[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
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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
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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.
[The justification follows:]
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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]
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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]
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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]
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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]
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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:]
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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.
[The justification follows:]
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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:]
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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:]
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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.
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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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