[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]



                 DEPARTMENTS OF LABOR, HEALTH AND HUMAN

               SERVICES, EDUCATION, AND RELATED AGENCIES

                        APPROPRIATIONS FOR 2002

_______________________________________________________________________

                                HEARINGS

                                BEFORE A

                           SUBCOMMITTEE OF THE

                       COMMITTEE ON APPROPRIATIONS

                         HOUSE OF REPRESENTATIVES

                      ONE HUNDRED SEVENTH CONGRESS
                              FIRST SESSION
                                ________
  SUBCOMMITTEE ON THE DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, 
                    EDUCATION, AND RELATED AGENCIES
                      RALPH REGULA, Ohio, Chairman
 C. W. BILL YOUNG, Florida           DAVID R. OBEY, Wisconsin
 ERNEST J. ISTOOK, Jr., Oklahoma     STENY H. HOYER, Maryland
 DAN MILLER, Florida                 NANCY PELOSI, California
 ROGER F. WICKER, Mississippi        NITA M. LOWEY, New York
 ANNE M. NORTHUP, Kentucky           ROSA L. DeLAURO, Connecticut
 RANDY ``DUKE'' CUNNINGHAM,          JESSE L. JACKSON, Jr., Illinois
California                           PATRICK J. KENNEDY, Rhode Island
 KAY GRANGER, Texas
 JOHN E. PETERSON, Pennsylvania
 DON SHERWOOD, Pennsylvania         
                   
 NOTE: Under Committee Rules, Mr. Young, as Chairman of the Full 
Committee, and Mr. Obey, as Ranking Minority Member of the Full 
Committee, are authorized to sit as Members of all Subcommittees.
       Craig Higgins, Carol Murphy, Susan Ross Firth, Meg Snyder,
             and Francine Mack-Salvador, Subcommittee Staff
                                ________
                                 PART 4A

                      NATIONAL INSTITUTES OF HEALTH

                              

                                ________
         Printed for the use of the Committee on Appropriations
                                ________
                     U.S. GOVERNMENT PRINTING OFFICE
 74-726                     WASHINGTON : 2001



                       COMMITTEE ON APPROPRIATIONS

                   C. W. BILL YOUNG, Florida, Chairman

 RALPH REGULA, Ohio                  DAVID R. OBEY, Wisconsin
 JERRY LEWIS, California             JOHN P. MURTHA, Pennsylvania
 HAROLD ROGERS, Kentucky             NORMAN D. DICKS, Washington
 JOE SKEEN, New Mexico               MARTIN OLAV SABO, Minnesota
 FRANK R. WOLF, Virginia             STENY H. HOYER, Maryland
 TOM DeLAY, Texas                    ALAN B. MOLLOHAN, West Virginia
 JIM KOLBE, Arizona                  MARCY KAPTUR, Ohio
 SONNY CALLAHAN, Alabama             NANCY PELOSI, California
 JAMES T. WALSH, New York            PETER J. VISCLOSKY, Indiana
 CHARLES H. TAYLOR, North Carolina   NITA M. LOWEY, New York
 DAVID L. HOBSON, Ohio               JOSE E. SERRANO, New York
 ERNEST J. ISTOOK, Jr., Oklahoma     ROSA L. DeLAURO, Connecticut
 HENRY BONILLA, Texas                JAMES P. MORAN, Virginia
 JOE KNOLLENBERG, Michigan           JOHN W. OLVER, Massachusetts
 DAN MILLER, Florida                 ED PASTOR, Arizona
 JACK KINGSTON, Georgia              CARRIE P. MEEK, Florida
 RODNEY P. FRELINGHUYSEN, New Jersey DAVID E. PRICE, North Carolina
 ROGER F. WICKER, Mississippi        CHET EDWARDS, Texas
 GEORGE R. NETHERCUTT, Jr.,          ROBERT E. ``BUD'' CRAMER, Jr., 
Washington                           Alabama
 RANDY ``DUKE'' CUNNINGHAM,          PATRICK J. KENNEDY, Rhode Island
California                           JAMES E. CLYBURN, South Carolina
 TODD TIAHRT, Kansas                 MAURICE D. HINCHEY, New York
 ZACH WAMP, Tennessee                LUCILLE ROYBAL-ALLARD, California
 TOM LATHAM, Iowa                    SAM FARR, California
 ANNE M. NORTHUP, Kentucky           JESSE L. JACKSON, Jr., Illinois
 ROBERT B. ADERHOLT, Alabama         CAROLYN C. KILPATRICK, Michigan
 JO ANN EMERSON, Missouri            ALLEN BOYD, Florida
 JOHN E. SUNUNU, New Hampshire       CHAKA FATTAH, Pennsylvania
 KAY GRANGER, Texas                  STEVEN R. ROTHMAN, New Jersey    
 JOHN E. PETERSON, Pennsylvania
 JOHN T. DOOLITTLE, California
 RAY LaHOOD, Illinois
 JOHN E. SWEENEY, New York
 DAVID VITTER, Louisiana
 DON SHERWOOD, Pennsylvania
   
 VIRGIL H. GOODE, Jr., Virginia     
   
                 James W. Dyer, Clerk and Staff Director

                                  (ii)

 
DEPARTMENTS OF LABOR, HEALTH AND HUMAN SERVICES, EDUCATION, AND RELATED 
                    AGENCIES APPROPRIATIONS FOR 2002

                              ----------                              

                                         Wednesday, March 28, 2001.

                     NATIONAL INSTITUTES OF HEALTH

                      RESEARCH ON CHRONIC DISEASES

                               WITNESSES

DR. RUTH KIRSCHSTEIN, ACTING DIRECTOR, NATIONAL INSTITUTES OF HEALTH
DR. CLAUDE LENFANT, DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
DR. ALLEN SPIEGEL, DIRECTOR, NATIONAL INSTITUTE OF DIABETES AND 
    DIGESTIVE AND KIDNEY DISEASES
DR. LAWRENCE TABAK, DIRECTOR, NATIONAL INSTITUTE OF DENTAL AND 
    CRANIOFACIAL RESEARCH
DR. STEPHEN KATZ, DIRECTOR, NATIONAL INSTITUTE OF ARTHRITIS AND 
    MUSCULOSKELETAL AND SKIN DISEASES
DR. JACK A. McLAUGHLIN, ACTING DIRECTOR, NATIONAL EYE INSTITUTE
DR. STEPHEN STRAUS, DIRECTOR, NATIONAL CENTER FOR COMPLEMENTARY AND 
    ALTERNATIVE MEDICINE
    Mr. Regula. Well, we will get started. We are happy to 
welcome you, Dr. Kirschstein, and all your team. You are very 
important people to the American public. I have heard over the 
last 2 weeks from about 175 public witnesses and then from 37 
of my colleagues yesterday, and a lot of what they are talking 
about and asking is to find a cure for a whole range of 
diseases. So what you do is extremely important to the people 
of this Nation, and I think you have had a lot of successes and 
we hope many more to come.
    I look forward to hearing your testimony this morning Dr. 
Kirschstein, I understand you will introduce your team in the 
order they are going to speak, so welcome.
    Dr. Kirschstein. Thank you, Mr. Regula. My colleagues and I 
are very pleased to be here to open the fiscal year 2002 round 
of hearings before this distinguished committee. Mr. Chairman, 
we are delighted that you, Congressman Miller and Congresswoman 
Pelosi visited us on February 27th and that many of us had an 
opportunity to tell you about our programs. And today my 
colleagues from six Institutes and Centers that have a very 
large investment in research related to chronic diseases will 
describe to you the research being done in that area.
    I should say that these six people were chosen because 
their Institutes primarily deal with chronic diseases, but in 
fact almost all the Institutes do research on diseases and 
disorders that are chronic in nature. We have chosen these as 
examples because they are so heavily invested in them. The 
chronic diseases, of course, afflict a very large segment of 
the American public and they include diseases that are due to 
genetic and developmental anomalies that are present at birth, 
appear early in life, and never go away--diseases that were 
once rapidly fatal but now can be treated. So patients spend 
years, indeed decades, living with these ailments and 
degenerative diseases that reflect sometimes the ravages of old 
age.
    All of these diseases are increasing in prevalence as 
expectancy for life increases. They all require long-term 
treatment, at great cost to society and to the individual. Many 
of them involve the loss of a good quality of life, loss of 
ability to do productive work, and the tremendous pain, 
suffering, and frustration that people experience as they 
attempt to adjust to such disabilities. They have a 
disproportionate impact on segments of the population that have 
the least ability to obtain medical help: minority populations, 
disadvantaged populations, both urban and rural, and others 
whose access to the health care system is inadequate.
    I am going to let my colleagues describe to you what they 
are doing in relationship to chronic diseases.
    Mr. Regula. Out of curiosity, how do you define 
``chronic''? What are the parameters of a chronic disease?
    Dr. Kirschstein. It is in contrast to an acute disease. A 
common cold is an acute disease. Influenza is an acute disease. 
Chronic diseases are ones that persist. There are not any 
general cures at the present time. You were talking about 
cures. These are diseases that exacerbate and then stay in a 
lower-level state, causing disability and suffering. My 
colleagues will also be describing them as we go along.
    Mr. Regula. Thank you.
    Dr. Kirschstein. We are going to start with Dr. Claude 
Lenfant, the Director of the National Heart, Lung, and Blood 
Institute.

                            Opening Remarks

    Dr. Lenfant. Thank you, Mr. Chairman. I am very pleased to 
have the opportunity to present to you the programs of the 
National Heart, Lung, and Blood Institute.
    Our Institute has the responsibility over a very wide range 
of chronic diseases of the heart, the lungs, the blood, and 
sleep disorders as well. Altogether, they affect more than 100 
million Americans. These diseases are truly a modern epidemic 
and, in many cases, are the consequences of the successes of 
medical research. Let me take one example to explain my point: 
coronary heart disease, which most often manifests itself with 
a heart attack.
    Thirty, 40 years ago, a heart attack was often a death 
sentence. At best, it was incapacitating for as long as the 
patient remained alive. Now, it is certainly true today that 
still many patients die from sudden deaths, but the fact is 
that the more typical patient with a heart attack will be 
successfully treated and will live decades of a natural life. 
This is why the death rate of coronary heart disease in this 
country has declined by more than half during the last 30 
years.
    However, often these patients will have another heart 
attack, and again another one, and again another one. They will 
all be treated as successfully as the first one. However, 
irreversible damage of the heart will develop and eventually 
result in heart failure. This condition is an ever-increasing 
public health problem.
    So what are we doing about it? We have a three-pronged 
research approach. Let me describe each of them very briefly.
    First, we are investigating the best way to prevent the 
development of coronary heart disease. This means to control 
and reduce risk factors of this disease such as high blood 
cholesterol, smoking, hypertension, obesity, and diabetes. In 
fact, many of the patients with diabetes are indeed dying from 
heart disease.
    Second, we are doing research to improve the treatment of 
heart attacks, using new surgical techniques and new approaches 
such as gene therapy to create new blood vessels in the damaged 
heart.
    And third, we support an extensive research program on 
heart failure, the complication of all the successful 
treatment. The work in this area is very exciting and 
forthcoming. This broad program spans from basic to applied and 
clinical research. And here again, we are using gene therapy, 
as well as cell transplantation to repair the damaged tissue.
    We are confident that we will be able to conquer heart 
failure and to improve the quality of life of the people who 
have it.
    Mr. Chairman, this paradigm of research that I briefly 
described about coronary heart disease, focusing on prevention, 
treating the disease and capitalizing on new approaches and 
scientific opportunities, applies to all the chronic conditions 
that we are involved with: asthma, chronic obstructive lung 
disease, some blood disorders, and sleep disorders as well.
    In addition, we are increasing our efforts with regard to 
population groups such as minorities and disadvantaged people 
where we see a higher prevalence of the disease we are 
concerned with.
    And finally, we are doing everything in our power to ensure 
that the results of our research are rapidly disseminated to 
the real world where they can have the maximum impact on public 
health.
    I will be pleased to answer questions and give more 
specific details.
    [The statement of Dr. Lenfant follows:]
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    Dr. Kirschstein. Mr. Chairman, shall we go on?
    Mr. Regula. Yes.
    Dr. Kirschstein. The second presenter is Dr. Allen Spiegel, 
the Director of the National Institute of Diabetes and 
Digestive and Kidney Diseases.
    Dr. Spiegel. Thank you. Mr. Chairman, and members of the 
committee, I am pleased to testify on behalf of the National 
Institute of Diabetes and Digestive and Kidney Diseases, NIDDK, 
which supports research on a wide range of chronic diseases, 
including inflammatory bowel disease, hepatitis, chronic 
bladder and prostate diseases, and kidney failure. Advances in 
biomedical research are critical if we are to reduce the 
enormous human and economic costs of these chronic diseases.

                            DIABETES EXAMPLE

    Numerous examples could illustrate this point, but let me 
focus this morning on diabetes. It affects 16 million 
Americans, and with the number of new cases increasing at an 
alarming rate, it is one of the most important health care 
issues facing our Nation. In type 1 or juvenile diabetes, 
recent advances have created new hope for a cure by using 
pancreatic islet transplantation to restore normal insulin 
production. To capitalize on these findings, we are supporting 
trials of islet transplantation, as well as research to 
overcome the inadequate supplies of islets. We are seeking new 
ways to prevent transplant rejection without lifelong treatment 
to suppress the immune system. Such alternative approaches 
increase the likelihood of achieving a true cure for type 1 
diabetes and also offer hope of preventing this disease in 
those at risk.
    In type 2 diabetes, new insights help explain the increased 
number of adults and even adolescents developing this disease. 
The surge in this disease appears to be caused by higher rates 
of obesity, a major risk factor. Now, we are beginning to 
understand precisely how obesity predisposes to type 2 
diabetes. Using powerful genetic technologies, investigators 
have identified novel proteins produced by fat cells. An 
increase in fat, as seen in obese patients, changes the levels 
of these proteins in a way that makes the body resistant to 
insulin. The development of new drugs that can target these 
proteins may now be possible for both treatment and prevention 
of type 2 diabetes. This is but one example of the dividends 
from NIDDK-supported research of the human genome. Another is 
the recent identification of a type 2 diabetes susceptibility 
gene in Mexican Americans, one of several minority groups known 
to be disproportionately affected by this disease.

                           PREVENTION EFFORTS

    Complementing our research to understand and treat diabetes 
are important prevention initiatives. We are expanding our 
National Diabetes Education Program which supports community 
diabetes awareness. We have a large clinical trial, the 
Diabetes Prevention Program, that is testing the ability of 
lifestyle and drug interventions to prevent type 2 diabetes in 
those at high risk. A positive outcome of this trial, whose 
completion is expected next year, would have major public 
health implications.
    A central goal of our research program is to prevent the 
devastating complications seen in types 1 and 2 diabetes. It is 
the leading cause of kidney failure, adult blindness, and lower 
limb amputations. It causes increased susceptibility to urinary 
tract infections, skin ulcers, periodontal disease, and fatty 
liver disease.
    Heart disease, as you have heard from my colleague, Dr. 
Lenfant, is the leading cause of death in diabetics. Because 
the complications of diabetes affect so many organ systems, the 
NIDDK has developed productive collaborations with many of the 
NIH institutes and centers, and our coordinated effort to 
understand, treat, and prevent diabetes and its complications 
offers the best hope of stemming the tide of the epidemic.
    While I have focused my remarks on diabetes, my comments 
apply as well to the many other chronic diseases within the 
NIDDK mission. With the increased funding Congress has 
provided, NIDDK-supported scientists are well positioned to 
identify the causes of these diseases and, with continued 
support, they will move forward to discover novel approaches to 
treatment and prevention so that we can remove the burden these 
diseases place on individuals, families, and the Nation.
    I appreciate the opportunity to address the committee and 
thank you for your attention.
    [The statement of Dr. Spiegel follows:]
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    Mr. Regula. Thank you. We have a vote on a rule, so I think 
we ought to recess and go vote. I don't want to interrupt the 
next witness when they are speaking. If you will be patient, we 
will be back as quickly as possible. We stand in recess.
    [Recess.]
    Mr. Regula. Sorry for the interruption. We will continue.
    Dr. Kirschstein. That is quite all right, Mr. Chairman.
    Dr. Kirschstein. We are now moving to the National Eye 
Institute. Dr. McLaughlin is the Acting Director.

                          CHRONIC EYE DISEASE

    Dr. McLaughlin. Mr. Chairman, members of the committee, 
most of us take our eyesight for granted. But chronic eye 
diseases can have a devastating effect on the quality of the 
lives that we lead. Chronic eye diseases include diabetic 
retinopathy, macular degeneration, retinitis pigmentosa, 
glaucoma, uveitis, cataract, and viral infections.

                          DIABETIC RETINOPATHY

    As we have heard, diabetes damages blood vessels throughout 
the body. In the eye, that damage causes swelling of the retina 
and blurred vision. Later, abnormal new blood vessels can grow 
uncontrollably within the retina. Bleeding of these new blood 
vessels and scar formation cause severe vision loss. Scientists 
are developing treatments to reduce that swelling and to 
prevent the abnormal growth of new blood vessels before sight-
threatening damage occurs.

                                 AGING

    The aging process also plays a significant role in 
blindness and visual impairment. For the elderly, vision loss 
ranks third behind arthritis and heart disease as a disabling 
condition causing need for assistance in daily living.

                          MACULAR DEGENERATION

    Macular degeneration can destroy the tiny part of the 
retina we need for sharp central vision. More than 13 million 
Americans over the age of 40 have some signs of macular 
degeneration. Of those 75 years of age and older, nearly one-
third are affected. As the number of older Americans increases 
over the next few decades, the magnitude of this public health 
problem will increase dramatically. In addition to laboratory 
research, NEI is supporting clinical trials that may help 
prevent catastrophic visual loss from this disease.

                                GLAUCOMA

    Glaucoma is another important public health problem. As 
many as 3 million Americans have the disease, but only about 
half are actually aware that they do. Glaucoma is also one of 
the major targets for NEI's research on eliminating health 
disparities. Glaucoma is the number one cause of blindness 
among African Americans and is six times higher in African 
Americans than in Caucasians.
    Vision loss in glaucoma results from the degeneration of 
nerve cells within the retina. Scientists seek a better 
understanding of the cell and molecular biology of this 
disease. They hope to discover new ways to prevent retinal 
nerve cells from degenerating and to rescue or replace cells 
that have already been damaged.

                     HELPING THE VISUALLY IMPAIRED

    Each of the chronic eye diseases can cause permanent visual 
impairment and blindness. But we can restore quality of life to 
those affected. Therefore, the NEI has expanded efforts to 
develop better assistive devices and strategies and to educate 
the public about low vision rehabilitation services.
    I would be happy to respond to any questions that you may 
have about these diseases or any other areas in vision 
research.
    [The statement of Dr. McLaughlin follows:]
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    Dr. Kirschstein. Next we will hear from Dr. Lawrence Tabak, 
the Director of the National Institute of Dental and 
Craniofacial Research.

                         Statement By Dr. Tabak

    Dr. Tabak. Mr. Chairman, and members of the Committee, the 
National Institute of Dental and Craniofacial Research promotes 
the general health of the American people by improving 
craniofacial, oral, and dental health through research. 
Virtually all Americans have experienced some form of chronic 
oral disease, and I will highlight a few of these. Women in 
particular are affected by Sjogren's syndrome, an autoimmune 
disease that destroys the glands that produce saliva and tears. 
Patients suffer from oral dryness, making it difficult for them 
to eat food and speak. Our scientists are developing an 
artificial salivary gland which could make a big difference in 
these patients' lives.
    Four hundred thousand Americans a year suffer oral 
complications from their cancer treatments. Some of the oral 
side effects are so debilitating that patients can't complete 
their treatment. Our Institute is leading a national campaign 
to raise awareness among oncologists, dentists, and cancer 
patients about how oral complications of cancer therapy can be 
prevented or managed.
    Tooth decay and periodontal diseases are among the most 
prevalent chronic infectious diseases, costing Americans $60 
billion a year. As we speak, we are holding a 
consensusconference on the best ways to diagnose and manage dental 
decay. We are also funding important research looking at the 
relationships between periodontal diseases and systemic diseases such 
as diabetes. Many people have experienced some form of oral-facial 
pain. Various factors can give rise to pain and dysfunction in the 
temporomandibular joints and surrounding muscles. Our Institute is the 
primary sponsor of research on these conditions, referred to as TMD. We 
are currently supporting clinical trials looking at the effects of 
conservative versus surgical management. So far, we are finding that 
surgery offers no increased benefits.
    Improvements in oral health, because of our research, saves 
the Nation nearly $5 billion a year. That is an annual savings 
amounting to more than the total funding for our Institute 
since its inception over 50 years ago. Our work is not 
finished, however. As the recent Surgeon General's report Oral 
Health in America indicated, many Americans are unaware that 
without oral health you can't be completely healthy.
    Thank you for the opportunity to provide you with this 
information about our Institute's chronic disease research 
efforts.
    [The statement of Dr. Tabak follows:]
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    Dr. Kirschstein. Next, Dr. Stephen Katz, Director of the 
National Institute of Arthritis and Musculoskeletal and Skin 
Diseases.
    Dr. Katz. Good morning. It is a privilege for me to report 
on highlights in research advances and opportunities from our 
Institute.
    The mission of the National Institute of Arthritis and 
Musculoskeletal and Skin Diseases is to improve the health of 
those affected with common, chronic, very costly, sometimes 
deforming, and often disabling diseases of bones, skin, joints 
and muscles.
    In rheumatoid arthritis, which is one of over 100 forms of 
arthritis, we have seen major advances, progress that derives 
from fundamental studies identifying the molecules that cause 
inflammation. New drugs, actually called biologicals, have been 
developed and are based on this fundamental knowledge. These 
new biologicals have relieved considerable suffering and 
improved function in hundreds of thousands of patients with 
rheumatoid arthritis. In the past year, this therapy has been 
used in children with juvenile arthritis, in a study 
coordinated by one of our Institute's centers, and the therapy 
has been shown to be very effective and is now being used 
worldwide for the treatment of juvenile rheumatoid arthritis.
    Osteoporosis is characterized by thinning of bones and a 
high risk of bone fractures. We have also seen considerable 
research advance in osteoporosis. During the past year, 
scientists working in the laboratory have identified some 
established drugs like statins that lower serum cholesterol and 
naturally occurring chemicals like the leptins that act to 
control food intake as potentially important in osteoporosis. 
We are working with our colleagues in the Heart Institute and 
others to pursue these promising opportunities.
    Finally, we have also seen major efforts in the muscular 
dystrophies, diseases that cause severe disability and even 
death in affected individuals. In the most common childhood 
form of muscular dystrophy, affected boys typically die in 
their third decade of life.
    During the past year we have teamed with our colleagues in 
the National Institute of Neurological Disorders and Strokes 
and the NIH Office of Rare Diseases, as well as voluntary and 
professional organizations, to support several major scientific 
conferences to identify promising research avenues to pursue in 
the many forms of muscular dystrophy. We have joined with the 
Neurology Institute in launching a research registry for some 
of these diseases and we have solicited research proposals from 
the scientific community to address the broad array of issues 
in this area.
    Mr. Chairman and members of the committee, people of all 
ages and all population groups will benefit from these 
investments that we have made.
    I would be happy to answer any questions that you might 
have. Thank you.
    [The statement of Dr. Katz follows:]
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    Dr. Kirschstein. Finally, we know, Mr. Chairman, the people 
that suffer from chronic diseases are turning more and more to 
alternative and complementary medicine, and Dr. Stephen Straus 
is the Director of the National Center for Complementary and 
Alternative Medicine.
    Dr. Straus. Thank you, Mr. Chairman, members of the 
committee and distinguished colleagues.
    Our purpose in the National Center is to rigorously test 
complementary and alternative medical, or CAM, practices to 
which Americans commonly turn. In partnership with many of the 
NIH Institutes and Centers, including all of those represented 
at the table today, we are energetically exploring CAM 
approaches to expand health care options for people with 
debilitating and life-threatening chronic diseases.
    The control of chronic pain is a major goal of our 
research. Through sophisticated imaging techniques, we now know 
that the activity of the brain's central pain processing 
centers is altered when needles are inserted at body sites that 
ancient Chinese practitioners associated with pain control. Our 
clinical trials are determining the range of conditions for 
which acupuncture is truly beneficial. In the largest such 
study ever conducted with the Arthritis Institute, we are 
comparing acupuncture and placebo for the pain caused by 
degenerative arthritis.
    Despite major scientific advances in treatment and 
prevention, some patients with coronary artery disease turn to 
a popular but controversial alternative known as EDTA chelation 
therapy. Because so little reliable data on chelation therapy 
exists, NCCAM and the Heart Institute are now poised to mount 
the first major, rigorously designed trial of chelation therapy 
for coronary artery disease.
    The vast majority of cancer patients turn to a CAM 
modality. Therefore, our grantees have initiated the first 
controlled trial of a Chinese herbal cocktail known as PC-SPES, 
for prostate cancer. The study focuses on African American men 
in whom there are disparate rates of prostate cancer morbidity.
    Postmenopausal women are concerned about the risk of breast 
and ovarian cancer associated with conventional hormonal 
replacement therapy. Preliminary studies of popular soybean 
extracts with estrogen-like activities have yielded unclear 
results about their benefits and risks for these women. NCCAM 
will assess the impact of soy supplements on the health of 
women with breast cancer.
    Cancer patients for whom a cure is no longer likely 
struggle to preserve their dignity and their quality of life. 
NCCAM will sponsor clinical trials aimed at preventing and 
ameliorating the side effects of chemotherapy and radiotherapy 
and enhancing overall well-being.
    A full palette of other studies are addressing herbal 
treatment for hepatitis; lutein, a dietary supplement for 
retinal disease; acupuncture for dental and craniofacial pain; 
and much more.
    Mr. Chairman, people turn to complementary and alternative 
medicine hoping to prevent or relieve chronic illnesses. I 
believe that clear and compelling research data will permit 
patients and parctitioners to embrace those approaches which 
prove safe and effective and reject those that are not.
    Thank you for your attention. I am happy to take your 
questions.
    [The statement of Dr. Straus follows:]
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                             LASIK SURGERY

    Mr. Regula. Thank all of you.
    To my colleagues we have passed out a list of questions 
prepared by the staff, feel free to use those as you choose. 
What we will try do in the first round is to hold questions to 
5 minutes, so we can give everybody an opportunity, and then go 
around again. In your questions you can either direct them to 
one of the Directors or, if you want to make a general 
question, Dr. Kirschstein, can call on one to answer.
    I just have a couple of quick questions. Related to the 
eyes, Dr. McLaughlin, have you done any research on the long-
term effects of laser surgery? It sounds like a great solution, 
but I wonder if it has a down-the-road impact.
    Dr. McLaughlin. Yes, sir, you are talking about lasik 
surgery that is so popular these days. The studies that have 
been conducted to date have been industry supported, but they 
have been very good studies. The FDA has been keeping track. Of 
course, that was part of the regulatory procedures in getting 
these different lasers approved. We are beginning to see in the 
published literature some rather long-term follow-up with these 
patients and the results are holding up. So I think it would be 
fair to say at this point that the procedure appears to be, as 
surgical procedures go, very safe and very efficacious. We are 
not seeing any long-term damage or rupture of the eye for 
example, due to increased riskfrom trauma that some may have 
speculated early on. So far so good, I think.

                      THE EYES AND OVERALL HEALTH

    Mr. Regula. Someone told me once that physicians in 
diagnosing say that the eyes will give you a lot of clue to 
overall health. Is that an accurate statement?
    Dr. McLaughlin. Yes, sir. Many people say that the eye is 
the window to the brain and actually to the body. Many of the 
conditions represented by my colleagues here damage the dyes. 
For example, in diabetes the diagnosis sometimes is first made 
by an eye doctor who is looking into the eyes and sees these 
engorged and leaking blood vessels.
    And we can go down the line. Rheumatoid arthritis is 
another, of the conditions that my colleagues deal with, that 
has ocular manifestations. So that is a very accurate 
statement.

                      EVALUATING UNPROVEN REMEDIES

    Mr. Regula. Dr. Straus, you apparently do explore some of 
these remedies. I hear on the radio advertised all kinds of 
esoteric cures: Grow a great head of hair, it says, overnight.
    Dr. Straus. It works. [Laughter]
    Mr. Regula. I won't enlarge on what the ads say but, how do 
you evaluate these so-called off-beat remedies and how do you 
inform the public whether they are good or bad?
    Dr. Straus. Well, this is what this fascinating job is 
about, Mr. Chairman. The fact is we have the scientific tools 
to do so. We can ask questions about these remedies, whatever 
their roots and historical origins, the same way we would test 
any new device, a procedure like angioplasty, new drugs for 
arthritis: through well-conducted controlled trials, using 
rigorous end points and conducted by trained investigators. We 
will get answers that are clear and compelling.

                 DISSEMINATION OF INFORMATION BY NCCAM

    Mr. Regula. And you do disseminate this information in some 
form or another to the public?
    Dr. Straus. Absolutely. Because there is such a dearth of 
quality data, that is a very large part of our strategic 
approach. We have a toll-free number that gets several thousand 
calls a month. We have a newsletter. Our Website got 530,000 
hits last month. We have partnered with the National Library of 
Medicine to make available by Internet to the American public 
on a touch key, 230,000 publications from 4,500 journals in 70 
languages, to help them know what is available and what isn't 
available. And we have town meetings. We just had one in 
Tucson, Arizona 3 weeks ago, standing room only, 600 
individuals bringing their questions to us and a panel of 
experts to talk about what is known and what isn't.
    Mr. Regula. So if someone hears an ad for some panacea for 
whatever their ailment might be, they could call your 800 
number and at least get the results of your research.
    Dr. Straus. Absolutely. I would say, however, that if it 
sounds too good to be true, it usually is.
    Mr. Regula. Mr. Wicker.

                           CHELATION THERAPY

    Mr. Wicker. Thank you very much. Let me ask you really 
quickly, Dr. Straus, what is your initial impression of 
chelation therapy? You say you are investigating it.
    Dr. Straus. Well, Dr. Lenfant and his colleagues and my 
colleagues are about to call for applications for the first 
large controlled trial. To date, there have only been very 
small studies of a few dozen individuals. Those studies raise 
questions about safety and thus far have not shown benefit.
    But it is such an important issue and there is such big 
public health question about its use that we have realized that 
the next step is to ask the question in a large and serious 
study.
    Mr. Wicker. Okay. Well, it may be that other members of the 
panel may want to comment for that on the record, but I want to 
get to a larger question, Dr. Kirschstein, that has been 
controversial in the past and obviously will continue to be, 
and that involves the subject of stem cell research. And let me 
say that I have been as big a supporter of NIH as I could 
possibly be, and I think the Congress is to be commended and 
the administration, too, for putting our money where our mouths 
are in terms of our effort to double the NIH budget over a 
period of 5 years or so.
    And yet when there are these tremendously controversial 
ethical problems, it lessens our opportunity to have a wide 
range of broad-based support across all constituent groups. I 
see people coming to my office from my district with first one 
chronic disease and another, and they have been told that 
embryonic stem cell research is the thing to ask for. And yet I 
have some literature that has been made available to Members of 
Congress that nonembryonic stem cell research is also very very 
promising in such a way that it does not raise these ethical 
problems which we have debated in the past and obviously we are 
going to have to debate in the future.
    I have an article here from the Globe and Mail, dated 
January 30th of this year, saying that a Dr. Mick Bhatia and 
his colleagues at the J.P. Robarts Institute in London, Ontario 
have made great strides in the area of adult stem cell 
research. They have been able to use a naturally occurring 
protein to get adult stem cells taken from bone marrow to 
behave in the same manner that human embryonic stem cells have 
shown.
    I also have an article here by Wesley J. Smith which 
indicates that there is great promise in getting stem cells 
from umbilical cord, umbilical cord blood, bone marrow, spleen, 
or human blood, and that great strides in nonembryonic stem 
cells have been made in generating muscle tissue, alleviating 
stroke symptoms, creating heart tissue and even blocking HIV 
growth. And Mr. Smith, in his article, raises the question, 
with all of these intriguing discoveries in adult stem cell 
accomplishments, why is Federal funding for embryonic and fetal 
research pushed so hard and so publicly, while adult stem cell 
and other alternative therapies are dammed with faint praise, 
if any?
    So I will let you or any member of the panel comment on 
that, if you will.
    Dr. Kirschstein. I will start, Mr. Wicker. You have heard a 
great deal today from my colleagues about the importance of 
research and scientific evidence. There is great promise in a 
number of stem cells, adult embryonic stem cell types from 
animals, blood stem cells from both the umbilical cord, and 
even stem cells that are adult and coming from brains of people 
who have unfortunately died through trauma or something of the 
sort.
    There has not yet been, and will not be as long as the 
prohibition lasts, any research on human embryo-derived stem 
cells, using Federal funds. Many groups that have family 
members who have serious, chronic diseases, genetic diseases, 
diseases that affect children at a young age--for example, we 
talked in your office a while ago about Duchenne's muscular 
dystrophy--are desperately looking for something that canhelp 
their particular relative.
    To date, we do not know--there is no true scientific 
evidence of--what can happen by the use of adult stem cells and 
the use of human embryo-derived stem cells, because we have not 
done the research in parallel. Many of the groups wish us to do 
this and we, as you know, developed guidelines of what could be 
done if the procedure for the use of Federal funds were to be 
approved. That was done in anticipation of what might happen, 
but no research has occurred as yet. Most of the advocacy 
groups would tell you that we will not know--and following true 
scientific methodology would tell you that we will not know for 
sure until the work can be done side by side, and we can see 
both sides.
    However, there is work continuing to be done using adult 
stem cells, a very considerable amount of work. Some of it is 
in the diseases that my colleagues have been talking about 
today, some in other diseases, particularly neurological 
diseases.
    Mr. Wicker. And it is quite promising.
    Dr. Kirschstein. It is quite promising, but we do not know 
for sure whether that promise will last, and that is 
essentially where we are today.
    Mr. Wicker. I know we are pushed for time, but there is a 
considerable body of chronic disease research going on in the 
private sector also; is that not correct?
    Dr. Kirschstein. Yes.
    Mr. Wicker. It just seems to me that when the Catholic 
bishops raise legitimate ethical concerns, when constituent 
groups from all over the country say that this is an area where 
we shouldn't be spending public taxpayer dollars, that there is 
an opportunity for you to develop this great body of research 
and perhaps trumpet it a little more with regard to the 
nonembryonic research and perhaps leave the more controversial 
destruction of a human embryo to the private sector and not 
take tax dollars from people who object on the basis of ethical 
consideration.
    Dr. Kirschstein. Mr. Wicker, we are very sensitive to this 
issue and we indeed do not trumpet one activity over the other. 
We report on the literature that you have been reporting on. We 
do not know the answers.
    There is one thing that I think might be said, and that is 
that we really have no information, unless it is published in 
scientific journals, about what is being done in the private 
sector. There is no requirement that people in the private 
sector follow any sort of guidance or any sort of guidelines. 
Therefore, we really cannot tell you with any certainty whether 
the work being done in the private sector is being done with 
the scientific rigor that we would demand, because we are 
scientists and because we are the NIH. If there were--and I am 
not saying there should be--but if there were Federal funds 
being used, we would apply scientific rigor.
    Mr. Wicker. Thank you.
    Dr. Kirschstein. Does anybody else wish to comment?
    Mr. Regula. We will probably have more opportunity to 
debate that. It is a rather sensitive subject.
    Mr. Sherwood.

                  TRANSLATING RESEARCH TO THE BEDSIDE

    Mr. Sherwood. Thank you. Dr. Lenfant, I am very pleased to 
represent Dr. Lynn Smaha of the Guthrie Clinic in Sierra, 
Pennsylvania, who, as we know, is the immediate past President 
of the American Heart Association, and he tells me that he will 
be chairing the April 2002 public NHLBI conference on 
cardiovascular health, for all to analyze how we are doing 
towards our healthy 2010 goals.
    And in that light, I would like to ask you a little bit 
this morning about your work on the translation of research to 
the bedside. In addition to discovering new science, we need to 
be able to apply the research to the treatment of patients. And 
could you speak to the committee about the new guidelines and 
how they will impact the treatment of high blood pressure and 
high cholesterol and so forth?
    Dr. Lenfant. Mr. Sherwood, I couldn't tell you enough how 
pleased I am that you asked this question and referred to Smaha 
who is a good friend of mine. In fact, when he acceded to the 
presidency of the Heart Association, that was through our 
discussions, he tried to do just what you are talking about, 
which is to increase the translation of what we know, what we 
know how to do, but unfortunately that we don't do. I could 
give you for the whole day here examples of scientific 
achievement and things which could be done but are not done for 
a number of reasons.
    Now, having said that, this conference that you are 
referring to is actually an effort to remedy that situation by 
calling upon the cooperation of the many Federal agencies, 
voluntary organizations, which are involved in the research and 
patient care. And we think that this debate, which will be 
mainly national but to an extent international, because many 
other countries have heard about this event and want to join to 
see what is being done, will be really a catalyst to strengthen 
this effort.
    But meanwhile, the Institute is and has been for many years 
engaged in the development of guidelines primarily in risk 
factors; for example, in heart disease risk factors. In May, we 
are going to release some new guidelines for the control and 
treatment of blood cholesterol which is, as you know, one of 
the most important risk factors in development of coronary 
heart disease and arteriosclerosis and other conditions.
    I should also tell you, Mr. Sherwood, that we are working 
very closely with the National Commission for Quality Care in 
order to assure that whatever we come up with moves into the 
public arena through managed care and similar organizations.
    Let me just give you an example of another activity that we 
have had which is called the National Heart Attack Alert 
Program. It is well known that the faster a patient with a 
heart attack receives care, the more likely his or her chances 
to survive. Years ago, the average time in this country was 
approximately 70, 75 minutes between event to access to care, 
and that could be in the ambulance.
    We started a program which is, again, called the National 
Heart Attack Alert Program, and it was reported just a few 
weeks ago at the American College of Cardiology, that this time 
has been reduced, working with the communities, the fire 
departments, the emergency services, the police departments, to 
32 minutes. You may not appreciate the impact that that has had 
on many many patients. Our goal is to try to reduce it to 22 
minutes.
    So the Institute is indeed engaged in many many similar 
activities related to cardiovascular disease, to chronic 
respiratory disease as well, and we essentially started a new 
program on sleep disorders, especially in children. During the 
last few days, some of you members of the committee may have 
heard, especially yesterday, actually a number of pieces on 
national and local news on sleep disorders. And it is 
interesting that it came at a time whenwe just started a 
program where we are quoting a thought of a comic in the newspaper 
which is Garfield the Cat, which has become our sleep star, talking to 
children on how it is important to have a good night's sleep.
    Thank you, Mr. Sherwood.
    Mr. Regula. Thank you. Ms. Pelosi.
    Ms. Pelosi. Thank you very much, Mr. Chairman. Dr. 
Kirschstein, welcome again. We are so proud of your work. Thank 
you once again for your magnificent hospitality at the NIH a 
few weeks ago when the Chairman took us there.
    Dr. Spiegel, thank you for your presentation. It gave us 
all hope. It was a wonderful occasion. God bless you for the 
work that you do, because so many people are depending on it.
    And with all this array of this tremendous resource before 
us today, it is hard to choose questions but, Dr. Katz, you are 
going to be my focus on the first round in any event.
    Dr. Katz. Thank you in advance.
    Mr. Hoyer. You haven't heard the question.

                             Women's Health

    Ms. Pelosi. He hears them quite a bit from me, as a matter 
of fact, but I want to just get an update. My colleagues, as 
you know Dr. Katz is the head of the National Institute of 
Arthritis, Musculoskeletal and Skin Diseases, NIAMS. And 
women's health issues have come so much to the forefront now, 
and many of them within NIAMS--lupus, osteoporosis, and 
others--that some call NIAMS the national institute of women's 
health, and I want to focus there.
    As you know, Dr. Katz, for several years we have all been 
following the research advances in Ehlers-Danlos syndrome and 
scleroderma; again, women disproportionately, if not totally, 
affected by this. Additional NIAMS research of these two 
diseases I think is needed to explore therapeutic interventions 
and to provide a basic science model to understand the 
mechanisms. Is there any progress to report on either 
scleroderma or Ehlers-Danlos?
    May I just say, whether it is because I have made these 
issues a priority, or for other reasons, so many cases are 
coming to my attention now, and I don't know if that is 
anecdotal or scientific, but I put it forth to you.
    Dr. Katz. Well, I appreciate that question, the opportunity 
to respond. It is true that the NIAMS views itself as an 
institute of women's health because so many of the diseases, 
not only the ones that you talked about--osteoporosis, 
scleroderma, osteoarthritis--but many other autoimmune diseases 
predominantly affect women, sometimes with a ratio of 9 to 1 or 
10 to 1, as in the case of scleroderma. I should tell you that 
we work very closely with our colleague, Dr. Vivian Penn, who 
is in charge of the Office of Research on Women's Health in the 
Office of the Director.
    In the past couple of years, we have had meetings that have 
addressed scientific opportunities and gaps in knowledge in 
both scleroderma and in Ehlers-Danlos as a part of the 
heritable connective tissue disorders.

                              Scleroderma

    Let me focus on scleroderma to start. Two years ago, there 
were two or three scientific meetings that were national as 
well as international meetings in which professional groups as 
well as voluntary groups participated to identify promising 
opportunities. As a consequence of those meetings, we 
identified some of the needs in the community, and I am happy 
to tell you that we did put out a request for applications 
during this past year, and we now have in-house about 28 
applications that address particularly new ideas and new 
research approaches in scleroderma in many areas, whether they 
be genetics, whether they be vascular, whether they be the 
study of fibrosis.
    As many of you know, scleroderma is a hardening not only of 
the skin but also a hardening of many of the internal organs 
from which a percentage of people die within 4 or 5 or 6 years 
of diagnosis. So we are looking to those new applications for 
new insights and new areas to pursue in the area of 
scleroderma.

                         Ehlers-Danlos Syndrome

    In the area of Ehlers-Danlos syndrome, we have more of a 
problem getting the scientific community to focus in this area. 
We have had meetings with the voluntary organizations of the 
heritable connective tissue disorders, as well as scientists 
from around the country and around the world, to try to 
identify some of those scientific opportunities to look not 
only new diagnostic criteria, but potential new therapeutic 
interventions. And I met with some of the people from the 
Ehlers-Danlos group just 2 days ago and we talked about how 
difficult it is to get some of the scientists in the community, 
good scientists, to become involved in this area. And we are 
working together with that group to try to identify not only 
the opportunities, but scientists to actually apply for funds, 
because that is one of our problems. Scientists are not even 
asking for funds to do research in this area. That is the 
reason for having these workshops, to try to identify not only 
the opportunities but also to proclaim our interest. And we are 
planning an announcement indicating our interest in funding 
research in that particular area.
    Ms. Pelosi. I see my time has expired. I will ask more in 
the next round, but I appreciate your response and we will 
continue.
    Mr. Regula. Mrs. DeLauro.

                 Heart Disease and Treatment for Women

    Ms. DeLauro. Good morning. Thank you very much. As I am 
sure, people are wandering in and out up here, but my apologies 
to you for not listening to all of the testimony, as I think I 
caught the end of my colleague Ms. Pelosi's comments.
    It is an array of stars always when you come through, and 
we are delighted. This is one of the most exhilarating parts of 
this job, and of this committee, being able to listen to all of 
you and what you are doing and how together we may be able to 
make some difference. You clearly do. The question is whether 
we will help you to do it.
    Let me just ask Dr. Lenfant, if I can, a couple of 
questions in this round. I am part of the Congressional Heart 
and Stroke Coalition. This is the issue of concern about the 
enormous toll that heart attack and other cardiovascular 
diseases take on women. We have got this year more than 500,000 
women who will die from cardiovascular disease, leading cause 
of death of women. And stroke is the number three killer of 
American women. However, my understanding--and correct me if I 
am wrong--is that there is still some controversy about the 
differences between how women and men with heart disease are 
diagnosed and how they are treated.
    And a couple of questions. What is the Heart, Lung and 
Blood Institute doing to address this issue? I know you have 
begun an educational program on women and heart disease, and 
could you elaborate on this proposed initiative?
    Dr. Lenfant. Well, thank you, Ms. DeLauro. This isagain one 
of these issues where we know much, not enough, but we do know much and 
that needs to be applied. For reasons which are somewhat unclear, there 
are a number of barriers between the translation--for the translation 
of what we know to relate actually to women.
    We have a very extensive research portfolio to refine what 
we know and to better identify the differences, but that is not 
as much the issue as making sure that women and their 
physicians know what needs to be done. And it is interesting 
that you refer to that educational program which had the first 
meeting actually Monday and Tuesday of this week, where we had 
participating with us to chat about what this program is going 
to be, what it is going to do, and how it is going to work.
    Approximately 70 or 80 representatives from various women's 
groups in the country attended, and in addition it was Webcast. 
And it happened that this morning, before I came here, I asked 
my colleague who monitors Webcasting information, and he told 
me that yesterday afternoon at the end of this conference, 
which was 2 o'clock, he received nearly 2,000 requests from 
women who want to participate and want to be part of this 
effort.
    This meeting that I just mentioned was to begin to chart, 
to design the program. Our responsibility now is not to drop 
the ball and to get it going. We are committed to doing it. We 
are working with many, many groups and we really expect that to 
be very, very successful.
    Ms. DeLauro. Wonderful.
    Dr. Lenfant. Women, no doubt, need to be helped. But to be 
helped, they have to know more about the conditions that affect 
them, and that is what this program has done. It is not to 
educate physicians; it is to educate women so that when they 
feel discomfort, they go to where they should be and insist 
that they receive the care that they should receive.
    Ms. DeLauro. That is terrific. I would love to have the 
information that you have been talking about and figure out 
ways in which we can work together and look at what we are 
doing with the Wisewoman program, to extend the opportunity for 
women to be treated across the country when they go into the 
breast and cervical cancer centers, that while they are there 
that we begin to screen for cardiovascular disease risk 
factors. This is really terrific and I thank you.
    Dr. Lenfant. I am excited about what we have and I am sure 
you would be amazed and impressed to see how many women and 
women's groups participated in this effort.

                    Treatment of Asthma in Children

    Ms. DeLauro. A quick question on asthma. The rate of 
childhood asthma in my State is among the worst in the Nation. 
That is in Connecticut. What has been done on the occurrence of 
pesticides and other airborne pollutants as they relate to 
childhood asthma? And talk about your working with CDC to look 
at research and the effectiveness of what are called inhaled 
corticosteroids in terms of treatment of children with asthma 
and what we might be able to do with that.
    I see that my time is up. Mr. Chairman, can I have Dr. 
Lenfant quickly answer the question?
    Mr. Regula. Yes.
    Dr. Lenfant. I will be very brief. Your second question 
first. We have clearly established that the quote-unquote gold 
standard in the treatment of asthma in children is 
corticosteroids, and it has been established very well that it 
does not have any consequences on their development. That is 
being disseminated.
    Your first question about the cooperation with other 
groups; following the directive of the Congress, the last 
Congress, we asked our Institute to form a Federal committee 
that involves all the agencies and voluntary organizations 
interested in asthma. That is going and so far going very well. 
It involves CDC, all the Institutes at the NIH, the EPA, all 
the agencies are involved.
    Ms. DeLauro. Thank you very very much, Dr. Lenfant. Thank 
you all of you. Thank you, Mr. Chairman.
    Mr. Regula. Mr. Hoyer.
    Mr. Hoyer. Thank you very much, Mr. Chairman. Dr. 
Kirschstein, this is a thematic hearing. Can you tell me the 
impact on the increases that have occurred over the last three 
cycles on our--either on an average, and also give me the 
spread in terms of our pay lines for each of the Institutes and 
what percentage of qualified science we are being able to fund 
as a result of our increases. And you might also wind into that 
answer the impact it is having on new young scientists going 
into basic biomedical research.
    Dr. Kirschstein. Mr. Hoyer, the directors who are with me, 
and the directors of the rest of the 27 Institutes, would have 
to give you the details. However, I think the most important 
thing that has happened is that there is a sense of continuity, 
a sense of stability that has come into the biomedical research 
community as a result of the last 3 years, or 2\1/2\ years of 
funding.
    The overall ability is to fund something like one-third of 
the research grant applications that are submitted. In some 
cases it is a little less. In some cases it is considerably 
more. But in general, it is about a third.
    You heard last year that while one-third is something we 
had always hoped we could get, the number of very good 
applications that are being received by most of these 
Institutes would make them pleased to pay 35 to 40 percent.
    This indicates that there are biomedical researchers who 
are reentering or entering the field and feel that they can 
compete because of this stability. It has been a shot in the 
arm for the entire community, and enormous progress is being 
made as a result.

             Funding Opportunities for Young Investigators

    Mr. Hoyer. Did anybody want to comment on that?
    Dr. Katz. Can I just add that with regard to young people, 
you heard at the Nobel laureates hearing last year, held in 
front of this subcommittee by Mr. Porter, that young people 
were concerned about how little support they were getting 
through the variousgrant programs. And it is only in the last 2 
to 3 years that we have really been able to generate new programs that 
give new life to this concern that you expressed probably 3 years ago 
at these hearings in terms of the funding opportunities. We have 
instituted the K-23 and K-24 programs that I know many of you were 
concerned with. The K-23 program is for people who are just getting out 
of residency, for supporting them in terms of learning about clinical 
research and gaining all of the tools that they need to become clinical 
researchers.
    There was also concern about the mid-level investigators in 
terms of the changing health care system. I shouldn't use the 
word ``encumbered,'' but these investigators they needed to see 
more and more patients in order to make a living. Well, what we 
have done by committee at the NIH and what has been embraced by 
the national community, including all of the scientists in that 
area, is to develop the K-24 program, which is a mid-level 
mentoring program. Now we also have the ability to implement a 
loan repayment program because of legislation that was passed 
in the past year. So all of these programs are very encouraging 
to young people to let them know that we do have a commitment 
to them because they are the future.
    Mr. Hoyer. Excellent. I would be interested if at some 
point in time you could provide for the record the pay lines 
for each of the Institutes and particularly the low and the 
high.
    Dr. Kirschstein. We will.
    [The information follows:]
    [GRAPHIC] [TIFF OMITTED] T4726A.040
    
    [GRAPHIC] [TIFF OMITTED] T4726A.041
    
    Mr. Hoyer. Obviously we are averaging a third, which is 
excellent, and far up where when we were in the teens in many 
of the Institutes as you recall 10 years ago.
    Let me ask a disease-specific question. I was going to ask 
about asthma, obviously of great concern, particularly, I think 
to those in the Boston to Richmond corridor where air pollution 
is a real problem and the incidence is very high. But it is 
high all over the country.
    Let me ask about Alzheimer's disease, evidence that 
vascular diseases including stroke, high blood pressure and 
diabetes are associated with increased risk. Also there is 
recent evidence that cholesterol-lowering drugs are having an 
impact on Alzheimer's. Can you give us an update on where we 
are, where we are going and what progress we are making?
    Dr. Kirschstein. Dr. Hodes will be here next week. I would 
suggest that you wait and ask him that question.
    Mr. Hoyer. Okay. Thank you.
    Mr. Regula. Mr. Jackson.

                          SICKLE CELL DISEASE

    Mr. Jackson. Thank you. Mr. Chairman, I have a series of 
questions, but my good friend from Mississippi raised a concern 
earlier today about stem cell research, so I can't resist 
making at least a preliminary statement about stem cell 
research. I am going to submit all of my questions for the 
record. I have several questions for NIDDK, NIDCR.
    Dr. Lenfant, I have two pages of questions for you 
regarding sickle cell research. They will be submitted for the 
record, and after I make my brief statement I am going to ask 
you a couple of them, Dr. Lenfant.
    Mr. Chairman, I understand the ethical dilemma of stem cell 
research. I am a graduate of a theological seminary and we have 
debated these issues and the ethics of stem cell research for 
quite some time when I was at the seminary. I also as a 
Representative believe in the use of taxpayer monies for good 
science conducted in an ethical way. I believe that every 
member of this committee who seeks to appropriate and double 
the size of NIH's budget believes in this as well.
    But since our prohibition of the use of federally funded 
stem cell research is not a blanket prohibition of private 
sector stem cell research--that is, this committee and this 
Congress has not sought to criminalize private sector research 
for stem cell activity--the Federal prohibition only serves to 
protect the discoveries and the advances for the private 
sector. And more often than not, their patents and intellectual 
property rights often come at great costs to the people who 
need these discoveries for their illnesses. That is, they 
cannot afford to have doctors apply the by-product of private 
sector stem cell research for their patients. And because their 
government abdicated their responsibilities, that research more 
often than not does not apply to them.
    My opinion is that if stem cell research is to be done at 
all in this country by the public sector or the private sector, 
it should be done under the careful oversight of representative 
government that has the best interests of the people at hand. 
That is what I want to say about stem cell research.
    But, Dr. Lenfant, obviously you are aware of this 
committee's effort to double the NIH budget over the next 5 
years. I am interested in how this has affected the 
appropriations for NHLBI and how the sickle cell disease 
program in particular at NHLBI has benefited from this overall 
increase.
    Dr. Lenfant. Thank you, Mr. Jackson. The NHLBI has a large 
research and translation program relative to sickle cell 
disease. Our research program includes several components. We 
have the core program, which is 10 centers of specialized 
research on sickle cell disease. And the number of 10, there is 
no magic in it, it is the number that has been mandated by the 
Congress. These programs are extremely active and have done a 
lot for sickle cell disease.
    In addition we have a number of clinical trials testing 
some specific procedures or medications. For example, just now 
we are initiating a clinical trial to test the efficacy of 
hydroxyurea, a drug which we know has been very effective in 
adults, but we do not know what it is going to do in children, 
and that is what this clinical trial is about.
    We have a clinical trial to see how we can reduce hip 
necrosis, which is a frequent complication of patients with 
sickle sell disease. We have another study to see how we can 
reduce the prevalence of stroke, which is a relatively frequent 
occurrence in children with sickle cell disease.

                       SICKLE CELL CENTER GRANTS

    Mr. Jackson. Dr. Lenfant, let me just follow up, if I 
might. I understand that the 10 comprehensive sickle cell 
center grants are up for recompetition and will be awarded 
another 5-year cycle in 2003.
    Dr. Lenfant. That is correct.
    Mr. Jackson. I would appreciate if you would describe the 
process for this committee. And I might add that when I look at 
the history of sickle cell centers, I know that the current 
list of centers is the first time that a minority institution 
has not been included. And you are well aware that sickle cell 
disease is one that disproportionately affects minorities. I 
understand in earlier years the RFA language stated that at 
least one minority institution would be funded. I am wondering 
what the NHLBI is doing to assist these institutions to become 
more competitive for center grants and are there any planning 
and development grants to assist in this process?
    Dr. Lenfant. Well, we work with all the institutions. But I 
have to say, Mr. Jackson, I am surprised that you have been 
told that there is no minority institution. In fact, I would 
say that one of the leading centers is directed by a minority 
researcher, which is a pioneer in the field.
    Mr. Jackson. I want to make it clear what I said. I do not 
want to be misunderstood. I did not ask the question as to 
whether or not there was a lead minority at an Institute. I 
said that not one institution that was at least minority, which 
was in the previous language, would be funded. That is what the 
RFA said in previous language, and I am making a distinction 
between a center headed by a minority and a minority-serving 
institution being funded.
    Dr. Lenfant. I stand corrected. I misunderstood you. That 
is correct. We do not have any minority institution at this 
time. We are working with them and encourage them to apply. The 
process that we follow for the reviews of the award of these 
centers is based on the scientific merit and how they are 
reviewed by their peers. One thing that we are doing is making 
sure that we have a large representation of minority 
investigators on the review groups. Hopefully, that may give a 
perspective to the group that it may not have otherwise.
    But the principle, Mr. Jackson--and I regret to have to say 
that--it has to be on the quality of what is being proposed. 
Sickle cell disease is a big, big problem. If this problem is 
to be resolved and helped, it has to be through the best 
possible science that we can support.
    Mr. Jackson. Mr. Chairman, I want to make something very, 
very clear and then I will conclude my statement. Mr. Chairman, 
you have been very gracious with my time today.
    Whenever I ask a question in this committee about minority-
serving institutions, I will always, as long as I am speaking 
to the NIH, presuppose that it is good science. So I do not 
need any qualification from anyone across NIH--and better we 
establish it early in the process--about good science. I am not 
asking for affirmative action. I am talking about good science.
    But it is hard for me to believe that of the 10 centers for 
a disease that primarily affects African Americans, that there 
is not a minority-serving institution that is engaged in good 
science trying to find a cure for the disease.
    We can talk about it in further hearings. Thank you, Mr. 
Chairman.
    Dr. Lenfant. I would welcome this opportunity, Mr. Jackson.
    Mr. Regula. Mrs. Lowey.
    Mrs. Lowey. Thank you, Mr. Chairman. Welcome, Dr. 
Kirschstein. It is always a pleasure for me to be with you 
today.

                      ACUPUNCTURE AND PAIN CONTROL

    Dr. Straus, I had an opportunity to meet with a good friend 
of mine, Jerry Kolberg, yesterday and we were talking about the 
center that he is establishing at the Hospital for Special 
Surgery, and I am so enthusiastic. And as you know, he uses 
acupuncture on a regular basis and he follows all the routines 
of the Institute. And so I look forward to really hearing the 
results, and having it at such a distinguished institution I 
think will be very important for that effort.
    You testified that research on the efficacy of acupuncture 
is ongoing. With the information you have, and we were talking 
about it for about an hour yesterday, can you tell us whether 
acupuncture is effective in providing pain relief? What are its 
limitations and does it deal primarily with relief of pain or 
does it have any action that can really get to the cause of the 
pain?
    Dr. Straus. Thank you, Mrs. Lowey. It would be an 
opportunity I would enjoy to come and speak to you and your 
staff in greater detail. But very briefly, let me say that a 
very large and disproportionate share of our research portfolio 
deals with pain issues and particularly the potential for 
acupuncture. I mentioned in my testimony that there are very 
powerful imaging techniques of the brain that now tell us that 
acupuncture seems to quiet down overactive pain control centers 
within the brain, so it actually gets to the root of the 
process in the brain by which pain is perceived and is 
registered to the mind.
    What we do not know is whether acupuncture works as wellas 
one would like and for which kinds of pain. The best data for 
acupuncture to date, such as it is, is for pain associated with dental 
pain, pain associated with arthritis, and the control of nausea 
following cancer chemotherapy. But the existing data on these came from 
numerous small studies and our responsibility is to compare the ability 
of acupuncture to affect pain in large, measurable ways that would be 
sufficiently compelling to recommend them to the general public. For 
that reason, we are not only studying how it works and exploring the 
range of its use with Dr. Katz and his colleagues and through our 
center in Baltimore, Maryland that Dr. Brian Berman heads, we are doing 
the largest ever study in several hundred individuals looking at its 
ability compared to other treatments to affect the pain of degenerative 
arthritis.
    The early signs from the smaller studies are promising. 
There is a tidal change in the scientific community's 
perception of what acupuncture might truly represent from 10 
years ago.
    Mrs. Lowey. Well, I think many of us will be very 
enthusiastic about hearing the results of this study, not to 
include anyone at this table. But I look forward to the work 
that is being done at Special Surgery.
    Dr. Straus. No more than I do.

           Complementary and Alternative Therapies in Cancer

    Mrs. Lowey. You also testified that research is beginning 
on alternate therapies for cancer, including whether 
alternative medicine is effective in treating the cancer 
itself, not just its symptoms or associated pain.
    Is there evidence to show now that alternate remedies can 
be used in primary treatment? Should we be careful in giving 
these remedies any credence, given the likely outcomes on 
survival? I would be interested in any information you have in 
that regard.
    Dr. Straus. Thank you, this is a very important issue 
because cancer affects patients so seriously. It leaves them at 
times hopeless and desperate and willing to try anything, and 
therefore prey to remarkable and untested claims.
    There is a potential that some alternative therapies can 
serve as primary cancer therapies. We have to be careful in 
studying those cancers that we are not displacing what we 
already think to be effective and curative cancer therapies.
    Among the approaches we are currently funding, there is a 
rather controversial study at Columbia University of a special 
dietary approach to the treatment of pancreatic cancer. This is 
justified because of the data from a small study suggesting 
that it was beneficial in 11 patients, and because the standard 
therapy for pancreatic cancer is so dismal. My father died from 
pancreatic cancer and I know how little conventional therapy 
affords. So we can justify it scientifically and ethically.
    We are mounting a series of initiatives over the coming 
fiscal year in partnership with the National Cancer Institute, 
who we meet with regularly to develop our strategies here; 
specifically, targeting alternative approaches as primary 
treatment.
    We have many opportunities for relief of symptoms that we 
are exploring, but this is a whole new initiative that is 
carefully structured.

                          Glucosamine Therapy

    Mrs. Lowey. If I may ask, Dr. Katz, because I think I am 
gradually running out of time, and I must ask you about 
Cosamine DS or the combination.
    Dr. Katz. We share in those studies.
    Mrs. Lowey. That is right. Do you want to both comment on 
it? Since last time, I began taking it. I am not sure it has 
done any good. If you can give us a report.
    From what I understand there has been some real evidence 
that it helps.
    Dr. Katz. Absolutely, and I appreciate the opportunity. 
This is a real partnership between an institute and a center in 
an area that we think is a big public health issue, 
osteoarthritis or degenerative arthritis that affects so many 
people around the country and around the world. We did initiate 
this study 2 years ago. The results are not in yet. This year 
there was a report from Europe that talked about the benefit of 
glucosamine and chondroitin sulfate at least in the alleviation 
of pain of patients with osteoarthritis. And the study that we 
are conducting together really takes this much further. It is 
much longer term. It is far more rigorous. There are more arms 
to the study, so we can really identify if something helps, 
whether it is the combination or just one compound alone.
    And very importantly, we are also looking at the functional 
benefit, so that we are not only looking at pain but we are 
also doing certain types of X-rays and MRIs to determine 
whether there is actually a functional benefit from glucosamine 
and chondroitin sulfate. This is a rigorously done study. It is 
going to take another 2 years to get the results.
    Mrs. Lowey. Are we going to be here to live through it? Are 
you sure that it does not have any negative effect?
    Dr. Katz. We certainly hope that you are going to be here. 
There have been no real negative effects reported, and the 
beneficial effect of the relief of pain should be encouraging 
enough, but we are looking at some of the more biological 
effects as well.
    Mrs. Lowey. I thought the idea was not so much the relief 
of pain but for those joints that are rubbing against each 
other, it was going to build some cartilage in between again.
    Dr. Katz. That is the theoretical reason for its use. 
Whether it is really true or not is what we are trying to 
pursue, because if it is true, it may lead to other forms of 
intervention that would be that much more beneficial.
    Dr. Straus. May I only add one point to Dr. Katz' excellent 
answer? And we are not only doing this definitive study, we are 
also doing studies to find out how it would work and whether 
that theory about boosting the growth and healing of the 
cartilage surfaces is correct. We are doing that in laboratory 
studies we are supporting.
    Mrs. Lowey. I think I have been indulged by the Chairman. 
Thank you very much, and thank you all for appearing and I look 
forward to hearing the results.

                    Number of People with Arthritis

    Mr. Regula. How many million people suffer from arthritis 
in one form or another? It must be a lot.
    Dr. Katz. It is a lot, and there are over 100 forms of 
arthritis. So we know that, for example, the most common form 
is osteoarthritis, degenerative joint disease, which occurs in 
over 20 million people in the country today. And because it is 
a disease of aging, the anticipation is that it will affect 
about half of the population over the age of 65. Many other 
forms of arthritis, of course, affect large groups of patients; 
rheumatoid arthritis, over 2 million people, but osteoarthritis 
is the major one.
    Mr. Regula. Mr. Peterson.
    Mr. Peterson. Thank you, Mr. Chairman. I cannot tellyou how 
delighted I am to have the chance to be on this Committee and to 
interact with this prestigious group. I will share that I was 
disappointed that I was not officially a member of the Committee and I 
missed the tour, and I will ask on behalf those of us who are new 
Members that if there is another opportunity, I would certainly----
    Dr. Kirschstein. Let us know when you want to come and we 
will be glad to have you.
    Mr. Regula. We will arrange it.
    Mr. Peterson. I don't want a tour just for me, but I am 
sure there are other members.
    Having worked on these issues at the State for 19 years and 
chaired Health for 10 years, I have found this committee very 
stimulating already and look forward to it.

                     Support for Clinical Research

    I am going to quickly go through a couple of questions 
here. One for Dr. Tabak. We have heard from public witnesses 
and the Association for Dental Research testified that there 
was a need for NIH to support more clinical research. What 
percentage of your research is clinical, and do you agree with 
that?
    Dr. Tabak. We certainly do require more clinical research. 
Much of our work is now at the stage where our basic science 
findings have matured sufficiently so that they can be 
translated into things that can be useful for making people 
healthier. So clearly we are at a position where we can begin 
to do more of this.
    Mr. Peterson. But do you agree with their major premise, 
then?
    Dr. Tabak. Yes, I do.
    Mr. Peterson. What percentage? You did not answer the 
percentage issue.
    Dr. Tabak. Depending on how you define clinical research, 
sir.
    Mr. Peterson. Give me a round, ballpark figure.
    Dr. Tabak. Perhaps I could provide it for the record.
    [The information follows:]

                  NIDCR Support for Clinical Research

    Approximately 29.4 percent of NIDCR's FY 2000 research 
budget was utilized to support clinical research. This 
percentage reflects the definition for clinical research that 
was developed and adopted in 1997 by the NIH Director's Panel 
on Clinical Research (aka the ``Nathan Committee''). This 
definition states, ``Clinical research is patient oriented; 
research conducted with human subjects (or on material of human 
origin such as tissues, specimens and cognitive phenomena) for 
which an investigator (or colleague) directly interacts with 
human subjects. This includes the development of trails, 
epidemiologic and behavioral studies, and outcomes research and 
health services research.''

    Mr. Peterson. Dr. Katz, we were talking about arthritis, 
and every family is affected. My mate suffers and has just 
lived with pain for too many years. And she was--I had her to a 
major medical center. She was put on Celebrex. She went off and 
on it because she continually has to measure when the side 
effects are greater than the relief of pain. She does have some 
fairly serious side effects.
    So her family physician, knowing that, recently advised her 
to go to Vasotec. Unfortunately, her side effects were so great 
that she thought she had the flu. She complained to me from 
home, and I was here Wednesday, and said that she just felt 
terrible. She thought she caught the flu. She was just sick. 
When I came home Thursday night, she told me how terrible she 
felt for several days and sick during the night, up during the 
night. And I said to her, are you on new medication? And she 
said, yes, I am taking Vasotec, but I just feel sick. And I 
said, get me the chart that you probably did not read from the 
pharmacy, and I read it, and she had every serious side effect 
and some of them are pretty serious.
    Should I report that kind of information to the company? I 
don't know who makes Vasotec, but it seemed to me if she had 
stayed on the Vasotec for 10 days it would have been lethal. 
She was a very sick person with serious side effects.
    Dr. Katz. As a physician, I would tell you that the first 
person to call is her physician to report it, and to stop 
taking that medication.
    Mr. Peterson. She did.
    Dr. Katz. The general issue with arthritis, since there are 
over 100 forms of arthritis, is, number one, to have a 
diagnosis, because various forms of arthritis are treated in 
different ways. Some, where we do not know the actual cause, 
are treated symptomatically for pain as with the new Cox-2 
inhibitors that she had tried. In others, types of arthritis we 
have made major advances, as I said in my opening statement. In 
rheumatoid arthritis there are very specific medications that 
are made, called biologicals, that have a very specific effect 
on the molecules that cause the inflammation.
    So it is important, number one, to have a diagnosis and, 
number two, to be aware that anything that you take, any 
medication that you take can have serious side effects and 
sometimes not so serious side effects. And I think that is one 
of the issues that Dr. Straus deals with in terms of 
complementary and alternative medicine.
    Mr. Peterson. I just have never seen side effects as 
serious as that. They were so serious she thought it was 
something else. She was just plain sick.
    That brings me to the issue, I represent the most rural 
district east of the Mississippi, rural Pennsylvania, and 
having worked on these issues with the tertiary centers, 
Hershey--not too much from Geisinger--and when I chaired Health 
at the Senate, we covered all the tertiary centers in 
Pennsylvania, and I know their access to the latest and the 
newest. But I covet I guess a better communication system that 
rural providers--you know, rural providers, we are often short 
of doctors in the rural areas and they have to say no to 
patients to take a day off to learn, which urban doctors maybe 
do not. And a lot of them are sole practitioners. They do not 
have anybody to take their patients, and because of necessity 
they do not do that as often.
    How do we develop a system that my citizens--we have 
excellent doctors, but I am not sure that the system of taking 
the wonderful findings that you keep coming up with, that they 
get disseminated as quickly as they should. How do we build a 
system to get that information out there?
    Dr. Kirschstein. Mr. Peterson, this is something that we 
have struggled with considerably, and we have developed a 
network of communications people who can provide such 
information. Particularly in this day and age with the use of 
the Web, our NIH Web pages and Institutes, home pages, are 
very, very helpful in that regard. Now, next week, or some 
weeks hence you will hear from the National Library of 
Medicine, which has developed a telemedicine system for 
providing information as well. So we are using many strategies.
    Dr. Spiegel?

                     DIABETIC RETINOPATHY SCREENING

    Dr. Spiegel. Perhaps I could give one concrete example, and 
my colleague in the National Eye Institute could amplify. We 
just cosponsored a workshop on diabetic retinopathy screening. 
We know that if you pick this up early, there are effective 
treatments. But the issue is the screening: How do your rural 
patients get there? And there are now telemedicine methods that 
will allow patients at a distance to have access to the finest 
care. Perhaps Dr. McLaughlin would want to comment.
    Dr. McLaughlin. I think that is well put. I think that is 
the future for many of these screening kinds of programs. The 
idea would be then to get the patients into the tertiary care 
centers and other areas where they could be treated with the 
most modern techniques.
    Mr. Peterson. With ophthalmology, I have multiple counties 
that do not have an ophthamologist and have to travel a county 
or two down the road to see one. That is improving. That whole 
network is improving, but I guess we do not utilize all of the 
means of telecommunications. And actually today physicians 
ought to be able to confer whenever they need with people at a 
major center to confirm their diagnosis or their questions 
about a diagnosis. And I think somehow we have to develop that 
system, that the tertiary centers have a relationship with the 
general hospitals and facilities, so that we have some equality 
of access to all of these wonderful new things that you are 
coming up with.

                    CONSENSUS DEVELOPMENT CONFERENCE

    Dr. Katz. The question you are asking is a great challenge. 
We have had at the NIH, and have had for quite some time, a 
system for disseminating information. That information may come 
from a specialist in the first place, but there must be a means 
to determine if the information is ready for prime time; that 
is, ready for the community to embrace. This system is known as 
consensus-development conferences, which are co-sponsored by 
the Office of Medical Applications and Research. And there is 
one such conference currently going on on dental caries, new 
findings in dental caries: What information should be taken to 
the dentists and the physicians who are seeing patients?
    We support a consensus development conference last year on 
osteoporosis, which is a very common problem. It affects a 
large number of people. The conference addressed the questions 
of when should testing be done, when should treatment be done, 
what kind of treatment? And this information is disseminated 
through many general medical journals to a large array of 
physicians around the country. And there have been many of 
these consensus development conferences which really try to get 
information to people who are actually seeing patients in urban 
as well as nonurban areas.
    Mr. Peterson. Thank you very much. I am sure I have 
exceeded my time.
    Mr. Regula. Do you use CDC as an agency to distribute 
information?
    Dr. Kirschstein. No, sir. CDC and we have different 
missions. We distribute our own information to a great extent. 
We use other modalities as well--the journals, for physicians 
practicing in rural areas. The Journal of the American Medical 
Association publishes the outcomes of these consensus 
development conferences.
    And let me add one thing, if I may. We have just had a new 
center established, which Mr. Jackson was very instrumental in 
setting up, the National Center for Minority Health and Health 
Disparities. The Center's focus includes not only minority 
individuals but also people from underserved populations, 
particularly those in rural areas. And we are beginning--this 
will be the first year you will hear from the director of that 
center--we are beginning to develop such programs.
    Mr. Regula. If you were to get a diagnosis from your local 
physician of a certain type of disease, could that individual 
plug into your web-site and get the latest research on that 
disease?
    Dr. Kirschstein. Yes, absolutely. Currently all the 
clinical trials in which NIH is engaged in are on the Website 
under something called--you saw a demonstration of this when 
you were out at NIH--clinicaltrials.gov. And pretty soon many 
of the private sector clinical trials, university clinical 
trials, pharmaceutical drug houses' clinical trials will also 
be on the Web.
    Mr. Regula. Thank you. Mr. Kennedy.
    Mr. Kennedy. Thank you, Mr. Chairman. Welcome, Dr. 
Kirschstein. It is a pleasure to have all of you here.
    I want to begin by saying when we are talking about chronic 
diseases, it is anything--and I think it is relevant that in 
terms of the stigma against mental illness, that NIMH is not 
here, nor are they scheduled to be here for any of our panel 
testimony. I think that when you think about the interrelation 
between diabetes, asthma, and all of these diseases we are 
talking about which are chronic, the interrelation with 
behavioral health is indisputable. With $5 out of every $100 
given to NIMH, I would like you to comment generally on that, 
and then I have some specific questions about diabetes and 
asthma that I would like to ask.
    Dr. Kirschstein. Unfortunately, Mr. Chairman, as you know, 
with the schedule it was not possible to have every one of the 
Institutes here. However, at the budget hearing on May 16th, I 
will be testifying on behalf of NIH's budget as a whole, and 
every single one of the Institute directors, including Dr. 
Steven Hyman, the director of the National Institute of Mental 
Health, will be here. The staff has said that questions can be 
addressed to them and they will come to the table and answer 
them. I regret not having NIMH here today, we all hoped Dr. 
Hyman could participate.
    Mr. Regula. May I interrupt? Members can submit questions 
for the record. Would they be able to submit questions to other 
Directors as a result of today's hearing?
    Dr. Kirschstein. Absolutely.
    Mr. Kennedy. That would be great.
    Mr. Regula. This hearing would provide a venue for doing 
that.

                     DEPRESSION AND CHRONIC ILLNESS

    Mr. Kennedy. Thank you, Mr. Chairman. I think it is 
pertinent because of the different questions that members have 
had about different things. Chronic illness, and you think 
about depression and how it is a leading cause of exacerbation 
of all these illnesses. It isn't just behavioral. I am an 
asthmatic, and for asthmatics not being able to manage your 
medications right is not just a behavioral problem. In 
diabetes, the enormous impact of people not being able to 
manage it. So much of this has to do with psychology. I think 
we are breaking the barriers down on the stigma on mental 
illness, and I hope that our research dollars come to fruition 
in terms of where this committee appropriates dollars, because 
I think that the cumulative effect is going to be 
extraordinary.
    Dr. Kirschstein. Dr. Spiegel.
    Dr. Spiegel. Mr. Kennedy, I couldn't agree with you more. 
In Dr. Hyman's absence, let me just mention that he and I, 
together with the NIH Office of Behavioral and Social Science 
Research, just sponsored a workshop, a couple of months ago on 
depression and chronic illness.Diabetes and end-stage kidney 
failure were two of the examples addressed. I am certain that the 
outcome of that is going to be an attempt at a research initiative in 
the next fiscal year that looks at the conjunction of these issues.
    Let me give you an example that illustrates your point. We 
know that there are changes in stress hormones under situations 
of depression that exacerbate attempts to control blood sugar. 
That is just one concrete example. We are very sensitive to 
this and are going to address it in a forceful way.
    Dr. Straus. Let me add, if I may, Mr. Kennedy, not only is 
behavioral medicine a part of all of our responsibilities, but 
we in the national center are now completing the largest study 
ever of a botanical treatment for depression using St. John's 
Wort and that data should be available this spring.

                                DIABETES

    Mr. Kennedy. I would like to ask, like I said, two 
questions; one about diabetes. In Rhode Island, we had over 
17,735 cases of diabetes-related hospitalizations and 969 
deaths just 2 years ago. The cost to the State is over $508 
million. That may not sound like a lot to everybody, but in 
Rhode Island, which is a small State, that is big dollars and 
the effect on people is enormous.
    I would like you to address what we are doing regarding 
stem cell research and how it plays a role in the problem of 
finding a sufficient number of these islet cells which are used 
for transplantation which will help especially juvenile 
diabetes and the onset of Type 1.

                           COSTS OF DIABETES

    Dr. Spiegel. Let me just say first that yes the costs are 
enormous. If you extrapolate from Rhode Island to the country 
as a whole, we are talking on the order of $100 billion 
annually in diabetes-related health care costs. It is clear 
that prevention is going to be the key in terms of cost 
effectiveness.
    We are taking a number of measures, including public 
awareness. Chairman Regula asked about these examples. We have 
the National Diabetes Education Program, for which we actually 
partner with the CDC in terms of increasing diabetes awareness.

               ISLET TRANSPLANTATION FOR TYPE 1 DIABETES

    Specific to your question about type 1 or juvenile diabetes 
and islet transplantation, there is now great hope, as I 
indicated in my opening statement, for a potential cure. One 
needs to be cautious about this. The studies that are being 
done, and which we and the National Institute of Allergy and 
Infectious Diseases are supporting, are looking at islet 
transplantation, not stem cell transplantation. These are 
islets harvested from cadaver donor pancreases. In several 
instances, the patients who have received these transplants 
have been insulin free, insulin independent, for over a year. 
For us, this defines a potential cure. Now, the notion is that 
if this is successful, there will not be an adequate supply of 
islets to treat the 800,000 to a million type 1 diabetics in 
the country. Even if Secretary Thompson, who is showing 
leadership in organ donation, is successful, where will we find 
the alternative sources?
    This is where the stem cell issue comes up, and Dr. 
Kirschstein has already explained and discussed what some of 
the issues are in terms of policy. What I can tell you is that 
we are vigorously supporting a multipronged effort on adult 
stem cell research and mouse embryonic stem cell research. That 
is something that we are forcefully and vigorously supporting. 
It offers tremendous hope of relating to this supply problem of 
islets.
    Dr. Kirschstein. Adult human.
    Dr. Spiegel. Adult human, as well as mouse embryonic.

                            ASTHMA TREATMENT

    Mr. Kennedy. On asthma, Dr. Lenfant, would you comment on 
what the latest clinical research networks are showing in terms 
of the treatment of asthma? Not just the causation of asthma 
but the treatment, since that has a lot to do with behavior as 
well.
    Dr. Lenfant. That is correct, Mr. Kennedy, and I should say 
that this clinical network that you are referring to has been 
producing some very interesting and important advances in the 
treatment of asthma.
    Looking at children, for example, we know today that 
corticosteroid is probably the ``gold standard'' medication. 
And more importantly, we know that it does not have any 
consequences on the development of these children, which was a 
big issue for a number of years.
    The treatment in adults is also advancing. I would like to 
take this opportunity to say that the medical and research 
community involved with asthma would make the following 
statement: that nobody needs to die from asthma. It is a 
condition that we can treat, treat very effectively. And one of 
the problems is, first of all, using what we know; and, second, 
as you mentioned, there are behavioral factors which are very 
important and need to be addressed.
    We do have clinical studies which are studying the 
interplay between the predeterminant factors: genetic factors, 
environmental factors, and behavioral factors. All three play a 
very important role, and at the present time we are trying to 
determine which is the most important and how to address them 
either in isolation or in combination.
    Mr. Kennedy. Thank you very much, Mr. Chairman.
    Mr. Regula. Will you be able to stay? This hearing is 
scheduled until 12 o'clock, but I hope you can stay. I want all 
the Members to have a chance to ask questions.
    Mr. Istook.
    Mr. Istook. Thank you, Mr. Chairman. Dr. Kirschstein, 
always good to see you. I very much appreciate your 
responsiveness on so many items.
    I was especially impressed by what Dr. Straus was saying on 
a couple of things regarding alternative medicine, which of 
course is part of the reason that so many of us supported the 
creation of that Institute. And hearing people comment about 
different orphan diseases certainly brings to mind what I would 
certainly support and I know many other people would also, with 
an Institute that would focus upon the rare diseases, trying to 
make sure that they do not fall between the cracks. And I know 
the challenges that you face in that.
    But what I really wanted to ask you about, Dr. Kirschstein, 
knowing that there is a challenge assimilating the growth that 
has been underway in medical research with the additional 
resources, certainly it has been brought up before that part of 
the challenge is making sure that there is sufficient quality 
research applications that are available. We hear different 
anecdotes at different times, questioning, because we know we 
have to match the resources to the ability to absorb them in a 
quality way.
    And also the ability of medical practitioners to absorb and 
assimilate the advances that are being made, because we are not 
just after pure knowledge. We understand the desire to have 
that, but we want to make sure that these are applied in the 
treatment of people.
    But that brings up another issue that seems to be 
surfacing. I know that BlueCross and BlueShield had a recent 
study, I think we may have provided you a summary of it, andI 
am picking up from more sources and getting into it more that is there 
a real concern that a lot of the recent escalation in health care costs 
may be attributed to the medical advances in the treatments and in the 
technology, because often when something can be done, people feel that 
it should be done and that therefore it must be done through their 
insurance carrier, through one of the Federal assistance programs, or 
whatever it may be. There is a lot of concern that the great resources 
being poured into medical research were having a side effect of driving 
the cost up faster of health care treatment and affecting affordability 
and therefore availability.
    Now, what I wanted to ask you on that, and I want to 
through this year and in the future explore this whole area 
with you more, but I would like to know to what extent NIH is 
trying to make sure that more cost-effective ways of providing 
treatment are not just a by-product of some research but is the 
goal of certain research; to make sure that the advances are 
actually done in a way that helps to bring down costs so that 
this treatment can be made available to more people and without 
being a driver in the overall cost of health care, which of 
course diminishes the availability to people.
    So I don't know to what extent you have analyzed that or 
whether it might bear from additional focus and be a proper 
topic of some of the directed research efforts. Could you give 
us some comments? Like I say, this is something I want to 
explore through the year as we go on.
    Dr. Kirschstein. It is not something that can be answered 
very quickly.
    Mr. Istook. Certainly.
    Dr. Kirschstein. Before I go to that point, let me talk 
about rare diseases. We have currently an Office of Rare 
Diseases and it does a magnificent job of coordinating 
activities, because each of those rare diseases has a home in 
one of the Institutes. It may be a neurological disease, it may 
be a disease of the digestive tract, it may be a disease of the 
heart or the lung or the blood. It may be arthritis, or a 
musculoskeletal, or skin disease. It may be a dental disease. 
The Institutes are where the expertise is, and the Office of 
Rare Diseases provides the substance to bring all of that 
together so that the individuals who form the national 
organization of rare diseases and so forth have a home where 
they can go for information and for conferences.
    So we think that is, frankly, a more appropriate way to do 
things, because the diseases are so diverse.
    Mr. Istook. I understand what you are talking about on 
keeping the topics together, and a big concern is not 
necessarily saying that all expertise has to reside in it but 
make sure there is an opportunity to direct resources.
    Dr. Kirschstein. Absolutely. Now, to get to your other 
subject, it is something that is a very difficult topic. And 
you are correct; much of what has been learned has led to 
advances in responsive technology, responsive drugs. And my 
colleagues will elaborate on this.
    Mr. Istook. Being on the cutting edge is always responsive.
    Dr. Kirschstein. Yes. As work goes along, there are 
opportunities to compare one technology versus another, one 
drug versus another. As one recent example, when we thought 
there was going to be a shortage of flu vaccine and we thought 
there was going to be an epidemic, the National Institute of 
Allergy and Infectious Diseases undertook a study to see if 
half of the amount of the prescribed vaccine would work as 
well, and indeed it showed that it could. That finding should 
therefore be able to be translated into how that vaccine is 
used. And our Institutes are very cognizant of this. We are 
beginning to have more and more studies that do involve 
economics and social issues as well. I could elaborate, but I 
think we should----
    Mr. Istook. Sure. We can explore that later, what resources 
need to be directed toward that goal.

           COST-EFFECTIVE THERAPIES FOR ORGAN TRANSPLANTATION

    Dr. Spiegel. Can I give one concrete example? When Chairman 
Regula, Mr. Miller, and Ms. Pelosi visited the NIH recently, 
they came to the Navy Transplantation and Autoimmunity Branch 
in the clinical center and met a young African American man 
with end-stage kidney disease, due to the same disease that 
Alonzo Mourning suffers from. He received a kidney transplant 
from his wife, a living donor. He received a new experimental 
therapy that indicates, very much to your point, that new 
cutting-edge therapies needn't be more expensive and can be 
both a scientific advance and cost effective.
    In addition to suppressing the entire immune system every 
day with 24 pills at a cost of $18,000 a year--that is chronic 
immunosuppression--Medicare covers that for several years, 
following the transplantation. Instead, he received a 
biological treatment at the time of the transplant and is 
essentially on just a couple of pills per day. This is early 
experimental therapy, but think of the cost saving, not to 
mention the greater potential efficacy in terms of not 
rejecting that kidney down the line. So there are numerous 
examples, but that is a concrete example. We are mindful of 
this and it is a very important point.
    Mr. Istook. Certainly. And we all understand that 
serendipity plays a key role in research. You do not know where 
you are going to wind up sometimes. But I think it is very 
important that advances that significantly reduce the cost of 
care be not just a nice by-product but be an actual goal that 
is receiving focus and resources accordingly.
    Dr. Kirschstein. We are also putting more and more 
resources into learning how to prevent diseases. And when we 
know how to prevent many of the diseases, then the cost of the 
therapies or the technology will diminish very significantly.
    Mr. Istook. Certainly. I look forward to continuing on this 
topic.
    Dr. McLaughlin. I think each us supports that kind of 
study. And one I might just mention: As you know, there are 
many corneal transplantations performed in this country each 
year, and there has been an idea that had grown up in the 
medical community that more extensive tissue typing of the 
cornea before the transplantation might help the success of the 
transplantation. We supported a clinical trial which, in fact, 
found just the opposite. So that now, the actual costs of 
corneal transplantations in this country are less than they 
might have been had this other idea run its course.
    There is now another study to determine whether corneas 
from older tissue donors may be used just as easily and as well 
as corneas from younger individuals. And so those are studies 
designed expressly to find out whether a cheaper, better 
alternative is possible.
    Mr. Regula. Mrs. Granger.
    Mrs. Granger. Thank you very much. I recently had a 
conversation with a physician who specialized in addiction 
treatment and research. And it was a very brief conversation, 
unfortunately, but he said there has been research recently 
that leads us to believe that our treatment for drug and 
alcohol addiction has been wrong. What they are learning in 
research is some of the causes and effects are different than 
what they supposed. Can you tell me what is going on there and 
what you are doing?
    Dr. Kirschstein. Well, the directors of the two Institutes 
who would be able to tell you in detail about that are 
unfortunately not here, and it is the same problem that we 
discussed with Mr. Kennedy. I would be pleased to transmit your 
question to Dr. Leshner and Dr. Gordis. In addition, they will 
be here at the May 16th hearing. So, since I am not an expert, 
I would rather have them answer the question.
    Dr. Straus. If I may, Mrs. Granger, the National Center for 
Complementary and Alternative Medicine hosts an entire research 
unit at the University of Minnesota in Minneapolis that is 
focusing on acupuncture and natural therapies used in Asia for 
many, many years for cocaine and heroin addiction. And our 
investigators, who I had the pleasure of visiting with 3 months 
ago, have very interesting findings that they have begun now to 
publish.
    Mrs. Granger. Good. There is a boot camp close to my 
district using acupuncture very effectively for alcohol and 
drug treatment and had very good results. I had a person I knew 
in my district who had the fetal tissue transplant for 
Parkinson's about 5 years ago, something like that, in Denver. 
I don't know what the follow-up or what results came from that 
research.
    Dr. Kirschstein. Fetal tissue transplants for Parkinson's 
Disease have been available to patients, particularly at the 
center in Denver, if they are willing to pay for the surgery. 
Recently, the National Institute of Neurological Disorders and 
Stroke conducted a controlled clinical trial in which tissue 
from the brains of fetuses was implanted into the brains of 
half of the patients while the other half of the patients with 
an equal severity of the disease, received in what is called 
sham surgery--the burr hole through which tissue would be put 
in was drilled, but no tissue was implanted. That paper was 
published very recently in the New England Journal of Medicine, 
and the results show that in patients under 60 there was some 
improvement. In patients over 60, and the majority of patients 
with Parkinson's Disease are over the age of 60, there was no 
improvement and there were some side effects that were of 
considerable concern. So the whole thing is being somewhat 
reevaluated now.
    Mrs. Granger. Thank you very much. Thank you, Mr. Chairman.
    Mr. Regula. Mr. Miller.

                      GENE THERAPY FOR HEMOPHILIA

    Mr. Miller. Good afternoon. Thank you all for being here. 
Let me ask two questions. One you briefly mentioned in your 
statement, Dr. Lenfant, is a subject that we talked about often 
and briefly during my visit to NIH last month, and that is 
hemophilia and what is happening with gene therapy. Give me a 
status report on what the potential is there. I know you all 
have been supportive of it and I appreciate that. Give me an 
updated report, if you would.
    Dr. Lenfant. Well, Mr. Miller, as gene therapy goes, I 
think it would be difficult to identify a condition where we 
could be more optimistic, guarded but optimistic, than 
hemophilia. Indeed, the field is progressing very well, and 
very fast.
    There are at the present time five Phase 1 clinical studies 
which are going on. Three of them are in biotech, company 
sponsored, and from what we are hearing, very successful, so 
much so that they are now planning to move into human 
applications.
    Then the two others, one is exclusively conducted by one of 
our grantees, and the other one is jointly between industry and 
one of our grantees. These studies are progressing very well 
and I feel that I really have to repeat what I said to you 
during your visit. I think that the general opinion today is 
that when gene therapy moves into a wider application, 
hemophilia has a good chance to be the disease that will 
benefit from this condition.
    Now, I would like to pick up on what was mentioned by Mr. 
Istook; you know, the tremendous cost of hemophilia in taking 
care of these patients. Gene therapy is going to wipe that out 
if it works, and here is a case where you see the most forward 
technology which is going to reduce the health care cost in a 
tremendous manner.

                              HEPATITIS C

    Mr. Miller. Let me continue on. I am not sure exactly where 
this sits, but since Dr. Spiegel brought it up--and maybe with 
Dr. Lenfant--it is the issue of hepatitis C. I am not sure 
which Institute. Obviously that has grown in the incidence of 
it or the numbers affected by it dramatically and potentially 
even much larger numbers. Could you give me a status report of 
what is happening there and what is the future with hepatitis 
C?
    Dr. Spiegel. I will give you a brief report and just 
indicate how in terms of coordination Dr. Lenfant's Institute 
has protected the blood supply, the discovery of the virus, and 
the development of a test. The Lasker Award, very prestigious 
in the United States, was given to Harvey Alter at the NIH 
Clinical Center. He shared it for the discovery of the virus 
and development of the test. So this has helped protect the 
blood supply.
    However, what about the millions of people who are 
suffering from this disease right now? We and the National 
Institute of Allergy and Infectious Diseases are working on 
both the basic and clinical aspects of it. NIAID is supporting 
research toward development of a vaccine, and that is a 
critical thing. That is prevention, the theme you have heard 
before. But again, the individuals who are already infected, 
NIDDK has mounted a very large multimillion-dollar, multicenter 
trial called HALT C. We know from studies we initially 
supported, and that industry picked up, that about 40 percent 
of individuals with hepatitis C respond to the combination of 
interferon and ribavirin. Unfortunately, many don't respond, 
particularly African Americans, for reasons we are not clear 
on. Therefore, we are launching an additional research 
initiative, a trial specifically looking at African 
Americansand why they seem more resistant to interferon.
    Mr. Miller. Is hepatitis C research basically just in 
yours, or is it----
    Dr. Spiegel. Hepatitis C is addressed by several NIH 
components at the wish of Congress which we follow. We have 
research responsibility for digestive diseases. The liver is a 
digestive organ and so we deal with infections of the liver. 
Gastroenterologists and hepatologists researchers are ones we 
support. Hepatitis C is also an infectious disease. For that 
reason, the NIAID deals with it. When it relates to the blood 
supply, hepatitis C is addressed by Dr. Lenfant of the National 
Heart Lung and Blood Institute. All of us coordinate. We are 
collaborating and cooperating in each of these areas.
    Dr. Kirschstein. In fact, the Department has a blood safety 
committee that considers all aspects of blood safety and works 
particularly on hepatitis C.
    Mr. Miller. Thank you very much.
    Mr. Regula. Well, I see we have a vote, so the timing is 
pretty good. For the Members, if you want to submit questions 
for the record, get them to staff by noon tomorrow. I have a 
lot of questions that I will submit for the record, but you 
have been very helpful this morning. We could spend all day on 
these issues. I want you to know we appreciate what you do out 
there. The American public probably isn't aware of how much the 
benefit of your research shows up in their physician's office, 
and I guess the best evidence of that is that the longevity 
factor in the United States has really gone up rather rapidly.
    Dr. Kirschstein. You are going to hear that next week from 
the panel.
    Mr. Regula. Well, that is proving that what you are doing 
gets results. Thank you all for coming.
    [The following questions were submitted to be answered for 
the record:]
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                                          Wednesday, April 4, 2001.

                         RESEARCH ON LIFE SPAN

                               WITNESSES

DR. RUTH KIRSCHSTEIN, ACTING DIRECTOR, NATIONAL INSTITUTES OF HEALTH
DR. RICHARD HODES, DIRECTOR, NATIONAL INSTITUTE ON AGING
DR. DUANE ALEXANDER, DIRECTOR, NATIONAL INSTITUTE OF CHILD HEALTH AND 
    HUMAN DEVELOPMENT
DR. KENNETH OLDEN, DIRECTOR, NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH 
    SCIENCES
DR. PATRICIA GRADY, DIRECTOR, NATIONAL INSTITUTE OF NURSING RESEARCH
    Mr. Regula. We'll call the subcommittee to order, and I 
think we'll get started. I see you have the team here again.
    Dr. Kirschstein. Yes, thank you, Mr. Chairman, good 
morning. We do have a team, and we're going to have, this 
morning, two panel presentations. The first is on research 
being conducted across the life span from infancy or even 
prenatal development to older people. Such research is 
absolutely critical in regard to the health of Americans of all 
ages, and to ensure that they can live productive, safe lives, 
have a high quality of life over many years, and have good care 
as needed.
    Again, as I stated last week, most of the other institutes 
and centers also have research activities that relate to stages 
of or the entire life span, but the missions of these four 
institutes fit in very well. So first----
    Mr. Regula. Well, it seemed to me, when you're talking life 
span, you cut across every discipline, because everything we do 
and everything that impacts on us is a part of the way of life 
that determines our life span, isn't it?
    Dr. Kirschstein. Exactly, Mr. Chairman, and it was a 
difficult decision. But we were limited by the number of people 
who could present. So the four groups that you will hear from 
today best represent what is being done.
    The first is Dr. Duane Alexander, the National Institute of 
Child Health and Human Development. So Dr. Alexander will make 
the first presentation. We're starting at the beginning.

                            Opening Remarks

    Dr. Alexander. Good morning, Mr. Chairman, and thank you 
for the opportunity to talk about the research of the NICHD, 
which was the first of the NIH institutes established to 
address life span issues. The 1962 legislation that established 
NICHD called for an institute focusing on the broad problems of 
human development, especially the health problems of mothers 
and children and developmental disorders.
    Over the ensuing years, the research of the institute has 
proved the wisdom of this founding concept, that the key to 
understanding, ameliorating and preventing mental retardation 
and many of the developmental disorders and diseases of 
childhood and adulthood lies in studies of the processes of 
development. From this research have come such discoveries as 
the HIB vaccine that has nearly eliminated the leading cause of 
acquired mental retardation in the United States, and medical 
care improvements that have reduced this Nation's infant 
mortality rate by 70 percent since the year the institute was 
established.
    Several examples of current areas of research illustrate 
the importance of this developmental approach to the health and 
well-being across the life span. We're learning that some 
maternal experiences during pregnancy appear to program the 
fetus to develop diseases during adulthood.

                       COMPLICATIONS OF PREGNANCY

    Mr. Regula. Can I interrupt you? Is that playing music when 
you're carrying a child, do you think that has an impact?
    Dr. Alexander. Well, we don't know for sure about that. But 
we do know that it's not seeing a rat that scares you during 
pregnancy and having a birthmark in the infant. That's an old 
myth that doesn't hold any longer.
    But we do know for example, we learned some years ago about 
rubella infection during pregnancy, and the horrible immediate 
consequences.
    Mr. Regula. Right.
    Dr. Alexander. What we're talking about here is longer term 
consequences, not apparent until adulthood, of experiences of 
the mother during pregnancy.
    For example, severe dietary restriction during pregnancy 
resulting in low birth weight is followed 40, 50, 60 years 
later by development of heart disease, obesity, diabetes. Much 
more likely in people exposed to that condition than others. 
And we're currently soliciting research to try and expand these 
studies.
    Complications of pregnancy, labor and delivery can portend 
a lifetime of problems. Pelvic floor disorders for the mother, 
brain injury for the child, which is more likely if her labor 
began too soon. Our research is trying toidentify ways to 
manage labor and delivery to reduce the likelihood of maternal pelvic 
floor disorders or of damage to the infant from the birth process, as 
well as ascertain the causes of premature labor and ways to prevent or 
stop it.

                             BIRTH DEFECTS

    Birth defects can be so severe that they're incompatible 
with life, but more often they allow survival with varying 
degrees of limitation of function that's often lifelong. Our 
research is applying the discoveries of the human genome 
project to assessing genetic factors contributing to birth 
defects, developing and evaluating corrective fetal surgery and 
developing improved medical rehabilitation techniques.
    We're also leading a multi-agency effort to design and 
conduct a longitudinal study of the effects of the environment 
on children's health and development, including birth defects 
and the fetal origins of adult diseases.
    One of the most important parts of the developmental 
process with life span ramifications is learning. Consequently, 
we developed major efforts to studying learning in normal 
children as well as for children for whom learning is a major 
challenge. Translating this research into practice is a current 
focus of our efforts. Learning to read, for example, is one of 
the most significant life span predictors not only of academic 
and economic success but of health and social behavior as well.
    These topics are but a few of the many examples that could 
be cited of the importance of research on development for 
health across the life span, and the enormous potential payoff 
for health and well being of focusing efforts on children 
before and after birth. With this Committee's help, we have 
accomplished much, and we will continue to do so in the future. 
Thank you.
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    Mr. Regula. I think what we'll do is maybe take some 
questions as we go here, because it's easier to remember. Mr. 
Hoyer?
    Mr. Hoyer. Dr. Hodes, have you already spoken?
    Dr. Hodes. No, sir.
    Mr. Hoyer. Oh, I was thinking to myself, I was two minutes 
late, this Chairman is so prompt. [Laughter.]
    Dr. Kirschstein. The order listed is not the way we went.
    Mr. Hoyer. The only progress occurs, Doctor, if we make 
progress at childhood, he says, Dr. Alexander, respectfully.
    Doctor, let me ask you about, I got half of your testimony, 
and I'm trying to catch up here, and my brains is not here yet. 
She will be here shortly, I hope. It's so tough to have to do 
this on your own. [Laughter.]
    Mr. Regula. Dangerous.
    Mr. Hoyer. Yes, it is dangerous. [Laughter.]

                            LEARNING PROGRAM

    Mr. Hoyer. I mean, the people who know what we're doing, of 
course, they're all behind us.
    Doctor, as you know, Carmella Walgren and others have 
talked to me about a program, and you and I have talked about a 
program that deals with the learning. You mentioned that in 
your statement. Would you expand a little bit on that, 
particularly as it relates to the program that she is 
interested in, so that we'll have some background for the 
Committee? Because I intend to pursue that in this Committee, 
and want to talk to the Chairman about it, and want him to know 
a lot about it.
    Dr. Alexander. This program in studying learning, both in 
normal children and in children for whom learning is a 
challenge, is a long term investment of the NICHD. We have 
through this research program determined what are the major 
factors that need to be in place for children to be able to 
learn to read, how those can best be taught in the public 
schools, and have transferred this information from the 
laboratory studies where they were developed to the classroom 
in what we call clinical trials in the classroom.
    For example, in the D.C. schools right now we are finishing 
up a five year study where we have been applying what we have 
learned in the laboratory to the classroom and demonstrated it 
in the poorest schools in the poorest neighborhoods in the 
District. With the interventions that we have developed for 
effective teaching of reading, we have taken schools where the 
overall reading percentile was below 10th percentile, and had 
all those schools above the 50th percentile after this 
intervention by third grade.

                         DEPRIVED ENVIRONMENTS

    Mr. Hoyer. Would you repeat that, because I think this is 
critically important. One of the challenges facing America 
today is to make sure that children who are most challenged in 
America, from culturally, educationally, economically deprived 
environments, can in fact get above the curve, so that they are 
ready to learn as they move along and also ready to, hopefully 
facilitate their graduation from high school, perhaps technical 
school, college, whatever, and compete.
    So would you repeat that, the success you've had in some of 
these areas?
    Dr. Alexander. Yes. I'm glad Mrs. Northup is here to hear 
this, because she has been a strong supporter of this research 
program, and has visited many of the schools in D.C. where we 
in fact are carrying out this intervention.
    Mr. Hoyer. Perhaps the amendment that we offer can be the 
Northup-Hoyer Amendment.
    Dr. Alexander. We have gone into schools in the District, 
and we have done this in other States as well, other places, 
where we are in the poorest schools in the District, with the 
lowest achievement levels, and taught the teachers the 
instruction methods based on the research, provided 
instructional materials based on research, and continued to 
work with the teachers in the classroom, training them how to 
provide this instruction.
    With this intervention, we have taken schools where the 
overall achievement has been below 10th 
percentile,significantly below, and brought the overall achievement 
above the 50th percentile in every school that we've been in. These are 
the same schools, the same kids, the same teachers, different 
instruction methods.
    There are schools where in the third grade every kid in the 
class is above the 75th percentile. And this is what this 
research has been able to accomplish, and it is ready for 
implementation on a far broader scale.
    Mr. Hoyer. I thank you. I know my time has expired, Mr. 
Chairman, but this is an extraordinary accomplishment. And the 
consequences of broader application of this to scale, that is, 
meeting the need that is out there, I think will have 
incredible returns for our society.
    Mr. Regula. What I'd like to do, as we get more members, 
once we finish the panel, is return to this, because I think 
this is extremely important information, and I'd like to have 
as many members as possible hear this facet of your testimony.
    Dr. Alexander. Delighted to do that, Mr. Chairman.
    Mr. Regula. And if you have a question, or maybe you'd 
rather defer until we come back to it, I don't know your time 
schedule. Go ahead. Will you be here when we come back to this 
testimony? Obviously you have a real interest in this. But 
that's your call.
    Mrs. Northup. I'll be glad to come back to it.
    Mr. Regula. Absolutely. And you'll have the first question. 
But just that part of your testimony I think is absolutely 
fascinating. We'll be back.
    Dr. Alexander. Thank you, Mr. Chairman.
    Dr. Kirschstein. We will move to the other end of the life 
span and we will be filling in with other facets later. So next 
is Dr. Richard Hodes, who is the Director of the National 
Institute on Aging.

                            OPENING REMARKS

    Dr. Hodes. Thank you, Mr. Chairman and members of the 
Committee. Thank you for this opportunity to appear before you 
at this theme hearing.

                            LIFE EXPECTANCY

    This Nation, in fact the entire world, is in the midst of a 
change in age profile that is unprecedented in the history of 
humanity. One hundred years ago, around 1900, the average life 
expectancy was about 49 years of age. Now it is approximately 
77. The concern that all of us share is that this extension in 
longevity not be accompanied by an increase in disability and 
disease. The basis for a good deal of the research supported at 
NIH is that we assure not only an extension of life in years, 
but a preservation or even improvement of life's quality.

                        LONGEVITY VS. DISABILITY

    The fact that increased life span does not carry with it an 
immutable sentence to increased disability has been 
demonstrated in research reported of late, and I'd like to 
first draw your attention to that. The figure demonstrated here 
is based on a national long term care survey, from 1982, which 
shows the number of Americans age 65 and over who were 
disabled. [Chart 1]
[GRAPHIC] [TIFF OMITTED] T4726A.171

    Since 1982, the number of individuals 65 and over in this 
country has increased substantially. The upper line, in blue, 
is the prediction of the number of Americans 65 and over who 
would be disabled if the rates calculated in 1982 had not 
changed but the numbers of older Americans had increased.
    In contrast, the line you see in red, the lower line, 
reflects the measurements of numbers of disabled Americans over 
the years. This reflects a continued, in fact, accelerating 
decrease in disability rates over this period, amounting at 
present to something in the area of 2 million fewer disabled 
Americans age 65 and older than would have been predicted if 
there had been no change in disability rates.
    This observation is heartening, and more importantly, 
perhaps, it creates for us now the challenge to understand what 
all the factors are that can be mobilized to assure the 
increase in acceleration of this so the quality of life is 
preserved from childhood into adulthood and into old age. In 
that respect, there are gratifying returns from research over 
the past year in several domains of science. For example, the 
most basic studies in genetics and molecular biology,have 
demonstrated now that genes in experimental animals are capable of 
extending life span, a healthy life span, to an even three-fold.
    In clinical studies of changes, in the cardiovascular 
system, it has been determined that changes in elasticity, 
stiffness and composition of the heart and vessels may be the 
prelude or precursors to disease which can occur later in life. 
By finding new points at which we can intervene, we can 
prevent, rather than be forced to treat after the fact, causes 
of disability.

                          ALZHEIMER'S DISEASE

    One of the major threats to independence and quality of 
life in older age is Alzheimer's disease. This is an area of 
research which is extremely important if we are to prevent an 
epidemic of this devastating disorder in years to come. The 
number of Americans currently afflicted is perhaps 4 million, 
and estimated to increase several fold if we do nothing to 
change this over the next decade, as the number of people at 
risk increases.
    However, progress in this area has been extraordinary. We 
have, for example, identified over the past year some of the 
genes that are capable of causing Alzheimer's disease in 
humans. The genes have been introduced into experimental mice, 
transgenic mice, genetically engineered to express these genes, 
providing for the first time an opportunity in experimental 
model systems to look at ways in which intervention is 
possible.
    And reflected here in this second slide, in the top left, 
is the brain of a mouse that expresses an Alzheimer's human 
gene. [Chart 2]
[GRAPHIC] [TIFF OMITTED] T4726A.172

    What's shown in brown is the staining for amyloid, the same 
material in the plaques, the lesions that characterize patients 
with Alzheimer's disease. This slide reflects the outcome of a 
recent experimental approach to actually immunize against the 
peptide that is responsible for these amyloid plaques. The 
immunization as shown in the bottom panel has indeed been 
effective in preventing or even treating and reducing after the 
fact the amount of amyloid deposit in these mice.
    Over the past months, these studies have been extended 
beyond just the pathology of the brain. In the bars to the 
left, you can see what is known about the ability of these mice 
to learn. Normal mice in the first bar learn very well. In the 
maze, for example, they make very few errors, the low bar 
reflecting few errors. The mice carrying the human Alzheimer's 
gene, in contrast, make a large number of errors. They never 
learn maze behavior well.
    The third bar in studies reported just in the past few 
months shows the outcome of treating these Alzheimer's model 
mice with the vaccine. As you can see, it shows an improvement 
in their ability to learn, paralleling the absence of lesions 
in the brain.
    Overall, these improvements in our understanding of 
knowledge that range from genetic studies to understanding of 
the environment and their application offer great promise to us 
and present a challenge for us in years to come to translate 
these basic facts, to continue their generation and to make a 
reality the hope to which we all aspire of quality of life 
throughout the life span.
    I thank you for the opportunity to speak with you and look 
forward to answering any questions that you might have.
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    Mr. Regula. Any questions at this point? We'll have another 
chance when we finish.

                            TRANSGENIC MICE

    Mr. Hoyer. Just to clarify, if I might, Mr. Chairman. The 
transgenic error rate, the transgenic plus AB vaccine, so you 
have reversed the inability to memorize?
    Dr. Hodes. Correct.
    Mr. Hoyer. So that on the left, in effect, the A and B are 
the same mouse?
    Dr. Hodes. Obviously, once you sacrifice a mouse to look at 
his brain, it's hard to go on treating it. [Laughter.]
    So they are a pair of mice, if you will. I'm not meaning to 
be facetious at all, but they can't----
    Mr. Hoyer. Therefore, this is not a picture, this is a 
slide.
    Dr. Hodes. It is a slide, that's right. So groups of mice 
in parallel are either treated or not treated.
    Mr. Hoyer. My brains are here now, and I shouldn't have 
made that mistake.
    But assuming that, okay, it is however a mouse with a 
similar brain pattern of A.
    Dr. Hodes. It's a genetically identical mouse.
    Mr. Hoyer. So you have reversed the malady, not simply 
prevented it.
    Dr. Hodes. That's right. Studies have done both. Miceare 
treated at an early stage in life, and they do not develop lesions. If 
mice are treated at a later stage, there is in fact a reversal of 
lesions.
    Mr. Hoyer. Thank you.
    Mr. Regula. Mrs. Northup.

                      ALZHEIMER'S DISEASE FUNDING

    Mrs. Northup. Doctor, we have increased the funding 
considerably to all of NIH over previous years. Can you give me 
an idea of how much the increase has been in the area of 
Alzheimer's?
    Dr. Hodes. The increase in Alzheimer's disease research, 
which now stands this year at an estimated $520.7 million has 
increased in proportion to the overall increase in the budget 
of NIA and of NIH.
    Mrs. Northup. Yesterday I had a group that came in from the 
Alzheimer's national organization, constituents from my 
district. And they had been, I guess, at morning meetings, and 
came in. Obviously, they'd like to double the research again, 
they'd like to get it up to $1 billion for Alzheimer's.
    But there were several statements that were made in the 
course of that meeting, one of them being that we know how to 
cure Alzheimer's, if we spent $1 billion, we would not have an 
Alzheimer's problem ever again in this country. Is that an 
accurate statement?
    Dr. Hodes. I wish that it were. Obviously we do not know 
with certainty how to treat Alzheimer's disease. I think what 
is true is that studies such as these and the results of other 
ongoing lines of research certainly have created more 
opportunities, providing a more promising prospect for a cure 
than has ever existed before. And that optimism, I think, is 
well founded.

                            CLINICAL TRIALS

    Mrs. Northup. More people working on it, but we do not know 
how to cure Alzheimer's. And if we wrote you a blank check for 
$1 billion next year, we would still have more cases diagnosed 
with Alzheimer's. I guess my concern is, who is disseminating 
that type of information? It's very effective, of course, to 
want more research in every area. You just happened to be the 
first person that came up. But it's been a series of these 
kinds of meetings, of groups that are being informed that we 
know how to cure these diseases, it's just, will we write the 
check today or not.
    And I just wondered if that is coming from you all or where 
you think that sort of message is coming from.
    Dr. Hodes. Yesterday morning at a hearing convened by 
Senators Specter and Harkin on the subject of Alzheimer's 
disease, we discussed at greater length many of the issues 
parallel to what we're talking about here. Certainly there was 
discussion of the trials which are in progress, those trials 
which have a firm scientific basis. But there was also great 
emphasis on the fact that indeed, the very reason for carrying 
out so many parallel trials is because we do not yet know which 
avenue is going to be successful.
    Mrs. Northup. Thank you.
    Mr. Regula. Ms. Pelosi?
    Ms. Pelosi. Mr. Chairman, I am going to follow your lead on 
this in terms of--do you want us to hold questions until later? 
I do have one quick question.

                            LIFE EXPECTANCY

    Mr. Regula. Okay, we're sort of mixing it up here.
    Ms. Pelosi. Doctor, I was thinking of our founding fathers 
here. They were Benjamin Franklin, Thomas Jefferson, John 
Adams, they all lived very long lives. I see this 49 years old 
as an average life span at the turn of the 19th century, into 
the 20th century. I have to think these had to be pretty 
remarkable people in every respect, they were living half again 
that long 100 years before.
    When we say average----
    Dr. Hodes. Your point is well taken. A single number, an 
average, is not sufficient to appreciate the full impact of 
what life expectancy means. So for example, in the 19th century 
and time preceding, many deaths occurred very early in life, 
and very severely reduced life expectancy. So the gains made up 
until the early 1900s, for example, were principally in life 
expectancy at early stages of life, which had a great impact on 
average.
    This century, in fact, for the first time, has seen a 
really substantial improvement in life expectancy in the latter 
portion of life span, so that now, for example, the probability 
of living longer, if one reaches the age of 40, 50, 60, 70 or 
80, is substantially greater than it was previously. And those 
are relatively novel advances in the history of the species.
    Ms. Pelosi. I'm pleased to yield to my colleague.
    Mr. Hoyer. I thank Ms. Pelosi for yielding.
    Dr. Hazeltine, whom I'm sure you know, spoke at the 
bipartisan retreat that we had. Ralph, I don't know whether you 
were there. But Dr. Hazeltine gave an opinion that, speaking to 
not necessarily people of my age, because my children are 
adults, and into their 30s. But to my younger colleagues, their 
children would have an average life expectancy of 100, and 
their grandchildren would have an average life expectancy of 
120. That was Dr. Hazeltine's opinion as to what the genetic 
and other medical research would allow in the future.
    I don't know whether you want to comment on that or not. We 
were all amazed. And obviously, the consequences for that for 
public policy are gargantuan and to some degree scary.
    Dr. Hodes. I think those predictions at the extreme are 
clearly quite controversial. But I think that statement 
shouldn't mask the fact that life expectancy continues to 
increase. For example, the number of Americans age 85 and 
older, at the turn of the last century, was 100,000. It was a 
very unusual event. And now, there's an estimate of 
approximately 4 million Americans age 85 and older.
    By 2050, that number is estimated to reach 19 or 20 
million. So that even under these relatively conservative 
estimates, the impact on society as you describe is going to be 
enormous. The distribution of age will be in a pattern that the 
species has never before experienced.
    Ms. Pelosi. Reclaiming my time, Mr. Chairman, for just one 
second. I just want to say one thing. As far as the Alzheimer's 
is concerned, would you infer from that that people will live 
maybe the same length of time, but they will live better? In 
other words, I don't know that everybody wants to live to be 
120, or even 100. But you would rather not have Alzheimer's in 
your later years.
    Dr. Hodes. Yes, I think for most people, the desire to live 
a long life is inextricably tied to the state of health.
    Mr. Regula. Okay. We're going to have to recess here. We 
have a suspension for the printing of documents regarding women 
in Congress. I assume a few of our colleagues want to vote on 
that.
    Here's what I want to do for a format, because we get 
caught up in these questions, and I can understand that. And we 
have another panel. So what I'll do, when we come back, we'll 
hear the rest of the panel, and then comments from youon that 
subject that you suggested about education, and then the first question 
will be Mrs. Northup, for what your comments are. Then we'll go to Mr. 
Sherwood and Mrs. Lowey. Then back to the rest of the members of the 
panel to just give everybody an equal chance to be heard.
    So we'll be back as quickly as possible.
    [Recess.]
    Mr. Regula. Okay, we'll resume. Dr. Kirschstein?
    Dr. Kirschstein. Mr. Chairman, the next two presenters are 
going to talk about activities that cross the life span. And 
the first is Dr. Patricia Grady, the Director of the National 
Institute of Nursing Research.

                            OPENING REMARKS

    Dr. Grady. Thank you, Dr. Kirschstein. Mr. Chairman, 
members of the Committee, it's a pleasure to be here this 
morning.
    The National Institute of Nursing Research supports 
clinical and basic science to provide a scientific basis for 
care. Our research addresses a broad range of life span issues, 
from low birth weight babies fighting for life to children and 
adolescents with risk factors for disease to the older people 
in our Nation who wish to extend the quality and quantity of 
their lives.
    This year, as NINR celebrates its 15th anniversary, it is 
encouraging to reflect on progress made so far. Let me provide 
three examples for you of studies across the life span.

                     PREVENTION OF LOW BIRTH WEIGHT

    The first of these relates to low birth weight. Clearly, a 
normal birth is an important first step to a healthy life. Yet 
the United States is a disappointing 26th among industrialized 
nations in the number of babies per 1,000 dying before their 
first birthday. Nurse investigators targeted low income, 
pregnant African American and Caucasian women at particular 
risk for low birth weight babies. They tested a program 
consisting of a home visit followed by low cost, low tech phone 
calls to monitor health and to address the problems of the 
women. The low birth weight rate dropped from 14 percent to 
10.9 percent in the study population. For African Americans 19 
years of age and older, the results were even better, down from 
17 to 11 percent. Cost savings to the hospital amounted to $277 
per pregnancy. This research intervention has been expended to 
include Hispanics, and the program is now in use in four 
locations across the country funded by private sector 
organizations, including a national HMO.

              PREVENTION OF ILLNESS AND MANAGING SYMPTOMS

    The second example reflects NINR's emphasis on preventing 
or managing illnesses that threaten the life span. Teens with 
diabetes have difficulty balancing diet and exercise to 
maintain proper blood sugar levels. Even when they know what to 
do, they don't always do it. Peer pressure is an important 
influence. A study in which researchers added coping skills 
training into an intensive diabetes therapy program shown on 
the poster in purple resulted in teens having consistently 
lower glucose levels than those receiving diabetes therapy 
alone. The coping skills training included strategy to deal 
with difficult daily situations for typical teens. Such 
decreases in blood sugar can prevent long term complications, 
including diabetic retinopathy and blindness.

                 EXTENDING QUALITY AND QUANTITY OF LIFE

    The third example is that of testing strategies to help the 
growing elderly population in our society live healthy, 
independent lives for as long as possible. Researchers have 
tested a traditional care model in older people hospitalized 
with common medical and surgical conditions. Using this model 
of following patients from the hospital to discharge to the 
home setting resulted in a 65 percent reduction in hospital 
stays, a 48 percent reduction in rehospitalization for 
complications, and a cost savings to the health care system of 
$600,000 for these 177 patients. This study is now being 
extended to address rural populations, for whom health care may 
be less accessible.

                            THE END OF LIFE

    Let me conclude by addressing the end of the life span. 
NINR is the coordinator at NIH for end of life and palliative 
care research, a relatively new area of study. Currently, we 
are funding research and training awards to study ethnic and 
cultural differences at the end of life, management of end of 
life symptoms and also decision making for advance directives.
    Mr. Chairman, I would be pleased to answer any questions 
you or the Committee members may have. Thank you.
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                        ENVIRONMENTAL EXPOSURES

    Mr. Regula. Okay, we'll go ahead with the panel.
    Dr. Kirschstein. The final speaker is Dr. Kenneth Olden, 
the Director of the National Institute of Environmental Health 
Sciences. The issue of the environment spans the whole life.
    Dr. Olden. Thank you.
    Mr. Chairman, I too am very grateful for the opportunity to 
appear before this Committee as part of the panel on life span. 
The environment can adversely influence every stage of human 
development from conception to death. As shown on my first 
exhibit, human illnesses are caused by genetics, environmental 
exposures and behavior as a function of age, stage of 
development and time of exposure. [Exhibit 1]
[GRAPHIC] [TIFF OMITTED] T4726A.186

    Behavior is not identified on the exhibit, because it is 
neither genetically predetermined nor acquired through the 
environment, though it is included in the definition.
    Typically, children and senior citizens are more 
susceptible to environmental exposures than a healthy 25 year-
old adult. The truth is, very few diseases are caused solely by 
genetics and very few diseases are caused solely by the 
environment. In fact, most diseases chronic--diseases such as 
cancer, Alzheimer's, Parkinson's, asthma, osteoporosis, and 
diabetes are caused by gene-environment interactions.
    The relationship between genes and the environment can be 
compared to that of a loaded gun. A loaded gun by itself causes 
no harm. It is only when the trigger is pulled that the 
potential for harm is initiated or released.
    Likewise, one can inherit a genetic predisposition to have 
a disease, but never, ever have the disease unless the 
environmental trigger is activated. Thus, to prevent most 
common diseases, such as the ones I mentioned earlier, will 
require an understanding of both the genetic and the 
environmental contributions to the development of these 
diseases.
    Now, to achieve this objective, NIEHS identified nine top 
priorities six years ago. Three of those priorities are shown 
in the next exhibit. [Exhibit 2]
[GRAPHIC] [TIFF OMITTED] T4726A.187

    The first is the identification of all the genes in the 
human genome that influence susceptibility to environmental 
exposures. It's called the Environmental Genome Project that 
I've discussed before this Committee in previous appearances.
    Second is the development of more efficient and informative 
approaches to identify environmental carcinogens and toxicants, 
also an issue that I've discussed here before, and lastly the 
development of direct measures to assess human exposure. Two 
weeks ago, the CDC released a report on exposure assessments 
that they had done. We were a part of initiating that effort 
four or five years ago by transferring about $3.5 million to 
CDC to initiate and develop the technologies to do this.
    Now, in summary, these and other investments will provide a 
solid, scientific foundation for disease prevention. I 
emphasize and underscore prevention. It will also revolutionize 
environmental health decision making, an important activity 
that this Congress has responsibility for.
    So I thank you, and I too would be very pleased to answer 
any questions that you may have.
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                   INTERACTION OF HEALTH ON EDUCATION

    Mr. Regula. Thank you. For the members of the Committee, 
we've asked Dr. Alexander to repeat a portion of his testimony 
which I found very fascinating, about the interaction of health 
on education. And then we'll start with questions in order, 
those who have come in. You two have had your shot until the 
second round. I haven't had any, so I'm being fair. [Laughter.]
    And we have another panel, so we need to move it, so they 
have adequate time also.
    So Dr. Alexander.
    Dr. Alexander. Thank you, Mr. Chairman.
    One of the developmental processes that the NICHD has 
studied over the years is the process of learning, both how 
children with normal ability learn and how children who have 
disabilities in this area learn. We have focused largely on how 
children learn to read.
    From that study, studies in the laboratory, we have learned 
what elements or what concepts have to be mastered by a child 
in order to learn to read successfully. We have learned how to 
teach those concepts successfully. We have learned how to 
screen and identify children before kindergarten age who are 
more likely to have difficulties in learning and mastering 
those concepts, and how to intervene successfully with them 
with extra help.
    In the classroom, the studies that we have done 
transferring the results from the laboratory to the classroom, 
we have demonstrated in schools around the country and in 
particular, here in the District of Columbia, that these 
techniques, when applied by regular classroom teachers in 
regular classroom settings, with the materials of instruction 
we have developed, are successful in markedly improving 
children's ability to master reading.
    Nationally, about 35 to 40 percent of children at the end 
of third grade read below grade level. We have done these 
intervention studies in some of the poorest schools, in some of 
the schools with the greatest difficulty, schools in poverty 
areas, where reading is extremely difficult for children. And 
in those schools our interventions have succeeded in decreasing 
that failure rate from 35 or 40 percent to 5 percent or below.
    In the intervention studies that we have done here in the 
District of Columbia, we have worked with nine schools with the 
intervention beginning in first grade working through third 
grade. We have had three control schools. All of these schools 
had achievement levels for children below the tenth percentile 
before we started. All of these schools now in the intervention 
classes have achievement levels above the 50th percentile by 
the end of third grade, and many of them are above 75th 
percentile. There are many classes where every child in the 
class is reading above the 75th percentile.
    Interestingly, the control schools have improved as well. 
We have had difficulty trying to figure out why the control 
schools have improved even better than other schools in the 
District. We finally found the answer. The teachers in the 
control schools were seeing how well the students in the 
intervention schools were learning. They went to the teachers 
in the intervention schools, found out what they were doing, 
went and bought with their own money the instructional 
materials that were being used in the intervention classes, 
used those in their schools and their levels have improved. Not 
as much as the intervention schools, but considerably above 
what the rest of the schools have been doing.
    So these methods work. We just completed a national reading 
panel that was established by the Congress and worked for about 
a year and a half reviewing all the research literature on 
reading. That panel concluded that the methodologies that we 
have developed from our research have been demonstrated to be 
effective not only in the laboratory but in the classroom, and 
are ready for scale-up, that is, implementation in the 
classroom on a wide basis. And they are ready to do that now.
    We are making some initial efforts in that transferprocess. 
We are also making efforts in our research, trying to work earlier, 
before kindergarten, with kids in a Head Start range of age, even early 
Head Start, to look at what components of a program in those stages 
work effectively to get kids to kindergarten more ready to learn than 
they are at the present time.
    So this is what the research is offering.
    Mr. Regula. I think that's dynamite information. Reading is 
where it is, Mrs. Northup.

                         DEVELOPMENTAL TESTING

    Mrs. Northup. Thank you. Thank you, Dr. Alexander. I have 
several questions. Let me start by saying that there is so much 
information that has been provided by NICHD over the years that 
I feel like has been largely missed by the education community. 
I feel like that in Washington, the Department of Education 
under Secretary Riley became more interested in that in the 
last couple of years. I'm eager to and hopeful that the new 
Department of Education will continue being even more engaged.
    At the beginning, there was almost no information at the 
Department of Education that we even did research. I thought 
that Secretary Riley did become very involved in that, in the 
last year or two. What I'd like to ask is, what we do about 
getting this to our own communities. In my community, every 
single thing that you talked about being important is not 
happening. And I don't think that it's so exceptional.
    Number one, when you test a child, in most communities, 
it's an enormous test, it's a several day test, it costs 
thousands of dollars. There are all sorts of authorities that 
are involved in it. So they delay investigating, doing this 
sort of testing, investigative testing, until almost third or 
fourth grade at the earliest. You're talking about a screening 
program for kindergartners. How much would it cost for every 
kindergartner, per child, to test kindergartners?
    Dr. Alexander. The tests that we have helped to support the 
development of are very simple, very cheap, easy to administer, 
they take about 20 minutes and are easy to score. The cost is 
probably less than $1 per child to administer and score these 
tests, and identify the ones who are most likely to have 
difficulties mastering the concepts for reading, really, 
prekindergarten, so that they can receive extra intervention, 
extra attention in the reading process, applying pretty much 
the same instructional methods, but with a more intensified 
approach. So they're really very cheap.
    Mrs. Northup. And you all, and NICHD is going to continue 
to make sure there's a sound research product going on, by 
testing whatever is proposed. One of the things that I've been 
so concerned about is, every single reading program or whatever 
is scientifically based, if you listen to the authors of it. 
And of course, sometimes that means market studies, sometimes 
it means how much the kids like the color pictures. It doesn't 
necessarily mean how well children learn to read.
    What I don't want is to create a new industry without 
knowing that we have the scientific basis for it. So will you 
all actually in your laboratories around the country be looking 
at these models, and identifying the ones that truly are 
research based?
    Dr. Alexander. We have done that to some extent already. I 
think we need to make a stronger effort with the developers of 
educational materials and the textbook publishers to really 
convey to them materials that are research based and tested by 
tried and true scientific methods, and not just based on 
consumer response research, so that we know the materials that 
are being marketed and put out there are effective and have 
been tested and are based on the science.

                        EARLY CHILDHOOD PROGRAMS

    Mrs. Northup. Last year, the Committee talked to you about 
more involvement with the early childhood programs 
specifically, family literacy programs and Head Start. The fact 
is, even with Head Start, kids are only at school a few hours a 
day. And a lot of children coming in at five years old not 
ready to read doesn't have to do with disability, it has to do 
with how much literacy has been wrapped around their life.
    And family literacy is one way to really significantly up 
the amount of literacy that surrounds the child. Yet I hear 
people say that they need more direction in early childhood, 
they need the actual books and, you know, a clearer idea of 
what works and how to convey that to families. Head Start 
programs that are dying to be more engaged with families, but 
need the research, need the information, say, this is an 
entirely new field.
    We asked you last year if you were moving in that 
direction. Have you been successful in that?
    Dr. Alexander. We're starting those efforts. The 
solicitation for that research is currently being prepared. It 
will be funded in fiscal 2002 on whatever scale we're able to 
do. Clearly, we need to know better than we do at the present 
time, in a scientifically tested way, how you can take children 
who are the Head Start age level and work with them in a Head 
Start kind of a program, transfer that to the home, so that we 
can improve the readiness of these children to learn once they 
reach kindergarten. That's the next research thrust for the 
Institute in this area.
    Mrs. Northup. Mr. Chairman, I know my time is up. Thank 
you.
    Mr. Regula. That's an absolutely fascinating subject. Mr. 
Sherwood.

                            READING PROGRAMS

    Mr. Sherwood. Well, Doctor, we're so interested in your 
testimony, but I need a little help on how you think we can 
transmit this through the system. I think that's what Mrs. 
Northup was talking about. You have made what I think are 
significant breakthroughs in the research. Do you have any 
suggestions for us on how we get the practical application?
    Dr. Alexander. There are a number of fronts we can approach 
this from. We're already working with the National Institute 
for Literacy on transferring to implementation the results of 
the panel, the National Reading Panel's conclusions about what 
works in terms of reading instruction.
    But we need to do more than that. We need to work at the 
level of teacher preparation in our teachers colleges and 
universities and what they are taught. Because much of what 
they're taught, frankly, is wrong. If they are taught at all 
how to teach children to read.
    Much of this information has not yet reached the 
instructional program in colleges and universities, and we need 
to make a major outreach effort in that. We also need to work 
in in-service training with teachers in terms of upgrading 
their skills, upgrading their knowledge of what works and what 
doesn't work in the classroom and making that kind of 
presentation.
    Dr. Reid Lyon, who is the head of our reading research 
program, has testified before 26 State legislatures about this 
reading research, and the results and itsimplications for 
education. So we have tried to do outreach at that level, but we have 
not really effectively gotten to the local level where these kinds of 
decisions are implemented, at the local school board level. And we need 
to do a more effective way of that.
    Finally, the reading panel recommended that we need to do 
more with individual parents. We have prepared materials, video 
tapes, short forms of the conclusions of the report for 
parents, so that they know what works effectively that they can 
do in implementing at home for helping children enter school 
ready to read and achieve once they're there.
    Mr. Sherwood. I would appreciate very much if you could 
forward to my office some of your work on that. Because I've 
put 20 years on a public school board, and these are the kinds 
of breakthroughs that we look for. My experience is that in the 
educational establishment, there is often some resistance, 
shall we say, to new ideas.
    Dr. Alexander. We have encountered that.
    Mr. Sherwood. I'd like to have this one in my arsenal. 
Thank you very much.
    Mr. Regula. Mrs. Lowey.
    Mrs. Lowey. Thank you very much, Mr. Chairman. I'll move on 
to another issue, although I too want to thank you for your 
report. What I have found in visiting so many schools, is that 
it's the leadership of the school that makes a difference. And 
they are open to assistance and help and in so many of my 
school districts, all the problems of the community converge on 
the school.
    Most people are average, including teachers. If they get 
this information and they get this training, I would say a 
great majority usually can make extraordinary progress. So I'm 
interested at some point in pursuing this. And together with 
Mrs. Northup, seeing how we can really expand this. I know the 
Chairman is interested as well.

               Research and Promotion of Healthy Changes

    But I want to go on to another area about which I continue 
to be frustrated. I believe Dr. Grady talked about the 
importance of early intervention and health and exercise. I 
think we've been talking about this, I've been here 12 years, 
but it goes back 50 years that we've been talking about this. I 
can remember just a whole range of programs that we worked on 
at the State level and the local level. And yet kids are still 
going around eating junk and not exercising and adults are 
getting fatter than ever.
    My question is could you elaborate on cooperative efforts 
between institutes to develop intervention and prevention 
programs. How can we do better, through CDC and the various 
institutes, in getting this out and changing behavior, rather 
than small steps here and there? In fact, I think that goes to 
so many things that we do. There are outstanding examples of 
excellence and the challenge for us here is how do you 
replicate these examples on a scale large enough so we're 
really making an impact on our population?
    Dr. Grady. Your point is well taken. We have been trying to 
deal with that ourselves across the campus. We have made some 
encouraging inroads, but it still takes the implementation at 
the State and local levels as well. We have several examples I 
can give you where that is beginning to happen. One of these is 
across the State of North Carolina, intervening with 
youngsters, school age children, who have risk factors for 
heart disease, to try to start early and prevent that.
    This study started at one local level in North Carolina, We 
worked with the National Heart, Lung and Blood Institute and 
implemented, using the guidelines from the American Heart 
Association and NHLBI to implement exercise and dietary 
modifications in these school age children, fourth to eighth 
grade levels. And we didn't just take the children out 
separately, since they don't like to be differentiated from the 
rest of the crowd at that age, but worked with all of the kids, 
integrated this into the curriculum of the school, so that the 
nurse researchers taught the teachers who then worked with the 
children.
    The results, we couldn't control what they ate, of course, 
although they got the information. But just adding regular 
exercise to their program, the results were so encouraging in 
terms of increasing their aerobic capacity, decreasing their 
cholesterol, increasing muscle mass, that the program spread 
throughout the State. One of the ways that Dr. Alexander 
mentioned earlier was used, in informing the other schools 
across the State and the legislative district, as to how the 
students were doing in their particular district or their 
particular schools compared to the norm of the State. This had 
the effect of spreading the program throughout the State. They 
are now working on trying to get this done nationally.
    Another example I can give you is one in which a researcher 
in California worked on what was a Spanish self-help 
questionnaire for women with arthritis. It turns out there were 
questionnaires and measurement tools, but only in English. So 
it was translated and tested in the Hispanic population, and 
validated and then used throughout that particular area of the 
State. It was very successful in terms of increasing mobility 
and in terms of decreasing pain by reports from these women. 
The Arthritis Foundation was so encouraged it adopted the 
program for the entire State of California and is working on 
getting it adopted across the country.
    There are other examples that I could give you. The example 
that I gave earlier of the telephone counseling for pregnant 
women to reduce low birth weight, that was a single, local 
study. But it was so encouraging that it then began to spread 
throughout the State. And now what I described to you is being 
supported by private sector funds and an HMO. The Federal 
funding ran out, but it was picked up because it was so 
effective.
    They are now working with fathers that are involved, 
whether they are spouses or not. And because it was very cost 
effective, it was able to spread. We hope it will spread 
further across the country.
    The last example, and this is one with adolescence as well, 
with the example I gave of the adding coping skills training to 
the teens with diabetes. We used the diabetes intensive 
therapy, the one from the recommendations of the Diabetes 
Complications Control Trial, a very large, multi-center trial 
which was run by the Diabetes, Digestive Disorders and Kidney 
Diseases Institute that you heard from earlier last week. By 
simply adding the coping skills training, the glucose levels 
decreased markedly.
    I am discussing a 12 month period of time. There was a six 
week training program, and then follow-up for up to a year. The 
children were monitored, but they didn't have additional 
training sessions unless there was a major problem. They are 
still being monitored, and the glucose levels are still within 
normalranges.
    Yale, New Haven has declared the diabetes coping skills 
program as a very important area, and it's spreading throughout 
the city and the State. I could give you more examples, but I 
would like to defer to my other colleagues on the panel. And I 
can give you anything else for the record that you might like.
    Mrs. Lowey. Mr. Chairman, I have a feeling, I'm not sure 
who the red light is for, but my time may be up----
    [Laughter.]
    Mrs. Lowey. I would hope, because I know our Chairman is 
very interested, if we could look at some of these programs and 
really figure out how we can replicate them on a scale large 
enough so that we can see an impact nationally. I know this is 
what is frustrating to so many of us. You see so many programs 
that are outstanding, and real changes, be it in health or 
education, they're all so connected. And yet we can't replicate 
them at a large enough scale.
    So I thank you for your indulgence, Mr. Chairman. I too 
want to thank the panel for your outstanding testimony.
    Mr. Regula. Next will be Mr. Jackson and then Mrs. Granger. 
Mr. Jackson.
    Mr. Jackson. Mr. Chairman, I have no questions.
    Mr. Regula. Mrs. Granger? Mr. Peterson?

                           Teachers Workshops

    Mr. Peterson. I thank you. Dr. Alexander, do you have 
materials that have been developed from your study that we 
could use to challenge our colleges and universities that are 
teaching our teachers?
    Dr. Alexander. Yes, we do.
    Mr. Peterson. Would you furnish those to us?
    Dr. Alexander. I'd be very happy to do that.
    Mr. Peterson. Do you also have materials that we can----
    Mr. Regula. Send all of us a copy.
    Mr. Peterson [continuing]. That we can challenge our 
schools? I have a few hundred in my district.
    Dr. Alexander. Yes, I'd be glad to do that. In fact, I've 
spoken directly to the dean of the college of education at Penn 
State about holding a teacher workshop in the summer, where we 
try to bring in teachers from around the State, and present 
these research findings and how it can be implemented in the 
classroom. And he's very interested in that, and we'll see if 
we can do it.

                            Health Behaviors

    Mr. Peterson. I'd like to challenge every university and 
every school, every elementary school principal and 
administrator, to take a hard look at these concepts, and at 
least make them react to it and think about some of it.
    I guess the other issue you talked about, health behaviors, 
we've never, we've had more information and data. But it's my 
view, and I was in the food business, and I know what people 
eat and I know what people do, it was a small town and I 
certainly watched a lot of people over my life live their live 
healthily or unhealthily.
    I think in the last decade we have gone backwards as far as 
health habits and health behaviors and people making the wrong 
choices at a young age, that are going to suffer for it the 
rest of their lives. I think our young people are just gambling 
with having a healthy life in many, many ways. How can you help 
us there?
    Dr. Alexander. Well, you're absolutely right, and putting 
your finger on a major problem. Eight of the ten leading causes 
of death in the United States are behavior related. Those 
health behaviors for the most part have their origins in 
childhood. That's the time when we should be most effective in 
trying to shape them for good.
    What we unfortunately don't know is how to do that most 
effectively. The research that has been done has often turned 
up with negative results. There was just a study published from 
California where they did interventions over a number of years 
in elementary school through high school, based on the best 
techniques we know, trying to get kids not to smoke. And by two 
years after high school graduation, smoking results were no 
different from the intervention schools than in the control 
schools.
    It's extremely frustrating that we don't have better 
information and knowledge how to intervene successfully. But 
because of the importance, we need to increase our investment 
and our efforts to learn what techniques work with kids at what 
ages most successfully to keep them from starting smoking, from 
engaging in other unhealthy behaviors, to keep weight under 
control, to have healthy nutritional habits and otherwise the 
health habits that are so important in what our health is going 
to be like as adults.

                             Youth Outreach

    Mr. Peterson. As the family structure has fractured, and 
young people don't have lives that, I mean, they don't have the 
habits and procedures that we had growing up, the routines, 
that's the word I'm looking for. Young people's lives are kind 
of unpatterned today, in my view. They're not thinking a lot 
about building for a future.
    I talk to a lot of young groups. Of course, they think 
they're going to be healthy, they think they can abuse their 
body in any way possible, they're just young, they're tough, 
they'll live forever. They have no idea of the risks they're 
taking. I guess I, being very interested in health issues, it's 
one that I just, I guess I'm most frustrated with, because at 
that young age is when you're going to make the difference in 
this country.
    I know at some point in time we were doing something on 
smoking and alcohol that kids were actually getting their 
parents to quit, or in alcohol, be more cautions, and tobacco, 
quit. There was a period of time there where young people were 
all helping their parents quit smoking. I don't hear that as 
much today. I don't know what we were doing then and what we're 
doing now. But for a while there, we had something that was 
working that children were having a positive impact on their 
families' health.
    Dr. Alexander. That's correct. And unfortunately, at the 
present time, the only group in which cigarette smoking is 
increasing is adolescent girls. Very frustrating. In spite of 
all the education efforts, in spite of what they know, the 
behavior is just the opposite. That's why we need to study and 
try to develop much more effective interventions than we have 
so far through research to try and counter these behaviors.
    Mr. Peterson. Thank you very much.
    Mr. Regula. Ms. DeLauro and then Mr. Hoyer.

                            Teacher Training

    Ms. DeLauro. Thank you very much, Mr. Chairman.
    Dr. Hodes, I saw you testifying before Senator Specter last 
night on C-SPAN. Thank you for the work that you're doing, 
particularly with the Alzheimer's issue. That was really 
terrific information. So thank you very much.
    I was going to ask some other questions, and I'm going to 
submit them for the record. I do want to talk about the reading 
issue, because I think it's critical. Dr. Alexander, I don't 
know, if you're doing any work in the State of Connecticut, 
where the GeneralAssembly in 1997, they talked about teaching 
teachers to teach reading. And out of that has come a program which I 
have worked with Mrs. Northup on and this Committee has provided some 
funds where there has been a collaborative effort with Yale Child 
Study, Haskins Lab, the State and locality, to train teachers in that 
balance between whole words and phonics and all that is involved in 
teaching children to read.
    Is that something that you're working with? And I have a 
follow-up question on the reading.
    Dr. Alexander. Yes, much of the information that I've 
reported and we've gathered has come from the Yale Reading 
Research Center headed by Bennett and Sally Shaywitz and from 
the Haskins Laboratories.
    Ms. DeLauro. Right.
    Dr. Alexander. They've been funded by us for a number of 
years, and have done absolutely outstanding work. And the 
longitudinal study that they have done at Yale has been a very 
important contributor to this.

                           EARLY INTERVENTION

    Ms. DeLauro. It was one of the most exciting presentations 
that I've ever seen, with classroom teachers and their 
excitement about how they are teaching, and the devices that 
they are bringing in to teach youngsters. And it's working. It 
is a great model. I actually was hoping that we could get some 
of those folks to come down, and the teachers particularly to 
come down and do a demonstration so we get some sense that 
there is a model in which we can move forward on.
    Given a hypothetical, because we don't have all the 
resources to do what we would like to do, but if every child 
could be part of a pre-K experience, Head Start experience, and 
you could deal with employing this kind of methodology that 
you're talking about, what do you view the outcomes would be, 
if we were willing to make those kinds of commitments to this 
issue?
    Dr. Alexander. Well, I think that the most likely outcome 
would be a much greater success in reading levels than we have 
at the present time. We don't know yet because we haven't 
really demonstrated it what the early intervention effects 
might be, that is, the pre-kindergarten. We think that we can 
do a more effective job in getting these children ready to 
learn once they hit school, but we haven't documented and 
demonstrated that yet.
    But we have demonstrated, and even with them coming to 
school as they are, as prepared as they are, that they do much 
better with these instructional methods than others. And these 
instructional methods don't cost more than the others. We're 
paying for unsuccessful, unproved methods. We ought to be 
paying to support successful methods, once they have been 
documented. And these have been documented, and they ought to 
be used and once they're in use, they won't be more expensive 
than what is being done now.

                          PREVENTION RESEARCH

    Ms. DeLauro. I think that gives us a little bit of 
direction in terms of some of the things that we ought to be 
thinking about with where resources might be placed, if we're 
concerned with further outcomes. We understand the difficulties 
that youngsters have if they can't read and what those outcomes 
are at a later time, which gets us into trying to deal with 
some band-aid solutions to the problems that children are.
    There was also a discussion on the smoking issue. We were 
down at the CDC a couple of days ago with the Chairman. They 
demonstrated that one of the leading causes of illness, serious 
illness, heart trouble, cancer, etc., comes from smoking. I've 
been particularly concerned about youngsters smoking. It is 
very troubling. The numbers are high in the State of 
Connecticut on young girls who begin to smoke.
    This research that you talked about, where is that properly 
placed? Who ought to be doing the research on how we deal with 
prevention with some of these issues?
    Dr. Alexander. Well, it needs to be done at a number of 
different levels. I think the failures that we've had from some 
of our large scale interventions indicate that we need to go 
back to the laboratory, back to very small scale studies, and 
look at what different types of approaches we might be using 
behaviorally with children before we start trying to scale up 
to very large studies. Those eventually are going to need to be 
done.
    But we don't know from a basic standpoint what are the most 
effective techniques to use for intervention with kids right 
now.
    Ms. DeLauro. Is that a proper role for the Federal 
Government to take on?
    Dr. Alexander. This clearly ought to be supported, I 
believe, yes.
    Dr. Kirschstein. Mr. Chairman, if I might intervene, the 
study that Dr. Alexander reported on was done under National 
Cancer Institute grants, and, because the data that came out 
were so unexpected, was presented to the entire senior staff of 
the Department of Health and Human Services, including the CDC. 
There is currently, I think, through Dr. Satcher, a 
reevaluation to see what might be done.
    Ms. DeLauro. Thank you very much. My time is up. Thank you 
very much, Mr. Chairman.
    Mr. Regula. Mr. Hoyer, you waive. Ms. Pelosi, you have one 
question.
    Ms. Pelosi. A comment, Mr. Chairman. I'm going to, in the 
interest of time, submit my questions for the record. But I 
just wanted to join you in thanking the panel and point out 
that, as I always do on the environmental health issue, this 
again is part of the thrust that we have had in this Committee, 
and Mr. Porter had a hearing last year, the first of its kind, 
really, and Dr. Olden testified at that time. It also relates 
to Dr. Alexander's Institute, and last year the bill urged you 
to establish a consortium of representatives from appropriate 
Federal agencies, CDC, EPA, NIH institutes, to plan and 
initiate pilot studies that will provide information necessary 
to develop and implement a national longitudinal study in 
environmental influences on children's health.
    You don't have to answer now, Dr. Alexander, that's one of 
the questions for the record.
    I just want to also reference what Dr. Olden said about the 
CDC report. This Committee in the past three or four years has 
increased from $7 million to nearly $47 million the funding for 
the CDC environmental health project, which also made that 
project possible. And in it, one of the findings was that the 
environmental health second hand smoking, environmental smoke, 
whatever the term of art is for it, had decreased four-fold 
because of measures to control second hand smoke. It was a very 
important finding. Many other important findings as well.
    All that is to say, Mr. Chairman, the environmental health 
issue is a very important one, and the work of all our 
Institutes here are important. In one way or another, 
environmental health plays into it. So thank you again, Mr. 
Chairman. I'll submit my questions for the record, as well as 
for Dr. Grady.

                            TEACHER TRAINING

    Mr. Regula. Thank you. I just want to ask all the members 
of the panel, let me use an example. Kent State does a lot of 
teacher training. Could we get somebody from your department to 
come out and talk to a group of teachers?
    Dr. Alexander. We do that all the time, yes, sir.
    Mr. Regula. How about on longevity? If you had a room full 
of 1,000 seniors, would you talk to them about some of the 
factors you mentioned?
    Dr. Kirschstein. Absolutely.
    Mr. Regula. This is good stuff. It ought to be spread 
across the country.
    Dr. Kirschstein. Mr. Chairman, when we're invited, we go. 
[Laughter.]
    Mrs. Northup. Mr. Chairman, I'd just like to give a case 
example. I actually invited several of the researchers to 
Louisville to speak to all the kindergarten through third grade 
teachers that wanted to come, and the University of Louisville 
School of Education. And they all came in. The teachers loved 
it. They loved it, they said, we need this, down deep, we've 
known this. There was a huge argument from the teachers at U of 
L. The instructors stood up and said, that's wrong, we don't 
want to do that, this fight ensued.
    And finally, the professors at U of L walked out, and the 
teachers who had mostly attended U of L said, they don't know, 
they haven't been in the classroom, they refused to look at the 
evidence. The teachers union in my district, I sort of engaged 
them in a field trip to go to Fort Lauderdale, where a number 
of the schools had adopted this. They have gone on record as 
voting to, this is the way they want reading taught in our 
schools.
    But I just want to prepare the panel for what might happen. 
[Laughter.]
    Mr. Regula. I think I'll take the chance.
    Well, thank all of you. This is great information. I wish 
all of America were listening in, and all of our colleagues.
    We'll now go to the next panel.
    [The following question was submitted to be answered for 
the record:]
[GRAPHIC] [TIFF OMITTED] T4726A.195

[GRAPHIC] [TIFF OMITTED] T4726A.196

                                          Wednesday, April 4, 2001.

                RESEARCH AND RESEARCH TRAINING PROGRAMS

                               WITNESSES

DR. RUTH KIRSCHSTEIN, ACTING DIRECTOR, NATIONAL INSTITUTES OF HEALTH
DR. JOHN RUFFIN, DIRECTOR, NATIONAL CENTER ON MINORITY HEALTH AND 
    HEALTH DISPARITIES
DR. VIVIAN PINN, DIRECTOR, OFFICE OF RESEARCH ON WOMEN'S HEALTH
DR. GERALD KEUSCH, DIRECTOR, FOGARTY INTERNATIONAL CENTER
DR. ANTHONY FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND 
    INFECTIOUS DISEASE
DR. FRANCIS COLLINS, DIRECTOR, NATIONAL HUMAN GENOME RESEARCH INSTITUTE
    Mr. Regula. Okay, we'll get started again. Dr. Kirschstein, 
you're in charge.
    Dr. Kirschstein. Mr. Chairman, the second panel this 
morning will discuss the research and research training 
programs, which, while of importance to all Americans regarding 
diseases and disorders and all populations, are of particular 
significance to special populations. It is expected that these 
efforts will lead to reductions in the health disparities 
between the various populations of the United states and the 
world, and increase longevity.
    I will not repeat what I have been saying that I could have 
other Institute directors here who would talk the same way, but 
we will start immediately. First, Dr. John Ruffin, who is 
making his first appearance as Director of the National Center 
for Minority Health and Health Disparities.

                            OPENING REMARKS

    Dr. Ruffin. Mr. Chairman and members of the Committee, I'm 
especially pleased to have this first opportunity to testify 
before you as the Director of the new National Center on 
Minority Health and Health Disparities. I'm also honored to 
appear on the panel with my distinguished colleagues and 
friends from the National Institutes of Health, Dr. Kirschstein 
and the Institute Center and Office directors who are here 
today.
    The Congress and Americans across the country have become 
increasingly aware that the health of minorities and other 
special populations has not benefitted from our Nation's 
progress and scientific discoveries, due to a wide range and 
variety of disparities in health outcomes attributable to race, 
ethnicity, gender, or lack of access to health care. It is 
clear that the American people are deeply concerned about these 
health inequities.
    A recent survey by Research America found that over 90 
percent of the American public advocates concerted research 
efforts to overcome these health disparities. We are fortunate 
that the Congress shares these concerns, and in its wisdom has 
created at the National Institute of Health the National Center 
on Minority Health and Health Disparities. This new center, 
established just 10 weeks ago, Mr. Chairman, represents a 
significant evolution of the former NIH Office of Research on 
Minority Health.
    Some have asked me about my vision for the new center. The 
key to this is embodied in what the creation of the center 
represents, as expressed by the Congress and the American 
people. The key is inclusion. Now we all sit at the table 
together as one. Now we have real opportunities to eliminate 
the disparities in health that afflict so many of our citizens.
    Our vision of the future is a collective one that is 
fundamentally linked to the development of the strategic plan 
for the center. The many partnerships we have developed 
willserve as the guiding force in preparing the elements of our plan. 
By working with the Health and Human Services Office of Minority 
Health, we have established working linkages with every State health 
agency. We already have enduring relationships with numerous other 
stakeholders, including research scientists, professional and 
scientific organizations, health care providers, consumer advocacy 
groups, academic institutions, educators, industry, and a multitude of 
leaders within special population groups.
    We have submitted a charter to establish an advisory 
council that will include a wide range of recognized experts in 
minority and other health disparities. We will ask these 
stakeholders to join with us as we develop the strategic plan 
for all of the center's activities.
    This level of inclusion also will aid in the development of 
targeted research, as well as the ultimate dissemination of our 
research findings across the country. We are fortunate that the 
Congress provided authority for the center to undertake a 
number of programs to assist in accomplishing the center's 
mission. In addition to funding investigator initiated grants, 
we will provide funding to institutions or consortia to develop 
centers of excellence in biomedical and behavioral research 
training for individuals from minority health disparity 
population or other health disparity populations. And we will 
fund endowments at centers of excellence to facilitate their 
research.
    We also will establish a national loan repayment program 
for health professionals who engage in minority health research 
or research into other health disparities.
    I'm pleased to inform you that we have developed a staffing 
structure for the center which includes three major divisions: 
the division of research, the division of scientific planning 
and policy analysis, and the division of community based 
research and outreach. I have accepted the position of Director 
of the new center with gratitude and humility. I'm thankful to 
have received the role to help shepherd our efforts toward the 
vision that we share. And I pledge to keep you informed of our 
progress.
    Having devoted the past 25 years of my life to improving 
the health status of minority populations, I bring my own 
energy and enthusiasm to pursue the many opportunities that lie 
ahead. I'm thankful to the Congress and the American people who 
had the wisdom and compassion to have our Nation embark on this 
noble endeavor.
    I'm also proud to join in these efforts with my colleagues 
at the National Institutes of Health, the world leader in 
biomedical and behavioral sciences. Now we have access to the 
great power, research expertise and resources of the NIH 
institutes and centers. And I appreciate the strong support 
that I have received at the NIH from every one of them. 
Together, we will accomplish our goal of making inclusion a 
reality, ensuring the health of all Americans.
    I appreciate the opportunity to address this Committee, Mr. 
Chairman, and I thank you for your attention.
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    Dr. Kirschstein. We will follow this by a presentation by 
Dr. Vivian Pinn, who is Director of the Office of Research on 
Women's Health.

                            OPENING REMARKS

    Dr. Pinn. Mr. Chairman and members of the Committee, I am 
honored to have this opportunity to tell you about women's 
health research at the NIH. The Office of Research on Women's 
Health was established in September 1990, as a focal point for 
women's health research at the NIH. We have enjoyed wonderful 
collaboration and support from all the institutes and centers 
at the NIH, and we collaborate with the institutes and centers, 
as well as with advocacy and scientific organizations who are 
among the more than 1,500 individuals that helped us develop 
our agenda for research on women's health for the 21st century, 
which is our current agenda and lays the road map for our 
current priorities and future priorities.
    Working closely with the institutes, we have supported 
research studies to define differences between the health of 
women and men. But because not all women are the same, we also 
support research to better understand factors that contribute 
to health disparities among diverse populations of women. Over 
the past decade, research has increasingly defined the effects 
of sex hormones on health, as well as the influences of 
genetic, environmental and behavioral factors. And I'd like to 
mention just a few examples.
    Now, studies are increasing our understanding of the sex 
differences in heart disease and better ways to prevent, detect 
and treat cardiovascular disease which is the leading cause of 
death for women. A project about which we are very excited is 
one that we are co-funding with the National Cancer Institute, 
which is one to test a vaccine against human papilloma virus, 
which is the major cause of cervical cancer. Such a vaccine 
could help prevent transmission of this sexually transmitted 
disease, and as a consequence also help to prevent cervical 
cancer.
    But we still face significant challenges in combating many 
other forms of cancer, including lung cancer, which is the 
leading cause of cancer death in women in the United States, 
and other gynecologic and other systemic cancers that affect 
women. Important research is underway to better understand why 
most autoimmune diseases, such as lupus and rheumatoid 
arthritis, disproportionately affect women. And I'd like to 
mention one example. I think you heard from Dr. Stephen Katz at 
NIAMS the other day about the strong collaboration that we have 
had with his institute, working together on so many projects 
related to women's health.
    One specific study that we are co-funding with NIAMS, and I 
think Dr. Ruffin's office also has supported, is a study called 
SELENA, Safety of Estrogen in Lupus Erythematosis National 
Assessment. This study represents one of the first studies to 
ever take a look at the safety and efficacy of the use of 
estrogen in both pre-menopausal and post-menopausal women who 
have lupus, a very important question that women have had for 
their physicians, and for which we have not had answers.
    Also, I'd like to point out that this study has been 
extremely successful in recruiting and retaining minority women 
in this study. We're also collaborating with NIDDK to support a 
number of studies to advance our understanding of diabetes in 
women and minorities, especially how to prevent cardiovascular 
disease in diabetic women.
    Menopause I have to mention because it is a subject of 
great importance to women, and of many questions for women and 
their physicians. Our office collaborates with many institutes 
to support studies such as the first study of the natural 
history of menopause, which we're funding with the National 
Institute of Aging, and that study is called the SWAN study, 
the Study of Woman Across the Nation, as well as other studies 
related to post-menopausal hormone therapy and prevention of 
conditions that lead to mortality and morbidity in the post-
menopausal woman.
    We have received much enthusiasm and a very enthusiastic 
response to a final program I'd like to mention to you, and 
it's a new program that our office initiated to facilitate 
mentored, interdisciplinary career development of researchers 
on women's health. We hear women ask for an end to 
fragmentation of their health care. We also hear from research 
centers about wanting to have collaboration between disciplines 
in research. So we developed, along with the support of nine 
institutes, especially the National Institute of Child Health 
and Human Development, and the Agency for Healthcare Research 
and Quality, we're delighted that this is really a cross-agency 
sponsored project also, a program we call BIRCWH, Building 
Interdisciplinary Research Careers in Women's Health.
    We have received much encouragement to expand this program, 
and that we are planning to do in the coming year because of 
the excitement over this opportunity for both mentoring and the 
development of new scientists who can work on women's health 
research. And new centers will be encouraged to focus on areas 
of high priority for women's health, including, for example, 
prevention of chronic diseases such as cardiovascular disease, 
addressing such factors as nutrition, hormones, exercise and 
obesity, or addressing sex and gender differences, as another 
example, in neuroendocrine, mood and anxiety disorders or 
mental health.
    With so many studies underway, the next decade can produce 
a wealth of additional scientific knowledge about the role of 
gender in health and disease, resulting in better prevention 
and treatment for women and members of their families. Thank 
you.
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    Mr. Regula. We have time for another one.
    Dr. Kirschstein. Mr. Chairman, the next speaker will be Dr. 
Gerald Keusch, the Director of the Fogarty International 
Center, who will talk about special populations throughout the 
world.

                            OPENING REMARKS

    Dr. Keusch. Mr. Regula and members of the Committee, it's a 
pleasure to appear before you on this panel on special 
populations and health disparities. In the brief time, and 
maybe getting briefer----
    [Laughter.]
    Dr. Keusch [continuing]. That I have, I'd like to make 
three points. First, today's themes are central to the work of 
the Fogarty International Center, the FIC. Through its 
international research and training programs, for example, on 
AIDS, FIC works to generate new knowledge and enhance capacity 
to reduce the burden of disease and early mortality in 
developing nations. The global reach of our activities is shown 
in the poster to your left.
    Including over 120 collaborating academic sites in the 
United States, a number, 28 to be exact, of the U.S. sites in 
17 States are part of a special program with Dr. Ruffin's 
center to nurture health sciences career development for U.S. 
minority students engaging in health disparity research, which 
involves over 150 students each year. We are also working with 
Dr. Pinn's office to enhance career paths forwomen scientists 
from developing countries and to address special issues for women's 
health.
    The second point, to ensure that science is applied to 
reducing the burden of disease globally, the center both 
innovates and adds value to other institutes and centers at the 
NIH. We currently collaborate with 16 institutes and centers, 
and three research offices at NIH, including those of the four 
directors here today.
    Research to improve health translates into better, more 
productive lives, more stable governments and economic 
development. Consequently, FIC's efforts promote our national 
vision of a healthy and sustainable world. An innovative new 
program on health and economic development being announced just 
today will allow multidisciplinary research groups to study the 
relationships between improvements in health, productivity and 
economic growth, encouraging collaborations between ministers 
of finance and health to make new investments in health and 
health research as we do in this country.
    Third, Fogarty International Center programs to train 
researchers in resource-poor nations, as shown in the second of 
the exhibits, benefits the United States as well. Recent 
studies in Uganda supported by Dr. Fauci's institute 
demonstrating the striking effectiveness of a simple drug 
regimen to reduce mother to infant transmission of the AIDS 
virus relied on collaborations with Ugandan scientists trained 
by Fogarty programs. These data from Africa support the use of 
the new regimen in the United States, and is now being applied 
in Uganda and elsewhere in sub-Saharan Africa.
    The child shown in the poster has cerebral malaria, the 
most deadly manifestation of this reemerging infection. 
Indicative of the Fogarty International Center's global 
leadership, the center is the secretariat for the multilateral 
initiative on malaria, a global effort to increase research 
efforts on malaria in Africa, while building research capacity 
among African scientists to enable them to effectively address 
their own health problems in the short term as well as in the 
long term.
    A program we are planning for the near future will link the 
Fogarty with Dr. Collins' Genome Institute. The revolution in 
sequencing the human genome he will discuss, and unraveling the 
secrets of many infectious agents at the gene level will have 
major impacts on our fight to combat disease. To ensure that 
this revolution does not bypass the developing world, we will 
embark on a research and training program in genetics and 
genomics, together with our NIH partners in our ongoing and 
future programs to build bioethics capacity, to enhance 
informatics capabilities and to create the expertise needed to 
conduct clinical trials in the partner countries are essential 
to this goal.
    There is so much to say, and so much to do. And as I said, 
so often so little time for me today to discuss the 
international aspects of today's themes and for those 
threatened every day by ill health and preventable premature 
death around the world. I'll be happy to answer any questions 
you would have, and thank you for your attention and interest.
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    Mr. Regula. Dr. Collins, we'll try to get yours in before 
we go. Oh, Dr. Fauci or whomever. All right.
    Dr. Kirschstein. Dr. Anthony Fauci, the director of the 
National Institute of Allergy and Infectious Disease.
    Mr. Regula. If you can truncate it a little bit, it would 
be helpful.
    What we have for the members is a vote on the rule on the 
tax bill, and then a five minute vote on the suspension on the 
Chesapeake.

                            OPENING REMARKS

    Dr. Fauci. Mr. Chairman, members of the Committee, I am 
going to refer you to some visuals I have on the side and spend 
my two and a half minutes or so discussing the mechanisms by 
which the NIAID has addressed health disparities. As you can 
see from this poster, which is the face sheet of our Strategic 
Plan for Addressing Health Disparities, which is available to 
you on the table behind you, you will see that there are a 
number of diseases, infectious and immunologically mediated, 
that are particularly relevant to the issue of health 
disparities. Because of time, I will only address two of these, 
HIV/AIDS and asthma.
    With regard to HIV/AIDS, the disparate prevalence of 
disease among blacks and Hispanics with whites in this country 
is a matter of grave concern. As you can see on the left hand 
side, when you look at rate per 100,000 population,there are 
almost 10 times as many blacks as whites who are now AIDS cases, and 
about 4 times as many more Hispanics as Whites. That is within a 
population in which only 12 percent of the population is African-
American.
    What are we doing to address that? We have a series of 
programs, only one of which I will mention, which is a network 
of clinical trials units, as well as community units throughout 
the Nation. We have made over the past several years a 
stipulation of the funding of these units that they present a 
plan and/or track record of how they have accrued minorities 
into their programs.
    Because of that, we've gone from an initial few percent of 
African-Americans in our trials over a decade ago to the 
situation now, when more than 40 percent of our accrued 
individuals in these trials are African-American.
    Next we have asthma. Asthma again is another extraordinary 
example of disparity among ethnic groups. You see on the left-
side of the poster deaths due to asthma and on the right 
hospitalizations due to asthma. There clearly is a striking 
disparity between African-Americans and whites. These issues 
have been addressed in our Inner City Asthma Program, most 
recently in collaboration with the CDC.
    This has been a highly successful program which has focused 
on asthma management, particularly symptom control, behavioral 
modification and self-medication. The results have been 
striking. The number of symptom days have dramatically 
decreased, as have the number of hospital days, predominantly 
among inner city minority children.
    And then finally, the last issue is that of vaccination. 
The best and most efficient way to eliminate health disparities 
is to eliminate the disease that is disparate among ethnic 
groups. This is an example of one vaccine program that has been 
highly successful. There is a disease that is disparate among 
minorities; it is caused by the microbe Haemophilos influenza 
type B, which is the leading cause of mental retardation and 
deafness in children, particularly minority children. By 
administration of a vaccine developed at the NIH through a 
collaboration among a number of institutes, including our own, 
this disease has been essentially eliminated in this country.
    We are going to continue to use the vaccine program 
directed at a number of other diseases as a major weapon 
against health disparities. I'd be happy to answer any 
questions, Mr. Chairman.
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    Mr. Regula. Thank you. Very thought provoking.
    We'll recess, come back as quickly as possible, and finish 
the panel, then we'll got to questions.
    [Recess.]
    Mr. Regula. Okay, we'll resume the hearing.
    Dr. Kirschstein. And lastly, Dr. Francis Collins, Director 
of the National Human Genome Research Institute, will make his 
presentation.
    Mr. Regula. Thank you.

                              ORAL REMARKS

    Dr. Collins. Thank you, Mr. Chairman, for the opportunity 
to be here today to discuss progress and plans of the National 
Human Genome Research Institute and the relevance of research 
on the human genome to our theme today of health disparities in 
special populations.
    A dozen years ago, a young American physician stood in the 
midst of a crowded medical ward in a rural hospital in West 
Africa. Serving there for the first time as a volunteer 
missionary doctor, he was prepared to see many cases of 
tuberculosis, malaria and sleeping sickness. And those were 
indeed common.
    But to his surprise, many of the beds were filled with men 
and women suffering from a disease that he had considered more 
western than West African diabetes. I'll return shortly to this 
West African story.

                      SEQUENCING THE HUMAN GENOME

    Well, much has happened in the last 12 years. Just six 
weeks ago an international consortium, that I've had the 
privilege to lead, published the initial analysis of the human 
book of life in the journal Nature. You see the cover of that 
here on this poster, and you have a copy of those articles at 
your place.
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    There's also a CD-ROM at your place containing the actual 
sequence of the human genome, our own DNA biological 
instruction book. On this iridescent disk are the 3.1 billion 
letters of the human DNA code.
    Yet we've learned that this instruction book is actually at 
least three books. It's a history book, a narrative of the 
journal of our species through time. It's a shop manual, a 
detailed guide to the intricacies of human design, known 
previously to God, but never before to humankind. It's a 
transformative textbook of medicine, with insights that will 
give health care providers ever greater power to treat, prevent 
and cure disease.

                             EDUCATION KIT

    Along with the publication of the human sequence, which has 
been made freely available to all on the world wide web, we've 
also produced an education kit which has been distributed to 
you. The kit should assist in the important process of public 
education about the human genome project and its significance 
for medicine and society. This kit is designed for use in high 
school biology classes but will find use in many other 
settings. The video it contains is available in both English 
and Spanish.

                VARIATIONS IN THE HUMAN GENOME SEQUENCE

    Why do some populations suffer disproportionately from 
certain illnesses? Why is heart disease more common in Finns 
than Japanese? Why does prostate cancer occur at higher 
frequency and with greater severity in African Americans than 
in northern Europeans? One must not leap to the conclusion that 
this is necessarily genetic, since environmental, socioeconomic 
and cultural factors may play a major role in such disparities.
    But to unravel these mysteries, it is crucial that research 
involving special populations moves forward swiftly and with 
their full participation. It is a very high priority for the 
National Human Genome Research Institute to study variations in 
the human genome sequence, that 0.1 percent of the genome that 
differs from one of us to the next, and to discern the role 
these differences play in health and disease in all 
populations.

                      WEST AFRICAN DIABETES STUDY

    In one example of a specific approach to a common illness, 
we have developed an exciting partnership with Howard 
University here in Washington, DC to study the genetic 
contributions to diabetes. We know that Type II diabetes is 
about twice as common in African Americans as it is in 
Caucasians. We also know that lifestyle factors, such as diet, 
play a significant role in this disease. Careful consideration 
leads to the conclusion that one might have the greatest 
likelihood of identifying the hereditary factors in a less-
diabetes promoting environment.
    This brings us back to the opening vignette: why not study 
diabetes in the founding population of African Americans, where 
the diet is less diabetogenic? With support from Dr. John 
Ruffin and the National Center for Minority Health and Health 
Disparities, that's exactly what we are now doing in Ghana and 
Nigeria.
    I'm enormously excited about the promise of this research 
project. You see, the American part-time missionary doctor in 
the opening scene was me. Twelve years ago, the tools to 
unravel the mysteries of hereditary factors in diabetes didn't 
exist. Now I find it enormously gratifying that this 
frustrating puzzle can be addressed, and ultimately solved, 
thanks to the empowering public data bases and technologies 
provided by the human genome project and supported by this 
Committee and this Congress.
    We still have much to do. We're essentially at the end of 
the beginning of genomics, and the real work to apply this to 
an understanding of disease lies mostly ahead. Yet I am 
convinced that the advances in understanding of health and 
disease that arise from the human genome project are the 
greatest hope that we have seen in decades for the prevention 
and cure of human illness in all populations.
    Thank you, and I'll be glad to answer your questions.
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    Mr. Regula. Thank you.

                     GENETIC IMPLICATIONS OF ASTHMA

    Asthma, is that genetic, or is it environmental? There 
seems to a growing incidence of asthmatic problems.
    Dr. Fauci. If you look at this side of the table, you have 
it all. It is part genetic. It is certainly part environmental, 
and it also is in response to certain infectious diseases where 
the airways become hyperactive in response to the microbe. So 
it involves so many interdigitating issues that you've heard 
this morning, including the one that you mentioned, i.e. 
genetic.
    Dr. Collins. There in fact are a number of studies underway 
looking specifically for genes that may contribute to the risk 
of asthma. A couple of those have reached exciting junctures. 
There's a gene on chromosome 5 that seems to confer such a 
risk. There is apparently a very interesting gene that's been 
uncovered by studying populations in an isolated island called 
Tristan da Cunha, where asthma is extremely frequent. A company 
that has been studying that entire population has uncovered a 
gene that they think may play a role in that, although that 
information is not yet public.

                  GENETIC INFORMATION TO FIGHT DISEASE

    Mr. Regula. Okay, once you know that, what do you do about 
it? Because we've got our genes, we're born with them.
    Dr. Collins. Very good question, Mr. Chairman, how does 
this help us? Well, it helps us in several ways. By discovering 
a gene that contributes to asthma risk, we shine a bright light 
on the cause of the illness that we've never had available to 
us before. It opens up the pathway that must be involved in 
triggering this illness. For many illnesses, including asthma, 
we don't currently have that kind of very fundamental molecular 
information about how the disease comes about.
    This is why every drug company has a genomics division. 
This is why a company studying Tristan Da Cunha paid for it out 
of private funds, because they believe by discovering that 
asthma susceptibility gene, they'll be able to design a drug 
that goes right to the heart of the matter, instead of treating 
some secondary symptom.
    This is our best and brightest hope for a transformation of 
therapeutic medicine into a new generation of approaches that 
go right to the nugget of the difficulty.
    Mr. Regula. Would you say that having genetic knowledge as 
a result of the genome project, that drugs can be formulated 
that will be more effective because they have this base of 
understanding?
    Dr. Collins. Yes, absolutely. There are already some 
examples of that emerging, although genomics is still a young 
field. There will be later on this week some additional 
publications, very exciting ones, about a new drug that's been 
designed for the treatment of leukemia, a drug which is based 
upon a precise molecular understanding of what the problem is 
in this particular type of adult leukemia called CML.
    That drug, called Glivec, designed by investigators at 
Novartis, basically blocks the action of the abnormal protein 
that's made in these malignant white cells. In the first 32 
patients that were given this drug in a phase one trial, 31 of 
them went into remission, an unheard-of result in an early 
stage of a drug evaluation.
    Mr. Regula. That's a cancer situation?
    Dr. Collins. That's a cancer situation. But cancer comes 
about, a malignancy comes about because of a genetic alteration 
in those cells. It's the same principle.
    Another example, there's a drug under development by Glaxo 
SmithKline to lower the risk of heart disease, which is also 
based on a genomic discovery of one of the factors that plays a 
role in risks of heart disease. They've come up with a small 
molecule drug that seems capable of reducing that. This drug is 
still early in clinical trials, but showing one of the greater 
promises that's come along for quite a while for heart diseases 
and based on understanding the genetic contributions to heart 
diseases.
    Mr. Regula. When we were out there, there was a young woman 
who had a remission of ovarian cancer. Exactly what did you use 
to cause that to happen? That was therapy?
    Dr. Kirschstein. Yes, that was therapy. It was 
animmunotherapy that Dr. Steve Rosenberg had developed. But again, it's 
probably related to the genetics of those particular ovarian cells. 
They may not have been inherited as such, but the cells may have been 
altered by some change that caused them to turn malignant.
    Mr. Regula. As I recall, the vaccine, if that's the right 
word, that you used to gain an immunity was created with her 
genetic code or----
    Dr. Kirschstein. That's right. They took her ovarian cancer 
cells and made a vaccine against them, and then treated that 
woman who had cancer that spread through the body with this 
``vaccine'' against the very cells that had become malignant.
    Mr. Regula. The vaccine was made from the cancer cells of 
the individual?
    Dr. Kirschstein. Yes. Yes.
    Dr. Fauci. One might ask the logical question, if the 
body's immune system is going to be responding to the cancer, 
why didn't it originally get rid of the cancer?
    Mr. Regula. It bypassed it.
    Dr. Fauci. Exactly. What happens is that when you present 
the particular, specific tumor antigen to the body, you present 
it in a way that makes the immune system respond in a much more 
vigorous way against that particular protein, while the natural 
response would never be powerful enough to catch up with the 
tumor.
    Mr. Regula. So that vaccine, made from that woman's cancer 
cells, becomes powerful enough that her own immune system will 
then kick in?
    Dr. Kirschstein. That's right.
    Dr. Fauci. Correct.
    Dr. Kirschstein. And that's the tailoring, again, to her 
own cells. Not all ovarian cancers, but her own cells.
    Mr. Regula. To make this widely used, you would have to 
have some additional research, I assume, because that may not 
work for every situation.
    Dr. Fauci. Immunotherapy of cancer, although there have 
been major advances, in some respects is still in its infancy. 
It's potential in understanding the specifics of the immune 
response cross-cuts a number of disciplines that many of us are 
responsible for, including the fundamental genetic capability 
for the immune system to respond to certain antigens whereas 
the immune system of another person, genetically a little bit 
different, cannot respond as well.
    When we understand that, that will be yet again another 
door that we went through in that long hallway of mysteries 
that we're trying to unravel.
    Mr. Regula. Mr. Sherwood.

                      GENETICS AND THE ENVIRONMENT

    Mr. Sherwood. Thank you, Mr. Chairman.
    It appears to me that in our commercial raising of animals 
for food that we have virtually eliminated a lot of the 
diseases that used to decimate our herds. We've done that 
through feed. Now, it's interesting to me that earlier today, 
Dr. Olden said that he set aside our behavioral aspect, because 
he said it's either all genetic or environmental. I wanted to 
question him on that, because that was pretty hard for me to 
understand.
    So I'd like a little comment from you folks. With this new 
understanding of how we're constructed and what goes wrong, 
what is the word that we put out to the public that everyone 
can help themselves through their diet and their behavior?
    Dr. Collins. I think that is a great question. I think the 
excitement about genetics in medical research is palpable. 
Every disease is now being approached and looked at through 
this lens, because of the ability that it offers you to 
understand at the molecular level the pathway that has gone 
awry.
    But we have to be careful about not overstating the 
significance of that in terms of its quantitative contribution 
to disease. Most diseases, like diabetes or heart disease or 
mental illness or asthma or multiple sclerosis, are a mix of 
genetic susceptibilities and environmental factors. And 
certainly when you come to human behavior, the same could be 
said. We have hereditary factors in personality, and we have 
things that happen to us as we're growing up that may also play 
a significant role.
    But let us also point out that there is something called 
free will, which hasn't gone out of fashion just because we've 
sequenced the human genome, I'm glad to report. So it's a very 
complicated mix of factors.
    So how does this play into how we advise people to maintain 
health? The genes that we've inherited, at least at the moment, 
are not things that we can change. You have a certain set of 
cards. They've been dealt. But how you play the hand is more 
within your control. And that's where the ability to practice 
healthy lifestyles kicks in.
    What we are getting to fairly soon in the next five or ten 
years is the ability for each of us to find out, by the 
analysis of our DNA, what our individual risks may be for 
particular future illnesses. This will allow a preventive 
medicine approach to be individualized, instead of telling 
everybody to do the same thing, which is now often what we are 
forced to do because we don't have any more personal 
information about folks. Obviously that raises many questions 
about who has access to that information and how do we prevent 
its misuse. We could talk for quite a long time about that.
    But its value in terms of practicing really effective 
preventive medicine where you empower the individual to do the 
things that are going to be most beneficial for their health, 
is really very compelling and is not that far off.
    Dr. Kirschstein. Mr. Sherwood, I'm sorry Dr. Olden is still 
not here. I'm sure he did not mean to imply that there was no 
place for behavioral research. He was going to concentrate on 
those two aspects of things. But behavior means learning how to 
handle the environmental situation as well as the genetic 
situation in which someone is placed. And we know that much of 
our prevention research must be concentrated on changing 
individual behaviors. We talked about that in the panel 
regarding smoking, for example.
    Mr. Sherwood. One of the panels a couple of days ago were 
talking about teeth and the effect of your teeth on your 
general health, and how in low income portions of society it 
was a very, very severe problem. But I was in Africa a while 
ago and we had the very distinct pleasure of being guided by 
some Zulu tribesmen who had grown up in a very rudimentary 
society. And they all had the most beautiful, bright white 
teeth. They had never lost them, these men were in their 40s, 
they'd never lost a tooth and they were in wonderful shape.
    So it led me to believe that they were either genetically 
predisposed or their diet was such that--either way, there was 
something we could learn from these Zulu tribesmen aboutdental 
health.
    Dr. Fauci. Or both.
    Mr. Sherwood. Or both. Thank you. Any comments?
    Dr. Collins. I think you have proposed an interesting 
research study. [Laughter.]
    Mr. Regula. Mr. Jackson.
    Mr. Jackson. Mr. Chairman, I have five questions, two of 
which I would like to submit for the record. If it's possible, 
I'd like to just read my questions and get the response all at 
one time.
    Dr. Ruffin, thank you for your leadership as the new 
Director of the National Center for Minority Health and Health 
Disparities. As you know, I was pleased to work with Senators 
Frist and Kennedy and former Secretary Dr. Sullivan and the 
minority health community to pass the legislation that elevated 
the Office of Research on Minority Health to a center last 
year.
    Based on last year's debate, it was clear to me that in 
addition to supporting research aimed at reducing health status 
disparities, a central goal of the new center was to support 
those research institutions which have a historic mission of 
serving the under-served and conducting health disparities 
research. Recognizing the important role these institutions 
play in our health care system, last year's legislation 
contained a number of mechanisms aimed at supporting their 
continued development as leaders in biomedical research.
    I am referring specifically to the research endowment 
program and the Centers for Excellence initiative. Dr. Ruffin, 
I'd be interested in knowing what the status of these important 
initiatives are, when we can expect the center to move forward 
in establishing these programs.
    Secondly, Dr. Ruffin, one of the main reasons Congress 
elevated the Office of Research on Minority Health to a 
national center was to provide the center with direct grant 
making authority. I hope that you can share with the Committee 
how you're using this new authority to benefit health 
disparities research.
    And my last question for Dr. Ruffin and Dr. Kirschstein, it 
appears to me that you're making significant progress in 
implementing the new programs at the new national center. And 
for that you're to be congratulated and commended. As Dr. 
Kirschstein knows, I am convinced that this new center can be a 
meaningful mechanism to provide infrastructure support, such as 
research endowments to those health professions institutions 
which have a mission to serve the needs of the minority 
community but do not have the public or private resources to 
compete on a level playing field.
    In terms of physical infrastructure development for 
minority institutions, I know that the National Center for 
Research Resources has several peer reviewed programs which 
have a strong history of supporting the research facility needs 
of these schools, including research centers at minority 
institutions programs as well as extramural facility 
construction programs.
    I guess I'm asking, with the new center, is it possible to 
consolidate the efforts of the National Resources Center with 
the efforts of this center in their efforts to create in many 
of these schools that focus on the disparities, the kind of 
facilities necessary to advance biomedical research?
    Thank you very much, Mr. Chairman.
    Dr. Ruffin. Let me start by clumping a couple of things 
together. For example, the grant making capabilities of the new 
center, as well as where we are, for example, with the research 
endowment. The reason I'd like to put those two together first 
is because one of the statements I made early on, Mr. Chairman, 
is that we are the new guy on the block here. The center is 
about 10 weeks old, and there are some operational things that 
must be put in place first.
    This is a real opportunity that the Congress has presented 
to us as well as a challenge. What we at NIH would like to do 
is, we would like to make sure that this time we get it right. 
One of the ways of getting it right is to make sure that we 
design a blueprint that we can all follow, you here at the 
Congress as well as those of us at the National Institutes of 
Health.
    So we've been working very, very hard to put in place the 
strategic plan that you've heard us talk about. This is a plan 
that involves all the institutes and centers at NIH. Congress, 
when the bill was formulated, indicated to us that we had one 
year after the enactment of the bill to put the strategic plan 
together.
    All of these elements that you've just mentioned, the 
centers of excellence, the loan repayment program, the research 
endowments, it's all a part of that strategic plan, which means 
that we are now getting advice from not only the stakeholders 
at the National Institutes of Health, all of the institutes and 
centers, but we're getting advice from all of our stakeholders 
around the country, individuals from rural areas around the 
country, academia, industry, all of the different stakeholders 
that I mentioned in my opening statement are now sending advice 
to us to be incorporated into the strategic plan as to just how 
we ought to implement the centers of excellence, the endowment 
program, the loan repayment program.
    So in that order, what we would like to do is to make sure 
we get the strategic plan first and get it right. The reason I 
put the grant making capability with that is that that too 
needs to follow a pattern. We have to put the right 
organizational structure into the center, which also means 
hiring. It means hiring grants management people to come into 
the center to help us, because we were in fact an office. Now 
we have to beef that office up to center status. And it 
requires that we have the right personnel within the center to 
make sure that that happens and that that happens right.
    So we're in the process of doing that. But at the same 
time, the ideas are beginning to come in. We have some notion, 
for example, of how we ought to implement some of these things 
when we're ready to launch them. So I can go into more detail 
about how we plan to do it, but I wanted to make sure that you 
understood the directions that we would like to follow first. 
We want to make sure that all of you have an opportunity for 
input into that strategic plan, so that we get it right.
    Dr. Kirschstein. In regards to the infrastructure, we are 
deeply aware of the fact that the infrastructure possibilities 
need to be beefed up very substantially within the historically 
black colleges and universities, as well as within the 
institutions that primarily serve the Hispanic populations, and 
particularly, for example, in the tribal colleges.
    The National Center for Research Resources has a large 
construction program. One of the limiting factors in thepast 
has been that none of these schools could meet some of the 
requirements, part of which was the matching situation related to the 
funds for construction. We are able to, and NCRR is beginning to waive 
those matching funds, so that we can make specific awards to those 
institutions and they will be doing so.
    Now, in terms of Dr. Ruffin's ability to work with the 
center, he already worked with the National Center for Research 
Resources. He has worked for years as have many of us with the 
people in the Center for Research Resources, including Dr. 
Vaitukaitus, the director. And somewhere in the course of his 
decision making related to the strategic plan, he may determine 
that even above and beyond the funds that she has the ability 
to put into certain activities, he may want to add money, and 
it can be a co-joined program.
    I will encourage that every way I can.
    Mr. Jackson. Thank you.
    Mr. Regula. Thank you.
    Well, it's late lunch time. We could be here all afternoon 
with questions, both this panel and the other one. But it's 
been a very productive morning, and I appreciate all of your 
being here. Perhaps as time permits we will do some oversight 
hearings.
    And one last request, Dr. Collins, I've been talking to 
staff about using that blank wall back there. I'd like to have 
that poster for a starter. Do you think we could arrange that?
    Dr. Collins. Mr. Chairman, that would be absolutely 
wonderful. What a great suggestion. We'd be delighted to donate 
this, or even a bigger version if you'd like. [Laughter.]
    Dr. Kirschstein. Mr. Chairman, the next time you come to 
visit, we should show you the posters that all of the 
institutes have for many of their programs, which are done by 
our outstanding art department. We would be pleased to have you 
select among them, to put a series of poster up on your wall if 
you'd like.
    Mr. Regula. You have more than one salted peanut here this 
morning. [Laughter.]
    Well, as a matter of fact, we're going to schedule a trip 
out there very shortly, because we have some new members that 
have not had an opportunity. I'm going to try to get all the 
members to come back. But I certainly want the new members to. 
And we'll be working on that, hopefully end of this month. 
We're off for two weeks, and then if not, in early May. Because 
there was a lot to see there. You had a lot to tell us.
    Dr. Kirschstein. We would welcome you and be pleased to 
show you all that we have to offer.
    Mr. Regula. Get your selection of posters ready. We'll be 
there. [Laughter.]
    Thank you all for being here.
    [The following questions were submitted to be answered for 
the record:]
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                                           Wednesday, May 16, 2001.

                     NATIONAL INSTITUTES OF HEALTH

                               WITNESSES

RUTH L. KIRSCHSTEIN, M.D., ACTING DIRECTOR, NATIONAL INSTITUTES OF 
    HEALTH
DR. RICHARD D. KLAUSNER, NATIONAL CANCER INSTITUTE
DR. CLAUDE LENFANT, DIRECTOR, NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
DR. LAWRENCE A. TABAK, DIRECTOR, NATIONAL INSTITUTE OF DENTAL AND 
    CRANIOFACIAL RESEARCH
DR. ALLEN M. SPIEGEL, NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND 
    KIDNEY DISEASES
DR. AUDREY S. PENN, ACTING DIRECTOR, NATIONAL INSTITUTE OF NEUROLOGICAL 
    DISORDERS AND STROKE
DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND 
    INFECTIOUS DISEASES
DR. MARVIN CASSMAN, DIRECTOR, NATIONAL INSTITUTE OF GENERAL MEDICAL 
    SCIENCES
DR. DUANE ALEXANDER, DIRECTOR, NATIONAL INSTITUTE OF CHILD HEALTH AND 
    HUMAN DEVELOPMENT
DR. JACK McLAUGHLIN, ACTING DIRECTOR, NATIONAL EYE INSTITUTE
DR. KENNETH OLDEN, DIRECTOR, NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH 
    SCIENCES
DR. RICHARD J. HODES, DIRECTOR, NATIONAL INSTITUTE ON AGING
DR. STEPHEN I. KATZ, DIRECTOR, NATIONAL INSTITUTE OF ARTHRITIS AND 
    MUSCULOSKELETAL AND SKIN DISEASES
DR. JAMES F. BATTEY, JR., DIRECTOR, NATIONAL INSTITUTE ON DEAFNESS AND 
    OTHER COMMUNICATION DISORDERS
DR. STEVEN E. HYMAN, DIRECTOR, NATIONAL INSTITUTE OF MENTAL HEALTH
DR. RICHARD NAKAMURA, DEPUTY DIRECTOR, NATIONAL INSTITUTE OF MENTAL 
    HEALTH
DR. ALAN I. LESHNER, DIRECTOR, NATIONAL INSTITUTE ON DRUG ABUSE
DR. ENOCH GORDIS, DIRECTOR, NATIONAL INSTITUTE ON ALCOHOL ABUSE AND 
    ALCOHOLISM
DR. PATRICIA A. GRADY, DIRECTOR, NATIONAL INSTITUTE OF NURSING RESEARCH
DR. DONNA DEAN, ACTING DIRECTOR, NATIONAL INSTITUTE OF BIOMEDICAL 
    IMAGING AND BIOENGINEERING
DR. JUDITH L. VAITUKAITIS, DIRECTOR, NATIONAL CENTER ON RESEARCH 
    RESOURCES
DR. STEPHEN E. STRAUS, DIRECTOR, NATIONAL CENTER FOR COMPLEMENTARY AND 
    ALTERNATIVE MEDICINE
DR. JOHN RUFFIN, DIRECTOR, NATIONAL CENTER ON MINORITY HEALTH AND 
    HEALTH DISPARITIES
DR. GERALD T. KEUSCH, DIRECTOR, FOGARTY INTERNATIONAL CENTER
DR. DONALD A.B. LINDBERG, DIRECTOR, NATIONAL LIBRARY OF MEDICINE
DR. YVONNE T. MADDOX, ACTING DEPUTY DIRECTOR, OFFICE OF THE DIRECTOR
DR. JACK WHITESCARVER, ACTING DIRECTOR, OFFICE OF AIDS RESEARCH
STEPHEN A. FICCA, ASSOCIATE DIRECTOR FOR RESEARCH SERVICES
SUSAN QUANTIUS, ASSOCIATE DIRECTOR FOR BUDGET
DENNIS P. WILLIAMS, DEPUTY ASSISTANT SECRETARY FOR BUDGET, DHHS
    Mr. Regula. We will get the hearing started. I think I 
should take advantage of all this medical expertise.
    Dr. Kirschstein. They have wonderful things to tell you, 
Mr. Chairman.
    Mr. Regula. I am sure that is true and I would love to hear 
from them because what you do out there is terrific. I had a 
group of college students in my office yesterday and I was 
telling them about NIH. I told them, you probably know very 
little about NIH, but what they do is very important in your 
life, more than you will ever realize. And I say the same thing 
when I have give speeches I think the American public vaguely 
knows you are there, but they don't really appreciate how the 
quality of their life has been improved by the activities of 
NIH. It is not only Americans but people around the world that 
have benefitted from your research. We are fortunate in this 
country to have both your agency as well as CDC and the work 
that's done on behalf of the people.
    Dr. Kirschstein, do you want to make your opening remarks? 
Your statements will be made a part of the record. Hopefully we 
will have more members show up. We have a lot on the agenda 
today, including the education bill on the House. Our Members 
have had many different irons in the fire each day. That makes 
it difficult. I hope we get an opportunity to talk to you. I 
understand you will be here tomorrow.
    Dr. Kirschstein. Yes, sir.
    Mr. Regula. So we will have some additional Members then. 
Dr. Kirschstein, it is all yours.

                           Opening Statement

    Dr. Kirschstein. Thank you, Mr. Chairman. I am honored to 
appear before you and the subcommittee representing my 
colleagues, the directors of the 27 institutes and centers, who 
each has presented a written statement.
    I am going to present the overall view of the President's 
budget for fiscal year 2002. It reflects the continuing 
commitments to double the NIH budget by fiscal 2003. It 
requests $23.04 billion, an increase of $2.8 billion, or 13.5 
percent more than the fiscal 2001.
    Mr. Regula. What was the rationale for saying we should 
double the budget? How would you make the case for that? I am 
not disputing it, but I am curious as to the logic, the thought 
process that went into the determination that it ought to be 
doubled.
    Dr. Kirschstein. Mr. Chairman, that logic was arrived at by 
a number of people, including a number of Members of Congress, 
your predecessor chairman of this subcommittee, as well as 
people in the Senate, a number of other Senators and 
Congressman, many people from the advocacy community. The 
important fact the data show is that the NIH budget has doubled 
repeatedly over the years, usually over a span of 7 to 9 years. 
And I think when all of those people who were considering it 
realized the scientific opportunities that were available, they 
said let's do it in 5.
    Mr. Regula. Well, it seems like a rational decision. I hope 
we can come close to the target, but it will depend on what 
kind of an allocation we have in terms of the budget. You may 
proceed.
    Dr. Kirschstein. The NIH is deeply gratified by the support 
of the American public and the Congress and the administration. 
And because of the additional funding, progress in the medical 
sciences has advanced at a speed that we only dreamed of a few 
years ago. This is a time of extraordinary scientific 
opportunity. Yet at the same time we must be sure that the 
public is aware of the latest information regarding prevention, 
diagnosis, treatment and possibly cure of disease. And in that 
regard I am sure you saw the paper this morning. Just yesterday 
the National Heart, Lung, and Blood Institute issued a major 
new practice guideline on the prevention and management of high 
cholesterol levels in adults. It was the first major revision 
in 10 years.
    Mr. Regula. I did decide not to have eggs this morning. It 
is scary, I must say.
    Dr. Kirschstein. Well, actually we would prefer not to have 
people frightened, but prefer to have people educated.
    Mr. Regula. That is a nice way to put it.
    Dr. Kirschstein. I just want to quote something that Dr. 
Lenfant, the Director of the National Heart, Lung, and Blood 
Institute said at the press conference. He said, ``Americans at 
high risk for heart attack are too often not identified and so 
don't receive sufficiently aggressive treatment. Yet studies 
show conclusively that lowering the level of low density 
lipoprotein, or LDL, the bad cholesterol, can reduce the short-
term risk for heart disease by as much as 40 percent. And you 
may wish to talk to Dr. Lenfant and have him expand on this 
later.
    Past investments have revealed new frontiers, new 
opportunities to understand diseases, to treat them, to prevent 
them, and even to cure them. Given the accelerating rate of 
progress and discovery, it is clear that more opportunities 
will present themselves. And we must seize these future 
opportunities.
    To do so, NIH is expanding its programs aimed at building 
the capacity to conduct clinical research.
    Mr. Regula. Excuse me a minute. I want to say to my 
colleagues we have the whole team here from NIH, 27 Institute 
and Center Directors, so you will have lots of opportunity to 
talk to them.
    Dr. Kirschstein. We are expanding our programs that aim at 
the capacity to conduct clinical research. For example, as you 
know, the 106th Congress authorized several new loan repayment 
programs which are vitally important in recruiting new clinical 
researchers. Two of these new programs, the Extramural Clinical 
Research and the Pediatric Research Loan Repayment Programs, 
will be supported by nearly all the institutes and centers in 
fiscal year 2002 with the President's request. But in addition, 
we will support the Clinical Research Loan Repayment Programs 
for Individuals from Disadvantaged Backgrounds and for Research 
on Minority Health Disparities.
    Along with that, we have two career development programs 
that were started in 1999, the Mentored Patient-oriented 
Research Career Awards for young investigators who need 
mentoring to start their career and the Mid-Career Investigator 
Awards in Patient-oriented Research. These are people in mid-
career who in turn will mentor young people, and both of those 
will be expanded to meet the increasing demand for clinical 
investigators of high quality. We will also markedly increase 
our support to enhance the capacity of academic institutions in 
States which have not fully participated in medical research, 
as Mr. Wicker knows. The Biomedical Research Infrastructure 
Network will provide each of these 23 States and Puerto Rico 
with a developmental grant of $2 million per year for 2 to 3 
years to plan and do feasibility studies, all of which will 
lead to an increase in research capacity and the ability to 
obtain biomedical research funds by those States. That program 
will start in fiscal year 2001.
    All of the institutes and centers, along with the National 
Center for Minority Health and Health Disparities, will expand 
their emphasis on health disparities as well. I would like to 
give you an example. A major clinical trial involving African-
Americans has been designed and is under way to identify ways 
to slow the progression of kidney disease due to hypertension. 
The study compares two major classes of drugs used to treat 
hypertension, calcium channel blockers and ACE inhibitors. When 
it is completed, there is reason to believe that there will be 
a very specific outcome and we will be able to provide and 
disseminate information about the optimal treatment of 
hypertension to prevent end-stage kidney disease in this 
minority group, which may be different than what has been 
anticipated and what has been the practice of medicine. But as 
we generate more and more data, there is a pressing need for 
scientists with expertise in biocomputing and bioinformatics. 
We will significantly expand our training programs to have 
scientists who can provide such abilities.
    Another thing is that the President's fiscal year 2002 
budget provides funds for the support of the high end 
instrumentation for both basic researchers and clinical 
scientists. This includes very high field NMR 
spectrometers,extremely sophisticated imaging systems, electron 
microscopes, high resolution mass spectrometers, and high performance 
supercomputers.
    The President's fiscal year 2002 budget also requests $40.2 
million for the newly legislated National Institute of 
Biomedical Imaging and Bioengineering, the focus of which is to 
develop new knowledge, create new technologies, and train 
researchers able to integrate fully the quantitative sciences 
with medical research. To continue the progress that we have 
made, the Nation must recruit, train and retain the best and 
the brightest scientists with careers in biomedical research. I 
would hope that some of the college students that you spoke to 
the other day could be intrigued into doing biomedical 
research, and I might add parenthetically, Mr. Chairman, that 
any time you talk to a group of college students, if you want 
us to show them NIH we would be delighted to provide such 
opportunities.
    Mr. Regula. I do occasionally have constituents that are 
interested, and my colleagues might be interested, too. Could 
we have them call you and give them some kind of input?
    Dr. Kirschstein. Absolutely. We would be pleased to do 
that.
    Mr. Regula. You have a great story to tell and we will 
certainly keep that in mind.
    Dr. Kirschstein. But to retain these best and brightest 
scientists and train them, the President's budget request a 10 
percent increase for stipends for pre- and post-doctoral 
training.
    Mr. Chairman, we also are expanding our programs of 
outreach to communities throughout the country. One example, 
but it is one that many of the institutes and centers could 
replicate throughout the country, but the one I want to bring 
to your attention today is the fact that the National Institute 
of Arthritis, Musculoskeletal and Skin Diseases has set up a 
community-based initiative at a Washington, D.C. Community 
health care center to provide diagnosis, treatment, and 
education programs as well as clinical investigations and 
education for the people who are being treated there. These are 
people with arthritis, lupus, and other rheumatic diseases and, 
as I say, all the institutes will be able and are mounting such 
programs.
    Finally, Mr. Chairman, one of the numerous wonderful 
examples of the enormous progress we have made and will 
continue to make was announced just last week. An important new 
cancer drug was approved, and I would like to call on my 
colleague, Dr. Richard Klausner, to tell you about this 
discovery, after which all of us are ready to answer any 
questions that you or the other members have.
    Dr. Klausner.

                   NEW LEUKEMIA DRUG GLEEVEC APPROVED

    Dr. Klausner. Mr. Chairman, members of the committee, thank 
you. A week ago we announced the extremely rapid, record time 
approval by FDA of what is clearly to my mind the most 
impressive drug ever in the long war against cancer. This is a 
drug that is specific for a type of molecular target that this 
committee has heard me talk about for the last 5 or 6 years. It 
was developed as a molecular target for a type of leukemia for 
which we have very few good treatments, most of which are quite 
expensive and toxic.
    This drug is an oral pill that can be taken once or twice a 
day. As you see here, there is a molecular machine which we 
first saw 40 years ago in a particular type of leukemia called 
CML. There are about 15,000 Americans currently with CML. In 
the clinical trial that was reported, of 53 patients for whom 
all other therapies had failed, 51 of them using an oral pill, 
with virtually no significant side effects except mild nausea, 
had their blood completely returned to normal. This is really 
quite remarkable. What is also remarkable about it is not only 
how it work and what it does, but actually what it represents. 
To some extent we weren't surprised

at how well the drug worked. Although, we were somewhat 
surprised at how little toxicity it had. The reason why we 
weren't surprised with how well it worked is because this 
drug's development had followed the paradigm that we at NIH are 
following in our attempt to finally understand the molecular 
nature of disease.
    [The information follows:]
    [GRAPHIC] [TIFF OMITTED] T4726A.329
    
                     THE MOLECULAR NATURE OF CANCER

    Dr. Klausner. If I could take a couple of minutes to show 
you how this came about. Basically, and I have shown this 
poster before, 25 years ago the cell, this diagram is for 
cancer but could represent any disease, was basically a black 
box. We could see the cell under the microscope, we saw its 
structures. We had no idea how it worked. Over the past 
generations we have been filling in the wiring diagrams, the 
circuitry. This may sound very arcane but it is very real. What 
we see now, after filling out the circuitry and identifying the 
components of the circuits that are altered in each disease, is 
in the next poster.
    [The information follows:]
    [GRAPHIC] [TIFF OMITTED] T4726A.330
    
    Dr. Klausner. This diagram is something that 5 years ago I 
couldn't draw at all, except maybe a couple of small parts of 
it. This poster represents our drawing of breast cancer and our 
identification of 68 different molecular targets that are 
altered in different kinds of breast cancer. It becomes clear 
that breast cancer is not one disease. This understanding 
brings to light another treatment theme in which a disease is 
defined by its molecular nature not its location. Listed with 
all of these molecular targets, for the first time, are drugs 
which are being evaluated to work against those targets just 
like the drug Gleevec that was approved last week. What does 
that mean? That means that we can go finally from illuminating 
the black box to having the circuitry, to having the molecular 
targets to having the drugs.
    [The information follows:]
    [GRAPHIC] [TIFF OMITTED] T4726A.331
    
    Dr. Klausner. On the next poster you see something that I 
think is quite dramatic and I think very much answers the 
chairman's question, how are we spending this money. We now see 
the movement from basic discovery to clinical trials. Again, 
this is just one example, breast cancer. There are 15 classes 
of molecular targets in a breast cancer cell that we have 
identified that have abnormality. So far 68 specific targets 
for which we have drugs, and this represents 130 open clinical 
trials, essentially none of which were opened 5 years ago, each 
now directed towards the kinds of molecular targets that led to 
this extraordinary drug that was approved last week.
    We can see in this portfolio the largest clinical trials 
enterprise in the world. That is the one that NIH runs. This is 
the NCI cancer treatments network, but also in dark blue 
represents trials largely in collaboration with or in 
association with private industry. This is such a complete 
transformation of our approach to disease and, while we 
illustrate it with cancer, it is exactly what any of my 
colleagues can describe to you for neurologic disease or 
infectious disease or heart disease and on and on.
    So I am pleased to answer any questions also you have about 
this new drug. It is, as I said, quite remarkable.
    Mr. Regula. Well, I am sure we will have some but I think 
we will keep going and we can come back. So go ahead.
    Dr. Kirschstein. So we are all pleased. That was the end of 
my statement. We are all pleased to go ahead and answer 
questions. I will be glad to start or whatever you wish.
    [The statement of Dr. Kirschstein follows:]
    [GRAPHIC] [TIFF OMITTED] T4726A.332
    
    [GRAPHIC] [TIFF OMITTED] T4726A.333
    
    [GRAPHIC] [TIFF OMITTED] T4726A.334
    
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    [GRAPHIC] [TIFF OMITTED] T4726A.338
    
                  TYPES OF CANCER GLEEVEC COULD TREAT

    Mr. Regula. Dr. Klausner, is this drug selective? It is not 
for every cancer, I assume?
    Dr. Klausner. That is right. That is one of the critical 
lessons, that we can actually predict, we believe, which 
cancers are likely candidates to be treated by this drug. There 
are three molecular machines that this drug shuts off. There 
are subsets of 15 different cancers that have these machines. 
So it was developed for this form of leukemia. Surgeon data was 
presented at the annual meetings in San Francisco on a very 
aggressive form of intestinal, abdominal cancer, for which we 
have no treatment. That cancer is also caused by one of the 
three molecular machines that this drug inhibits and there are 
absolutely remarkable responses. In fact, the vast majority of 
patients that have alteration in the other molecular machines 
that this drug inhibits, in these abdominal cancers that look 
nothing like leukemia, also respond. Again a single oral drug, 
once, twice or three times a day, with very few side effects.
    Mr. Regula. I presume you will gain new information that 
will expand the treatment to the various cancers that you can 
treat?
    Dr. Klausner. Yes. Right now we are in the process of 
opening about 2 dozen clinical trials around the country for 
looking at the effect of this particular drug in the variety of 
cancers that have the molecular targets for this drug.
    Mr. Regula. Mr. Wicker, if you would take the Chair and you 
can go ahead with your questions.
    Mr. Wicker [presiding]. I will announce to members that 
this is a Journal vote, a procedural vote and some of us may or 
may not wish to go and cast that procedural vote, but we will 
keep the hearing open during that time. I was going to get back 
to the cancer because when we go back and tell our 
constituents, Dr. Klausner, I don't want us to overstate what 
we have done. How many forms of leukemia are there and what 
percentage of the disease does this new drug address?
    Dr. Klausner. This drug addresses about 20 percent of all 
leukemias. And as I said, we need to do the clinical trials, 
which are all being opened, to see whether there are a fraction 
of brain tumors, breast cancers, ovarian cancers, especially 
lung cancers are particularly indicated, some of which utilize 
the same molecular targets that this drug is able to get. We 
will only know where this drug works on leukemia and with the 
new evidence of this intestinal malignancy whether it works for 
other cancers.
    The take-home lesson is that disease needs to be redefined 
not by, in the case of cancer, where it started--that is how we 
defined it for hundreds of years--but what is inside the 
disease, what is causing the disease, what is the machine. Then 
the treatments now will be aligned with not whether it is 
breast cancer or brain cancer, but whether it is breast cancer 
with this molecular target, or whether this is brain cancer 
with this type of molecular target. We will have to develop a 
new way of organizing and thinking about in essence the names 
of these very diseases.

                        EFFECTIVENESS OF GLEEVEC

    Mr. Wicker. Let me make sure I understood correctly. With 
regards to the clinical trial that you were performing, did I 
understand you to say that there were 52 patients that did not 
respond to any other type of treatment?
    Dr. Klausner. Right. In one of the clinical trials of this 
form of leukemia, called CML, the trial used by the FDA for 
approval, 53 patients were enrolled who had tried other 
treatments, the best available treatments, and those treatments 
had all failed. Fifty one of those patients had a complete 
return to a normal blood count. And----
    Mr. Wicker. 51 out of 53.
    Dr. Klausner. 51 out of 53.
    Mr. Wicker. Would it be fair for me to extrapolate that 
among the 20 percent of leukemia patients that have this type 
of disease we have virtually found a cure for that portion?
    Dr. Klausner. We have found what looks like a terrific 
treatment. The issue of a cure depends upon our following 
patients to know how long this drug will work. In fact, there 
is no way to know that until we follow the patients. What I can 
tell you, of the 51 patients, some of whom have been followed 
for almost 2 years, none of those 51 that have responded have 
relapsed while continuing to take the drug. But we will only 
know when we have actually cured it, cured the disease in any 
of the patients as we watch them for their lifetimes. Now what 
we don't know is whether patients have to keep taking the drug 
and again that will require additional clinical trials.
    Mr. Wicker. Sure. Thank you very much. As a matter of fact, 
you may wish to just stay at the table in case other people 
want to follow up. We have had you jumping up and down like a 
jack in the box, so we will keep you there.
    Dr. Kirschstein, do you want to follow up on that answer?
    Dr. Kirschstein. No, we are ready to go ahead. Because the 
hearing, the way the hearings were being held was modified this 
year, we have made an arrangement, because since all of the 
institute's directors would be here today, questions would be 
put to any of them, and that is why we have the extra 
microphone.

                              IDEA PROGRAM

    Mr. Wicker. I understand that but this is marvelous news, 
and thank you for making a special effort to tell us about 
that.
    Let me go back, Dr. Kirschstein, to the IDeA Program and 
the BRIN network, Biomedical Research Infrastructure Network.I 
understand you to say that of the 23 States involved in this program, 
which is designed to develop the capacity to complete more effectively, 
within the peer review process, each State will receive an additional 
$2 million.
    Dr. Kirschstein. $2 million for each of 3 years, so it is a 
total of $6 million. During that time we will continue to work 
and provide technical assistance to the academic institutions 
within the State. As you know, Mr. Wicker, we have been working 
very closely with the faculty and administrative folks at the 
University of Mississippi, both at Ole Miss and at Jackson. 
They have been coming up to visit us and we have been there on 
several occasions, and we will continue to do this with all of 
the other States and Puerto Rico as well. At the end of the--
coming to the end of the 3-year period of $6 million of 
support, we will evaluate and they will evaluate the situation 
and we will make a determination whether they need another 3 
years of feasibility studies in order to be able to further 
develop and go from there. But we are going to work intensively 
with all of these institutions.
    Mr. Wicker. Are you developing at the central office the 
guidelines that the States will use for developing their 
capacity or do you leave them flexibility?
    Dr. Kirschstein. We leave them some flexibility within the 
guidelines, but when we issued the request for applications 
there was specific guidelines with flexibilities. Before we 
asked them to submit an application we had a meeting of 
representatives of all of the academic institutions from all of 
the States. We broke into workshop groups where they could ask 
specific questions and get the technical assistance. We have 
since visited many of the States and provided technical 
assistance. We have been on the phone with them. We have really 
worked very intimately with them to assure that the best 
performance could be mounted.

                             COBRE PROGRAM

    Mr. Wicker. Okay. Well, I appreciate knowing what you have 
just told me. Let me ask you what else you are doing in this 
regard. I notice that the budget request for IDeA is $135 
million and the budget request for BRIN $75 million. The 23 
States times 2 is $46 million. So in addition to the $46 
million, what are your plans for the other monies that you are 
requesting?
    Dr. Kirschstein. I will start the answer and then Dr. 
Vaitukaitis may want to expand on it. We had started a program 
before the new BRIN called the COBRE program, the Centers of 
Biomedical Research Excellence, and there are a number of 
awards which Dr. Vaitukaitis can provide in detail for you, but 
they carry commitments and we also have a recompetition for 
that. And so a good deal of the other money will be used for 
that program and then we will try in further fiscal years to 
expand both of these programs.
    Dr. Vaitukaitis. Mr. Wicker, there is one additional 
competition----
    Mr. Wicker. Press that button.
    Dr. Vaitukaitis. There is an additional competition for 
COBRE applications this fiscal year. Mississippi has competed 
very well in the BRIN competition. Those awards will add to 
what we term the commitment base for the next fiscal year. Out 
of the $135 million, we will have to pay the noncompeting 
renewals for those awards. Then there is $35 million for new 
funding for the BRIN program in fiscal year 2002, which will 
allow an expansion of the BRIN activity. Many of the 
representatives from the States have expressed the need to 
expand their research facilities, and to recruit post-docs and 
graduate students. We want to be responsive to that need.
    Dr. Kirschstein. I might add, Mr. Wicker, that we have had 
for many, many years a program that was started by Mr. Natcher, 
actually what is called the AREA program, or the Academic 
Research Enhancement Award program, which has been for--as 
opposed to States--colleges and universities that had not 
participated throughout the country, regardless of the States 
in which they were located, had not participated fully. And so 
we have about $21.5 million in that program and have been 
working actively with those colleges and universities, a number 
of which, Millsaps for example, are in Mississippi.
    Mr. Wicker. Right. Well, I won't pursue this any further, 
except to say I appreciate what you are doing in this regard 
and let me make one other point. There are many researchers in 
these 23 States that are already fully capable of competing 
against anyone in an objective peer review process. And there 
is a feeling, and I know you are aware of this, that there is 
an institutional bias toward awarding the grant to those who 
have always gotten the awards. And whether you think that is 
accurate or not, that is out there. And I would simply ask that 
everyone involved in the process be mindful of that feeling. 
And let's be certain that the best people in that large body of 
research actually get the awards, and oftentimes that can be 
the new guy on the block.
    Dr. Kirschstein. We absolutely agree with you and we are 
working very hard in that regard.
    Mr. Wicker. Well, my office seems to be determined--I will 
ask Mr. Istook to take up questions.
    Mr. Istook. I can get the phone for you. Thank you, 
Chairman.
    Dr. Kirschstein, I want to first of all express my 
appreciation for your responsiveness in addressing the issues 
that have been of concern to me and other members. That is very 
noted and very much appreciated.
    Dr. Kirschstein. Thank you.

                         CHROMIUM AND DIABETES

    Mr. Istook. It is both a challenge and a marvelous 
opportunity to be administering things at a time that you do 
have the budget growth, the expansion of the medical research 
funding. And as I have discussed in part with you before and 
wanted to kind of use this opportunity to repeat, I think as we 
are going through the expansion process of the NIH budget, I 
have some particular concerns that I wanted to reiterate. One 
is to make sure that we direct significant research dollars 
towards reducing the cost of health care. We do not want the 
advances in medicine to drive people out. I mentioned to you 
earlier this year about studies indicating that medical 
research and its results are becoming cost drivers. We will 
say, well, if you can do it therefore you must do it. And 
therefore it has got to be conferred by insurance and insurance 
costs escalate and we get into that cycle. Yes, I understand 
that there is certainly potential for using the medical 
research process to focus on the ways that may reduce the costs 
of care, which I think should be a significant effort, and as 
part of that, putting major emphasis on providing care and 
treatments and providing new ways and better ways of care and 
treatment for that health care which is generating the greatest 
national expenditure and especially that that is provided at 
taxpayer expensethrough Medicare-Medicaid or other programs 
there. We have discussed before my concerns with discrepancies which 
still exist. I know there has been efforts to address them, but I think 
there still exists between the ratio of a prevalence of the disease to 
the amount of research dollars and I understand severity goes in there 
as well. Diabetes is one we have talked about, among others, with a 
need to have research focused there.
    And I do want to mention before I get off this particular 
topic, Dr. Kirschstein, I know there has been some research 
that has been mentioned in a committee report by Dr. Richard 
Anderson at the Department of Agriculture Human Nutrition 
Department concerning a potential link between chromium 
supplementation and deficiency and treatment of diabetes. And I 
would certainly hope--as I understand, trying to replicate his 
research to validate different things and find areas of pursuit 
would probably be a cost in the range of about $3 million, and 
I would certainly hope that you might find the potential for 
replicating and verifying, or for that matter if it is not 
verified, but pursuing that as something that I believe could 
be significant.
    Let me stop a moment before I cover the other things on my 
checklist because I see you want to comment on that.
    Dr. Kirschstein. Mr. Istook, we have been considering the 
issue of the use of chromium in diabetes. We had a workshop and 
I would like to ask Dr. Spiegel to make a comment on that.
    Mr. Istook. Yes, because I am looking at the funding.
    Dr. Spiegel. Thank you, Dr. Kirschstein, and I appreciate 
the question, Mr. Istook. Shortly before I became a director of 
NIDDK, as you know, there was a workshop from the Office of 
Dietary Supplements at NIH looking at the question of chromium 
and diabetes. Given the looming nature of the diabetes epidemic 
and its costs, as you have emphasized, I feel we need to 
explore any avenue, particularly a potentially cost effective 
avenue, toward treatment. But of course, as you have stressed, 
the treatment needs to be effective. The Office of Dietary 
Supplements commissioned a systematic review of all the 
clinical literature on this subject and came to the conclusion 
that at the moment the evidence for an effect of chromium in 
patients with type 2 diabetes is actually equivocal; that is, 
unproven, unclear, and yet there is some promise there. And 
because of this they have pointed to the need for small, 
focused clinical trials as well as further studies on both the 
safety as well as even measuring the amount of chromium in 
blood, which it turns out there was no real way of assessing. 
As a result of this review, NIDDK, the National Center for 
Complementary and Alternative Medicine, as well as the Office 
of Dietary Supplements will be starting an initiative to be 
funded in fiscal year 2002 entitled Chromium as Adjuvant 
Therapy in Type 2 Diabetes and Impaired Glucose Tolerance. This 
will be encouraging studies both on basic mechanisms as well as 
small scale, so-called phase 1 and 2 clinical trials, to 
examine this question.
    Finally, the National Institute of General Medical Sciences 
in a more general initiative called Metals in Medicine is 
looking at a number of these kinds of trace metals and elements 
and NIDDK along with the Environmental Health and Safety 
Institute and the Office of Dietary Supplements is joining this 
initiative, with our focus specifically on chromium and 
diabetes.
    So clearly we have taken this very seriously. We do want to 
explore this important and potentially cost effective avenue.

                      BROAD RESEARCH DISSEMINATION

    Mr. Istook. I very much appreciate that and it sounds like 
you have described a multi-faceted approach to the different 
aspects of it. Again, that is part of the responsiveness that 
we certainly appreciate.
    Dr. Kirschstein, as far as NIH priorities as far as 
focusing research on things that reduce the cost of health 
care, secondly, I remain hopeful that we can establish costs as 
a positive criteria in awarding research grants to qualified 
applicants. Of course always we are speaking of qualified 
applicants. Third, of course, and I think Mr. Wicker was 
addressing this, continuing the programs to distribute a 
significant volume of research grants more carefully and use 
that greater geographic area more carefully to improve the 
quality of care, in essence increasing the transfer between 
clinical research and practitioners when they do it, because if 
you do not have them in the same geographical setting you were 
not going to have someone that is treating patients in Ames, 
Iowa rubbing shoulders with researchers at the health center at 
the University of Pittsburgh, for example. But the more broadly 
that research is disseminated, then the more broadly the 
results of that research will be disseminated to the practicing 
community, which I know is the goal. We do not want things to 
be there and sit on a shelf and be read once every year or two. 
And I certainly hope and I want to work with you in the next 
few weeks and try to see if there is some specifics, and I will 
get a letter to you outlining these things, trying to see what 
specifically might we be able to do part of it in terms of the 
dollars part of it, in terms of programs and approaches to make 
sure we meet those objectives, which I hope are objectives with 
which you agree.
    Dr. Kirschstein. We do agree and there are, as I said, a 
number of community outreach programs already which are doing 
so. Dr. Alan Leshner, the Director of the National Institute on 
Drug Abuse, could speak about the community outreach programs 
in drug abuse which are at the specific level of community 
along with researchers.
    Dr. Leshner.
    Dr. Leshner. We have recently started a treatment network 
around the country, now consisting of 14 nodes, that are 
actually building partnerships in the development and in the 
dissemination of new science-based drug addiction treatments to 
practitioners on the front lines. We have over 80 community-
based drug treatment programs who are literally partners in 
this research process to demonstrate the effectiveness and 
usefulness of variouis treatments. In the 2002 budget request 
we plan to do exactly the same thing for drug abuse prevention, 
use science to build bridges between prevention researchers and 
the practitioners on the front lines. As you know, in the case 
of drug abuse a lot of practitioners are not scientifically 
trained as they may be in some of the other illnesses, and 
therefore we have found this approach to be particularly useful 
in bringing science into communities everywhere throughout the 
country.
    Mr. Istook. I appreciate your comments and as you and Dr. 
Kirschstein know, of course, my concern extends far beyond the 
drug abuse as a possibility and trying to make sure through the 
peer review process and, as Mr. Wicker mentioned, through all 
other aspects that we achieve these goals of getting it, and I 
know that you are working with people on that and on focusing 
the research dollars, and Iknow you have people here with you 
working to do that on ways that will make the medical treatment more 
cost effective and thereby more widely available.
    Dr. Kirschstein. We agree with you. Dr. Leshner, for 
example, is simply presenting an example which any one of the 
institutes could replicate.
    Mr. Istook. Right. I just hope in the era of the expanding 
funding we are in, I would hate to have people who are devoted 
to pure research have objections to the dollars, which I think 
needs to be significant, that go into these ways to find more 
cost effective methods.
    Dr. Kirschstein. We agree.
    Mr. Istook. Thank you. Thank you, Mr. Chairman.

                          THE COST OF GLEEVEC

    Mr. Regula [presiding]. I was telling one of my colleagues 
on the way over to vote about Dr. Klausner's testimony, and the 
question she asked is, how much will the daily cost for that 
treatment be because she is on Ways and Means and they are 
going to have to deal with this on Medicare. Do you have a 
number?
    Dr. Klausner. Yes. The cost which is set by the company, 
Novartis, would be between about $2,000 and $2,400 a month. I 
think we were all impressed by Novartis' approach to funding. 
Basically the drug will be free to anyone with an income of 
less than, I think it was $48,000 a year, free, and then a 
sliding scale from 48 to $100,000 a year. One of the issues 
raised is this is an oral cancer drug--and that, of course, is 
one of the things that we and the patients really like about 
it. However, Medicare does not cover oral cancer drugs and as 
we move from expecting drugs to be based in the hospital and 
IV, I think oral drugs need to be addressed in terms of what 
Medicare does and doesn't cover.
    Mr. Regula. Well, obviously the Ways and Means Committee in 
talking about Medicare reform will have to address this 
question of an oral drug, and we talk about making drugs part 
of the reimbursement.
    Dr. Kirschstein. Within the Department of Health and Human 
Services, under Secretary Thompson, there has been a great deal 
of interchange between agencies and I am sure we will have a 
great deal with HCFA.
    Mr. Regula. Mr. Cunningham.

                        PROSTATE CANCER MEETINGS

    Mr. Cunningham. Thank you, Mr. Chairman. Doctor, I don't 
think you have to but I think he's already agreed to do it, but 
we haven't been able to put it together. But Dr. Klausner and I 
have been friends for a long time, and I would like to 
recoordinate one of the areas in Washington, D.C. That has 
never been done, Dr. Klausner, is the town hall meeting on 
cancer. The highest rate of prostate cancer is among African 
Americans and the highest prostate cancer source is right here 
in Washington, D.C. I think it would be very, very valuable to 
do that. All I would do is introduce it and turn it over to the 
professionals.
    And the second thing is UCSD in San Diego, which is 
adjacent to my district but not in my district, but you know 
the issues along with their cancer research with Dr. Larry 
Goldstein and folks like that, if you could come out and we 
could do a second town hall meeting out there, I think those 
two things would be very valuable in getting our information 
out on what we were really trying to do. And I don't think I 
would have to get your boss' permission to do that but I would 
like to commit you for that.
    Dr. Kirschstein. Not only would we be pleased to do so, but 
here in Washington I think Dr. Klausner should be joined by Dr. 
John Ruffin, who is the Director of the National Center for 
Minority Health and Health Disparities, because that is a 
health disparity between African American and white 
populations.
    Mr. Cunningham. I am on the D.C. Committee also, but we are 
working with the mayor, Mayor Anthony Williams, but they are 
trying to find a place and time to do it. I think it would be a 
good thing and something that is never done.
    Dr. Klausner. Yes, we have been in touch with the Mayor's 
office about it and, as you may recall, I was in San Diego last 
September and met with all the cancer centers and we had a 
public meeting, although there was a tremendous desire to have 
another one. As you know, I am always delighted to do public 
meetings.

                 ESTABLISHMENT OF A MEN'S HEALTH OFFICE

    Mr. Cunningham. Just for the exposure of UCSD, we would 
like you to come out and do that and offer it again to the 
public. Another issue is trying to establish an Office of Men's 
Health like we have the Women's and I understand there was some 
problems. There is an individual or something that is really 
pushing and trying to fire up against the women's issues and 
stuff. I want to assure you, Doc, that it is a center that will 
offer information to men. The Women's Health Organization right 
now is not legislative. It has only been appointed. I would 
like to make it permanent within NIH and we would like to do 
the same thing with Men's to coordinate. In no way do I plan on 
this competing with the men's health department. And I will 
send you the panes on the scope and everything. But women's 
health is I think advanced because of the office and you know 
there is a lot of carryover things, not only in cancer but 
diabetes, HIV and whatever it is, and we would like to 
establish this office and I think it would help both of us.
    Dr. Kirschstein. At the Department?
    Mr. Cunningham. Yes, ma'am. Thank you, Mr. Chairman.
    Mr. Regula. Mr. Kennedy, I think you were next, or was it 
Mr. Jackson?
    Mr. Kennedy. Thank you, Mr. Chairman. We had a great 
meeting.
    Mr. Regula. I'm sorry, it was Mr. Jackson.
    Mr. Jackson. That is okay, Mr. Chairman. I will yield my 
time and then swap later.
    Mr. Kennedy. Thank you, Mr. Chairman, my good friends and 
colleague Mr. Jackson. I had a great meeting the other day, Mr. 
Chairman. I was out at NIH and we learned a lot. I went through 
more traffic signals on the campus of NIH than I did my whole 
ride out to get to NIH, so I have a better appreciation for the 
size of NIH, and those who haven't been out there definitely 
need to go. It is very impressive. It is good to know. We have 
a Pentagon of sorts for finding out about the cures of illness 
around this country and be mobilizing.
    Dr. Kirschstein. We prefer to think it is more like a 
university.

                 RELATED AREAS OF NEUROSCIENCE RESEARCH

    Mr. Kennedy. Well, since we are all in the defense mode and 
terminology around here, especially with the new majority, I 
think it is probably best to put it in these terms. Perhaps we 
will get a better result for funding. Anyway, I would like to 
ask you about some of the issues that I talked about yesterday. 
As you know, I have beenespecially interested in the research 
of mental illness in adolescents, and I understand that the National 
Advisory Mental Health Council has formed a working group to consider 
what is needed to accelerate research in mental illness in children and 
adolescents and to work on the front lines to promote this with 
clinicians.
    Can you provide this committee with information about the 
progress and importance of this work group and what the NIH is 
doing to further the science in the area of mental illness?
    Dr. Kirschstein. Mr. Kennedy, thank you. As you know, the 
Director of the National Institute of Mental Health, Dr. Steven 
Hyman, was with Secretary Thompson at the World Health Assembly 
in Geneva, but Dr. Richard Nakamura is here to talk on this 
subject. He is the Deputy Director.
    Dr. Nakamura. Thank you very much. The National Institute 
of Mental Health will release an Advisory Council report on 
child mental health at its May meeting. I cannot talk about all 
the details of that report at this moment, but I would like to 
emphasize that this was part of an overarching plan, which the 
Surgeon General also participated in, and he will be at our 
council meeting to talk about. A key challenge is to increase 
the research infrastructure. As you may know, training 
researchers who are competent in both psychiatry and in child 
issues is a long and tortuous process, and we have had some 
trouble increasing the number of researchers in that area.
    Mr. Kennedy. Let me ask you, what percentage of the dollars 
spent at NIH go into researching mental illness?
    Dr. Nakamura. Virtually all of our dollars go into 
researching mental illness.
    Mr. Kennedy. But in terms of mental illness itself, 
including the broad range of mental disorders and neurological 
problems and depression and the like, what percentage of the 
NIH?
    Dr. Kirschstein. It is $1.6 billion on the total budget of 
20 billion approximately. Is that right? $1.2 for fiscal year 
2000----
    Mr. Kennedy. That covers all neurological disorders?
    Dr. Kirschstein. That covers the mental disorders, covers 
mental diseases. It does not cover mental retardation. 
Neurological diseases are covered by something like nine 
institutes that do studies in drug abuse, alcoholism, mental 
illness. There is an area of overlap, neurological diseases, 
eye diseases, deafness and communicative disorders, and I do 
not have those figures but when you add them up--we can provide 
that to you for the record.
    [The information follows:]

    NIH funding for the related areas of neuroscience research, 
mental health, mental disorders, and depression follows: You 
will also find that the following areas have overlap.

                                          NATIONAL INSTITUTES OF HEALTH
                                              [Dollars in millions]
----------------------------------------------------------------------------------------------------------------
                                                                FY 2000      FY 2001      FY 2002     Percent of
                                                                 actual      estimate     estimate    NIH budget
----------------------------------------------------------------------------------------------------------------
Neuroscience Research.......................................     $3,341.0     $3,796.3     $4,259.8         18.5
Mental Health Research......................................      1,277.6      1,443.9      1,613.9          7.0
Mental Disorders............................................        881.8        998.1      1,113.6          4.8
Depression Research.........................................        161.7        183.1        203.8          0.9
----------------------------------------------------------------------------------------------------------------

    Mr. Kennedy. I would be appreciative of that as well. But 
on the area of mental illness itself, depression and the like, 
as you know, the World Health Organization----
    Dr. Kirschstein. That is about 5 years, approximately.

                          Behavioral Research

    Mr. Kennedy. Given the fact that behavioral science is such 
an integral part of all treatment and diabetes and 
cardiovascular and everything, osteoporosis and everything that 
you cover at the NIH, what are you doing to incorporate more 
behavioral science research into the practice of all of these 
other institutes.
    Dr. Kirschstein. Well, actually there is a great deal of 
behavioral research not necessarily related to mental illness, 
and that was why I was making the differentiation. There is a 
great deal of behavioral research being supported throughout 
this institute. So this report that is in the newspaper this 
morning, and that Dr. Lenfant will comment on if you wish, 
clearly is related to changing diet to a therapeutic regimen 
that does not involve necessarily drugs, but may involve drugs 
in order to change behavior regarding diet, regarding exercise, 
regarding how patients take care of their hypertension and take 
care of their cholesterol levels, the need for earlier 
diagnosis and so forth. All of that is related to behavior of 
patients and people who are not patients who do not even know 
that they are ill in any way.
    In addition, in order to coordinate all the activities 
ofbehavioral sciences we have an office within the Office of the 
Director, the Office of Behavioral and Social Sciences Research, headed 
by Dr. Raynard Kington, who came to us from the National Center for 
Health Statistics and who is very cognizant of work that is needed in 
behavioral sciences, has been increasing that through a coordinating 
committee that he chairs and is particularly concerned about behavioral 
research related to minority populations.
    Mr. Kennedy. The National Institute of General Medical 
Sciences, though, does not support any training in behavioral 
science?
    Dr. Kirschstein. Training, maybe. Dr. Cassman.
    Mr. Cassman. Yes. Mr. Kennedy, of our training programs, 
the bulk are institutional and they are multi-disciplinary. 
Some of them have the option to include behavioral science. For 
example, our Medical Scientist Training Program explicitly, in 
its announcement, says that behavioral sciences can be one part 
of the program. We don't require that of any of the programs. 
It depends on the university's own local strength and if they 
feel they have a strength in that area, they are certainly free 
to include that as part of the program.
    Furthermore, we have a program called Systems and 
Integrated Biology that can incorporate neurobiology and other 
areas that are linked to behavioral science.
    We don't have a specific program in behavioral science, 
largely because NIGMS operates most of our studies and most of 
our training programs linked to specific biological 
disciplinary areas that we support. Behavioral science in some 
part and in some of these cases can be part of these, and 
certainly we are open to that as an element.

                 Behavioral and Social Science Research

    Mr. Kennedy. I will just say if we are going to double the 
NIH budget, and this is my conclusion, it is my impression that 
the NIH needs to do a lot more in the area of behavioral 
science research because if you look at all the core mental 
health, alcohol, substance abuse fields, you look at the life 
threatening health conditions like cancer, heart disease, AIDS 
and other problems, all a result of behavioral science, 
nutrition, the whole thing. So it seems to me that we have some 
very serious health projects originating from behavior, and I 
would like to see the NIH do more and I would like to get your 
kind of--I know there are so many different institutes that may 
have something to do with this and it just seems to me from 
your answers that there is a lot that I am missing. So if you 
could bring all that, coalesce all that together in a briefing 
to me, that would be great.
    Dr. Kirschstein. We will have the Office of Behavioral and 
Social Sciences coordinate this and bring forward to you all of 
the activities of all of the institutes, which I think is 
really quite impressive.
    Mr. Kennedy. That would be great and I have some other 
questions I will submit for the record.
    Thank you, Mr. Chairman.
    [The information follows:]
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    Mr. Regula. I might say we will have another round if you 
are interested because we have quite a bit of time yet.
    Mr. Kennedy. Yes, I would.
    Mr. Regula. Mr. Jackson.

                       RESEARCH ENDOWMENT PROGRAM

    Mr. Jackson. Thank you, Mr. Chairman. I just have three 
questions, one for Dr. Kirschstein, Dr. Penn, and Dr. Speigel. 
Dr. Kirschstein, one of the centerpiece provisions of the 
legislation that established the National Center for Minority 
Health and Health Disparities last year was the Research 
Endowment Program. As you know, this program was designed to 
assist institutions that have a history and mission of 
addressing health status disparities and developing their 
biomedical research capabilities. I am hoping that you can give 
us an update on the status of this important program, and do 
you expect to make awards in fiscal year 2001?
    My question of Dr. Penn concerns strokes. America's number 
three killer and leading cause of permanent disability 
disproportionately strikes African Americans. I understand that 
compared to whites, young African-Americans have a two to 
threefold greater risk of clot caused strokes and black men and 
women are more likely to die from strokes. I am interested in 
what is being done to prevent stroke in the African American 
population.
    And lastly, Dr. Spiegel, I understand that one of your top 
priorities at NIDDK as the Director is to ensure that NIDDK 
collaborates with other institutes. I understand this has been 
especially important to juvenile diabetes research because the 
complications of disease affects many organ systems. I am 
interested how successful you have been thus far in your effort 
to coordinate with other institutes.
    Thank you, Mr. Chairman, and thank you, Dr. Kirschstein.
    Dr. Kirschstein. Thank you, Mr. Jackson. As you know, the 
Research Endowment Program is something that the NIH had to 
learn a lot about because it had not had any experience in that 
regard. The budget proposed to be spent in fiscal year 2001 is 
$6 million and I think 6 million more in 2002. But I would like 
to ask Dr. Ruffin to give us the specifics.
    Mr. Ruffin. Thank you very much, Mr. Jackson, and thanks 
for asking the question. As you know, the Research Endowment 
along with the Centers of Excellence as well as along with the 
Loan Repayment Program are the centerpiece for the activities 
in the center, and what we have been trying to do is to put all 
this together in somewhat of a systematic way, making sure, for 
example, that we follow the instructions of the legislation of 
putting together an advisory committee to advise us on exactly 
how to proceed with these kinds of issues.
    Dr. Kirschstein is quite right, the Research Endowment 
Program is a new undertaking for the National Institutes of 
Health, but we are beginning now to get the advice that we need 
from the National Advisory Committee. The strategic plan that 
we are using to focus our attention on the total aspect of the 
center is now in a draft form, and we are beginning to get a 
picture of what we can do.
    To answer your question specifically, yes, we will be 
funding some activities on the Research Endowment Program this 
year in the amount of about $6 million, as Dr. Kirschstein has 
indicated, and another $6 million is in the plans for 2002 to 
get the Research Endowment Program under way. We look for that 
program to expand as time goes on, but I think that is going to 
expand as the Centers of Excellence expands.
    Mr. Jackson. Thank you, sir.
    Dr. Kirschstein. Dr. Penn.

                              STROKE BELTS

    Dr. Penn. Good morning, Mr. Jackson. Good morning, Mr. 
Regula. We at the Neurological Disorders and Stroke Institute 
are very concerned about stroke in general because it is so 
disabling and there are so many people with strokes, but 
particularly about the problem in the African American 
community. As you know, this is the case all over the country. 
There is a specific area called the Stroke Belt, where a lot of 
people have strokes; as a matter of fact, both white 
populations and African American populations.
    So we are working on this. We actually have funded three or 
four major grants to investigators looking at major urban areas 
like Chicago and even here in D.C. But in particular we have a 
new proposal coming from Alabama which will be a very large 
epidemiological study of what really is happening in this 
Stroke Belt as it pertains to the Alabama community. We are 
interested in the mechanisms of this. Is it in the genes? As 
you said, it is not only the blockage type of stroke, but it is 
also hypertension. Hypertension is extremely high in the 
African American population. Also helping us are the new team 
of neurologists and neuroscientists at the Morehouse School of 
Medicine which we have fostered with the help of the NCRR, the 
National Center for Research Resources, and Dr. Ruffin's 
office. We are extending our specialized neuroscience division 
to have a program in health disparities, and actually this week 
the advisory committee is meeting. So we are not only giving 
grant funds to people who are already working on this, but we 
are developing new programs because we agree we do not know, we 
really do not know why more people in this area have strokes.
    Mr. Jackson. Thank you, Doctor.
    Dr. Kirschstein. Dr. Spiegel.

                                DIABETES

    Dr. Spiegel. Thank you. Diabetes is certainly a major 
public health threat to the entire U.S. Population, and it 
should be and is a trans-NIH problem. I agree that I have taken 
on the responsibility of addressing this with all of my 
colleagues, and I will apologize in advance if I don't 
enumerate in the interest of time all of them. But first and 
foremost, with type 1, which used to be called juvenile onset 
diabetes, we will work very closely with our sister institute, 
the Institute of Allergy and Infectious Diseases, in studies 
both in terms of understanding the autoimmune pathogenesis, 
prevention and reversal of the disease and islet 
transplantation. There we are also aided by the National Center 
for Research Resources, in which resources are being infused to 
islet harvest from cadaveric pancreases for what could be a 
cure for type 1 diabetes.
    In terms of the predominant form, type 2, or what used to 
be called adult-onset but is now a bad term because we know it 
occurs in kids as well, we have a multi-pronged approach. One 
involves cardiovascular mortality, and here we work closely 
with the Heart, Lung, and Blood Institute. In fact, there are 
parallel clinical trials looking at cardiovascular mortality, 
the ACCORD study at the Heart, Lung, and Blood Institute and 
Look Ahead Action for Health in Diabetes that we are 
supporting.
    In the guidelines for cholesterol that were covered, and I 
am sure Dr. Lenfant can comment on, diabetes was specifically 
enumerated as a very important risk factor, and this is going 
to heighten the sensitivity. So a diabetic, even without a 
previous heart attack, is at greater risk, andthere are 
outreach programs both in the Heart, Lung, and Blood Institute and in 
our institute that are addressing this.
    There are other examples in terms of the unfortunate 
complications. For example, with the National Institute of 
Neurological Disorders and Stroke we are addressing the nerve 
damage that occurs and the low blood sugar that is so 
threatening and very, very difficult. With the National Eye 
Institute, where blindness is an important result, we are 
looking at genetic susceptibility to these complications.
    The Genome Institute, for example, which in its extramural 
program funds nondisease specific research, nonetheless has, 
under Dr. Collins' leadership, specific efforts in terms of the 
genetics of type 2 diabetes relating particularly to African 
Americans in studies that involve Howard University as well.
    The situation in terms of end-stage renal disease which I 
want to point out, in terms of Mr. Istook's comments, concerns 
how cost-effective it would be if we could prevent diabetes, 
the major cause of end-stage renal disease. We are launching a 
National Kidney Disease Education Program. We are also 
launching a number of studies to look at the underlying 
pathogenesis and genetic susceptibility, and these studies are 
going to be important, I believe, in reducing the incidence of 
this particular problem.
    Let me also point out that Mr. Kennedy asked questions 
about mental health and its relation to chronic disease. With 
the National Institute of Mental Health, we sponsored a 
workshop on depression and diabetes and other chronic diseases, 
including renal disease, and from this there will be an 
initiative from which both behavioral scientists, psychiatrists 
and diabetologists will come together to address this problem.
    Finally, let me just mention that Dr. Klausner, the head of 
the National Cancer Institute, has in fact approached me, 
pointing out that so much of their effort in angiogenesis, the 
formation of blood vessels, which is important in terms of 
feeding tumors, is also very relevant to the vascular 
complications of diabetes. And so there we may have a 
commonality and be able to share resources to address this 
problem as well.
    Mr. Jackson. Thank you, Dr. Spiegel. Thank you, Mr. 
Chairman.
    Mr. Regula. Mr. Obey.

                        DOUBLING THE NIH BUDGET

    Mr. Obey. Thank you, Mr. Chairman. I will not be able to 
stay long. I have to get back over to another hearing across 
the hall. But I guess I just want to repeat something that I 
have said several times before in this room and then ask a 
couple of questions.
    Doctor, I think the health care budget that is being 
proposed by the administration is preposterous. Everyone knows 
that politically funding for the Institutes of Health 
represents the holy picture portion of the Federal health care 
budget. Politicians in both parties sponsor political holy 
pictures to show how much they are for health care by using 
their support for NIH as a misleading metaphor for their 
support for all of health and science, and as a result we have 
an incredibly warped set of proposals before this Congress and 
even the subcommittee. NIH is supposed to get a 15 percent 
increase under this budget. But take a look at other pieces of 
the science budget. Research and development spending will be 
cut 2 percent at NSF. That is a mind boggling, stupid thing for 
this government to do and for this administration to propose.
    NIH is certainly built, at least in part, on the basic 
information produced by a number of other agencies, including 
NSF. NSF deals with not only what we know about human health, 
it deals with what we know about the universe, about 
communications, about energy, about everything across the 
board. For them to be cut by 2 percent while NIH is getting 
this large increase to me is an incredibly warped way to 
approach budgeting.
    I think for people who make more than $200,000 a year to be 
guaranteed tax cuts larger than $8,000 rather than increasing 
the overall health budget above that presented by the 
administration is also absurdly warped. No sensible person that 
I know of who understands anything about science would think 
that the interest of NIH would be served by having it 
exclusively receive significant increases while the rest of the 
scientific agencies in the government are squeezed. And even 
within this subcommittee, if you take a look at some of the 
items that are being cut, it is hard for me to justify cutting 
health resources, HRSA, by 10 percent, and cutting CDC by 4 
percent below the current year.
    So I simply wanted to get that off my chest and then I 
wanted to ask a couple of questions. We see these 5-year 
increases coming at us of roughly 100 percent. By the time you 
get into the budget details NIH isn't going to be able to 
actually double its funding level in the time that was 
contemplated originally. But we can leave that for another day.
    What were the outyear projections for NIH funding levels? 
The budget in fact projects a 2.2 annual growth rate in fiscal 
2004, isn't that correct?
    Dr. Kirschstein. That is correct.
    Mr. Obey. How are we contributing to the stability of 
science and to the ability of researchers to plan if we are 
piling on money and then dropping off a cliff in the outyears 
in terms of what will actually be contemplated as the size of 
the tax cuts get larger and larger?
    Dr. Kirschstein. Mr. Obey, you are correct, the President's 
budget proposal proposes increases in the sixth, and seventh 
year by 2 to 3 percent. These funding levels are basically 
determined on an annual basis. But nevertheless, based on that 
proposal that has gone forward by the President, we need to 
begin to think about this. I and all the institute directors 
assembled here, as well as my senior staff, many of whom are at 
the table, have begun to do this. We are going to be working 
very hard to think over the summer and consider what policies 
we need to implement. We are fully aware of the fact that even 
if we do not provide a stable atmosphere for the science it is 
not going to stop. There will be continued exciting 
opportunities in science. Dr. Klausner described new molecular 
targets for cancer therapies. The rest of the institute 
directors could tell you about the things that they can do 
also, and it is not going to stop because the, quote-unquote, 
doubling is going to stop.
    So we are going to try to do some planning to allow for a 
flattening rather than a sudden drop-off.
    Mr. Obey. I guess all I would say is thinking about that 
needs to be done not so much by you, but, for example, at OMB, 
who designed this turkey in the first place, because those 
folks are accurately reflecting what we will be able to do for 
NIH in the outyears as that tax cut wedge grows and grows and 
grows in the outyears.
    The second question: I understand that the administration 
is asking Congress to consider allowing them to fund grants for 
the full 3 years up front rather than a piece at a time. What 
implication does that hold for the outyears? Don't we in fact 
face a situation where these numbers again are really telling 
us that in the outyears there ain't gonna be no dough, and so 
you are going to fund the grants all at once so you don't have 
a large number of grants overhanging in those outyears without 
the dollars to pay for them?
    Dr. Kirschstein. As you know, Mr. Obey, these thoughts have 
been before this committee and before NIH on previous 
occasions. The statement that was in the President's budget was 
that NIH would look into the situation and report on how it 
might be able to handle some small part of its portfolio or at 
least some part of its portfolio in the way that you described 
as full funding. Up until now that has always been ruled by the 
General Accounting Office as being something that could not be 
parsed in that way. So we are reviewing our portfolio, we are 
in discussions with the Department and obviously will meet with 
OMB at some point, but I cannot tell you what will happen.
    Mr. Obey. I have several other questions for the record, 
Mr. Chairman. I have to go back across the hall, but let me say 
again it isn't that I begrudge your agency the increase that 
the President is proposing. My point is that I think that 
increase is being used as political cover to hide the wretched 
mistakes that are being made long term in the basic science 
budget across the board. I think there will be an awful lot of 
people who think that they can get away with carving up the 
rest of science the way the President has talked about if they 
simply vote for the increase for your agency so they can show 
that they have been civilized with respect to that request.
    That may work politically. It doesn't really work long term 
in terms of science. It doesn't really work in terms of meeting 
the opportunities that are before us. It doesn't really work in 
setting out a wise and thoughtful as opposed to a politically 
popular approach to Federal budgeting. But I guess all too 
often that is the way this town works.
    Thank you, Mr. Chairman.

                            AWARDING GRANTS

    Mr. Regula. I checked with one of the universities in Ohio 
as to what they were getting in the way of grants and they sent 
me a list. I was rather surprised. There was a whole series of 
grants for $200,000, $300,000. Is this the way that it is 
handled, that you don't give a university not a lump sum but 
rather specific grants are made to different departments?
    Dr. Kirschstein. The grant awards are made to the 
institution, in this case a university in Ohio, on behalf of a 
proposal or an application that a particular scientist or group 
of scientists puts in to the NIH. But the grant award is made 
to the institution for that individual.
    Mr. Regula. So what they sent me was a list of about 25 
different grants that that institution was receiving, 
unfortunately, I don't have the letter with me. The institution 
makes the application; is that correct?
    Dr. Kirschstein. The scientist prepares the scientific and 
budgetary application describing his or her scientific project, 
the personnel that he needs, the equipment that he needs, and 
all the other aspects of the proposal, which then goes to the 
administration of the university, which adds in the indirect 
costs, that is, the overhead that is needed. And the entire 
package is submitted on behalf of the scientist by the 
institution. The reason for that is that it is the 
institution's responsibility to assure that if that grant is 
awarded all the requirements that we have in regard to, if, it 
is a clinical study, protection of patients, if it is a study 
that involves animals, requires animal welfare assurances, and 
all those other assurances, plus the responsibilities of that 
institution to provide for the individual the space, the 
requirements for infrastructure, library, heating, light, 
animal care rooms, et cetera.
    Mr. Regula. Once a scientist gets a grant, is the award for 
a complete project because otherwise there is no assurance that 
it will continue? I think it is a question Mr. Obey was 
raising, and it is a question you have raised in your 
testimony. How do we ensure that in making grants which are 
based on an annual appropriation. Tell me how it works.
    Dr. Kirschstein. A scientist requests a period of time 
somewhere between 3 to 5 years. Based on the merits of the 
proposal as judged by peer review groups, based on what can be 
seen to be the needs of how long it might take to fulfill the 
goals of that proposal, the awards will be made with the idea 
that it will go for 3 to 5 years. The average length of time 
now is 4 years. And NIH develops--although the first year is 
paid, NIH develops what is called a commitment base and it is 
committed to the second, third and, if there is a fourth, 
fourth year.
    Mr. Regula. But is the amount of money for the grant for 
the total period of time?
    Dr. Kirschstein. It depends. We have a total amount and 
then we have it broken down by year because it is not always an 
equal amount every year. There may be start-up funds. But when 
you look at our budget, our mechanism table, there are two line 
items for research grant proposals. One is new or competing for 
renewal and the other is noncompeting, so that the second, 
third and fourth year of the proposal that an individual 
scientist has requested and for which he or she has been given 
an award are in that noncompeting line, which is about 60-ish 
to 70 percent of the entire amount that would be spent, would 
be proposed in the budget.
    Mr. Regula. As I went through the Ohio list, I noticed a 
number of them are $200,000, $300,000.
    Dr. Kirschstein. The average costs of a grant is about 
$300,000 per year.
    Mr. Regula. Oh, that would be $300,000 per year. But the 
commitment is maybe $900,000.
    Dr. Kirschstein. The commitment may be $900,000 or more.

                        PROGRAMS AND INITIATIVES

    Mr. Regula. Biomedical research has become more complex and 
requires more than just biomedical scientists. It also requires 
the expertise of mathematicians, computer scientists and 
engineers. What is NIH doing to bring other disciplines such as 
I just outlined into the biomedical research community?
    Dr. Kirschstein. We have specific programs and initiatives. 
We have one called Biomedical Information Science and 
Technology Initiative, BISTI, B-I-S-T-I, and we have 
specifically developed new training programs, because one of 
the things that is important is that biological scientists are 
not skilled in some of these new computer and mathematical 
technologies and mathematicians and physicists do not know much 
biology. The National Institute of General Medical Sciences has 
juststarted a training program as well as a research grant 
program in computational biology and there will be cross-disciplinary 
activity.
    We also have the new institute that Congress enacted at the 
end of the last session, the National Institute of Biomedical 
Imaging and Bioengineering. In preparation for the activity 
that I have been describing to you for the last several years, 
we have had an Office of Bioengineering, Bioinformatics and 
Bioimaging, which has been operated out of the Office of the 
Director. That office will merge into the new institute.

                       FDA APPROVAL OF NEW DRUGS

    Mr. Regula. Question, Dr. Kirschstein, are we creating a 
bottleneck of discoveries with limited ways to put them to use? 
In other words, is the Food and Drug Administration in a 
position to review on a current basis new drug therapies? Are 
our other health care agencies in a position to incorporate new 
treatment and prevention protocols into their programs? We have 
the one on cancer. Is that FDA approved?
    Dr. Kirschstein. Yes, sir. In fact Dr. Klausner would tell 
you, and if you wish him to expand he can, that it was approved 
in record time because when it was clear this was a drug of 
such importance the FDA in communication with the National 
Cancer Institute realized that it should be put on a fast 
track.
    Mr. Regula. Is it on the market now?
    Dr. Klausner. Yes.
    Dr. Kirschstein. It was approved by the FDA last week. 
Maybe you can speak to that, but it was approved last week.
    Dr. Klausner. Yes. There is an example. As we saw this drug 
developing, the NCI, the FDA, and the sponsoring company met. 
We met with the FDA to review what is coming down the line. 
This took about 2\1/2\ months from the presentation by the 
company for a new drug application for approval. It was 
approved last Thursday, I believe, and it is available on the 
market I am told as of this past Monday.

                   GLEEVEC AVAILABILITY TO THE PUBLIC

    Mr. Regula. I am intrigued by the fact that the drug 
company, as I understand it, is saying if your income is less 
than $48,000 they will provide the drug free of charge.
    Dr. Klausner. That is right.
    Mr. Regula. Then it is a sliding scale from that point 
upwards?
    Dr. Klausner. Up to $100,000.
    Mr. Regula. It is a couple thousand a month.
    Dr. Klausner. It is between $2,000 and $2,400 a month.
    Mr. Regula. Isn't that a unique arrangement?
    Dr. Klausner. Many drug companies have indigent patient 
programs, but I think this is to my mind the most impressive 
that I have seen.
    Mr. Regula. You made a statement, and it is news to me, 
that drug companies have indigent patient programs.
    Dr. Klausner. Yes, that is quite common.
    Mr. Regula. How does that work? Does the patient take his 
financial statement to the drugstore?
    Dr. Klausner. Well, to be honest, I don't know how each of 
the programs work, and so maybe what we can do is provide you 
some written information about how these different indigent 
drug programs work. But it is quite common.
    [The information follows:]

            Novartis Patient Assistance Program for Gleevec

    Many individual pharmaceutical companies offer patent 
assistance programs to help patients who cannot afford their 
needed medications; however, there is no standard across the 
industry. Some are formal and apply across the company; others 
are informal and are designated to accommodate specific factors 
about individual drugs such as availability. In the case of 
Gleevec, developed and produced by Novartis, the company 
operates the ``Gleevec Reimbursement Hotline.'' Currently, 
patient assistance is only available for Gleevec if the patient 
is being treated for chronic myeloid leukemia. Dr. Daniel 
Vassella, GEO of Novartis, described the patient asistance 
program at a recent press conference announcing the Food and 
Drug Administration approval of Gleevec. According to Dr. 
Vassella, Novartis provides Gleevec at no cost for those 
uninsured patients whose income is less than $43,000. For 
incomes in the $43,000 to $100,000 range, uninsured patients 
contribute on a sliding scale. Gleevec Hotline staff assist 
patients seeking to receive the drug under the patient 
assistance program.

    Mr. Regula. I don't think the general public knows that 
because there is a tendency to attribute many ills to the drug 
companies' financial practices, and that is probably something 
that is not widely known in terms of a service they provide the 
public.
    Mr. Peterson, would you take the Chair. I think Mr. Jackson 
and Mr. Kennedy have some more questions on another round.

                              RURAL HEALTH

    Mr. Peterson [presiding]. Thank you and good morning. You 
have both had a round, right? So I will take one and then we 
will come back to you. On page 7 of your written testimony you 
talk about eliminating health disparities and, as you go on and 
read, you talk about women's health, minority health, but I 
never see the word ``rural,'' and I want to tell you the 
disparity between rural and urban is immense. Why is it not in 
here?
    Dr. Kirschstein. It is not there as rural. It is there as 
underserved populations and indeed the name of a new center is 
the National Center for Minority Health and Health Disparities. 
Now what we have done is actually started planning in a broad 
way for minority health, but we have many programs and have 
been involved in programs relating to rural health for some 
time. All of the institutes have outreach programs which go to 
the community, rural and urban, disadvantaged and underserved 
populations. So we are not ignoring it.
    In the more lengthy statements, particularly mine and 
particularly from the National Center and furthermore probably 
some of the other institutes like the Cancer Institute, the 
Heart Institute, and the Infectious Disease Institute, there 
really is a great deal more about rural health. We are fully 
cognizant of the need.
    Mr. Peterson. It is not uncommon to have the word ``rural'' 
not used, but a lot of Americans live in rural America. It is a 
large population. In my State it is a third of the people. In 
Pennsylvania a third of the people live in towns less than 
2,500. That is rural. I just want to make the point very 
strongly that it would be more comforting if the word were 
included. I guess I am not surprised that it is not because I 
have ran into it for years.
    Dr. Kirschstein. We will take that under advisement.
    Mr. Peterson. Because health care should be available to 
everybody.
    Dr. Kirschstein. Absolutely. One of the problems is the 
delivery of health care in rural populations, because the 
physicians are not necessarily there. But we are involved in 
some of the activities in that regard as well.
    Mr. Peterson. If you could help us outline the disparity in 
the payment system, if rural got a fairer, not equal tobut a 
fairer part of the payment system in rural, because the quality of life 
is there.
    Dr. Kirschstein. Unfortunately, that is not within the 
jurisdiction of NIH.

                           CLINICAL RESEARCH

    Mr. Peterson. I know that but if you can help point out the 
disparity, you can help us with the message.
    Clinical research, earlier you talked about clinical 
research, delivering basic discoveries into medical practice. 
What percentage of your budget goes into clinical research?
    Dr. Kirschstein. About a third.
    Mr. Peterson. About a third.
    Dr. Kirschstein. Has that figure been constant? I am a new 
player here.
    Dr. Kirschstein. I think it may have been constant, but one 
of the things that I think is important is that the 
opportunities for clinical research are greater than they have 
ever been before, and I think we will be finding that there are 
increases going on, and one of the ways we are going to get to 
that is twofold. We need more clinical researchers. We need 
more people who have finished their entire medical school, 
professional school training, gone on to internship and in some 
specialization, who at that point in their lives are in their 
30s, may have started families, and the daunting idea of going 
back to learn the skills of research on top of having learned 
clinical medicine needs some incentive, and we have got several 
incentives.

                         LOAN REPAYMENT PROGRAM

    Now for the first time starting in fiscal year 2002, we 
have the ability to have a loan repayment program for people 
who have finished medical school, professional schools, dental 
schools, other schools, who want to do clinical research who 
can come to NIH from universities and to areas around the 
country and we will provide loan repayment for them up to 
$35,000 a year for 3 years.
    Now this is something new for NIH in terms of having had 
the many legislative mandates to be able to do it for the 
country as a whole. We have had this program for scientists, 
clinical scientists within our own NIH intramural program on 
the Bethesda campus, so we are feeling our way and we will 
start in fiscal year 2002 with a pilot program because we do 
not know quite how it will run. We are estimating that we will 
provide about 260 individuals with loan repayment the first 
year; that is about $28 million. And because when you pay the 
$35,000 a year the law also provides that we have to pay the 
taxes on the interest on the loan, and that together with the 
$35,000 comes to about $100,000 a year per individual. We will 
do that through a mechanism that requires us to have an 
individual contractual arrangement with each one of these 
individuals, and that will be through our research and 
development research contract line. I know there has been some 
concern as to why that line increased, and that is the reason 
for it. Once we see how the program is established and working, 
we plan to expand it.
    Now there is a second way in which we want to expand, and 
we are expanding clinical research activities. It is that it is 
not abundantly sure or clear that within the framework of 4 
years of medical school that medical students or professional 
students of any sort, nursing students, learn to do research as 
opposed to learning how to care for patients. And so the tasks 
of learning research and how to do research, how to design a 
clinical study, how to assure that when the study is done it is 
statistically significant, how to provide information to the 
Food and Drug Administration when you submit, for example, an 
investigational new drug application, how to analyze the study 
in the end, all of that has not necessarily been taught in 
medical school.

                       CAREER DEVELOPMENT AWARDS

    So we have provided to the institutions where there are 
individuals in training grants awards called Curriculum 
Development Awards so they can teach such individuals to do 
clinical research, and then for individuals who are new 
investigators, just beginning to develop their careers, we have 
Early Career Development Awards for 5 years, free up time so 
they can do research as opposed--if they are in a university 
medical school community service area, but particularly medical 
schools--they can free up time from having to see patients 
purely for care, and those individuals are in turn mentored by 
people in their middle career. So we have a Mid-Career 
Development Award, which is people who are further along but at 
the same time mentor the young people. And with that, we are 
hoping to be able to increase the pool of clinical 
investigators.
    We have made some estimate of how many awards in each of 
these categories we would make and we have doubled the amount 
for the young people. We have got 49 of the Curriculum 
Development Award. We think that pretty much covers the 
waterfront. We also have a loan repayment program for 
underserved individuals, which means that people from rural 
areas, for example, who went to medical schools who are 
disadvantaged and maybe go back to the rural area would be 
eligible for a program.
    Mr. Peterson. How large a program is that?
    Dr. Kirschstein. That is just starting and we will be 
making a few awards this year, so I can't tell you how much 
that will be yet.

                            AWARDING GRANTS

    Mr. Peterson. I would like to talk to you about that. 
Following up on the conversation you had with Chairman Regula, 
let's assume that I have successfully got a grant from you for 
200,000 a year for 5 years, X university. Let's say 3 years 
into it, it is showing a lot less promise. Do you ever pull the 
plug, or is this commitment there whether I am succeeding or 
not?
    Dr. Kirschstein. No. Every grant that is awarded is 
overseen within one of the institutes by an administrator with 
a scientific background. We call them health scientist 
administrators. It is their responsibility to follow the 
progress that is going on in the particular portfolio of grant 
that they oversee. Each grantee is required to submit a yearly 
progress report. We encourage our scientist administrators to 
keep contact with their grantees and, if there are some 
specific difficulties, to work with them to see if they can 
correct them. If there is something that really goes wrong and 
the scientist, the grantee is either not responsive or not 
submitting progress reports, under rare circumstance we might 
pull a plug.
    Mr. Peterson. But not very often.
    Dr. Kirschstein. That is right, because we want to be in a 
cooperative mode to make sure that our initial investment was 
properly made, because if we pull a plug then that money is 
down the drain.
    Mr. Peterson. We all make mistakes in judgment, and I know 
in our society we are very hesitant to admit to that and pull 
the plug.
    Dr. Kirschstein. Dr. Baldwin, who is responsible for this, 
may want to add something, but I think we are doing apretty 
good job.
    Dr. Baldwin. When we make these awards as grants, they are 
not contracts. This is an assistance mechanism where we are in 
a shared activity with the grantee. Your first priority as a 
project officer would be to work with that grantee, to see 
where there were problems. If a grantee is having problems, he 
or she may want to come to you and say, ``I need to change the 
direction and do something else within the scope of the 
research grant that I have started, or this line of 
experimentation did not work and I want to shift it in another 
way.''
    The obligation, as Dr. Kirschstein pointed out, is to make 
sure that our initial investment is maximized and you would 
work with that investigator to make sure that was a productive 
course. It would be very rare that we terminate funding because 
in the 4-year grant the investigator really wants very much to 
have a successful line of research. It is our intention to work 
with investigators to see that they do that.
    Mr. Peterson. There are times that things are not going the 
direction we think they are going to or not as much promise as 
we had hoped.
    Dr. Baldwin. But there is the opportunity within a grant, a 
mechanism to make adjustments, to make changes. Maybe one 
animal model did not work as well. You want to try something 
else, maybe another line of inquiry. So the incentive there is 
to work on that so it is something that is successful.
    Dr. Kirschstein. Because we also know other people within 
that university setting or other scientists in universities 
around the country who might be able to help them, we try to 
make matches with people so they can get ideas and suggest that 
they attend conferences and suggest they collaborate with other 
scientists. We do everything we can to make sure that it is 
successful.
    Mr. Peterson. Okay, thank you.
    Mr. Kennedy.

                     ASTHMA AND ENVIRONMENTAL RISKS

    Mr. Kennedy. Thank you. Would you explain the 
interinstitute work done between the National Heart, Lung, and 
Blood Institute and the National Institutes on Environmental 
Health Sciences and Infectious Diseases to address the 
incidences of asthma and the environmental risks and how we are 
going to address this growing epidemic?
    Dr. Kirschstein. I think what I would like to do is ask 
each of the three institute directors to give us a little bit 
of a flavor of what is going on. Let's start with Dr. Lenfant, 
the Director of the Heart, Lung, and Blood Institute, going to 
Dr. Fauci next and then Dr. Olden.
    Mr. Kennedy. Thank you.
    Dr. Lenfant. Thank you. Mr. Kennedy, as you point out, the 
Asthma Program is indeed shared between three institutes, the 
Environmental Health Institute, the Allergy and Infectious 
Diseases Institute, and us. We coordinate our research 
approaches in the sense that asthma has been a huge, difficult 
disease to address. There are many aspects which need to be 
investigated and that is shared between the three institutes. 
Our institute does a fairly substantial complement to that 
disease.
    Now, your question, as I understand it, is the prevalence, 
the incidence, and what are we doing to deduce the cause. Today 
we consider there probably are 12 million people in the United 
States who may suffer from asthma, with a higher prevalence 
among children and, among children, a higher prevalence in 
minorities and disadvantaged populations.
    Let me also say, as I pointed out the last time we were 
here, Mr. Kennedy, that asthma is a chronic disease, which is 
serious but basically if it is well addressed by the patients 
and the family and the environment in which that person lives, 
no one really should die from this condition. Yet we have in 
the United States between 5,000 and 6,000 patients who die each 
year from, quote/unquote, severe asthma. But the fact is that 
it does not need to be severe except in some very exceptional 
circumstances.
    To address it there are a number of ways to reduce the 
prevalence and the incidence, hopefully. There are of course 
many, many research programs which address the cause of the 
disease and how we can address it. There are some observations 
which have been made which are terribly exciting and very 
promising, which is the interplay, if you want, between early 
infections and how controlling these early infections may in 
fact lead to the development of asthma, and the issue here is 
the following. There are some populations in this world where, 
as you know, early infections are a terrible problem. When I 
say early, I mean infant, almost from birth on. And the 
prevalence of asthma in these conditions is far less--in fact 
nonexistent as opposed to Western countries where you have 
control of all these infectious processes. So that is an avenue 
which is being pursued very actively and which is very exciting 
and I believe promising.
    Dr. Kirschstein. Maybe we should ask Dr. Fauci to follow 
that.

                            ASTHMA PROGRESS

    Dr. Lenfant. In lieu of control, if you want, in the 
general population there is a program called the National 
Asthma Education and Prevention Program, which brings together 
all the Federal agencies as well as the voluntary organizations 
and professional societies which are interested in having a 
commitment to the treatment of asthma. Are we making progress? 
I think so. First of all, the mortality is reducing, slowly but 
is reducing a little bit. And second, especially children get 
better treatment, and we know that by the number, the index 
which is used to measure that, which is how many days they are 
missing school, whether they have a normal life or not, and all 
of these are actually positive.
    So with that, I think I should let my colleague speak.
    Dr. Kirschstein. Dr. Fauci.
    Dr. Fauci. Thank you, Mr. Kennedy, for giving me the 
opportunity to address this issue. I agree with Claude 
completely. There is a very strong interaction and synergy 
between the three institutes: NIAID, Heart, Lung, and Blood, 
and you will hear in a moment from Environmental Health 
Sciences.
    The reason I am pleased to be up here is that a couple of 
questions that were asked during the hearing by you 
specifically relate to this particular area. One is the 
disparities in health that Mr. Jackson mentioned and the other 
is the role of behavioral research, and I think that we can 
address both of these very briefly.
    With regard to the role that NIAID plays in collaboration 
with our sister institutes, we cofund several initiatives with 
the Environmental Health Institute, including the Asthma and 
Allergic Diseases Research Center, which look at fundamental 
basic mechanisms. Since ours is an institute that is involved 
predominantly with immunological mechanisms, we look very 
carefully at theimmunological mechanisms themselves and 
triggers, such as environmental triggers that actually induce these 
immunological mechanisms.
    With regard to the disparities it is clear that asthma is 
right there among the top disparities between white and African 
Americans, not only in the incidence of asthma. The actual 
disparity is greater in children. The difference in 
hospitalizations between whites and African Americans is about 
three to four times among African Americans and deaths are four 
to six times greater. One of the areas that we have focused a 
lot of attention on is our Inner City Asthma Program, where we 
have made some very simple observations related to the 
prevalence of seemingly mundane things like the presence and 
abundance of cockroach allergens in inner city apartment 
complexes which trigger asthma, and also the lack of education 
among the physicians caring for these patients, as well as the 
patients themselves. In what we call self-management, we have 
developed some very simple mechanisms like education by nurses 
who go into the home to teach individuals how they can manage 
their asthma themselves. We have already started to show a 
significant impact on decreasing the hospitalizations and 
decreasing the disparities. So we believe it has been a very 
successful program.
    Mr. Kennedy. That sounds very promising and I am excited 
about it, and I would love to get some more information on 
that.
    Dr. Fauci. I would be happy to provide that.
    Mr. Kennedy. That is terrific. Thank you for your good 
work.
    [The information follows:]

    The NIAID is forwarding to Mr. Kennedy's office a summary 
of NIAID research programs in asthma; a summary of NIAID funded 
major research advances; along with a copy of the booklet from 
the NIAID/NIEHS Bi-Annual Asthma Research Centers Meeting, 
which was held June 7-8, 2001. The booklet includes summaries 
of the research conducted in the Asthma and Allergic Diseases 
Centers program, the InnerCity Asthma Study, and several other 
projects in allergic and respiratory diseases. Copy retained in 
Committee files.

                                 ASTHMA

    Dr. Kirschstein. Dr. Olden, the Director of the National 
Institute of Environmental Health Sciences.
    Dr. Olden. Thank you, Mr. Kennedy. I will not repeat what 
Dr. Fauci and Dr. Lenfant emphasized, but let me say you are 
right in your statement that asthma is both a genetic and an 
environmental disease. We are supporting a number of projects 
that are different from the ones that you have just heard 
about; for example, the National Allergen Survey that we have 
conducted in partnership with Housing and Urban Development, 
where the objective was to identify allergens by population-
based sampling in homes in the U.S. That study is now complete 
and has been reported out.
    The other effort that we have ongoing is the health effects 
of air pollutants. We provide probably more than 50 percent of 
the science that is used by regulatory agencies, such as the 
Environmental Protection Agency, in setting regulatory 
standards for things like ozone, acid, aerosols, and so forth. 
We have two major efforts in this area. One is on lung 
development and function as it relates to the severity of air 
pollution, and that study is being carried out in California.
    Next we have a number of studies on health disparities, not 
only poor versus affluent but also urban versus rural. And 
these studies again are very significant. In cities like New 
York City, where we compare asthma rates in areas like 
Greenwich Village versus East Harlem versus the Soho District 
of New York, and the hospitalization rates are 16 times 
different. In other words, the poorest area is being the most 
impacted.
    And finally, we created with CDC and the Environmental 
Protection Agency in 1998, eight Children's Environmental 
Health Science Research Centers. The focus is on translation of 
the basic sciences into intervention strategies, and most of 
these centers are focusing on asthma.
    Mr. Kennedy. Terrific. I would like to visit one of those 
and see how it is working.
    Mr. Peterson. Would the gentleman yield?
    Mr. Kennedy. Yes.
    Mr. Peterson. Sir, in your studies of parents, do you 
separate the smokers and nonsmokers?
    Dr. Olden. In the study that Dr. Fauci indicated, the Inner 
City Asthma Project, the first phase of the project was to look 
at the effects of things like smoking indoors on the severity 
of asthma. And so yes, we do separate smokers from nonsmokers.
    Mr. Peterson. So in your final conclusions you have a 
conclusion for nonsmokers and for smokers?
    Dr. Olden. Yes.
    Mr. Peterson. I think that is very important because every 
study I have seen has a huge difference. The combination of 
smoking and other pollutants is the deadliest.
    Dr. Olden. The first phase of the project, as Dr. Fauci 
indicated, was to identify what triggers asthma, or what are 
the allergens. Cigarette smoking was one of them, and dust 
mites and cockroach allergens were others.
    Mr. Peterson. Thank you.

                           THE AGING PROCESS

    Mr. Kennedy. Thank you. I would like to conclude by going 
back to one of my original questions on the mental health 
issue, seniors, what you are doing to address the aging 
population and not chalk off depression as part of the natural 
aging process.
    Dr. Kirschstein. Dr. Richard Hodes can tell you about that. 
He is the Director of the National Institute on Aging, and I 
think he has a good story to tell.
    Mr. Kennedy. Thank you.
    Dr. Hodes. Thank you for the question and for the 
opportunity. As you have noted, it is really critical not to 
chalk off depression or a great many other problems that can 
accompany aging as normal accompaniments of aging. In the case 
of mental health and other such disorders, we work closely with 
other agencies, including the National Institute of Mental 
Health. Another prominent area of concern is changes in 
cognition, dementia, and Alzheimer's disease. In addition to 
studies that are directed as to specific disease processes, we 
are working to try tounderstand the processes that occur as a 
part of aging to determine which of those are in fact modifiable.
    For example, in studies which have followed rates of 
disability among older people in longitudinal studies, the fear 
that as we have succeeded in increasing longevity we might see 
an inevitable increase in disability, is not substantiated. 
There is a real preventive aspect of disability reflected in 
the fact, for example, that in longitudinal studies followed 
since about 1982 through the present, if one predicted the 
number of people who would be disabled at present based on the 
rates that were in existence in 1982 and compared those to what 
have been observed at present, there has been a dramatic 
decrease that equates to something like 2 million fewer 
Americans disabled than would have been the case if the rates 
had not changed.
    That is a critical observation, but it is also a challenge 
to try to understand what factors are responsible for decreases 
in disability and what can be done to increase and even 
accelerate this trend.
    Among the aspects which have likely contributed to the 
decrease, which have great correlations, are some which are 
medical and technological and others that are behavioral. For 
example, the increased education levels in older Americans as 
cohorts who come through, who have been better educated and 
have learned undoubtedly to modify some of the behavioral 
aspects of their lives, appear to be some of the most specific 
and strongest correlates. It has been gratifying that these 
changes and improvements in the most recent studies reported 
this month have extended to men as well as women, and for the 
first time to minority populations. The actual improvement in 
disability rates has been occurring at a more rapid rate, for 
example, in black than in non-black populations in this 
country.

                        AGING AND MENTAL HEALTH

    Mr. Kennedy. That is encouraging, to get back to the point 
of behavioral science and how important behavioral science is 
in limiting disabilities. But in terms of mental health, given 
the high incidence of mental health, depression and the like 
amongst senior citizens and the senior boom population, what is 
our policy in the Aging Institute to address this enormous 
challenge to our medical community in that right now there is 
an overutilization of service really as a result of undiagnosed 
mental illness?
    Dr. Hodes. Yes. In that respect we are working with the 
National Institute of Mental Health in trying to assess the 
accuracy of diagnosis and ultimately to improve interventions, 
both behavioral and pharmacologic. Some aspects of alternatives 
for care, which have been most promising as well, now have 
enriched options beyond, for example, an extreme 
institutionalization versus unsupported independent home care. 
And a great deal of research is looking to identify ways in 
which, in depression and other illness, it is possible to 
provide the right sort of support to maximize independence, to 
be cost effective and, most importantly, maximize the quality 
of life for those affected.
    Mr. Kennedy. I will be interested in working with you to 
develop a policy on this because I think we will need one to 
try to make the golden years golden for seniors.
    Dr. Hodes. Thank you. We look forward to that.
    Mr. Regula [presiding]. Mr. Miller.
    Mr. Miller. Dr. Kirschstein, it is nice to see you again. I 
am sorry I missed the very beginning of this hearing. I always 
enjoy coming to hear presentations by the NIH, and I would like 
to come out to visit NIH.
    Mr. Freeh is testifying for the final time across the hall 
and there is some controversy surrounding that, and luckily we 
don't have that controversy.
    Mr. Regula. He got C-SPAN this morning.

                    ORGANIZATIONAL STRUCTURE OF NIH

    Mr. Miller. As John Porter used to say, this is the crown 
jewel of the Federal government. It is always so exciting for 
me to be a strong supporter of the NIH. I have some concerns 
and I see organization charts of the NIH and I keep seeing it 
gets larger and larger and larger. And it is growing through 
the Appropriations Committee because when is the last time it 
was ever reauthorized?
    Dr. Kirschstein. 1993.
    Mr. Miller. 1993.
    Dr. Kirschstein. Some individual parts, but the total 
reauthorization for NIH, 1993.
    Mr. Miller. How many different agencies or centers, 
institutes have been created in NIH through the appropriations 
process?
    Dr. Kirschstein. Through the appropriations process? There 
is one that I know of.
    Mr. Miller. The Imaging Institute.
    Dr. Kirschstein. No, that was created through other 
legislation. The National Center for Minority Health and Health 
Disparities was created through legislation. I believe the 
National Center for Complementary and Alternative Medicine was 
created through appropriations. I think that may be the only 
one.
    Mr. Miller. So they are getting authorization. I get 
concerned. One thing Congress is always getting criticism for 
is earmarking. However, one thing we are always proud of, I 
thought, is that we do not earmark NIH. We are on a slippery 
slope if we have to put this much money for cancer research. We 
do not want to go down that road, and I hope the new chairman 
will concur with that. In some agencies we do a tremendous 
amount of earmarking. How do we avoid that problem and that 
slippery slope? I know, for example, my colleagues from less 
populated, smaller States that don't get a lot of money and 
say, wait a minute, we do not get our fair share of money and 
the people from Massachusetts say we get more than our fair 
share of money. Florida, I am not sure how we fit in but I am 
not sure that is a critical decision to even consider.
    We have gone through the debate of critical decisions that 
AIDS gets more per capita than cancer does. I am really 
concerned that politics is going to drive the budget agenda and 
I really think it will affect the country's support of NIH. 
Comments on that in general?

                           PEER REVIEW SYSTEM

    Dr. Kirschstein. I think you are absolutely right. The 
bedrock of what NIH does and the thing that makes it what Mr. 
Porter called the crown jewel is the quality of the science, 
and that is inherently focused by the peer review system. On 
the other hand, as we were saying to Mr. Istook and Mr. Wicker 
this morning, it is true that there probably has been less 
attention paid to helping to develop some of the areas, 
particularly 23 States which do not have a certain level of 
support, as well as Puerto Rico, and we now have designed 
programs that can bring those States funds for feasibility 
studies, planning grants that we will provide to the academic 
institutions that have joined in consortia from one or twoat 
the most from within those States, to provide a grant of money, $2 
million a year for 3 years, to see what they can do to find a strength, 
a scientific strength that can then be moved forward.
    Mr. Miller. I hope we do not get to the point where we say 
this university gets this money.
    Dr. Kirschstein. No, I think you are absolutely right, but 
we do want to see if academic institutions, if they work 
together, can find some small, maybe larger part of a 
scientific area that they can develop and make it into an area 
which is suitable to pass a peer review institution.
    Mr. Miller. The institutional award system has increased?
    Dr. Kirschstein. That is what I am talking about.
    Mr. Miller. We do set aside for the minority medical 
schools research monies, right?
    Dr. Kirschstein. No, we do not set aside.
    Mr. Miller. It is a straight line item; isn't that a better 
way to say it?
    Dr. Kirschstein. No, there is now a National Center for 
Minority Health and Disparities.
    Mr. Miller. What is the one in Memphis?
    Dr. Kirschstein. The Department has an initiative in 
Nashville, where money for Meharry was provided, and I do not 
know. That is not at NIH.
    Mr. Miller. That is HHS.
    Dr. Kirschstein. Is that correct, Dr. Ruffin?
    Dr. Ruffin. That is correct.
    Mr. Miller. I hope this administration will resist the 
temptation by Congress to get into that slippery slope. Nothing 
may be even. Mississippi may complain about something but they 
have more military construction than another state and someone 
else has more NOAA research. So it will never be 100 percent 
even. We cannot make that our goal. We need to stay focused on 
that.

                         ORGAN TRANSPLANTATION

    Let me switch to one issue. Organ donations have been a 
problem. There are only limited numbers of organs. What is the 
research being done as far as living donor type programs? I 
know people share some organs and such, and where is that 
leading and what is NIH doing in the whole issue of organ 
donation?
    Dr. Kirschstein. As you know from your visit, Mr. Miller, 
the NIH has considerable programs related to organ donations, 
but primarily aimed at making sure that when an individual 
receives an organ that it is such that it will not be rejected 
because of the immune response. And for example, the National 
Institute of Allergy and Infectious Diseases and the Institute 
on Diabetes, Digestive, and Kidney Diseases because kidney 
transplants--and presumably as they develop, islet cell 
transplants--will be very important to both of them.
    Mr. Miller. How about the growth of organs in a laboratory; 
is that science fiction?
    Dr. Kirschstein. Let's get Dr. Fauci and we will go 
further. Talk about the network.
    Dr. Fauci. There are several ways to answer the question, 
and I won't take the time to do that. I will just give you one 
or two. There are a few areas of research that are relevant to 
the problem that you are addressing. One of them has to do with 
the immunological mechanisms that are responsible for the 
rejection of transplanted organs, be they cells that are 
infused or be they whole solid organs that are transplanted. 
What we have been doing in collaboration with the Diabetes 
Institute has been looking at the question of tolerizing 
individuals; for example, the infusion of islet cells of the 
pancreas in order to hopefully cure diabetes. There have been 
very striking results--Dr. Spiegel might want to elucidate--on 
individuals who are given pancreatic islet cell transplants 
with a new form of immunosuppression, with a larger number of 
islet cells that were transfused and with the deletion of 
glucocorticoids from their regime. The results were truly 
striking, and these individuals are no longer insulin 
dependent. What we are looking at now is trying to get the 
immune system to not recognize these particular transplanted 
cells and hopefully, in the future whole organs like kidneys 
and liver to not recognize as foreign. This immunological 
mechanism is called tolerance, where you essentially fool the 
body's immune cells that are specifically geared towards 
rejecting the transplant in a way that they can see it but they 
do not react against it. We think that that is going to have a 
major impact on the arena of transplantation. It also extends 
to manipulating immune systems for autoimmunity for asthma, et 
cetera, but the main flagship of that has been and will 
continue to be the area of transplantation.
    Dr. Kirschstein. Dr. Spiegel, from the Diabetes Institute, 
wants to add something.

                             MOTTEP PROGRAM

    Dr. Spiegel. Thank you very much, Mr. Miller. Let me 
address both end-stage kidney disease, and end-stage liver 
diseases for both of which there are insufficient donor organs 
available. Certainly I will come back to what Mr. Istook said, 
prevention of both of these is of course the hallmark, the 
crucial issue in terms of preventing even the need for a 
transplant, and we have important programs in effect both in 
terms of liver but particularly in terms of kidney disease; for 
example, blood pressure control and the so-called ACE 
inhibitors as a way of preventing the progression to end-stage 
kidney disease where you need either dialysis or an organ 
transplant.
    But to get to your question in terms of the inadequate 
number of donors, of course living kidney donors, that has been 
state of the art for some time. But in some populations there 
are not sufficient donors available. For this we have a program 
called MOTTEP, specifically to increase among minorities, 
particularly African Americans, the number of donors, to 
increase awareness in the community. In Native Americans we 
have actually made videos, which I have viewed, to go out to 
various tribal leaders and try to make them aware of certain 
cultural issues and sensitivities in terms of organ donation. 
But this is important because as I have said before, diabetes 
is rampant in Native Americans, is decimating individuals 
because of kidney failure.
    And finally, there have been interesting developments in 
terms of living donor liver transplantation, not just parent to 
child but also adult to adult. This is an important 
development, but one I think we have to watch cautiously, and 
for this reason we have an important workshop which will be 
implemented in the form of a data base to see the long-term 
effects not only in terms of the recipients but the donors.
    So these are ways to increase the availability of 
transplantation. As I said before, prevention with the kind of 
targeted therapies that we heard about will be more of a cost-
effective solution.
    Dr. Kirschstein. Then of course it is possible to dowhat 
has been called reparative medicine or tissue engineering. A great deal 
of work has been going on in which cells from various organisms are 
grown in a culture in order to see whether they can be possibly used in 
that regard. Most of that success is related to skin grafts for burns, 
but a great deal of other activities is going on. In fact, this summer 
we will be having our annual Bioengineering Conference, and it will be 
on reparative medicine.
    Mr. Miller. Thank you very much. We are all very proud of 
what you do and proud of what the NIH is. Thank you very much 
for everything. And I would like to follow up on other issues 
but we need to move on.
    Mr. Regula. Time is our enemy on this stuff. Mr. Jackson.
    Mr. Jackson. Mr. Chairman, I have no further questions.

                           STEM CELL RESEARCH

    Mr. Regula. Tell me about stem cell research and 
particularly, I read where they think that other sources for 
stem cells would be available. What is the story on that?
    Dr. Kirschstein. Mr. Chairman, there have been many reports 
recently in both the literature, scientific literature and also 
in the media, about the type of stem cell that is called an 
adult stem cell. It is a less differentiated cell that is 
derived from adults, particularly animals, but some humans as 
well. For one reason or another the cell is not developed to 
full maturity but may be somewhat able to form other issues 
than the tissue from which it is derived.
    There have been reports of fat being used for adult stem 
cells, reports of blood cells, hematopoietic cells, reports of 
blood cells from the umbilical cord blood being used as stem 
cells. In addition, in animals of course there have been 
studies of embryonic tissue and there have been some studies 
using human fetal tissue. Such studies using fetal tissue are 
legal to be done using Federal funds, as are animals studies 
using animal embryonic totipotential cells. Studies using human 
embryonic totipotential cells cannot be done. Therefore, if 
there is work going on in that regard in this country, and we 
believe there is but we do not know, it is being done with 
private sources of funding.
    The guidelines that were published in final form last 
December related to the use of human embryonic pluripotential 
cells and fetal cells must be followed if Federal funds are 
used, so that any work that is being done on human embryonic 
cells using private funds--neither has to follow the guidelines 
nor do the individuals have to report in any way either by 
scientific publication or any other way to their scientific 
colleagues, to the Federal Government or to anyone else. It is, 
therefore, almost impossible to compare properly the studies on 
adult human stem cells with the work that is being done on 
human embryonic stem cells. What we know from animal studies is 
that there is potential for both, and there have been some 
comparative studies using animal cells. But we really do not 
know. This is why I said at the previous hearing and I repeat 
today that until we have a full comparison it is going to be 
very, very difficult to make determinations about this. And at 
the moment this is a field that is probably moving very, very 
rapidly, but we don't have the full picture.
    Mr. Regula. Another issue that came up in our public 
witness hearings was the so-called rare diseases, and the 
feeling that, well, it is not a rare disease if it afflicts 
you. The question is how do you decide whether or not to do 
research on rare diseases?

                             RARE DISEASES

    Dr. Kirschstein. You are absolutely right. Any disease that 
affects particular individuals is a disease that needs to be 
studied and we should do something about it. A rare disease, 
there is a specific definition of a rare disease, which frankly 
I cannot remember at the moment, but I am sure my staff will 
find it for me. But it is a matter of what the prevalence of 
that disease is among the population. Does it effect one in X 
number of people, et cetera.
    We do indeed do a great deal of research on so-called rare 
diseases. Indeed, we have an office on rare diseases within the 
Office of the Director. It is an outgrowth of what the Food and 
Drug Administration has had for a very long time, which is an 
Office on Rare Drugs for Rare Diseases, for which there is not 
very much incentive to develop some of those drugs and the FDA 
had special provisions by which those could be developed.
    We spend approximately $2.5 billion a year on various rare 
diseases throughout all the institutes because there are rare 
diseases that affect the nervous system, there are rare 
diseases of the blood system, there are rare infections. There 
are rare diseases that affect the musculoskeletal system. So 
that we do do a great deal of research on rare diseases, but it 
is coordinated through this office which hold workshops and 
provides information very broadly through a rare diseases 
database to the organizations which have been formed around the 
country, not only of advocates of particular rare diseases, but 
to an organization, for example, called the National 
Organization for Rare Diseases, NORD, and others. So we do do a 
great deal of work.
    Mr. Regula. So all of that information would be on your 
web-site?
    Dr. Kirschstein. Exactly.
    Mr. Regula. So that an individual who had a rare disease--
--
    Dr. Kirschstein. The office also handles inquiries and 
other institutes do also. About a particular rare disease, 
people are even referred them to the website or given 
information. Another thing, in order to study a rare disease, 
it cannot be done all over the country because there aren't 
sufficient numbers of people, so that if an investigator is 
particularly interested in a particular rare disease he or she 
may let the world know that and provide for these patients and 
their families--there are very often young children involved--
to come to either the NIH intramural program or to a particular 
center for a clinical research study so as to accumulate with 
such a number of patients to be able to make important 
determinations.

                       CLINICAL RESEARCH PROJECTS

    Mr. Regula. How do you decide--do you take some individual 
cases or private patients out there?
    Dr. Kirschstein. No, sir, the hospital is the largest 
research hospital in the United States, and the patients who 
are cared for there are involved in and must be enrolled in 
studies, protocols, which are the way one does a clinical 
research project.
    Mr. Regula. They have to agree to certain conditions?
    Dr. Kirschstein. They have to agree to come. They have to 
be within the study that is being investigated within the NIH, 
and they have to agree to enter a research project. In 
addition, we have some studies that involve so-called normal 
individuals who participate in studies to set normal 
parameters. Theseare volunteers.
    Mr. Regula. Do you want to comment on the----
    Dr. Kirschstein. Yes, my colleague suggests that I tell you 
that all the clinical research that is supported by NIH is, and 
you, I believe, saw a demonstration of this the last time you 
were there, on a database called clinical trials.gov run 
through the National Library of Medicine, in which every 
clinical trial supported by NIH, including these on rare 
diseases, is listed and patients can go to that for 
information.
    Now the law requires that we expand the database to be on 
all clinical trials, which is an enormous task, so we are 
gradually moving to include trials done by private 
organizations and then by the pharmaceutical industry.

                          EXTRAMURAL RESEARCH

    Mr. Regula. What percentage of your budget is in-house 
research as opposed to----
    Dr. Kirschstein. About 10 percent is within the intramural 
program and probably a little bit less, 9.8 or something like 
that.
    Mr. Regula. So most of it is done by a grant or contract 
with outside sources?
    Dr. Kirschstein. 80 percent of our budget goes to research 
grants and/or research contracts and a grant is, as Dr. Baldwin 
said, a shared responsibility between the university and the 
NIH, a contract is something that NIH--a research contract is 
awarded when NIH wants to have the research done and that is 
solely the government's responsibility.

                     EVALUATION OF SCIENTIFIC IDEAS

    Mr. Regula. Tell me the process of how you arrive at a 
subject that is going to be covered. For example, we have the 
pill that you can take for cancer and you have all these 
gentlemen and ladies that are Directors but how does it start? 
What is the procedure, until it gets to the university and then 
when it gets back?
    Dr. Kirschstein. First of all, a great deal of our 
research, the preponderant part of it, is based on the creative 
ideas of investigators at universities, medical schools.
    Mr. Regula. They give you the ideas?
    Dr. Kirschstein. They have ideas and they present them.
    Mr. Regula. And they would go to one of the Directors?
    Dr. Kirschstein. If it is a creative idea about what to do 
in the area of heart disease, it would go to the National 
Heart, Lung, and Blood Institute. If it is a research project 
that involves children, it would go to the National Institute--
--
    Mr. Regula. You have peer review panels that each of you 
work with; is that correct?
    Dr. Kirschstein. Yes, and we have a central group, which 
tomorrow you will hear about, the Center for Scientific Review, 
the majority of these investigator-initiated research, are 
reviewed by the panels in that group.

                           PEER REVIEW PANEL

    Mr. Regula. How do you choose the peer review panels? Do 
each of you have a voice in that?
    Dr. Kirschstein. They do and I do, but they start out by 
being, and Dr. Ehrenfeld will be able to describe this to you 
in more detail tomorrow, by determining that there is a need 
because of the volume of applications.
    Mr. Regula. As I understand it, only about 30 percent of 
the proposals you get actually are funded.
    Dr. Kirschstein. But all of them have to be reviewed.
    Mr. Regula. I understand that.
    Dr. Kirschstein. So 100 percent get reviewed and if there 
are large numbers in the area of cardiology, for example, then 
there has to be some peer review group that has cardiologists 
and physiologists who know the heart and biochemists who know 
the chemicals involved in the heart, et cetera, and clinicians 
review those grants. So we start off with that. We try very 
hard to make that a group of people who are knowledgeable, not 
only about heart disease as a whole but about the underlying 
science. They have to be representative of the population of 
the United States, women, minorities, and then they provide the 
first level of review.
    Mr. Regula. I assume each year there are new----
    Dr. Kirschstein. They have terms of 4 years. If you look at 
the members of a review group for a study section, they have a 
term for four years and they are overlapping, so about one-
fourth go off at the end of one year. So there is continuity.
    Mr. Regula. I understand. But 10 years from now the NIH 
could be doing research on diseases we haven't even heard of; 
is that correct?
    Dr. Kirschstein. Exactly. That is why----
    Mr. Regula. It is an ongoing process?
    Dr. Kirschstein. Dr. Ehrenfeld now is involved in the first 
major overhaul of the study sections for the peer review for 
the Center for Scientific Review. That has not been done for a 
long time, and the first phase of that has been finished and 
she is moving into the second phase. She can tell you more 
about that either today or tomorrow.
    Mr. Regula. Well, we have a vote on, so we are going to run 
out of time here. We will have several questions for the 
record. I was going to pursue the one on cholesterol, but I 
think we will pass it up.
    Dr. Kirschstein. Dr. Lenfant will be pleased to answer that 
for the record.

                         CHOLESTEROL GUIDELINES

    Mr. Regula. You might take a couple of minutes now. How are 
these guidelines chosen? I suppose it will change all our 
dietary habits.
    Dr. Lenfant. Mr. Chairman, as I was coming here I heard 
somebody whisper a good question, and indeed, it is a very good 
question. They do not come out of thin air. They are out of a 
result of a lengthy, thorough, deliberative process. In this 
case 27 top scientists in the country working in this area got 
together, each with their own ideas, you can be sure of that, 
and after 22 months of deliberations they have finally came up 
with what you see, and that is the best judgment. Now, the word 
``guidelines'' is a bit misleading. It is not the universal 
prescription. It is the best judgments for the most common 
case, or cases I should say. But there are people who should 
not and will not follow the guidelines. But for most people, 
that is the best recommendation we can come up from the 
viewpoint of public health.
    Mr. Regula. Will this generate new ideas on nutrition in 
terms of the impact that the food we consume has on our 
cholesterol?
    Dr. Lenfant. Yes, there are some foods, a few that you 
mentioned, the eggs that you did not take this morning. That is 
a food which is rich in cholesterol, but just to tell you the 
complexity of what we are talking about, I don't know if you 
are sensitive to dietary cholesterol but other people are not, 
so you really have to evaluate each individual case likesalt, 
for example, and high blood pressure, the object of considerable debate 
in the scientific community. You may be sensitive to salt. Mr. Miller 
may not be. That is what we have to deal with.
    Mr. Regula. Each of us processes food in a different way. 
The physiology of each person is different.

                         IMPACT ON HEART ATTACK

    Dr. Lenfant. I am going to have to take the opportunity to 
say if these guidelines are followed it is probably one of the 
best things that can happen to the treatment and prevention of 
heart attack.
    Mr. Regula. Isn't heart attack and stroke the two most 
prevalent----

                        HEART DISEASE PREVALENCE

    Dr. Lenfant. You have approximately 500,000 people who die 
in this country from heart attack each year. Stroke, I think it 
is 150,000 who die. The prevalence is the number of people 
with, say, heart disease; coronary heart disease is about 12, 
13 million people. For stroke I don't know what it is. It is 
over 700,000.

                           CANCER DEATH RATE

    Mr. Regula. That is more prevalent than cancer, isn't it, 
in terms of death rate?
    Dr. Lenfant. I think so.
    Dr. Klausner. In terms of number of deaths this year we 
predict there will be about 560,000 deaths.
    Mr. Regula. Well, thank you very much. I appreciate all of 
you being here and your patience, and we look forward to seeing 
you tomorrow.
    Dr. Kirschstein. Thank you, Mr. Regula.
    [The statements of each Institute and Center Director and 
questions that were submitted to be anwered for the record 
follows:]
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                           W I T N E S S E S

                              ----------                              
                                                                   Page
Alexander, Dr. Duane.............................................

205, 415

Battey, Dr. J.F., Jr.............................................   415
Cassman, Dr. Marvin..............................................   415
Collins, Dr. Francis.............................................   263
Dean, Dr. Donna..................................................   415
Fauci, Dr. A.S...................................................

263, 415

Ficca, S.A.......................................................   416
Gordis, Dr. Enoch................................................   415
Grady, Dr. P.A...................................................

205, 415

Hodes, Dr. R.J...................................................

205, 415

Hyman, Dr. S.E...................................................   415
Katz, Dr. S.I....................................................

1, 415

Keusch, Dr. G.T..................................................

263, 415

Kirschstein, Dr. Ruth............................................

1, 205, 263, 415

Klausner, Dr. R.D................................................   415
Lenfant, Dr. Claude..............................................

1, 415

Leshner, Dr. A.I.................................................   415
Lindberg, Dr. D.A.B..............................................   416
Maddox, Dr. Y.T..................................................   416
McLaughlin, Dr. J.A..............................................

1, 415

Nakamura, Dr. Richard............................................   415
Olden, Dr. Kenneth...............................................

205, 415

Penn, Dr. A.S....................................................   415
Pinn, Dr. Vivian.................................................   263
Quantius, Susan..................................................   416
Ruffin, Dr. John.................................................

263, 415

Spiegel, Dr. A.M.................................................

1, 415

Straus, Dr. S.E..................................................

1, 415

Tabak, Dr. L.A...................................................

1, 415

Vaitukaitis, Dr. J.L.............................................   415
Whitescarver, Dr. Jack...........................................   416
Williams, D.P....................................................   416


                               I N D E X

                              ----------                              

                     NATIONAL INSTITUTES OF HEALTH
                     Chronic Disease Theme Hearing

                                                                   Page
Acupuncture and Pain Control.....................................    65
Aging............................................................    20
Arthritis Therapies..............................................   142
Asthma Treatment.................................................    74
Asthma...........................................................   152
Bench to Bedside.................................................    85
Biomimetics......................................................   104
Bladder Progress Review Group....................................   145
Cancer and Sharks................................................   122
Cardiovascular Disease and Diabetes..............................   193
Chelation Therapy................................................    52
Cholesterol Controls.............................................   191
Chromium and Diabetes............................................   118
Chronic Diseases.................................................   111
Chronic Eye Disease..............................................    20
Clinical Research................................................   150
Clinical Research Networks.....................................181, 188
Clinical Trials for Kidney Disease...............................   199
Complementary and Alternative Therapies in Cancer................    66
Consensus Development Conference.................................    71
Cooley's Anemia..................................................   171
Cost of Diabetes.................................................    73
Cost of Health Care..............................................   115
Cost-Effective Therapies of Organ Transplantation................    76
Craniofacial Birth Defects.......................................   132
Crohn's Disease................................................120, 156
Daily Dialysis...................................................   187
Depression and Chronic Illness...................................    72
Description of Chronic Disease...................................     1
Diabetes.........................................................    73
Diabetes and Obesity.............................................   100
Diabetes Example.................................................    11
Diabetes Prevention Efforts......................................    11
Diabetes Research Collaboration..................................   183
Diabetes Research Working Group..................................   144
Diabetes Retinopathy.............................................    20
Diabetic Retinopathy Screening...................................    70
Diabetes Therapies other than Insulin............................   156
Dissemination of Information by NCCAM............................    52
Education Programs: NCCAM........................................    97
Education Programs: NEI..........................................    94
Education Programs: NHLBI........................................    88
Education Programs: NIAMS........................................    95
Education Programs: NIDCR........................................    91
Education Programs: NIDDK........................................    93
Ehlers-Danlos Syndrome..........................................57, 167
Environmental Approaches to Obesity Prevention...................    98
Ethnic Minorities and Oral Cancer................................   175
Evaluating Unproven Remedies.....................................    51
Eye Diseases of Aging Population.................................   105
Focal Segmental Glomerulosclerosis...............................   172
Funding Opportunities for Young Investigators....................    59
Funding Mechanisms for Botanical Product Studies.................   173
Future NIDDK Diabetes Research...................................   144
Gene Therapy for Hemophilia......................................    78
Glaucoma.........................................................    20
Glucosamine Therapy..............................................    67
Head and Neck Cancer.............................................   148
Health Promotion.................................................    87
Heart Disease and Treatment for Women............................    57
Helping the Visually Impaired....................................    21
Hemophilia.......................................................   121
Hepatitis C......................................................    78
Hepatitis C Coordination.........................................   123
High Blood Pressure..............................................   181
Hygiene Hypothesis...............................................   188
Hypertension and Kidney Disease..................................   192
Importance of Oral Health........................................   150
Incidence of Asthma in Households................................   190
Integration of Conventional and Alternative Medicine.............   110
Interstitial Cystitis............................................   168
Investment in Medical Research...................................    60
Islet Transplants and Stem Cells.................................   198
Islet Transplation for Type 1 Diabetes...........................    73
Jackson Heart Study..............................................   129
Juvenile Arthritis.............................................135, 159
Kidney Disease and Hypertension..................................   158
Laser Treatment for Diabetic Retinopathy.........................   107
Lasers and Age-Related Macular Degeneration......................   141
Lasik Surgery....................................................    51
Link Between Periodontal and Systemic Diseases...................   163
Liver Transplantation............................................   122
Lyme Disease.....................................................   108
Macular Degeneration.............................................    20
Medically Necessary Dental Care..................................   160
Minority Clinical Investigators..................................   179
Multicenter Randomized Clinical Trials...........................   203
Muscular Dystrophy.............................................128, 136
Muscular Skeletal Tumors.........................................   202
National Kidney Disease Education Program........................   157
Nationwide Health Tracking Network...............................    83
New Institutes...................................................   126
NIDDK and the ``Edmonton Protocol''..............................   197
Number of Individuals with Glomerular Injury Diseases............   175
Number of People with Arthritis..................................    68
Obesity Prevention and Intervention..............................   195
Opening Remarks..................................................     1
Opening Remarks--NCCAM...........................................    43
Opening Remarks--NEI.............................................    20
Opening Remarks--NHLBI...........................................     2
Opening Remarks--NIAMS...........................................    35
Opening Remarks--NIDCR...........................................    27
Opening Remarks--NIDDK...........................................    11
Opening Statement--NCCAM.........................................    45
Opening Statement--NEI...........................................    22
Opening Statement--NHLBI.........................................     4
Opening Statement--NIAMS.........................................    36
Opening Statement--NIDCR.........................................    28
Opening Statement--NIDDK.........................................    13
Oral and Systemic Disease......................................131, 147
Oral Cancer....................................................147, 163
Oral Health Research and the Native American Population..........   199
Osteoporosis.....................................................   201
Other Diseases and Retinal Degeneration..........................   141
Pain Research....................................................   102
Pediatric Heart Disease..........................................   138
Plans and Priorities for PKD Research............................   113
Polycystic Kidney Disease Research and PKD Strategic Plan........   133
Polycystic Kidney Disease Strategic Plan.........................   114
Port Wine Stain..................................................   174
Prevalence of Glomerular Injury Disorders........................   175
Prevention of Chronic Diseases...................................    80
Primary Sclerosing Cholangitis...................................   134
Priority Setting.................................................   108
Progress Being Made on Polycystic Kidney Disease.................   113
Public Advocacy Organizations....................................   162
Research Priority Setting........................................   109
Research Registries..............................................   167
Risks Associated with the Use of Botanical Products..............   142
Saliva Research..................................................   151
Scleroderma.....................................................56, 136
Sickle Cell......................................................   176
Sickle Cell Anemia...............................................   139
Sickle Cell Disease..............................................    63
Sickle Cell Letter Grants........................................    64
Sjogren's Syndrome...............................................   161
Sleep Disorders..................................................   139
Standardization of Botanical Products............................   174
Stem Cell Research...............................................   146
Support for Clinical Research....................................    69
Technology Transfer..............................................   117
Temporomandibular Disorders......................................   164
The Eye and Overall Health.......................................    51
Translating Research to the Bedside..............................    54
Treatment of Asthma in Children..................................    58
Treatment for Crohn's Disease Using Inflammatory Signals.........   102
Type 1 Diabetes in Very Young Children...........................   195
Type 2 Diabetes and Obesity......................................   185
Women's Health...................................................    56

              Life Span/Special Populations Theme Hearing

Advances in Biomedical Research..................................   389
AIDS Vaccine Research............................................   402
Alzheimer's Disease.......................................217, 318, 341
Alzheimer's Disease Funding......................................   228
Anti-HIV Drugs...................................................   312
Arthritis........................................................   343
Arthritis Research and the Human Genome Project..................   342
Asthma...........................................................   361
Birth Defects....................................................   206
Breast Cancer....................................................   358
Clinical Trials................................................229, 408
Clinical Trials in Developing Countries..........................   399
Collaborative Research...........................................   409
Communicating Research Developments..............................   400
Complication of Pregnancy........................................   206
Cooley's Anemia..................................................   370
Coordination Among Women's Health Offices........................   364
Crohn's Disease..................................................   337
Deprived Environments............................................   213
Development of Strategic Plan and Budget.........................   394
Developmental Testing............................................   251
Differences in Disease Risk Factors for Men and Women and for 
  African American Women versus Asian Women......................   395
Early Childhood Programs.........................................   252
Early Intervention...............................................   258
Education Kit....................................................   296
Ensuring a Sufficient Supply of Nurse Researchers................   408
Environmental Exposures..........................................   238
Environmental Influences.........................................   335
Equal Funding Resources for Men's and Women's Health.............   313
Exercise.........................................................   372
Exposure to Chemicals..........................................350, 354
Extending Quality and Quantity of Life...........................   231
Gene Therapy.....................................................   404
Genetic Implications of Asthma...................................   304
Genetic Information to Fight Disease.............................   304
Genetic Susceptibility to Environmental Exposures................   411
Genetics and the Environment.....................................   306
Genetics vs. Environment.........................................   319
Health Behaviors...............................................256, 317
Health Disparities...............................................   405
Health Disparities Among the Rural Poor..........................   335
Health Disparities--Domestic and International...................   384
Health Disparities Outreach Efforts..............................   337
Health Disparities Strategic Plan................................   393
Health Professionals.............................................   403
Health Status and Economic Development...........................   387
Helping Caregivers of Patients with Various Diseases.............   357
HIV/AIDS.........................................................   353
HIV/AIDS Research................................................   352
HPV..............................................................   359
Immune Tolerance.................................................   311
Implementation of the Center.....................................   392
Improving Children's Mathematical Skills.........................   332
Including Both Men and Women in Research.........................   322
Increasing the Number of Minority Researchers....................   351
Interaction of Health on Education...............................   250
Lack of Sub-Population Analysis of Clinical Trial Data and NIH's 
  Response to Criticism that without Sub-Group Analysis Women are 
  Really not Benefiting from the Research........................   396
Learning Program.................................................   213
Life Expectancy................................................214, 229
Long Range Studies on Healthy Lifestyle and Reduction of Risks to 
  Health.........................................................   322
Longevity vs Disability..........................................   215
Longitudinal Cohort Study......................................349, 410
Lyme Disease.....................................................   366
Maternal-Fetal Medicine..........................................   369
Meeting the 21st Century Needs for Nurse Researchers.............   351
Men's Health...................................................344, 347
Men's Health Funding--Equal Funding Resources for Men's Health 
  and Women's Health.............................................   313
Men's Health Funding--Men Die Sooner than Women..................   313
Microbicides.....................................................   367
Minority Health..................................................   388
Moving Research to the Private Sector............................   405
Multi-Disciplinary Research Centers on Women's Health............   395
National Campaign to Change Children's Health Behaviors..........   379
National Literacy Screening Initiative...........................   327
National Reading Panel...........................................   325
Nationwide Health Tracking Network...............................   382
Needs of Caregivers of Alzheimer's Disease Patients..............   357
Office of Research on Men's Health...............................   391
Office of Research on Women's Health.............................   364
Opening Remarks..................................................   205
Opening Remarks--FIC.............................................   277
Opening Remarks--NCMHD...........................................   263
Opening Remarks--NIA.............................................   214
Opening Remarks--NIAID...........................................   286
Opening Remarks--NICHD...........................................   205
Opening Remarks--NIEHS...........................................   238
Opening Remarks--NINR............................................   230
Opening Remarks--ORWH............................................   270
Opening Statement--FIC...........................................   279
Opening Statement--NCMHD.........................................   266
Opening Statement--NHGRI.........................................   298
Opening Statement--NIA...........................................   220
Opening Statement--NIAID.........................................   288
Opening Statement--NICHD.........................................   208
Opening Statement--NIEHS.........................................   243
Opening Statement--NINR..........................................   233
Opening Statement--ORWH..........................................   272
Oral Remarks--NHGRI..............................................   294
Patient and Caregiver Needs from Hospital to Home................   321
Pelvic Floor Dysfunction and Incontinence........................   371
Phonics Based System.............................................   330
Prenatal Development.............................................   343
Prenatal Health and the Rural Poor...............................   333
Preventing Low Birth Weight in Rural Populations.................   320
Preventing the Spread of Disease Internationally.................   339
Prevention of Illness and Managing Symptoms......................   231
Prevention of Low Birth Weight...................................   231
Prevention Research..............................................   258
Priority Setting.................................................   380
Prostate Cancer Screening........................................   336
Reading Programs.................................................   252
Regulation.......................................................   315
Research Activities in Developing World..........................   355
Research and Promotion of Healthy Changes........................   254
Research on the End of Life......................................   406
Rural Health Care..............................................346, 393
Sequencing the Human Genome......................................   294
Sleep Disorders..................................................   334
Spanish to English Reading Initiative............................   331
Teacher Training...............................................257, 260
Teachers Workshops...............................................   255
Teaching Older Students How to Read..............................   328
The End of Life..................................................   231
The National Nursing Shortage....................................   407
Transgenic Mice..................................................   228
Tuberculosis.....................................................   356
Vaccine Against Human Papillomavirus.............................   394
Variations in the Human Genome Sequence..........................   296
West African Diabetes Study......................................   296
Youth Outreach...................................................   257

                          House Budget Hearing

Aging and Mental Health..........................................   534
Animal Facilities Improvement Program............................   771
Asthma.........................................................532, 843
Asthma and Environmental Risks...................................   530
Asthma Progress..................................................   531
Awarding Grants................................................524, 529
Bacterial Identification.........................................   768
Behavioral and Social Science Research.........................444, 842
Behavioral Health Research.......................................   776
Behavioral Research............................................443, 840
Biomedical Imaging Research......................................   772
BRDPI............................................................   729
Breast Cancer and Environmental Research Act.....................   826
Bridges to the Future Outcome Data...............................   774
Broad Research Dissemination.....................................   439
Cancer Death Rate................................................   543
Career Development Awards........................................   529
Caribbean Primate Research Center (CPRC).........................   779
Center for Scientific Review (CSR)...............................   793
Chimp Sanctuary..................................................   769
Cholesterol Guidelines...........................................   542
Chromium and Diabetes............................................   437
Clinical Center Construction.....................................   779
Clinical Research................................................   527
Clinical Research Projects.......................................   540
Clinical Research Support........................................   825
Clinical Researchers.............................................   835
Clinical Trials..................................................   780
Cobalt Study.....................................................   834
Cobre Program....................................................   436
Computer-Based Models and Simulations............................   755
Cost of Grant Renewals...........................................   810
Diabetes.......................................................520, 846
Diabetes BBA Funds...............................................   799
Diabetes Research Working Group Recommendations..................   802
Director's Discretionary Fund....................................   724
Dissemination of Information.....................................   762
Doubling the NIH Budget..........................................   522
Effectiveness of Gleevec.........................................   435
Establishment of Men's Health Office.............................   441
Ethical and Legal Implications of Genetics Advances..............   808
Evaluation of Scientific Ideas...................................   541
Extramural Construction..........................................   835
Extramural Facilities............................................   773
Extramural Loan Repayment Program................................   741
Extramural Research..............................................   540
Extramural Research Facilities...................................   850
FDA Approval of New Drugs........................................   525
Federal Financial Assistance Management..........................   729
Five Year Facilities Plan........................................   778
Five Year Prostate Cancer Plan...................................   742
Foundation for the National Institutes of Health.................   743
FTEs.............................................................   723
Funding for minority Institutions...............................749-755
Funding for Various Programs.....................................   771
Gender Analysis in Research Studies..............................   823
Getting NIH Information to the Public............................   790
Gleevec Availability to the Public...............................   526
Glue Grant Program...............................................   776
Grant Applications...............................................   738
Grant Regulation.................................................   794
Health Disparities...............................................   731
Heart Disease Prevalence.........................................   543
Hemophilia Progress..............................................   791
Herpes Virus.....................................................   767
HIV/AIDS Research................................................   821
HIV Prevention Trial Network.....................................   820
HPV Testing......................................................   730
IdeA Program.....................................................   435
Imaging........................................................768, 851
Impact on Heart Attack...........................................   542
Information Technology.........................................756, 774
Information Technology Security and Innovation Fund..............   759
Innovative Approaches to Disease Prevention......................   828
Islet Cell Resource Center.......................................   768
Leukemia and Lymphoma and Other Blood Cancers....................   848
Liver Transplanation.............................................   792
Loan Repayment Programm........................................528, 828
Measuring Success................................................   740
Medlar Centers...................................................   785
Medline Database.................................................   785
Mental Health of Seniors.........................................   839
Mental Illness in Children.......................................   837
Microbicides Research............................................   818
MOTTEP Program...................................................   537
Mutual Interest..................................................   760
NDRI Agreement...................................................   772
New Investigators................................................   723
New Leukemia Drug Gleevec Approved...............................   419
Next Generation Internet.........................................   784
NIH Research Training Grants.....................................   778
Office of Dietary Supplements....................................   748
Office of Research on Women's Health.............................   774
Opening Statement--B&F...........................................   716
Opening Statement--FIC...........................................   687
Opening Statement--NCCAM.........................................   676
Opening Statement--NCI...........................................   544
Opening Statement--NCMHD.........................................   682
Opening Statement--NCRR..........................................   669
Opening Statement--NEI...........................................   597
Opening Statement--NHGRI.........................................   657
Opening Statement--NHLBI.........................................   549
Opening Statement--NIA...........................................   609
Opening Statement--NIAAA.........................................   648
Opening Statement--NIAID.........................................   580
Opening Statement--NIAMS.........................................   619
Opening Statement--NIBIB.........................................   666
Opening Statement--NIDA..........................................   642
Opening Statement--NIDDK.........................................   566
Opening Statement--NIEHS.........................................   602
Opening Statement--NIH...........................................   428
Opening Statement--NICHD.........................................   592
Opening Statement--NIDCD.........................................   626
Opening Statement--NIDCR.........................................   559
Opening Statement--NIGMS.........................................   586
Opening Statement--NIMH..........................................   631
Opening Statement--NINDS.........................................   574
Opening Statement--NINR..........................................   653
Opening Statement--NLM...........................................    69
Opening Statement--OAR...........................................   705
Opening Statement--OD............................................   700
Opening Statement/Remarks........................................   416
Organ Transplantation............................................   536
Organizational Structure of NIH..................................   535
Peer Review--DOD and NIH.........................................   766
Peer Review Panel................................................   541
Peer Review System...............................................   536
Planning and Budget Authority....................................   814
Planning for Future Year's Budget................................   803
Post-Doubling of NIH Budget......................................   738
Priorities.......................................................   797
Priority Setting.................................................   799
Private Patents on Federally Funded Research.....................   796
Program Evaluation...............................................   727
Programs and Initiatives.........................................   525
Prostate Cancer Meetings.........................................   440
Protein Structure Database.......................................   777
Pubmed Central...................................................   761
Pubmed Central Advisory Committee................................   786
Quality of Research..............................................   797
Rare Diseases....................................................   539
Rare Disease Information Center..................................   742
RCMI Program.....................................................   770
Related Areas of Neuroscience Research...........................   442
Research Applicants..............................................   761
Research Endowment Program.......................................   519
Research Initiatives.............................................   728
Research Management and Support..................................   763
Research Opportunities...........................................   822
Review Group Assignments.........................................   764
Review Process...................................................   764
Rural Health.....................................................   527
Service Center...................................................   763
Shift Toward Research and Development Contracts..................   812
Stem Cell Research.............................................538, 788
Stroke Belts.....................................................   520
Study Section Recommendations....................................   766
Telemedicine Projects............................................   780
The Aging Process................................................   533
The Cost of Gleevec..............................................   440
The Molecular Nature of Cancer...................................   423
Types of Cancer Gleevec Could Treat..............................   434
Veterinary Training..............................................   770
World Health Organization and Mental Health......................   837

                                
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