[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
PART 1 (Pages 1-572)
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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)
Corporation for Public Broadcasting
Department of Education
Department of Health and Human Services
Department of Labor
Nondepartmental witnesses
Federal Mediation and Conciliation Service
Physician Payment Review Commission
Prospective Payment Assessment Commission
United States Institute of Peace
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__________
Printed for the use of the Committee on Appropriations
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index.html
__________
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
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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.
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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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
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.
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\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.
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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.
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\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.
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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.
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\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/
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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\
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\2\ Grant BF, Dawson DA, Stinson FS, Chou SP, Dufour MC, and
Pickering RP. Drug and Alcohol Dependence 2004. 74: 223-234.
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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.
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\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.
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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.
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\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.
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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.
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\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.
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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.
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\1\ Starfield B, et al. The effects of specialist supply on
populations' health: assessing the evidence. Health Affairs. 15 March
2005.
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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\
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\2\ National Association of Community Health Centers, The Robert
Graham Center. Access Denied: A Look at America's Medically
Disenfranchised. March 2007.
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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.
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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\
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\4\ University of California, San Francisco.
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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
sshannon@aacom.org, or Michael J. Dyer, AACOM's Vice President for
Government Relations at (301) 968-4152 or mdyer@aacom.org.
______
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\
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\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.
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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.
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\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.)
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\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\
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\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.
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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.
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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 jbrunell@acc.org 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.
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\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.
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\2\ American Nephrology Nurses' Association. (2006). Chronic Kidney
Disease Fact Sheet [Brochure]. ANNA Chronic Kidney Disease Special
Interest Group: Author.
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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\
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\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
sprouty@corpsnetwork.org.
______
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.
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\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
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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.
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\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
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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\
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\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 jgoldberg@familiesusa.org.
______
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.
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\1\ Heart Rhythm Foundation, Arrhythmia Key Facts, 2004 http://
www.heartrhythmfoundation.org/facts/arrhythmia.asp
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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\
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\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.
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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\
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\3\ American Stroke Association and American Heart Association,
Heart Disease and Stroke Statistics_2005 Update, 2005 http://
www.americanheart.org/downloadable/heart/
1105390918119HDSStats2005Update.pdf
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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\
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\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
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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.
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\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
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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\
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\7\ Task Force on the Future of American Innovation, The Knowledge
Economy: Is the United States Losing it's Competitive Edge?, February
16, 2005.
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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 (nminor@hrsonline.org 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 jsawyer@nachc.com.
______
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\
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\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).
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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\
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\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).
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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\
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\7\ Nat'l Ctr. for Injury Prevention and Control, Costs of Intimate
Partner Violence Against Women in the United States (Atlanta, Ga.,
2003).
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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\
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\8\ Learn more about the MyStrength campaign at http://
www.mystrength.org (accessed March 28, 2007).
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--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\
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\9\ For more information about the CARe initiative, visit http://
www.four-h.purdue.edu/care/main.html (accessed March 28, 2007).
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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.
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\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).
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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\
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\11\ Passed as part of the Violence Against Women Act 2005
Reauthorization, Public Law 109-162.
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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\
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\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).
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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\
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\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.
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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\
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\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.
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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\
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\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.
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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\
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\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.
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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.
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\8\ Scarcella, C.A. (2004). The Cost of Protecting Vulnerable
Children IV: How Child Welfare Funding Fared during the Recession,
Washington, DC. Urban Institute.
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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.
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\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).
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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.
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\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.
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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\
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\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.
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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\
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\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.
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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.
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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.
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\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\
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\3\ Calculated from data provided by the Rhode Island Public
Utilities Commission.
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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\
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\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.
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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\
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\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.
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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\
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\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.
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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.
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\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.
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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.
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\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).
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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.
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\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).
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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).
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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
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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\
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\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; cschmid@theaidsinstitute.org. 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
-