminate healthcare 
disparities. In order to continue the progress that the Title VII 
Health Professions Training programs (including AHECs and HETCs) have 
already made towards this goal, an additional Federal investment is 
required. NAO recommends that the Title VII Health Professions Training 
programs are funded at $300 million in fiscal year 2008, including $33 
million for AHECs and $4.371 million for HETCs.
                                 ______
                                 
 Prepared Statement of the National Association of Children's Hospitals

    The National Association of Children's Hospitals thanks the 
subcommittee for the opportunity to submit a statement for the hearing 
record in support of the Children's Hospitals' Graduate Medical 
Education (CHGME) Program in the Health Resources and Services 
Administration.
    On behalf of the Nation's 60 independent children's teaching 
hospitals, N.A.C.H. very much appreciates the subcommittee's early 
commitment to provide Federal GME funding for these hospitals. In 1999, 
2000, and 2006, Congress authorized and reauthorized the CHGME program 
to give independent children's teaching hospitals a level of Federal 
support for their teaching programs, which seeks to be comparable to 
what adult teaching hospitals receive from Medicare.
    We appreciate very much the continuation of $297 million for CHGME 
in the final Fiscal Year 2007 Continuing Resolution, the same level as 
Congress appropriated for fiscal year 2006. The fiscal year 2007 
appropriation marks the first time since Congress first agreed to 
appropriate $305 million for CHGME in fiscal year 2004 that the 
program's funding has not been reduced due to across-the-board spending 
cuts in health and human services.
    CHGME has Been a Success.--CHGME support to children's hospitals 
now approaches about 80 percent of the level of Medicare GME support to 
adult hospitals. CHGME has made it possible for children's hospitals to 
strengthen their training of pediatric physicians at a time of national 
shortages, without having to sacrifice the hospitals' clinical or 
research programs. And it has enabled the hospitals to achieve strong 
financial positions, which are essential to their ability to fulfill 
their capital intensive missions.
    For fiscal year 2008, we respectfully request $330 million, the 
annual authorization level that Congress enacted and the president 
signed into law last year. It would make up for the erosion in funding 
for the CHGME program over the last 4 years and address the cost of 
inflation. It is important in a program with both wage-related and 
medical teaching costs. Full funding would ensure the hospitals will 
have the resources necessary to train and educate the Nation's 
pediatric workforce.

                   N.A.C.H. AND CHILDREN'S HOSPITALS

    N.A.C.H. is a not-for-profit trade association, representing more 
than 135 children's hospitals. They include independent acute care 
children's hospitals, children's hospitals within larger medical 
centers, and independent children's specialty and hospitals. N.A.C.H. 
helps its members fulfill their missions of clinical care, education, 
research and advocacy for all children.
    Children's hospitals are regional and national centers of 
excellence for children with serious and complex conditions. They are 
centers of biomedical and health services research for children and are 
the major training centers for pediatric researchers, as well as a 
significant number of children's doctors. They also are major safety 
net providers, serving a disproportionate share of children from low-
income families, and they are advocates for the public health of all 
children.
    Although they represent less than 5 percent of all hospitals in the 
country, the three major types of children's hospitals provide 41 
percent of the inpatient care for all children, 42 percent of the 
inpatient care for children assisted by Medicaid, and most hospital 
care for children with serious conditions.

                     BACKGROUND: THE NEED FOR CHGME

    While they account for less than 1 percent of all hospitals, 
independent children's teaching hospitals alone train 35 percent of all 
pediatricians, half of all pediatric specialists and the majority of 
pediatric researchers. They provide required pediatric rotations for 
many other residents and train more than 4,800 resident FTEs annually. 
Shortages of pediatric specialists across the Nation only heighten the 
importance of these hospitals.
    Prior to initial funding of the CHGME program for fiscal year 2000, 
the eligible hospitals were facing enormous challenges to their ability 
to maintain their training programs. The increasingly price competitive 
medical marketplace was resulting in more and more payers failing to 
cover the costs of care, including the costs associated with teaching.
    Because they see few if any Medicare patients, independent 
children's hospitals were essentially left out of Medicare GME, which 
had become the one major source of GME financing for other teaching 
hospitals. They received only 1/200th (or less than 0.5 percent) of the 
Federal GME support that all other teaching hospitals received under 
Medicare. This lack of GME financing, combined with financial 
challenges stemming from their other missions, threatened their 
teaching programs, as well as other services.
    Safety Net Institutions.--Independent children's hospitals are a 
significant part of the health care safety net for low-income children, 
which puts them at financial risk. In fiscal year 2005 children 
assisted by Medicaid were, on average, 55 percent of all inpatient days 
of care. Yet, Medicaid average, paid only 78 percent of costs. Without 
disproportionate share hospital payments, Medicaid would pay even less. 
Medicaid payment shortfalls for outpatient and physician care are even 
greater.
    The independent children's hospitals also are essential providers 
of care for seriously and chronically ill children. They devote more 
than 75 percent of their care to children with one or more chronic or 
congenital conditions. They provide the majority of inpatient care to 
children with many serious illnesses--from children with cancer or 
cerebral palsy, for example, to children needing heart surgery or organ 
transplants. In some regions, they are the only source of pediatric 
specialty care. The severity and complexity of illness and the services 
these institutions must maintain to assure access to this quality care 
for all children are often poorly reimbursed.
    Lastly, many of the independent children's hospitals are a vital 
part of the emergency and critical care services in their regions. They 
are part of the emergency response system that must be in place for 
public health emergencies. Expenses associated with disaster 
preparedness add to their continuing costs in meeting children's needs.
    Mounting Financial Pressures.--The CHGME program, and its 
relatively quick progress to full funding in fiscal year 2002, came at 
a critical time. In 1997, when Congress first considered establishing 
CHGME, a growing number of independent children's hospitals had 
financial losses; many more faced mounting financial pressures. More 
than 10 percent had negative total margins, more than 20 percent had 
negative operating margins, and nearly 60 percent had negative patient 
care margins. Some of the Nation's most prominent children's hospitals 
were at financial risk. Thanks to CHGME, these hospitals have been able 
to maintain and strengthen their training programs.
    Pediatric Workforce.--The important role CHGME plays in the 
continual development of our Nation's pediatric workforce is not lost 
on the larger pediatric community, including the American Academy of 
Pediatrics and Association of Medical School Pediatric Department 
Chairs. They support CHGME and recognize it is critical not only to the 
future of the individual hospitals but also to provision of children's 
health care and advancements in pediatric medicine. This year, the 
chairs of more than 40 medical school pediatric departments have 
endorsed full funding for the program, regardless of whether they are 
affiliated with a CHGME hospital. For example, the pediatric leadership 
of Iowa has endorsed full funding for CHGME, even though Iowa's own 
children's hospitals do not receive CHGME funding, because it is so 
important to the institutions around the country from which Iowa 
recruits pediatric subspecialists.

                         CONGRESSIONAL RESPONSE

    In the absence of movement toward broader GME financing reform, 
Congress in 1999 authorized the Children's Hospitals' GME discretionary 
grant program to address the existing inequity in GME financing for the 
independent children's hospitals. The legislation was reauthorized in 
2000 through fiscal year 2005 and provided $285 million for fiscal year 
2001 and such sums as necessary in the years beyond. Congress passed 
the initial authorization as part of the ``Healthcare Research and 
Quality Act of 1999.'' It passed the first 5-year reauthorization as 
part of the ``Children's Health Act of 2000.'' Last year, it passed the 
second 5-year reauthorization as part of the ``Children's Hospital GME 
Support Reauthorization Act of 2007,'' which authorized $330 million 
for each of the 5 years, through fiscal year 2011.
    With this subcommittee's support, Congress appropriated initial 
funding for CHGME in fiscal year 2000, before the enactment of its 
authorization. Following enactment, Congress moved substantially toward 
full funding for the program in fiscal year 2001 and completed that 
goal, providing $285 million in fiscal year 2002, $290 million in 
fiscal year 2003, $303 million in fiscal year 2004, $301 million in 
fiscal year 2005, $297 million in fiscal year 2006, and $297 million in 
fiscal year 2007. (In the fiscal year 2004, 2005, 2006, the funding 
levels are net of across-the-board cuts in discretionary funding. For 
example, Congress appropriated $305 million for fiscal year 2004; the 
net appropriation, after cut, was $303 million.)
    Health Resources and Services Administration.--The CHGME funding is 
distributed through HRSA to 60 children's hospitals according to a 
formula based on the number and type of full-time equivalent residents 
trained, in accordance with Medicare rules, as well as the complexity 
of care and intensity of teaching the hospitals provide. Consistent 
with the authorization, HRSA allocates the annual appropriation in 
monthly payments to eligible hospitals.

                            CHGME'S SUCCESS

    The annual CHGME appropriations represent an extraordinary 
achievement for the future of children's health and the Nation's 
independent children's teaching hospitals:
  --Thanks to CHGME, the Federal Government has made substantial 
        progress in providing more equitable Federal GME support to 
        independent children's hospitals. They now receive about 80 
        percent of the level of Federal GME support that Medicare 
        provides to other teaching hospitals. It is still not equity, 
        but it is dramatic improvement from the 0.5 percent of 1998.
  --Thanks to CHGME, children's hospitals have been able to make a 
        substantial improvement in their contribution to the Nation's 
        pediatric workforce, without having to sacrifice their clinical 
        or research missions. Between 2000 and 2004, without the CHGME 
        hospitals being able to increase the numbers of general 
        pediatric residents they trained, the Nation would have 
        experienced a net decline in the number of new pediatricians. 
        During the same period, CHGME hospitals also accounted for more 
        than 80 percent of the new pediatric subspecialty programs and 
        more than 60 percent of the new pediatric subspecialists 
        trained.
  --Thanks to CHGME, children's hospitals have been able to achieve 
        strong, financial positions. According to Moody's Investor 
        Services, before 2000, children's hospitals tended to have 
        negative to break-even financial margins. Since then, they have 
        improved their margins and CHGME is one of the major reasons.

                        FISCAL YEAR 2008 REQUEST

    N.A.C.H. respectfully requests that the subcommittee provide 
equitable GME funding for independent children's hospitals by providing 
$330 million in fiscal year 2008, the full authorization level. Such 
funding is vital for a program that has wage-related and medical 
teaching costs and experienced 3 years of reductions due to across-the-
board cuts before fiscal year 2007.
    Adequate, equitable funding for CHGME is an ongoing need. 
Children's hospitals train new pediatric residents and researchers 
every year. Children's hospitals have appreciated very much the support 
they have received, including the attainment of the program's 
authorized full funding level in fiscal year 2002 and continuation of 
full funding with an inflation adjustment in fiscal year 2003 and 
fiscal year 2004. Congress can restore this progress by providing $330 
million in fiscal year 2008.
    Continuing equitable CHGME funding is more important than ever in 
light of continued budget pressures in many States for reductions in 
Medicaid spending. Because children's hospitals devote a substantial 
portion of their care to children from low-income families, they are 
especially affected by Medicaid. Support for a strong investment in GME 
at children's hospitals is also consistent with the concern Congress 
has expressed for the health and well-being of children--through 
education, health and social welfare programs. And it is consistent 
with the subcommittee's emphasis on the importance of investment in the 
National Institutes of Health for which we are grateful.
    The CHGME funding has been essential to the ability of the 
independent children's hospitals to sustain their GME programs. At the 
same time, it has enabled them to do so without sacrificing support for 
other critically important services that also rely on hospital subsidy, 
such as many specialty and critical care services, child abuse 
prevention and treatment services, services to low-income children with 
inadequate or no coverage, mental health and dental services, and 
community advocacy, such as immunization and motor vehicle safety 
campaigns.
    In conclusion, CHGME is a success. It is an invaluable investment 
in children's health. The future of pediatric medicine and children's 
access to pediatric care depends on it. N.A.C.H. is joined by the 
American Academy of Pediatrics, American Hospital Association and 
others in recommending $330 million for fiscal year 2008.
                                 ______
                                 
  Prepared Statement of the National Association of Community Health 
                                Centers

    On behalf of more than 1,000 Health Center organizations across the 
country serving more than 16 million patients, the National Association 
of Community Health Centers (NACHC) is pleased to submit this statement 
for the record, and to thank the subcommittee for its continued support 
and investment in the Health Centers program.

                          ABOUT HEALTH CENTERS

    Over more than 40 years, the Health Centers program has grown from 
a small demonstration project providing desperately needed primary care 
services in underserved communities to one of the fundamental elements 
of our Nation's health care safety net. Funding was approved in 1965 
for the first two Neighborhood Health Center demonstration projects, 
one in Boston, Massachusetts, and the other in Mound Bayou, 
Mississippi.
    Today, Health Centers serve as the primary health care safety net 
for many communities across the country and the Federal grant program 
enables more low-income and uninsured patients to receive care each 
year. Health Centers currently serve as the family doctor for one in 
eight uninsured individuals, and one in every five low-income children. 
Health Centers are helping thousands of communities address a range of 
increasing (and costly) health problems, including prenatal and infant 
health development, chronic illnesses including diabetes and asthma, 
mental health, substance addiction, domestic violence and HIV/AIDS.
    Federal law requires that every Health Center be governed by a 
community board with a patient majority--a true patient democracy. 
Health Centers are required to be located in a federally designated 
Medically Underserved Area (MUA), and must provide a package of 
comprehensive primary care services to anyone who comes in the door, 
regardless of their ability to pay. Because of these characteristics, 
the insurance status of Health Center patients differs dramatically 
from other primary care providers. As a result, the role of public 
dollars is substantial. Federal grant dollars, which make up roughly 
one-quarter of Health Centers' operating revenues, are intended to 
cover the costs of serving uninsured patients; just over 40 percent of 
revenues are from reimbursement through Federal insurance programs, 
principally Medicare and Medicaid. The balance of the revenues are from 
State and community partnerships, privately insured individuals, and 
patient's ability to pay.
    The Health Centers program is administered by the Bureau of Primary 
Health Care (BPHC) at the Health Resources and Services Administration 
(HRSA), within the U.S. Department of Health and Human Services (HHS).

                           FUNDING BACKGROUND

    We greatly appreciate that the subcommittee has approved 
substantial funding increases for the Health Centers program over the 
past several years, the result of which has been a broad expansion 
effort enabling Health Centers to serve many of those that remain 
underserved in our country. Since 2001, in addition to the overall 
funding increase, the subcommittee has provided specific increases in 
funding to stabilize existing centers, as well as to meet the goals of 
the President's initiative--to significantly impact health care 
delivery in 1,200 communities through new or expanded Health Centers. 
With the funding provided in fiscal year 2007, that goal will be met 
this year.
    The Health Centers program has succeeded in expanding access to 
primary and preventive care services in underserved communities across 
the country. The Office of Management and Budget rated the Health 
Centers program as one of the top 10 Federal programs, and the best 
competitive grant program within all of HHS.
    Yet despite this record expansion, hundreds of communities have 
submitted applications since fiscal year 2002 that received high 
ratings, but could not be funded due to lack of funds. There is clearly 
a tremendous need and a tremendous desire to expand Health Center 
services to new communities. With additional resources, Health Centers 
stand ready to provide low-cost, highly effective care to millions more 
uninsured and underserved individuals and families.

    FISCAL YEAR 2008 AND BEYOND: TOWARD 30 MILLION PATIENTS BY 2015

    In his fiscal year 2008 budget proposal, President Bush requested a 
total funding level of $1.988 billion for the Health Centers program. 
While this represents a slight increase over the President's request in 
fiscal year 2007, it is essentially the same as the enacted level for 
fiscal year 2007, as Congress funded the program above the President's 
request last year. NACHC is requesting an increase of $200 million for 
fiscal year 2008, for a total funding level of $2.188 billion.
    In order to truly serve those in need across the country, Health 
Centers must expand their operations and develop new centers in areas 
of need. This request represents the next step, an investment in a 
longer-term plan to provide a health care home in a Health Center to 30 
million Americans by 2015, and to eventually bring access to care in a 
Health Center to every American who needs it within 15 years. We hope 
to work with the subcommittee to guide this investment around several 
priorities. First, in the face of rising costs of care and a rising 
percentage of new patients without insurance coverage, a significant 
and strategic investment in existing Health Centers is needed to allow 
them to meet the demand for their services in the communities they 
serve today. Second, new and expanded Health Centers should be brought 
to communities with little or no access to care through planning grants 
and new access point funding targeted to those communities most in 
need. Lastly, in order to make a comprehensive range of necessary 
services available at every Health Center, funding should be made 
available to add mental health, oral health and pharmacy services in 
high need communities.
    In 2005, President Bush called for ``a Community Health Center in 
every poor county'' in America. NACHC supports the goal of bringing 
care to those areas of the country with high poverty and no current 
access to a Health Center. However, NACHC has expressed the preference 
that such an expansion address the lack of access in the neediest 
communities of the country, and that eligibility for new funding not be 
limited to certain geographic areas such as counties. Further, the 
President's budget includes proposed legislative language waiving the 
statutorily designated proportionality requirements for Migrant, Public 
Housing and Homeless Health Centers in order to implement this second 
expansion initiative. NACHC strongly opposes this change.
    In addition to the expansion efforts, it is critical that Federal 
funding for Health Centers keep pace with the growing cost of 
delivering care. NACHC requests that the subcommittee designate $59 
million of any increase in funding to be used to make base grant 
adjustments for existing centers, allowing an average increase of 3 
percent in current Health Center grants. Under the subcommittee's 
leadership, Congress has provided base grant adjustments for existing 
centers in 6 out of the 8 previous fiscal years, including $25 million 
in fiscal year 2007. A recent study by NACHC found that in the 2 years 
that these adjustments were not included in the Health Centers 
appropriation, the number of patient visits per grantee actually 
decreased.
    NACHC appreciates the subcommittee's leadership in stabilizing the 
Federal Tort Claims Act (FTCA) judgment fund for Health Centers in past 
years. For fiscal year 2008, the President has requested that 
$44,000,000 be appropriated for this purpose. This is $500,000 below 
last year's level. NACHC supports maintaining the judgment fund at a 
total funding level of $44,500,000.
    In 1997, Congress authorized and began funding the HRSA Loan 
Guarantee Program (LGP) for the construction, renovation, and 
modernization of Health Centers. Demand for this guarantee program has 
accelerated significantly in the last several years. NACHC expects that 
at the current rate of usage, the remaining credit subsidy will be 
entirely used during calendar year 2008. In response that the success 
of this program, NACHC is requesting an additional $5 million be 
provided until expended for additional loan guarantees. The LGP has 
proven to be a vital resource for Health Centers across the country--in 
particular, those on the Gulf Coast--as they seek financing to fund the 
facilities necessary to accommodate the growth in patient visits 
resulting from recent expansion efforts.
    Finally, in addition to increased funding for the Health Centers 
program, expanding access to vital preventive and primary health care 
in underserved communities will also depend on commensurate growth in a 
number of high-priority programs, including:
  --$150 million for the National Health Service Corps, the largest 
        single source of health professionals for Health Centers. Such 
        an increase will enable the NHSC to place an additional 800 
        medical professionals;
  --$450 million for Health Professions Training Programs under Title 
        VII/VIII, including $30 million for Area Health Education 
        Centers (AHECs); and
  --$250 million for Title III of the Ryan White AIDS Program, which 
        provides grants to Health Centers and other primary care 
        providers for outpatient early intervention services.

                               CONCLUSION

    America's Health Centers are grateful to the subcommittee for its 
ongoing efforts to support and stabilize the Health Centers program and 
to expand health centers' reach into more than 5,000 communities 
nationwide. As a result of those efforts, more than 16 million people 
have access to the affordable, effective primary care services that our 
Nation's Health Centers provide.
    We respectfully ask that the subcommittee continue that investment, 
as the work of caring for our uninsured and medically underserved is 
far from complete. A recent NACHC study found that some 56 million 
Americans are still without regular access to primary care. America's 
Health Centers look forward to meeting that need and rising to the 
challenge of providing a health care system that works for all 
Americans. We look forward to working with you over the coming year to 
move toward that goal.
    If you need any additional information or have any questions 
related to Health Centers or NACHC, please do not hesitate to contact 
me or John Sawyer, Assistant Director of Federal Affairs, at (202) 331-
4603, or via email at [email protected].
                                 ______
                                 
     Prepared Statement of the National Center for Victims of Crime

    The National Center for Victims of Crime submits this testimony to 
urge members of the Subcommittee on Labor, Health and Human Services, 
Education, and Related Agencies to fully fund the Rape Prevention and 
Education (RPE) Grant program at $80 million. Rape crisis centers rely 
on this money to educate their communities about the prevention of 
sexual abuse and assault. RPE Grant funds provide the foundation for 
crucial efforts to end sexual violence.
    As the leading national resource and advocacy organization for 
victims of crime, the National Center understands the vital necessity 
of sexual assault education and outreach programs for victims and their 
communities. Every day, our Helpline staff speaks to sexual assault 
victims and connects them with local services. We also work with rape 
crisis centers and State sexual assault coalitions across the country 
who have all described to us their desperate struggles to meet their 
communities' needs. They report that without greater RPE Grant program 
funding, they cannot continue their education and prevention efforts.

                 PREVALENCE OF RAPE AND SEXUAL ASSAULT

    The incidence of sexual assault in this country remains 
unconscionably high. The latest National Crime Victimization Survey 
reports that 191,670 people were raped or sexually assaulted in 
2005.\1\ The crime of sexual violence affects people of all backgrounds 
and ages--children and adults, males and females. Approximately 1 in 6 
women and 1 in 33 men in America have experienced an attempted or 
completed rape as a child or adult.\2\ Young adults and teens are 
particularly at risk, with people aged 16 to 24 being raped at 
significantly higher rates than any other age group,\3\ and nearly 5 
percent of college women being sexually assaulted during any given 
calendar year.\4\
---------------------------------------------------------------------------
    \1\ Bureau of Justice Statistics, U.S. Dept. of Justice, Criminal 
Victimization 2005 (Sept. 2006).
    \2\ Id.
    \3\ Id.
    \4\ Fisher, Cullen, & Turner, Nat'l Inst. of Justice & Bureau of 
Justice Statistics, the Sexual Victimization of College Women (2000).
---------------------------------------------------------------------------
              IMPACT ON VICTIMS, FAMILIES, AND COMMUNITIES

    Sexual assault exacts a terrible cost on individual victims, their 
families, and our Nation. The annual cost of sexual assault to victims 
is approximately $26 million.\5\ Moreover, victims of sexual violence 
experience higher rates of depression, anxiety disorders, mental 
illness, addiction, eating disorders, and self-esteem problems than 
non-victims. Rape survivors are six times more likely to commit suicide 
than victims of other crimes.\6\
---------------------------------------------------------------------------
    \5\ Bureau of Justice Statistics, U.S. Dept. of Justice, Criminal 
Victimization 2005 (Sept. 2006).
    \6\ Arthur H. Green, M.D., Sexual Abuse: Immediate and Long-Term 
Effects and Intervention, 32 J. AM. ACAD. Child Adolescent Psychiatry. 
5, (Sept. 1993).
---------------------------------------------------------------------------
    Workplaces and communities are also affected when victims suffer. 
Rape victims face a loss of economic productivity through unemployment, 
underemployment, and absence from work. According to the Centers for 
Disease Control and Prevention (CDC), 21 percent of victims who have 
been raped by an intimate partner report losing time from work as a 
result of their victimization.\7\
---------------------------------------------------------------------------
    \7\ Nat'l Ctr. for Injury Prevention and Control, Costs of Intimate 
Partner Violence Against Women in the United States (Atlanta, Ga., 
2003).
---------------------------------------------------------------------------
      PURPOSES OF THE RAPE PREVENTION AND EDUCATION GRANT PROGRAM

    Understanding the far-reaching impact of sexual violence and the 
importance of prevention, Congress established the CDC's Rape 
Prevention and Education Program through the Violence Against Women Act 
of 1994. RPE funding provides formula grants to States and territories 
to support rape prevention and education programs conducted by rape 
crisis centers, State sexual assault coalitions, and other public and 
private nonprofit entities. Funding is used for:
  --Educational seminars for professionals, the public, schools, 
        colleges, and universities;
  --Hotline operations;
  --Education and training programs aimed at preventing sexual violence 
        at colleges and universities; and,
  --Education about date rape drugs.
    These education and outreach activities are crucial not only to 
help change public attitudes and behaviors, but also to train allied 
professionals on issues related to sexual violence so they can better 
understand victims and make appropriate referrals.
    RPE funding also supports the National Sexual Violence Resource 
Center (NSVRC), a project operated by the Pennsylvania Coalition 
Against Rape (PCAR). NSVRC provides information, materials, and 
resources on sexual violence to policy makers, Federal, and State 
agencies, college campuses, State, territory and tribal sexual assault 
coalitions, the media, and the public.

                   EDUCATIONAL SEMINARS AND TRAININGS

    Rape prevention and education efforts make crucial contributions to 
ending sexual violence by helping to change attitudes about rape and 
reduce the isolation of victims. Educational efforts around the country 
include:
  --Kansas: During the 2005 fiscal year, RPE Grant-funded projects 
        provided 2,212 educational sessions to 15,010 students and 267 
        professionals.
  --Mississippi: Over the past 5 years, RPE projects conducted a total 
        of 1,923 community education sessions with 66,422 participants. 
        In addition, the Mississippi Coalition Against Sexual Assault 
        offered a training program for home health workers, nursing 
        home employees, and others in contact with the elderly 
        population to help them identify and respond to signs of abuse 
        and assault.
  --Pennsylvania: During the 2006 fiscal year, the PCAR provided 24,213 
        sexual assault education programs to students and 3,469 
        prevention education programs to the community.
    Many of these educational sessions and trainings, like those 
conducted in Mississippi, focused on increasing awareness of sexual 
violence in underserved and at-risk communities. Such outreach also 
consistently results in an increased number of victims contacting local 
rape crisis centers for services and support. However, as operation 
costs increase and funding levels have stagnated, such remarkable 
efforts cannot expand and grow to reach these vulnerable populations.

                           HOTLINE OPERATIONS

    The RPE Grant program also provides crucial support for State and 
local hotlines, which offer 24-hour crisis intervention, referrals, and 
information about sexual violence. Importantly, hotline operations 
allow trained advocates and rape crisis counselors to reach more 
physically or culturally isolated communities. Recent successes 
include:
  --Massachusetts: Funds from the RPE Grant program permit rape crisis 
        centers across Massachusetts to provide 24-hour hotline 
        services for victims of sexual assault and their families. The 
        program also supports Llamanos, a Spanish-language, toll-free, 
        sexual assault hotline for Latino survivors and their families. 
        Llamanos also provides training for 13 rape crisis centers, 
        five community health organizations, and eight additional 
        community-based agencies serving the Latino population. 
        Together, these hotline services received more than 12,000 
        calls in the past fiscal year.
  --Louisiana: Since Hurricane Katrina struck in 2005, the RPE Grant-
        funded Louisiana Foundation Against Sexual Assault (LaFASA) has 
        provided hotline services specifically for hurricane victims 
        who were sexually assaulted in the aftermath of the storm. 
        Witnesses, survivors, and their families can call and receive 
        support, counseling, and referral information.

     PREVENTING SEXUAL VIOLENCE IN SCHOOLS AND ON COLLEGE CAMPUSES

    Recognizing that attitudes and beliefs regarding sexual violence 
are formed early in life, many RPE grantees emphasize education and 
prevention programs for young people. As youths become aware of the 
frequency of acquaintance rape, they can and do broaden their efforts 
to protect themselves, from merely locking doors against strangers to 
taking precautions with those they know. RPE-funded programs, in 
collaboration with students and campus personnel, have developed and 
continue to implement sexual violence prevention programs for schools 
across the Nation. These programs aim to reduce first-time male 
perpetration of sexual violence, address norms and beliefs that support 
or condone sexual violence, and empower bystanders to respond 
constructively when they recognize abusive relationships. Examples of 
these programs include:
  --Iowa.--During the 2006 fiscal year, community prevention 
        specialists conducted 4,599 educational sessions for a total of 
        71,521 students in grades pre-K through 12. In addition, 244 
        sexual violence prevention sessions were offered to 14,128 
        students at Iowa colleges and State universities. After one 
        Iowa event, some female students who had repeatedly endured 
        degrading harassment from fellow classmates came forward to 
        report the incidents to campus authorities, who intervened.
  --California.--The RPE Grant program funds MyStrength, California's 
        innovative statewide social marketing campaign. This program, 
        which follows a national evidence-based model targeting 14- to 
        18-year-old males, aims to help prevent first-time perpetration 
        of sexual violence.\8\
---------------------------------------------------------------------------
    \8\ Learn more about the MyStrength campaign at http://
www.mystrength.org (accessed March 28, 2007).
---------------------------------------------------------------------------
  --Indiana.--The Communities Against Rape Initiative (CARe) is a 
        statewide collaboration supported by the RPE Grant program that 
        helps develop and implement rape prevention curricula for 
        rural, urban, and suburban schools. Since its founding in 1997, 
        CARe has trained more than 1,000 Indiana teachers to use the 
        curricula. Pre- and post-test results from more than 4,600 
        students show positive changes in students' knowledge and 
        attitudes about rape.\9\
---------------------------------------------------------------------------
    \9\ For more information about the CARe initiative, visit http://
www.four-h.purdue.edu/care/main.html (accessed March 28, 2007).
---------------------------------------------------------------------------
    All these remarkable programs and initiatives report that even with 
such successes, much more could be done to raise awareness about sexual 
violence in local communities if RPE funding were increased. For 
instance, the California Coalition Against Sexual Assault (CALCASA) 
reports that if the national RPE Program were fully funded, the 
MyStrength campaign could saturate the State with marketing materials, 
and MyStrength clubs could be sustained in hundreds of high schools 
throughout California. Such efforts would advance our fight to end 
sexual violence against men, women, and children.

                    DRUG-FACILITATED SEXUAL VIOLENCE

    Drug-facilitated rape is staggeringly pervasive in this country. A 
recent report from the National Institute on Alcohol Abuse and 
Alcoholism (NIAAA) shows that more than 70,000 students between the 
ages of 18 and 24 survive an alcohol or drug-related sexual assault 
each year.\10\ Drugs are used to render victims incapable of providing 
consent for sexual activity or defending themselves against rape. 
Because detection and prosecution remain difficult, the best means to 
prevent these crimes is education. The RPE Grant program funds efforts 
to raise public awareness of the risk and symptoms associated with 
Rohypnol, gamma-hydroxybutyrate (GHB), and other common date rape 
drugs.
---------------------------------------------------------------------------
    \10\ Task Force of the Nat'l Advisory Council on Alcohol Abuse and 
Alcoholism, National Institutes of Health, A Call to Action: Changing 
the Culture of Drinking at U.S. Colleges (2002).
---------------------------------------------------------------------------
        RAPE PREVENTION AND EDUCATION FUNDING MUST BE INCREASED

    Program after program has told the National Center that due to lack 
of funding they are unable to expand their outreach efforts, staff and 
volunteers have been taxed to the limit, and they are unable to reprint 
popular educational materials. Without full funding, these programs 
cannot make continued progress against sexual violence. Although the 
Violence Against Women Act of 2005 (VAWA) reauthorized the Rape 
Prevention and Education Grant program at $80 million, funding for the 
past several years has remained at approximately $42 million.\11\
---------------------------------------------------------------------------
    \11\ Passed as part of the Violence Against Women Act 2005 
Reauthorization, Public Law 109-162.
---------------------------------------------------------------------------
    When Congress reauthorized the Rape Prevention and Education Grant 
program as part of VAWA, it recognized the importance of this program 
in reducing sexual victimization. The National Center calls on Congress 
to honor its commitment to preventing rape by providing full funding 
for the Rape Prevention and Education Grant program for the 2008 fiscal 
year.
                                 ______
                                 
        Prepared Statement of the National Child Abuse Coalition

    The National Child Abuse Coalition, committed to strengthening the 
Federal response to the protection of children and the prevention child 
abuse and neglect, urges fiscal year 2008 funding for the Child Abuse 
Prevention and Treatment Act (CAPTA) programs at the authorized level 
of $200 million:
  --CAPTA basic State grants at $84 million;
  --CAPTA community-based prevention grants at $80 million; and
  --CAPTA research and demonstration grants at $36 million.
    Basic State Grants.--At current funding, child protection agencies 
are unable to serve close to half the abused and neglected children in 
their caseloads.
    CAPTA funds programs have not kept pace with the needs of 
communities for supporting families and protecting children. States are 
hard pressed to treat children or protect them from further harm. In 
2004, according to the most recent HHS data, an estimated 3 million 
reports of possible abuse and neglect were made to States, and almost 
900,000 of these reports were substantiated. In 2004, just over 40 
percent of the child victims received no services following a 
substantiated report of maltreatment: suspected abuse reported, report 
investigated, report substantiated, case closed. Almost 1,500 children 
died as a result of abuse or neglect. The most endangered are the 
youngest: more than 80 percent of children who were killed were under 
age 4.
    CAPTA's Basic State Grants help States protect children. The 
Nation's child welfare system has long been stretched beyond capacity. 
No State passed the test when measured against the HHS Child and Family 
Service Reviews to evaluate a State's performance in protecting 
children. Federal officials repeatedly cited States for certain 
deficiencies: significant numbers of children suffering abuse or 
neglect more than once in a 6-month period; caseworkers not visiting 
children often enough to assess needs; and not providing promised 
medical and mental health services.
    Funding CAPTA State grants at $84 million would enable State child 
protective services to expand post-investigative services for child 
victims, shorten the time to the delivery of services, and increase 
services to other at-risk families.
    Community-Based Prevention Grants.--For every Federal dollar spent 
on foster care and adoption subsidies, we spend less than 13 cents in 
Federal child welfare funding on preventing and treating child abuse 
and neglect.
    Annual direct costs of child abuse and neglect in the United States 
total over $24 billion in hospitalizations, chronic health and mental 
health care, child welfare services, law enforcement, and courts. 
Indirect costs from special education, other health and mental health 
care, crime, and lost productivity, total more than $94 billion 
annually.\1\ Community services to prevent child abuse are far less 
costly than the damage inflicted on children from abuse and neglect. A 
GAO evaluation of child abuse prevention efforts found ``total Federal 
costs of providing prevention programs for low-income populations were 
nearly offset after 4 years.'' \2\
---------------------------------------------------------------------------
    \1\ Fromm, S. (2001). Total Estimated Cost of Child Abuse and 
Neglect in the United States. Prevent Child Abuse America.
    \2\ U.S. General Accounting Office (1992). Child Abuse: Prevention 
Programs Need Greater Emphasis (GAO/HRD-92-99).
---------------------------------------------------------------------------
    CAPTA's Prevention Grants help States to develop community-based 
prevention services, including parenting education, home visiting 
services, and respite care. We spend billions of dollars every year on 
foster care to protect the children who have been the most seriously 
injured; we can do a much better job at protecting children before the 
damage is so bad that we have no other choice than to remove them from 
their homes. Funding CAPTA prevention grants at $80 million would help 
communities support proven, cost-effective approaches to preventing 
child abuse and neglect.
    Discretionary Research and Demonstration Grants.--Current funding 
levels short-change community efforts to develop innovative programs to 
serve children and families and to improve our knowledge about child 
maltreatment.
    We urge Congress to approve the President's proposed increase of 
$10 million to support home visitation programs, with funds available 
to promote an array of research- and evidence-based home visitation 
models that enable communities to provide the most appropriate services 
suited to the families needing them.
    The U.S. Advisory Board on Child Abuse and Neglect recommended as 
the highlight of its 1991 report, Creating Caring Communities, the 
establishment of universal voluntary home visitor services. The Centers 
for Disease Control (CDC) Task Force on Community Preventive Services 
in its 2003 report evaluating the effectiveness of strategies for 
preventing child maltreatment ``recommends early childhood home 
visitation for prevention of child abuse and neglect in families at 
risk for maltreatment, including disadvantaged populations and families 
with low-birth weight infants.'' \3\
---------------------------------------------------------------------------
    \3\ Hahn, R.A., Bilukha, O.O., Crosby, A., Fullilove, M.T., 
Liberman, A., Moscicki, E.K., et al. (2003). First reports evaluating 
the effectiveness of strategies for preventing violence: Early 
childhood home visitation. Center for Disease Control, Morbidity and 
Mortality Weekly Report, 52, 109.
---------------------------------------------------------------------------
    Research evidence supports the value of a range of early childhood 
home visitation models using professionals, nurses, paraprofessionals, 
and trained volunteers from the community in improving parenting and 
family health and preventing child maltreatment.
    For example, results from the randomized trial of the Healthy 
Families New York program based on the Healthy Families America model 
using Family Support Workers (specially trained paraprofessionals who 
live in the target community and share the same language and cultural 
background as program participants) showed that the program had 
positive effects in the areas of parenting and child abuse and neglect, 
birth outcomes, and health care. According to the research team 
analyzing the Healthy Families program in New York, the results for the 
subgroup of participants who resemble the clients typically served by 
the Nurse Family Partnership (NFP) model of home visiting by nurses are 
similar to those found in randomized trials of NFP.\4\
---------------------------------------------------------------------------
    \4\ DuMont, K., et al. (2006). Healthy Families New York Randomized 
Trial: Impacts on Parenting After the First Two Years. New York State 
Office of Children and Families. Working Paper Series.
---------------------------------------------------------------------------
    In another randomized trial, adolescent mothers who received case 
management services and Parents as Teachers (PAT) home visitors were 
significantly less likely to be subjected to child abuse investigations 
than control group mothers who received neither case management nor PAT 
home visitation.\5\ Randomized trials of the Parent-Child Home Program, 
a home visitation early literacy and parenting program model, show 
significant ongoing positive effects on parents' interaction with their 
children, in contrast to control group families examined before and 
after completion of the program.\6\
---------------------------------------------------------------------------
    \5\ Wagner, M.M. & Clayton, S.L. (1999). The Parents as Teachers 
Program: Results from Two Demonstrations. The Future of Children: Home 
Visiting: Recent Program Evaluations, 9(1), 91-115.
    \6\ Joint Dissemination Review Panel of U.S. Department of 
Education. (1978). Unanimous Approval of Research Findings, 1967-1978, 
Mother-Child Home Program of Verbal Interaction Project. Freeport, NY: 
Verbal Interaction Project.
    O'Hara, J.M. & Levenstein, P. (1981). Second Year Progress Report: 
9/15/80-9/14/81: Tracing the Parent-Child Network. Final Report, Grant 
No. NIEG 800042, National Institute of Education, U.S. Department of 
Education.
    Levenstein, P., O'Hara, J.M., & Madden, J. (1983) , ``The Mother-
Child Home Program of the Verbal Interaction Project'', in Consortium 
for Longitudinal Studies, ed., As the Twig is Bent Hillsdale, NJ: 
Lawrence Erlbaum Associates.
    Levenstein, P. & O'Hara, J.M., (1993) ``The necessary lightness of 
mother-child play'', in K.B. MacDonald, eds., Parents and Children 
Playing Albany, NY: State University of New York Press.
---------------------------------------------------------------------------
    In another study of home visiting models funded by CDC, researchers 
concluded from a literature review of evaluations of home visitation 
programs that where randomized trials might not always be feasible, 
non-randomized studies are important to validate research or provide 
stronger evidence when the randomized trial is compromised. In its 
review of evaluations of various models, the report found that the 
evaluated programs reduced child maltreatment by approximately 39 
percent, overall.\7\
---------------------------------------------------------------------------
    \7\ Hahn, R., et al. (2005). Home Visiting Programs to Prevent 
Child Abuse: Taking Silver and Bronze Along With Gold. U.S. Centers for 
Disease Control and Prevention. Child Abuse and Neglect: The 
International Journal. Vol. 29, p. 215-218.
---------------------------------------------------------------------------
    Funding research and program innovations at $36 million, as the 
President requests, would provide support for a diversity of home 
visitation models, as well as the field-initiated research, training, 
technical assistance, and data collection also authorized by CAPTA out 
of this money.

              CHILD WELFARE SPENDING: A FAILURE TO INVEST

    Our failure to invest in our child protective service system and 
community-based programs for preventing child maltreatment has created 
a spending gap of almost $17 billion in services to intervene on behalf 
of children. Current available data peg Federal, State, and local 
dollars for child protective services and preventive services at only 
about $3.1 billion of the estimated $20.2 billion total cost of what we 
ought to be spending.
    According to the Urban Institute, States reported spending $22 
billion on child welfare in 2002, and they could categorize how $17.4 
billion of the funds were used.\8\ Of that amount, $10 billion was 
spent for out-of-home placements, $1.7 billion on administration, $2.6 
billion on adoption, and $3.1 billion (about 18 percent) on all other 
services, including prevention, family preservation and support 
services, and child protective services.
---------------------------------------------------------------------------
    \8\ Scarcella, C.A. (2004). The Cost of Protecting Vulnerable 
Children IV: How Child Welfare Funding Fared during the Recession, 
Washington, DC. Urban Institute.
---------------------------------------------------------------------------
    Failure to invest in a working child protection system results in a 
national failure to keep children free from harm. The cost to child 
protective services in 2002 of investigating the 1.745 million children 
who were screened in for investigations, plus the expense that would 
have been incurred if services had been provided to all of the 896,000 
substantiated child victims (as well as to the 708,000 children in 
unsubstantiated reports who also received some services), totals $7.2 
billion. Second, consider the cost of preventive services--$13 billion 
if offered to the 3 million child maltreatment victims identified in 
the HHS National Incidence Study III. That's a total cost of $18.4 
billion. Yet, in 2002, States spent only $3.1 billion in Federal, 
State, and local funds on protective and preventive services for 
children. Our national child welfare policy represents a morally 
unacceptable failure to invest in this system.
    These are conservative cost figures. When adjusted to account for 
inflation, data indicate that investigations by child protective 
service agencies cost approximately $1,011 per case. The cost per case 
to provide basic in-home services such as homemaker assistance or 
family counseling is $3,360.\9\ These costs are low to start with. Pay 
scales in child welfare are generally low and noncompetitive--
significantly lower, for example, than salaries for teachers, school 
counselors, nurses and public-health social workers \10\--which brings 
these costs in at a low level.
---------------------------------------------------------------------------
    \9\ Courtney, M.E. (1998). ``The Costs of Child Protection in the 
Context of Welfare Reform''. The Future of Children, Vol. 8, No. 1.
    \10\ U.S. General Accounting Office (2003). HHS Could Play a 
Greater Role in Helping Child Welfare Agencies Recruit and Retain Staff 
(GAO-03-357).
---------------------------------------------------------------------------
    What does the spending gap mean? States report having difficulty in 
recruiting and retaining child welfare workers,\11\ because of issues 
like low salaries, high caseloads, insufficient training and limited 
supervision, and the turnover of child welfare workers--estimated to be 
between 30 and 40 percent annually nationwide.\12\ The average caseload 
for child welfare workers is double the recommended level, and 
obviously much higher in many jurisdictions.\13\ Because our system is 
weighted toward protecting the most seriously injured children, we wait 
until it gets so bad that we have to step in. Far less attention in 
policy or funding is directed at preventing harm to children from ever 
happening in the first place or providing the appropriate services and 
treatment needed by families and children victimized by abuse or 
neglect.
---------------------------------------------------------------------------
    \11\ U.S. General Accounting Office (1995). Child Welfare: Complex 
Needs Strain Capacity to Provide Services (GAO/HEHS-95-208).
    \12\ U.S. General Accounting Office (2003). HHS Could Play a 
Greater Role in Helping Child Welfare Agencies Recruit and Retain Staff 
(GAO-03-357).
    \13\ Alliance for Children and Families, American Public Human 
Services Association, Child Welfare League of America (2001). The child 
welfare workforce challenge: Results from a preliminary study. Dallas.
---------------------------------------------------------------------------
    Increasing funding for CAPTA's basic State grants and community-
based prevention grants will help to begin to address the current 
imbalance. It is time to invest additional resources to work in 
partnership with the States to help families and prevent children from 
being abused and neglected.

                        THE CASE FOR PREVENTION

    Our present system of treating abused and neglected children and 
offering some help to troubled families is overworked and inadequate to 
the task. Hundreds of thousands of children are currently identified as 
having been abused, but receive no services to prevent further abuse. 
We must focus attention on children and families known to the system in 
order to prevent reoccurrence of abuse, as well as provide services to 
families earlier, before problems become severe. Putting dollars aside 
for prevention is sound investing, not luxury spending.
    We know that child abuse prevention fights crime, because research 
has shown us that victims of child abuse are more likely to engage in 
criminality later in life, and that childhood abuse increases the odds 
of future delinquency and adult criminality overall by 40 percent.\14\ 
We know that preventing child maltreatment helps to prevent failure in 
school. Typically abused and neglected children suffer poor prospects 
for success in school, exhibiting poor initiative, language and other 
developmental delays, and a disproportionate amount of incompetence and 
failure.\15\ Ensuring that children are ready to learn means ensuring 
that children are safe at home. We know that preventing child abuse can 
help to prevent disabling conditions in children. Physical abuse of 
children can result in brain damage, mental retardation, cerebral 
palsy, and learning disorders.\16\
---------------------------------------------------------------------------
    \14\ C.S. Widom (1992). The Cycle of Violence. Washington, DC: 
National Institute of Justice.
    \15\ S.R. Morgan (1976). The Battered Child in the Classroom. 
Journal of Pediatric Psychology.
    \16\ H.P. Martin & M.A. Rodeheffer (1980). The Psychological Impact 
of Abuse in Children. In: G.J. Williams. Traumatic Abuse and Neglect of 
Children at Home. Baltimore, MD: Johns Hopkins University Press.
---------------------------------------------------------------------------
    Research conducted by CDC in collaboration with Kaiser Permanente 
shows us that childhood abuse is linked with behaviors later in life 
which result in the development of chronic diseases that cause death 
and disability, such as heart disease, cancer, chronic lung and liver 
diseases, and skeletal fracture, and that the adult victims of child 
maltreatment are more likely suffer from depression and suicide 
attempts.\17\
---------------------------------------------------------------------------
    \17\ V.J. Felitti, R.F. Anda, et al. (1998). Relationship of 
Childhood Abuse and Household Dysfunction to Many of the Leading Causes 
of Death in Adults. The Adverse Childhood Experiences (ACE) Study. 
American Journal of Preventive Medicine.
---------------------------------------------------------------------------
    Community-based services to overburdened families are far less 
costly than the damage inflicted on children that leads to outlays for 
child protective services, law enforcement, courts, foster care, health 
care and the treatment of adults recovering from child abuse. A range 
of services, such as voluntary home-visiting, family support services, 
parent mutual support programs, parenting education, and respite care 
contribute to a community's successful strategy to prevent child abuse 
and neglect.
    National Child Abuse Coalition Member Organizations: Alliance for 
Children and Families, American Academy of Pediatrics, American Bar 
Association, American Humane Association, American Professional Society 
on the Abuse of Children, American Psychological Association, 
Association of University Centers on Disabilities, Boys and Girls Clubs 
of America, CHILD Inc., Child Welfare League of America, Children's 
Defense Fund, First Star, General Federation of Women's Clubs, National 
Alliance of Children's Trust and Prevention Funds, National Association 
of Children's Hospitals, National Association of Counsel for Children, 
National Association of Social Workers, Nat'l. Center for Child 
Traumatic Stress, National Center for State Courts, National CASA 
Association, National Education Association, National Exchange Club 
Foundation, National PTA, National Respite Coalition, Parents 
Anonymous, Prevent Child Abuse America, Voices for America's Children.
                                 ______
                                 
   Prepared Statement of the National Coalition for Osteoporosis and 
                         Related Bone Diseases

    Mr. Chairman and members of the committee: The National Coalition 
for Osteoporosis and Related Bone Diseases (Bone Coalition) is pleased 
to have the opportunity to present our views on the fiscal year 2008 
budget for the National Institutes of Health (NIH). We are appreciative 
of your continued support of the NIH. The Federal investment made to 
date has allowed for new research opportunities to be pursued that hold 
the potential to prevent and one day possibly cure diseases such as 
osteoporosis, osteogenesis imperfecta and Paget's disease of bone.
    The leaders of the Coalition are the National Osteoporosis 
Foundation, the Amerian Society for Bone and Mineral Research, the 
Osteogenesis Imperfecta Foundation and the Paget Foundation for Paget's 
Disease of Bone and Related Disorders. Throughout our existence, the 
Coalition has remained committed to reducing the impact of bone disease 
through expanded biomedical, clinical, epidemiological and behavioral 
research.
    Bone health is integral to the overall health and well being of the 
Nation's population. The bony skeleton is a remarkable organ that not 
only serves a structural function, providing mobility, support, and 
protection for the soft tissues, but also functions as a reservoir or 
storehouse for essential minerals and growth factors. It may even 
potentially act as an endocrine organ.
    The 2004 Surgeon General's Report on Bone Health and Osteoporosis 
calls bone health an ``often overlooked aspect of physical health'' and 
further States that ``[a] healthy skeletal system with strong bones is 
essential to overall health and quality of life. Yet, today, far too 
many Americans suffer from bone diseases and fractures.''
    Bone diseases such as osteoporosis, osteogenesis imperfecta, and 
Paget's disease of bone remain a major public health problem in this 
country and the financial, physical and psychosocial consequences of 
bone diseases significantly diminish quality of life and burden 
society.
    Osteoporosis.--Is a disease characterized by low bone mass and 
structural deterioration of bone tissue, leading to bone fragility and 
an increased susceptibility to fractures, particularly of the hip, 
spine, and wrist. This is due to several factors such as the aging of 
our population, increased use of steroids and other drugs that have 
deleterious affects on bone, and increased immobilized patients and 
nursing home populations. Over 10 million Americans have osteoporosis, 
the majority of whom (80 percent) are women; 34 million more have low 
bone mass and are at increased risk for the disease. The estimated 
national direct expenditures for osteoporosis and related fractures 
total $18 billion each year in 2002 dollars.
    Paget's Disease of Bone.--The second most prevalent bone disease 
after osteoporosis--is a chronic skeletal disorder that may result in 
enlarged or deformed bones in one or more regions of the skeleton. 
Excessive bone breakdown and formation can result in bone that is 
dense, but fragile. Complications may include arthritis, fractures, 
bowing of limbs, neurological complications, and hearing loss if the 
disease affects the skull. Prevalence in the population ranges from 1.5 
percent to 8 percent depending on the person's age and geographical 
location. Paget's disease primarily affects people over 50.
    Osteogenesis Imperfecta.--Causes brittle bones that break easily 
due to a problem with collagen production. For example, a cough or 
sneeze can break a rib, rolling over can break a leg. Besides fragile 
bones, people with OI may have hearing loss, brittle teeth, short 
stature, skeletal deformities, and respiratory difficulties. OI affects 
between 20,000 to 50,000 Americans. In severe cases fractures occur 
before and during birth. In some cases, an affected child can suffer 
repeated fractures before a diagnosis can be made. Undiagnosed OI may 
result in accusations of child abuse.
    Cancer Metastasis to Bone.--A frequent complication of cancer is 
its spread to bone (bone metastasis) that occurs in up to 80 percent of 
patients with myeloma and 70 percent of patients with either breast or 
prostate cancer--causing severe bone pain and pathologic fractures. 
Only 20 percent of breast cancer patients and 5 percent of lung cancer 
patients survive more than 5 years after discovery of bone metastasis.
    Musculoskeletal Trauma and Skeletal Pain.--Of the 60 million 
Americans injured annually, more than one-half incur injuries to the 
musculoskeletal system. In the United States, back pain is a major 
reason listed for lost time from work and sports injuries are 
increasing in ``weekend warriors'' of both sexes. In our military, bone 
trauma is now accounting for over 50 percent of all combat injuries.

                  HOW HAS BONE RESEARCH HELPED PEOPLE?

    NIH-supported research in bone health has led to important 
discoveries and has generated new treatments and pharmaceutical 
products.
  --Research has taught us that those with low bone mass are at risk 
        for osteoporosis. These individuals can then address their risk 
        with exercise, diet, other behavioral and lifestyle changes, 
        and medication.
  --Research has decreased fracture risk and extended the lifespan to 
        normal for people with OI.
  --Research has identified drugs which improve the quality of life of 
        people whose cancer has metastasized to bone.
  --Research has led us to develop simple, non-invasive and accurate 
        tests that can determine bone mass and help predict fracture 
        risk.
  --Research has identified and demonstrated a variety of drugs that 
        can reduce bone loss and fractures, and even build new bone. 
        Thirty years ago, there was no treatment for osteoporosis.
  --Research has helped us to understand the need for weight-bearing 
        exercise to build and maintain bone in order to reduce fracture 
        risk. Falling can be reduced by strength-building exercise that 
        increases balance and flexibility.
  --Research has led to the discovery of a recessive form of 
        osteogenesis imperfecta, providing new possibilities for 
        prevention, treatment and a cure. But much remains to be done.

                 FUTURE OPPORTUNITIES FOR BONE RESEARCH

    Osteoporosis.--Research has the potential to add important new 
information to our understanding of osteoporosis.
  --Therapies such as calcium supplementation and physical activity 
        need to be explored to help chronically ill children reach and 
        maintain peak bone mass.
  --Data on the beneficial and/or adverse effects of bone therapies 
        such as bisphosphonates in children as well as adults with many 
        chronic diseases such as diabetes, inflammatory arthritis and 
        osteogenesis imperfecta are almost non-existent and are sorely 
        needed.
  --The pathophysiology of bone loss in diverse populations needs to be 
        studied in order to develop targeted therapies to improve bone 
        density and bone quality.
  --Racial differences in bone and the origin of racial differences in 
        fracture patterns need to be identified to understand important 
        determinants of fracture and their underlying biology.
  --Patients at risk for fracture who do not meet current criteria for 
        osteoporosis need to be identified. In addition, the effects of 
        current and developing osteoporosis treatments on these 
        patients need to be studied.
  --Research into gene targeting which could cure osteogenesis 
        imperfecta is a few short years away from human trials. 
        Continued research into drug therapies is needed to improve 
        bone quality, allowing people with osteogenesis imperfecta to 
        live independently.
    Congenic and Genetic Disease of Bone.--Thousands of children and 
adolescents nationwide suffer from musculoskeletal disorders and 
malformations, many of which have devastating effects on mortality and 
disability. Diseases such as osteogenesis imperfecta, fibrous 
dysplasia, osteopetrosis, and Paget's disease are caused by poorly 
understood genetic mutations. In Paget's disease, underlying genetic 
defects can also be exacerbated by environmental factors. Increased 
research on the role of the environmental and genetic factors in the 
development of Paget's disease could lead to the identification of new 
therapeutic targets for the disease. The science of genetics has led to 
tremendous advances in our understanding of numerous systems that 
affect bone health, but little of this technology is being applied to 
bone research. Knowledge of complex gene pathways must be used to 
deepen our understanding of bone biology to gain better insight into 
the causes of these debilitating diseases. Research is needed that:
  --Focuses on mechanisms of preventing fractures and improving bone 
        quality and correcting malformations, on innovations in 
        surgical and non-surgical approaches to treatment, on physical 
        factors that affect growth, and on genetic defects that cause 
        bone disease.
  --Expands research on skeletal stem cell biology and the genetics and 
        pathophysiology of rare disorders such as fibrous dysplasia, 
        melhoreostosis, XLinked hypophosphatemic rickets and 
        fibrodysplasia ossificans progressiva.
    Cancer Metastasis to Bone.--Immune response plays a role in cancer 
metastasis. Osteoimmunology--the study of the relationships between the 
immune system and bone homeostasis--is an emerging area of research and 
may help scientists prevent and treat the spread of cancer to bone. 
Research is needed to:
  --Determine mechanisms and to identify, block and treat cancer 
        metastasis to bone.
  --Expand research on osteosarcoma to improve survival and quality of 
        life and to prevent metastatic osteosarcoma in children and 
        teenagers who develop this cancer.
  --Expand research on tumor dormancy as it relates to bone metastasis.
    Musculoskeletal Trauma and Skeletal Pain.--Research is needed to 
better understand the epidemiology of back pain, improve on existing 
diagnostic techniques for back pain, as well as to develop new ones. 
Furthermore, expanded research is needed to improve diagnostic and 
therapeutic approaches to significantly lower the impact of 
musculoskeletal traumas, and on research on accelerated fracture 
healing, the use of biochemical or physical bone stimulation, the role 
of hematopoietic niches to preserve bone stem cells, the use of 
mesenchymal bone stem cells, and biomaterials and biologicals in bone 
repair and regeneration, and research into repair of nonunion fractures 
in osteogenesis imperfecta.
    Bone Strength.--Research is also needed in the area of bone 
strength. Although bone mineral density has been a useful predictor of 
susceptibility to fracture, other properties of the skeleton contribute 
to bone strength, such as geometry and composition. At this time, 
little is understood as to how these properties influence bone 
strength. However, research clearly indicates that exercise that causes 
mechanotransduction plays a key role in the maintenance of bone; and 
loss of bone due to immobilization as occurs in patients in hospitals 
and nursing homes may be preventable with therapies that mimic 
mechanotransduction. Bone strength is also influenced by the amount of 
mineral, however, how the bone becomes mineralized is not well 
understood. Understanding this process should assist in prevention of 
pathologic mineralization as occurs in hardening of the arteries that 
causes heart attacks. Research, including research on bone structure 
and periosteal biology, is needed which will achieve identification of 
the parameters that influence bone strength and lead to better 
prediction for prevention and treatment of bone diseases such as 
osteoporosis, osteogenesis imperfecta, bone loss due to kidney disease, 
and hardening of the arteries.
    To move this research forward, Congress must provide sufficient 
funding to the National Institutes of Health to sustain the robust 
research atmosphere in which to address the challenges in the bone 
field. Research must continue to be accelerated in order to improve the 
health of the Nation.

                             RECOMMENDATION

    The National Coalition for Osteoporosis and Related Bone Diseases 
supports:
  --a 6.7 percent increase in funding for the National Institutes of 
        Health as recommended by the Ad Hoc Group for Medical Research, 
        the Campaign for Medical Research, the Federation of American 
        Societies for Experimental Biology, the National Health 
        Council, and Research!America.
  --a 6.7 percent increase for the National Institute of Arthritis and 
        Musculoskeletal and Skin Diseases, the lead institute for bone 
        research.
  --increased funding for NIA, NIDCR, NIDDK, NCI and NICHD, other 
        Institutes that also fund bone-related research, as well as 
        additional support for bone programs at NIBIB and NCAM.
    Thank you for the opportunity to submit our statement regarding the 
fiscal year 2008 budget for the National Institutes of Health.
                                 ______
                                 
Prepared Statement of the National Consumer Law Center on Behalf of Our 
                         Low-Income Clients \1\
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    \1\ Mass Union of Public Housing Tenants and Pennsylvania Utility 
Law Project.
---------------------------------------------------------------------------
    The Federal Low Income Home Energy Assistance Program (LIHEAP) \2\ 
is the cornerstone of government efforts to help needy seniors and 
families avoid hypothermia in the winter and heat stress (even death) 
in the summer. We are in a sustained period of much higher household 
energy prices and expenditures and the demand for this program is 
growing as increases in energy prices far outstrip the ability of low 
income households to pay. In light of the crucial safety net function 
of this program in protecting the health and well-being of low-income 
seniors, the disabled and families with very young children, we 
respectfully request that LIHEAP be fully funded at its authorized 
level of $5.1 billion for fiscal year 2008 and that advance funding of 
$5.1 billion be provided for the program in fiscal year 2009.
---------------------------------------------------------------------------
    \2\ 42 U.S.C. Sec. Sec. 8621 et seq.
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           COST OF HOME ENERGY REMAINS AT RECORD HIGH LEVELS

    Residential heating expenditures remain at record high levels. 
According to the Department of Energy's Energy Information 
Administration's March 2007 Short-Term Energy Outlook, this winter's 
average residential heating expenditures are projected to be 53 percent 
higher for heating oil, 29.6 percent higher for natural gas, 39.4 
percent higher for propane, and 18.6 percent higher for electricity 
than the averaged expenditures for 2000-2005. This U.S. Department of 
Energy short-term forecast of residential heating expenditures shows 
that, on average, residential bills are still among the highest on 
record. The cost of electricity, used for both heating and cooling, has 
been increasing rapidly due, in part, to increases in the price of 
natural gas used to generate electricity in many power plants and the 
lifting of price caps in States that restructured their electric 
markets.
    In a brief span of time, energy bills have walloped low-income 
households. In 2008, LIHEAP eligible households are predicted to spend, 
depending on the type of heating fuel used, 63 percent more on their 
total residential energy bills than in 2001 if they used heating oil, 
36 percent more if they used natural gas, 47 percent more if they used 
propane and 34 percent more if they use electricity. The effect of 
these continually rising prices on low-income households is 
devastating.

STATES' DATA ON ELECTRIC AND NATURAL GAS DISCONNECTIONS AND ARREARAGES 
              SHOW THAT MORE HOUSEHOLDS ARE FALLING BEHIND

    Not surprisingly, the steady and dramatic rise in residential 
energy costs has resulted in increases in electric and natural gas 
arrearages and disconnections. For example, utility service 
disconnections in Rhode Island increased by over 92 percent between the 
years 2000 and 2006. Similarly, the gap between service disconnections 
and reconnections increased, suggesting increased durations of service 
loss and greater numbers of households that do not regain access to 
service under their own accounts.\3\
---------------------------------------------------------------------------
    \3\ Calculated from data provided by the Rhode Island Public 
Utilities Commission.
---------------------------------------------------------------------------
    Although there are winter utility shut-off moratoria in place for 
many States, not every home is protected against energy shut-offs in 
the middle of winter. As we approach the lifting of winter shut-off 
moratoria, we expect to see a wave of disconnections as households are 
unable to afford the cost of the energy bills.
    Iowa.--Despite milder winter temperatures this winter, the 
continued high cost of natural gas has set back a record number of low-
income households in Iowa. In February 2007, the number of low-income 
households with past due energy accounts was the second highest on 
record for this time of year since these data have been tracked. As an 
indication of the effect of long term effect of rising home energy 
prices, the total number of LIHEAP households in arrears in February 
2007 was 80 percent higher than 5 years ago at this point in time and 
151 percent higher than in February 1999. The total amount of 
arrearages of LIHEAP households has also grown sharply due to the 
increase in prices. By February 2007, the total amount of LIHEAP 
household arrears had increased 42 percent from the same period 5 years 
ago and 163 percent compared to arrears in February 1999. The total 
number of LIHEAP households served in fiscal year 2007 is expected to 
remain at the record high level of fiscal year 2006, yet the program 
received $16 million less under the fiscal year 2007 appropriations. In 
order to serve the increased demand for LIHEAP this heating season the 
program reduced benefits by 30 percent and redirected LIHEAP funds 
normally dedicated to the summer pre-purchase of deliverable fuels (a 
program component that maximizes purchasing power).\4\
---------------------------------------------------------------------------
    \4\ Iowa Bureau of Energy Assistance, National Energy Assistance 
Directors' Association's ``LIHEAP Survey Results--Status of fiscal year 
2007 Program Funding (March 7, 2007) and the National Energy Assistance 
Directors' Association, ``The Low Income Home Energy Assistance 
Program: Providing Heating and Cooling Assistance to Low-Income 
Families During a Period of High Energy Prices (February 9, 2007). 
NEADA documents are available at www.neada.org.
---------------------------------------------------------------------------
    Ohio.--In Ohio, the number of households entering into the State's 
low-income energy affordability program, the Percentage of Income 
Payment Program (PIPP), increased 13 percent from January 2006 to 
January 2007. The increase is an even more dramatic 64 percent between 
January 2002 and January 2007. The total dollar amount owed (arrearage) 
by low-income PIPP customers increased 8 percent from January 2006 to 
January 2007 and 62 percent when comparing PIPP customer arrears from 
January 2002 to January 2007. The National Energy Assistance Directors 
Association estimates that the number of households applying for energy 
assistance in fiscal year 2007 is likely to remain at fiscal year 2006 
levels, for Ohio that would mean an estimated 30 percent more 
households when compared to Ohio households that received heating 
assistance in fiscal year 2002.\5\
---------------------------------------------------------------------------
    \5\ Public Utilities Commission of Ohio, National Energy Assistance 
Directors' Association's ``LIHEAP Survey Results--Status of Fiscal Year 
2007 Program Funding (March 7, 2007), the National Energy Assistance 
Directors, ``Est. Total Households Receiving LIHEAP Heating Assistance 
by State--Projected Applications for Fiscal Year 2006 (2/13/06) and 
``Estimated Total Households Receiving LIHEAP Heating Assistance by 
State Actuals in 2002, 2003; Projected in 2004.'' NEADA documents are 
available at www.neada.org.
---------------------------------------------------------------------------
    Pennsylvania.--Utilities in Pennsylvania that are regulated by the 
Pennsylvania Public Utility Commission (PA PUC) have established 
universal service programs that assist utility customers in paying 
bills and reducing energy usage. Even with these programs, electric and 
natural gas utility customers find it difficult to keep pace with their 
energy burdens. The PA PUC estimates that more than 19,700 households 
entered the current heating season without heat-related utility 
service--this number includes about 3,700 households who are heating 
with potentially unsafe heating sources such as kerosene or electric 
space heaters and kitchen ovens. In mid-December 2006 an additional 
9,000 residences where electric service was previously terminated were 
vacant and over 7,500 residences where natural gas service was 
terminated were vacant. In 2006, the number of terminations increased 
32 percent compared with terminations in 2004. As of February 2007, 
18.9 percent of residential electric customers and 16.3 percent of 
natural gas customers were overdue on their energy bills. The National 
Energy Assistance Directors Association estimates that the number of 
households applying for energy assistance in fiscal year 2007 is likely 
to remain at fiscal year 2006 levels, for Pennsylvania that would mean 
an estimated increase of over 354,065 LIHEAP households from in fiscal 
year 2005 levels. However, in fiscal year 2007 Pennsylvania is 
experiencing a 34 percent reduction in LIHEAP funding compared to 
levels in fiscal year 2006. This reduction in funding has resulted in a 
32 percent cut to the average LIHEAP crisis benefit from $422 in fiscal 
year 2006 to $285 in fiscal year 2007 (year to date).\6\
---------------------------------------------------------------------------
    \6\ Pennsylvania Public Utility Commission Bureau of Consumer 
Services, National Energy Assistance Directors' Association's ``LIHEAP 
Survey Results--Status of Fiscal Year 2007 Program Funding (March 7, 
2007) and National Energy Assistance Directors' Association, ``The Low 
Income Home Energy Assistance Program: Providing Heating and Cooling 
Assistance to Low-Income Families During a Period of High Energy Prices 
(February 9, 2007). NEADA documents are available at http://
www.neada.org.
---------------------------------------------------------------------------

 LIHEAP IS A CRITICAL SAFETY NET PROGRAM FOR THE ELDERLY, THE DISABLED 
                   AND HOUSEHOLDS WITH YOUNG CHILDREN

    In fiscal year 2006, 5.7 million households received LIHEAP heating 
assistance, the highest number of households served in 13 years. 
Preliminary estimates by the National Energy Assistance Directors' 
Association are that fiscal year 2007 participation rates will remain 
near the same record levels as in fiscal year 2006.\7\ Yet, energy 
prices have been on a continued upward climb. These two trends cut into 
the ability of the LIHEAP program to help protect our most vulnerable 
citizens from extreme weather conditions that cause illness, physical 
harm and even death.
---------------------------------------------------------------------------
    \7\ National Energy Assistance Directors' Association, Talking 
Points in Support of Additional Federal and State Grant Funding for 
Energy Assistance (Jan. 19, 2007) available at www.NEADA.org.
---------------------------------------------------------------------------
    Recent national studies have documented the dire choices low-income 
households are faced with when energy bills are unaffordable. Because 
adequate heating and cooling are tied to the habitability of the home, 
low-income families will go to great lengths to pay their energy bills. 
Low-income households faced with unaffordable energy bills cut back on 
necessities such as food, medicine and medical care.\8\ The U.S. 
Department of Agriculture recently released a study that shows the 
connection between low-income households, especially those with elderly 
persons, experiencing very low food security and heating and cooling 
seasons when energy bills are high.\9\  A pediatric study in Boston 
documented an increase in the number of extremely low weight children, 
age 6 to 24 months, in the 3 months following the coldest months, when 
compared to the rest of the year.\10\  Clearly, families are going 
without food during the winter to pay their heating bills, and their 
children fail to thrive and grow.
---------------------------------------------------------------------------
    \8\ See e.g., National Energy Assistance Directors' Association, 
2005 National Energy Assistance Survey, Tables in section IV,G 
(September 2005) (To pay their energy bills, 20 percent of LIHEAP 
recipients went without food, 35 percent went without medical or dental 
care, 32 percent did not fill or took less than the full dose of a 
prescribed medicine). Available at http://www.neada.org/comm/surveys/
NEADA_2005_National_Energy_Assistance_Survey.pdf.
    \9\ Mark Nord and Linda S. Kantor, Seasonal Variation in Food 
Insecurity Is Associated with Heating and Cooling Costs Among Low-
Income Elderly Americans, The Journal of Nutrition, 136 (Nov. 2006) 
2939-2944.
    \10\ Deborah A. Frank, MD et al., Heat or Eat: The Low Income Home 
Energy Assistance Program and Nutritional and Health Risks Among 
Children Less Than 3 years of Age, AAP Pediatrics v.118, no.5 (Nov. 
2006) e1293-e1302. See also, Child Health Impact Working Group, 
Unhealthy Consequences: Energy Costs and Child Health: A Child Health 
Impact Assessment Of Energy Costs And The Low Income Home Energy 
Assistance Program (Boston: Nov. 2006).
---------------------------------------------------------------------------
    When people are unable to afford paying their home energy bills, 
dangerous and even fatal results occur. Families resort to using unsafe 
heating sources, such as space heaters, ovens and burners, all of which 
are fire hazards.\11\  In the summer, the inability to afford cooling 
bills can result in heat-related deaths and illness. The loss of 
essential utility services can be devastating, especially for poor 
families that can find themselves facing hypothermia in the winter, 
hyperthermia in the summer, eviction, property damage from frozen 
pipes, the use of dangerous alternative sources of heat.
---------------------------------------------------------------------------
    \11\ John R. Hall, Jr., Home Heating Fire Patterns and Trends (In 
2003 there were over 53,000 heating-equipment related home fires 
resulting in 260 deaths (73 percent of the deaths involved portable 
space heaters) and 1,260 injuries and $494 million in property damage), 
National Fire Protection Association (Nov. 2006).
---------------------------------------------------------------------------
    LIHEAP is an administratively efficient and effective targeted 
health and safety program that works to bring fuel costs within a 
manageable range for vulnerable low-income seniors, the disabled and 
families with young children. LIHEAP must be fully funded at its 
authorized level of $5.1 billion in fiscal year 2008 in light of the 
steady increase in home energy costs and the increased need for 
assistance to protect the health and safety of low income families by 
making their energy bills more affordable. In addition, fiscal year 
2009 advance funding would facilitate the efficient administration of 
the State LIHEAP programs. Advanced funding provided certainty of 
funding levels to States to set income guidelines and benefit levels 
before the start of the heating season. States can also plan the 
components of their program year (e.g., amounts set aside for heating, 
cooling and emergency assistance, weatherization, self-sufficiency and 
leveraging activities).
                                 ______
                                 
     Prepared Statement of the National Council of Social Security 
                        Management Associations

    Chairman Harkin, Senator Specter and members of the subcommittee, 
my name is Richard Warsinskey and I represent the National Council of 
Social Security Management Associations (NCSSMA). I have been the 
manager of the Social Security office in Downtown Cleveland, Ohio for 
nearly 12 years and have worked for the Social Security Administration 
for 31 years. On behalf of our membership, I am pleased to have the 
opportunity to submit this written testimony to the subcommittee.
    The NCSSMA is a membership organization of nearly 3,400 Social 
Security Administration (SSA) managers and supervisors who provide 
leadership in over 1,300 Field Offices and Teleservice Centers 
throughout the country. We are the front-line service providers for SSA 
in communities all over the Nation. We are also the Federal employees 
with whom many of your staff members work to resolve problems and 
issues for your constituents who receive Social Security retirement 
benefits, survivors or disability benefits, or Supplemental Security 
Income. From the time our organization was founded over 36 years ago, 
the NCSSMA has been a strong advocate of efficient and prompt locally 
delivered services nationwide to meet the variety of needs of 
beneficiaries, claimants, and the general public. We consider our top 
priority to be a strong and stable Social Security Administration, one 
that delivers quality and prompt community based service to the people 
we serve--your constituents.

   IMPACT OF SSA'S APPROPRIATED FUNDING LEVEL ON SSA FIELD OFFICES & 
                          TELESERVICE CENTERS

    For fiscal year 2008, the President has proposed an increase for 
SSA of approximately $304 million over the final level of funding for 
fiscal year 2007. And yet, staffing levels in offices across the 
country are being cut. In fact, SSA will lose about 4,000 positions 
from the beginning of fiscal year 2006 to fiscal year 2008. The most 
significant staffing losses in SSA have occurred in the agency's Field 
Offices. Field Offices have lost about 2,300 positions in the past 18 
months and about 1,200 positions since September 2006. The vast 
majority of these losses have been in the most critical positions in 
the Field: Claims Representatives and Service Representatives. All of 
this comes after 5 years of reductions to the President's Budget 
Requests, which total $720.0 million, and about 8,000 work years. It is 
interesting to note that while total Executive Branch Employment is 
expected to increase 2.1 percent from fiscal year 2006 to fiscal year 
2008, SSA's employment is expected to decrease by 6.2 percent.
    In 2007, an average of 858,000 people are visiting Social Security 
Administration Field Offices every week. At the same time, Field 
Offices are also being overwhelmed by business-related telephone calls. 
SSA Field Offices are receiving approximately 68 million business 
related phone calls a year. This is in addition to the 44 million phone 
calls handled by live agents that are received by SSA's 1-800 number on 
an annual basis. The fact that the public can't get through to SSA on 
the telephone is creating an overwhelming amount of walk-in traffic in 
many Field Offices. Waiting times in many Field Offices are running 2 
to 3 hours long. Some visitors are even experiencing wait times of over 
4 hours.
    SSA is also facing a retirement wave as many of its employees were 
hired around the time SSA took over the Supplemental Security Income 
(SSI) program in 1974. It is important for the agency to be able to 
replace this wealth of experience. It can take up to 4 years before 
newly hired Claims Representatives become fully proficient in the very 
complicated programs SSA administers.
    The impact of inadequate resources in recent years is apparent in 
the severe cutbacks in processing Continuing Disability Review cases 
and SSI Redeterminations. For every $1 spent on a Continuing Disability 
Review, $10 is saved. SSA currently has a backlog of 1.3 million 
Continuing Disability Review cases. The agency also saves $7 for every 
$1 spent on an SSI redetermination. SSA was unable to process over 2.0 
million of these cases in the past few years due to the lack of 
resources.
    In recent months I have received hundreds of messages from SSA 
Field Office management describing how the stress in their offices is 
incredible. Health problems are growing. It truly is a dire situation. 
I would like to share with you part of a communication I received from 
a member of Field Office management:
    ``We have lost five employees recently. Two had strokes in the 
office in the last month and it may have been due to all the stress. 
Another employee is retiring next month. We are simply being hammered 
with work. The number of people visiting our office is well beyond our 
capacity to handle them. About 30.0 percent of our visitors live 
outside our service area. We don't receive staff for these extra 
visitors and the loss of staff has made it an impossible situation.
    ``We really have a very dedicated and wonderful staff. But so many 
are about to have a breakdown. We are just desperate to get help.''
    Even if SSA receives the funding increase recommended by the 
President for fiscal year 2008, staffing will be cut because SSA's 
expenditures continue to increase in several areas. Salaries and 
benefit costs, including those for the Disability Determination 
Services, rent, and security costs, are totaling more than the annual 
increases in appropriated funds. And for fiscal year 2007, SSA's final 
level of funding was just enough to avoid an agency-wide furlough. 
Although a furlough was avoided, the agency will be faced with limited 
hiring for the entire year after only being able to replace one out of 
three staffing losses last year.
    As a result, the fiscal year 2008 President's budget request will 
provide fewer, not additional, resources for SSA. Therefore, we are in 
strong support of the additional funding recommended in the Fiscal Year 
2008 Senate Budget Resolution. These additional funds would be a major 
step in restoring SSA's service to appropriate levels.

                         SURVEY OF OUR MEMBERS

    Our association just completed a survey of our members. Over 2,000 
responded. The gravity of the losses in the Field Offices can be seen 
in an answer to one question. The question was: `` Do you have enough 
staff to keep workloads current?'' Only 3.2 percent answered ``yes'' to 
this question.
    The losses in staff in Field Offices are having a significant 
impact on our ability to provide good service. In answer to the 
question: ``What percent of the time are Field Offices able to provide 
prompt telephone service?'' nearly 63 percent said they can only do 
this 50 percent or less of the time. Nearly a third said they can 
provide prompt telephone service less than 25 percent of the time. The 
impact of these staffing losses can also be seen in the increased 
waiting times for the public. In answer to the question as to whether 
waiting times had increased in the past 2 years, 80 percent said 
``yes'' and nearly a third said the waiting times were significantly 
longer.

                          DISABILITY BACKLOGS

    It is also important to note that receiving prompt service is not 
the case for hundreds of thousands of claimants that have filed for 
Social Security and SSI Disability benefits. There are currently over 
three quarter of a million hearings pending. And at the moment, it is 
taking 510 days, on average, for a hearings decision. Nearly 300,000 
hearings have been pending over a year. SSA estimates that the hearings 
backlog could grow to 1 million cases by 2010 if additional resources 
are not provided for SSA.
    SSA also has a total of about 1.4 million disability cases pending 
at the initial claims, reconsideration, and hearings levels. We 
estimate about 125,000 of these cases belong to veterans and about half 
of these are pending at the hearings level.
    Every day SSA Field Offices and Teleservice Centers throughout the 
country are being contacted by people regarding the status of their 
hearings as I am sure most congressional offices are. Many of these 
people are desperate and have insufficient funds to live on and the 
delays only add to their sense of hopelessness.
    At the beginning of this decade there were only about 311,000 
hearings pending, and the average time for processing was just 274 
days. So the pending cases have grown 130.0 percent in 6 years, and the 
average time to process a case has increased by 234 days. These long 
waits occur after most claimants have passed the first two stages of 
their claim, having received an initial decision and a reconsideration. 
By this point, over 200 days on average have already passed by.

                THE IMPACT OF THE BABY BOOMERS RETIRING
 
   Next year, in 2008, the first of 78 million baby boomers will be 
eligible for Social Security retirement. So there will be a steady rise 
in retirement claims with SSA--along with an increasing number of 
contacts by these retirees with SSA once they start receiving benefits.
    At the end of 2006, there were 40.3 million people receiving 
retirement and survivor benefits. This figure is expected to rise by 
about 1 million a year over the next 10 years and accelerate after 
this. SSA took about 3.3 million retirement and survivor claims last 
year. So we are looking at a significant increase in work for SSA 
offices.

                       THE COMMISSIONER'S BUDGET

    Because SSA is an independent agency, the Commissioner is required 
by law to prepare an annual budget request for SSA, which is submitted 
by the President to Congress without revision, together with the 
President's budget request for SSA. This budget request reflects what 
the Commissioner has evaluated as the level of funding necessary to 
meet the agency's service delivery improvements and fiscal stewardship 
responsibilities through 2012. The Commissioner's budget request also 
factors in that SSA has received less than the President's recommended 
level of funding in recent years, thus leading to the need for 
additional resources in the future to meet the full service delivery 
plan. The budget amount submitted by the Commissioner of Social 
Security for fiscal year 2008 is $10.44 billion. This $10.44 billion is 
$843 million more than what the President requested. The difference 
between these proposed funding levels is significant. Of more 
significance is the difference between the final funding levels 
approved by Congress for SSA in comparison to the budget requests 
submitted in recent years by the Commissioner. Inadequate levels of 
resources have contributed to the growing inability of SSA to provide 
adequate levels of service.

                       SOCIAL SECURITY TRUST FUND

    The Social Security Trust Fund currently totals approximately $2.0 
trillion. The Social Security Trust Fund is intended to pay benefits to 
future beneficiaries and finance the operations of the Social Security 
Administration. The additional funding for SSA proposed in the fiscal 
year 2008 Senate Budget Resolution represents about 1/65th of 1 percent 
of $2 trillion. Don't the workers who have paid into this trust fund 
with their taxes deserve to receive due consideration and the very 
benefits they have paid for in a timely manner?
    The Social Security Trust Fund contains the necessary resources to 
make up the difference between the level requested by SSA's 
Commissioner and the President. Yet, because of the levels of service 
that SSA and its various components that process disability claims are 
currently able to provide, many of these taxpayers must wait so long 
for service that they die before a decision is made on their case. They 
never receive the benefits that they have paid for. This also applies 
to receiving good service in Social Security Administration Field 
Offices--it currently is not at the level it ought to be and people are 
not receiving what they have paid for and what they deserve.

                               CONCLUSION

    The NCSSMA believes that the American public wants and deserves to 
receive good and timely service for the tax dollars they have paid to 
receive Social Security. We urge approval of at least the amount 
included in the Fiscal Year 2008 Senate Budget Resolution, and 
encourage you to consider providing the level of funding requested by 
the Commissioner of Social Security. This additional funding would 
certainly begin the necessary process to restore the levels of service 
that the public deserves from SSA.
    On behalf of the members of the NCSSMA, I thank you again for the 
opportunity to submit this written testimony to the subcommittee. Our 
members are not only dedicated SSA employees, but they are also 
personally committed to the mission of the agency and to providing the 
best service possible to the American public. We respectfully ask that 
you consider our comments and would appreciate any assistance you can 
provide in ensuring that the American public receives the necessary 
service that they deserve from the Social Security Administration.
                                 ______
                                 
Prepared Statement of the National Federation of Community Broadcasters

    Thank you for the opportunity to submit testimony to this 
subcommittee regarding the appropriation for the Corporation for Public 
Broadcasting (CPB). As the president and CEO of the National Federation 
of Community Broadcasters, I speak on behalf of 250 community radio 
stations and related organizations across the country. Nearly half our 
members are rural stations and half are controlled by people of color. 
In addition, our members include many of the new Low Power FM stations 
that are putting new local voices on the airwaves. NFCB is the sole 
national organization representing this group of stations which provide 
service in the smallest communities of this country as well as the 
largest metropolitan areas.
    In summary, the points we wish to make to this subcommittee are 
that NFCB:
  --Requests $440 million in funding for CPB for fiscal year 2010;
  --Requests $40 million in fiscal year 2008 for conversion of public 
        radio and television to digital broadcasting;
  --Requests $27 million in fiscal year 2008 for replacement of the 
        radio interconnection system;
  --Requests that advance funding for CPB is maintained to preserve 
        journalistic integrity and facilitate planning and local 
        fundraising by public broadcasters;
  --Reject the administration's proposal to rescind $107.35 million of 
        already-appropriated 2008 CPB funds;
  --Supports CPB activities in facilitating programming and services to 
        Native American, African American and Latino radio stations;
  --Supports CPB's efforts to help public radio stations utilize new 
        distribution technologies and requests that the subcommittee 
        ensure that these technologies are available to all public 
        radio services and not just the ones with the greatest 
        resources.
    Community Radio fully supports $440 million in Federal funding for 
the Corporation for Public Broadcasting in fiscal year 2010. Federal 
support distributed through CPB is an essential resource for rural 
stations and for those stations serving communities of color. These 
stations provide critical, life-saving information to their listeners 
and are often in communities with very small populations and limited 
economic bases, thus the community is unable to financially support the 
station without Federal funds.
    In larger towns and cities, sustaining grants from CPB enable 
Community Radio stations to provide a reliable source of noncommercial 
programming about the communities themselves. Local programming is an 
increasingly rare commodity in a Nation that is dominated by national 
program services and concentrated ownership of the media.
    For over 30 years, CPB appropriations have been enacted 2 years in 
advance. This insulation has allowed pubic broadcasting to grow into a 
respected, independent, national resource that leverages its Federal 
support with significant local funds. Knowing what funding will be 
available in advance has allowed local stations to plan for programming 
and community service and to explore additional non-governmental 
support to augment the Federal funds. Most importantly, the insulation 
that advance funding provides ``go[es] a long way toward eliminating 
both the risk of and the appearance of undue interference with and 
control of public broadcasting.'' (House Report 94-245.)
    For the last few years, CPB has increased support to rural stations 
and committed resources to help public radio take advantage of new 
technologies such as the Internet, satellite radio and digital 
broadcasting. We commend these activities which we feel provide better 
service to the American people but want to be sure that the smaller 
stations with more limited resources are not left out of this 
technological transition. We ask that the subcommittee include language 
in the appropriation that will ensure that funds are available to help 
the entire public radio system utilize the new technologies, 
particularly rural and minority stations.
    NFCB commends CPB for the leadership it has shown in supporting and 
fostering the programming services to Latino stations and to Native 
American stations. For example, Satelite Radio Bilingue provides 24 
hours of programming to stations across the United States and Puerto 
Rico addressing issues in Spanish of particular interest to the Latino 
population. At the same time, Native Voice One (NV1) is distributing 
programming for the Native American stations. There are now over 33 
stations controlled by and serving Native Americans.
    Two years ago CPB funded the establishment of the Center for Native 
American Public Radio (CNAPR). After 2 years in operation, CNAPR has 
helped with the renewal of licenses and expansion of the 
interconnection system to all Native stations and has raised the 
possibility of Native Nations owning their own, locally controlled 
station. In the process of this work, it was recognized that radio 
would not be available to all Native Nations and broadband and other 
new technologies would be necessary. CNAPR has been repositioned as 
Native Public Media and is working hard to double the number of Native 
stations within the next 3 years. These stations are critical in 
serving local isolated communities (all but one are on Indian 
Reservations) and in preserving cultures that are in danger of being 
lost. CPB's 2003 assessment recognized that ``. . . Native Radio faces 
enormous challenges and operates in very difficult environments.'' CPB 
funding is critical to these rural, minority stations. CPB's funding of 
the Intertribal Native Radio Summit in 2001 helped to pull these 
isolated stations together into a system of stations that can support 
each other. The CPB assessment goes on to say ``Nevertheless, the 
Native Radio system is relatively new, fragile and still needs help 
building its capacity at this time in its development.'' Native Public 
Media promises to leverage additional, new funding to ensure that these 
stations can continue to provide essential services to their 
communities.
    CPB also funded a Summit for Latino Public Radio which took place 
in September 2002 in Rohnert Park, California, home of the first Latino 
Public Radio station. These Summits have expanded the circle of support 
for Native and Latino Public Radio and identified projects that will 
improve efficiency among the stations through collaborations and 
explore new ways of reaching the target audiences.
    CPB plays a very important role for the public and Community Radio 
system; they are the convener of discussions on critical issues facing 
us as a system. They support research so that we have a better 
understanding of how we are serving listeners, and they provide funding 
for programming, new ventures, expansion to new listeners, and projects 
that improve the efficiency of the system. This is particularly 
important at a time when there are so many changes in the radio and 
media environment with new distribution technologies and media 
consolidation. An example of this support is the grant that NFCB 
received to update and publish our Public Radio Legal Handbook online. 
This provides easy-to-read information to stations about complying with 
governmental regulations so that stations can function legally and use 
their precious resources for programming instead of legal fees.
    Finally, Community Radio supports $40 million in fiscal year 2008 
for conversion to digital broadcasting by public radio and television. 
It is critical that this digital funding be in addition to the on-going 
operational support that CPB provides. The President's proposal that 
digital money should be taken from the fiscal year 2008 CPB 
appropriation would effectively cut stations' grants by over 25 
percent. This would have a devastating impact on stations trying to 
recover from hard economic times. And it would come at a time when the 
local voices of community and public radio are especially important to 
notify and support people during emergency situations and to help 
communities deal with the loss of loved ones--things that commercial 
radio is no longer able to do because of media consolidation.
    While public television's digital conversion needs are mandated by 
the FCC, public radio is converting to digital to provide more public 
service and to keep up with commercial radio. The Federal 
Communications Commission has approved a standard for digital radio 
transmission and to allow multicasting. CPB has provided funding for 
554 transmitters to convert to digital and is working with radio 
transmitter and receiver manufacturers to build in the capacity to 
provide a second channel of programming. Most exciting to public and 
community radio is the encouraging results of tests that National 
Public Radio has conducted, with funding from CPB, that indicate that 
stations can broadcast at least three high-quality signals, even while 
they continue to provide the analog signal. The development of second 
and third audio channels will potentially double or triple the service 
that public radio can provide, particularly in service to unserved and 
underserved communities. This initial funding still leaves nearly 250 
radio transmitters that will ultimately need to convert to digital or 
be left behind.
    Federal funds distributed by the CPB should be available to all 
public radio stations eligible for Federal equipment support through 
the Public Telecommunications Facilities Program (PTFP) of the National 
Telecommunications and Information Agency of the Department of 
Commerce. In previous years, Federal support for public radio has been 
distributed through the PTFP grant program. The PTFP criteria for 
funding are exacting, but allow for wider participation among public 
stations. Stations eligible for PTFP funding and not for CPB funding 
include small-budget, rural and minority controlled stations and the 
new Low Power FM service.
    Community Radio strongly supports funding for the public radio 
interconnection system. Public Radio pioneered the use of satellite 
technology to distribute programming. The new ContentDepot system that 
the Public Radio Satellite System is launching continues this tradition 
of cutting edge technology. The satellite capacity that supports this 
system must be renewed and upgrades are necessary at the stations and 
the network operations level. Interconnection is vital to the delivery 
of the high quality programming that public broadcasting provides to 
the American people.
    This is a period of tremendous change. Digital is transforming the 
way we do things; new distribution avenues like digital satellite 
broadcasting and the Internet are changing how we define the business 
we are in; and, the concentration of ownership in commercial radio 
makes public radio in general, and Community Radio in particular, more 
important as a local voice than we have ever been. New Low Power FM 
stations are providing new local voices in their communities. Community 
radio is providing essential local emergency information, programming 
about the local impact of the major global events taking place, 
culturally appropriate information and entertainment in the language of 
the native culture, as well as helping to preserve cultures that are in 
danger of dying out. During the natural disasters of the last couple of 
years, radio proved once again to be the most dependable and available 
medium to get emergency information to the public.
    During these challenging times, the role of CPB as a convener of 
the system becomes even more important. The funding that it provides 
will allow the smaller stations to participate along with the larger 
stations which have more resources, as we move into a new era of 
communications.
    Thank you for your consideration of our testimony.
                                 ______
                                 
Prepared Statement of the NIH Task Force of the Bioengineering Division

    The NIH Task Force of the Bioengineering Division of the Basic 
Engineering Group of the Council on Engineering of ASME (``Task 
Force''), is pleased to provide comments on the bioengineering-related 
programs in the National Institutes of Health (NIH) fiscal year 2008 
budget request. The ASME Bioengineering Division is focused on the 
application of mechanical engineering knowledge, skills and principles 
to the conception, design, development, analysis and operation of 
biomechanical systems.

                      IMPORTANCE OF BIOENGINEERING

    Bioengineering is an interdisciplinary field that applies physical, 
chemical and mathematical sciences and engineering principles to the 
study of biology, medicine, behavior, and health. It advances knowledge 
from the molecular to the organ systems level, and develops new and 
novel biologics, materials processes, implants, devices, and 
informatics approaches for the prevention, diagnosis, and treatment of 
disease, for patient rehabilitation, and for improving health. 
Bioengineers have employed mechanical engineering principles in the 
development of many life-saving and life-improving technologies, such 
as the artificial heart, prosthetic joints and numerous rehabilitation 
technologies.

                               BACKGROUND

    The NIH is the world's largest and most eminent organization 
dedicated to improving health through medical science. During the last 
50 years, NIH has played a leading role in the major breakthroughs that 
have increased average life expectancy by 15 to 20 years.
    The NIH is comprised of different Institutes and Centers that 
support a wide spectrum of research activities including basic 
research, disease- and treatment-related studies, and epidemiological 
analyses. The missions of individual Institutes and Centers focus on 
either a particular organ (e.g. heart, kidney, eye), a given disease 
(e.g. cancer, infectious diseases, mental illness), or a stage of life 
(e.g. childhood, old age), or may encompass crosscutting needs (e.g., 
sequencing of the human genome and the National Institute of Biomedical 
Imaging and Bioengineering (NIBIB)).
    The total fiscal year 2008 NIH budget request is $28.85 billion, 
which represents a $330 million (1.1 percent) reduction from the $29.18 
billion approved in the fiscal year 2007 continuing joint resolution. 
While the Task Force is grateful to Congress for the unexpected $600 
million boost to NIH as it wrapped up the fiscal year 2007 
appropriations, we are greatly concerned about the decrease in funding 
for fiscal year 2008. Research and development is expected to account 
for 97 percent of the total fiscal year 2008 NIH budget, or $28.3 
billion. With this, the administration estimates that a total of 10,188 
new, competing research project grants (RPGs) could be supported, which 
is an increase of 566 RPGs over fiscal year 2007. While the overall 
fiscal year 2008 budget decreased compared to fiscal year 2007, the 
budgets allotted to some institutes and centers actually increased, 
while all others decreased. The largest increase went to the National 
Institute of Allergy and Infectious Disease (NIAID), which will receive 
$4.59 billion, a total that includes a $200 million contribution to the 
Global Fund for HIV/AIDS.
    The NIH Roadmap for biomedical research will receive $486 million 
in fiscal year 2008, which is an increase of $3 million from fiscal 
year 2007. Each institute and center will be required to contribute 1.3 
percent of its fiscal year 2008 budget to the NIH Roadmap initiative. 
Since all institutes and centers were freed of their obligation to 
transfer 1.2 percent of their budgets to this initiative in fiscal year 
2007, an effective 2.5 percent reduction in the budget of each will 
hence result.

                         NIBIB RESEARCH FUNDING

    The administration's fiscal year 2008 budget requests $300 million 
for the NIBIB, an increase of $4 million or 1.3 percent from the fiscal 
year 2007 continuing joint resolution. Taking into account the 3.7 
percent inflation rate (as estimated by the Bureau of Economic 
Analysis) this effectively amounts to a decrease in funding by 2.4 
percent. However, the number of research project applications to NIBIB 
continues to grow (a 5 percent increase was noted in fiscal year 2006 
over fiscal year 2005, for example). The decrease in the NIBIB budget 
combined with the increase in the number of NIBIB extramural research 
grant applications will result in a sharp decrease in the success rate 
for bioengineering-related grants. In fact, the success rate for 
applications to the NIBIB is already one of the lowest among all NIH 
institutes and centers (17 percent in fiscal year 2006 versus 20 
percent in fiscal year 2005).

                       TASK FORCE RECOMMENDATIONS

    The Task Force is concerned that bioengineering-based research 
continues to constitute a small portion of the total NIH budget. Yet 
there is an increasing need for advanced engineering concepts to be 
applied to basic and translational biomedical problems for the 
potential of recent biological advances to be realized. Moreover, the 
United States is rapidly falling behind our counterparts in the 
European Union and Pacific Rim with regards to bioengineering advances. 
Our request for increased bioengineering funding addresses these 
critical issues. The Task Force wishes to emphasize that, in many 
cases, bioengineering-based solutions to health care problems result in 
a reduction in health care costs. Therefore, we strongly urge Congress 
to provide increased funding for bioengineering within the NIBIB and 
across NIH.
    The NIBIB requires exceptional and urgent consideration for funding 
increases in the coming years due to its fiscal year 2006 application 
success rate of only 17 percent, which is sure to decrease even further 
for fiscal year 2007 and fiscal year 2008 given the proposed budget 
estimates. This rate is below average with respect to the NIH as a 
whole and is a direct manifestation of the continued growth of the 
bioengineering field outpacing funding increases to the NIBIB.
    While the Task Force supports new Federal proposals that seek to 
double Federal research and development in the physical sciences over 
the next decade, we believe that strong Federal support for 
bioengineering and the life sciences is especially essential to the 
health and competitiveness of the United States. The disturbing trend 
in the inflation rate outpacing the NIBIB budget increase rate will 
begin to reverse the tremendous gains the United States has made in the 
bioengineering field over the last decade. Four years of falling 
budgets are a sharp contrast from the 15 percent annual increases 
during the NIH doubling period and will have a long-lasting, 
deleterious impact.
    ASME International is a non-profit technical and educational 
organization with 125,000 members worldwide. The Society's members work 
in all sectors of the economy, including industry, academic, and 
government. This statement represents the views of the ASME NIH Task 
Force of the Bioengineering Division and is not necessarily a position 
of ASME as a whole.
                                 ______
                                 
         Prepared Statement of the National League for Nursing

    The National League for Nursing is the sole organization 
representing leaders in nursing education and nurse faculty across all 
the types of nursing programs in the United States. With more than 
1,100 nursing schools and health care agencies, some 20,000 individual 
members comprising nurses, educators, administrators, public members, 
and 18 constituent leagues, the National League for Nursing is the 
premier organization--established 114 years ago--dedicated to 
excellence in nursing education that prepares the nursing workforce to 
meet the needs of our diverse populations in an ever-changing health 
care environment. The NLN appreciates this opportunity to discuss the 
status of nursing education and the damage that could ensue to patients 
and our Nation's health care by the ill-considered cuts aimed at Title 
VIII.
    The NLN endorses the subcommittee's past policy strategies for 
health care capacity-building through nursing education. We likewise 
respect your recognition of the requisite role nurses play in the 
delivery of cost-efficient health care services and the generation of 
quality health outcomes.
    We are disturbed, however, that the 7-year and counting nursing 
shortage is outpacing the level of Federal resources and investments 
that have been expended by Congress to help alleviate the nationwide 
nursing scarcity. The NLN is gravely concerned that the 
administration's proposed fiscal year 2008 appropriations for nursing 
education are inconsistent with the health care reality facing our 
Nation. The President's budget proposes a decrease of funding of $44 
million (or 29 percent) for the Title VIII--Nursing Workforce 
Development Programs. This budget cut will diminish training and 
development, a shortsighted and hazardous course of action that 
potentially further jeopardizes the delivery of health care for the 
people in the United States.
    As the nursing community has pointed out many times before, more 
than three decades ago during another less serious nursing shortage, 
Congress appropriated $153 million for nurse education programs. In 
today's dollars, that amount would be worth more than $615 million--
four times the amount the Federal Government currently is spending on 
Title VIII programs.
    The National League for Nursing contends that the Federal strategy 
should be to broaden, not curtail, Title VIII initiatives by increasing 
investments to be consistent with national demand. We urge the 
subcommittee to fund the Title VIII programs at a minimum level of $200 
million for fiscal year 2008. The NLN also advocates that section 811 
of Title VIII--Advanced Education Nursing Program--be restored and 
funded at an augmented level equal to the other Title VIII programs.

              NURSE SHORTAGE AFFECTED BY FACULTY SHORTAGE

    The subcommittee is well aware that today's nursing shortage is 
real and unique from any experienced in the past with an aging 
workforce and too few people entering the profession at the rate 
necessary to meet growing health care requirements. NLN research 
provides evidence of a strong correlation between the shortage of nurse 
faculty and the inability of nursing programs to keep pace with the 
demand for new registered nurses (RNs). Without faculty to educate our 
future nurses, the shortage cannot be resolved.
    The NLN's Nursing Data Review 2004-2005.--Baccalaureate, Associate 
Degree, and Diploma Program revealed that graduations from RN programs 
contributed an estimated 84,878 additional prospective nurses to the RN 
labor supply falling far short of the Nation's demands. In its biennial 
10-year employment projections for 2004-2014, the U.S. Department of 
Labor's Bureau of Labor Statistics (BLS) reported that over the next 10 
years, about 70,000 new RN jobs and 50,000 replacement jobs will accrue 
each year, for a total of 120,000 RN job openings per year. Multiply 
that annual sum by 10 years, and BLS's model-based findings estimate 
that 1.2 million new RN workers will be needed from 2004-2014. This 
growth represents a 29 percent projected change over the next 10 years.
    The NLN's 2004-2005 data review shows that nursing school 
applications surged in recent years, rising more than 59 percent over 
the past decade. The 2004-2005 academic year was no exception as almost 
25,000 additional applications were submitted to nursing schools at all 
degree levels. Nonetheless, an estimated 147,000 qualified applications 
were turned away owing in large part to the lack of faculty necessary 
to teach additional students. Alarmingly too, this NLN review 
determined that new admissions fell by more than 27 percent in 2004-
2005 after 2 years of reported increases. The significant dip in 
admissions seems to mark a turning point, reinforcing that a key 
priority in tackling the nurse shortage has to be scaling up the 
capacity to accept qualified applicants.

                   TRENDS STRESSING FACULTY SHORTAGE

    It is not surprising that the problem of nurse faculty vacancies 
often is described as acute and as exacerbating the national nurse-
workforce shortfall. The NLN's research, reported in its Nurse 
Educators 2006: A Report of the Faculty Census Survey of RN and 
Graduate Programs, indicated that the nurse faculty vacancies in the 
United States continued to grow even as the numbers of full- and part-
time educators increased. The estimated number of budgeted, unfilled, 
full-time positions countrywide in 2006 was 1,390. This number 
represents a 7.9 percent vacancy rate in baccalaureate and higher 
degree programs, which is an increase of 32 percent since 2002; and a 
5.6 percent vacancy rate in associate degree programs, which translates 
to a 10 percent rise in the same period.
    The data in the 2006 faculty census survey describe several trends, 
of which the following three are critical:

                    AGING OF THE FACULTY POPULATION

    Nursing programs responding to the survey indicated that almost 
two-thirds of all full-time nurse faculty members were 45- to 60-years 
old and likely to retire in the next 5 to 15 years. A mean of 1.4 full-
time faculty members per program left their positions in 2006, with 24 
percent of these departures due to retirement. It is an open question 
where schools of nursing will find replacements for these experienced 
individuals.

                DECREASE IN DOCTORALLY PREPARED FACULTY

    Data show that nurse faculty are less well-credentialed in 2006 
than they were 4 years earlier when the last NLN faculty census was 
conducted. A little over 43 percent of full-time baccalaureate and 
higher degree program faculty hold earned doctorates; whereas only 6.6 
percent of associate degree program full-time faculty and 0.7 percent 
of diploma program full-time faculty are doctorally prepared. The 
overwhelming majority of the full-time faculty in associate degree (83 
percent) and diploma (92.6 percent) programs hold the master's degree 
as their highest earned credential. The master's degree was the most 
common credential among part-time faculty members.

                     INCREASE IN PART-TIME FACULTY

    Nearly 45 percent of the estimated mean number of faculty full-time 
equivalents are part-time faculty. Nationwide, the mean number of 
faculty members per institution had grown to 14.9 full-time and 12.1 
part-time faculty in 2006, compared to 12.3 full-time and 7.4 part-time 
in 2002. The estimated number of part-time baccalaureate faculty has 
grown 72.5 percent since 2002. Over 58 percent of baccalaureate and 
higher degree programs and almost half of associate degree programs 
(47.5 percent) reported hiring part-time faculty as their primary 
strategy to compensate for unfilled, budgeted, full-time positions. 
While the use of part-time faculty allows for greater flexibility, 
often they are not an integral part of the design, implementation, and 
evaluation of the overall nursing program.

                      THE FEDERAL FUNDING REALITY

    Today's undersized supply of appropriately prepared nurses and 
nursing faculty does not bode well for our Nation, where the shortages 
are deepening health disparities, inflated costs, and poor quality of 
health care outcomes. Congress moved in the right policy direction in 
passing the Nurse Reinvestment Act in 2002. That act made Title VIII 
programs a comprehensive system of capacity-building strategies to 
develop nurses by providing schools of nursing with grants to 
strengthen programs, through such activities as faculty recruitment and 
retention efforts, facility and equipment acquisition, clinical lab 
enhancements, and loans, scholarships and services that enable students 
to overcome obstacles to completing their nursing education programs. 
Yet, as the HRSA Title VIII data show, it is abundantly clear that 
Congress must step up in providing critical attention and significantly 
more funding to this ongoing systemic problem.
    Nursing Education Loan Repayment Program.--In fiscal year 2005, 
with 4,465 applicants to the Title VIII Nursing Education Loan 
Repayment Program, 803 awards were made (599 initial 2-year awards and 
204 amendment awards), or 18 percent of applicants received awards. In 
fiscal year 2006, there were 4,222 applicants to the program; 615 
awards were made (373 initial 2-year awards and 242 amendment awards) 
with 14.6 percent of applicants receiving awards.
    Nursing Scholarship Program.--In fiscal year 2005, 3,482 
applications were submitted to the Nursing Scholarship Program, and 212 
awards, or 6.1 percent of the applicants received scholarships. In 
fiscal year 2006, there were 3,320 applicants to the same program and 
218, or 6.6 percent, awards were.
    Advanced Education Nursing (AEN) Program.--This program supports 
the graduate education that is the foundation to professional 
development of advanced practice nurses, whether with clinical 
specialties or with a specialty in teaching. In fiscal year 2005, AEN 
supported 11,949 graduate nursing students across the specialties. The 
President's proposed fiscal year 2008 budget eliminates this program, 
which is fundamental to appropriately preparing future nursing faculty, 
the engine of the workforce pipeline. AEN must be restored and fully 
funded in order to prevent the Nation from losing ground in the effort 
to remedy the nurse and nurse faculty shortages.

             NATIONAL INSTITUTE OF NURSING RESEARCH (NINR)

    We would be remiss in not acknowledging that nursing research is an 
integral part of the effectiveness of nursing care. NINR provides the 
knowledge base for improving the quality of patient care and reducing 
health care costs and demands. Critical to enhancing research within 
the nursing profession is the infrastructure development that increases 
the pool of nurse investigators and nurse educators, expands programs 
to develop partnerships between research-intensive environments and 
smaller colleges and universities, and promotes career development for 
minority researchers. Yet, as noted by the expanding list of non-
nursing journals that publish the investigator findings of NINR-
sponsored research, an investment in NINR goes far beyond just the 
nursing community and produces research results for all health care 
providers.
    The relatively small investment made by the Federal Government in 
NINR is well justified for the outcomes received. For example, NINR has 
supported research that:
  --Led to nursing intervention enabling excellent metabolic control in 
        diabetic adolescents;
  --Devised ways to sustain reduced high blood pressure in young 
        African-American men;
  --Reduced the burdens of caregivers of persons with dementia or other 
        chronic care needs; and
  --Developed a successful, national model for Spanish speakers in a 
        community-based Arthritis Self-Management Program.
    As the only organization that collects data across all levels of 
the nursing education pipeline, the NLN can state with authority that 
the nursing shortage in this country will not be reversed until the 
concurrent shortage of qualified nurse educators is addressed. Without 
adequate faculty, there are simply too few spots in nursing education 
programs to train all the qualified applicants out there. This 
challenge requires millions of dollars of increased funding for the 
professional development of nurses. The NLN urges Congress to 
strengthen existing Title VIII nurse education programs by funding them 
at a minimum level of $200 million for fiscal year 2008.
    Your support will help ensure that nurses exist in the future who 
are prepared and qualified to take care of you, your family, and all 
those in this country who will need our care.
                                 ______
                                 
          Prepared Statement of the National Marfan Foundation

    Chairman Harkin, ranking member Specter, and members of the 
subcommittee, the National Marfan Foundation thanks you for the 
opportunity to submit testimony regarding the fiscal year 2008 budget 
for the National Heart, Lung and Blood Institute, the National 
Institute of Arthritis, Musculoskeletal and Skin Diseases, and the 
Centers for Disease Control and Prevention. We are extremely grateful 
for the subcommittee's strong support of the NIH and CDC, particularly 
as it relates to life threatening genetic disorders such as Marfan 
syndrome. Thanks to your leadership, we are at a time of unprecedented 
hope for Marfan syndrome patients and their families.
    It is estimated that 200,000 people in the United States are 
affected by the Marfan syndrome or a related disorder. Marfan syndrome 
is a genetic disorder of the connective tissue that manifests itself in 
many areas of body, including the heart, eyes, skeleton, lungs and 
blood vessels. It is a progressive condition that can cause 
deterioration in each of these body systems. The most serious and life-
threatening aspect of the syndrome however, is a weakening of the 
aorta. The aorta is the largest artery that takes oxygenated blood to 
the body from the heart. Over time, many Marfan syndrome patients 
experience a dramatic weakening of the aorta which can cause the vessel 
to dissect and tear.
    Fortunately, early surgical intervention can prevent a dissection 
and strengthen the aorta and the aortic valves. If preventive surgery 
is performed before a dissection occurs, the success rate of the 
procedure is over 95 percent. Unfortunately, if surgery is initiated 
after a dissection has occurred, the success rate drops below 50 
percent. Aortic dissection is a leading killer in the United States, 
and 20 percent of the people it affects have a genetic predisposition, 
like Marfan syndrome, to developing the complication.
    Fortunately, new research offers hope that a commonly prescribed 
blood pressure medication, losartan, might be effective in preventing 
this frequent and devastating event.

                NATIONAL HEART LUNG AND BLOOD INSTITUTE

    As NHLBI Director Dr. Elizabeth Nabel told the subcommittee during 
her appearance at the April 20th hearing on the ``Burden of Chronic 
Disease'' there is landmark clinical trial underway sponsored by 
NHLBI's Pediatric Heart Network to determine the effects of losartan on 
aortic growth:

    ``After the discovery that Marfan syndrome is associated with the 
mutation in the gene encoding a protein called fibrillin-1, researchers 
tried for many years, without success, to develop treatment strategies 
that involved repair of replacement of fibrillin-1. Recently, a major 
breakthrough occurred with the discovery that one of the functions of 
fibrillin-1 is to bind to another protein, TGF-beta, and regulate its 
effects. After careful analysis revealed aberrant TGF-beta activity in 
patients with Marfan syndrome, researchers began to concentrate on 
treating Marfan syndrome by normalizing the activity of TGF-beta. 
Losartan, which is known to affect TGF-beta activity, was tested in a 
mouse model of Marfan syndrome. The results, published only last April, 
showed that drug was remarkably effective in blocking the development 
of aortic aneurysms, as well as lung defects associated with the 
syndrome.
    Based on this promising finding, the NHLBI Pediatric Heart Network, 
is now undertaking a clinical trial of losartan in patients with Marfan 
syndrome. About 600 patients aged 6 months to 25 years will be enrolled 
and followed for 3 years. This development illustrates the outstanding 
value of basic science discoveries, and identifying new directions for 
clinical applications. Moreover, the ability to organize and initiate a 
clinical trial within months of such a discovery is testimony to 
effectiveness of the NHLBI Network in providing the infrastructure and 
expertise to capitalize on new findings as they emerge.''

    Dr. Hal Dietz, the Victor A. McKusick professor of genetics in the 
McKusick-Nathans Institute of Genetic Medicine at the Johns Hopkins 
University School of Medicine, and the director of the William S. 
Smilow Center for Marfan Syndrome Research, is the driving force behind 
this groundbreaking research. Dr. Dietz uncovered the role that 
fibrillin-1 and TGF-beta play in aortic enlargement, and demonstrated 
the benefits of losartan in halting aortic growth in mice. He is the 
reason we have reached this time of such promise, and we are proud to 
have supported his cutting-edge research for many years.
    We are also extremely grateful to Dr. Nabel and her colleagues at 
NHLBI for their leadership in advancing the losartan clinical trial. 
The Pediatric Heart Network, lead by Dr. Lynn Mahony and Dr. Gail 
Pearson, has demonstrated tremendous skill and dedication in 
facilitating this complex trial in a very short time-frame. We deeply 
value their hard work and commitment. NMF is a proud partner with NHLBI 
in supporting this promising research. The Foundation is actively 
supporting patient travel costs, and funding ancillary studies to the 
trial focused on additional manifestations of the Marfan syndrome that 
might be impacted losartan.
    Finally, we are excited that NHLBI has formed a ``Working Group on 
Research in Marfan Syndrome and Related Conditions'' jointly sponsored 
by the NMF. The panel is chaired by Dr. Dietz and comprised of experts 
in all aspects of basic and clinical science related to the syndrome. 
The mission of the Working Group is to identify current research 
opportunities and challenges with a 5-10 year horizon, and to make 
recommendations for areas that require leadership by the NHLBI in order 
to move forward. We look forward to partnering with NHLBI to advance 
the goals outlined by the Working Group.
    In order to support the important mission of the NHLBI, and its 
activities related to Marfan syndrome, NMF joins with the Ad Hoc Group 
for Medical Research, the Campaign for Medical Research, the Federation 
of American Societies for Experimental Biology, the National Health 
Council, and Research!America in recommending a 6.7 percent for NIH 
overall and NHLBI specifically in fiscal year 2008.
 national institute of arthritis and musckuloskeletal and skin diseases
    NMF is proud of its longstanding partnership with the National 
Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. 
Steven Katz has been a strong proponent of basic research on Marfan 
syndrome during his tenure as NIAMS director and has generously 
supported several ``Conferences on Heritable Disorders of Connective 
Tissue.'' Moreover, the Institute has provided invaluable support for 
Dr. Dietz's mouse model studies. The discoveries of fibrillin-1, TGF-
beta, and their role in muscle regeneration and connective tissue 
function were made possible in part through collaboration with NIAMS.
    As the losartan clinical trail moves forward, we hope to expand our 
partnership with NIAMS to support ancillary studies that fall under the 
mission and jurisdiction of the Institute. One of the areas of great 
interest to researchers and patients, is the role that losartan may 
play in strengthening muscle tissue in Marfan patients. In response to 
our request for proposals for ancillary studies grants, NMF received 
applications focused on this area that scored extremely well under the 
peer review of our Scientific Advisory Board. We appreciate the 
subcommittee's ongoing support of NIAMS and our collaboration with the 
Institute on these emerging research opportunities.
    To support the mission of the Institute in fiscal year 2008, NMF 
recommends a 6.7 percent increase for NIAMS.

               CENTERS FOR DISEASE CONTROL AND PREVENTION

    We are grateful for the subcommittee's encouragement last year of 
collaborations between the CDC and the Marfan syndrome community. One 
of the most important things we can do to prevent untimely deaths from 
aortic aneurysms is to increase awareness of Marfan syndrome and 
related connective tissue disorders. Education and prevention are two 
of the cornerstone missions of the Foundation. However, despite our 
efforts to raise awareness among the general public and the health care 
community, we know of too many families who have lost a loved one 
because they did not know that they were affected.
    Recently, the NMF leadership traveled to Atlanta to visit with the 
Centers for Disease Control and Prevention to explore potential 
partnerships in the area of awareness and prevention of aortic 
dissections. We look forward to working with the National Center on 
Birth Defects and Developmental Disabilities (NCBDD) to prevent 
needless loss of life from the cardiovascular complications associated 
with Marfan syndrome. We applaud the leadership of the NCBDD's Division 
of Human Development and Disability for their interest in this area and 
appreciate the subcommittee's support of this partnership. We have 
discussed a number of potential collaborations with the CDC focused on 
the need for early diagnosis and treatment of Marfan syndrome, in order 
to enhance the quality and length of life for patients.
    In order to support the important work of the CDC, NMF joins with 
the ``CDC Coalition'' in recommending an appropriation of $10.7 billion 
for the agency in fiscal year 2008. We would also encourage a 
corresponding percentage increase for the NCBDD and its Division of 
Human Development and Disability.

                  ABOUT THE NATIONAL MARFAN FOUNDATION

    The NMF is a non-profit voluntary health organization founded in 
1981. NMF is dedicated to saving lives and improving the quality of 
life for individuals and families affected by the Marfan syndrome and 
related disorders. The Foundation has three major goals: (i) to provide 
accurate and timely information about the Marfan syndrome to affected 
individuals, family members, physicians and other health professionals; 
(ii) to provide a means for those with Marfan syndrome and their 
relatives to share in experiences, to support one another and to 
improve their medical care and (iii) to support and foster research.
                                 ______
                                 
       Prepared Statement of the ARCH National Respite Coalition

    Mr. Chairman, I am Jill Kagan, Chair of the ARCH National Respite 
Coalition, a network of respite providers, family caregivers, State and 
local agencies and organizations across the United States who support 
respite. This statement is presented on behalf of the undersigned 
organizations, many of which are members of the Lifespan Respite Task 
Force, a coalition of over 80 national and more than 100 State and 
local groups who supported the passage of the Lifespan Respite Care Act 
(Public Law 109-442). Together, we are requesting that the subcommittee 
include funding for the newly enacted Lifespan Respite Care Act in the 
fiscal year 2008 Labor, HHS and Education Appropriations bill at its 
modestly authorized level of $40,000,000. We join the 17 Members of the 
Senate who, along with Senator Hillary Rodham Clinton (D-NY) and 
Senator John Warner (R-VA), are sending a letter to the subcommittee 
making this same request.

                           WHO NEEDS RESPITE?

    A national survey found that 44 million family caregivers are 
providing care to individuals over age 18 with disabilities or chronic 
conditions (National Alliance for Caregiving [NAC] and AARP, 2004). In 
2001, the last year Federal data were collected, 9,400,000 children 
under age 18 were identified with chronic or disabling conditions 
(National Survey of Children with Special Health Care Needs, U.S. 
Health Resources and Services Administration, 2001). These surveys 
suggest that a conservative estimate of the Nation's family caregivers 
probably exceeds 50 million.
    Compound this picture with the growing number of caregivers known 
as the ``sandwich generation'' caring for young children as well as an 
aging family member. It is estimated that between 20 and 40 percent of 
caregivers have children under the age of 18 to care for in addition to 
a parent or other relative with a disability. And in the United States, 
6,700,000 children, with and without disabilities, are in the primary 
custody of an aging grandparent or other relative other than their 
parents.
    These family caregivers are providing about 80 percent of all long-
term care in the United States. It has been estimated that in the 
United States these family caregivers provide $306,000,000,000 in 
uncompensated care, an amount comparable to Medicare spending in 2004 
and more than twice what is spent nationwide on nursing homes and paid 
home care combined (Presentation by P.S Arno, PhD, Albert Einstein 
College of Medicine, January 2006).

                         WHAT IS RESPITE NEED?

    State and local surveys have shown respite to be the most 
frequently requested service of the Nation's family caregivers, 
including the most recent study, ``Evercare Study of Caregivers in 
Decline'' (Evercare and NAC, 2006). Yet respite is unused, in short 
supply, inaccessible, or unaffordable to a majority of the Nation's 
family caregivers. The 2004 survey of caregivers found that despite the 
fact that the most frequently reported unmet needs were ``finding time 
for myself,'' (35 percent), ``managing emotional and physical stress'' 
(29 percent), and ``balancing work and family responsibilities'' (29 
percent), only 5 percent of family caregivers were receiving respite 
(NAC and AARP, 2004).
    Barriers to accessing respite include reluctance to ask for help, 
fragmented and narrowly targeted services, cost, and the lack of 
information about how to find or choose a provider. Even when respite 
is an allowable funded service, a critically short supply of well 
trained respite providers may prohibit a family from making use of a 
service they so desperately need.
    Twenty of 35 state-sponsored respite programs surveyed in 1991 
reported that they were unable to meet the demand for respite services. 
In the last 15 years, we suspect that not too much has changed. A 
recent study conducted by the Family Caregiver Alliance identified 150 
family caregiver support programs in all 50 States and Washington, DC 
funded with State-only or State/Federal dollars. Most of the funding 
comes through the Federal National Family Caregiver Support Program. As 
a result, programs are administered by local area agencies on aging and 
primarily serve the elderly. And again, some programs provide only 
limited respite, if at all. Only about one-third of these 150 
identified programs serve caregivers who provide care to adults age 18-
60 who must meet stringent eligibility criteria. As the report 
concluded, ``State program administrators see the lack of resources to 
meet caregiver needs in general and limited respite care options as the 
top unmet needs of family caregivers in the States.''
    The 25 State respite coalitions and other National Respite Network 
members confirm that long waiting lists or turning away of clients 
because of lack of resources is still the norm.
    While most families take great joy in helping their family members 
to live at home, it has been well documented that family caregivers 
experience physical and emotional problems directly related to their 
caregiving responsibilities. Three-fifths of family caregivers age 19-
64 surveyed recently by the Commonwealth Fund reported fair or poor 
health, one or more chronic conditions, or a disability, compared with 
only one-third of non-caregivers (Ho, Collins, Davis and Doty, 2005). A 
study of elderly spousal caregivers (aged 66-96) found that caregivers 
who experience caregiving-related stress have a 63 percent higher 
mortality rate than noncaregivers of the same age (Schulz and Beach, 
December 1999).
    Supports that would ease their burden, most importantly respite 
care, are too often out of reach or completely unavailable. Even the 
simple things we take for granted, like getting enough rest or going 
shopping, become rare and precious events. One Massachusetts mother of 
a seriously ill child spoke to the demands of constant caregiving: ``I 
recall begging for some type of in-home support. It was during this 
period when I fell asleep twice while driving on the Massachusetts 
Turnpike on the way to appointments at Children's Hospital. The lack of 
respite put our lives and the lives of everyone driving near me at 
risk.''
    Restrictive eligibility criteria also preclude many families from 
receiving services or continuing to receive services they once were 
eligible for. A mother of a 12-year-old with autism was denied 
additional respite by her State DD (Developmental Disability) agency 
because she was not a single mother, was not at poverty level, wasn't 
exhibiting any emotional or physical conditions herself, and had only 
one child with a disability. As she told us, ``Do I have to endure a 
failed marriage or serious health consequences for myself or my family 
before I can qualify for respite? Respite is supposed to be a 
preventive service.''
    For the millions of families of children with disabilities, respite 
has been an actual lifesaver. However, for many of these families, 
their children will age out of the system when they turn 21 and they 
will lose many of the services, such as respite, that they currently 
receive. In fact, 46 percent of U.S. State units on aging identified 
respite as the greatest unmet need of older families caring for adults 
with lifelong disabilities. An Alabama mom of a 19-year-old-daughter 
with multiple disabilities who requires constant care recently told us 
about her fears at a respite summit in Alabama. ``My daughter Casey has 
cerebral palsy, she does not communicate, she is incontinent she eats a 
pureed diet, she utilizes a wheelchair, she is unable to bathe or dress 
herself. At 5 feet 5 inches and 87 pounds I carry her from her bedroom 
to the bathroom to bathe her, and back again to dress her. Without 
respite services, I do not think I could continue to provide the 
necessary long-term care that is required for my daughter. As I age, I 
do wonder how much longer I will be able to maintain my daily ritual as 
my daughter's primary caregiver.''
    Disparate and inadequate funding streams exist for respite in many 
States. But even under the Medicaid program, respite is allowable only 
through State waivers for home and community-based care. Under these 
waivers, respite services are capped and limited to narrow eligibility 
categories. Long waiting lists are the norm.
    Respite may not exist at all in some States for adult children with 
disabilities still living at home, or individuals under age 60 with 
conditions such as ALS, MS, spinal cord or traumatic brain injuries, or 
children with serious emotional conditions. In Tennessee, a young woman 
in her twenties gave up school, career and a relationship to move in 
and take care of her 53 year-old mom with MS when her dad left because 
of the strain of caregiving. She went for years providing constant care 
to her mom with almost no support. Now 31, she wrote, ``And I was 
young--I still am--and I have the energy, but--it starts to weigh. 
Because we've been able to have respite care, we've developed a small 
pool of people and friends that will also come and stand in. And it has 
made all the difference.''

              RESPITE BENEFITS FAMILIES AND IS COST SAVING

    Respite has been shown to improve the health and well-being of 
family caregivers that in turn helps avoid or delay out-of-home 
placements, such as nursing homes or foster care, minimizes the 
precursors that can lead to abuse and neglect, and strengthens 
marriages and family stability.
    The budgetary benefits that accrue because of respite are just as 
compelling, especially in the policy arena. Delaying a nursing home 
placement for just one individual with Alzheimer's or other chronic 
condition for several months can save government long-term care 
programs thousands of dollars. Moreover, data from an ongoing research 
project of the Oklahoma State University on the effects of respite care 
found that the number of hospitalizations, as well as the number of 
medical care claims decreased as the number of respite care days 
increased (fiscal year 1998 Oklahoma Maternal and Child Health Block 
Grant Annual Report, July 1999). A Massachusetts social services 
program designed to provide cost-effective family-centered respite care 
for children with complex medical needs found that for families 
participating for more than 1 year, the number of hospitalizations 
decreased by 75 percent, physician visits decreased by 64 percent, and 
antibiotics use decreased by 71 percent (Mausner, S., 1995).
    In the private sector, a study by Metropolitan Life Insurance 
Company and the National Alliance for Caregivers found that U.S. 
businesses lose from $17,100,000,000 to $33,600,000,000 per year in 
lost productivity of family caregivers (MetLife and National Alliance 
for Caregiving, 2006). In an Iowa survey of parents of children with 
disabilities, a significant relationship was demonstrated between the 
severity of a child's disability and their parents missing more work 
hours than other employees. They also found that the lack of available 
respite care appeared to interfere with parents accepting job 
opportunities. (Abelson, A.G., 1999) Offering respite to working family 
caregivers could help improve job performance and employers could 
potentially save billions.

                LIFESPAN RESPITE CARE PROGRAM WILL HELP

    The Lifespan Respite Care Act is based on the success of statewide 
Lifespan Respite programs in four States: Oregon, Nebraska, Wisconsin 
and Oklahoma. Michigan passed State Lifespan Respite legislation in 
2004 but has not provided the funding to implement the program, and a 
State Lifespan Respite bill is currently pending in the Arizona State 
legislature.
    Lifespan Respite, which is a coordinated system of community-based 
respite services, helps States use limited resources across age and 
disability groups more effectively, instead of each separate State 
agency or community-based organization being forced to constantly 
reinvent the wheel or beg for small pots of money. Pools of providers 
can be recruited, trained and shared, administrative burdens can be 
reduced by coordinating resources, and the savings used to fund new 
respite services for families who may not currently qualify for any 
existing Federal or State program.
    The State Lifespan Respite programs provide best practices on which 
to build a national respite policy. The programs have been recognized 
by prominent policy organizations, including the National Conference of 
State Legislatures, which recommended the Nebraska program as a model 
for State solutions to community-based long-term care. The National 
Governors Association and the President's Committee for People with 
Intellectual Disabilities also have highlighted lifespan respite 
systems as viable solutions. And most recently, the White House 
Conference on Aging recommended enactment of the Lifespan Respite Care 
Act to Congress.
    The purpose of the new law is to expand and enhance respite 
services, improve coordination, and improve respite access and quality. 
Under a competitive grant program, States would be required to 
establish State and local coordinated Lifespan Respite care systems to 
serve families regardless of age or special need, provide new planned 
and emergency respite services, train and recruit respite workers and 
volunteers and assist caregivers in gaining access to services. Those 
eligible would include family members, foster parents or other adults 
providing unpaid care to adults who require care to meet basic needs or 
prevent injury and to children who require care beyond that required by 
children generally to meet basic needs.
    The Federal Lifespan Respite program would be administered by the 
U.S. Department of Health and Human Services [HHS], which would provide 
competitive grants to statewide agencies through Aging and Disability 
Resource Centers working in collaboration with State respite coalitions 
or other State respite organizations. The program is authorized at 
$40,000,000 in fiscal year 2008 rising to $95,000,000 in fiscal year 
2011.
    No other Federal program mandates respite as its sole focus. No 
other Federal program would help ensure respite quality or choice, and 
no current Federal program allows funds for respite start-up, training 
or coordination or to address basic accessibility and affordability 
issues for families. We urge you to include $40,000,000 in the fiscal 
year 2008 Labor, HHS, Education appropriations bill so that Lifespan 
Respite Programs can be replicated in the States and more families, 
with access to respite, will be able to continue to play the 
significant role in long-term care that they are fulfilling today.

                         NATIONAL ORGANIZATIONS

    American Association of People with Disabilities; American 
Association on Intellectual and Developmental Disabilities; American 
Dance Therapy Association;American Network of Community Options and 
Resources; American Psychological Association; Association of 
University Centers on Disabilities; Autism Society of America; Bazelon 
Center for Mental Health Law; Christopher and Dana Reeve Foundation; 
Chronic Illness Coalition; Easter Seals; Epilepsy Foundation; Family 
Voices; Generations United; National Association of Councils on 
Developmental Disabilities; National Association for Home Care and 
Hospice; National Association of Social Workers; National Association 
of State Head Injury Administrators; National Council on Aging; 
National Down Syndrome Congress; National Down Syndrome Society; 
National Family Caregivers Association; National Gerontological Nursing 
Association; National Multiple Sclerosis Society; National Organization 
For Empowering Caregivers; National Rehabilitation Association; 
National Respite Coalition; National Spinal Cord Injury Association; 
Older Women's League; Paralyzed Veterans of America; The ALS 
Association; The Arc of the United States; United Cerebral Palsy; Well 
Spouse Association; Wilson's Disease Association.

                     STATE AND LOCAL ORGANIZATIONS

    Alabama Lifespan Respite Resource Network; Allegheny County Respite 
Care Coalition, Pittsburgh, PA; Arizona Lifespan Respite Coalition (in 
formation); Catholic Family and Child Services, Yakima, WA; East 
Central Alabama United Cerebral Palsy; Easter Seals of Southern 
Georgia; Families Together, Inc., Wichita, Kansas; Family Voices 
Vermont; Illinois Respite Coalition; Iowa Respite and Crisis Care 
Coalition; Kansas Respite Coalition; Louisiana Developmental 
Disabilities Council; Maryland Respite Care Coalition; Michigan Respite 
Resource Network; Nebraska Respite Coalition; New Jersey Family Support 
Center; New Jersey Lifespan Respite Task Force; North Carolina Respite 
and Crisis Care Coalition; Oklahoma Respite Resource Network; Parent to 
Parent of Vermont; Partnership for People with Disabilities, Virginia 
Commonwealth University; Pennsylvania Respite Coalition; Respite and 
Crisis Care Coalition of Washington; Respite Care Association of 
Wisconsin; South Carolina Respite Coalition; Tennessee Respite 
Coalition; Tennessee Voices for Children; The Arc of King County, WA; 
United Cerebral Palsy of Huntsville and Tennessee Valley, Huntsville, 
AL; United Cerebral Palsy of Pennsylvanial; and Virginia Respite 
Resource Project.
                                 ______
                                 
          Prepared Statement of the National Sleep Foundation

              SUMMARY OF FISCAL YEAR 2008 RECOMMENDATIONS

    Provide a $10,000,000 increase in funding in fiscal year 2008 to 
the Centers for Disease Control and Prevention (CDC) to undertake data 
collection activities and create awareness and training programs 
related to sleep, sleep disorders and the consequences of sleep 
deprivation to improve public health and safety.
    Encourage CDC to continue to take a leadership role in partnering 
with other Federal agencies and voluntary health organizations in the 
National Sleep Awareness Roundtable to create collaborative sleep 
education and public awareness initiatives. In view of CDC's success 
with similar initiatives, encourage the CDC to financially support the 
Roundtable and its initiatives.
    Provide direction and funding of $1,000,000 to United States 
Surgeon General to develop and implement steps leading to the 
development of a report on sleep and sleep disorders in order to call 
attention to the public health impact of inadequate and disorder sleep 
in order to protect and advance the health and safety of the Nation.
    Mr. Chairman and members of the subcommittee, thank you for 
allowing me to submit testimony on behalf of the National Sleep 
Foundation (NSF). I am Dr. Barbara Phillips, Chair of the NSF Board of 
Directors and professor at the University of Kentucky College of 
Health, Department of Preventive Medicine. NSF is an independent, non-
profit organization that is dedicated to improving public health and 
safety by achieving understanding of sleep and sleep disorders, and by 
supporting sleep-related education, research, and advocacy. We work 
with sleep specialists and other health care professionals, 
researchers, patients and drowsy driving victims throughout the country 
as well as collaborate with many government, voluntary organizations 
and corporations to prevent health and safety problems related to sleep 
deprivation and untreated sleep disorders.
    Sleep problems, whether in the form of medical disorders or related 
to work schedules and a 24/7 lifestyle, are ubiquitous in our society. 
It is estimated that sleep-related problems affect 50 to 70 million 
Americans of all ages and socioeconomic classes. Sleep disorders are 
common in both men and women; however, important disparities in 
prevalence and severity of certain sleep disorders have been identified 
in minorities and underserved populations. Despite the high prevalence 
of sleep disorders, the overwhelming majority of sufferers remain 
undiagnosed and untreated, creating unnecessary public health and 
safety problems, as well as increased health care expenses. Surveys 
conducted by the National Sleep Foundation show that more than 60 
percent of adults have never been asked about the quality of their 
sleep by a physician, and fewer than 20 percent have ever initiated 
such a discussion.
    Additionally, Americans are chronically sleep deprived as a result 
of demanding lifestyles and a lack of education about the impact of 
sleep loss. Sleepiness affects vigilance, reaction times, learning 
abilities, alertness, mood, hand-eye coordination, and the accuracy of 
short-term memory. Sleepiness, as a result of untreated disorders or 
sleep deprivation, has been identified as the cause of a growing number 
of on-the-job accidents and automobile crashes.
    According to the National Highway Traffic Safety Administration's 
2002 National Survey of Distracted and Drowsy Driving Attitudes and 
Behaviors, an estimated 1.35 million drivers have been involved in a 
drowsy driving crash in the past 5 years. According to NSF's 2006 Sleep 
in America poll, 51 percent of all adolescents who drive report that 
they have driven drowsy at least once in the past year. In fact, 15 
percent of drivers in 10th to 12th grades say they drive drowsy once a 
week or more! A large number of academic studies have linked work 
accidents, absenteeism, and poor school performance to sleep 
deprivation and circadian effects.
    The recent Institute of Medicine (IOM) report, Sleep Disorders and 
Sleep Deprivation: An Unmet Public Health Problem, found the cumulative 
effects of sleep loss and sleep disorders represent an under-recognized 
public health problem and have been associated with a wide range of 
negative health consequences, including hypertension, diabetes, 
depression, heart attack, stroke, and at-risk behaviors--all of which 
represent long-term targets of the Department of Health and Human 
Services (HHS). Moreover, the personal and national economic impact is 
staggering. The IOM estimates that the direct and indirect costs 
associated with sleep disorders and sleep deprivation total hundreds of 
billions of dollars annually.
    Sleep science and government reports have clearly demonstrated the 
importance of sleep to health, safety, productivity and well-being, yet 
studies continue to show that millions of Americans are at risk for 
serious health and safety consequences of untreated sleep disorders and 
inadequate sleep. Unfortunately, despite recommendations in numerous 
Federal reports, there are no on-going national educational programs 
regarding sleep and fatigue issues aimed at the general public, health 
care professional, underserved communities or at-risk groups.
    NSF believes that every American needs to understand that good 
health includes healthy sleep, just as it includes regular exercise and 
balanced nutrition. We must elevate sleep to the top of the national 
health agenda. We need your help to make this happen.
    Our biggest challenge is bridging the gap between the outstanding 
scientific advances we have seen in recent years and the level of 
knowledge about sleep held by health care practitioners, educators, 
employers, and the general public. Because resources are limited and 
the challenges great, we think creative and new partnerships are needed 
to fully develop sleep awareness, education, and training initiatives. 
Consequently, the NSF is spearheading two important initiatives to 
raise public and physician awareness of the importance of sleep to the 
health, safety and well-being of the Nation.
    First, for the last 3 years, Congress has recommended that the CDC 
support activities related to sleep and sleep disorders. As a result, 
CDC's National Center for Chronic Disease Prevention and Health 
Promotion has been collaborating with more than twenty voluntary 
organizations and Federal agencies to form the National Sleep Awareness 
Roundtable (NSART), which was officially launched in March of this 
year. NSART is currently working through four task forces--public 
awareness, research, patient access to care, and public policy--to 
develop a National Action Plan. This document will address what is 
required to organize a successful collaboration to implement effective 
public and professional awareness and education initiatives to improve 
sleep literacy and healthy sleep behaviors. NSART is seeking to expand 
its membership by reaching out to new organizations and State and 
Federal agencies that are interested in raising awareness of sleep 
issues and implementing NSART's National Action Plan.
    The CDC has taken initial steps to begin to consider how sleep 
affects public health issues, but it needs appropriate resources to 
take additional actions, as recommended by the IOM and other 
governmental reports. Currently, the CDC budget does not include a line 
item for sleep-related activities.
    With adequate resources, the CDC could:
  --Add sleep-related items to established surveillance systems to 
        build the evidence base for the prevalence of sleep disorders 
        and their co-morbidities in order to increase awareness of 
        these issues on the national, State, and local levels.
  --Support the development of targeted approaches for delivering 
        messages to promote sleep, along with exercise and nutrition, 
        as a healthy behavior, and for increasing public and 
        professional education and awareness regarding the public 
        health impact of untreated sleep disorders and chronic sleep 
        loss.
  --Develop training materials for health care professionals regarding 
        the signs and symptoms of sleep disorders, as well as 
        countermeasures for drowsy driving and workplace accidents 
        related to sleep loss, shift work, and long work hours.
  --Increase and enhance fellowship opportunities to attract promising 
        researchers at universities and colleges across the country to 
        conduct epidemiological activities and health cost assessments 
        regarding sleep.
    NSF and members of the National Sleep Awareness Roundtable believe 
that a partnership with CDC is critical to address the public health 
impact of sleep and sleep disorders. We hope that the committee will 
provide funding of $10,000,000 to the CDC to begin programs as outlined 
here and to support efforts developed by NSART through a cooperative 
agreement similar to other roundtables in which CDC participates.
    Second, at the National Institutes of Health's Frontiers of 
Knowledge in Sleep and Sleep Disorders conference in 2004, the U.S. 
Surgeon General acknowledged widespread illiteracy in our country 
regarding sleep loss and untreated sleep disorders. He emphasized that 
sleep problems are easily related to the three top areas of the 
national health agenda: prevention, preparedness, and health 
disparities. Prevention of some of our Nation's most pressing health 
problems would be fostered by attending to sleep disorders. Sleep 
deprivation and fatigue are major barriers to maximizing preparedness 
and response in times of crisis. Finally, like many health and safety 
concerns, access to knowledge and medical care for sleep problems is 
beyond the reach of many Americans.
    For the last 2 years, Congress has directed the Office of the 
Surgeon General to help promote sleep as a public health concern 
through the development of a Surgeon General's Report on Sleep and 
Sleep Disorders, in order to call attention to the importance of sleep 
and develop strategies to protect and advance the health and safety of 
the Nation. The Surgeon General has expressed interest in addressing 
this issue through the development of a conference or workshop on how 
sleep impacts public health, but currently lacks the funding to 
proceed.
    Therefore, NSF respectfully requests that the committee provide 
direction and $1,000,000 in funding to the Office of the Surgeon 
General to develop a workshop and a call to action related to sleep and 
public health, in preparation for a Report on Sleep and Sleep 
Disorders.
    The IOM report includes important recommendations that support the 
sprit of these efforts and other specific actions to be taken by the 
CDC and the Office of the Surgeon General to raise awareness of sleep 
health and sleep disorders and to collect surveillance data to evaluate 
future education and intervention initiatives. CDC and the Surgeon 
General must receive direction and appropriate funding in order to 
continue partnering with voluntary health organizations and State and 
Federal agencies to increase support for initiatives that help ensure 
the health and safety of all Americans.
    Thank you again for the opportunity to present you with this 
testimony.
                                 ______
                                 
  Prepared Statement of the National Technical Institute for the Deaf

    Mr. Chairman and members of the committee: I am pleased to present 
the fiscal year 2008 budget request for the National Technical 
Institute for the Deaf, one of eight colleges of the RIT, in Rochester, 
NY. We serve the university needs of approximately 1,100 deaf/hard-of-
hearing students from across the nation and 150 hearing students, on a 
campus of over 14,000 students. Created by Congress, we provide 
postsecondary technical education to prepare deaf/hard-of-hearing 
students for successful employment.
    NTID has fulfilled this mandate with distinction for 39 years.

                             BUDGET REQUEST

    NTID's fiscal year 2008 request is $60,757,000. This consists of 
$59,052,000 for continuing operations and $1,705,000 for construction 
projects initiating replacement of aging mechanical systems. The NTID 
request and the President's are shown below.

----------------------------------------------------------------------------------------------------------------
                                                             Operations        Construction          Total
----------------------------------------------------------------------------------------------------------------
NTID request...........................................        $59,052,000         $1,705,000        $60,757,000
President's Request....................................         55,349,000            913,000         56,262,000
                                                        --------------------------------------------------------
      Difference.......................................          3,703,000            792,000          4,495,000
----------------------------------------------------------------------------------------------------------------

    We are respectfully requesting that the committee restore the 
appropriation to the NTID requested level. Our operations request does 
not include additional funding for new academic programs or headcount. 
Instead, we are committed to fund all program improvements and 
increases in headcount, if any, through the reallocation of existing 
resources.
    We commit because we have consistently minimized requests. From 
fiscal year 2003 to fiscal year 2007 we saved of $6.2 million by 
increasing revenues and reducing/reallocating headcounts. These 
difficult savings controlled budget requests while allowing expansion 
in areas such as speech-to-test services for deaf/hard-of-hearing 
students who do not know sign language.
    We are proud of those accomplishments; however, those actions leave 
limited flexibility regarding what we respectfully submit is inadequate 
funding proposed in the President's budget. Significant reductions 
threaten our vitality, and leave us with options such as the following:
    1. Not Funding Technology Needs.--Student curricula demand state-
of-the-art technology updates to prepare students for jobs. For deaf/
hard-of-hearing students, technology to support the delivery of 
instruction is critical. We spend $1,000,000/year for technology; 
eliminating that would reduce programming development and quality.
    2. Not Supporting Endowment Allocations.--The Education of the Deaf 
Act authorizes matching private donations from appropriations, to 
reduce dependence on Federal funds. In fiscal year 2006, NTID matched 
over $900,000; we do not want to stop this practice.
    3. Not Supporting Outreach Efforts, Which Impact Future 
Enrollment.--Approximately $542,000 supports six programs designed to: 
attract junior/senior high school students to NTID; create a Community 
College Referral Program; and establish a Summer English Institute. All 
are designed to increase future enrollments.
    4. It Does Not Include a Fair Labor Standards Act (FLSA) Lawsuit 
Against RIT With a $2.5 Million Settlement Proposal Announced in March, 
2007.--It affects 170 current RIT employees including about 140 NTID 
employees (mostly sign language interpreters), and others who have 
worked for NTID within the last 6 years. A proportion of the settlement 
may be paid by NTID in fiscal year 2008; the exact amount is to be 
determined.
    With the reclassification of positions from exempt-from-overtime to 
non-exempt-from-overtime, we expect an increase in our compensation 
expenses. The financial impact is to be determined; however, its impact 
is immediate, beginning April 16, 2007.
    5. It Does Not Recognize the Effect of Inflation and the Impact of 
Freezing Positions.--NTID budgeted a 3 percent salary increase in 
fiscal year 2007, but the RIT increase was 3.5 percent; we follow RIT 
per our Department of Education agreements. At level fiscal year 2008 
funding we will consider freezing open positions, including those we 
have aggressively filled such as speech-to-text services which expanded 
in response to an Office of Civil Rights ruling.
    NTID expenses are driven by inflationary pressures. We must fund 
salary, health care, and energy costs increases, and the rising costs 
of RIT services, which are subject to the same pressures. Taken 
together, these costs represent over 80 percent of NTID's total 
expenditures.
    The President's request for fiscal year 2008 ignores inflationary 
increases and returns to fiscal year 2006 levels. Our requested 
increase of $3,703,000 in fiscal year 2008 operations over that fiscal 
year 2006 level is the equivalent of having obtained an increase of 3.3 
percent both from fiscal year 2006 to fiscal year 2007 (which we did 
not receive) and from fiscal year 2007 to fiscal year 2008. We believe 
these requests are supported by the rationale above on the negative 
impact of various potential reductions.
    Regarding construction, the President's request partially funds the 
$1.7 million needed to replace mechanical heating, ventilation, and 
air-conditioning systems (well past their expected lives in 40 year old 
buildings) and the delivery of energy to NTID buildings. The systems 
have been well maintained but on-going maintenance difficulties dictate 
replacement at this time.

                               ENROLLMENT

    Total enrollment is at 1,250 for school year 2006-2007 (fiscal year 
2007), and was 1,256 students last year. NTID anticipates maintaining 
or increasing enrollment for school year 2007-2008 (fiscal year 2008). 
A 5-year summary of student enrollment follows.

                                                            NTID ENROLLMENTS--5 YEAR NUMBERS
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                      Deaf/Hard-of-Hearing Students                 Hearing Students
                                                              --------------------------------------------------------------------------------   Grand
                         School Year                                                                       Interpreting                          Total
                                                               Undergrad   Grad RIT     MSSE     Subtotal     Program       MSSE     Subtotal
--------------------------------------------------------------------------------------------------------------------------------------------------------
2002-3.......................................................      1,093         29         16      1,138           65          28         93      1,231
2003-4.......................................................      1,064         45         41      1,150           92          28        120      1,270
2004-5.......................................................      1,055         42         49      1,146          100          35        135      1,281
2005-6.......................................................      1,013         53         38      1,104          116          36        152      1,256
2006-7.......................................................      1,017         47         31      1,095          130          25        155      1,250
--------------------------------------------------------------------------------------------------------------------------------------------------------

    The number of students studying in our interpreting program has 
grown substantially, the number in our graduate secondary teacher 
preparation program--MSSE--has fluctuated (totaling both MSSE columns 
above), and the sub-total of deaf/hard-of-hearing students has declined 
from 1,138 in 2002-2003 to 1,095 in 2006-2007, a decline of 43 
students. However, the decline in enrollment of deaf/hard-of-hearing 
students parallels almost one-for-one the drop in international 
students from 90 enrolled in 2002-2003 to 42 enrolled in 2006-2007, a 
decline of 48 students. A change in the Education of the Deaf Act 
increased the surcharge on tuition for international students from 50 
percent to 100 percent, resulting in the significant decline.

       INCREASING NUMBERS OF STUDENTS WITH SECONDARY DISABILITIES

    NTID is working with significantly increased numbers of students 
with disabilities in addition to deafness. The table shows the number 
and percent of students receiving services from the RIT Disability 
Services Office, which serves students with physical or mental 
impairments that limit one or more major life activities. Their 
services assure equal access to education based upon legal foundations 
established by Federal law--the Rehabilitation Act of 1973 including 
section 504, and the Americans with Disabilities Act of 1990.

 NUMBER AND PERCENT OF STUDENTS RECEIVING SECONDARY DISABILITY SERVICES
------------------------------------------------------------------------
                     Year                          Number      Percent
------------------------------------------------------------------------
1998-1999.....................................           33          3.0
1999-2000.....................................           57          5.0
2000-2001.....................................           82          7.6
2001-2002.....................................           78          7.2
2002-2003.....................................           97          8.6
2003-2004.....................................           95          8.7
2004-2005.....................................          110         10.3
2005-2006.....................................          129         12.7
------------------------------------------------------------------------

    While we are unable to calculate the additional budgetary costs, it 
is clear that services are increasing significantly year-by-year, with 
associated increased costs.

                        STUDENT ACCOMPLISHMENTS

    Our recently reported placement rate indicates that 95 percent of 
NTID's fiscal year 2005 graduates in the labor force were employed 
(using the methodology of the Bureau of Labor Statistics) in jobs 
commensurate with the level of their academic training. Over the last 5 
years, a large proportion (83 percent) were employed in science, 
engineering, business, and visual communications.
    In fiscal year 2005, new research conducted with the Social 
Security Administration and Cornell University examined 10,196 
graduates and withdrawals spanning 25 years. It shows that graduation 
from NTID has significant economic benefits over a lifetime of work. 
Baccalaureate graduates earn, on average during their peak earning 
years, $12,020 more per year than students who attend, but withdraw 
without a degree; sub-baccalaureate graduates earn $4,762 more. 
Students who withdraw experience twice the rate of unemployment as 
graduates.
    NTID clearly makes a significant, positive difference in the 
earnings, and in turn in the lives of those who graduate.
    While 60 percent of students attending NTID receive benefits 
through the Supplemental Security Income program (SSI), by the time 
they are at age 50, less than 3 percent of graduates continue to draw 
SSI benefits. Graduates also access Social Security Disability 
Insurance (SSDI), fundamentally an unemployment benefit, at far lesser 
rates than withdrawals. By age 50, withdrawals were twice as likely to 
be receiving SSDI as degree graduates.
    A large percentage of non-graduates will continue to depend heavily 
on Federal income support throughout their lives. But NTID graduation 
significantly reduces dependence on welfare programs. Considering the 
added taxes graduates pay as a result of their increased earnings, and 
the savings derived from reduced dependency on the Federal income 
support programs, the Federal investment in NTID returns significant 
societal dividends.

                            NTID BACKGROUND

    Academic Programs.--NTID offers high quality, career-focused, 
associate degree programs that lead to placement in well-paying 
technical careers. A cooperative education component ties closely to 
high demand employment opportunities. We are expanding transfer 
associate degree programs to better serve the higher achieving segment 
of our student population who seek bachelors and masters degrees in an 
increasingly demanding marketplace. These transfer programs provide for 
seamless transition to baccalaureate studies. Finally, we support 
students in RIT baccalaureate programs. One of NTID's greatest 
strengths is its outstanding track record of assisting high-potential 
students to gain admission to and to graduate from the other colleges 
of RIT at rates that are better than their hearing peers.
    Research.--The research program and agenda are guided and organized 
according to these general research areas: Language and Literacy, 
Teaching and Learning, Socio-cultural Influences, Career Development, 
Technology Integration, and Institutional Research. All benefit 
enrolled students as well as deaf/hard-of-hearing adults throughout the 
country.
    Outreach.--Extended outreach activities to junior and senior high 
school students, expand their horizons regarding a college education.
    Student Life.--The new Student Development Center, funded by a $2.0 
million gift from a private individual and $1.5 million fiscal year 
2005 Federal appropriations has been occupied. Our activities foster 
student leadership and community service, and providing opportunities 
to explore other educational interests.

                                SUMMARY

    The fiscal year 2008 request will allow NTID to continue its 
mission of preparing deaf/hard-of-hearing people to enter the workplace 
and society and compete with their hearing peers. Our alumni have 
demonstrated that they can achieve full independence and become 
contributing members of society; they can earn a living and live a 
satisfying life as a result of the postsecondary education received at 
NTID. Collaborative research between NTID and the Social Security 
Administration shows that NTID graduates over their lifetimes are 
employed at a much higher rates, earn substantially more (therefore 
paying significantly more in taxes), and participate at a much lower 
rate in Federal welfare programs.
    We are hopeful that the members of the committee will agree that 
NTID, with its outstanding record of service to deaf/hard-of-hearing 
people, remains deserving of their support and confidence.
                                 ______
                                 
Prepared Statement of the National Tuberculosis Controllers Association

    The National Tuberculosis Controllers Association (NTCA) is pleased 
to submit our recommendations for TB control programs in the Labor 
Health and Human Services and Education Appropriations subcommittee 
purview.
    The National Tuberculosis Controllers Association (NTCA) is a 
membership organization composed of persons who are working, or have 
worked in Tuberculosis Control programs in the United States and it's 
Pacific Affiliated Islands. Membership is also extended to our partners 
in other TB-related organizations and to any other persons who have 
interest in Tuberculosis control issues.
    The United States is now facing unprecedented threats in our 
progress towards the goal of eliminating TB and even our fundamental 
responsibility to control TB, due to regressive cuts to programs that 
are essential to contain the disease and prevent the creation of new 
highly dangerous strains of drug resistance.

                 PREVALENCE OF TB IN THE UNITED STATES

    Tuberculosis (TB) is a disease caused by a bacterium that is spread 
through the air--that is, it is spread from person-to-person by sharing 
the air that we breathe. Infection affects some people immediately, but 
for many, it becomes ``dormant,'' to become active at a later time. It 
is estimated that one-third of the world's population is infected with 
TB in this latent form, and indeed, these people form a reservoir of a 
disease that kills more than 2 million adults and children each year 
(1 every 15 seconds) and remains the leading cause of human death from 
an infectious disease today.
    In the United States, efforts to control the disease following its 
resurgence in the early 1990's have created a public health 
infrastructure that has been able to achieve that goal in many sectors. 
At the heart of this endeavor is the Centers for Disease and Control's 
(CDC) Division of TB Elimination (DTBE), which coordinates prevention 
and control activities to States through cooperative agreement awards 
to support categorical infrastructure. Following interim analyses, the 
Institute of Medicine (IOM) declared in its 2000 report, Ending 
Neglect, the Elimination of Tuberculosis in the United States, that TB 
could be eliminated as a public health problem in the United States by 
2010. The 13,767 cases reported in 2006 represent the lowest absolute 
number of cases ever recorded in our country. But we are far from TB 
elimination. The lower numbers have again lulled us into a false sense 
of security, and as Federal support once again is being withdrawn, we 
are facing another potential and more dangerous challenge to our 
public's health.
    The majority of U.S. TB cases come from outside U.S. borders. 
Fifty-five percent of 2006 TB cases were non-U.S. born, but the 
majority of these individuals have resided in the United States for 
more than 5 years and are citizens. Twenty States reported increases in 
TB cases in 2006 over 2005, with the District of Columbia recording the 
highest TB case rate (12.6/100,000) in the Nation.
    White, U.S.-born people no longer make up the majority of TB cases 
in the United States--TB now embraces racial and ethnic minorities as 
never before. African Americans have 8 times the risk of developing TB 
as whites; Hispanics and Asians have 8 and 21 times the risk, 
respectively. Our health systems have been slow to adapt to the needs 
of these populations.

                        CHALLENGES TO TB CONTROL

    In its November 2005 statement, CDC recognized 5 critical 
challenges to controlling TB in the United States. Addressing each 
challenge requires intact and fully functional local public health 
systems that are able to reach people at-risk, unique to populations in 
individual States and to the disease. Our State and local TB programs 
are losing the front-line, experienced staff that provide adequate case 
management to persons with active (and infectious) TB and ensure safe 
completion of treatment (at least 6-9 months of multiple medications), 
preventing the emergence of drug resistance among those who do not take 
medications appropriately. As programs lose funding, it is these 
essential, ``core'' services that are being compromised, or even 
eliminated entirely.
    The Division of TB Elimination has been level-funded for at least 
12 years; in 2006, our State and local programs were asked to absorb a 
real cut of 4.8 percent in Federal funding. The impact has been 
stealthy, but clear. These are examples:
    In Massachusetts, 77 percent of reported TB cases are foreign-born, 
and among this group, about 95 percent are drug-resistant. The State 
also has fewer staff resources to handle these cases since nine field 
staff positions (21 percent of the work force) have been lost since 
2002.
    In New York City, 1,185 patients had to be managed by 26 fewer 
nurses and field staff (an 18 percent cut).
    California has more than 20 percent of our national cases, 2,800, 
of whom 78 percent are foreign-born. California reports an 11 percent 
rate of drug resistance and yet had to deal with a 9 percent reduction 
in its Federal support versus 2005.
    California and New York both reported cases of the new Extensively 
Drug-Resistant (XDR)-TB strain in 2006. These strains are virtually 
resistant to current treatment regimens and are associated high levels 
of mortality.
    In December, Dr. Michael Fleenor, Chair of the National Advisory 
Committee on the Elimination of Tuberculosis, wrote to Secretary 
Leavitt and to CDC Director Gerberding to express concerns of the 
Council concerning the current negative impact of these funding 
reductions and to point out the urgent need to address these concerns 
in light of the new strains of XDR-TB. XDR-TB is produced by the 
failure to effectively treat individuals with other multidrug resistant 
TB (MDR TB) strains. Each of the 118 MDR TB cases reported in the 
United States in 2005 has the potential to become XDR TB without the 
expertise and infrastructure to cure the disease through directly 
observed treatment. Make no mistake--XDRTB is already in the United 
States and only our public health infrastructure prevents the 
production of more cases!
    The resurgence of tuberculosis and the emergence of Multi-Drug 
Resistant TB (MDRTB), organisms resistant to the two most effective 
drugs in the 1990's resulted from a collapse of the same infrastructure 
that we have since struggled to re-create, and are in the process of 
disassembling once again at this very moment. In short, we are being 
set up to fail. Earlier this year, U.S. Assistant Surgeon General and 
DTBE Director, Dr. Kenneth Castro warned the TB control community to 
anticipate a further reduction of 25 percent in Federal support for TB 
control over the next 5 years. Such a reduction bodes poorly for 
sustained efforts to control the disease, and, in the face of emerging 
XDR-TB, is a potential disaster.
    There is another lethal disease, to which governmental response 
was, on balance, both swift and appropriate, and from which we can 
learn: SARS. XDR-TB is, in many ways imminently more dangerous than 
SARS. While both are virtually untreatable, have extremely high death 
rates and are transmissible from person to person, TB unlike SARS, has 
both a human reservoir and a state of Latent Infection. TB, both 
regular and XDR, can lie dormant, only to emerge months or years later 
and spread person to person. Yet today we are facing funding cutbacks 
rather than vitally needed increases to keep our defensive 
infrastructure intact against TB.
    In order to put our domestic situation in proper context. Basic and 
applied research is sorely needed to help us understand the complex 
interactions between the TB organism and human beings which gives rise 
to latent and active disease. Research will provide insights as to how 
we might reduce the length, complexity, and toxicity of our currently 
limited drugs; it will provide us with tools to diagnose TB disease and 
dormant infection quickly; and it will help us understand how to reach 
people at-risk to prevent TB from developing. Laboratories must have 
better tools to identify and report drug resistance cheaply and 
quickly. And we must use our understanding and our resources to assist 
other countries in controlling the disease and preventing the emergence 
of active disease in those with dormant infection--for the world's 
problem truly is our problem too.
    The CDC DTBE clearly has demonstrated its ability to work closely 
with State and local public health TB programs to address issues of TB 
control. This association and cooperative partnership is responsible 
for the successes we have achieved over the past 15 years and it should 
be reinforced by assuring adequate support for the unprecedented 
challenges we are now facing. The current funding level of $137.4 
million for DTBE actually represents a 23 percent decrease over the 
past decade, adjusted for inflation. The NTCA recommends that the 
committee adopt the National Coalition for the Elimination of 
Tuberculosis's recommendation of an increase of $390.6 million in 
project funding for the CDC's Division of Tuberculosis Elimination for 
a total of $528 million in fiscal year 2008. This includes:
  --To Maintain Control of Core Activities and Regional Medical 
        Training and Consultation Centers (RTMCC's)--$185 million
  --Preparedness & Outbreak Response Capacity for XDR TB--$45 million.
  --Accelerating the Decline--$75 million.
  --For Research and Development of New Tools, Drugs and Diagnostics--
        $110 million.
  --For Intensified Support for Action to Accelerate Control (ISAAC). 
        Includes Enhancements to Surveillance, Laboratory, Border 
        Health, Health Disparities, Evaluation, and Research 
        Translation (Turning Research Into Practice)--$113 million.

                               CONCLUSION

    Clearly, the responsibility for TB control is a shared one. The CDC 
DTBE has an excellent track record of working closely with State and 
local health departments, providers and communities; the successful 
control of TB among residents of New Orleans during the hurricane is a 
recent example. Without the expertise and public health infrastructure 
that was in place, the 130 TB cases that were distributed from New 
Orleans to emergency shelters across the United States would have led 
to multiple outbreaks of TB. However, the ongoing budget cuts at the 
CDC directly impair TB prevention and control core activities within 
the States and seriously compromise a remarkable successful 
relationship. We have seen this pattern before. We know this will leave 
us once again at risk of an even more deadly epidemic of tuberculosis. 
The NCTA appreciates the opportunity to submit this statement to the 
subcommittee.
                                 ______
                                 
             Prepared Statement of the NephCure Foundation

            SUMMARY OF RECOMMENDATIONS FOR FISCAL YEAR 2008

    A 6.7 percent increase for the National Institutes of Health (NIH) 
and the National Institute of Diabetes and Digestive and Kidney 
Diseases (NIDDK).
    Continue to expand the NIDDK's Nephrotic Syndrome (NS) and Focal 
Segmental Glomerularsclerosis (FSGS) research portfolios by 
aggressively supporting grant proposals in this area and creating a 
Glomerular Diesease Registry.
    Encourage the National Center for Minority Health and Health 
Disparities (NCMHD) to initiate studies into the incidence and cause of 
NS and FSGS in minority populations.
    Mr. Chairman and members of the subcommittee, the NephCure 
Foundation (NCF) is grateful for the opportunity to present testimony 
before you. NCF is a non-profit organization that is driven by a panel 
of respected medical experts and a dedicated band of patients and 
families that work together to save kidneys and also lives. NCF is the 
only non-profit organization exclusively devoted to fighting idiopathic 
nephrotic syndrome (NS) and focal segmental glomerulosclerosis (FSGS). 
Now in our sixth year, the NephCure Foundation continues to work 
tirelessly to support glomerular disease research.

                        FSGS: ONE FAMILY'S STORY

    Bradly Grizzard, was diagnosed with focal segmental 
glomerulosclerosis (FSGS) in 2002. In May of 2005, his mother donated 
one of her kidneys to him.
    FSGS is one of a cluster of glomerular diseases that attack the 
tiny filtering units contained in each human kidney, known as nephrons. 
Glomerular disease attacks the portion of the nephron called the 
glomerulus, scarring and often destroying these filters. Currently, 
scientists do not know why glomerular injury occurs, and there is no 
known cure for these diseases.
    Upon diagnosis, an FSGS patient's health often takes a rapid 
downward plunge at and it is extremely difficult to make a comeback. 
Bradly was a star football player at his high school and was being 
recruited by college football coaches before FSGS attacked his body. 
When his kidneys failed, he was forced to give up football, as well as 
juggle college classes with several hours of dialysis a day. He was 
lucky that his mother's kidney was a match, but even so, the first few 
hospitals that they approached refused to perform the transplant. They 
were eventually able to find a doctor and a hospital that was willing 
to perform the operation, and the transplanted kidney is now working 
well. Even though Bradly is now feeling much stronger, he must remain 
on costly immunosuppressant drugs for the rest of his life. These drugs 
cause many unpleasant side effects and medical complications.
    Sadly, Bradly's story is far from unique. There are thousands of 
people in this country who have had their lives disrupted due to the 
sudden onset of FSGS. Furthermore, although kidney transplants have 
been very successful for thousands of FSGS patients, many patients end 
up rejecting the transplanted kidney. A large percentage of patients 
even see the FSGS comes back and attacks the transplanted kidney. In 
either case, the patient must then again rely on daily dialysis as a 
means of survival. There are thousands of young people who are in a 
race against time, hoping for a treatment that will save their lives. 
The NephCure Foundation today raises its voice to speak for them all, 
asking you to take specific actions that will aid our mission to find 
the cause and cure of NS/FSGS.
    First and foremost, we join the Ad Hoc Group for Medical Research 
Funding in asking for a 6.7 percent increase for the National 
Institutes of Health (NIH) and the National Institute of Diabetes and 
Digestive and Kidney Diseases (NIDDK).

                        MORE RESEARCH IS NEEDED

    Little progress has been made on finding the cause of or the cure 
for FSGS. Scientists tell NCF that much more research needs to be done 
on the basic science behind the disease.
    NCF is thankful that the NIDDK is continuing to work with us on the 
FSGS clinical trial. Currently, 150-175 patients nationwide are 
enrolled in the trial. Recently, the steering committee charged with 
providing programmatic direction to the trial decided on several 
changes which would accelerate progress. NCF is also working with the 
NIDDK to cosponsor ancillary basic biological material studies of the 
enrolled patients.
    NCF is pleased to learn that the NIDDK is intending to re-release 
the program announcement (PA) entitled, ``Exploratory Basic Research in 
Glomerular Disease'' (PA-06-228). After being originally introduced as 
a R21 PA in March of 2006, PA-06-228 was rescinded along with all other 
non-clinical R21 programs when they were folded into the general NIH 
wide solicitation. NCF is optimistic that re-issuing this PA under the 
RO1 mechanism, as intended, will stimulate significant research into 
glomerular diseases.
    As health information technology continues to advance, disease 
registries and databases are fast becoming a crucial resource and vital 
source of information. The basic understanding of numerous conditions 
has been greatly improved by compiling patient information and disease 
data. At this time, no such registry exists for glomerular diseases. 
NCF has been informed by researchers and scientists that such a 
registry would greatly increase the clinical knowledge of NS and FSGS.
    We ask the committee to encourage the NIDDK to help find the cause 
and the cure for glomerular disease by continuing its support for the 
FSGS clinical trial and the ancillary basic biological material 
studies. We also ask the NIDDK to continue to add glomerular disease to 
program announcements. Additionally, we would like the committee to 
recommend that the NIDDK place a high priority on any initiatives that 
seek to establish a glomerular disease registry.

              TOO LITTLE EDUCATION ABOUT A GROWING PROBLEM

    When glomerular disease strikes, the resulting nephrotic syndrome 
causes a loss of protein in the urine and edema. The edema often 
manifests itself as puffy eyelids, a symptom that many parents and 
physicians mistake as allergies. With experts projecting a substantial 
increase in nephrotic syndrome in the coming years, there is a clear 
need to educate pediatricians and family physicians about glomerular 
disease and its symptoms.
    NCF has conducted numerous education programs. A national FSGS 
conference was held in Philadelphia from June 3-4, 2006. This 
conference sought to provide attendees with the most up to date 
information on this disease. Through speakers, information sessions, 
and informal conversations with other patient families, attendees 
realized that they are not alone and will be further energized for the 
effort to find a cause and a cure for FSGS.
    Also, last summer, the NIDDK sponsored a working group scientific 
conference. This working group advised NIDDK on animal models, 
reagents, and other resources for the study of glomerular disease.
    NCF also applaud the work of the NIDDK in establishing the National 
Kidney Disease Education Program (NKDEP), and we seek your support in 
urging the NIDDK to make sure that glomerular disease remains a focus 
of the NKDEP.
    We ask the committee to encourage the NIDDK to have glomerular 
disease receive high visibility in its education and outreach efforts, 
and to continue these efforts in conjunction with the NephCure 
Foundation's work. These efforts should be targeted towards both 
physicians and patients.

            GLOMERULAR DISEASE STRIKES MINORITY POPULATIONS

    Nephrologists tell NCF that glomerular disease strikes a 
disproportionate number of African-Americans. No one knows why this is, 
but some studies have suggested that a genetic sensitivity to sodium 
may be partly responsible. DNA studies of African Americans who suffer 
from FSGS may lead to insights that would benefit the thousands of 
African Americans who suffer from kidney disease.
    NCF asks that the NIH pay special attention to why this disease 
affects minority populations to such a large degree. NCF wishes to work 
with the NIDDK and the National Center for Minority Health and Health 
Disparities (NCMHD) to encourage the creation of programs to study the 
high incidence of glomerular disease within the African-American 
population.
    There is also evidence to suggest that the incidence of glomerular 
disease is higher among Hispanic-Americans than in the general 
population. An article in the February 2006 edition of the NIDDK 
publication Recent Advances and Emerging Opportunities, discussed the 
case of Frankie Cervantes, a 6 year old boy of Mexican and Panamian 
descent. Frankie has FSGS, and like Bradly, received a transplanted 
kidney from his mother. We applaud the NIDDK for highlighting FSGS in 
their publication, and for translating the article about Frankie into 
both English and Spanish. Only through similar efforts at cross-
cultural education can the African-American and Hispanic-American 
communities learn more about glomerular disease.
    We ask the committee to join with us in urging the NIDDK and the 
National Center for Minority Health and Health Disparities (NCMHD) to 
collaborate on research that studies the incidence and cause of this 
disease among minority populations. We also ask that the NIDDK and the 
NCMHD undertake culturally appropriate efforts aimed at educating 
minority populations about glomerular disease.
    Thank you again for this opportunity and please contact us if you 
have any questions or require additional information.
                                 ______
                                 
              Prepared Statement of NTM Info and Research

                         AGENCY RECOMMENDATIONS

    CDC: NTMIR requests a $7,000,000 allocation in the budget to enable 
CDC, Infectious Diseases HIV/AIDS, STD and TB Prevention Program to 
launch an external partnership to develop and implement a public health 
education and outreach initiative to promote NTM education for health 
care providers and the general public. Further NTMIR requests that CDC 
develop specific epidemiology studies regarding prevalence, geographic, 
demographic and host specific data regarding NTM infection in the 
population.
    NIH: NTMIR requests an allocation in the budget to enable NIH, 
NHLBI to advance diagnostics and treatments for patients suffering from 
pulmonary Nontuberculous Mycobacteria (NTM) disease. NTMIR further 
requests that NHLBI issue a program announcement or other appropriate 
mechanism to ensure the initiation of grant proposals
    NIH: NTMIR requests an allocation in the budget to enable NIH, 
NIAID to collaborate further with NHLBI, the advocacy community and 
other Federal agencies to advance the understanding of NTM by 
establishing a national registry of patients and to issue a program 
announcement, an NIH partnership funding program or other appropriate 
mechanism to ensure the initiation of grant proposals and other 
activities in NTM.
    Thank you for the opportunity to submit a statement on behalf of 
NTM Info & Research and all the patients suffering with pulmonary NTM 
disease.

     WHAT IS PULMONARY NONTUBERCULOUS MYCOBACTERIAL DISEASE (NTM)?

    NTM is an infectious disease considered to be of environmental 
origin as these bacteria are ubiquitous in the water and soil that 
surround us. Although NTM is diagnosed by the same basic test used to 
diagnose traditional tuberculosis (TB), it is significantly more 
difficult to treat. NTM progressively diminishes lung capacity, with 
all the attendant negative consequences in life.
    Unfortunately, even though TB has a significantly high profile, NTM 
does not because education and awareness have been lacking. 
Furthermore, there is growing evidence that NTM is many times more 
prevalent than TB in the United States. For example, the State of 
Florida Infectious Disease Laboratory reports receiving over twice as 
many specimens that are NTM positive for every one that is positive for 
TB. Even more startling, the Agency for Health Care Administration for 
Florida hospital patient discharges shows almost 9 times the number of 
patients with the primary diagnosis of NTM versus those with TB.
    Doctors in leading treating facilities are reporting that even 
though NTM is not reportable, they are seeing more NTM patients than TB 
patients. A current report from Toronto, Ontario indicates that the 
prevalence may be six times higher than the older data we have in the 
United States.
    NTM is not limited to one strain and has certain strains that are 
inherently resistant to drug therapy, and in all cases multiple drugs 
are required on a lengthy to permanent basis. A significant number of 
patients require short- to long-term intravenous medication and this is 
a particular hardship for the elderly because Medicare does not cover 
in-home therapy. Medicare recipients must be hospitalized one to three 
times a week driving treatment costs significantly higher than in 
alternate settings.

                      NTM INFO & RESEARCH (NTMIR)

    NTMIR was founded through a partnership of concerned patients and 
interested physicians who see increasing numbers of people affected by 
this devastating disease. NTMIR was created to expand professional 
awareness, diagnosis and treatment, facilitate research and provide 
patient support. Our mission is a public/private partnership to advance 
the science and the outcomes for countless patients with NTM disease.
    NTMIR has already demonstrated a track record of success since it 
commenced its activities just 3 years ago. These include, successful 
implementation of the NTMInfo.org website and online support group, 
patient education throughout the country through the replication of an 
NTM information pamphlet, initiating professional education and Grand 
Round lectures to increase professional education both for specialists 
and family physicians, establishment of a partnership of cooperation 
with public health in the State of Florida and with the American Lung 
Association of Florida. NTMIR negotiated an agreement between a major 
pharmaceutical company, the FDA and a division of HRSA to provide an 
urgently needed drug for patients who could not otherwise obtain it, 
some of whom might have died without it.
Fern Leitman's Story
    In September 1996, shortly after lung surgery, Fern's health 
deteriorated to the point where her doctors suggested that her children 
be called. Fern was rushed to a procedure room to put a bronchoscope 
into her lungs to see what was happening.
    NTM can affect any one of us . . . but for some unknown reason it 
affects more women than men.
    Fern's normal morning routine starts with pulmonary therapy to 
clear her airways. Then there is a sinus wash. With breakfast, Fern 
takes five different oral drugs and IV medicines. In addition, there 
are inhaled medicines. The total time from awakening to being able to 
leave the house is usually 4 hours.

    THE NEEDS OF NTM PATIENTS HAVE GONE UNMET--MORE CAN BE DONE NOW!

    While tuberculosis is often known to appear in inner cities and 
immigrant populations, NTM knows no such boundaries. However, current 
epidemiologic data is not available. The latest data that we have from 
the Centers for Disease Control was collected in the 1980's and we 
urgently need newer data. Current data from the University of Toronto 
suggests that the prevalence may be six times higher than our older 
information. We have no reason to believe that Toronto is any different 
than Chicago, Miami or any other major U.S. city.
                                 ______
                                 
           Prepared Statement of the Oncology Nursing Society

                                OVERVIEW

    The Oncology Nursing Society (ONS) appreciates the opportunity to 
submit written comments for the record regarding fiscal year 2008 
funding for cancer and nursing related programs. ONS, the largest 
professional oncology group in the United States, composed of more than 
35,000 nurses and other health professionals, exists to promote 
excellence in oncology nursing and the provision of quality care to 
those individuals affected by cancer.
    This year more than 1,444,920 Americans will be diagnosed with 
cancer, and more than 565,000 will lose their battle with this terrible 
disease. Despite these grim statistics, significant gains in the War 
Against Cancer have been made through our Nation's investment in cancer 
research and its application. Research holds the key to improved cancer 
prevention, early detection, diagnosis, and treatment, but such 
breakthroughs are meaningless, unless we can deliver them to all 
Americans in need. Moreover, a recent survey of ONS members found that 
the nursing shortage is having an adverse impact in oncology physician 
offices and hospital outpatient departments. Some respondents indicated 
that when a nurse leaves their practice, they are unable to hire a 
replacement due to the shortage--leaving them short-staffed and posing 
scheduling challenges for the practice and the patients.
    To ensure that all people with cancer have access to the 
comprehensive, quality care they need and deserve, ONS advocates 
ongoing and significant Federal funding for cancer research and 
application, as well as funding for programs that help ensure an 
adequate oncology nursing workforce to care for people with cancer. The 
Society stands ready to work with policymakers at the local, State, and 
Federal levels to advance policies and programs that will reduce and 
prevent suffering from cancer and sustain and strengthen the Nation's 
nursing workforce. We thank the subcommittee for its consideration of 
our fiscal year 2008 funding request detailed below.

    SECURING AND MAINTAINING AN ADEQUATE ONCOLOGY NURSING WORKFORCE

    Oncology nurses are on the front lines in the provision of quality 
cancer care for individuals with cancer--administering chemotherapy, 
managing patient therapies and side-effects, working with insurance 
companies to ensure that patients receive the appropriate treatment, 
providing counseling to patients and family members, and engaging in 
myriad other activities on behalf of people with cancer and their 
families. Cancer is a complex, multifaceted chronic disease, and people 
with cancer require specialty-nursing interventions at every step of 
the cancer experience. People with cancer are best served by nurses 
specialized in oncology care, who are certified in that specialty. 
Overall, age is the number one risk factor for developing cancer. 
Approximately 77 percent of all cancers are diagnosed at age 55 and 
older.
    As the overall number of nurses will drop precipitously in the 
coming years, we likely will experience a commensurate decrease in the 
number of nurses trained in the specialty of oncology. With an 
increasing number of people with cancer needing high-quality health 
care, coupled with an inadequate nursing workforce, our Nation could 
quickly face a cancer care crisis of serious proportion, with limited 
access to quality cancer care, particularly in traditionally 
underserved areas. A study in the New England Journal of Medicine found 
that nursing shortages in hospitals are associated with a higher risk 
of complications--such as urinary tract infections and pneumonia, 
longer hospital stays, and even patient death. Without an adequate 
supply of nurses, there will not be enough qualified oncology nurses to 
provide the quality cancer care to a growing population of people in 
need, and patient health and well-being could suffer.
    Further, of additional concern is that our Nation also will face a 
shortage of nurses available and able to conduct cancer research and 
clinical trials. With a shortage of cancer research nurses, progress 
against cancer will take longer because of scarce human resources 
coupled with the reality that some practices and cancer centers 
resources could be funneled away from cancer research to pay for the 
hiring and retention of oncology nurses to provide direct patient care. 
Without a sufficient supply of trained, educated, and experienced 
oncology nurses, we are concerned that our Nation may falter in its 
delivery and application of the benefits from our Federal investment in 
research.
    ONS has joined with others in the nursing community in advocating 
$200 million as the fiscal year 2008 funding level necessary to support 
implementation of the Nurse Reinvestment Act and the range of nursing 
workforce development programs housed at the U.S. Health Resources and 
Services Administration (HRSA). Enacted in 2002, the Nurse Reinvestment 
Act (Public Law 107-205) included new and expanded initiatives, 
including loan forgiveness, scholarships, career ladder opportunities, 
and public service announcements to advance nursing as a career. 
Despite the enactment of this critical measure, HRSA fails to have the 
resources necessary to meet the current and growing demands for our 
Nation's nursing workforce. For example, in fiscal year 2006 HRSA 
received 4,222 applications for the Nurse Education Loan Repayment 
Program, but only had the funds to award 615 of those applications. 
Also, in fiscal year 2006 HRSA received 3,320 applications for the 
Nursing Scholarship Program, but only had funding to support 218 
awards.
    While a number of years ago one of the biggest factors associated 
with the shortage was a lack of interested and qualified applicants, 
due to the efforts of the nursing community and other interested 
stakeholders, the number of applicants is growing. As such, now one of 
the greatest factors contributing to the shortage is that nursing 
programs are turning away qualified applicants to entry-level 
baccalaureate programs, due to a shortage of nursing faculty. According 
to the American Association of Colleges of Nursing (AACN), U.S. nursing 
schools turned away 42,866 qualified applicants from baccalaureate and 
graduate nursing programs in 2006, due to insufficient number of 
faculty. The nurse faculty shortage is only expected to worsen with 
time, as half of the RN workforce is expected to reach retirement age 
with in the next 10 to 15 years. At the same time, significant numbers 
of faculty are expected to retire in the coming years, with 
insufficient numbers of candidates in the pipeline to take their 
places. If funded sufficiently, the components and programs of the 
Nurse Reinvestment Act will help address the multiple factors 
contributing to the nursing shortage.
    The nursing community opposes the President's fiscal year 2008 
budget proposal that decreases nursing workforce funding by $44 
million--a cut which eliminates all funding for advanced nursing 
education programs. With additional funding in fiscal year 2008, these 
important programs will have much-needed resources to address the 
multiple factors contributing to the nationwide nursing shortage, 
including the shortage of faculty--a principal factor contributing to 
the current shortage. Advanced nursing education programs play an 
integral role in supporting registered nurses interested in advancing 
in their practice and becoming faculty. As such, these programs must be 
adequately funded in the coming year.
    ONS strongly urges Congress to provide HRSA with a minimum of $200 
million in fiscal year 2008 to ensure that the agency has the resources 
necessary to fund a higher rate of nursing scholarships and loan 
repayment applications and support other essential endeavors to sustain 
and boost our Nation's nursing workforce. Nurses--along with patients, 
family members, hospitals, and others--have joined together in calling 
upon Congress to provide this essential level of funding. One Voice 
Against Cancer (OVAC), a collaboration of more than 45 national 
nonprofit organizations representing millions of Americans, and the 
National Coalition for Cancer Research (NCCR), is a non-profit 
organization comprised of 26 national organization, also advocate $200 
million for the Nurse Reinvestment Act in fiscal year 2008. ONS and its 
allies have serious concerns that without full funding, the Nurse 
Reinvestment Act will prove an empty promise, and the current and 
expected nursing shortage will worsen, and people will not have access 
to the quality care they need and deserve.

            SUSTAIN AND SEIZE CANCER RESEARCH OPPORTUNITIES

    Our Nation has benefited immensely from past Federal investment in 
biomedical research at the National Institutes of Health (NIH). ONS has 
joined with the broader health community in advocating a 6.7 percent 
increase ($32.831 billion) for NIH in fiscal year 2008. This will allow 
NIH to sustain and build on its research progress, resulting from the 
recent doubling of its budget, while avoiding the severe disruption to 
that progress that would result from a minimal increase. Cancer 
research is producing extraordinary breakthroughs--leading to new 
therapies that translate into longer survival and improved quality of 
life for cancer patients. We have seen extraordinary advances in cancer 
research, resulting from our national investment, which have produced 
effective prevention, early detection and treatment methods for many 
cancers. To that end, ONS calls upon Congress to allocate $5.131 
billion to the National Cancer Institute (NCI) in fiscal year 2008 to 
support the battle against cancer.
    The National Institute of Nursing Research (NINR) supports basic 
and clinical research to establish a scientific basis for the care of 
individuals across the life span--from management of patients during 
illness and recovery, to the reduction of risks for disease and 
disability and the promotion of healthy lifestyles. These efforts are 
crucial in translating scientific advances into cost-effective health 
care that does not compromise quality of care for patients. 
Additionally, NINR fosters collaborations with many other disciplines 
in areas of mutual interest, such as long-term care for older people, 
the special needs of women across the life span, bioethical issues 
associated with genetic testing and counseling, and the impact of 
environmental influences on risk factors for chronic illnesses, such as 
cancer. ONS joins with others in the nursing community in advocating a 
fiscal year 2008 allocation of $150 million for NINR.

 BOOST OUR NATION'S INVESTMENT IN CANCER PREVENTION, EARLY DETECTION, 
                             AND AWARENESS

    Approximately two-thirds of cancer cases are preventable through 
lifestyle and behavioral factors and improved practice of cancer 
screening. Although the potential for reducing the human, economic, and 
social costs of cancer by focusing on prevention and early detection 
efforts remains great, our Nation does not invest sufficiently in these 
strategies. In 2005, the United States spend over $2.0 trillion in 
healthcare--$6,683 for every man, woman, and child; however we only 
allocate approximately 1 percent of that amount for population-based 
prevention efforts. The Nation must make significant and unprecedented 
Federal investments today to address the burden of cancer and other 
chronic diseases, and to reduce the demand on the healthcare system and 
diminish suffering in our Nation both for today and tomorrow.
    As the Nation's leading prevention agency, the Centers for Disease 
Control and Prevention (CDC) plays an important role in translating and 
delivering, at the community level, what is learned from research. 
Therefore, ONS joins with our partners in the cancer community--
including OVAC--in calling on Congress to provide additional resources 
for the CDC to support and expand much-needed and proven effective 
cancer prevention, early detection, and risk reduction efforts. 
Specifically, ONS advocates the following fiscal year 2008 funding 
levels for the following CDC programs: $250 million for the National 
Breast and Cervical Cancer Early Detection Program; $65 million for the 
National Cancer Registries Program; $25 million for the Colorectal 
Cancer Prevention and Control Initiative; $50 million for the 
Comprehensive Cancer Control Initiative; $25 million for the Prostate 
Cancer Control Initiative; $5 million for the National Skin Cancer 
Prevention Education Program; $10 million for the Ovarian Cancer 
Control Initiative; $6 million for the Geraldine Ferraro Blood Cancer 
Program; $145 million for the National Tobacco Control Program; and $65 
million for the Nutrition, Physical Activity, and Obesity Program.

                               CONCLUSION

    ONS maintains a strong commitment to working with Members of 
Congress, other nursing societies, patient organizations, and other 
stakeholders to ensure that the oncology nurses of today continue to 
practice tomorrow, and that we recruit and retain new oncology nurses 
to meet the unfortunate growing demand that we will face in the coming 
years. By providing the fiscal year 2008 funding levels detailed above, 
we believe the subcommittee will be taking the steps necessary to 
ensure that our Nation has a sufficient nursing workforce to care for 
the patients of today and tomorrow and that our Nation continues to 
make gains in our fight against cancer.
                                 ______
                                 
        Prepared Statement of Parent Project Muscular Dystrophy

    Chairman Harkin, ranking member Specter, and members of the 
committee: I want to thank you for this opportunity to submit testimony 
for the written record. My name is Pat Furlong, Co-Founder and CEO of 
Parent Project Muscular Dystrophy (PPMD) and the mother of two sons who 
battled Duchenne Muscular Dystrophy (DMD).
    The past year has been historical for PPMD and the entire Duchenne 
and Becker Muscular Dystrophy (DBMD) Community. Right now, a drug that 
holds tremendous potential for a percentage of patients suffering not 
only from Duchenne but from other neurological conditions, like Cystic 
Fibrosis, is in a Phase 2 clinical trial, and has received Fast Track 
designation from the Food and Drug Administration (FDA). We all waited 
anxiously and were relieved when PTC Therapeutics reported an increase 
presence of dystrophin in Duchenne patients involved in the initial 
Phase 2 clinical trial, and we are very hopeful more good news will be 
on the way. While the drug in question--PTC 124--is being developed by 
a private entity, I can say with confidence that we would not have 
reached this milestone if not for the significant investments made into 
DMD research by the National Institutes of Health (NIH).
    It is for this very reason that NIH's investments into Duchenne and 
Becker research must not only be sustained but strengthened. All six 
Senator Paul Wellstone MD Research Centers of Excellence are in 
operation, and the Muscular Dystrophy Coordinating Committee (MDCC) is 
working to advance the government-wide MD agenda.
    At the Centers for Disease Control and Prevention (CDC), active 
surveillance of Duchenne is taking place in five States, and we are 
making progress toward developing a DMD Patient Registry, replete with 
evidence-based care considerations, In addition, PPMD has partnered 
with the CDC on an education and outreach initiative that has produced 
materials that help explain Duchenne to children, enable doctors to 
offer accurate and timely diagnoses, and help parents ensure their 
children get the care they need and deserve. Through the pilot work in 
Mississippi, CDC and PPMD have taken concrete steps to educate people 
on the early warning signs of DBMD so patients get the earliest 
diagnosis possible.
    I want to continue to urge the committee to support Federal funding 
for DBMD. Specifically, we are seeking:
  --A $2.5 million increase in MD activities at the CDC. Of this 
        increase:
    --$2.25 million should be dedicated to advancing efforts to develop 
            and launch an International DBMD Patient Registry.
    --$250,000 should be used to continue the successful joint CDC/PPMD 
            Education & Outreach initiative, bringing the total for 
            this project to $1 million.
  --Increased funding at the NIH to ensure the continued support of the 
        six MD Centers of Excellence and other research initiatives 
        focused on DBMD.
    We are very well aware of the significant budgetary pressures--both 
internal and external--that you will be dealing with this year. That's 
why we believe we have put forth a reasonable request that seeks the 
funding necessary to sustain and advance the successes attained to 
date. Without such an investment, we fear we will lose ground and not 
receive the greatest return on investment possible.
    On behalf of all families impacted by Duchenne and Becker MD, I 
thank you for your past support. I urge your panel and the entire 
Senate to continue to lead the way in providing critically needed 
dollars to support DBMD research at the NIH and patient support and 
related initiatives at the CDC.
                                 ______
                                 
 Prepared Statement of the People for the Ethical Treatment of Animals

    Chairman Harkin, ranking member Specter, and members of the 
subcommittee: People for the Ethical Treatment of Animals (PETA) is the 
world's largest animal rights organization, with 1.6 million members 
and supporters. We greatly appreciate the opportunity to submit 
testimony regarding the fiscal year 2008 appropriations for the 
Interagency Coordinating Committee on the Validation of Alternative 
Methods (ICCVAM). The following national animal and health protection 
organizations support these comments: The American Anti-Vivisection 
Society, the Alternatives Research and Development Foundation, In 
Defense of Animals, and the Physicians Committee for Responsible 
Medicine.
    As you are aware, Federal regulatory agencies require most 
chemicals and many other products to undergo tests that measure their 
toxicity levels. Unfortunately, most of these tests involve the 
suffering and death of animals. Other problems include agencies 
needlessly duplicating each other's tests, lack of innovation (e.g., 
relying on outdated and flawed test methods developed decades ago), and 
underutilization of scientific expertise outside of the U.S. Government 
(e.g., ignoring better methods used in other countries).
    ICCVAM was created in 1997 to solve the three regulatory testing 
problems of animal suffering, wasteful duplication, and lack of 
innovation. It was made a permanent committee under the National 
Institute of Environmental Health Sciences in 2000.
    Contrary to its ostensible purpose, however, ICCVAM has become a 
major obstacle to the adoption of more sophisticated and accurate test 
methods--in many cases, methods that have been widely adopted by the 
rest of the industrialized world. Instead, ICCVAM is clinging to 
decades-old animal-poisoning tests that were never proven relevant to 
humans to begin with.
    This causes two major problems. First, animals are being harmed 
needlessly when non-animal tests could be adopted instead. Second, 
public health is being undermined, as non-animal test methods have been 
demonstrated to be more accurate, more sensitive, and more protective 
of public health.\1\
---------------------------------------------------------------------------
    \1\ For example, in 1971, scientists Weil and Scala examined the 
reliability of data from eye irritancy tests--in which chemicals are 
dripped into rabbits' eyes--and concluded that, because of significant 
variability in test results from day to day and lab to lab, this test 
should not be used as a standard regulatory toxicity study (Weil CS and 
Scala RA. 1971. Toxicol. Appl. Pharmacol. 17: 276-360). In 1986, 
Freeberg and colleagues studied 281 cases of accidental human eye 
exposure to 14 household products and compared the outcome with the 
results of rabbit eye irritation tests. They found that the animal test 
failed to correctly predict the human eye response more than half (52 
percent) of the time (Freeberg FE and others. 1986. J. Toxicol. 
Cutaneous & Ocular Toxicol. 5: 115-23). A few years later, Koch and 
colleagues at the U.S. Food and Drug Administration stated that there 
was no clear relationship between the rabbit eye response and the 
exposure of the human eye to chemicals or products and that the Draize 
test is ``plagued'' with a lack of reproducibility. (Koch WH. 1989. 
Cutaneous & Ocular Toxicol. 8: 17-22). The Multicenter Evaluation of In 
Vitro Cytotoxicity (MEIC) study examined the results of rat and mouse 
``lethal dose'' toxicity studies--in which groups of animals are force-
fed massive doses of a chemical until half of them convulse and die. 
The researchers found that rodent lethal dose tests were, at best, 65 
percent predictive of acute toxicity in humans. By contrast, the MEIC 
study found that a ``battery'' of four non-animal tests using human 
cells was able to predict human toxicity with 84 percent accuracy (U.S. 
National Toxicology Program Interagency Centre for the Evaluation of 
Alternative Toxicological Methods. 2000 Sep. The Multicenter Evaluation 
of In Vitro Cytotoxicity (MEIC)--Summary).
---------------------------------------------------------------------------
    In addition, test methods that use animals render our Federal 
agencies impotent in their efforts to regulate health and environmental 
hazards because the fact that these methods are not human-relevant 
leads to continual--and successful--court challenges on the part of 
industry.
    ICCVAM's counterpart in Europe--the European Centre for the 
Validation of Alternative Methods (ECVAM)--has developed and validated 
a number of non-animal methods. Yet ICCVAM fails to even adopt the 
ECVAM-validated methods, becoming a bottleneck for the adoption of new 
methods in the United States.\2\
---------------------------------------------------------------------------
    \2\ In its 10-year history, it has validated only one non-animal 
test method that originated in the United States.
---------------------------------------------------------------------------
    Worse, ICCVAM and its lead agency, the U.S. Environmental 
Protection Agency (EPA), have repeatedly and blatantly violated both 
the letter and the spirit of a major tenet of the Organization for 
Economic Cooperation and Development (OECD) Council Decision, of which 
the United States is a member. The OECD's 1981 Mutual Acceptance of 
Data in the Assessment of Chemicals provides that: ``[D]ata generated 
in the testing of chemicals in an OECD Member country in accordance 
with OECD Test Guidelines and OECD Principles of Good Laboratory 
Practice shall be accepted in other Member countries for purposes of 
assessment and other uses relating to the protection of man and the 
environment.''
    Presented below are five specific recent examples:
    1. Skin Corrosion Testing.--Two types of non-animal tests for skin 
corrosion, the Transcutaneous Electrical Resistance method (OECD 430) 
and human skin model studies (OECD 431), were successfully validated in 
partnership with ECVAM and endorsed by ECVAM's Scientific Advisory 
Committee (ESAC) in 1998, accepted by EU regulators in June 2000, and 
published as OECD Test Guidelines in April 2004. The OECD specifically 
accepts the tests as part of a strictly non-animal weight-of-evidence 
assessment of skin corrosion. Yet ICCVAM arbitrarily insists on 
confirmatory testing in rabbits of any negative results.
    2. Phototoxicity Testing.--The cell-based 3T3 Neutral Red Uptake 
Phototoxicity Test is also ECVAM validated, ESAC endorsed, and codified 
in both EU regulations and as an OECD Test Guideline (OECD 432). 
However, the regulatory acceptance of this method in the United States 
remains uncertain.
    3. Ocular Testing.--In 2005, ICCVAM reviewed several non-animal 
methods to replace the infamous Draize test, in which chemicals are 
dripped into the eyes of restrained (though not anesthetized) rabbits. 
These methods (which use actual animal eyes from slaughterhouses) have 
been accepted by some countries for more than a decade and are 
currently accepted throughout the EU through mutual acceptance of data. 
Nevertheless, ICCVAM has placed severe restrictions on their use.
    4. Acute toxicity testing.--ICCVAM convened an international 
workshop in 2000 to discuss a non-animal (cell-based) method that had 
the potential to replace acute toxicity testing in animals. Acute 
toxicity testing, otherwise known as lethal poisoning, means taking a 
group of animals and forcing them to ingest or inhale a toxic substance 
in increasing amounts until half of the animals die. Although this 
method is almost universally recognized as an extremely cruel, crude, 
and imprecise test method that causes a tremendous amount of animal 
suffering, it remains the backbone of regulatory testing.
    The workshop resulted in a report stating that that the cell-based 
methods could be used immediately to reduce the numbers of animals 
killed and that, within 3 years--given the proper funding and effort--
the method could be validated as a full replacement measure. It is now 
7 years later, and ICCVAM has made no progress in implementing the 
cell-based methods even as a reduction measure and has cynically 
ignored its potential as a replacement measure.
    5. Pyrogenicity (Fever-Inducing) Testing.--According to a March 
2006 European Union press release, ECVAM ``approved six new alternative 
testing methods that will reduce the need for certain drugs and 
chemicals to be tested on animals. The new tests use cell cultures 
rather than animals to establish the toxicity of cancer drugs and 
identify contaminated drugs.'' Five of the tests replace the use of 
animals in pyrogenicity testing (for fever-inducing bacteria) for which 
hundreds of thousands of rabbits are currently used every year.
    Despite the fact that these methods were less expensive than animal 
tests and that, as stated in the news release, ``the tests approved . . 
. will not only reduce the number of animals needed for testing, but 
will also increase the accuracy of the tests, thereby making the 
products concerned safer'' (emphasis added), ICCVAM's peer review panel 
concluded that the methods were not valid as replacements for the 
rabbit test.

                            RECOMMENDATIONS

    ICCVAM follows a double standard that sets ever-increasing hurdles 
for every non-animal method while accepting every animal test as the 
unquestioned gold standard. Companies are now attempting to circumvent 
ICCVAM, submitting their data from non-animal test methods directly to 
the relevant agency to consider, knowing that it is pointless to send a 
non-animal method to ICCVAM for review.
    If Congress is to continue funding ICCVAM, the agency must be held 
accountable for its failures to date and be required to fulfill its 
mandate ``to establish, wherever feasible, guidelines, recommendations, 
and regulations that promote the regulatory acceptance of new or 
revised scientifically valid toxicological tests that protect human and 
animal health and the environment while reducing, refining, or 
replacing animal tests and ensuring human safety and product 
effectiveness'' (Public Law 106-545). At the very least, there should 
be reciprocity between ECVAM and ICCVAM and ICCVAM should be required 
to expeditiously adopt non-animal test methods developed and validated 
in Europe.
    In its 2007 appropriations, Congress included report language that 
required ICCVAM to develop a 5-year plan to ``identify areas of high 
priority for new and revised non-animal and alternative assays or 
batteries of those assays to create a path forward for the replacement, 
reduction and refinement of animal tests'' by November 15, 2007 (House 
Report 109-15). In December 2006, PETA, The Humane Society of the 
United States, and other national animal protection organizations 
submitted extensive comments to NIEHS regarding essential components of 
this plan.
    We respectfully request that the committee include the following 
report language for fiscal year 2008: ``The committee understands that 
the American animal protection community has submitted recommendations 
for items to be included in ICCVAM's 5-year plan to identify areas of 
high priority for new and revised non-animal and alternative assays or 
batteries of those assays to create a path forward for the replacement, 
reduction and refinement of animal tests. The committee requests that 
these recommendations be adopted by ICCVAM or, upon presentation of the 
plan to the committee by November 15, 2007, an explanation of any 
exclusions of the aforementioned recommendations be included.''
    Thank you for your consideration of our request.
                                 ______
                                 
Prepared Statement of the Population Association of America/Association 
                         of Population Centers

                              INTRODUCTION

    Thank you, Chairman Harkin, ranking member Specter, and other 
distinguished members of the subcommittee, for this opportunity to 
express support for the National Institutes of Health (NIH) and the 
National Center for Health Statistics (NCHS)--two agencies important to 
our organizations.

           BACKGROUND ON THE PAA/APC AND DEMOGRAPHIC RESEARCH

    The PAA is a scientific organization comprised of over 3,000 
population research professionals, including demographers, 
sociologists, statisticians, and economists. The APC is a similar 
organization comprised of over 30 universities and research groups that 
foster collaborative demographic research and data sharing, translate 
basic population research for policy makers, and provide educational 
and training opportunities in population studies.
    Demography is the study of populations and how or why they change. 
Demographers, as well as other population researchers, collect and 
analyze data on trends in births, deaths, and disabilities as well as 
racial, ethnic, and socioeconomic changes in populations. Major policy 
issues population researchers are studying include the demographic 
causes and consequences of population aging, trends in fertility, 
marriage, and divorce and their effects on the health and well being of 
children, and immigration and migration and how changes in these 
patterns affect the ethnic and cultural diversity of our population and 
the Nation's health and environment.
    The NIH mission is to support research that will improve the health 
of our population. The health of our population is fundamentally 
intertwined with the demography of our population. Recognizing the 
connection between health and demography, the NIH supports population 
research programs primarily through the National Institute on Aging 
(NIA) and the National Institute of Child Health and Human Development 
(NICHD).

                      NATIONAL INSTITUTE ON AGING

    According to the Census Bureau, by 2029, all of the baby boomers 
(those born between 1946 and 1964) will be age 65 years and over. As a 
result, the population age 65-74 years will increase from 6 percent to 
10 percent of the total population between 2005 and 2030. This 
substantial growth in the older population is driving policymakers to 
consider dramatic changes in Federal entitlement programs, such as 
Medicare and Social Security, and other budgetary changes that could 
affect programs serving the elderly. Further, the macroeconomic and 
global impact of population aging on competitiveness in the world 
economy is becoming a bigger issue--as illustrated during the recent 
Global Summit on Aging sponsored by NIA and the State Department. To 
inform this debate, policymakers need objective, reliable data about 
the antecedents and impact of changing social, demographic, economic, 
and health characteristics of the older population. The NIA Behavioral 
and Social Research (BSR) program is the primary source of Federal 
support for research on these topics.
    In addition to supporting an impressive research portfolio, that 
includes the prestigious Centers of Demography of Aging Program, the 
NIA BSR program also supports several large, accessible data surveys. 
Two such surveys, the National Long-Term Care Survey (NLTCS) and the 
Health and Retirement Study (HRS) have become seminal sources of 
information to assess the health and socioeconomic status of older 
people in the United States.
    By using NLTCS data, investigators identified the declining rate of 
disability in older Americans first observed in the mid-1990s. In 2006, 
an analysis of the latest data found the prevalence of chronic 
disability among people 65 and older fell from 26.5 percent in 1982 to 
19 percent in 2004/2005. The findings suggest that older Americans' 
health and function continue to improve at a critical time in the aging 
of the population. If it continues, this trend could have momentous 
impact on reducing the need for costly long-term care.
    In 2006, NIA announced a 6-year renewal of the HRS. The HRS, now 
entering its 15th year, has tracked 27,000 people, and has provided 
data on a number of issues, including the role families play in the 
provision of resources to needy elderly and the economic and health 
consequences of a spouse's death. The Social Security Administration 
recognizes and funds the HRS as one of its ``Research Partners'' and 
posts the study on its home page to improve its availability to the 
public and policymakers. HRS is particularly valuable because its 
longitudinal design allows researchers: (1) the ability to immediately 
study the impact of important policy changes such as Medicare Part D; 
and (2) the opportunity to gain insight into future health-related 
policy issues that may be on the horizon, such as recent HRS data 
indicating an increase in pre-retirees self-reported rates of 
disability.
    With additional support in fiscal year 2008, the NIA BSR program 
could fully fund its existing centers and support its ongoing surveys. 
Additional support would allow NIA to expand the centers' role in 
understanding the domestic macroeconomic as well as the global 
competitiveness impact of population aging and fully fund initiatives 
in fiscal year 2008 addressing financial challenges faced by older 
Americans.
    NIA could also use additional resources to support individual 
investigator awards by precluding an 18 percent cut in competing 
awards, improving its funding payline, and sustaining training and 
research opportunities for new investigators.

        NATIONAL INSTITUTE ON CHILD HEALTH AND HUMAN DEVELOPMENT

    Since its establishment in 1968, the NICHD Center for Population 
Research has supported research on population processes and change. 
Today, this research is housed in the Center's Demographic and 
Behavioral Sciences Branch (DBSB). The Branch encompasses research in 
four broad areas: family and fertility, mortality and health, migration 
and population distribution, and population composition. In addition to 
funding research projects in these areas, DBSB also supports a highly 
regarded population research infrastructure program and a number of 
large database studies, including the Fragile Families and Child Well 
Being Study and National Longitudinal Study of Adolescent Health.
    NICHD-funded demographic research has consistently provided 
critical scientific knowledge on issues of greatest consequence for 
American families: work-family conflicts, marriage and child bearing, 
childcare, and family and household behavior. However, in the realm of 
public health, demographic research is having an even larger impact, 
particularly on issues regarding adolescent and minority health. For 
example, in 2006, researchers with the National Longitudinal Study of 
Adolescent Health, reported findings illustrating that by the time they 
reach early adulthood (age 19-24), a large proportion of American youth 
have begun the poor practices contributing to three leading causes of 
preventable death in the United States: smoking, poor diet and physical 
inactivity, and alcohol abuse. This study is striking in that it found 
the health situation of young people--in terms of behavior, health 
conditions, and access to and use of care--deteriorates markedly 
between the teen and young adult years. The study reinforces the 
importance of educating young people about adopting healthy lifestyles 
after they leave high school and the parental home.
    Understanding the role of marriage and stable families in the 
health and development of children is another major focus of the NICHD 
DBSB. Consistently, research has shown children raised in stable family 
environments have positive health and development outcomes. Therefore, 
NICHD supports research to elucidate factors that contribute to family 
formation and strong partnerships. Recent findings have identified 
factors that can destabilize relationships between new parents. These 
factors include serious health or developmental problems of the 
parents' child, lower earnings, less education, and a father who has 
other children with different mothers. A new study published in 2006 
produced the first measures of multi-partnered fertility (having 
children by more than one partner) in U.S. urban areas. The study found 
that in 59 percent of unmarried couples with a new baby, at least one 
parent had a child from another relationship. Previous research 
demonstrates multi-partnered fertility has potentially serious 
implications for both child well-being and marriage promotion efforts 
because of the demands of existing commitments and relationships. 
Policymakers and community programs can use these findings to support 
unstable families and improve the health and well being of children.
    With additional support in fiscal year 2008, NICHD could restore 
full funding to its large-scale surveys, which serve as a resource for 
researchers nationwide. Furthermore, the Institute could apply 
additional resources toward improving its funding payline, which has 
gone from the 20th percentile range in 2003 to the 15th percentile in 
January 2007. Additional support could be used to preclude cuts of 17 
percent to 22 percent in applications approved for funding and to 
support and stabilize essential training and career development 
programs necessary to prepare the next generation of researchers.

                 NATIONAL CENTER FOR HEALTH STATISTICS

    Located within the Centers for Disease Control (CDC), the National 
Center for Health Statistics (NCHS) is the Nation's principal health 
statistics agency, providing data on the health of the U.S. population 
and backing essential data collection activities. Most notably, NCHS 
funds and manages the National Vital Statistics System, which contracts 
with the States to collect birth and death certificate information. 
NCHS also funds a number of complex large surveys to help policy 
makers, public health officials, and researchers understand the 
population's health, influences on health, and health outcomes. These 
surveys include the National Health and Nutrition Examination Survey, 
National Health Interview Survey, and National Survey of Family Growth. 
Together, NCHS programs provide credible data necessary to answer basic 
questions about the State of our Nation's health.
    The President's fiscal year 2008 budget requests $109.9 million in 
program funds for National Center for Health Statistics. This 
recommendation represents an increase of $900,000 over the fiscal year 
2007. Despite this modest increase, if enacted, the President's request 
would only allow NCHS to purchase 10 months of vital statistics data. 
Recently, PAA and APC joined 150 other organizations in sending a 
letter (http://www.chsr.org/nchsletterhouse031507.pdf) to the House and 
Senate Appropriations Committees expressing concern about this matter 
and asking that NCHS receive $117 million in fiscal year 2008, an $8 
million increase over its fiscal year 2007 level. Without at least $3 
million in additional funding, the United States will become the first 
industrialized Nation unable to continuously collect birth, death, and 
other vital information. The full $8 million increase is necessary to 
not only restore integrity and stability to the vital statistics 
program, but also to restore other important data collection and 
analysis initiatives and to modernize systems NCHS uses to manage and 
protect its data.

                            RECOMMENDATIONS

    PAA and APC join the Ad Hoc Group for Medical Research in 
supporting an fiscal year 2008 appropriation of $30.8 billion, a 6.7 
percent increase over the fiscal year 2007 appropriation, for the NIH. 
We also urge the subcommittee to include language in the fiscal year 
2008 bill allowing the National Children's Study to continue and to 
appropriate $111 million for NCS in fiscal year 2008 through the NIH 
Office of the Director.
    PAA and APC, as members of the Friends of NCHS, support a fiscal 
year 2008 appropriation of $117 million, a 7 percent increase over the 
fiscal year 2007 appropriation, for the NCHS. This funding is needed to 
maintain the Nation's vital statistics system and to sustain and update 
the agency's major survey operations.
    Thank you for considering our requests and for supporting Federal 
programs that benefit the field of demographic research.
                                 ______
                                 
    Prepared Statement of Project R&R: Release and Restitution for 
                    Chimpanzees in U.S. Laboratories

    Project R&R, whose advisory board of chimpanzee experts includes 12 
organizations with a combined membership of 500,000, respectfully 
submits testimony on our funding priority.
    We request that Federal funding for breeding chimpanzees for 
research, or for projects that require breeding, be terminated. We do 
so for the following reasons:
  --A ``surplus'' of chimpanzees has resulted from over-breeding in the 
        1980s for HIV/AIDS research and later findings that they are a 
        poor HIV/AIDS model.\1\
---------------------------------------------------------------------------
    \1\ National Research Council (1997) Chimpanzees in research: 
strategies for their ethical care, management and use. National 
Academies Press: Washington, D.C.
---------------------------------------------------------------------------
  --There are enough chimpanzees to address existing federally funded 
        research.\2\
---------------------------------------------------------------------------
    \2\ Report of the Chimpanzee Management Plan Working Group to the 
National Advisory Research Resources Council; May 18, 2005.
---------------------------------------------------------------------------
  --As a result of the ``surplus,'' the government funds a national 
        sanctuary system.\3\
---------------------------------------------------------------------------
    \3\ http://www.ncrr.nih.gov/compmed/cm_chimp.asp
---------------------------------------------------------------------------
  --The current population costs in excess of about $11 million Federal 
        per year.
  --Breeding more chimpanzees increases taxpayers' financial burden.
  --Expansion of the population compounds existing concerns about their 
        quality of care.
  --While there is a breeding moratorium, NIH still funds research 
        projects requiring breeding.\4\ 
---------------------------------------------------------------------------
    \4\ Ibid.
---------------------------------------------------------------------------
  --The public is concerned about the use of chimpanzees in research.
                               background
    Of an estimated 1,300 chimpanzees in laboratories in the United 
States today, approximately 850 are federally owned or supported. In 
the mid-1990s, the National Research Council (NRC) made recommendations 
to address the ``surplus'' that included a moratorium on breeding 
federally-owned or supported chimpanzees for at least 5 years \5\ 
(implemented in 1995). The National Advisory Research Resources 
Council, which advises NCRR on funding activities, policies, and 
program, met on 09/15/05 and recommended that NCRR extend the 
moratorium to 12/07. The recommendation was accepted \6\--reasons 
included the high costs associated with care and the fact that 
chimpanzees are a poor model for human HIV research.\7\ \8\
---------------------------------------------------------------------------
    \5\ National Research Council (1997) Chimpanzees in research: 
strategies for their ethical care, management and use. National 
Academies Press: Washington, D.C.
    \6\ http://www.ncrr.nih.gov/compmed/cm_chimp.asp
    \7\ Muchmore, E., (2001) Chimpanzee models for human disease and 
immunobiology, Immunological Reviews, 183, 86-93.
    \8\ Reynolds, V., (1995) Moral issues in relation to chimpanzee 
field studies and experiments, Alternatives to Laboratory Animals, 23, 
621-625.
---------------------------------------------------------------------------
                      CIRCUMVENTING THE MORATORIUM

    Despite the moratorium, NIH funds research projects requiring 
breeding. For example, the National Institute of Allergy and Infectious 
Diseases (NIAID) maintains a contract with the New Iberia Research 
Center (NIRC) to provide 10 to 12 infants annually for research. The 10 
year contract entitled ``Leasing of chimpanzees for the conduct of 
research'' was allotted over $22 million (some $3.9 million plus has 
been spent since 2002).\9\
---------------------------------------------------------------------------
    \9\ Source: http://dcis.hhs.gov/nih/nih_daily_active_web.html (See 
contract No. 272022754)
---------------------------------------------------------------------------
    NIRC has also received $5.47 million from 09/00 to 08/05 for a 
grant from NCRR to maintain 138 chimpanzees for breeding. NIH/NCRR 
spends more than $1 million annually to maintain the NIRC breeding 
colony.\10\  These grants result in $9 million going to breeding-
related activities at NIRC alone since 2000.
---------------------------------------------------------------------------
    \10\ http://nirc.louisiana.edu/divisions/nihgrants.html
---------------------------------------------------------------------------
    Such expenditures circumvent the intent of the breeding moratorium, 
compelling the need to prevent the growing financial burden of 
increasing numbers of chimpanzees, particularly since, by the 
government's own admission, a ``surplus'' already exists.

                    COSTS FOR CHIMPANZEE MAINTENANCE

    The cost of care for chimpanzees is a major concern, particularly 
with NIH's tightening budget. In 1995, the Institute for Laboratory 
Animal Research (ILAR) published a study that projected the future 
costs of maintaining chimpanzees in U.S. research.\11\ ILAR, a division 
of the National Academies of Science, functions as ``an advisor to the 
Federal Government, the biomedical research community, and the 
public.'' \12\
---------------------------------------------------------------------------
    \11\ Dyke, B., Williams-Blangero, S. et al, 1995 ``Future costs of 
chimpanzees in U.S. research institutions,'' ILAR Journal V37(4) http:/
/dels.nas.edu/ilar_n/ilarjournal/37_4/37_4Future.shtml
    \12\ Institute for Laboratory Animal Research, website at http://
dels.nas.edu/ilar_n/ilarhome/about.shtml
---------------------------------------------------------------------------
    The ILAR study examined the per diem costs of the existing 
population of chimpanzees at six facilities. Taking into account a 
variety of factors such as longevity, distribution of sex, and 
complexity of care, it projected costs of maintaining the present 
colony over the next 60 years. To account for inflation, an annual 4 
percent increase was incorporated, corresponding approximately to the 
Biomedical Research and Development Price Index.
    The results of the study indicated that the lifetime cost of 
maintaining chimpanzees over the next 60 years--the approximate 
lifespan of chimpanzees in captivity--will exceed $3.14 billion. The 
1995 projection, however, was based on a population of 1,447 
chimpanzees. The present population of federally owned or supported 
chimpanzees in 2007, due to factors such as the implementation of the 
partial breeding moratorium in 1995, the end of the Air Force's use of 
chimpanzees and the close of the Coulston Foundation in 2002 (to which 
the majority of Air Force chimpanzees were sent), stands closer to 850. 
This represents approximately 59 percent of the 1,447 number used in 
ILAR's projection. Thus we can estimate the Federal cost of the 
existing colony to be $1.85 billion. The remainder of the original 
estimated $3.14 billion figure will now be carried by the U.S. public 
which contributes to the private sanctuaries caring for formerly 
federally owned or supported chimpanzees (minus a slight decrease in 
this estimate due to mortality). Thus, the caring American public has 
been burdened with the ethical obligation of some estimated $1.29 
billion to care for chimpanzees from laboratories, without any further 
obligation for this care placed on the laboratories themselves and with 
none of these privately funded sanctuaries having, at this time, access 
to Federal dollars for their chimpanzee care. Given the American 
public's deep and growing concern over the use of chimpanzees in 
research, the NIH's history of breeding has created a hidden, even if 
self-assumed, ``tax'' for that faction of the public concerned about 
the humane and ethical treatment of chimpanzees from research for which 
NIH no longer assumes any financial responsibility.
    The ILAR projection also concluded that the 2006 annual costs would 
be approximately $18.8 million. Adjusting this number by 59 percent 
results in $11 million spent in 2006 alone to maintain chimpanzees for 
research.
    It is important to note that $11 million represents only a partial 
estimate of the entire Federal expenditure for chimpanzee research. The 
total population of U.S. chimpanzees available for research is 
estimated at 1,300. Approximately 500 of these chimpanzees are 
privately owned. Privately owned chimpanzees are also partially funded 
by Federal research dollars. Therefore, the 2006 estimate of annual 
expenditure actually exceeds $11 million by an undetermined amount.

                            DELIVERY OF CARE

    USDA inspection reports indicate that facilities housing 
chimpanzees for research are not adequately meeting basic housing 
needs. Inspection reports for the NIRC 2004 showed some chimpanzees 
being housed in less than the minimal space requirements. The facility 
was given 1 year to correct the non-compliance, which needed to be 
further extended as construction of new housing facilities was still 
not completed. NIRC was also cited 7 times during its 12/04 inspection 
for improperly sanitizing cages and living quarters, as well as for 
failing to provide adequate environment enhancement.
    Inspection reports filed on the Southwest Foundation for Biomedical 
Research and the Yerkes Primate Facility, both National Primate 
Research Centers, also demonstrate multiple non-compliant items for 
failing to keep chimpanzee areas in well-maintained condition, and 
failing to maintain safe facilities free of dangers due to disrepair.

                              A POOR MODEL

    It is widely agreed within the scientific community that 
chimpanzees are a poor model for HIV. Years of research demonstrated 
that HIV-infected chimpanzees do not develop AIDS. Similarly, while 
chimpanzees are used in current hepatitis C research, they do not model 
the course of the human disease. The decoding of the chimpanzee genome 
pointed out similarities as well as differences between humans and 
chimpanzees. Some of those greatest differences relate to the immune 
system.\13\ Such differences question the validity of using chimpanzees 
in infectious disease research, further arguing the need to curb 
populations and costs.
---------------------------------------------------------------------------
    \13\ The Chimpanzee Sequencing and Analysis Consortium/Mikkelsen, 
TS, et al., (1 September 2005) Initial sequence of the chimpanzee 
genome and comparison with the human genome, Nature 437, 69-87.
---------------------------------------------------------------------------
                            ETHICAL CONCERNS

    The U.S. public is concerned about the use of chimpanzees in 
research because of their intellectual, emotional and social 
similarities to humans. A 2005 poll conducted by the Humane Research 
Council revealed that 4 out of 5 (83 percent) of the U.S. public 
recognize chimpanzees as highly intelligent, social individuals who 
have an extensive capacity to communicate. A full 71 percent of 
Americans support the release of chimpanzees if they have been used in 
research for more than 10 years.\14\ A 2001 poll conducted by Zogby 
International showed that 90 percent of Americans believe it is 
unacceptable to confine chimpanzees in government-approved cages.\15\
---------------------------------------------------------------------------
    \14\ U.S. Public Opinion of Chimpanzee Research, Support for a Ban, 
and Related Issues, Prepared for the New England Anti-Vivisection 
Society, by the Humane Research Council, 2005.
    \15\ Public Opinion Poll, Prepared for the Chimpanzee 
Collaboratory, by Zogby International, 2001.
---------------------------------------------------------------------------
                               CONCLUSION

    We respectfully request that the following language appear in the 
Senate Labor, Health and Human Services, Education and Related Agencies 
Appropriations Subcommittee Report for fiscal year 2008:
    ``None of these funds shall be used for the breeding of chimpanzees 
or research projects that require the breeding of chimpanzees.''
    We hope the committee will accommodate this modest request that 
will save the government substantial money, benefit chimpanzees, and 
allay some concerns and financial responsibilities of the public at 
large. Thank you for your consideration.
                                 ______
                                 
      Prepared Statement of the Pulmonary Hypertension Association

    Mr. Chairman, thank you for the opportunity to submit testimony on 
behalf of the Pulmonary Hypertension Association (PHA).
    I am honored today to represent the hundreds of thousands of 
Americans who are fighting a courageous battle against a devastating 
disease. Pulmonary hypertension (PH) is a serious and often fatal 
condition where the blood pressure in the lungs rises to dangerously 
high levels. In PH patients, the walls of the arteries that take blood 
from the right side of the heart to the lungs thicken and constrict. As 
a result, the right side of the heart has to pump harder to move blood 
into the lungs, causing it to enlarge and ultimately fail.
    PH can occur without a known cause or be secondary to other 
conditions such as: collagen vascular diseases (i.e., scleroderma and 
lupus), blood clots, HIV, sickle cell, or liver disease. PH does not 
discriminate based on race, gender, or age. Patients develop symptoms 
that include shortness of breath, fatigue, chest pain, dizziness, and 
fainting. Unfortunately, these symptoms are frequently misdiagnosed, 
leaving patients with the false impression that they have a minor 
pulmonary or cardiovascular condition. By the time many patients 
receive an accurate diagnosis, the disease has progressed to a late 
stage, making it impossible to receive a necessary heart or lung 
transplant.
    PH is chronic and incurable with a poor survival rate. Fortunately, 
new treatments are providing a significantly improved quality of life 
for patients. Recent data indicates that the length of survival is 
continuing to improve, with some patients managing the disorder for 20 
years or longer.
    Seventeen years ago, when three patients who were searching to end 
their own isolation founded the Pulmonary Hypertension Association, 
there were less than 200 diagnosed cases of this disease. It was 
virtually unknown among the general population and not well known in 
the medical community. They soon realized that this was unacceptable, 
and formally established PHA, which is headquartered in Silver Spring, 
Maryland.
    Today, PHA includes:
  --Over 7,000 patients, family members, and medical professionals as 
        members and an additional 28,000 supporters and friends.
  --A network of over 140 patient support groups.
  --An active and growing patient-to-patient telephone helpline.
  --Three research programs that, through partnerships with the 
        National Heart, Lung and Blood Institute and the American 
        Thoracic Society, will have directed more than $6 million 
        toward PH research as of December, 2007.
  --Numerous electronic and print publications, including the first 
        medical journal devoted to pulmonary hypertension--published 
        quarterly and distributed to all cardiologists, pulmonologists, 
        and rheumatologists in the United States.
  --A website dedicated to providing educational and support resources 
        to patients, medical professionals, and the public that, over 
        the past 9 years, has grown from receiving 600 visitors a month 
        to 220,000 visitors a month.

                  THE PULMONARY HYPERTENSION COMMUNITY

    Mr. Chairman, I am privileged to serve as the president of the 
Pulmonary Hypertension Association and to interact daily with the 
patients and family members who are seeking to live their lives to the 
fullest in the face of this deadly, incurable disease. I would like to 
share with you the stories of two remarkable PH patients, Emily Stibbs 
and Charity Tillemann-Dick. Emily's and Charity's stories illustrate 
the impact of pulmonary hypertension not only on PH patients, but also 
on everyone who care about them.
    When their daughter Emily was 5, Jack and Marcia Stibbs noticed 
that she could not keep up with the other children in the neighborhood. 
She seemed to lack the energy and strength to run and play. This 
condition worsened to the point where she would have to stop and rest 
after coming down the steps in the morning. Jack and Marcia noticed 
that when she was sitting on the bottom step in the morning, Emily's 
lips appeared to have a bluish color.
    Jack and Marcia pressed for an answer to these problems for several 
months, and Emily was finally diagnosed with pulmonary hypertension. 
Doctors told the Stibbs family that Emily's probable remaining lifespan 
was 3 years.
    Charity Tillemann-Dick's diagnosis with pulmonary hypertension took 
not months, but years. When Charity was in her late-teens, she had the 
opportunity to travel abroad and share her considerable talents as a 
budding opera singer at her grandfather's 75th birthday party in 
Budapest. Just before the performance, Charity collapsed, but the 
episode was explained away as a case of nerves.
    Over the next few years, Charity continued to have occasional 
fainting spells as well as a progressive loss in energy. She was 
diagnosed as being everything from out of shape to anemic. When Charity 
finally received an accurate diagnosis, her PH had progressed further, 
and was therefore more difficult to treat, than it would have been if 
she had been diagnosed while the disease was in its early stages.
    I am happy to report that, with treatment, Charity has continued to 
live a full and accomplished life, including performances at several 
world capitals. Emily, too, has outlived her 3-year prognosis by 7 
years and continues to thrive. There is, however, no cure for pulmonary 
hypertension. Each day, courageous patients of every age lose their 
battle with PH.
    Thanks to congressional action, and to advances in medical research 
largely supported by the NHLBI and other government agencies, Emily and 
Charity have an increased chance of living with their pulmonary 
hypertension for many more years. However, additional support is needed 
for research and related activities to continue to develop treatments 
that will extend the life expectancy of PH patients beyond the NIH 
estimate of 2.8 years after diagnosis.

            FISCAL YEAR 2008 APPROPRIATIONS RECOMMENDATIONS

National Heart, Lung and Blood Institute
    Mr. Chairman, PHA commends the National Heart, Lung and Blood 
Institute for its strong support of PH research, particularly through 
the creation of the Specialized Centers of Clinically Oriented Research 
in PH. We are very excited about the promise these Centers hold for the 
development of new treatments and for progress on the road to a cure. 
In addition, we applaud the NHLBI and the National Institutes of Health 
Office of Rare Diseases for their co-sponsorship a two-day scientific 
conference on pulmonary hypertension in December 2006. This important 
event provided an opportunity for leading PH researchers from the 
United States and abroad to discuss the State of the science in 
pulmonary hypertension and future research directions.
    According to these leading researchers, we are on the verge of 
significant breakthroughs in our understanding of PH and the 
development of new and advanced treatments. Twelve years ago, a 
diagnosis of PH was essentially a death sentence, with only one 
approved treatment for the disease. Thanks to advancements made through 
the public and private sector, patients today are living longer and 
better lives with a choice of five FDA approved therapies. Recognizing 
that we have made tremendous progress, we are also mindful that we are 
a long way from where we want to be in (1) the management of PH as a 
treatable chronic disease, and (2) a cure.
    One crucial step in continuing the progress we have made in the 
treatment of PH is the creation of a pulmonary hypertension research 
network. Such a network would link leading researchers around the 
United States, providing them with access to a wider pool of shared 
patient data. In addition, the network would provide researchers with 
the opportunities to collaborate on studies and to strengthen the 
interconnections between basic and clinical science in the field of 
pulmonary hypertension research. Such a network is in the tradition of 
the NHLBI, which, to its credit and to the benefit of the American 
public, has supported numerous similar networks including the Acute 
Respiratory Distress Syndrome Network and the Idiopathic Pulmonary 
Fibrosis Clinical Research Network.
    In order to maintain the important momentum in pulmonary 
hypertension research that has developed over the past few years, and 
to create a much needed pulmonary hypertension research network, the 
Pulmonary Hypertension Association encourages the subcommittee to 
provide the National Institutes of Health, particularly the NHLBI, with 
a 6.7 percent increase in funding in fiscal year 2008.
Centers for Disease Control and Prevention
    PHA applauds the subcommittee for its leadership over the years in 
encouraging the Centers for Disease Control and Prevention to initiate 
a Pulmonary Hypertension Education and Awareness Program. We know for a 
fact that Americans are dying due to a lack of awareness of PH, and a 
lack of understanding about the many new treatment options. This 
unfortunate reality is particularly true among minority and underserved 
populations. However Mr. Chairman, you don't have to rely solely on our 
word regarding the need for additional education and awareness 
activities. On November 11, 2005 the CDC released a long-awaited 
Morbidity and Mortality Report on pulmonary hypertension. In that 
report, the CDC states:
    (1) ``More research is needed concerning the cause, prevention, and 
treatment of pulmonary hypertension. Public health initiatives should 
include increasing physician awareness that early detection is needed 
to initiate prompt, effective disease management. Additional 
epidemiologic initiatives also are needed to ascertain prevalence and 
incidence of various pulmonary hypertension disease entities.'' (Page 
1, MMWR Surveillance Summary--Vol. 54 No. SS-5)
    (2) ``Prevention efforts, including broad based public health 
efforts to increase awareness of pulmonary hypertension and to foster 
appropriate diagnostic evaluation and timely treatment from health care 
providers, should be considered. The science base for the etiology, 
pathogenesis, and complications of pulmonary hypertension disease 
entities must be further investigated to improve prevention, treatment, 
and case management. Additional epidemiologic activities also are 
needed to ascertain the prevalence and incidence of various disease 
entities.'' (Page 7, MMWR Surveillance Summary--Vol. 54 No. SS-5)
    Mr. Chairman, we are grateful to the CDC for their recent support 
of a DVD highlighting the proper diagnosis of PH. However, despite 
repeated encouragement from the subcommittee over the past 5 years, CDC 
has not taken any steps to establish an education and awareness program 
on PH. Therefore, we respectfully request that you provide $250,000 in 
fiscal year 2008 for the establishment of a PH awareness initiative 
through the Pulmonary Hypertension Association.
``Gift of Life'' Donation Initiative at HRSA
    Mr. Chairman, PHA applauds the success of the Health Resources and 
Services Administration's ``Gift of Life'' Donation Initiative. This 
important program is working to increase organ donation rates across 
the country. Unfortunately, the only ``treatment'' option available to 
many late-stage PH patients is a lung, or heart and lung, 
transplantation. This grim reality is why PHA established ``Bonnie's 
Gift Project.''
    ``Bonnie's Gift'' was started in memory of Bonnie Dukart, one of 
PHA's most active and respected leaders. Bonnie battled with PH for 
almost 20 years until her death in 2001 following a double lung 
transplant. Prior to her death, Bonnie expressed an interest in the 
development of a program within PHA related to transplant information 
and awareness. PHA will use ``Bonnie's Gift'' as a way to disseminate 
information about PH, transplantation, and the importance of organ 
donation, as well as organ donation cards, to our community.
    PHA has had a very successful partnership with HRSA's ``Gift of 
Life'' Donation Program in recent years. Collectively, we have worked 
to increase organ donation rates and raise awareness about the need for 
PH patients to ``early list'' on transplantation waiting lists. For 
fiscal year 2008, PHA recommends an appropriation of $25 million (an 
increase of $2 million) for this important program.
    Mr. Chairman, once again thank you for the opportunity to present 
the views of the Pulmonary Hypertension Association. We look forward to 
continuing to work with you and the subcommittee to improve the lives 
of pulmonary hypertension patients.
                                 ______
                                 
   Prepared Statement of the Ryan White Title III Medical Providers 
                               Coalition

    The members of the Ryan White Title III Medical Providers Coalition 
are pleased to submit this statement for the record in strong support 
of a $35 million increase to Title III (Part C) of the Ryan White 
Program for the fiscal year 2008 appropriations cycle. The Title III 
Coalition was founded to ensure that the voices of the HIV clinicians 
working on the frontlines of the AIDS epidemic in rural and urban 
communities across the Nation are represented in policy and program 
discussions that affect their ability to meet the medical needs of 
their patients with HIV/AIDS, including the national debate over the 
appropriate funding levels for the Ryan White CARE Act programs.
    We formed our coalition in part to garner attention to the daily 
challenges we face in finding the necessary resources to ensure that 
our patients receive the comprehensive and complex medical care and 
services needed to sustain their health.
    Title III of the Ryan White CARE Act provides grants to support 
outpatient medical services to HIV-positive individuals in underserved 
communities with no other source of care and treatment. Many Title III 
grants are in communities in which they are the only service providers 
accessible to un- and under-insured individuals. Our clinics use Title 
III funds to provide the range of services required to effectively 
manage and treat HIV disease, including physician care, medications, 
adherence counseling, laboratory testing, nutrition counseling and in 
some cases, mental health and substance abuse treatment.
    Our clinical programs are seeing increasing numbers of patients 
with HIV/AIDS, with many of them presenting with serious, complex 
conditions in addition to HIV disease, such as hepatitis C. We expect 
this trend to increase as States implement the Centers for Disease 
Control and Prevention's (CDC) recommendations for making HIV testing a 
more routine component of medical care. Additional resources for 
medical care, drug treatments and critical enabling services are 
essential if we are to continue providing state-of-the-art HIV care to 
our current patients and those newly identified with HIV disease.
    As you finalize the funding recommendations for fiscal year 2008, 
we urge you to provide an urgently needed increase in funding for Title 
III (Part C) medical programs. After years of flat funding or decreases 
in grant awards, we estimate that the true need for these programs is 
an increase of at least $83.3 million over fiscal year 2007. This 
amount is based on the estimated annual cost of delivering HIV-related 
outpatient care ($2,414) multiplied by the current Title III caseload 
(191,229) plus the number of new patients that the Health Resources and 
Services Administration (HRSA) estimates will enter Title III programs 
in 2008 (36,333).
    We appreciate the funding constraints that the committee is facing 
in determining fiscal year 2008 funding levels for a whole range of 
critical health programs. Therefore, at a minimum, we urge you to 
include a nominal $35 million increase for Title III housed under the 
Ryan White Program, with a prioritization of increases within that $35 
million to current programs with the highest increases of patient 
burden. This proposed $35 million increase, albeit inadequate to 
respond to the flat funding and growing caseloads that have 
characterized our programs for a number of years, will help us to 
continue to provide our patients with the essential medical care 
necessary to preserve health and prevent disease progression.
    While Title III (Part C) funds are critical to our ability to meet 
the medical needs of low-income people with HIV/AIDS in our 
communities, the other Titles now referred to as Parts of the Ryan 
White CARE Act also are vital to supporting our HIV care systems. Many 
of us receive funding from multiple parts of the Ryan White CARE Act 
and use these resources to patch together a comprehensive system of 
care for our patients. We strongly support the Ryan White funding 
requests put forward by organizations representing other members of the 
HIVAIDS community.
    The HIV Medicine Association (HIVMA) and the American Academy of 
HIV Medicine (AAHIVM)--together representing most HIV clinical 
providers in the country--have joined forces to help assemble the Title 
III Coalition. Leadership of the Coalition includes providers from a 
wide range of settings, from New York City to New Orleans to Oakland, 
California.
    If you have questions about the coalition, please contact Andrea 
Weddle at 703-299-1215 or Greg Smiley at 202-659-0699.
                                 ______
                                 
    Prepared Statement of the Society for Investigative Dermatology

SUMMARY OF THE SOCIETY FOR INVESTIGATIVE DERMATOLOGY'S FISCAL YEAR 2008 
                            RECOMMENDATIONS

    A 6.7 percent increase for all of the National Institutes of Health 
(NIH) and for the National Institute of Arthritis and Musculoskeletal 
and Skin Diseases (NIAMS).
    Establish a skin disease clinical trials network that will collect 
baseline data for specific orphan diseases and facilitate the exchange 
of scientific data across disciplines and institutes.
    Encourage NIAMS to develop collaborative funding mechanisms with 
other NIH institutes and private foundations that leverage skin biology 
studies as a developmental model that will serve for the advancement of 
research across a multitude of diseases and specialties.
    Encourage NIAMS to sponsor studies that capture general and skin-
disease specific measures in order to generate incidence, prevalence 
and quality of life data attributable to skin diseases.
    Increase the number of training awards through the NIH designed to 
facilitate the entry of more individuals into careers in skin disease 
research.

                               BACKGROUND

    The Society for Investigative Dermatology (SID) was founded in 
1938. Its 2,000 members represent over 40 countries worldwide, 
including scientists and physician researchers working in universities, 
hospitals and industry.
    Along with our colleagues from the American Academy of Dermatology 
Association (AADA), members of the SID are dedicated to the advancement 
and promotion of the sciences relevant to skin health and disease 
through education, advocacy and the scholarly exchange of scientific 
information.
    This collective commitment to research is evidenced in the 
scientific journal published by the SID, the Journal of Investigative 
Dermatology (JID). The JID is a catalyst for the exchange of scientific 
information pertaining to the 3,000 skin diseases that afflict nearly 
80 million Americans annually.
    The purpose of submitting testimony is to increase awareness of the 
need for more skin research, based on the burden attributable to skin 
disease. It will also highlight some of the advancements that past 
support has enabled.
    We join with the Ad Hoc Group for Medical Research Funding in 
asking for a 6.7 percent increase for the National Institutes of Health 
(NIH) and the National Institute of Arthritis and Musculoskeletal and 
Skin Diseases (NIAMS).

                         BURDEN OF SKIN DISEASE

    Prior bill report language directed NIAMS to ``consider supporting 
the development of new tools to measure the burden of skin diseases, 
and the training of researchers in this important area''. There are 
only a handful of researchers working on NIH-sponsored research that 
will provide such measures.
    Skin disease impacts our citizens more than previously estimated. A 
report released in 2004 by the SID and the AADA, ``The Burden of Skin 
Disease'', compiled data from only 21 of the known 3,000 skin diseases 
and disorders. The estimated economic costs to society each year from 
those 21 diseases totaled nearly $39 billion.
    The true impact extends far beyond mere economics. These patients 
encounter discomfort and pain, physical disfigurement, disability, 
dependency and death. Skin conditions affect an individual's ability to 
interact with others and compromise the self-confidence of those 
inflicted.
    One of the most striking findings in the study was the lack of 
general and skin-disease specific measures that are needed to generate 
data surrounding the incidence, prevalence, economic burden, quality of 
life and handicaps attributable to these diseases.
    We ask the committee to devote the resources needed to develop 
components of national health surveys that capture dermatological data 
above and beyond skin cancer incidence and prevalence.

                           RESEARCH ADVANCES

    Skin is the body's largest organ and serves as the primary barrier 
to external pathogens and toxins. Researchers at the NIH campus and 
institutions around the country are working diligently to define how 
the skin functions to protect us, how this fails in disease, and how 
compromised functions in disease can be restored.
    Cell biology allows scientists to understand the life cycle of skin 
and hair-producing cells and identify the causes of disease, leading to 
better treatments and preventative measures. Advances in wound healing 
and skin ulcers are helping the elderly, veterans and patients with 
diabetes and burns. Lasers continue to provide less invasive options 
for patients requiring surgery.
    Fundamental discoveries resulting from skin biology and 
translational research have yielded advances that are broadly 
applicable to human development and disease. Continued investment is 
required to fully capitalize on these ground-breaking advances.
    Important new research findings include the following:
  --The genes responsible for skin cancer and inherited skin diseases 
        have been identified, making targeted therapy possible.
  --The molecular mechanisms of auto-immune and inflammatory skin 
        diseases are better understood, allowing for the use of 
        focused, selective immunosuppressive therapy with greater 
        safety and efficacy.
  --Oral medications to treat and prevent viral and fungal diseases 
        have become available.
  --Lasers have made possible the removal of disfiguring skin 
        malformations.
  --Modern phototherapy and photochemotherapy allow for more effective 
        treatment of inflammatory skin disease, lymphoma, depigmenting 
        disorders and auto-immune diseases.
  --Retinoids and sunscreens have reduced the risk of skin cancer in 
        the elderly, in transplant patients, and in other populations.
  --Painless transdermal drug delivery has become available.
    Recent developments in the areas of clinical epidemiology, 
biostatistics, economics and the quantitative social sciences have 
begun to provide objective evaluation measures, although additional and 
improved measures are still desperately needed. These measures will 
help to identify effective interventions and allow us to better 
quantify contributions to the quality of life and health of Americans.
    We ask the NIH to work to identify additional biomarkers in order 
to better understand skin disease pathways and interaction with other 
diseases and environmental factors.

           TRANSLATING DISCOVERY TO TREATMENTS FOR AMERICANS

    The goal of skin disease research is to improve the quality of life 
for the one in three Americans that suffer from skin disease. That goal 
is embedded in the collective missions of the SID and the intramural 
and extramural scientists funded through the skin portfolios of many of 
the 27 institutes and centers of the NIH.
    Medical research organizations such as the SID are the direct 
recipients of the awards made possible through the rigorous peer-
reviewed grant system in place at the NIH. The ultimate beneficiaries 
are the nearly 80 million Americans that stand to benefit from the 
discoveries resulting from research grants.
    Inadequate levels of Federal funding have forced the institute 
administrators to reduce certain types of the available funding 
mechanisms currently in place at the NIH, to decrease success rates, to 
increase administrative cost reductions, to consider decreasing the 
number of awards and to cut award levels in existing programs.
    Unfortunately, this reality impairs the ability of hypothesis-
driven research to drive the research system. Adequate funding levels 
will allow the peer-review system to work at full potential, leading to 
findings that translate into better care for those suffering from 
debilitating diseases. Without sufficient funding provided specifically 
for skin research, nearly one third of the Nation would be denied any 
hope for a better quality of life.
    We are grateful for the past support that has been given to the NIH 
and ask you to look for innovative ways to avoid flat or decreased 
funding levels for the institutes that are charged with improving the 
health of all Americans.
                                 ______
                                 
     Prepared Statement of the Society for Maternal-Fetal Medicine

    Mr. Chairman and members of the committee: The Society for 
Maternal-Fetal Medicine is pleased to have the opportunity to testify 
on behalf of the fiscal year 2008 budget for the National Institute of 
Child Health and Human Development and to extend to the committee our 
appreciation for the support you have provided over the years to the 
National Institutes of Health, and in particular the National Institute 
of Child Health and Human Development.
    Established in 1977, the Society for Maternal-Fetal Medicine (SMFM) 
is a not-for-profit organization of over 2,000 members that are 
dedicated to improving perinatal care through research and education. 
Maternal-fetal medicine doctors have advanced knowledge of the 
obstetrical, medical, genetic and surgical complications of pregnancy 
and their effects on both the mother and fetus. The many advances in 
research have allowed the maternal-fetal medicine physician to provide 
the direct care needed to treat the special problems that high risk 
mothers and fetuses face.
    Having a high-risk pregnancy means that a woman has a greater 
chance of complications because of conditions in her pregnancy, her own 
medical status or lifestyle, or due to external factors. Many times, 
complications are unexpected and may occur without warning. Other 
times, there are certain risk factors that make problems more likely. 
For example:
  --Preterm Birth.--Preterm birth is defined as births occurring before 
        37 weeks of gestation. Prematurity is the leading cause of 
        newborn death and an estimated 20 percent of infants who 
        survive suffer long term consequences, including cerebral 
        palsy, mental retardation, and developmental delays that affect 
        the child's ability to do well in school. The rate of preterm 
        births has increased 30 percent since 1981 and in 2004, 508,000 
        babies were born prematurely.
      Due to the growing problem of preterm birth, expanded research is 
        needed on the underlying causes of preterm delivery and the 
        development of treatments for the prevention of premature 
        birth. SMFM recommends that the NIH Common Fund be utilized as 
        a mechanism to fund research on preterm birth. As reported in 
        the 2006 Institute of Medicine report, ``Preterm Birth: Causes, 
        Consequences, and Prevention,'' a multidisciplinary research 
        approach is needed to better understand premature birth.
  --Adverse Pregnancy Outcome in Nulliparous Women.--A recent national 
        study showed that the rate of preterm births among first 
        pregnancies has increased over 50 percent over the past decade 
        and comprise about 40 percent of pregnant women in the United 
        States. The rate of adverse pregnancy outcomes is unpredictable 
        and substantial. For example, at least 12 percent of these 
        women will have a preterm delivery, with associated high rate 
        of neonatal mortality and long term morbidity. The data also 
        revealed that women in their first pregnancy are at highest 
        risk for developing pre-eclampsia, which puts them at risk for 
        devastating maternal complications, fetal death, and preterm 
        delivery. Once one of these adverse outcomes has occurred, 
        these women are considered at increased risk in their next 
        pregnancy. In addition, the study also showed a racial 
        disparity with Black women at a two-fold higher risk than white 
        women. The prediction and prevention of the first adverse 
        outcome is problematic and there is a paucity of research on 
        the etiology, mechanism, and potential preventive interventions 
        for poor pregnancy outcomes in this population.
      SMFM recommends that NICHD launch an intensive research study of 
        first pregnancy women in order to fill the major gap in our 
        knowledge for the prevention of these complications.
  --Outcomes of Assisted Reproductive Technology.--The increasing use 
        of assisted reproductive technology (ART) over the past two 
        decades has allowed thousands of infertile couples to have 
        children, currently accounting for 1.1 percent of the total 
        U.S. births and 17.1 percent of U.S. multiple births (CDC, 
        2002). ART includes all fertility treatments in which both eggs 
        and sperm are handled in vitro such as in vitro fertilization 
        with transcervical embryo transfer, gamete and zygote 
        intrafallopian transfer, frozen-embryo transfer, and donor 
        embryo transfer. Between 1996 and 2002, the number of births 
        after ART treatment in the United States increased by 120 
        percent. ART is a significant contributor to preterm delivery 
        and associated risks of prematurity. There is recent evidence 
        of higher rates of adverse pregnancy outcomes even in singleton 
        pregnancies associated with ART including increased preterm and 
        term low birth weight, very low birth weight, preterm delivery, 
        fetal growth restriction, genetic disorders, and congenital 
        anomalies. The risks of birth defects are two times higher in 
        ART babies as compared with naturally conceived singleton 
        babies.
      There is a lack of research on the mechanism for this increase in 
        the adverse pregnancy outcomes. There is also insufficient 
        research to date concerning the prevalence of adult chronic 
        conditions, learning and behavioral disorders, and other 
        reproductive effects in ART babies. Given the data for more 
        proximal outcomes, these long-term outcomes should also receive 
        further study. Preliminary results indicate that there may be 
        an increase incidence of autism in ART offspring.
      SMFM recommends a multi-center observational prospective cohort 
        study on ART be conducted that would emphasize pregnancy 
        outcomes--short- and long-term effects on children--to 
        determine if the increase in adverse pregnancy outcomes are 
        specifically related to the ART procedures versus underlying 
        factors within the couple, such as coexisting maternal disease, 
        the causes of infertility, or differences in behavioral risk 
        and examine each step in the ART process to understand the 
        mechanism for increased adverse pregnancy outcomes.
    The National Institute of Child Health and Human Development is to 
be congratulated for its efforts to advance our understanding of the 
magnitude of complications related to pregnancy and for its efforts to 
sustain the investment in research during this time of tight budget 
constraints.
  --A recent study found that molecules in blood can foretell the 
        development of preeclampsia, a life-threatening complication of 
        pregnancy. This finding appears to be an important step in 
        developing a cure for preeclampsia.
  --Researchers have developed an experimental vaccine that reduces 
        stillbirths among rodents born to mothers infected with 
        cytomegalovirus (CMV)--a common virus that can also cause 
        mental retardation and hearing loss in newborn children who 
        were infected in early fetal life.
    According to NIH Director Elias Zerhouni, ``medical science has 
dramatically improved our ability to help very small and premature 
babies survive. But as the rate of premature births continue to rise, 
it is even more critical that we develop ways to prevent many of the 
complications related to prematurity so that these children can lead 
healthy, robust lives.''

                            RECOMMENDATIONS

    SMFM urges this committee to continue to provide NICHD with 
sufficient funds so that the Institute can continue to make momentous 
advances in research that will result in improved health of mothers and 
children. We recommend:
  --Fund NIH at the amount authorized for fiscal year 2008 in the NIH 
        Reform Act of 2006.
  --Provide $1,448,544,000 for NICHD in fiscal year 2008.
  --Full funding for the--
    --Maternal Fetal Medicine Units Network so that it can continue to 
            address issues pertaining to preterm births and low birth-
            weight deliveries.
    --Genomics and Proteomics Network for Premature Birth, which will 
            hasten a better understanding behind the pathophysiology of 
            premature birth, discover novel diagnostic biomarkers and 
            ultimately aid in formulating more effective interventional 
            strategies to prevent premature birth.
    --Stillbirth Collaborative Research Network which is addressing 
            stillbirth, a major public health issue with morbidity 
            equality to that of all infant deaths.
    Thank you for allowing SMFM the opportunity to present our views to 
the committee.
                                 ______
                                 
           Prepared Statement of the Society for Neuroscience

                              INTRODUCTION

    Mr. Chairman and members of the subcommittee, I am David Van Essen, 
PhD, president of the Society for Neuroscience (SfN) and the Edison 
Professor of Neurobiology and Head of the Department of Anatomy and 
Neurobiology at Washington University in St. Louis, MO. I also 
currently serve on the Advisory Council of the National Institute of 
Neurological Disorders and Stroke.
    I am writing in my capacity as SfN president to request your 
support for biomedical research funding at the National Institutes of 
Health (NIH). During the past several decades, NIH funding has allowed 
the neuroscience community to improve health outcomes and the quality 
of life for millions of Americans.

                 WHAT IS THE SOCIETY FOR NEUROSCIENCE?

    SfN is a nonprofit membership organization made up of more than 
36,500 basic scientists and physicians who study the brain and nervous 
system. Recognizing the tremendous potential for the study of the brain 
and nervous system as a separate field, the Society was formed in 1969. 
Since then, SfN has grown from 500 members to the world's largest 
organization of scientists devoted to the study of the brain. Today, 
there are more than 300 training programs in neuroscience in the United 
States alone.
    Neuroscience includes the study of how the brain senses and 
perceives our world, how it learns and remembers, how it controls our 
movements and our emotions, how it regulates sleep and responds to 
stress, how it develops and ages, and how it malfunctions in countless 
neurological and psychological disorders. Neuroscience also involves 
studies of the molecules, cells and genes responsible for proper 
nervous system functioning.
    SfN's primary goal is to advance the understanding of the brain and 
the nervous system in health and disease. As such, each fall, some 
30,000 scientists from around the world gather to exchange ideas about 
cutting-edge research on the brain, spinal cord, and nervous system at 
the Society's annual meeting.

                       THANK YOU FOR PAST SUPPORT

    SfN would like to thank the members of this subcommittee for their 
past support, which resulted in the doubling of NIH budget between 1998 
and 2003. In particular, we are extremely grateful that the fiscal year 
2007 Joint Resolution included an additional $620 million for NIH above 
the fiscal year 2006 funding level. This additional money will allow 
NIH to award an extra 500 research grants. It will also create a new 
$40 million program to support innovative, outside-the-box research, as 
well as $91 million for grants to first-time investigators.

                              MY RESEARCH

    Currently, my research focuses on the structure and function of the 
cerebral cortex in humans and nonhuman primates. The cerebral cortex is 
the dominant structure of the human brain. It plays a key role in 
mediating our perceptions of the world around us, our cognitive 
capabilities, our emotions, and the control of our movements. It is 
highly variable from one individual to the next and is largely 
responsible for our unique personalities. Many neurological and 
psychiatric disorders arise from abnormalities of the cerebral cortex 
that are caused by hereditary or developmental factors or by injuries 
to cortical gray matter or to the underlying white matter.
    My laboratory has developed novel methods of computerized brain 
mapping that allow accurate mapping of the complex convolutions of the 
cerebral cortex and accurate comparisons between individuals. Using 
these methods, we have worked with many collaborators to characterize 
patterns of cortical development in prematurely born human infants and 
abnormalities of cortical folding in specific disorders, including 
William's Syndrome, autism, and schizophrenia. We have compared humans 
and in macaque monkeys (an intensively studied nonhuman primate), in 
order to better understand the differences that reflect the dramatic 
evolution of the human brain as well as the similarities that reflect 
common principles of cortical structure and function. In addition, my 
laboratory is active in the newly emerging field of neuroinformatics; 
we have developed a database and related tools to help neuroscientists 
communicate their discoveries and share their experimental data more 
effectively, thereby accelerating the pace of discovery and the 
efficiency of the neuroscience research enterprise.

                     NIH-FUNDED RESEARCH SUCCESSES

    Today, scientists have a greatly improved understanding of how the 
brain functions thanks to NIH-funded research. To illustrate this 
progress SfN has created a 36-part series, called Brain Research 
Success Stories, which discuss some of the progress that has resulted 
from Federal funding for biomedical research. The following are just a 
few areas where our research efforts have helped the American public:
    (1) Down Syndrome.--About one out of every 800 babies is born with 
Down Syndrome (DS) a disorder that includes a combination of birth 
defects such as mental retardation, certain physical distinctions, and 
an increased risk of several medical conditions, including heart 
problems, intestinal malformations, and visual or hearing impairments.
    DS often results in high medical and non-medical costs, such as 
special education, rehabilitation, and other services. Data from 1992 
suggests that each new case of DS costs over $450,000 each year.
    NIH-funded research has led to the development of several medical 
tests that help identify whether a pregnant woman is carrying a baby 
with DS. These tests allow parents to prepare themselves mentally and 
financially, and give them time to secure intervention programs that 
can aid in their child's development.
    Once a child is born, research shows that early intervention 
programs can benefit those with DS. For example, adolescents with DS 
who received intervention programs early in life had significantly 
higher scores on measures of intellectual functioning than a comparison 
group. Such improvements might help those with DS live more 
independently and maintain a job later in life.
    (2) Schizophrenia.--This disease affects nearly 2 million 
Americans, and costs the United States over $32 billion a year in lost 
productivity and treatment. This devastating brain disorder torments 
sufferers with hallucinations, delusions, disordered thinking patterns, 
and memory deficits.
    In the past, many individuals with schizophrenia became permanently 
lost to the social withdrawal and other behavioral problems 
characteristic of this disease, which is rooted in abnormal biology of 
the brain. However, thanks to NIH-funded research, new treatments, such 
as clozapine, have been developed.
    Today's medications have fewer side effects and are more effective 
than older treatments. They help to quell the psychotic symptoms of 
schizophrenia, allowing patients to function more effectively in 
society. The medications also appear to cut the financial burden of the 
disease, decreasing hospital stays and treatment costs.
    (3) Amyotrophic Lateral Sclerosis.--Each year, 5,000 Americans are 
diagnosed with the progressive neurological disease, called amyotrophic 
lateral sclerosis (ALS), also known as Lou Gehrig's disease. The cost 
of treating these people is $300 million annually. ALS takes a quick 
toll on sufferers. Affected individuals may first notice muscle 
weakness, twitching, or cramping. The disease then progressively 
disables a person's ability to walk, talk, or swallow and, ultimately, 
to breathe. Many spend their last days completely unable to move, while 
their minds remain alert. ALS usually occurs in midlife and kills 
patients within 3 to 5 years of occurrence.
    Government-funded ALS research produced a number of important 
findings in the early 1990s. First, researchers were able to start 
pinning down how the disease progresses by identifying the role of the 
potentially toxic amino acid glutamate. ALS sufferers tend to have 
higher levels of this chemical messenger in certain parts of their 
body, and scientists have noted that nerve cells exposed to high 
concentrations of glutamate over a long time start to die.
    Researchers were able to use this basic research discovery to 
develop riuzole, an anti-glutamate drug that extends the lives of ALS 
patients. The first drug shown to change the course of ALS, it was 
approved by the Food and Drug Administration in 1995. In 1993, 
researchers supported by NIH identified a genetic component of the 
hereditary form of ALS and subsequently developed an animal model for 
ALS. This has allowed researchers to advance their study of the disease 
and to test dozens of potential treatments.

             RESEARCH IMPROVES HEALTH AND FUELS THE ECONOMY

    Diseases of the nervous system pose an enormous public health and 
economic challenge, as they directly affect nearly one in three 
Americans at some point in life, and indirectly affect nearly everyone 
by the adverse impact on family and friends. Understanding how the 
brain and nervous system develops, works, and ages--in health and 
disease--is the goal of neuroscientists. Improved health outcomes and 
positive economic data support the assertion that biomedical research 
is needed today to improve public health and save money tomorrow. 
Research drives innovation and productivity, creates jobs, and fuels 
local and regional economies.
    Not only does research save lives and fuel today's economy, it is 
also a wise investment in the future. For example, 5 million Americans 
suffer from Alzheimer's disease today, and the cost of caring for these 
people is staggering. Medicare expenditures are $91 billion each year, 
and the cost to American businesses exceeds $60 billion annually, 
including lost productivity of employees who are caregivers. As the 
baby boom generation ages and the cost of medical services increases, 
these figures will only grow. Treatments that could delay the onset and 
progression of the disease by 5 years could save $50 billion in 
healthcare costs each year. Research funded by the NIH is critical for 
the development of such treatments. The cost of investing in NIH today 
is minor compared to both current and future healthcare costs.

             PRESIDENT'S BUDGET NEGATIVELY IMPACTS RESEARCH

    SfN is disappointed that the Bush administration's fiscal year 2008 
budget proposes to cut funding for the National Institutes of Health by 
more than a half billion dollars in fiscal year 2008.
    Mr. Chairman, inflation has eaten into the NIH budget. The NIH now 
projects the Biomedical Research and Development Price Index (BRDPI) 
may increase by 3.7 percent for both fiscal year 2007 and fiscal year 
2008; 3.6 percent for fiscal year 2009 and 2010; and 3.5 percent for 
fiscal year 2011 and fiscal year 2012. Unfortunately, the President's 
budget for NIH did not factor in the increases in biomedical research 
inflation.
    Several years of funding for NIH that are well below inflation 
rates has made efficient research planning difficult, led to a slower 
rate of research progress, and delayed the payoffs from recent 
scientific advances. As you know, basic research projects take years 
from conception to completion. Many excellent research projects have 
been curtailed in recent years because of the low percent age of grants 
receiving funding. In order to have maximum impact in our search to 
understand and treat disorders, we need a consistent, adequate level of 
funding. Without such a strategy, the Federal Government runs the great 
risk of spending many more dollars later on in medical costs and time 
lost from work. In recent months, we have been speaking with leaders in 
the biotechnology and pharmaceutical industries, who depend on NIH-
funded discoveries a vital prelude to and driver of their product 
development efforts. They agree that rather than considering funding 
for NIH an expense, it should be considered an investment to address 
problems our country will face tomorrow.
    We need a funding stream that keeps pace with the potential for 
advances that will help people lead healthier, more productive lives. 
NIH became the premier biomedical research institution it is today only 
through sustained support from congressional leaders, like you, to 
invest in the best facilities, research, and projects selected through 
a non-political, rigorous, and competitive peer review system that is 
envied and is now being emulated around the world.

                    FISCAL YEAR 2008 BUDGET REQUEST

    NIH funded research saves lives and fuels the U.S. economy. 
Further, sustained investment in the NIH will lead to more effective 
treatments that will lessen future healthcare costs for the baby boom 
generation. Unfortunately, inflation and relatively flat funding have 
eaten into the NIH budget.
    The Society for Neuroscience supports a 6.7 percent increase in 
funding for NIH per year for each of the next 3 fiscal years. This 
increase translates to an additional $1.9 billion for NIH in fiscal 
years 2008, 2009, and 2010.
    This sustained increase is necessary to make-up for lost purchasing 
power that has occurred in the past 3 years. In addition, increased 
funding will help NIH to achieve future research goals by, among other 
things, helping to ensure that our best and brightest young people will 
enter the field and continue to make neuroscience research advances 
that are so vital to achieving a healthier Nation and a robust economy.
    Mr. Chairman, thank you for the opportunity to submit testimony 
before this subcommittee.
                                 ______
                                 
   Prepared Statement of the Society of Teachers of Family Medicine; 
 Association of Departments of Family Medicine; Association of Family 
Medicine Residency Directors; and North American Primary Care Research 
                                 Group

  HEALTH PROFESSIONS: PRIMARY CARE MEDICINE AND DENTISTRY (TITLE VII, 
                              SECTION 747)

    We request that this committee fund the Primary Care Medicine and 
Dentistry Cluster (section 747 of Title VII) at no less than the fiscal 
year 2005 level of $88.8 million. This cluster received $48.9 million 
in the final fiscal year 2007 spending resolution, but the President's 
budget for fiscal year 2008 eliminates Title VII Health Professions 
Grants, except for $10 million in Scholarships for Disadvantaged 
Students.
    In fiscal year 2006, funding for the health professions programs 
was cut dramatically. The primary care medicine and dentistry cluster 
was cut by 54 percent. The effect was to prevent any new competitive 
grant applications for that year and to cut the funding of those grants 
that were continuing in their second or third year. This year, instead 
of providing the committee with national studies regarding the 
effectiveness of these programs, we would like to put a human face to 
the impact of the cuts in fiscal year 2006. Below are anecdotes 
received from across the country showing, in their own words, how the 
institutions that apply for and receive these grants were affected by 
the loss of almost $50 million of Federal funding.
    University of Iowa, Department of Family Medicine.--At Iowa, we 
furloughed 5 individuals (that means let them go) related to our 
educational and academic mission. We have had to shift funding from 
other core areas and reduce or eliminate programs that focused mostly 
on primary care fellowship training, academic development, preceptor 
education development and travel support to rural Iowa communities. Our 
department had consistently received about $800,000 to $1,000,000 a 
year over the last 30 years and now we have none of that support. Paul 
James, MD, Chair, Department of Family Medicine
    University of Buffalo, Department of Family Medicine.--Here at the 
University at Buffalo we have laid off a PhD Clinical Psychologist who 
had been with the Department for 9 years. He participated actively in 
our clerkship training and in our residency training. He taught both 
students and residents about helping patients change behaviors (quit 
smoking, etc) and trained residents in dealing with difficult or non-
compliant patients as well as the more difficult and time consuming 
issues of long term family therapy. We also laid off a master degree 
medical education specialist. We are the only medical school department 
to have had a person like this on our staff but she assured that our 
exams measured the goals of our training and our curriculum taught to 
these goals. Tom Rosenthal, MD, Chair, Department of Family Medicine
    Tufts University, Division of Family Medicine.--At Tufts, we hired 
three minority faculty to increase the diversity of our faculty and now 
we will have to let go of one of them and reduce the time significantly 
of the other two because of our loss of funding. We also have an 
educational program that teaches students how to interview patients who 
do not speak English through a medical interpreter. We will have to cut 
that program as well. Wayne Altman, MD FAAFP
    Montana Family Medicine Residency.--Many of our successes, 
including the integration of a top notch primary care mental illness 
management and collaborative program and a Northern Plains Indian 
cultural education program, have been possible only through Title VII 
funding. Our growth as a rather isolated residency--the only one in the 
State in any specialty, and remote from our affiliated University--is 
dependent on grant programs that are specifically designed for family 
medicine resident training . . . Geographically isolated programs like 
ours in Montana and also Alaska, and Wyoming also need to develop their 
own infra-
structure . . . Roxanne Fahrenwald MD, Director, Montana Family 
Medicine Residency.
    University of North Carolina, Department of Family Practice.--We 
cut one of our objectives [in our continuation grant] because there was 
not enough money to pay for it. It was a session on health disparities 
that we intended to introduce to all of our clerkship students, and 
then have them look at the issue during their clinical experience in a 
practice. The money we had intended to pay for the faculty involved was 
eliminated and she had to make it up from patient care time. Bob 
Gwyther, MD
    Thomas Jefferson University, Department of Family and Community 
Medicine.--. . . . Predoctoral--Unable to expand our rural Physician 
Shortage Area Program (which has successfully increased the rural 
physician supply in Pennsylvania) to the State of Delaware; and unable 
to develop and implement new curricula focusing on vulnerable 
populations in the areas of health literacy, oral health, domestic 
violence, and medical professionalism. Howard Rabinowitz, MD [This 
entry was extracted from a longer list of six program areas that were 
deeply affected by these cuts]
    WWAMI (a Partnership Between the University of Washington School of 
Medicine and the States of Wyoming, Alaska, Montana, and Idaho).--We 
have had some programmatic impacts on the faculty development 
fellowship program across the five WWAMI States. For us the impact of 
the funding cut was having to eliminate the support for a second year 
of training that would have exported fellows' projects to other 
programs and nationally. This was the opportunity to make use of what 
they had gained in the fellowship year in a way that solidified their 
learning and spread that learning to others. These changes meant the 
discipline, the region, and BHP [Bureau of Health Professions] didn't 
get to reap the benefit of these physicians' activities. In a sense 
they lost the public good beyond the training of the individual 
faculty. [emphasis added] Finally we lost the chance to see if that new 
model worked. Ardis Davis, MSW

         THE AGENCY FOR HEALTH CARE RESEARCH AND QUALITY (AHRQ)

    We request funding of $350 million for AHRQ in fiscal year 2008. 
This is an increase of $31 million over fiscal year 2007, and $20 
million more than the President's fiscal year 2008 budget request. It 
should be noted however that a much larger investment should be made, 
as recommended by The Institute of Medicine's report, Crossing the 
Quality Chasm: A New Health System for the 21st Century (2001). It 
recommended $1 billion a year for AHRQ to ``develop strategies, goals, 
and actions plans for achieving substantial improvements in quality in 
the next 5 years . . .'' The report looked at redesigning health care 
delivery in the United States. AHRQ is a linchpin in retooling the 
American health care system.
    For the last several years, funding for AHRQ has remained 
relatively stagnant, while it's portfolio of work has increased 
dramatically. Our researchers are finding that investigator-initiated 
grants are very difficult to obtain. In their own words, this is the 
status of AHRQ funding:
    Brown University, Department of Family Medicine.--AHRQ funds so 
little new research we discourage people from applying to them. They 
could fund practice innovation; networks; new models of care; guideline 
research; doctor-patient communication research; electronic health 
record research. Jeffrey Borkan, MD, Chair
    University of Connecticut, Department of Family Medicine.--A 
general plea for more ``investigator initiated'' research at AHRQ is 
very important. Most of their funds recently have been targeted to 
special initiatives and the new or experienced health services 
researcher is getting discouraged because there is no money to fund 
good ideas that develop a line of research. When I was on the study 
section I saw a lot of good, fundable research go unfunded because of 
pay lines. This will dry up the pipeline of HSR researchers. The 
agency's funding level needs to be re-expanded . . . to enable the REAL 
health services research and quality-of-care/outcomes research to 
proceed (especially as there is, more than ever, a huge need to 
restructure the delivery of healthcare, and a need to measure the 
outcomes of those changes) Rob Cushman, MD Chair, and Judith Fifield, 
PhD
    Oregon Health and Sciences University, Department of Family 
Medicine.--Lately, I know AHRQ has had a difficult time funding K-award 
for junior researchers. Last year, they went three cycles without 
funding anyone. This lack of funding will have a grave affect on 
building the research infrastructure for primary care and health 
services research. Specific to R03 and R01 awards, they have been 
unable to fund countless worthy projects. In Oregon, we've had a lot of 
State policy experiments that desperately need further study, but 
applications to AHRQ have been rejected. Jennifer E. DeVoe, MD, DPhil

                  NATIONAL INSTITUTES OF HEALTH (NIH)

    This is the first time that our organizations have made a request 
for funding for the NIH. Historically, much of the work that has been 
done at NIH hasn't been open to the kinds of questions that family 
medicine researchers have been concerned about. We are encouraged by 
the development of the NIH Roadmap and the Clinical and Translational 
Science Awards (CTSA), along with the establishment, in statute, of a 
funding stream for the common fund that NIH is moving to becoming a 
more fertile arena for family medicine and other primary care research. 
Hence, we support the Ad Hoc Group for Medical Research and others' 
call for an increase in NIH funding by 6.7 percent in each of the next 
3 years. However, there are major strides we believe NIH needs to make 
to ensure that the promise of bench to bedside research truly becomes 
bench to bedside to community--and back. What do we mean by that? In 
their own words:
    University of Connecticut, Department of Family Medicine.--Adding 
more ``action research'', in which the community (including, but not 
exclusively, the community clinicians) participates more in the 
definition of the problem, the design of the solution, and the 
dissemination and management of the results as they evolve, could 
augment the impactfulness of the eventual findings. Rob Cushman, MD, 
Chair
    University of Buffalo, Department of Family Medicine.--I think 
Family Medicine would like to see more opportunities for PBRN and 
community based participatory research approaches to further the 
translation of research from bedside to patient. In parallel, current 
study sections are heavily weighted with bench and clinical trial 
researchers. Having more family medicine researchers participate on 
review boards will help get more of these types of grants funded. Tom 
Rosenthal, MD, Chair
    University of Massachusetts, Department of Family Medicine and 
Community Health.--As for NIH, trying to sell real-world interventions 
that may not be scientifically pure but answer relevant questions for 
improving care to study sections remains a challenge. Many editorials 
have been written about the lack of applicability of much RCT evidence 
to real-world practice situations because the populations have been so 
carefully selected that they are not remotely representative of primary 
care patients. Furthermore, for primary care researchers, the need to 
choose a disease or organ and focus narrowly to succeed at NIH is quite 
problematic--research affecting primary care needs to focus on 
patients, providers, and processes . . . Barry Saver, MD, MPH

                               CONCLUSION

    We hope that the committee will be able, with the more generous 
figures included in the fiscal year 2008 House and Senate Budget 
Resolutions this year, to fund increases in these three important 
programs: health professions primary care medicine and dentistry 
training, AHRQ, and NIH. Certainly, at a minimum, we request that 
funding cuts to the health professions primary care medicine and 
dentistry training program be restored to at least fiscal year 2005 
levels of $88.8 million. As a reminder however, these programs were 
funded at a historic high of $93 million in fiscal year 2002, and we 
support a return to that figure.
                                 ______
                                 
   Prepared Statement of the Society for Women's Health Research and 
                   Women's Health Research Coalition

    On the behalf of the Society for Women's Health Research and the 
Women's Health Research Coalition, we are pleased to submit the 
following testimony in support of Federal funding of biomedical 
research at NIH and, more specifically, an investment into women's 
health research.
    The Society for Women's Health Research is the only national non-
profit women's health organization whose mission is to improve the 
health of women through research, education, and advocacy. Founded in 
1990, the Society brought to national attention the need for the 
appropriate inclusion of women in major medical research studies and 
the need for more information about conditions affecting women 
disproportionately, predominately, or differently than men. In 1999, 
the Women's Health Research Coalition was created by the Society as a 
grassroots advocacy effort consisting of scientists, researchers, and 
clinicians from across the country that are concerned and committed to 
improving women's health research.
    The Society and Coalition are committed to advancing the health of 
women through the discovery of new and useful scientific knowledge. We 
believe that sustained funding for biomedical and women's health 
research programs conducted and supported across the Federal agencies 
is absolutely essential if we are to meet the health needs of the 
population and advance the Nation's research capability.

                     NATIONAL INSTITUTES OF HEALTH

    From decoding the human genome to elucidating the scientific 
components of human physiology, behavior, and disease, scientists are 
unearthing exciting new discoveries which have the potential to make 
our lives and the lives of our families longer and healthier. The 
National Institutes of Health (NIH) has facilitated these advances by 
conducting and supporting our Nation's biomedical research. 
Congressional investment and support for NIH has made the United States 
the world leader in medical research and has provided a direct and 
significant impact on women's health research and the careers of women 
scientists over the last decade.
    Great strides and advancements have been made since the doubling of 
the NIH budget from $13.7 billion in 1998 to $27 billion in 2003. 
However, we are concerned that the momentum driving new research has 
been eroded under the current budgetary constraints. Medical research 
must be considered an essential investment--an investment in thousands 
of newly trained and aspiring scientists; an investment to remain 
competitive in the global marketplace; and an investment in our 
Nation's health. A large majority of Americans believe they are 
receiving the highest quality and latest advancements in health care 
and they depend upon Congress to make a strong investment in biomedical 
research at NIH to continue that expectation.
    Unfortunately, the administration's fiscal year 2008 budget request 
of $28.6 billion for NIH is unraveling the successes gained from the 
doubling of NIH's budget. NIH only truly receives $28.3 billion in the 
proposed budget due to the transfer of $300 million to the Global Fund 
to Fight HIV/AIDS. Further, the proposed budget actually represents a 
decrease of $511 million when compared to the amount provided for NIH 
research activities in the fiscal year 2007 continuing resolution. Not 
only does the proposed decrease not keep pace with the inflation rate, 
but it is lower than that of the Biomedical Research and Development 
Price Index.
    Without a robust budget, NIH will be forced to reduce the number of 
grants it is able to fund. In this current fiscal year, 500 fewer 
grants would have been funded by NIH had it not received additional 
funding under the fiscal year 2007 continuing resolution. The number of 
new grants funded by NIH has already been dropping steadily since 
fiscal year 2003 and this trend must stop. This shrinking pool of 
available grants has a significant impact on scientists who depend upon 
NIH support to cover their salaries and laboratory expenses to conduct 
high quality biomedical research. Failure to obtain a grant results in 
reduced likelihood of achieving tenure. This means that new and less 
established researchers will be forced to consider other careers, with 
the end result being the loss of the critical workforce so desperately 
needed to sustain America's cutting edge in biomedical research.
    In order to continue the momentum of scientific advancement and 
expedite the translation of research from the laboratory to the 
patient, the Society calls for a 6.7 percent increase over fiscal year 
2007 actual budget for the NIH for fiscal year 2008. In addition, we 
request that Congress strongly encourage the NIH to assure that women's 
health research receives resources sufficient to meet the health needs 
of all women.
    Scientists have long known of the anatomical differences between 
men and women, but only within the past decade have they begun to 
uncover significant biological and physiological differences. Sex-based 
biology, the study of biological and physiological differences between 
men and women, has revolutionized the way that the scientific community 
views the sexes. Sex differences play an important role in disease 
susceptibility, prevalence, time of onset and severity and are evident 
in cancer, obesity, coronary heart disease, immune dysfunction, mental 
health disorders, and other illnesses. Congress recognizes the 
importance of this research and should support NIH at an appropriate 
level of funding and direct NIH to continue expanding research into 
sex-based biology.

                  OFFICE OF RESEARCH ON WOMEN'S HEALTH

    The NIH Office of Research on Women's Health (ORWH) has a 
fundamental role in coordinating women's health research at NIH, 
advising the NIH Director on matters relating to research on women's 
health; strengthening and enhancing research related to diseases, 
disorders, and conditions that affect women; working to ensure that 
women are appropriately represented in research studies supported by 
NIH; and developing opportunities for and support of recruitment, 
retention, re-entry and advancement of women in biomedical careers. 
ORWH has a pivotal role within the NIH structure and beyond to maintain 
and advance not only biomedical research in women's health but also 
careers of women in science and medicine. ORWH co-chaired a task force 
with the Director of NIH examining a report by the National Academies 
of Science regarding women in medicine and science. It is through ORWH 
that many initiatives can be achieved to strengthen the position of 
women scientists. Further, ORWH strives to address sex and gender 
perspectives of women's health and women's health research, as well as 
differences among special populations of women across the entire life 
span, from birth through adolescence, reproductive years, menopausal 
years and elderly years.
    Two highly successful programs supported by ORWH that are critical 
to furthering the advancement of women's health research are Building 
Interdisciplinary Research Careers in Women's Health (BIRCWH) and 
Specialized Centers of Research on Sex and Gender Factors Affecting 
Women's Health (SCOR). These programs benefit the health of both women 
and men through sex and gender research, interdisciplinary scientific 
collaboration, and provide tremendously important support for young 
investigators in a mentored environment.
    The BIRCWH program is an innovative, trans-NIH career development 
program that provides protected research time for junior faculty by 
pairing them with senior investigators in an interdisciplinary mentored 
environment. What makes BIRCWH so unique is that it bridges advanced 
training with research independence across scientific disciplines. It 
is expected that each scholar's BIRCWH experience will culminate in the 
development of an established independent researcher in women's health. 
The BIRCWH has released four RFAs (1999, 2001, 2004, and 2006). Since 
2000, 287 scholars have been trained (76 percent women) in the 24 
centers resulting in over 882 publications, 750 abstracts, 83 NIH 
grants and 85 awards from industry and institutional sources. Each 
BIRCWH receives approximately $500,000 a year, most of which comes from 
the ORWH budget.
    The SCOR program, administered by the National Institute of 
Arthritis and Musculoskeletal and Skin Diseases, was developed by ORWH 
in 2000 through an initial RFA that resulted in 11 SCOR Centers out of 
36 applications. SCORs are designed to increase the transfer of basic 
research findings into clinical practice by housing laboratory and 
clinical studies under one roof. The program was designed to complement 
other federally supported programs addressing women's health issues 
such as BIRCWH. The eleven SCOR programs are conducting 
interdisciplinary research focused on major medical problems affecting 
women and comparing gender difference to health and disease. Each SCOR 
works hard to transfer their basic research findings into the clinical 
practice setting. A second RFA is due to be funded in 2007 with 
virtually no hope of expanding or matching the number of current SCOR 
programs, due to anticipated budget shortfalls. Each program costs 
approximately $1 million per year.
    Despite the advancement of women's health research and ORWH's 
innovative programs to advance women scientists, it received a $15,000 
decrease for fiscal year 2007 after having also received a cut of 
$249,000 for fiscal year 2006 from the Office of the Director. It is 
unconscionable to cut the funds from this critical program at NIH. This 
research is vital to women and men and we implore Congress to direct 
NIH to continue its support of ORWH and its programs.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

    The Department of Health and Human Services (HHS) has several 
offices that enhance the focus of the government on women's health 
research. Agencies with offices, advisors or coordinators for women's 
health or women's health research are the Department of HHS, the Food 
and Drug Administration, the Centers for Disease Control and 
Prevention, the Agency for Healthcare Quality and Research, the Indian 
Health Service, the Substance Abuse and Mental Health Services 
Administration, the Health Resources and Services Administration, and 
the Centers for Medicare and Medicaid Services. These agencies need to 
be funded at levels adequate for them to perform their assigned 
missions. We ask that the committee report clarify that Congress 
supports the permanent existence of these various offices and would 
like to see them appropriately funded to insure that their programs can 
continue and be strengthened in the coming fiscal year.

                      HHS OFFICE OF WOMEN'S HEALTH

    The HHS Office of Women's Health (OWH) is the Government's champion 
and focal point for women's health issues. It works to redress 
inequities in research, health care services, and education that have 
historically placed the health of women at risk. The OWH coordinates 
women's health efforts in HHS to eliminate disparities in health status 
and supports culturally sensitive educational programs that encourage 
women to take personal responsibility for their own health and 
wellness. An extraordinary program initiated by the OWH is the National 
Centers of Excellence in Women's Health (CoEs).
    Developed in 1996, the CoE's offer a new model for university-based 
women's health care. Selected on a competitive basis, the current 
twenty CoEs throughout the country seek to improve the health of all 
women across the lifespan through the integration of comprehensive 
clinical health care, research, medical training, community outreach 
and public education, and medical school faculty leadership 
development. The CoEs are able to reach a more diverse population of 
women, including more women of color and women beyond their 
reproductive years. However, CoEs are vulnerable to pressures of 
obtaining adequate funding and having to compete for scarce resources. 
A CoE designation by the OWH is critical not only to patients and 
surrounding communities but also to establishing foundation and other 
non-government funding. The CoEs must continue to exist and must have 
their funding assured if women are to be able to continue to access 
quality care through the life cycle. It is our understanding that the 
funding for CoEs is being cut in fiscal year 2007 and 2008. This must 
not happen.
    In fiscal year 2006, OWH received a $1 million decrease in its 
budget, bringing it to $28 million, and in fiscal year 2007 under the 
continuing resolution it was flat funded at the fiscal year 2006 level. 
The President's proposed fiscal year 2008 budget decreases OWH funding 
by $1 million again, bringing the budget down to $27 million. We urge 
Congress to provide an increase of $2 million for the HHS OWH, to bring 
funding back up to the fiscal year 2005 level. This will allow OWH to 
continue and to sustain and expand the National Centers of Excellence 
in Women's Health.

               AGENCY FOR HEALTHCARE AND RESEARCH QUALITY

    The Agency for Healthcare Research and Quality (AHRQ) is the lead 
Public Health Service Agency focused on health care quality, including 
coordination of all Federal quality improvement efforts and health 
services research. AHRQ's work serves as a catalyst for change by 
promoting the results of research findings and incorporating those 
findings into improvements in the delivery and financing of health 
care. This important information provided by AHRQ is brought to the 
attention of policymakers, health care providers, and consumers who can 
make a difference in the quality of health care that women receive.
    AHRQ has a valuable role in improving health care for women. 
Through AHRQ's research projects and findings, lives have been saved 
and underserved populations have been treated. For example, women 
treated in emergency rooms are less likely to receive life-saving 
medication for a heart attack. AHRQ funded the development of two 
software tools, now standard features on hospital electrocardiograph 
machines that have improved diagnostic accuracy and dramatically 
increased the timely use of ``clot-dissolving'' medications in women 
having heart attacks.
    While AHRQ has made great strides in women's health research, the 
administration's budget for fiscal year 2008 could threaten such life-
saving research. Even with the administration's proposed budget for 
fiscal year 2008, which includes an $11 million increase, this does not 
address the major shortfall which this Agency has been operating under 
for years. Furthermore, this budget increase is targeted for a specific 
program and does not help to address the lack of funding that the 
women's health office has experienced for years. If instead a budget of 
$319 million were enacted, AHRQ would be virtually flat funded for the 
fifth year in a row at fiscal year 2007 levels. Flat funding seriously 
jeopardizes the research and quality improvement programs that Congress 
demands or mandates from AHRQ.
    We encourage Congress to fund AHRQ at $443 million for fiscal year 
2008. This will ensure that adequate resources are available for high 
priority research, including women's health care, gender-based 
analyses, Medicare, and health disparities.
    In conclusion, Mr. Chairman, we thank you and this committee for 
its strong record of support for medical and health services research 
and its unwavering commitment to the health of the Nation through its 
support of peer-reviewed research. We look forward to continuing to 
work with you to build a healthier future for all Americans.
                                 ______
                                 
           Prepared Statement of the Spina Bifida Association

                                SUMMARY

    On behalf of the more than 70,000 individuals and their families 
who are affected by Spina Bifida--the Nation's most common, permanently 
disabling birth defect--the Spina Bifida Association (SBA) appreciates 
the opportunity to submit written testimony for the record regarding 
fiscal year 2008 funding for the National Spina Bifida Program and 
other related Spina Bifida initiatives.
    SBA respectfully requests that the subcommittee provide the 
following allocations in fiscal year 2008 to help improve quality-of-
life for people with Spina Bifida:
    (1) $7 million to the National Spina Bifida Program at the National 
Center on Birth Defects and Developmental Disabilities at the Centers 
for Disease Control and Prevention (CDC) to support existing program 
initiatives and allow for the further development of the National Spina 
Bifida Patient Registry; and
    (2) $200,000 to the Agency for Healthcare and Quality to support 
its validation of quality patient treatment data measures for the 
National Spina Bifida Patient Registry.
    As you may know, these funding requests are supported by a broad 
bipartisan group of Members of Congress, including congressional Spina 
Bifida caucus leaders, Representatives Bart Stupak, Chris Smith, Ileana 
Ros-Lehtinen, and Dan Burton, among many others.

                          COST OF SPINA BIFIDA

    It is important to note that the lifetime costs associated with a 
typical case of Spina Bifida--including medical care, special 
education, therapy services, and loss of earnings--are as much as $1 
million. The total societal cost of Spina Bifida is estimated to exceed 
$750 million per year, with just the Social Security Administration 
payments to individuals with Spina Bifida exceeding $82 million per 
year. Moreover, tens of millions of dollars are spent on medical care 
paid for by the Medicaid and Medicare Programs. Our Nation must do more 
to help reduce the emotional, financial, and physical toll of Spina 
Bifida on the individuals and families affected. Efforts to reduce and 
prevent suffering from Spina Bifida help to save money and save lives.

  IMPROVING QUALITY-OF-LIFE THROUGH THE NATIONAL SPINA BIFIDA PROGRAM

    SBA has worked with Members of Congress to ensure that our Nation 
is taking all the steps possible to prevent Spina Bifida and diminish 
suffering for those currently living with this condition. With 
appropriate, affordable, and high-quality medical, physical, and 
emotional care, most people born with Spina Bifida likely will have a 
normal or near normal life expectancy. The National Spina Bifida 
Program at the CDC works on two critical levels--to reduce and prevent 
Spina Bifida incidence and morbidity and to improve quality-of-life for 
those living with Spina Bifida. The program seeks to ensure that what 
is known by scientists is practiced and experienced by the 70,000 
individuals and families affected by Spina Bifida. Moreover, the 
National Spina Bifida Program works to improve the outlook for a life 
challenged by this complicated birth defect--principally identifying 
valuable therapies from in-utero throughout the lifespan and making 
them available and accessible to those in need.
    The National Spina Bifida Program serves as a national center for 
information and support to help ensure that individuals, families, and 
other caregivers, such as health professionals, have the most up-to-
date information about effective interventions for the myriad primary 
and secondary conditions associated with Spina Bifida. Among many other 
activities, the program helps individuals with Spina Bifida and their 
families learn how to treat and prevent secondary health problems, such 
as bladder and bowel control difficulties, learning disabilities, 
depression, latex allergy, obesity, skin breakdown and social and 
sexual issues. Children with Spina Bifida often have learning 
disabilities and may have difficulty with paying attention, expressing 
or understanding language, and grasping reading and math. All of these 
problems can be treated or prevented, but only if those affected by 
Spina Bifida--and their caregivers--are properly educated and taught 
what they need to know to maintain the highest level of health and 
well-being possible. The National Spina Bifida Program's secondary 
prevention activities represent a tangible quality-of-life difference 
to the 70,000 individuals living with Spina Bifida with the goal being 
living well with Spina Bifida.
    One way to increase research in Spina Bifida, improve quality and 
save precious resources is to establish a patient registry for Spina 
Bifida. Plans are underway to create the National Spina Bifida Patient 
Registry intended to determine both the best practices clinically and 
the cost effectiveness of treatment of Spina Bifida and the support the 
creation of quality measures to improve care overall. It is only 
through research towards improved care that we can truly save lives 
while realizing a significant cost savings.
    In fiscal year 2007, SBA requested $6 million be allocated to the 
National Spina Bifida Program to support and expand the National Spina 
Bifida Program. Although the House version o the fiscal year 2007 LHHS 
appropriations bill provided the $6 million request; the fiscal year 
2007 Continuing Appropriations Resolution provided $5.025 million 
(level funding) for this program. SBA understands and appreciates that 
the Congress and the Nation face difficult budgetary challenges. 
However, the progress being made by the National Spina Bifida Program 
must be sustained and expanded to ensure that people with Spina 
Bifida--over the course of their lifespan--have the support and access 
to quality care they need and deserve. To that end, SBA advocates that 
Congress allocate $7 million in fiscal year 2008 to the National Spina 
Bifida Program it can continue its current scope of the work and 
increase its folic acid awareness and Spina Bifida prevention efforts, 
further develop the National Spina Bifida Patient Registry, and sustain 
the National Spina Bifida Clearinghouse and Resource Center. Increasing 
funding for the National Spina Bifida Program will help ensure that our 
Nation continues to mount a comprehensive effort to prevent and reduce 
suffering from Spina Bifida.

                        PREVENTING SPINA BIFIDA

    While the exact cause of Spina Bifida is unknown, over the last 
decade, medical research has confirmed a link between a woman's folate 
level before pregnancy and the occurrence of Spina Bifida. Sixty-five 
million women are at-risk of having a child born with Spina Bifida and 
each year approximately 3,000 pregnancies in this country are affected 
by Spina Bifida, resulting in 1,500 births. The consumption of 400 
micrograms of folic acid daily prior to becoming pregnant and 
throughout the first trimester of pregnancy can help reduce incidence 
of Spina Bifida up to 75 percent. There are few public health 
challenges that our Nation can tackle and conquer by three-fourths in 
such a straightforward fashion. However, we must still be concerned 
with addressing the 25 percent of Spina Bifida cases that cannot be 
prevented by folic acid consumption, as well as ensuring that all women 
of childbearing age--particularly those most at-risk for a Spina Bifida 
pregnancy--consume adequate amounts of folic acid prior to becoming 
pregnant.
    The good news is that progress has been made in convincing women of 
the importance of folic acid consumption and the need to maintain diet 
rich in folic acid. Since 1968, the CDC has led the Nation in 
monitoring birth defects and developmental disabilities, linking these 
health outcomes with maternal and/or environmental factors that 
increase risk, and identifying effective means of reducing such risks. 
This public health success should be celebrated, but it is only half of 
the equation as approximately 3,000 pregnancies still are affected by 
this devastating birth defect. The Nation's public education campaign 
around folic acid consumption must be enhanced and broadened to reach 
segments of the population that have yet to heed this call--such an 
investment will help ensure that as many cases of Spina Bifida can be 
prevented as possible.
    SBA works collaboratively with CDC, the March of Dimes and the 
National Council on Folic Acid to increase awareness of the benefits of 
folic acid, particular for those at elevated risk of having a baby with 
neural tube defects (those who have Spina Bifida themselves or those 
who have already conceived a baby with Spina Bifida). With additional 
funding in fiscal year 2008 these activities could be expanded to reach 
the broader population in need of these public health education, health 
promotion, and disease prevention messages. SBA advocates that Congress 
provide additional funding to CDC to allow for a particular public 
health education and awareness focus on at-risk populations (e.g. 
Hispanic-Latino communities) and health professionals who can help 
disseminate information about the importance of folic acid consumption 
among women of childbearing age.
    In addition to a $7 million fiscal year 2008 allocation for the 
National Spina Bifida Program, SBA supports a fiscal year 2008 
allocation of $137.6 million for the NCBDDD so the agency can enhance 
its programs and initiatives to prevent birth defects and developmental 
disabilities and promote health and wellness among people with 
disabilities.

        IMPROVING HEALTH CARE FOR INDIVIDUALS WITH SPINA BIFIDA

    The mission of the Agency for Healthcare Research and Quality 
(AHRQ) is to improve the outcomes and quality of health care; reduce 
its costs; improve patient safety; decrease medical errors; and broaden 
access to essential health services. The work conducted by the agency 
is vital to the evaluation of new treatments in order to ensure that 
individuals and their families living with Spina Bifida continue to 
receive the high quality health care that they need and deserve--SBA 
urges the subcommittee to allocate $200,000 in fiscal year 2008 to AHRQ 
so the agency can continue to support and expand the development of a 
National Spina Bifida Patient Registry. This funding will allow AHRQ to 
direct and lead the effort to validate quality patient treatment data 
measures for the National Spina Bifida Patient Registry, which will 
help improve the quality of care provided throughout the Nation's 
system of Spina Bifida Clinics. In addition, SBA recommends that AHRQ 
receive an overall funding allocation of $350 million in fiscal year 
2008 so that it can continue to conduct follow-up efforts to evaluate 
Spina Bifida treatments and sustain and expand its myriad initiatives 
to improve quality of health care throughout the Nation.

         SUSTAIN AND SEIZE SPINA BIFIDA RESEARCH OPPORTUNITIES

    Our Nation has benefited immensely from our past Federal investment 
in biomedical research at the National Institutes of Health (NIH). SBA 
joins with the rest of the public health and research community in 
advocating that NIH receive a 6.7 percent increase ($30.869 billion) in 
fiscal year 2008. This funding will support applied and basic 
biomedical, psychosocial, educational, and rehabilitative research to 
improve the understanding of the etiology, prevention, cure and 
treatment of Spina Bifida and its related conditions. In addition, SBA 
requests that the subcommittee include language in the report 
accompanying the fiscal year 2008 LHHS measure to:
  --Urge the National Institute of Child Health and Human Development 
        (NICHD)--expansion of its role--and support of--a more 
        comprehensive Spina Bifida research portfolio;
  --Commend the National Institute of Diabetes and Digestive and Kidney 
        Diseases (NIDDK) for its interest in exploring issues related 
        to the neurogenic bladder and to encourage the institute to 
        forge ahead with its work in this important topic area; and
  --Encourage the National Institute of Neurological Diseases and 
        Stroke (NINDS) to continue and expand its research related to 
        the treatment and management of hydrocephalus.

                               CONCLUSION

    SBA stands ready to work with the subcommittee and other Members of 
Congress to advance policies that will reduce and prevent suffering 
from Spina Bifida. Again, we thank you for the opportunity to present 
our views on funding for programs that will improve the quality-of-life 
for the 70,000 Americans and their families living with Spina Bifida 
and stand ready to answer any questions you may have.
                                 ______
                                 
                Prepared Statement of The AIDS Institute

    The AIDS Institute, a national public policy research, advocacy, 
and education organization, is pleased to comment in support of 
critical HIV/AIDS and Hepatitis programs as part of the fiscal year 
2008 Labor, Health, and Education and Related Services appropriation 
measure. We thank you for your consistent support of these programs 
over the years, and trust you will do your best to adequately fund them 
in the future in order to provide for, and protect the health of many 
Americans.

                                HIV/AIDS

    HIV/AIDS remains one of the world's worst health pandemics in 
history. In the United States, according to the CDC, an estimated 1.2 
million people have been infected, 40,000 new infections each occur 
each year, and 531,000 people have died.
    Persons of minority races and ethnicities are disproportionately 
affected by HIV/AIDS. African Americans, who make up approximately 13 
percent of the United States population, account for half of the HIV/
AIDS cases. HIV/AIDS also disproportionately affects the poor, and 
about 70 percent of those infected rely on public health care 
financing.
    The U.S. Government has played a leading role in fighting AIDS, 
both here and abroad. The vast majority of the discretionary programs 
supporting HIV/AIDS efforts domestically and a portion of our Nation's 
contribution to the global AIDS effort are funded through your 
subcommittee. The AIDS Institute, working in coalition with other AIDS 
organizations, have developed funding request numbers for each of these 
domestic and global AIDS programs. The AIDS Institute asks that you do 
your best to adequately fund these programs at the requested level.
    We are keenly aware of budget constraints and competing interests 
for limited dollars. Unfortunately, despite the growing need, almost 
all domestic HIV/AIDS programs in recent years have experienced funding 
decreases, and in fiscal year 2007 all programs except one part of the 
Ryan White program were flat funded by the Joint Resolution.
    This year, the President has proposed increases to three new 
domestic HIV/AIDS programs: $25 million for the AIDS Drug Assistance 
Program (ADAP); $6.3 million for early treatment Ryan White programs; 
and $63 million for HIV testing. The AIDS Institute applauds this and 
encourages the committee to fund them. The President has proposed a $6 
million decrease for Ryan White AIDS Education and Treatment Centers 
(AETCs) and $30 million to implement the Early Diagnosis Grant Program. 
The AIDS Institute opposes these proposals and asks you to as well.

                           RYAN WHITE CARE ACT
                        [In millions of dollars]
------------------------------------------------------------------------
                                                              Amount
------------------------------------------------------------------------
Fiscal year:
    2007................................................           2,112
    2008 President's Request............................           2,133
    2008 Community Request..............................           2,794
------------------------------------------------------------------------

    The centerpiece of the government's response to caring and treating 
low-income individuals with HIV/AIDS are those programs funded under 
the Ryan White CARE Act. CARE Act programs currently reach over 571,000 
low-income, uninsured, and underinsured people each year. Providing 
care and treatment for those who have HIV/AIDS is not only 
compassionate, but is cost-effective in the long run, and serves as a 
tool in prevention of HIV/AIDS.
    In fiscal year 2007, all programs except Part B base funding, were 
flat funded. This is on top of many years of funding decreases, except 
for minor increases for ADAP. It is now time to reverse these funding 
decreases and provide these vitally important programs with the 
community requested level of funding. Consider the following:
    (1) Caseload levels are increasing. People are living longer due to 
lifesaving medications; there are 40,000 new infections each year; and 
the CDC has recommended routine voluntary HIV testing in all healthcare 
settings for everyone from the ages of 13 to 64. CDC estimates its 
proposed $63 million testing initiative will result in 31,000 new 
infections being diagnosed. All of this will necessitate the need for 
more CARE Act services and medications.
    (2) The price of healthcare, including medications, is increasing 
and Medicaid benefits are being scaled-back at both the State and 
Federal levels.
    (3) Funding under the recently reauthorized CARE Act is being 
distributed through a different formula which, without additional 
funding, will result in many cities and States losing funding. While 
some jurisdictions are experiencing increases, others are receiving 
decreases. Congress can help limit the drastic funding losses caused by 
formula changes by increasing the overall funding levels.
    (4) ADAP funding shortfalls are causing States to place clients on 
waiting lists, limiting drug formularies, and increasing eligibility 
requirements. In January 2007, four States reported having waiting 
lists, totaling 558 people. In the State of South Carolina there are 
540 people on its waiting list. Six other ADAPs reported other cost 
containment measures, including three with capped enrollment and others 
with formulary reductions, eligibility restrictions and limiting annual 
client expenditures. Since ADAP received no increase last year and a 
mere $2.2 million the year before, severe restrictions are anticipated 
in many States across the country.
    (5) Two reports conclude there are a staggering number of people in 
the United States who are not receiving life-saving AIDS medications. 
The Institute of Medicine report ``Public Financing and Delivery of 
HIV/AIDS Care, Securing the Legacy of Ryan White'' concluded that 
233,069 people in the United States who know their HIV status do not 
have continuous access to antiretrovirals. A study by the CDC titled, 
``Estimated number of HIV-infected persons eligible for and receiving 
antiretroviral therapy, 2003 United States'', reached similar 
conclusions. According to the CDC, 212,000, or 44 percent of eligible 
people living with HIV/AIDS, aged 15-49 in the United States, are not 
receiving antiretroviral therapy.
    Fiscal Year 2007 Administration Proposals.--While we appreciate the 
$25 million increase for ADAP proposed by the administration, it is far 
from the $233 million that is truly needed. As we seek to provide 
lifesaving medications to those abroad, we must ensure we are providing 
medications to our own in the United States. The administration has 
also proposed to increase funding for Part C (Title III) early 
treatment programs by $6.3 million. Again, while this increase is 
appreciated, it is far short of the increased need of $88 million for 
funding over 360 community-based primary health clinics and public 
health providers.
    The President has proposed an unprecedented decrease of $6 million 
for AIDS Education and Treatment Centers (AETCs), which train more than 
100,000 people per year. The new CARE Act now requires them to add 
trainings on Hepatitis B and C and culturally competent training for 
Native American and Alaska Native populations. To meet current needs, 
AETCs require a $15.3 million increase.
    Funding increases for other Ryan White CARE Act programs are also 
urgently needed. While patient caseloads increase, over the past 5 
years, Part A (Title I) has been cut by $15 million, over the past 4 
years Part C (Title III) has been cut by $5 million, and Part D (Title 
IV) by $2 million.
    Part A, which used to cover 51 urban areas most affected by HIV/
AIDS, now includes 56 areas, but received no increased funds, meaning 
there will be less money to go around. They are requesting an increase 
of $236 million. Part B Base, which provides funds to the States 
received an increase of $70 million in fiscal year 2007, but still 
lacks the adequate levels and is requesting an increase of $57 million.
    Title IV, which funds HIV care, psychosocial and other essential 
services to women, infants, children and youth, is requesting an 
increase of $46 million. The AIDS Institute also supports an increase 
of $6 million to Dental Reimbursement and Partnerships Programs.
    The AIDS Institute supports continued and increased funding for the 
Minority AIDS Initiative (MAI). MAI funds services nationwide that 
address the disproportionate impact that HIV has on communities of 
color.

     CENTERS FOR DISEASE CONTROL AND PREVENTION--HIV PREVENTION AND
                              SURVEILLANCE
                        [In millions of dollars]
------------------------------------------------------------------------
                                                                Amount
------------------------------------------------------------------------
Fiscal year:
    2007...................................................          652
    2008 President's Request...............................          745
    2008 Community Request.................................        1,049
------------------------------------------------------------------------

    While the number of new HIV infections in the United States has 
greatly decreased since the 1980's, there are still an estimated 40,000 
new infections each year. As with other domestic AIDS programs, 
prevention funding is severely lagging and CDC's AIDS funding has 
declined in the last 5 years. It is not surprising given the budget 
decreases, the goal of reducing the infection rate in half by 2005 was 
not reached.
    Fiscal Year 2008 Administration Proposals.--The AIDS Institute is 
in strong support of the President's proposed increase of $63 million 
to support HIV testing of more than 2 million people, mostly African-
Americans, in 10 jurisdictions with the highest rates of new 
infections, as well as the incarcerated and injecting drug users. 
Knowledge of one's HIV status, particularly for high risk individuals, 
is an effective prevention tool. Approximately one-quarter of the over 
1 million people living with HIV in the United States (252,000 to 
312,000 persons) are unaware of their HIV status. This initiative 
should help prevent future infections and bring more people into 
lifesaving treatment and care. The AIDS Institute urges the committee 
to fund this extremely worthy program.
    The administration is also proposing $30 million to implement the 
Early Diagnosis Grant Program, as called for by the new CARE Act. No 
State currently meets the grant conditions, which go beyond current CDC 
testing recommendations. We recommend that this funding be spent on 
other CDC HIV/AIDS prevention programs.
    While The AIDS Institute supports increased testing programs, we do 
not support funding these efforts at the expense of prevention 
intervention programs, which are already under funded.
    Efforts to improve prevention methods and weed out non-effective 
programs should be a constant undertaking and be guided by science and 
fact based decision-making. It is for these reasons The AIDS Institute 
opposes abstinence-only until marriage programs, for which the 
President requested a $28 million increase. While we support 
abstinence-based prevention programs as part of a comprehensive 
prevention message, there is no scientific proof that abstinence-only 
programs are effective. On the contrary, they reject proven prevention 
tools, such as condoms, and fail to address the needs of homosexuals, 
who can not marry, and who remain greatly impacted by HIV/AIDS.

              NATIONAL INSTITUTES OF HEALTH--AIDS RESEARCH
                        [In millions of dollars]
------------------------------------------------------------------------
                                                                Amount
------------------------------------------------------------------------
Fiscal year:
    2007...................................................        2,903
    2008 President's Request...............................        2,905
    2008 Community Request.................................        3,200
------------------------------------------------------------------------

    Through the NIH, research is conducted to understand the AIDS virus 
and its complicated mutations; discover new drug treatments; develop a 
vaccine and other prevention programs such as microbicides; and 
ultimately, a cure. Much of this work at the NIH is done in cooperation 
with private funding. The critically important work performed by the 
NIH not only benefits those in the United States, but the entire world.
    This research has already helped in the development of many highly 
effective new drug treatments, prolonging the lives of millions of 
people. As neither a cure nor a vaccine exists, and patients continue 
to build resistance to existing medications, additional research must 
continue. We ask the committee to fund critical AIDS research at the 
community requested level of $3.2 billion.

       SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION

    Many persons infected with HIV also experience drug abuse and/or 
mental health problems, and require the programs funded by SAMHSA. 
Given the growing need for services, we are disappointed by proposed 
funding cuts at SAMHSA, including $47 million for the Center for 
Substance Abuse Treatment, $36 million for the Center for Substance 
Abuse Prevention, and $76 million for the Center for Mental Health 
Services. We ask the committee to reject these cuts, and adequately 
fund these programs

                            VIRAL HEPATITIS

    Viral Hepatitis, whether A, B, or C, is an infectious disease that 
also deserve increased attention by the Federal Government. According 
to the CDC, there are an estimated 1.25 million Americans chronically 
infected with Hepatitis B, and 60,000 new infections each year. 
Although there is no cure, a vaccine is available, and a few treatment 
options are available. An estimated 4.1 million (1.6 percent) Americans 
have been infected with Hepatitis C, of whom 3.2 million are 
chronically infected. Currently, there is no vaccine and very few 
treatment options. It is believed that one-third of those infected with 
HIV are co-infected with Hepatitis C.
    Given these numbers, we are disappointed the administration is 
calling for continued level funding of $17.5 million for Viral 
Hepatitis at the CDC. This amount is less than what was funded in 
fiscal year 2003 and falls short of the $50 million that is needed. 
These funds are needed to establish a program to lower the incidence of 
Hepatitis through education, outreach, and surveillance, and to support 
such initiatives as the CDC National Hepatitis C Prevention Strategy 
and the 2002 NIH Consensus Statement on the Management of Hepatitis C 
and accompanying recommendations.
    The administration is proposing to cut the 317 Immunization Grant 
Program funds that serve as the major source in the public sector for 
at-risk adult immunizations. Instead of facing cuts, this cost-
effective program should be significantly enhanced in order to protect 
people from Hepatitis A and B. We recommend funding the 317 Program at 
$802 million for fiscal year 2008 in order to fully realize the public 
health benefits of immunization.
    The AIDS Institute asks that you give great weight to our testimony 
and remember it as you deliberate over the fiscal year 2008 
appropriation bill. Should you have any questions or comments, feel 
free to contact Carl Schmid, Director of Federal Affairs, The AIDS 
Institute, 1705 DeSales Street, NW, Washington, DC 20036; (202) 462-
3042; [email protected]. Thank you very much.
                                 ______
                                 
       Prepared Statement of The Humane Society Legislative Fund

    The Humane Society Legislative Fund (HSLF) supports a strong 
commitment by the Federal Government to research, development, 
standardization, validation and acceptance of non-animal and other 
alternative test methods. We are also submitting our testimony on 
behalf of The Humane Society of the United States and The Procter & 
Gamble Company. Thank you for the opportunity to present testimony 
relevant for the fiscal year 2008 budget request for the National 
Institute of Environmental Health Sciences (NIEHS) for the fiscal year 
2008 activities of the National Toxicology Program Center for the 
Evaluation of Alternative Toxicological Test Methods (NICEATM), the 
support center for the Interagency Coordinating Committee for the 
Validation of Alternative Test Methods (ICCVAM).
    In 2000, the passage of the ICCVAM Authorization Act into Public 
Law 106-545, created a new paradigm for the field of toxicology. It 
requires Federal regulatory agencies to ensure that new and revised 
animal and alternative test methods be scientifically validated prior 
to recommending or requiring use by industry. An internationally agreed 
upon definition of validation is supported by the 15 Federal regulatory 
and research agencies that compose the ICCVAM, including the EPA. The 
definition is: ``the process by which the reliability and relevance of 
a procedure are established for a specific use.''

                         FUNCTION OF THE ICCVAM

    The ICCVAM performs an invaluable function for regulatory agencies, 
industry, public health and animal protection organizations by 
assessing the validation of new, revised and alternative toxicological 
test methods that have interagency application. After appropriate 
independent peer review of the test method, the ICCVAM recommends the 
test to the Federal regulatory agencies that regulate the particular 
endpoint the test measures. In turn, the Federal agencies maintain 
their authority to incorporate the validated test methods as 
appropriate for the agencies' regulatory mandates. This streamlined 
approach to assessment of validation of new, revised and alternative 
test methods has reduced the regulator burden of individual agencies, 
provided a ``one-stop shop'' for industry, animal protection, public 
health and environmental advocates for consideration of methods and set 
uniform criteria for what constitutes a validated test methods. In 
addition, from the perspective of animal protection advocates, ICCVAM 
can serve to appropriately assess test methods that can refine, reduce 
and replace the use of animals in toxicological testing. This function 
will provide credibility to the argument that scientifically validated 
alternative test methods, which refine, reduce or replace animals, 
should be expeditiously integrated into Federal toxicological 
regulations, requirements and recommendations.

                         HISTORY OF THE ICCVAM

    The ICCVAM is currently composed of representatives from the 
relevant Federal regulatory and research agencies. It was created from 
an initial mandate in the NIH Revitalization Act of 1993 for NIEHS to 
``(a) establish criteria for the validation and regulatory acceptance 
of alternative testing methods, and (b) recommend a process through 
which scientifically validated alternative methods can be accepted for 
regulatory use.'' In 1994, NIEHS established the ad hoc ICCVAM to write 
a report that would recommend criteria and processes for validation and 
regulatory acceptance of toxicological testing methods that would be 
useful to Federal agencies and the scientific community. Through a 
series of public meetings, interested stakeholders and agency 
representatives from all 14 regulatory and research agencies, developed 
the NIH Publication No. 97-3981, ``Validation and Regulatory Acceptance 
of Toxicological Test Methods.'' This report, and subsequent revisions, 
has become the sound science guide for consideration of new, revised 
and alternative test methods by the Federal agencies and interested 
stakeholders.
    After publication of the report, the ad hoc ICCVAM moved to 
standing status under the NIEHS' NICEATM. Representatives from Federal 
regulatory and research agencies and their programs have continued to 
meet, with advice from the NICEATM's Advisory Committee and independent 
peer review committees, to assess the validation of new, revised and 
alternative toxicological methods. Since then, several methods have 
undergone rigorous assessment and are deemed scientifically valid and 
acceptable. In addition, the ICCVAM is working to streamline assessment 
of methods from the European Union (EU) that have already been 
validated for use within the EU. The open public comment process, input 
by interested stakeholders and the continued commitment by the Federal 
agencies has led to ICCVAM's success. It has resulted in a more 
coordinated review process for rigorous scientific assessment of the 
validation of new, revised and alternative test methods.

                 REQUEST FOR COMMITTEE REPORT LANGUAGE

    In 2006, the NICEATM/ICCVAM at the request of the U.S. Congress 
began a process of developing a 5-year roadmap for assertively setting 
goals to prioritize ending the use of antiquated animal tests for 
specific endpoints. The HSLF and other national animal protection 
organizations provided extensive comments on the process and priorities 
for the roadmap.
    While the stream of methods forwarded to the ICCVAM for assessment 
has remained relatively steady, it is imperative that the ICCVAM take a 
more proactive role in isolating areas where new methods development is 
on the verge of replacing animal tests. These areas should form a 
collective call by the Federal agencies that compose ICCVAM to fund any 
necessary additional research, development, validation and validation 
assessment that is required to eliminate the animal methods. We also 
strongly urge the NICEATM/ICCVAM to closely coordinate research, 
development and validation efforts with its European counterpart, the 
European Centre for the Validation of Alternative Methods (ECVAM) to 
ensure the best use of available funds and sound science. This 
coordination should also reflect a willingness by the Federal agencies 
comprising ICCVAM to more readily accept validated test methods 
proposed by the ECVAM to ensure industry has a uniform approach to 
worldwide chemical safety evaluation.
    We respectfully request the subcommittee consider the following 
report language for the Senate Labor, Health and Human Services, 
Education and Related Agencies Appropriations bill to ensure that the 
5-year roadmap is completed in a timely manner:

    ``The committee commends the National Interagency Center for the 
Evaluation of Alternative Methods/Interagency Coordinating Committee on 
the Validation of Alternative Methods (NICEATM/ICCVAM) for commencing a 
process for developing a 5-year plan to research, develop, translate 
and validate new and revised non-animal and other alternative assays 
for integration of relevant and reliable methods into the Federal 
agency testing programs. The 5-year plan shall be used to prioritize 
areas, including tiered testing and evaluation frameworks, which have 
the potential to most significantly and rapidly reduce, refine or 
replace laboratory animal methods. The committee directs a transparent, 
public process for developing this plan and recommends the plan be 
presented to the committee by November 15, 2007. Funding for completing 
the 5-year plan shall not reduce the NICEATM/ICCVAM appropriation.''
                                 ______
                                 
     Prepared Statement of The Humane Society of the United States

    On behalf of The Humane Society of the United States (SUS) and our 
more than 10 million supporters nationwide, we appreciate the 
opportunity to provide testimony on our top funding priority for the 
Labor, Health and Human Services, Education and Related Agencies 
Subcommittee in fiscal year 2008. We are also submitting our testimony 
on behalf of The Humane Society Legislative Fund (HSLF). Thank you for 
the opportunity to present testimony relevant for the fiscal year 2008 
budget request.

                  BREEDING OF CHIMPANZEES FOR RESEARCH

    The HSUS requests that no Federal funding be appropriated for 
breeding of chimpanzees for research, or for research that requires 
breeding of chimpanzees, for the following reasons:
  --The National Center for Research Resources has a publicly-declared 
        moratorium (extended until December 2007) on breeding 
        chimpanzees which prohibits breeding of federally owned or 
        supported chimpanzees or NIH funding of projects that require 
        chimpanzee breeding (NCRR written communication, February 28, 
        2006).
  --The United States currently has a surplus of chimpanzees available 
        for use in research due to overzealous breeding for HIV 
        research and subsequent findings that they are a poor HIV 
        model.\1\
---------------------------------------------------------------------------
    \1\ NRC (National Research Council) (1997) Chimpanzees in research: 
strategies for their ethical care, management and use. National 
Academies Press: Washington, D.C.
---------------------------------------------------------------------------
  --The cost of maintaining chimpanzees in laboratories is exorbitant, 
        totaling between $4.7 and $9.3 million each year for the 
        current population of approximately 800 federally owned or 
        supported chimpanzees ($15-39 per day per chimpanzee; $500,000 
        per chimpanzee's 50-year lifetime). Breeding of additional 
        chimpanzees into laboratories will only perpetuate a number of 
        burdens on the government--up to 60 years per chimpanzee born 
        into the system.
  --Expansion of the chimpanzee population in laboratories only creates 
        more concerns than presently exist about their quality of care.
  --Use of chimpanzees in research raises strong public concerns.

                         BACKGROUND AND HISTORY

    Beginning in 1995, the National Research Council (NRC) confirmed a 
chimpanzee surplus and recommended a moratorium on breeding of 
federally owned or supported chimpanzees,\1\ who now number 
approximately 800 of the 1,300 total chimpanzees available for research 
in the United States. According to a National Research Resources 
Advisory Council September 15, 2005 meeting, the National Center for 
Research Resources (NCRR) of NIH extended the moratorium until December 
2007 because of high costs of chimpanzee care, lack of existing colony 
information, and failure of chimpanzees as a model, such as for HIV. 
Further, it has also been noted that ``a huge number'' of chimpanzees 
were not being used in active research protocols and were therefore 
``just sitting there.'' \2\ NCRR will be making a decision this year as 
to whether the breeding moratorium should continue. There is no 
justification for breeding of additional chimpanzees for research; 
therefore The HSUS hopes that NCRR will continue the moratorium into 
the future. Importantly, however, lack of Federal funding for breeding 
will ensure that no breeding of federally owned or supported 
chimpanzees for research will occur in fiscal year 2008.
---------------------------------------------------------------------------
    \2\ Cohen, J. (2007) Biomedical Research: The Endangered Lab Chimp. 
Science. 315:450-452.
---------------------------------------------------------------------------
    Furthermore, despite the moratorium on breeding, there are cases in 
which the moratorium is not being obeyed, further prompting the need 
for congressional action.

                     DEVIATIONS FROM THE MORATORIUM

    Despite the NCRR breeding moratorium, which prohibits breeding of 
federally owned or supported chimpanzees or NIH funding of projects 
that require chimpanzee breeding (NCRR written communication, February 
28, 2006), chimpanzee breeding is still being funded by NIH. For 
example, the National Institute of Allergy and Infectious Diseases 
maintains a contract with New Iberia Research Center in Louisiana to 
provide 10 to 12 infant chimpanzees annually for research projects. The 
10-year contract entitled ``Leasing of chimpanzees for the conduct of 
research'' has been allotted over $22 million, with $3.9 million 
awarded since its inception in September 2002.

           CONCERNS REGARDING CHIMPANZEE CARE IN LABORATORIES

    Inspections conducted by the U.S. Department of Agriculture 
demonstrate that basic chimpanzee housing requirements are often not 
being met. Inspection reports for three federally funded chimpanzee 
facilities reported housing of chimpanzees in less than minimal space 
requirements, inadequate environmental enhancement for primates, and/or 
general disrepair of facilities. Problems at three major chimpanzee 
research facilities add further argument against the breeding of even 
more chimpanzees.

   CHIMPANZEES HAVE OFTEN BEEN A POOR MODEL FOR HUMAN HEALTH RESEARCH

    The scientific community recognizes that chimpanzees are poor 
models for HIV because chimpanzees do not develop AIDS. Similarly, 
though chimpanzees do not model the course of the human Hepatitis C 
virus, they continue to be widely used for this research. According to 
the chimpanzee genome, some of the greatest differences between 
chimpanzees and humans relate to the immune system,\3\ calling into 
question the validity of infectious disease research using chimpanzees.
---------------------------------------------------------------------------
    \3\ The Chimpanzee Sequencing and Analysis Consortium/Mikkelsen, 
ts, et al., (1 September 2005) initial sequence of the chimpanzee 
genome and comparison with the human genome, Nature 437, 69-87.
---------------------------------------------------------------------------
         ETHICAL AND PUBLIC CONCERNS ABOUT CHIMPANZEE RESEARCH

    Chimpanzee research raises serious ethical issues, particularly 
because of their extremely close similarities to humans in terms of 
intelligence and emotions. Americans are clearly concerned about these 
issues: 90 percent believe it is unacceptable to confine chimpanzees 
individually in government-approved cages; 71 percent believe that 
chimpanzees who have been in the laboratory for over 10 years should be 
sent to sanctuary for retirement (chimpanzees can live to be 60 years 
old); \4\ and 54 percent believe that it is unacceptable for 
chimpanzees to ``undergo research which causes them to suffer for human 
benefit.'' \5\
---------------------------------------------------------------------------
    \4\ 2006 poll conducted by the Humane Research Council for Project 
Release & Restitution for Chimpanzees in laboratories.
    \5\ 2001 poll conducted by Zogby International for the Chimpanzee 
Collaboratory.
---------------------------------------------------------------------------
    We respectfully request the following committee bill or report 
language: ``The committee directs that no funds provided in this act be 
used to support the breeding of chimpanzees for research or to support 
research that requires breeding of chimpanzees.''
    We appreciate the opportunity to share our views for the Labor, 
Health and Human Services, Education and Related Agencies 
Appropriations Act for fiscal year 2008. We hope the committee will be 
able to accommodate this modest request that will save the government a 
substantial sum of money, benefit chimpanzees, and allay some concerns 
of the public at large. Thank you for your consideration.
                                 ______
                                 
          Prepared Statement of the Trust for America's Health

    Trust for America's Health (TFAH), a national non-profit, 
nonpartisan organization dedicated to saving lives by protecting the 
health of every community and working to make disease prevention a 
national priority, is pleased to provide the subcommittee with the 
following testimony. In order to provide the resources to build a 21st 
century public health system that gives all communities a strong 
defense against today's health threats, TFAH identifies a number of 
programs essential to achieving this goal.

   BOLSTERING THE NATION'S ABILITY TO DETECT AND CONTROL INFECTIOUS 
                  DISEASES SUCH AS PANDEMIC INFLUENZA

    Pandemic Preparedness ($1.542 billion, $350 million over the 
President's request).--In November 2005, the President requested a 
total of $7.1 billion to respond to an influenza pandemic. To date, 
Congress has appropriated just over $6 billion of that request. We were 
pleased that the fiscal year 2008 budget proposal would honor that 
commitment with an additional $1.2 billion for pandemic preparedness 
activities, including making improvements in vaccine technology and 
manufacturing; stockpiling antivirals, diagnostics and medical 
supplies; developing contingency planning; enhancing risk 
communication; and enhancing global and domestic health surveillance.
    The emergency supplemental passed by the House and Senate contains 
$625 million of the $870 in one-time pandemic flu funding recommended 
in the President's fiscal year 2008 budget proposal, primarily for 
purchasing antiviral medications and medical supplies. In addition, 
there is a need for an ongoing annual investment, particularly at the 
CDC, to ensure that preparedness efforts are sustained and effective. 
These activities require funding beyond the life cycle of the 
supplemental appropriations vehicles. TFAH supports the remaining $245 
million in one-time pandemic flu funding not included in the emergency 
supplemental; and $322 million for ongoing pandemic preparedness 
activities in the Department of Health and Human Services, which 
includes $158 million at the CDC.
    Further, we support $350 million in annual recurring funding for 
State and local pandemic preparedness activities. States would use this 
funding to exercise response plans, make revisions and updates to 
plans, and build medical surge capacity. In the midst of a pandemic, it 
could be difficult to shift resources from one part of the country to 
another, so every jurisdiction must be prepared. In fiscal year 2006, 
Congress provided $600 million in one-time funding for State and local 
pandemic preparedness, but this funding will expire at the end of 
fiscal year 2007, and no such funds have been requested for fiscal year 
2008.

                        GLOBAL DISEASE DETECTION

    Global surveillance for infectious disease outbreaks is also 
critical. The CDC's Global Disease Detection initiative aims to 
recognize infectious disease outbreaks faster, improve the ability to 
control and prevent outbreaks, and detect emerging microbial threats. 
In fiscal year 2006, Global Disease Detection centers across the globe 
help countries investigate numerous outbreaks, including avian 
influenza, hemorrhagic fever, meningitis, cholera and unexplained 
sudden death. TFAH recommends funding the Global Disease Detection 
initiative at $45 million, which is an increase of $12.5 million over 
the President's requested level.

          UPGRADING STATE AND LOCAL BIOTERRORISM PREPAREDNESS

    The terrorism events of 2001 and the subsequent anthrax and ricin 
attacks illustrated the need for a responsive public health system and 
demonstrated that the existing structure has enormous gaps. The Federal 
Government took unprecedented first steps towards improved preparedness 
by providing funding to State and local public health departments to 
better respond to terrorism. These funds have allowed States and 
localities to conduct needs assessments, develop terrorism response 
plans and training activities, strengthen epidemiology and surveillance 
capabilities, and upgrade lab capacity and communications systems. Yet 
a great deal of work remains to be done.
    The December 2006 TFAH Report, Ready or Not?--Protecting the 
Public's Health from Diseases, Disasters and Bioterrorism, examined 10 
key indicators to assess areas of both improvement and ongoing 
vulnerability in our Nation's effort to protect against bioterrorism. 
The report found that 5 years after the September 11th and anthrax 
tragedies, emergency health preparedness is still inadequate in 
America. To address these shortcomings, we recommend the following:
  --State and Local Capacity ($919 million, $221 million over the 
        President's request).--CDC distributes grants to 50 States and 
        four metropolitan areas for public health infrastructure 
        upgrades to respond to acts of terrorism or infectious disease 
        outbreaks. In fiscal year 2008, the President proposes to cut 
        funding for this program by $125.4 million, a nearly 25 percent 
        cut since fiscal year 2005. This would force health departments 
        to cut staff dedicated to preparedness; laboratories would lose 
        trained personnel and the ability to purchase new technology; 
        and disease surveillance and response efforts would be 
        hindered.
  --Hospital Preparedness Grants ($650 million, $236 million over the 
        President's request).--The primary focus of the National 
        Bioterrorism Hospital Preparedness Program is to improve the 
        capacity of the Nation's hospitals and other supporting 
        healthcare entities to respond to bioterrorist attacks, 
        infectious disease epidemics, and other large-scale emergencies 
        by enabling hospitals, EMS, and health centers to plan a 
        coordinated response. The President proposes to cut funding for 
        hospital preparedness grants by $60 million in fiscal year 
        2008.

                CHRONIC DISEASES CONTINUE TO TAKE A TOLL

    Chronic diseases account for 70 percent of all deaths in the United 
States and untold disability and suffering. In fact, five of our top 
six causes of death--heart disease, cancer, stroke, chronic obstructive 
pulmonary disease, and diabetes--are chronic diseases. The treatment of 
chronic diseases consumes three-quarters of the $1.7 trillion the 
United States spends annually on health care.
    Smoking, for example, is the single most preventable cause of death 
and disease in the United States, causing 440,000 premature deaths 
annually. And increasingly, obesity is a significant risk factor in 
such major chronic disease killers as heart disease, stroke and 
diabetes.

                 FIGHTING THE EMERGING OBESITY EPIDEMIC

    The number of overweight and obese individuals has reached epidemic 
proportions in the United States with 64.5 percent of the adult 
population being diagnosed as obese (119 million). In the United 
States, the percentage of young people who are overweight has tripled 
in the last 20 years. Despite this troubling trend, the President's 
proposed fiscal year 2008 budget provides no increases for existing 
obesity-related programs.
  --Division of Nutrition and Physical Activity (DNPA) ($65 million, 
        $23.6 million over the President's request).--CDC's grant 
        funding allows State health departments to develop a nutrition 
        and physical activity infrastructure; develop a primary 
        prevention plan for nutrition and physical activity to 
        coordinate and link partners in and out of State government; 
        identify and assess data sources to monitor the burden of 
        obesity; and evaluate the progress and impact of the State 
        plans and intervention projects. Currently, only 28 States 
        receive DNPA grants, 7 at basic implementation, and 21 at 
        capacity-building levels. An increase to $65 million would fund 
        all 50 States and provide $5 million for the National Fresh 
        Fruit and Vegetable Nutrition Program.
  --School Health Programs ($75.8 million, $20 million over the 
        President's request).--CDC's grant funding assists States in 
        improving the health of children through a school level program 
        that engages families and communities and develops health 
        education, physical education, school meals, health services, 
        healthy school environments, and staff health promotion. 
        Currently, school health programs are funded in only 23 States. 
        The recommended increase of $20 million would expand the number 
        of States to 40.
  --STEPS to a Healthier United States ($43.6 million, $17.3 million 
        over the President's request).--STEPS grants support 
        communities, cities and tribal entities to implement health 
        promotion programs and community initiatives. STEPS works with 
        health care and insurance systems to combat obesity in over 40 
        communities, cities, and tribal entities. The President's 
        budget proposes to cut funding for STEPS by $17.2 million.
  --Adolescent Health Promotion Initiative ($17.3 million, equal to the 
        President's request).--This new initiative aims to help schools 
        encourage regular physical activity, healthy eating, and injury 
        prevention. Schools will have access to the Department of 
        Health and Human Services' (HHS) School Health Index, which 
        they can use to make self-assessments and develop action plans. 
        Schools can apply for one of CDC's approximately 3,600 School 
        Culture of Wellness Grants to help implement their action 
        plans.

                              IMMUNIZATION

    Immunization through vaccination of children and adults is proven 
effective as a means to prevent some of the most important infectious 
diseases. Immunization should remain a high public health priority, 
and, to ensure that its benefits are fully realized, the Federal 
Government should increase its commitment to these life saving public 
health interventions.
    National Immunization Program ($802.5 million, $257.5 million over 
the President's request).--This program provides for childhood and 
adult operations/infrastructure grants, the purchase of childhood and 
adult vaccines, and related prevention activities. Each day, 11,000 
babies are born in the United States who will need up to 28 
vaccinations before they are 2 years old. Even so, nearly 1 million 2-
year-olds do not receive all the recommended doses. Every dollar spent 
on vaccines saves an extraordinary amount downstream: $27 with DTaP 
(Diphtheria, Tetanus and Pertussis), $26 with MMR (Measles, Mumps and 
Rubella), and $15 with Hepatitis B. However, the vaccine cost to fully 
immunize one child has risen in the past 6 years alone from $186 to 
$570.
    Currently, the CDC provides grants to all 50 States, six cities and 
eight current or former territories to carry out immunization 
activities. TFAH recommends providing $802.5 million for the National 
Immunization Program at CDC. This includes $720 million for the 317 
Immunization Program ($245 million for State operations/infrastructure 
grants, and $475 million for the purchase of childhood vaccines); and 
$82.543 million for program operations ($4.887 million for vaccine 
tracking and $77.656 million for prevention activities).

                  SUPPORTING OTHER PUBLIC HEALTH TOOLS

    TFAH supports additional funding for disease detection and 
surveillance activities which are vital to stemming an infectious 
disease outbreak, tracking rises in chronic diseases, or responding to 
a bioterror event.
    Federal and State public health laboratory capabilities ($47 
million, $20 million over the President's request).--Additional funds 
are needed to upgrade facilities and equipment and to bolster the 
workforce. This funding is essential if scientists are to have the 
capability to conduct clinical testing for potentially dangerous 
chemicals, such as ricin, cyanide, nerve agents, and pesticide exposure 
or test for novel strains of influenza. Of the suggested $20 million 
increase, TFAH recommends that $10 million be used to enhance State 
public health laboratory biomonitoring capabilities, with $10 million 
used to bolster the intramural CDC lab program.
    Environment and Health Outcome Tracking ($50 million, $26 million 
over the President's request).--The program links environmental and 
health data in order to identify problems and effective solutions to 
reduce the burden of chronic disease. Additional funds would enable the 
program to fund additional States and local health departments, or 
order to systematically and comprehensively track respiratory diseases, 
developmental disorders, birth defects, cancers and environmental 
exposures to help scientists find answers about causes and cures of 
these diseases. Further, the program plans to issue a major national 
report on the environment and health in 2008, and expects to make 
operational its Web-based environmental tracking system and roll out a 
report reflecting data from funded States within 2 years.
    Mr. Chairman, thank you again for the opportunity to submit 
testimony on the urgent need to enhance Federal funding for core public 
health programs.
                                 ______
                                 
       Prepared Statement of the United Tribes Technical College

    For 38 years, United Tribes Technical College (UTTC) has been 
providing postsecondary vocational education, job training and family 
services to Indian students from throughout the Nation. We are governed 
by the five tribes located wholly or in part in North Dakota. We are an 
educational institution that consistently has excellent results, 
placing Indian people in good jobs and reducing welfare rolls. The 
Perkins funds constitute about half of our operating budget. We do not 
have a tax base or State appropriated funds on which to rely.
    The request of the United Tribes Technical College Board for the 
section 117 of the Perkins Act, Tribally Controlled Postsecondary 
Career and Technical Institutions Program is:
  --$8.5 million or $1.1 million above the administration's request and 
        the fiscal year 2007 enacted level. Funding under section 117 
        of the Perkins Act has in recent years it has been distributed 
        on a formula basis.
    UTTC Performance Indicators. UTTC has:
  --An 87 percent retention rate,
  --A placement rate of 95 percent (job placement and going on to 4-
        year institutions),
  --A projected return on Federal investment of 1 to 20 (2005 study 
        comparing the projected earnings generated over a 28-year 
        period of UTTC Associate of Applied Science and Bachelor degree 
        graduates of June 2005 with the cost of educating them.), and
  --The highest level of accreditation. The North Central Association 
        of Colleges and Schools has accredited UTTC again in 2001 for 
        the longest period of time allowable--10 years or until 2011--
        and with no stipulations. We are also the only tribal college 
        accredited to offer on-line associate degrees.
    The Demand for our Services is Growing and we are Serving More 
Students.--For the 2006-2007 school year we enrolled 1,018 students (an 
unduplicated count). The majority of our students are from the Great 
Plains States, an area that, according to the 2003 BIA Labor Force 
Report, has an Indian reservation jobless rate of 76 percent. UTTC is 
proud that we have an annual placement rate of 95 percent.
    In addition, we have served 254 students during school year 2005-
2006 in our Theodore Jamerson Elementary school, and 350 children, 
birth to 5, were served in the child developments centers for 2005-
2006.
    UTTC Course Offerings and Partnerships With Other Educational 
Institutions.--We offer 15 vocational/technical programs and award a 
total of 24 2-year degree and 1-year certificates. We are accredited by 
the North Central Association of Colleges and Schools.
    Licensed Practical Nursing.--This is our program with the highest 
number of students. We have an agreement with the University of North 
Dakota system that allows our students to transfer their credits to 
these 4-year nursing programs.
    Medical Transcription and Coding Certificate Program.--Our newest 
academic endeavor is our Medical Transcription and Coding Certificate 
Program which is offered through the college's Exact Med Training 
program and supported by Department of Labor funds.
    Tribal Environmental Science.--Our Tribal Environmental Science 
program is being offered through a National Science Foundation Tribal 
College and Universities Program grant. The 5-year project supports 
UTTC in implementing a program that leads to a 2-year Associate of 
Applied Science degree in Tribal Environmental Science.
    Injury Prevention.--Through our Injury Prevention Program we are 
addressing the injury death rate among Indians, which is 2.8 times that 
of the U.S. population We received assistance through Indian Health 
Service to offer the only degree-granting Injury Prevention program in 
the Nation. Injuries are the number one cause of mortality among Native 
people for ages 1-44 and the third for overall death rates.
    Online Education.--We are working to bridge the ``digital divide'' 
by providing web-based education and Interactive Video Network courses 
from our North Dakota campus to American Indians residing at other 
remote sites and as well as to students on our campus. This spring 
semester 2007, we have 61 students registered in online courses, of 
which 48 students are studying exclusively online (approximately 34 
FTE) and 13 are campus-based students. These online students come from 
the following States: Colorado, Georgia, Hawaii, Idaho, Kentucky, 
Nebraska, North Dakota, Oklahoma, Oregon, South Dakota, West Virginia, 
and Wisconsin.
    Online courses provide the scheduling flexibility students need, 
especially those students with young children. We offer online full 
degree programs in the areas of Early Childhood Education, Injury 
Prevention, Health Information Technology, Nutrition and Food Service 
and Elementary Education. All totaled, 156 online course seats are 
filled by students this semester. Over 50 courses are currently offered 
online, including those in the Medical Transcription and Coding program 
and those offered through an MOU with Owens Valley Career Development 
Center.
    Our newest online course is suicidology--the study of suicide, its 
causes, and its prevention and of the behavior of those to threaten or 
attempt suicide--and we expect that with additional outreach that there 
will be a significant demand for this course. We also offer a training 
program through the Environmental Protection Agency to train 
environmental professionals in Indian Country. The Indian Country 
Environmental Hazard Assessment Program is a training course designed 
to help mitigate environmental hazards in reservation communities.
    United Tribes Technical College is accredited by the Higher 
Learning Commission of the North Central Association of Colleges and 
Schools to provide associate degrees online. This approval is required 
in order for us to offer Federal financial aid to students enrolled in 
these online courses. We are the only tribal college accredited to 
offer associate degrees online.
    Computer Information and Technology.--The Computer Support 
Technician program is at maximum student capacity because of 
limitations on learning resources for computer instruction. In order to 
keep up with student demand and the latest technology, we will need 
more classrooms, equipment and instructors. Our program includes all of 
the Microsoft Systems certifications that translate into higher income 
earning potential for graduates.
    Nutrition and Food Services.--UTTC will meet the challenge of 
fighting diabetes in Indian Country through education. Indians and 
Alaska Natives have a disproportionately high rate of type 2 diabetes, 
and have a diabetes mortality rate that is three times higher than the 
general U.S. population. The increase in diabetes among Indians and 
Alaska Natives is most prevalent among young adults aged 25-34, with a 
160 percent increase from 1990-2004. Diabetes mortality is 3.1 times 
higher in the Indian/Alaska Native population than in the general U.S. 
population (Source: fiscal year 2008 Indian Health Service Budget 
Justification).
    As a 1994 Tribal Land Grant institution, we offer a Nutrition and 
Food Services Associate of Applied Science degree in an effort to 
increase the number of Indians with expertise in nutrition and 
dietetics. Currently, there are only a handful of Indian professionals 
in the country with training in these areas. Among our offerings is a 
Nutrition and Food Services degree with a strong emphasis on diabetes 
education, traditional food preparation, and food safety.
    We have also established the United Tribes Diabetes Education 
Center to assist local tribal communities and our students and staff in 
decreasing the prevalence of diabetes by providing diabetes educational 
programs, materials and training. We publish and make available tribal 
food guides to our on-campus community and to tribes.
    Business Management/Tribal Management.--Another of our newer 
programs is business and tribal management designed to help tribal 
leaders be more effective administrators. We continue to refine our 
curricula for this program.
    Job Training and Economic Development.--UTTC is a designated 
Minority Business Development Center serving Montana, South Dakota and 
North Dakota. We also administer a Workforce Investment Act program and 
an internship program with private employers in the region.
    Economic Development Administration funding was made available to 
open a ``University Center.'' The Center is used to help create 
economic development opportunities in tribal communities. While most 
States have such centers, this center is the first-ever tribal center.
    Upcoming Endeavors.--We continue to seek a Memorandum of 
Understanding with the BIA's Police Academy in New Mexico that would 
allow our criminal justice program to be recognized for the purpose of 
BIA and Tribal police certification, so that Tribal members from the 
BIA regions in the Northern Plains, Northwest, Rocky Mountain, and 
Midwest areas would not have to travel so far from their families to 
receive training. Our criminal justice program is accredited and 
recognized as meeting the requirements of most police departments in 
our region. We also anticipate providing similar training for 
correctional officers, a vital need in Indian country.
    Additionally, we are interested in developing training programs 
that would assist the BIA in the area of provision of trust services. 
We have several technology disciplines and instructors that are capable 
of providing those kinds of services with minimum of additional 
training.
    Department of Education Study Documents our Facility/Housing 
Needs.--The 1998 Carl Perkins Vocational Education and Applied 
Technology Act required the Department of Education to study the 
facilities, housing and training needs of our institution. That report 
was published in November 2000 (``Assessment of Training and Housing 
Needs within Tribally Controlled Postsecondary Vocational Institutions, 
November 2000, American Institute of Research''). The report identified 
the need for $17 million for the renovation of existing housing and 
instructional buildings and $30 million for the construction of housing 
and instructional facilities. These figures do not take into account 
the costs of inflation since the study was completed in 2000.
    We continue to identify housing as our greatest need. Some families 
must wait from 1 to 3 years for admittance due to lack of available 
housing. Since 2005 we have assisted 311 families with off campus 
housing, a very expensive proposition. In order to accommodate the 
enrollment increase, UTTC partners with local renters and two county 
housing authorities (Burleigh, Morton).
    UTTC has worked hard to combine sources of funding for desperately 
needed new facilities--within the past few years we have built a 86-bed 
single-student dormitory on campus, a family student apartment complex, 
and a Wellness Center. Sources of funds included the U.S. Department of 
Education, the U.S. Department of Agriculture, the American Indian 
College Fund, the Shakopee-Mdewakanton Sioux Tribe, among others. We 
still have a critical housing shortage and more housing must be built 
to accommodate those on the waiting list and to meet expected increased 
enrollment. We also have housing which needs renovation to meet safety 
codes.
    UTTC has acquired an additional 132 acres of land. We have also 
developed a master facility plan. This plan includes the development of 
a new campus on which would be single-student and family housing, 
classrooms, recreational facilities, offices and related 
infrastructure. A new campus will address our need for expanded 
facilities to accommodate our growing student population. It will also 
enable us to effectively address safety code requirements, Americans 
with Disabilities Act requirements, and to become more efficient in 
facility management.
    Thank you for your consideration of our request. We cannot survive 
without the basic core vocational/technical education funds that come 
through the Department of Education. They are essential to the 
operation of our campus and to the welfare of Indian people throughout 
the Great Plains region and beyond.


       LIST OF WITNESSES, COMMUNICATIONS, AND PREPARED STATEMENTS

                              ----------                              
                                                                   Page

Academy of Radiology Research, prepared statement................   583
AIDS Action Council, prepared statement..........................   586
Alexander, Dr. Duane F., M.D., Director, National Institute of 
  Child Health and Human Development, National Institutes of 
  Health, Department of Health and Human Services................   553
    Prepared statement...........................................   556
Alpha-1 Foundation, prepared statement...........................   589
Alving, Dr. Barbara M., Director, National Center for Research 
  Resources, National Institutes of Health, Department of Health 
  and Human Services.............................................   470
    Prepared statement...........................................   474
Alzheimer's Association, prepared statement......................   591
American:
    Academy of:
        Family Physicians, prepared statement....................   594
        Pediatrics, prepared statement...........................   596
        Physician Assistants, prepared statement.................   601
    Association:
        For:
            Cancer Research, prepared statement..................   603
            Dental Research (AADR), prepared statement...........   613
            Geriatric Psychiatry, prepared statement.............   618
        Of:
            Colleges of:
                Nursing, prepared statement......................   606
                Osteopathic Medicine, prepared statement.........   609
                Pharmacy, prepared statement.....................   611
            Immunologists, prepared statement....................   620
            Museums, prepared statement..........................   623
            Nurse Anesthetists, prepared statement...............   626
    Brain Coalition, prepared statement..........................   629
    College of:
        Cardiology, prepared statement...........................   631
        Obstetricians and Gynecologists, prepared statement......   634
    Dental Education Association (ADEA), prepared statement......   613
    Heart Association, prepared statement........................   639
    Indian Higher Education Consortium, prepared statement.......   643
    Lung Association, prepared statement.........................   646
    National Red Cross, prepared statement.......................   649
    Nephrology Nurses' Association, prepared statement...........   650
    Optometric Association, prepared statement...................   652
    Public Health Association, prepared statement................   654
    Society:
        For Pharmacology and Experimental Therapeutics, prepared 
          statement..............................................   660
        Of:
            Nephrology, prepared statement.......................   657
            Tropical Medicine and Hygiene, prepared statement....   663
    Thoracic Society, prepared statement.........................   666
Americans for:
    Nursing Shortage Relief (ANSR) Alliance, prepared statement..   671
    The Arts, prepared statement.................................   669
ARCH National Respite Coalition, prepared statement..............   825
Association:
    For:
        Clinical Research Training, prepared statement...........   681
        Psychological Science, prepared statement................   687
        Research in Vision and Ophthalmology (ARVO), prepared 
          state- 
          ment...................................................   690
    Of:
        Academic Health Sciences Libraries, prepared statement...   674
        American:
            Cancer Institutes, prepared statement................   677
            Publishers, prepared statement.......................   680
        Departments of Family Medicine, prepared statement.......   861
        Family Medicine Residency Directors, prepared statement..   861
        Maternal and Child Health Programs, prepared statement...   681
        Minority Health Professions Schools, prepared statement..   684
        Women's Health, Obstetric and Neonatal Nurses, prepared 
          statement..............................................   692
Autism Society of America, prepared statement....................   696

Battey, James F., Jr., M.D., Director, National Institute on 
  Deafness and Other Communications Disorders, National 
  Institutes of Health, Department of Health and Human Services..   120
    Prepared statement...........................................   122
Berg, Dr. Jeremy, Director, National Institute of General Medical 
  Sciences, National Institutes of Health, Department of Health 
  and Human Services.............................................   391
    Prepared statement...........................................   397
    Summary statement............................................   392
Brugge, Joan S., Ph.D., Chair, Department of Cell Biology, 
  Harvard Medical School, Boston, Massachusetts..................    42
    Prepared statement...........................................    45

Centers for Disease Control and Prevention Coalition, prepared 
  statement......................................................   697
Chao, Hon. Elaine L., Secretary, Office of the Secretary, 
  Department of La-
  bor............................................................   169
    Prepared statement...........................................   176
    Summary statement............................................   174
Chapman, Allison, prepared statement.............................   312
Charles R. Drew University of Medicine and Science, prepared 
  statement......................................................   701
Coalition:
    For:
        American Trauma Care, prepared statement.................   708
        Health Funding, prepared statement.......................   712
        International Education, prepared statement..............   715
        The Advancement of Health Through Behavioral and Social 
          Science Research, prepared statement...................   705
    Of:
        EPSCoR/IDeA States, prepared statement...................   710
        Northeastern Governors, prepared statement...............   719
Cobbs, Josh......................................................   302
Cochran, Senator Thad, U.S. Senator from Mississippi.............   522
    Prepared statements........................................311, 357
    Questions submitted by.....................................254, 324
College Board, prepared statement................................   720
Collins, Dr. Francis S., Director, National Human Genome Research 
  Institute, National Institutes of Health, Department of Health 
  and Human Services.............................................   399
    Prepared statement...........................................   407
Colston, Marguerite, director of communications, Autism Society 
  of America, Bethesda, Maryland.................................   276
    Prepared statement...........................................   278
Consortium of Social Sciences Associations, prepared statement...   724
Cooley's Anemia Foundation, prepared statement...................   722
COPD Foundation, prepared statement..............................   727
Corps Network, prepared statement................................   729
Council of State and Territorial Epidemiologists, prepared 
  statement......................................................   732
Cystic Fibrosis Foundation, prepared statement...................   735

Durbin, Senator Richard J., U.S. Senator from Illinois:
    Prepared statement...........................................   298
    Questions submitted by.......................................   151

Endocrine Society, prepared statement............................   737

Fair Allocations in Research Foundation, prepared statement......   739
Families USA Global Health Initiative's, prepared statement......   741
Fauci, Dr. Anthony S., Director, National Institute of Allergy 
  and Infectious Diseases, National Institutes of Health, 
  Department of Health and Human Services........................   451
    Prepared statement...........................................   459
    Summary statement............................................   452
Favell, Dr. Judith E., chief executive officer, AdvoServ, 
  executive director, the Celeste Foundation, Mount Dora, Florida   280
    Prepared statement...........................................   282
Fight Crime: Invest in Kids, prepared statement..................   744
Foster Grandparent Program, prepared statement...................   746
Friends of the:
    Health Resources and Services Administration, prepared 
      statement..................................................   749
    NIDA Coalition, prepared statement...........................   752
FSH Society, Inc., letter from...................................   749

Gallaudet University, prepared statement.........................   755
Gerberding, Dr. Julie, Director, Centers for Disease Control and 
  Prevention, Department of Health and Human Services............   259
    Prepared statement...........................................   264
    Summary statement............................................   262
Grady, Dr. Patricia A., Director, National Institute of Nursing 
  Research, National Institutes of Health, Department of Health 
  and Human Services.............................................   477
    Prepared statement...........................................   479

Harkin, Senator Tom, U.S. Senator from Iowa:
    Opening statements..............1, 93, 169, 259, 327, 391, 451, 521
    Prepared statement...........................................   260
    Questions submitted by.............66, 142, 213, 379, 445, 513, 581
Health Professions and Nursing Education Coalition, prepared 
  statement......................................................   757
Heart Rhythm Society, prepared statement.........................   760
Hepatitis Foundation International, prepared statement...........   763
HIV Medicine Association, prepared statement.....................   765
Hodes, Dr. Richard J., Director, National Institute on Aging, 
  National Institutes of Health, Department of Health and Human 
  Services.......................................................   327
    Prepared statement...........................................   331
    Summary statement............................................   329
Hutchison, Senator Kay Bailey, U.S. Senator from Texas, questions 
  submitted by...................................................   256

Infectious Diseases Society of America, prepared statement.......   767
Inouye, Senator Daniel K., U.S. Senator from Hawaii:
    Prepared statements.......................................311,  357
    Questions submitted by.............90, 149, 252, 322, 381, 446, 515
Insel, Dr. Thomas R., Director, National Institute of Mental 
  Health, National Institutes of Health, Department of Health and 
  Human Services................................................93, 268
    Prepared statements.........................................96, 270
    Summary statement............................................    95
International Foundation for Functional Gastrointestinal 
  Disorders, prepared statement..................................   770
Iverson, Brent, Ph.D., university distinguished teaching 
  professor of Organic Chemistry and Biochemistry, the University 
  of Texas at Austin, Austin, Texas..............................    38
    Prepared statement...........................................    40

Jeffrey Modell Foundation, prepared statement....................   773

Katz, Dr. Stephen I., Director, National Institute of Arthritis 
  and Musculoskeletal and Skin Diseases, National Institutes of 
  Health, Department of Health and Human Services................   335
    Prepared statement...........................................   338
Kirschstein, Ruth L., M.D., Acting Director, National Center for 
  Complementary and Alternative Medicine, National Institutes of 
  Health, Department of Health and Human Services................   521
    Prepared statement...........................................   530
    Summary Statement............................................   524
Krakow, Robert J., Esq., president, A-CHAMP, prepared statement..   314

Landis, Story, Ph.D., Director, National Institute of 
  Neurological Disorders and Stroke, National Institutes of 
  Health, Department of Health and Human Services................   126
    Prepared statement...........................................   130
Li, Ting-Kai, M.D., Director, National Institute on Alcohol Abuse 
  and Alcoholism, National Institutes of Health, Department of 
  Health and Human Services......................................   108
    Prepared statement...........................................   111
Lindberg, Dr. Donald A.B., Director, National Library of 
  Medicine, National Institutes of Health, Department of Health 
  and Human Services.............................................   409
    Prepared statement...........................................   413
Lupus Foundation of America, prepared statement..................   776
Lymphoma Research Foundation, prepared statement.................   778

March of Dimes Foundation, prepared statement....................   781
Meharry Medical College, prepared statement......................   784
Morehouse School of Medicine, prepared statement.................   787

Nabel, Dr. Elizabeth G., Director, National Heart, Lung and Blood 
  Institute, National Institutes of Health, Department of Health 
  and Human Services.............................................   340
    Prepared statement...........................................   343
National
    Alliance:
        For Eye and Vision Research (NAEVR), prepared statement..   793
        To End Homelessness, prepared statement..................   790
    Area Health Education Centers Organization, prepared 
      statement..................................................   795
    Association of:
        Children's Hospitals, prepared statement.................   797
        Community Health Centers, prepared statement.............   800
    Autism Association, prepared statement.......................   313
    Center for Victims of Crime, prepared statement..............   802
    Child Abuse Coalition, prepared statement....................   805
    Coalition for Osteoporosis and Related Bone Diseases, 
      prepared statement.........................................   808
    Consumer Law Center on Behalf of Our Low-Income Clients, 
      prepared statement.........................................   811
    Council of Social Security Management Associations, prepared 
      state-
      ment.......................................................   814
    Federation of Community Broadcasters, prepared statement.....   817
    League for Nursing, prepared statement.......................   820
    Marfan Foundation, prepared statement........................   823
    Sleep Foundation, prepared statement.........................   829
    Technical Institute for the Deaf, prepared statement.........   831
    Tuberculosis Controllers Association, prepared statement.....   834
NephCure Foundation, prepared statement..........................   836
Niederhuber, Dr. John E., Director, National Cancer Institute, 
  National Institutes of Health, Department of Health and Human 
  Services.......................................................   463
    Prepared statement...........................................   465
NIH Task Force of the Bioengineering Division, prepared statement   819
North American Primary Care Research Group, prepared statement...   861
NTM Info and Research, prepared statement........................   838

Oncology Nursing Society, prepared statement.....................   840

Parent Project Muscular Dystrophy, prepared statement............   842
People for the Ethical Treatment of Animals, prepared statement..   843
Pettigrew, Dr. Roderic I., Director, National Institute of 
  Biomedical Imaging and Bioengineering, National Institutes of 
  Health, Department of Health and Human Services................   416
    Prepared statement...........................................   421
Population Association of America/Association of Population 
  Centers, prepared statement....................................   845
Project R&R: Release and Restitution for Chimpanzees in U.S. 
  Laboratories, prepared statement...............................   848
Pulmonary Hypertension Association, prepared statement...........   851
Rodgers, Dr. Griffin P., Director, National Institute of Diabetes 
  and Digestive and Kidney Diseases, National Institutes of 
  Health, Department of Health and Human Services................   345
    Prepared statement...........................................   347
Ruffin, Dr. John, Director, National Center on Minority Health 
  and Health Disparities, National Institutes of Health, 
  Department of Health and Human Services........................   482
    Prepared statement...........................................   484
Ryan White Title III Medical Providers Coalition, prepared 
  statement......................................................   853

Schwartz, Dr. David, M.D., Director, National Institute of 
  Environmental Health and Sciences, National Institutes of 
  Health, Department of Health and Human Services................   540
    Prepared statement...........................................   545
Sieving, Dr. Paul A., M.D., Ph.D., Director, National Eye 
  Institute, National Institutes of Health, Department of Health 
  and Human Services.............................................   548
    Prepared statement...........................................   550
Siliciano, Robert, M.D., Ph.D., professor of medicine and 
  principal investigator, Howard Hughes Medical Institute, Johns 
  Hopkins University School of Medicine, Baltimore, Maryland.....    47
    Prepared statement...........................................    49
Society for:
    Investigative Dermatology, prepared statement................   854
    Maternal-Fetal Medicine, prepared statement..................   856
    Neuroscience, prepared statement.............................   858
    Women's Health Research and Women's Health Research 
      Coalition, prepared statement..............................   863
    Teachers of Family Medicine, prepared statement..............   861
Specter, Senator Arlen, U.S. Senator from Pennsylvania:
    Opening statements........................2, 94, 170, 261, 328, 522
    Questions submitted by..................68, 159, 253, 382, 448, 519
Spina Bifida Association, prepared statement.....................   866
Strittmatter, Stephen M., M.D., Ph.D., professor of Neurology and 
  Neurobiology, Yale University School of Medicine, New Haven, 
  Connecti-
  cut............................................................    55
    Prepared statement...........................................    57

Tabak, Dr. Lawrence A., D.D.S, Ph.D., Director, National 
  Institute of Dental and Craniofacial Research, National 
  Institutes of Health, Department of Health and Human Services..   532
    Prepared statement...........................................   537
The AIDS Institute, prepared statement...........................   869
The Humane Society Legislative Fund, prepared statement..........   872
The Humane Society of the United States, prepared statement......   874
Trust for America's Health, prepared statement...................   876

United Nations Foundation, prepared statement....................   649
United Tribes Technical College, prepared statement..............   878

van Voorst, Mark, CEO/president of Lifespire, prepared statement.   320
Volkow, Nora D., M.D., Director, National Institute on Drug 
  Abuse, National Institutes of Health, Department of Health and 
  Human Services.................................................   101
    Prepared statement...........................................   103

Whitford, Bradley, volunteer spokesperson, Autism Speaks.........   288
    Prepared statement...........................................   289
Wolk, Anna W., prepared statement................................   312
Wright, Robert C., co-founder, Autism Speaks, Fairfield, 
  Connecticut....................................................   283
    Prepared Statement...........................................   286

Zerhouni, Hon. Elias A., M.D., Director, National Institutes of 
  Health, Department of Health and Human Services................     1
    Prepared statement...........................................     7
    Summary statement............................................     4


                             SUBJECT INDEX

                              ----------                              

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

               Centers for Disease Control and Prevention

                                                                   Page

Addendum.........................................................   319
Allocation for Autism............................................   295
Autism:
    And the Environment..........................................   290
    Developmental Disabilities Program...........................   324
    In Other Countries...........................................   294
    Spectrum Disorder............................................   322
Budget Allocations...............................................   272
Care of Individuals With ASD Living in Hawaii....................   324
CDC's Work in Autism Spectrum Disorders Prevalence...............   265
Centers for Autism and Developmental Disabilities Research and 
  Epidemiology...................................................   325
Combating Autism Act.............................................   323
Community Control of Services and Resources......................   316
Crisis Number Two: Who Will Provide the Supports and Services?...   321
Environmental Role of Autism Research............................   292
Epidemiologic Research...........................................   266
Future Opportunities.............................................   268
How Can We Cure Autism?..........................................   272
How Is Research Combating Autism?................................   271
Interagency Autism Coordinating Committee (``IACC'')...........319, 323
Leading Research Hypotheses on the Cause of Autism...............   325
Learn the Signs. Act Early.......................................   267
National:
    Institute of Mental Health...................................   268
    Institutes of Health.........................................   268
New Directions for Research......................................   275
Recent Prevalence Estimates......................................   265
Research.........................................................   317
Seeking Innovations in Service Delivery..........................   282
Suggestions for Some Areas of Research on Autism.................   319
The Future.......................................................   272
Treatment........................................................   318
What Causes Autism?..............................................   270
What Is Autism?..................................................   270

                     National Institutes of Health

A Record of Real Success.........................................   466
Access to Scientific Literature..................................   411
Addiction:
    And Obesity..................................................   147
    A Brain Disease..............................................   165
    In Other Countries...........................................   107
Additional Advances..............................................   552
Adopt a School Program...........................................   432
Advanced Technologies Accelerate Progress........................   468
Advancing:
    Clinical Research in Mental Health...........................    96
    Translational Research.......................................   476
Age-related:
    Eye Disease Study............................................   575
    Macular Degeneration.......................................548, 551
Alcohol:
    Advertising..................................................   116
    And Cancer...................................................   166
Alzheimer's Disease.......................................150, 330, 382
    And:
        Neuroimaging.............................................   370
        The Neuroscience of Aging................................   332
    Treatments...................................................   369
Angiogenesis and AMD.............................................   551
Anthrax Antibiotics and Anti-Toxin...............................   509
Artificial Pancreas..............................................   387
Asthma:
    Among Hawaiians..............................................   382
    Research.....................................................   573
Attracting Students to Science and Technology Careers............   493
Autism...........................................................   567
    Research...................................................568, 571
Autoimmune Diseases..............................................   366
Basic:
    Behavioral Research..........................................   446
    Neuroscience.................................................   136
    Research and Hearing.........................................   163
Behavioral Research..............................................67, 90
Better Treatments for Women in the Criminal Justice System.......   157
Binge Drinking...................................................   117
Biodefense Research..............................................   461
Biological, Radiological, or Chemical Attack.....................   491
Bipolar Disorder Research........................................   143
Blood Cell Formation.............................................   379
Brain Injury and Alcohol.........................................   118
Bridging the Physical and Life Sciences..........................   421
Budget:
    Cut by More Than $500 Million................................    25
    Priorities: Nurturing a New Generation of Scientists and 
      Sustaining Innovation......................................    12
Building the Evidence Base of Integrative Medicine...............   530
CAM and:
    Inflammation Research........................................   563
    Pediatric Populations........................................   565
Cancer:
    In Pacific Island Subpopulations.............................   516
    Spore's Program..............................................   505
    Stem Cells...................................................   510
Chronic:
    Disease......................................................    98
    Kidney Disease...............................................   389
    Obstructive Pulmonary Disease................................   342
    Pain.........................................................   534
Clinical:
    And Translational Research.................................470, 547
    Trials.....................................................162, 356
        Network and NIMH.........................................   142
Cochlear Implants................................................   121
Collaborations With Samhsa on Services Research..................   155
Common Fund......................................................    35
Complex Genetic Diseases.........................................   339
Congenital Defects...............................................   494
Coordination With:
    CDC..........................................................   463
    Department of Defense......................................463, 491
COPD.............................................................   344
    Causes.......................................................   360
Cost to Cure Cancer..............................................    24
Craniofacial Construction and Reconstruction.....................   538
Creating the Competitive-Edge....................................   485
Criminal Justice System..........................................   117
Current Challenges...............................................     8
Decline in Cancer Death Rate.....................................    21
Delivering Authoritative Information.............................   531
Delving Deeply Into the Cancer Cell Environment..................   468
Dengue Fever.....................................................   517
Dental Disparities: Rigorous Science, Practical Results..........   539
Developing:
    Assistive Devices............................................   123
    Improved Prosthetics.........................................   558
    Partnerships.................................................   348
Diabetes.........................................................   387
    And:
        Native Hawaiians.........................................   381
        Stroke...................................................   128
    Prevention Program (DPP).....................................   374
Diabetic Retinopathy.............................................   388
Diagnosis........................................................   114
Disability and Old Age...........................................   329
Disease Mechanisms in AMD........................................   551
Down Syndrome....................................................   581
Drug Abuse:
    Being a Chronic Disease......................................   108
    Factors......................................................   107
    Treatment....................................................   164
Drugs:
    And Mental Health............................................    99
    For Children.................................................   385
Duchenne Muscular Dystrophy......................................   160
Early:
    Childhood Caries.............................................   533
    Detection of Liver Cancer....................................   389
Eating Disorders.................................................   100
Economic Benefits of:
    Mental Health Research.......................................   162
    NINDS Research...............................................   160
Effects of President's Budget....................................   159
Electronic Health Records........................................   411
Emerging and Re-Emerging Infectious Diseases...................458, 459
End of Life......................................................   497
Enhancing Community Engagement...................................   476
Epigenetics......................................................   100
    Beyond the Sequence of DNA...................................   547
Epilepsy.........................................................   152
Exercise and Diabetes............................................   372
Explanation of HapMap............................................   430
Exposure Biology Program.......................................543, 546
Eyegene..........................................................   550
Fabry Disease....................................................   151
Facing the Future: Integrative Approaches to Advance Public 
  Health.........................................................   537
Federal Investment in Research is a Critical Component of Our 
  Nation's Competitiveness.......................................    52
Feeding and Sustaining the Scientific Talent Pipeline............   423
Fertility Preservation...........................................   553
Fibromyalgia.....................................................   367
Flat Funding Threatens Our Young Investigators...................    53
Food Allergies.................................................490, 515
    And Anaphylaxis..............................................   513
Forging new Pathways to Care.....................................   349
4 P's--Predictive, Pre-emptive, Preventive, and Participatory....     6
Funding:
    Influenza Vaccine Research...................................   489
    Research on Severe Mental Illness............................   154
GCRC Transition Into CTSA........................................   512
Gene Therapy.....................................................   576
    Research in Eye Disease......................................   443
Generational Cancer..............................................   493
Genes and:
    Communication Disorders......................................   122
    The Environment..............................................   349
Genetic:
    Factors for Addiction........................................   137
    Susceptibility to Heart Disease..............................   342
Genomic Medicine.................................................   552
Genomics.........................................................   497
Going Forward....................................................   531
Hair Cell Regeneration...........................................   122
Head:
    And Neck Cancer..............................................   538
    Off Environmental Asthma in Louisiana........................   543
    Start........................................................   139
Health:
    Care Costs...................................................   425
    Disparities..................................................   503
    Effects of Noise.............................................   573
Healthy Aging..................................................333, 383
Hearing Loss.....................................................   163
Heart Disease:
    Advances.....................................................   340
    In Children..................................................   386
Helping Developing Nations Overcome Disease......................   558
Hepatitis B......................................................   381
HIV/AIDS.........................................................   106
    Research.....................................................   461
How Hearing Happens..............................................   120
Human Micro Biome Project........................................   436
Imagine the Future...............................................   486
Immunizations....................................................   570
Impact of:
    An Additional $1.9 Billion...................................    34
    Clinical Research............................................   130
    Past NIH Research............................................     7
Indirect Costs of Mental Illnesses...............................    97
Information:
    Dissemination................................................   504
    Resources for Hawaiians......................................   447
    Services for the Public......................................   415
Institutional Development Award..................................   472
Integrative Medicine.............................................   524
Interagency Collaborations.......................................   469
Intramural Program...............................................   431
Investing in the Future..........................................   398
Justification of NIH Funding.....................................    53
Knockout Mouse Project...........................................   427
LAM..............................................................   379
    Longitudinal Study...........................................   361
    Treatment Trial..............................................   362
Leveraging Prior Investments.....................................   347
Low Back Pain..................................................336, 377
Lutein Research..................................................   575
Macular Degeneration.............................................   439
Maintaining Momentum Toward 21st Century Medicine and Health.....    10
Managing Vital Information in Times of Disaster..................   415
Marfan Syndrome..................................................   343
Matrix of Opportunities..........................................   474
Medical:
    Rehabilitation...............................................   556
    Screening....................................................   495
Medications:
    Development..................................................   115
    For Alcohol Dependence.......................................   115
Medline Plus Magazine............................................   434
Mental Disorders are Chronic Brain Disorders.....................    96
Migraine Headaches...............................................   132
Minority Health..................................................   515
Multiple Drug Resistant and Extensively Drug Resistant TB........   508
Muscle Degeneration..............................................   385
Nanotechnologies for Personalized and Preemptive Medicine........   422
Nanotechnology...................................................   442
National:
    Advisory Council on Complementary and Alternative Medicine.559, 560
    Children's Study.............................................   570
        Plan.....................................................   571
    Institute of:
        Mental Health............................................   159
            Budget...............................................   136
        Neurological Disorders and Strokes.......................   159
        Institute on:
            Alcohol Abuse and Alcoholism.........................   160
                Outreach.........................................   116
            Deafness and Other Communication Disorders...........   159
            Drug Abuse...........................................   160
    Primate Research Centers.....................................   511
Native Hawaiians and Cancer......................................   515
Natural Research Products........................................   564
NCCAM'S Role and the Changing Nature of Medicine.................   530
NCI:
    Funding......................................................   492
    Surveillance of Cancer Health in Native Hawaiian Populations.   516
NCMHD Programs...................................................   487
Necrotizing Enterocolitis........................................   555
Neuroimaging.....................................................   384
Neuroscience Blueprint...........................................    99
New:
    And Expanded Initiatives.....................................   408
    Approach to Newborn Screening................................   580
Newborn Screening................................................   554
Next Generation Minimally-Invasive Technologies..................   422
NHLBI Strategic Plan.............................................   343
NIAID and Native Hawaiians.......................................   517
NIEHS Autism Research............................................   572
NIH:
    Blueprint....................................................   139
    Collaboration..............................................423, 424
    Genes, Environment and Health Initiative.....................   427
    Leadership in Stem Cell Research.............................    20
    Office of Women's Health.....................................    28
    Success Rate.................................................    62
    Support for My Work on HIV/AIDS..............................    50
NINR Research Programs...........................................   480
NLM:
    Facilities...................................................   445
    Future Priorities............................................   413
Non-Surgical Biopsy Through New Approaches to Optical Imaging....   422
Nursing..........................................................   517
    Re-Entry.....................................................   500
    Shortage.....................................................   499
Nurturing Intellectual Capital...................................   397
Obesity..........................................................   388
Obsessive-Compulsive Disorder....................................   143
Ongoing NHGRI Initiatives........................................   407
OPASI............................................................    89
Opportunities....................................................   544
Oral Cancer......................................................   535
Osteoarthritis............................................337, 364, 365
    Initiative...................................................   385
Osteoporosis.....................................................   362
Other:
    Areas of Interest............................................   409
    Benefits of Lifestyle Interventions in Older Adults..........   376
Outreach.........................................................   526
    On Addiction Research........................................   145
Ovarian Cancer...................................................   519
Pancreatic Cancer................................................   506
Pandemic Flu and Other Infectious Diseases.......................   503
Paradigm for the Future..........................................     5
Parkinson's Disease..............................................   145
Partnerships for Research Progress...............................    97
Peanut Allergies in China........................................   490
Personalized Medicine............................................   423
Physical Activity in Preventing Disability in the Elderly........   371
PKD..............................................................   380
Planning for the Future..........................................   132
Post-Traumatic Stress Disorder...................................   135
Practice-based Research Networks.................................   539
Preserving Fertility for Women Facing Cancer Treatment...........   556
Preterm Births...................................................   566
Preventing:
    And Diagnosing Communication Disorders.......................   123
    Disabilities Through Newborn Screening.......................   557
    Disability...................................................   554
Prevention.......................................................   113
    Efforts--Genes, Environment, and Development.................   104
    Medicine.....................................................   338
    Research.....................................................    26
Professional Judgment Cost to Cure Cancer........................    24
Protecting our Children as we Treat Their Illnesses..............   557
Public:
    Access.................................................37, 434, 448
    Health:
        And Prevention...........................................   551
        Burden of Mental Illness.................................    96
Putting Research Into Practice...................................   106
Quantify Funding Decisions.......................................    23
Reaching the Patient and Community...............................   469
Reading First....................................................   577
    Science......................................................   578
Reducing Another Cause of Infant Mortality: NEC..................   557
Reduction in Societal Burden & Health Care Costs.................    30
Regeneration:
    Of Hair Cells................................................   124
    Medicine.....................................................   364
Research:
    Advances.....................................................   330
    Centers in Minority Institutions.............................   473
    Impacts Health Care Costs....................................    54
    On:
        Family-Based Treatment Programs..........................   157
        Immune-Mediated Diseases.................................   462
        Self Management..........................................   156
        The Health Effects of Noise Exposure.....................   574
    Training.....................................................   526
Resources for Food Allergies.....................................   490
Response to Complementary and Alternative Medicine...............   558
Revised Mechanism Table..........................................    68
RNA:
    And Flu Vaccine..............................................   440
    Versus DNA...................................................   393
Salivary Diagnostics...........................................536, 538
School Nutrition Programs........................................   360
Scientific Information Resources--Near and Long Term.............   414
Services Research for Severe Mental Illness......................   155
Sickle Cell Disease............................................342, 344
Smoking, Genetics, and Cleft Palate..............................   534
Sodium...........................................................   379
Spinal Muscular Atrophy...................................133, 161, 579
Stages in the History of Type 2 Diabetes--Legend.................   351
Stem:
    Cell Research................................................    18
    Cells........................................................   162
Strategic:
    Plan.........................................................   541
    Vision for the Future: From Curative to Preemptive Medicine..     9
Strategies to Protect Your Hearing...............................   124
Stress...........................................................   137
    And Addiction................................................   138
Stroke.........................................................134, 144
Success of NIEHS Autism Grant Applications.......................   570
Suicide..........................................................   149
Support for Women Pursuing Professional Careers..................   501
Sustaining our Present Research Capital..........................    29
Temporomandibular:
    Joint/Muscle Disorders.......................................   567
    Muscle and Joint Disorders...................................   539
Terrorism Preparedness...........................................   518
Thimerosal.......................................................   570
Tobacco-Related Research.........................................   514
Tools Breed Innovation...........................................   397
Training:
    And Career Development.......................................   543
    Nurse Faculty................................................   499
    The Next Generation of:
        CAM Researchers..........................................   531
        Cancer Researchers.......................................   469
Training the Workforce: Removing the Barriers....................   485
Trans-Cranial Magnetic Stimulation...............................   134
Transforming Clinical Research...................................   475
Translating:
    Emerging Technologies Into Practice..........................   421
    Promise Into Progress........................................   130
Translational:
    And Clinical Research........................................   339
    Research.....................................................    68
Traumatic Brain Injury...........................................   118
Treatment Research...............................................   115
Treatments--Novel Approaches.....................................   105
Tuberculosis.....................................................   507
Two Win Nobel Prize for Discovering Bacterium Tied to Stomach 
  Ailments.......................................................   412
Underage Drinking..............................................147, 165
Understanding:
    Cancer.......................................................    22
    Health Disparities...........................................   484
Universal Vaccine..............................................457, 487
Vaccines.........................................................   487
    And Autoimmune Disease.......................................   489
Value of Partnerships............................................   486
Violence, Trauma and Female Drug Addiction.......................   158
Vision for the Future............................................     4
Vulvodynia.......................................................    66
Wincart..........................................................   516
Women and Heart Disease..........................................   386
Workforce to Meet new Challenges.................................   547
Younger Generation...............................................   355

                          DEPARTMENT OF LABOR

                        Office of the Secretary

Administrative Funding for State Unemployment Compensation 
  Programs.......................................................   256
Adult Training Opportunities.....................................   222
A-76 Circular, Competitive Sourcing..............................   246
CAFTA Funding....................................................   186
Community:
    Service Employment for Older Americans.......................   217
    Based Job Training Grants....................................   214
Competition for High-growth Job Training Grants..................   192
Congressional Earmarks...........................................   190
Department of Labor..............................................   240
    Budget Request...............................................   172
Disability Program Navigators....................................   227
Dislocated Worker Program........................................   224
EBSA FTE and Funding Levels......................................   228
Efficiencies in Job Corps Operations.............................   218
Emergency Standard for Health Care Workers.......................   188
Employment Standards Administraiton..............................   230
Ergonomic:
    Enforcement..................................................   200
    Guidelines...................................................   201
Ergonomics...........................................200, 237, 239, 244
Family and Medical Leave Act.....................................   232
    Enforcement..................................................   184
Financial Reporting Guidance.....................................   216
Fiscal Year 2008 Priorities......................................   177
Funding for:
    International Child Labor....................................   185
    Migrant Job Training.........................................   188
Funds Spent on Administration....................................   214
High-growth Job Training Grants................................191, 198
Higher Education and Advanced Skill Training Initiatives.........   255
H-2B Labor Certification.........................................   189
International:
    Labor Organization...........................................   207
    Funding Through ILAB.........................................   208
Jim Sourwine Tribute...........................................169, 170
Job:
    Corps:
        Marketing Campaign.......................................   219
        Office...................................................   218
        Recruitment..............................................   219
    Training Funding.............................................   187
MAUI Community College Nursing Distance Education................   252
Migrant and Seasonal Farmworker Program..........................   216
Mine Communications Technologies.................................   172
Money Spent on Bureaucracies and Overhead Costs..................   223
MSHA's:
    Aracoma Mine Report..........................................   206
    Review of Mine Accidents.....................................   203
Musculoskeletal Disorder Reporting Form..........................   201
National Emphasis Program for Refineries.........................   235
Number Trained Under Career Advancement Accounts.................   213
Occupational Safety and Health Administration....................   233
    Susan Harwood Grants.........................................   188
Office of:
    Disability Employment Policy.................................   210
        Grants...................................................   211
        Working to Eliminate Barriers to Employment..............   247
    Workers' Compensation Programs...............................   253
Oil Refining Industry Inspections................................   172
Other Programs...................................................   181
Ottumwa Job Corps Center.........................................   183
Pandemic:
    Flu..........................................................   187
    Influenza Preparedness.......................................   245
Pension Protection Act of 2006...................................   228
Performance Review Board.........................................   208
PERM Fee.........................................................   245
Personal Protective Equipment..................................207, 244
Preparing Workers for new Opportunities..........................   179
Prisoner Reentry Initiative......................................   227
    And Responsible Reintegration of Youthful Offenders..........   227
Process Safety Management........................................   236
Proposals to Streamline and Strengthen WIA.......................   254
Protecting Workers':
    Pay, Benefits, and Union Dues................................   177
    Safety and Health............................................   177
Recent Accomplishments...........................................   176
Recipients of High-growth Job Training Grants....................   192
Refocusing the Workforce System..................................   223
Request for Philadelphia Shipyard Funding........................   253
Targeted Inspections.............................................   235
TCIR and DART Rates for the Five Years Prior to Acceptance Into 
  VPP............................................................   237
Teacher Salary Initiative........................................   218
Technology Training for Women....................................   252
Voluntary Protection Programs....................................   236
Wage and Hour Division...........................................   232
WIA:
    Adult Program................................................   220
    Carryover Balances...........................................   194
    Funding Flexibility..........................................   197
    Reallocation and Rescission..................................   215
    Reforms......................................................   195
Workforce Investment System....................................193, 199
Youth Activities:
    Alternative Education........................................   225
    Youth Pilot Project..........................................   225

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