[House Hearing, 107 Congress]
[From the U.S. Government Publishing Office]
THE NATIONAL INSTITUTES OF HEALTH: INVESTING IN RESEARCH TO PREVENT AND
CURE DISEASE
=======================================================================
HEARING
before the
SUBCOMMITTEE ON HEALTH
of the
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
JUNE 6, 2002
__________
Serial No. 107-122
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Printed for the use of the Committee on Energy and Commerce
Available via the World Wide Web: http://www.access.gpo.gov/congress/
house
__________
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COMMITTEE ON ENERGY AND COMMERCE
W.J. ``BILLY'' TAUZIN, Louisiana, Chairman
MICHAEL BILIRAKIS, Florida JOHN D. DINGELL, Michigan
JOE BARTON, Texas HENRY A. WAXMAN, California
FRED UPTON, Michigan EDWARD J. MARKEY, Massachusetts
CLIFF STEARNS, Florida RALPH M. HALL, Texas
PAUL E. GILLMOR, Ohio RICK BOUCHER, Virginia
JAMES C. GREENWOOD, Pennsylvania EDOLPHUS TOWNS, New York
CHRISTOPHER COX, California FRANK PALLONE, Jr., New Jersey
NATHAN DEAL, Georgia SHERROD BROWN, Ohio
RICHARD BURR, North Carolina BART GORDON, Tennessee
ED WHITFIELD, Kentucky PETER DEUTSCH, Florida
GREG GANSKE, Iowa BOBBY L. RUSH, Illinois
CHARLIE NORWOOD, Georgia ANNA G. ESHOO, California
BARBARA CUBIN, Wyoming BART STUPAK, Michigan
JOHN SHIMKUS, Illinois ELIOT L. ENGEL, New York
HEATHER WILSON, New Mexico TOM SAWYER, Ohio
JOHN B. SHADEGG, Arizona ALBERT R. WYNN, Maryland
CHARLES ``CHIP'' PICKERING, GENE GREEN, Texas
Mississippi KAREN McCARTHY, Missouri
VITO FOSSELLA, New York TED STRICKLAND, Ohio
ROY BLUNT, Missouri DIANA DeGETTE, Colorado
TOM DAVIS, Virginia THOMAS M. BARRETT, Wisconsin
ED BRYANT, Tennessee BILL LUTHER, Minnesota
ROBERT L. EHRLICH, Jr., Maryland LOIS CAPPS, California
STEVE BUYER, Indiana MICHAEL F. DOYLE, Pennsylvania
GEORGE RADANOVICH, California CHRISTOPHER JOHN, Louisiana
CHARLES F. BASS, New Hampshire JANE HARMAN, California
JOSEPH R. PITTS, Pennsylvania
MARY BONO, California
GREG WALDEN, Oregon
LEE TERRY, Nebraska
ERNIE FLETCHER, Kentucky
David V. Marventano, Staff Director
James D. Barnette, General Counsel
Reid P.F. Stuntz, Minority Staff Director and Chief Counsel
______
Subcommittee on Health
MICHAEL BILIRAKIS, Florida, Chairman
JOE BARTON, Texas SHERROD BROWN, Ohio
FRED UPTON, Michigan HENRY A. WAXMAN, California
JAMES C. GREENWOOD, Pennsylvania TED STRICKLAND, Ohio
NATHAN DEAL, Georgia THOMAS M. BARRETT, Wisconsin
RICHARD BURR, North Carolina LOIS CAPPS, California
ED WHITFIELD, Kentucky RALPH M. HALL, Texas
GREG GANSKE, Iowa EDOLPHUS TOWNS, New York
CHARLIE NORWOOD, Georgia FRANK PALLONE, Jr., New Jersey
Vice Chairman PETER DEUTSCH, Florida
BARBARA CUBIN, Wyoming ANNA G. ESHOO, California
HEATHER WILSON, New Mexico BART STUPAK, Michigan
JOHN B. SHADEGG, Arizona ELIOT L. ENGEL, New York
CHARLES ``CHIP'' PICKERING, ALBERT R. WYNN, Maryland
Mississippi GENE GREEN, Texas
ED BRYANT, Tennessee JOHN D. DINGELL, Michigan,
ROBERT L. EHRLICH, Jr., Maryland (Ex Officio)
STEVE BUYER, Indiana
JOSEPH R. PITTS, Pennsylvania
W.J. ``BILLY'' TAUZIN, Louisiana
(Ex Officio)
(ii)
C O N T E N T S
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Page
Testimony of:
Bonow, Robert O., President-Elect, American Heart Association 40
Hargis, Eric R., President and CEO, The Epilepsy Foundation.. 45
Jones, Daniel, Vice Chancellor, University Medical Center,
University of Mississippi.................................. 53
Lenfant, Claude, Director, National Heart, Lung, and Blood
Institute, National Institutes of Health, U.S. Department
of Health and Human Services............................... 6
Penn, Audrey S., Acting Director, National Institute of
Neurological Disorders and Stroke, National Institutes of
Health, U.S. Department of Health and Human Services....... 11
Sanchez, Eduardo J., Commissioner, Texas Department of Health 49
(iii)
THE NATIONAL INSTITUTES OF HEALTH: INVESTING IN RESEARCH TO PREVENT AND
CURE DISEASE
----------
THURSDAY, JUNE 6, 2002
House of Representatives,
Committee on Energy and Commerce,
Subcommittee on Health,
Washington, DC.
The subcommittee met, pursuant to notice, at 10:05 a.m., in
room 2123, Rayburn House Office Building, Hon. Michael
Bilirakis (chairman) presiding.
Members present: Representatives Bilirakis, Deal, Norwood,
Shadegg, Pickering, Bryant, Buyer, Brown, Strickland, Barrett,
Capps, Stupak, and Green.
Staff present: Cheryl Jaeger, majority professional staff;
Steven Tilton, health policy coordinator; Eugenia Edwards,
legislative clerk; John Ford, minority counsel; and Jessica
McNiece, staff assistant.
Mr. Bilirakis. Good morning. I don't like to start a
hearing without at least one member of the minority being
present. But, as you may have just heard, we have a journal
vote on the floor. So it is a start of maybe a tough day; I
don't know. I think probably the best bet is for us to break
before we even start, run over and make that vote. By then, I
am sure Mr. Brown and others will be here and then we could
start. So if you will forgive us, we will go ahead and do that.
Thank you.
[Brief recess.]
Mr. Bilirakis. The hearing will come to order. I again
apologize on behalf of the committee. There may be another
similar type of vote called in a few minutes, unfortunately. We
shall see.
All right, I call this hearing to order. I would like to
thank our witnesses for appearing before the subcommittee
today, particularly those of you that altered your schedules to
be here. The subcommittee certainly values your expertise, and
we are grateful for your cooperation and attendance.
Over the past 5 years Congress has shown its commitment to
scientific research by setting a path that would double the
budget of the National Institutes of Health. I am proud to have
been an active participant in that effort.
These increased resources have ensured that our best
scientists and researchers have access to the funds they need
to develop treatments and cures for diseases. This funding has
enabled the NIH to maintain its exalted status as the premiere
research institution in the world.
President Bush's fiscal year 2003 budget includes the final
installment in the 5-year plan to double the NIH budget. I know
we all hope and expect that Congress will follow suit and
appropriate the necessary funds to complete this important
effort.
As is always appropriate with large investments of taxpayer
dollars, I believe that it is our responsibility to review,
with the assistance of the scientific experts at the NIH, how
these new resources are being used. More specifically, how are
the various institutes managing these large annual increases?
Have we found new cures? If so, are they helping Americans live
healthier lives?
Given the vastness and the complexity of the NIH, the
subcommittee is focusing on two institutes today: the National
Heart, Lung, and Blood Institute and the National Institute of
Neurological Disorders and Stroke. These institutes are
critical in the discovery of basic causes of a number of
diseases. These discoveries will help put researchers on the
correct paths to cure illnesses like Parkinson's, alpha-1,
heart disease, and stroke, which devastate millions of
Americans every year.
I would like to thank Dr. Lenfant and Dr. Penn for
appearing before this subcommittee today to outline how they
are progressing in the war against disease.
I am particularly pleased that part of today's hearing will
focus on the Stroke Treatment and Ongoing Prevention Act of
2001, which was introduced by two members of our subcommittee,
Mr. Pickering and Ms. Capps. I am very supportive of the
provisions contained in this bill and look forward to working
with my colleagues on this issue.
Now I am pleased to yield to the ranking member, Mr. Brown,
for an opening statement.
Mr. Brown. I thank the chairman for holding this morning's
hearing. I want extend a special welcome to Dr. Bonow with the
American Heart Association. The Heart Association, as the
chairman said, has been working with Ms. Capps and others on
the stop strokes bill.
Congress will double the NIH budget by 2003. It is rare for
virtually all Members to endorse any kind of large increase in
Federal spending for one purpose like this, but when I think
about constituents I have met over the past 10 years who rely
on research funded by NIH, doubling the budget is an easy sell
to Congress and to the American public.
We have all met children who give themselves daily shots of
insulin, families who have lost a loved one to lupus or heart
disease or Duchenne's muscular dystrophy. I have a constituent
in my district who lost her husband to CJD 3 months after he
woke up with a headache. Our increased investments at NIH
afford even more opportunities to confront these diseases.
I want to briefly touch on other aspects of NIH's role that
I hope we will devote more attention to during future hearings
on NIH. I am interested in how the institutes respond to a
medical need that is not being addressed by the private sector.
I have been told repeatedly by infectious disease specialists,
especially talking to people involved in tuberculosis and
malaria and AIDS, that one area where such a gap currently
exists, especially in the area again of tuberculosis, is in the
development of new antibiotics.
In April 2000 the FDA approved Zyvox, the first in a new
class of antibiotics to be approved in more than 3 decades. We
desperately need new antibiotics, especially as antibiotic
resistance becomes more and more of a problem to fight
infectious diseases like drug-resistant tuberculosis, like
pneumococcus, and other bacterial infections.
According to WHO, too few new drugs are being developed to
replace those antibiotics that have lost their effectiveness.
Take tuberculosis, for instance, where four drugs are
administered to people that have drug-sensitive tuberculosis,
and then if their tuberculosis is drug-resistant, two other
antibiotics are given to those patients. They are old
antibiotics. They are weaker antibiotics that are drug-
sensitive because they have not been on the market for so long,
and they have much worst side effects than other kinds of
antibiotics.
Fourteen thousand Americans die of resistant infections
each year. Tens of millions die worldwide of treatable
infections. Eleven hundred people a day in India die of
tuberculosis. Instead of reverting to older drugs with greater
and worst side effects, we should be encouraging drug companies
to devote their considerable resources to antibiotic R&D, but
if the private sector, as has been the case apparently, is
unwilling to develop these needed antibiotic drugs, this
responsibility should fall, and must fall, on NIH with many of
its new resources available from taxpayers.
Another area I am interested in is the role NIH invariably
plays in the economics and allocation of health care in this
country. Ideally, NIH could steer clear of thorny issues like
health care costs and access, and focus exclusively on
producing and supporting medical research.
Unfortunately, the agency's technology transfer policies
have an obvious direct bearing on the return consumers receive
on our investment as taxpayers in NIH. When NIH licenses a
patent on an NIH-developed medical breakthrough like Taxol, the
agency's private sector partner is awarded a period of market
exclusivity. During that exclusivity periods, consumers pay
monopoly prices for a drug that their tax dollars produced. How
long should that exclusivity period be? Affordability and
access hinge on NIH driving a hard bargain. I haven't seen them
do much of that. This subcommittee has a responsibility to
ensure that NIH does that.
NIH also has the power to break the patent on any product
that was developed with U.S. tax dollars. That is a pretty big
stick to use to convince drug companies to stop overcharging
the American consumers.
If drug inflation weren't a major issue, if American
consumers weren't paying two, three, and four times what
consumers in Canada and France and Israel and Japan and England
and Germany were paying, I am sure no one would look at that
option given to NIH seriously. But prescription drug inflation
is a major problem. We all know that Americans are paying more
than consumers in any other country for the same drugs.
NIH has information on drug costs that this country needs
that this committee should see. You know how much it costs to
develop a drug, including the cost of failures. You have the
information necessary to clear the air to reality-check the
drug industry's claim that R&D costs average $800 million per
drug, which the media obediently picks up and repeats over and
over and over. We have never seen the facts from your agency,
from the FDA, or from the drug companies themselves.
We want to respond appropriately to the public's outrage at
prescription drug prices. We need to understand how these
prices relate to costs. There is no way around it.
Because this hearing is not, however, focused on the issues
I have just raised, I obviously don't expect answers today. I
will ask for written responses, share those responses with the
subcommittee, and my other colleagues, and hope that we can
pursue, Mr. Chairman, these thoughts and questions and ideas in
subsequent hearings.
Our investment in NIH, again, is compromised when Americans
are priced out of access. Research and access and costs are
linked. We can't ignore that.
Thank you, Mr. Chairman.
Mr. Bilirakis. I thank the gentleman. Mr. Deal, for an
opening statement?
Mr. Deal. I have none.
Mr. Bilirakis. Mr. Stupak?
Mr. Stupak. I will waive my opening statement, Mr.
Chairman.
[Additional statements submitted for the record follow:]
Prepared Statement of Hon. Charlie Norwood, a Representative in
Congress from the State of Georgia
Mr. Chairman, I would like to thank you for holding this hearing
this morning. In the interests of our witness's time, I will be brief.
The National Institutes of Health are one of our most important
national resources. The research done at the NIH makes a real
difference in the health of Americans. From basic research to
collaborative efforts to cutting edge science, the NIH leads the way in
health research.
Work done at the National Institute of Neurological Disorders and
Stroke has taught us the importance of early intervention when people
suffer a stroke. We have taken that research and translated it into
legislation to educate the public on the importance of recognizing the
signs of stroke. My colleagues Ms. Capps and Mr. Pickering have
introduced the Stroke Treatment and Ongoing Prevention Act to improve
stroke care and increase public awareness. I am pleased to be a
cosponsor of their effort. This is what makes the NIH so valuable--the
application of NIH research into valuable public policy.
Mr. Chairman, I would like to thank our witness for appearing
before us today. I look forward to their testimony and yield back the
balance of my time.
______
Prepared Statement of Hon. W.J. ``Billy'' Tauzin, Chairman, Committee
on Energy and Commerce
Thank you, Mr. Chairman, for holding this hearing today. I commend
the Chairman for taking a closer look at the National Institutes of
Health, one of the most promising investments we have made to advance
public health.
Taxpayer dollars invested in medical research will yield untold
benefits to all Americans. It is absolutely essential that we ensure
that the investments we have put in place at the National Institutes of
Health are maximized.
Today's hearing will be the first in a series of hearings the
Committee plans to hold to learn more about the amazing research being
conducted at the Institutes and Centers of the NIH, and to explore
options to strengthen the research programs. For the last five years,
Congress has committed to doubling the budget of the National
Institutes of Health. If we move to adopt the President's request to
fund the NIH for fiscal year 2003 at $26.5 billion, we will have
completed the fifth and final year of this investment initiative. Given
that we have expanded the budget for NIH rather rapidly, I believe this
hearing is particularly timely.
I am pleased that we have the opportunity to hear from not only
one, but two directors of the institutes at NIH today: Dr. Claude
Lenfant and Dr. Audrey Penn, of the National Heart, Lung and Blood
Institute and the National Institute for Neurological Disorders and
Stroke, respectively. Thank you, for taking the time to address our
Committee this morning. I look forward to becoming more familiar with
the advancements being made at these institutes with the additional
resources Congress has allocated.
Cardiovascular disease is currently the leading cause of death in
America, and stroke the third leading cause of death. Although great
strides have been made to reduce the burden of cardiovascular disease
and stroke through improvements in detection and treatment, the death
rate for both are still too high. Furthermore, when we talk about
doubling the overall budget of the NIH, this increase in funding did
not necessarily translate into a unilateral doubling of all budgets in
all scientific areas. Funding for stroke research, for example, has
remained relatively flat over the past five years. This obviously begs
the question: are we investing taxpayer dollars at NIH wisely? Are we
capitalizing on real opportunities for scientific innovation that will
have a major impact on public health?
The National Institutes of Health truly is a shining example of a
public-private partnership. Over 80 percent of NIH dollars are
distributed through extramural grants. The grant structure we have
built through the National Institutes of Health has become a
significant resource for both public and private institutions across
the United States. Scientists are competing for the opportunity to be
the next Jonas Salk, to be the one who discovers a vaccine that is so
widespread that a deadly disease like polio is no longer an immediate
threat. Scientists are competing for the opportunity to discover new
scientific theories and laws that will help guide and advance research
on all disease fronts. It is easy to forget that two decades ago,
mapping the humane genome seemed an unattainable goal. But yet, now, we
are there, and I would like to think that the investments we have made
at the federal level have helped to speed the development.
Funding medical research and innovation is a worthwhile investment
of limited taxpayer dollars. Research takes time and patience, and not
all of our investments in research can be clearly tracked to a tangible
end product like a new diagnostic or vaccine. But this research,
nonetheless, helps us as a nation move forward in our efforts to
improve public health.
We all need to better understand how medical research is conducted.
We also need to better understand what impediments are currently in
place that unnecessarily delay new research developments and
shortchange the potential impact of research findings. Only when we
learn about the barriers to high-quality research, can we begin to
remove them.
I would like to thank all of the witnesses for coming before the
Committee today to demonstrate the impact critical research plays in
saving and improving American lives. I hope and pray that we will
ultimately reach a point in time that all Americans will be free from
disease. Congress needs to be a proud partner with the NIH and the
public in this important goal.
Thank you, Mr. Chairman. I look forward to hearing from the
witnesses.
______
Prepared Statement of Hon. John D. Dingell, a Representative in
Congress from the State of Michigan
Mr. Chairman, thank you for holding this hearing to examine how the
National Institutes of Health (NIH) is investing taxpayer dollars to
improve and expand their research activities. I would also like to
thank the directors from the National Heart, Lung, and Blood Institute
(NHLBI) and the National Institute of Neurological Disorders and
Strokes (NINDS), as well as all of our other witnesses, for their
testimony before us today.
NIH is a vital and significant institution which conducts basic
research, observational- and population-based research, clinical
research, and health services research. The contribution that NIH, and
its 27 individual institutes, makes to our medical community and the
general public is unparalleled and invaluable.
Our stewardship of this multibillion dollar investment of public
money is crucial to maintaining public support for these programs.
Taxpayers expect their money to be spent in an efficient and effective
manner. I hope that we will ask tough questions.
Continued funding for NHLBI is important, as this institution seeks
to conduct research on diseases of the heart, blood vessels, lungs, and
blood; sleep disorders; and blood resources management. Cardiovascular
disease is the leading cause of death in America. NHLBI conducts
research related to the causes, prevention, diagnosis, and treatment of
some of today's most pressing and dangerous health problems.
NINDS, another valued research institution, currently leads the
neuroscience community in research on brain disease. This institution
works to address problems in minority health disparities, Parkinson's
disease, brain tumors, epilepsy, and stroke. Since stroke is the third
leading cause of death in the United States, claiming the life of one
American every three and a half minutes, the work of NINDS is vitally
important to future of America's health.
My friend and colleague, Representative Capps, has worked very hard
to increase funding and focus attention on stroke research, and I
encourage all of my colleagues to join me in sponsoring Representative
Capps's STOP Stroke Act.
Thank you again for holding this hearing, and I look forward to the
testimony of our distinguished guests.
Mr. Bilirakis. All right, we will go right into the panel
then. First, Drs. Lenfant and Penn, you know that you submitted
your written statement; it is a part of the record. We would
hope you would complement, if you will, or supplement it
orally.
The first panel consists of Dr. Claude Lenfant--am I
pronouncing that correctly?
Dr. Lenfant. Yes.
Mr. Bilirakis. [continuing] Director of the National Heart,
Lung, and Blood Institute here in Bethesda, Maryland, and Dr.
Audrey S. Penn, Acting Director for the National Institute of
Neurological Disorders and Strokes, also out of Bethesda.
Dr. Lenfant, why don't we start off with you, please, sir?
STATEMENTS OF CLAUDE LENFANT, DIRECTOR, NATIONAL HEART, LUNG,
AND BLOOD INSTITUTE, NATIONAL INSTITUTES OF HEALTH, U.S.
DEPARTMENT OF HEALTH AND HUMAN SERVICES; AND AUDREY S. PENN,
ACTING DIRECTOR, NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS
AND STROKE, NATIONAL INSTITUTES OF HEALTH, U.S. DEPARTMENT OF
HEALTH AND HUMAN SERVICES
Mr. Lenfant. Thank you very much, Mr. Chairman. I truly
welcome the opportunity to appear before you today and to
present some of our programs, a panoramic view, I should say,
of some of the programs that we are supporting. As requested, I
will limit my comments to cardiovascular diseases, specifically
coronary heart disease, stroke, and congestive heart failure,
and also on blood diseases and resources.
When the institute was created 50 years ago, Mr. Chairman,
this country was in the middle of a true epidemic of heart
disease. Now today, thanks to decades of research, heart
disease death rates have receded quite markedly. Just to give
you an example, since the peak of the epidemic, which was in
1968, the death rate from coronary heart disease has declined
by 68 percent, and likewise for stroke.
In addition, all of us in this room today can expect to
live 6 years longer than was the case 30 years ago. Four of the
6 years are due to the decline of the death rate from heart
disease and the progress that we have accomplished with regard
to this condition.
However, I should say that we are far from out of the
problems of heart disease. Today the majority of Americans will
die from heart disease. In addition, the societal burden of
living with heart disease is absolutely tremendous. Patients
spend up to $30 billion each year to take care of their
condition in acute care, hospital, medication, whatever else. A
recent study has revealed that 13 of the top 22 prescriptions
taken in the United States are for cardiovascular diseases.
Thus, it is very clear that the research that we are
pursuing is an important step and vital to reduce the
tremendous burden. Let me take the case of heart failure, which
accounts for a new public health problem and a new epidemic in
this country. Ironically, I should say that this problem which
is emerging is actually the cost of our success. Indeed, having
saved many people from dying from acute events such as heart
attack, we have created a large population with damage of their
hearts.
What we now have at our disposal is a number of palliative
measures ranging from medications to instrumental intervention
such as left ventricular assist devices, but that is not a cure
for these patients. However, I should say that we are seeing
surprising new research directions which may eventually bring
us to a cure. I am referring to cell transplantation treatments
which may really contribute a great to the treatment of heart
failure in the future.
The mapping of the human genome, which has been very much
discussed in the last months, few months, years, I should say,
gives us another group of new opportunities on which we are
capitalizing as much as we can. We can expect that in years
from now, hopefully sooner than later, we would be able to help
in the prevention of cardiovascular disease, to predict the
evolution of a disease if it develops, and, finally, perhaps
more important, to develop treatments which will be
personalized for the patients.
If you will allow me to be a bit futuristic, I can envision
the time when a child is born, that child will be given at the
same time a birth certificate and a small CD that will include
each of her genetic profiles that could be used for the whole
life of this patient, to be sure that this patient, that this
subject is treated very adequately when diseased.
As we pursue these and other avenues, we are working very
hard to strengthen our clinical research programs. As you might
expect, we are pursuing a number of clinical trials which
include medical as well as surgical intervention. They also
include trials to examine the value of lifestyle interventions.
We have clinical trials today to evaluate dietary
approaches which could be acceptable to the public. We have
clinical trials to prevent excessive gain of weight, which, as
you know, is a very significant problem in this country, as
well as to prevent a decline in physical activities, which,
unfortunately, occurs in our younger population, and that, in
turn, will lead eventually to excess weight and obesity.
Let me now turn briefly to work in blood disease, and
especially in sickle cell disease, a condition which affects
70,000 of our minority citizens. Here again, I am glad to
report to you some progress. In 1960, the lifespan of a patient
with sickle cell disease, the most severe cases, was
approximately 10 years. Today I am glad to tell you that it is
between 40 and 50 years.
Studies are ongoing to address the problem of sickle cell
anemia and other hemoglobin disorders, as well as the problem
of the transplantation of hematopoietic cell, that is, a cell
which supplies all the other cells in the blood.
I am also pleased to know that as today we talk a lot about
gene therapy, hemophilia, a very serious condition, inherited
blood condition, may as it turns out not too far away be the
first disease to be treated by gene therapy.
I was asked to make some comments on blood safety. Here
again, I have to report to you that over the last 20 years,
when the problems of blood contamination and transmission of
disease by way of blood transfusion became so apparent with the
occurrence of AIDS, at that time the risk of contracting
hepatitis C, for example, from a transfusion was about 1 in
100--no, it was 1 in 25 units of blood transfused. Today that
number has been reduced to one chance out of 1.7 million
transfusions.
The last thing that I want to mention, Mr. Chairman, is
that all this research that we have supported will do no good
to anyone unless it is translated and disseminated to the
public and to the health professionals. To this end, the
institute has undertaken a number of programs to assure
benefits to the patients.
One which was referred to by Mr. Brown is the Stroke Belt,
an initiative that was begun by the institute years ago. The
Stroke Belt is in 11 States from the southeastern United States
where the prevalence of stroke and high blood pressure, which
is one of the main causes of stroke, was very high. The
mortality rate in these States from coronary heart disease and
from stroke was the highest in the country.
I am pleased to tell you that today, between the early
eighties and the mid-nineties, the reduction in stroke in these
States has been the highest that we have witnessed in the
entire United States. This shows that, indeed, we can do
something, and an organization like me, like my colleague from
the NINDS and all the other institutes are working very hard to
take to the patients what we can.
That concludes my remarks, Mr. Chairman, and I would be
pleased to answer questions.
[The prepared statement of Claude Lenfant follows:]
Prepared Statement of Claud Lenfant, Director, National Heart, Lung,
and Blood Institute, National Institutes of Health
Mr. Chairman and Members of the Subcommittee: I am pleased to have
this opportunity to discuss the programs and activities of the National
Heart, Lung, and Blood Institute (NHLBI). As requested, my comments
will focus specifically on cardiovascular diseases--which include,
among others, coronary heart disease, stroke, and congestive heart
failure--and on blood diseases and resources.
cardiovascular diseases
To begin with a historical perspective, let me mention that when
the NHLBI was founded more than 50 years ago, this country was in the
throes of an epidemic of heart disease. Beginning at the turn of the
20th century, and particularly after the end of World War I, heart
disease death rates increased quite precipitously among men and
ominously among women. One could envision no end to this trend, as
medical science was largely ignorant about the causes of heart disease
and extremely limited in its ability to treat or prevent it. Now,
thanks to decades of research, heart disease death rates among men have
receded to the level of 100 years ago, and among women they are about
37 percent lower. Stroke death rates have plummeted, due in great
measure to improvements in detection and treatment of high blood
pressure. The average American can expect to live 5+ years longer today
than was the case 30 years ago, and nearly 4 years of that gain in life
expectancy can be attributed to our progress against cardiovascular
diseases. I believe it is fair to say that medical science has made
more advances in this area than in any other major disease.
Nonetheless, many challenges remain. As the following chart
illustrates, we in this country are far more likely to die of
cardiovascular diseases than of any other cause.
Moreover, the societal burden of living with these diseases is
considerable. Cardiovascular disease patients spend more than 30
million days each year in acute-care hospitals--far more than patients
with other diagnoses. And, a recent study revealed that 13 of the top
22 prescription drugs taken in the United States address cardiovascular
problems. Thus, beyond the suffering caused by these diseases, the
health-care costs demand our attention.
Heart failure accounts for a large and growing public health burden
that has, in effect, become our next epidemic. Ironically, it is a cost
of our success: having saved many people from dying of acute events,
such as heart attack, we have created a large and vulnerable population
with heart muscle damage. We now have at our disposal a number of
palliative measures, ranging from drugs to instrumental interventions
such as the left ventricular assist device. While they improve
patients' quality of life by alleviating symptoms and reducing
hospitalizations, they are by no means a cure. However, current
research provides grounds for cautious optimism that a cure may
ultimately be found. For example, we are stimulating research on cell-
based therapy in the wake of astonishing discoveries that, contrary to
everything we thought we knew before, cells of the heart and other
organs are capable of regeneration. If we could find a way to harness
and direct the body's ability to grow new cells, we would have an
entirely new approach to therapy for diseases such as end-stage heart
failure.
The mapping of the human genome has provided an extraordinary
opportunity to understand the genetic underpinnings of disease. We have
initiated Programs of Genomic Applications, which seek to maximize the
fruits of the new information in order to identify the causes of
disease, determine who is susceptible to it, and tailor treatments and,
possibly, cures to the individual. We have also launched a program to
identify genetic modifiers of disease--genes that determine, for
instance, why some people with high blood pressure suffer heart
attacks, while others have strokes, still others experience kidney
failure, and some escape with few ill effects. The ability to predict
the course of disease in a given patient will open up a new era of
therapeutic approaches. Accumulating evidence suggests that
inflammation--the body's normal, protective response to injury or
infection--may be at the core of many chronic degenerative diseases
such as atherosclerosis. This notion is supported by recent findings
that blood levels of a substance called C-reactive protein, a marker of
inflammatory activity, are correlated with risk of heart attack and
stroke. Understanding the delicate balancing act of the immune system
could pave the way for new preventive and therapeutic strategies.
Related work from a number of laboratories has found that exposure to a
variety of infectious agents is associated with development of vascular
disease. We are vigorously pursuing basic research to elucidate the
mechanisms underlying these phenomena in the expectation that it may
ultimately lead to new approaches, perhaps even vaccines, to prevent
cardiovascular disease.
As we pursue these and other basic research avenues, we are working
to strengthen clinical research to ensure that findings from the
laboratory have a swift and effective impact on patient care. Our
research centers program has been reconfigured as Specialized Centers
of Clinically Oriented Research to sharpen its focus on the patient. We
also conduct numerous clinical trials of promising approaches to treat
or prevent disease. As you might expect, they include trials of medical
and surgical interventions, but they also include trials that examine
the value of lifestyle interventions such as the Dietary Approaches to
Stop Hypertension (DASH) diet--an eating pattern that is rich in
fruits, vegetables, and low-fat dairy products and low in fat and
cholesterol--which has been shown to lower blood pressure. The DASH
diet is now being tested in the context of an intensive behavioral
intervention to promote other lifestyle changes to lower blood pressure
(e.g., decreased salt and alcohol consumption, increased physical
activity, and weight control). Two other trials focus on preventing
excessive weight gain among teenaged African American girls--a
population that is highly susceptible to weight-related problems such
as high blood pressure and diabetes in adulthood--and on preventing the
decline of physical activity that typically occurs among girls during
the middle-school years.
blood diseases and resources
Turning to blood diseases and resources, we also have much progress
to report. In sickle cell disease, which affects approximately 70,000
Americans, we have found that hydroxyurea, a chemotherapeutic drug that
is taken by mouth, decreases the frequency of acute pain crises in
adults and may actually prolong the life span. We are funding a study
to determine whether benefits of this drug can be extended to very
young children, thereby preventing primary damage to organs such as the
spleen and kidneys. Clinical studies funded by the NHLBI also have
proven the efficacy of transfusions in preventing the recurrence of
stroke in young children with sickle cell disease.
Clinical trials are also in progress to establish whether a cure is
possible for Cooley's anemia and other hemoglobin disorders such as
sickle cell disease through transplantation of hematopoietic (blood-
forming) stem cells obtained from sibling donors. The cells can come
from the circulating blood of the sibling or from umbilical cord blood,
in cases where there is a newborn brother or sister. Also in this area,
the NHLBI is funding studies on cord blood transplantation in children
and adults to determine the most appropriate role for this source of
stem cells in blood diseases such as acute leukemia. This approach may
provide new hope for thousands of patients in need of a transplant,
because cord blood is readily available, can be collected at no risk to
the newborn donor, is less likely than bone marrow to transmit
infection, and may work well despite less precise tissue matching,
Gene therapy for the eventual cure of hemophilia is now under
development by several companies. The original research leading to the
actual commercial development of this approach came from funding
provided by the NHLBI. Our own research in this area is gaining
addition momentum with recent funding of Programs of Excellence in Gene
Therapy, which are designed to move these studies rapidly into the
clinical arena within the context of careful and appropriate safeguards
for patient safety and welfare.
In the early 1980s the Institute created a research program in
transfusion medicine that has actively pursued methods to improve the
safety of the U.S. blood supply. I am happy to report great success in
this endeavor. For instance, the risk of contracting hepatitis C from a
transfusion--a great public health concern--is now about 1 in 1.7
million units, whereas it was an estimated 1 in 25 units 2 decades ago.
Taken as a whole, our investment in transfusion medicine research has
given the United States a blood supply that is the safest in the world.
education and outreach
To maximize the impact of research findings on the people whom we
serve, the NHLBI is strongly committed to educating patients, health
professionals, and the public about disease risk, diagnosis, treatment,
and prevention. Over the past 3 decades, we have conducted education
programs in high blood pressure, cholesterol, blood resources, smoking,
asthma, heart attack awareness, obesity, and sleep disorders. Two
campaigns--one that has been under way for some time and one that is
brand new--may be of particular interest to the Subcommittee.
The NHLBI Stroke Belt Initiative had its origins in observations
during the 1980s that a band of states located generally in the
southeastern portion of the country (depicted in the graphic on the top
of the page that follows) suffered an excessive death toll from stroke,
and that extraordinary rates of high blood pressure were the culprit.
In subsequent years, we worked with state health departments and other
groups to address improvement of blood pressure control in these
populations. The approaches taken are too numerous to mention, but they
included church-based screenings (``High Blood Pressure Sunday,'' the
first Sunday in May, is now established in many communities, and
features sermons, gospel music, and cooking related to lowering blood
pressure) and screening at baseball games (the ``Strike out Stroke''
campaign, which began with the Atlanta Braves). As we look back on
these efforts, it is clear that stroke is still a major problem in the
Southeast. However, it is also apparent (see second graphic) that some
of the greatest gains in reducing the number of stroke deaths per
100,000 population over the past 2 decades have occurred in the Stroke
Belt states. Building on what has been learned about improving the
health of high-risk communities, we are now working to extend our reach
to other vulnerable subsets of the population. We have established what
we call EDUCs (Enhanced Dissemination and Utilization Centers) in
communities whose residents are at especially high risk of developing
cardiovascular disease. These projects are mobilizing community
resources--including health centers, churches, schools, businesses, and
soup kitchens--to increase awareness and control of cardiovascular
disease risk factors.
Our very recent campaign, Act in Time to Heart Attack Signs,
addresses a missed opportunity to save lives. More than 1 million
Americans suffer heart attacks each year, and about 460,000 of these
attacks are fatal. In many cases, the deaths occur because heart attack
victims do not get to the hospital in time to benefit from the
treatments we have to offer. Why? Often, patients fail to recognize the
symptoms of heart attack, shrink from the notion of calling an
ambulance, or worry that they will feel foolish if their distress turns
out to be ``indigestion.'' The new educational initiative seeks to
counteract misconceptions about heart attack symptoms, alleviate
patient fears, and emphasize the importance of getting treatment
promptly. Materials have been developed--for the public and for
doctors--to teach people the key messages: (1) recognize the symptoms
and (2) call 9-1-1. Although the program is only in its 9th month, the
Act in Time message is already an official course of the American Red
Cross, and the National Council on the Aging is offering Act in Time in
senior centers throughout the country.
conclusion
We are confident that our approach, which is driven both by
compelling public health needs and by extraordinary scientific
opportunities, will continue to yield progress in the future. I would
be pleased to answer any questions that the Subcommittee may have about
the programs and plans of the NHLBI.
Mr. Bilirakis. Thank you very much, Doctor.
Dr. Penn?
STATEMENT OF AUDREY S. PENN
Ms. Penn. Mr. Chairman and members of the committee, I am,
indeed, Dr. Audrey Penn, Acting Director of the National
Institute of Neurological Disorders and Stroke. I am here today
to discuss our efforts at addressing stroke, the third leading
cause of death and a leading cause of disability in the United
States, with a total cost to the Nation estimated to be in
excess of $40 billion and immeasurable personal and emotional
costs to the victims and their families.
As the institute name implies, stroke is a priority for
NINDS. We are committed to developing safe and effective
treatments for all forms of stroke, including strategies to
maximize knowledge of warning signals, to apply known
preventative measures, to minimize damage, and protect
compromised brain, to avert recurrences, and to restore full
function.
Historically, NINDS has committed more funding to stroke
research than any other single disease or disorder within our
mission. In fiscal year 2001 our funding for stroke research
was more than $117 million, and across NIH the total was $239
million.
Now, as you all know, a stroke is a brain attack which
occurs when a clot blocks blood flow supplying the brain. An
ischemic stroke occurs then or, when a blood vessel ruptures,
you have a brain hemorrhage. In contrast to a heart attack, a
stroke doesn't usually hurt. Instead, specific regions of the
brain supplied by the compromised blood vessels stop
functioning, resulting in unilateral loss of strength or
sensation, loss of speech or vision, and even loss of
consciousness, if it is big.
In some persons, there may be brief episodes, transient
ischemic attacks, which, if recognized, provide warnings that
can allow us to use preventative strategies. It is critically
important that all be instructed in the warning signs of
stroke, and I would encourage everyone here to take home a copy
of these bookmarks which list the risk factors and the warning
signs, and are supplied actually in English and Spanish.
Over 3 decades, NINDS has supported a series of productive
clinical studies of stroke. Atrial fibrillation and irregular
heart rhythm significantly predisposes to embolic stroke,
especially in those over 60. We have supported clinical trials
in over 3,800 patients which confirm that aspirin and warfarin,
which is a blood-thinning agent, were so beneficial that stroke
incidence was cut by 50 to 80 percent. Optimal use of warfarin
in appropriate patients could prevent 40,000 strokes per year
and save $600 million per year in health care costs. In 60
percent of patients with atrialfibrillation younger than the
age of 75, a daily adult aspirin provides adequate protection
against stroke, with minimal complications.
Transient ischemic attacks, which serve as warnings of
impending stroke, can suggest the presence of stenosis in the
carotid arteries in the neck, which is related to
arteriosclerosis. So we have studied different surgical
strategies and examined them in a series of major clinical
trials leading to changes in practice and standard use of
carotid endarterectomy to clean out the plaque.
In another trial, which required over 10 years to complete,
we developed the first FDA-approved acute treatment for
ischemic stroke, and this is tissue plasminogen activator, or
t-PA, which dissolves blood clots and restores blood flow, if
you give it intravenously within 3 hours of the stroke. The
impressive results show that more patients were out of the
hospital, free of major neurological impairments, not in
rehabilitation centers or nursing homes, and back to their
usual activities at the end of 3 months.
So to develop units that can deliver rapid treatment for
strokes and conduct high-quality translational research, the
institute has issued a grant solicitation for Specialized
Programs of Translational Research in Acute Stroke, which are
known as SPOTRIAS. The SPOTRIAS programs will combine the
latest methods used in neurology critical care units with
research into neuro-protection, reversal of brain damage, and
restoration of function after acute stroke.
In the past several years, research--actually, it started
in the early 1990's in our institute as well--has revealed
remarkable capacity of alternate parts of the brain to take
over functions which have been lost in response to injury. So
new brain imaging techniques that measure the activity of the
brain cells involved are providing insights into how they do
this, and rehabilitation medicine and neurology are also
beginning to apply what has been learned about this, this so-
called brain plasticity, to encourage stroke recovery through a
method called constraint-induced therapy.
Dr. Lenfant referred to the increased incidence of stroke
in the Stroke Belt which involves, in particular, our African
American population, but also the general population. We are
working with the National Heart, Lung, and Blood Institute and
the National Center for Research Resources in developing a
Stroke and Cardiovascular Prevention-Intervention Research
Program at the Morehouse School of Medicine in Atlanta,
Georgia. We also have an Acute Brain Attack Research Program in
the Baltimore-Washington area, the pilot of which is the 24-
Hour Stroke Research Program at Suburban Hospital in Bethesda,
Maryland, part of our intramural program.
It is critical to continue to pursue and encourage basic
research into mechanisms of stroke, and continuous advances in
our knowledge of the biology of brain cells and of brain blood
vessels, both normal and abnormal, are critical, including
mechanisms of cell survival and death, neural growth factors,
stem cell therapy, neuronal plasticity, and glial cell biology.
We have funded many new projects to study strategies to protect
these brain cells from the loss of glucose and oxygen
consequent to stroke. We even have evidence that inflammation
is involved right at the brain blood vessels.
We recognize that scientific opportunities and research
needs, coupled with the increases in the NINDS budget, as a
result of the recent doubling efforts, mandate the
identification of clear scientific priorities, so that the
institute can determine the best uses for its resources. So we
convened a Stroke Progress Review Group, the PRG, of over 140
prominent scientists, clinicians, consumer advocates,
representatives of several concerned NIH institutes, and
industry representatives, which developed a comprehensive
document that identifies the scientific priorities to achieve
breakthroughs in stroke. I believe all of you have copies of
the Stroke PRG report.
So, we also recognize that supporting research is only part
of the battle, and it is critical to help people recognize that
they are having a stroke, to think of stroke as an emergency
and as a treatable disease, so that they call 911 to seek help
immediately. So, we direct an extensive education and outreach
effort for health care professionals and the general public,
and these include ``Know Stroke: Know the Signs. Act in Time.''
campaigns, where we have a variety of extremely well-received
public education materials, including television and radio
spots really given to us by the industry.
Some of our public education strategies are targeted to
specific at-risk minority communities. We had a ``Stroke
Sunday'' program at a local African American church in October
2000, which included participation by the then Surgeon General.
We have partnerships, including the Brain Attack Coalition,
which is a group of professional voluntary and government
groups. We have signed a Memorandum of Understanding with the
National Heart, Lung, and Blood Institute, the Centers for
Disease Control and Prevention, and the Health and Human
Services Office of Disease Prevention and Health Promotion, and
the American Heart Association, to foster cooperation in
reaching the heart disease and stroke goals for the Nation,
which were articulated in the ``Healthy People 2010''
Initiative.
So we feel we have made, and continue to make,
contributions, significant contributions to achievements in
stroke research which have impacted, and will impact,
prevention, treatment, and rehabilitation. Encouraged by the
recent progress in understanding the vascular biology of the
brain, and enabled by the support we are getting from Congress,
I can assure you that NINDS is committed to pursuing all of
these opportunities to alleviate the devastating effects of
stroke on our society.
Thank you very much for the opportunity to talk to you, and
I will be glad to answer any questions.
[The prepared statement of Audrey S. Penn follows:]
Prepared Statement of Audrey S. Penn, Acting Director, National
Institute of Neurological Disorders and Stroke, National Institutes of
Health
Mr. Chairman and Members of the Committee, I am Dr. Audrey Penn,
Acting Director of the National Institute of Neurological Disorders and
Stroke (NINDS). I am pleased to be here before you today to discuss our
efforts in addressing stroke--the third leading cause of death in the
United States after heart disease and cancer, and a leading cause of
long-term disability. The National Institute of Neurological Disorders
and Stroke at the National Institutes of Health (NIH) is the leading
federal organization committed to research on improving stroke
prevention, treatment, and recovery, through increased understanding of
how to protect and restore the brain. Historically, NINDS has committed
more funding to stroke research than to any other single disease or
disorder within our mission. In Fiscal Year (FY) 2001, NINDS funding
for stroke research was more than $117 million, and the NIH total was
nearly $239 million. More importantly, our stroke programs impact all
areas of scientific opportunity and public health priority--from stroke
awareness to rehabilitation--and are advancing the state of cutting-
edge knowledge about the ways to prevent, diagnose, treat, and educate
the public and health professionals about stroke.
background
As many of you know, a stroke is a ``brain attack'' caused by an
interruption of blood flow to the brain. There are two different types
of stroke--ischemic and hemorrhagic. Ischemic strokes occur when blood
flowing to a region of the brain is reduced or blocked, either by a
blood clot or by the narrowing of a vessel supplying blood to the
brain. Approximately 80 percent of all strokes are ischemic. The
remaining 20 percent of strokes are caused by the rupture of a blood
vessel, and leakage of blood into the brain tissue. These hemorrhagic
strokes can occur from the rupture of an aneurysm, which is a blood-
filled sac ballooning from a vessel wall, or leakage from a vessel wall
itself weakened by an underlying condition like high blood pressure.
At every conceivable level, stroke is a tremendous public health
burden to our country. More than 600,000 people experience a stroke
each year. Of the more than 4 million stroke survivors alive today,
many experience permanent impairments of their ability to move, think,
understand and use language, or speak--losses that compromise their
independence and quality of life. Furthermore, stroke risk increases
with age, and as the American population is growing older, the number
of persons at risk for experiencing a stroke is increasing. Over the
past several decades, NINDS has supported some of the most significant
achievements in stroke research, which have contributed to reductions
in the death rate from stroke. We continue to be committed to reducing
this burden.
historical progress in stroke prevention and treatment
NINDS has a long and distinguished history of supporting productive
clinical studies in the field of stroke prevention and acute treatment.
Indeed, successes in prevention date back more than twenty years, and
there has been remarkable progress in stroke prevention--which reflects
sustained efforts of private organizations, NIH, and other government
agencies. Stroke prevention is also highly cost-effective because it
averts the direct costs of hospitalization and rehabilitation. As NINDS
celebrated its 50th anniversary, the U.S. Centers for Disease Control
and Prevention estimated that the age-standardized stroke death rate
declined by 70 percent for the U.S. population from 1950 to 1996 [MMWR
Weekly 48:649-56 1999], and the American Heart Association tallied a 15
percent decline just from 1988 to 1998. I would like to briefly
summarize a few of the major NINDS-supported efforts, which have
included dozens of clinical trials, that have contributed significantly
to our knowledge of stroke.
Several early studies investigated medical management approaches to
the prevention of recurrent strokes in people with atrial fibrillation
(AF). This irregular heart rate and rhythm is a common disorder in
older Americans, and a significant stroke risk factor. It has been
estimated that two million Americans, primarily over the age of 60,
have AF and are six times more likely to have a stroke as a result. The
drugs aspirin and warfarin had been used to prevent recurrent stroke in
these individuals, however their use was based on little hard
scientific evidence. To address this issue, NINDS supported a series of
three trials in Stroke Prevention in Atrial Fibrillation-- referred to
as the SPAF trials. The SPAF I, II and III trials evaluated the use of
aspirin and warfarin for stroke prevention in more than 3,800 human
subjects. The SPAF I study reported in 1990 that both aspirin and
warfarin were so beneficial in preventing stroke in patients with
atrial fibrillation that the risk of stroke was cut by 50 to 80
percent. The results suggested that 20,000 to 30,000 strokes could be
prevented each year with proper treatment. The SPAF II study results in
1994 identified the 60 percent of people with atrial fibrillation for
whom a daily adult aspirin provides adequate protection against stroke
with minimal complications. This group consists of those younger than
75 and those older than 75 with no additional stroke risk factors such
as high blood pressure or heart disease. SPAF III, which included 1,044
patients at 20 medical centers in the U.S. and Canada, studied the
remaining 40 percent of atrial fibrillation patients with additional
risk factors for stroke and for whom warfarin had been shown to be
effective. The study was stopped ahead of schedule in 1996 because
early results clearly demonstrated the benefit of standard warfarin
therapy over the combination therapy of aspirin and fixed-dose
warfarin, in these high-risk patients. Other reports have estimated
that the use of warfarin to prevent strokes in persons with AF costs as
much as $1,000 annually, but a year of post-stroke treatment can cost
$25,000. Based on these estimates, optimal use of standard warfarin
therapy in the appropriate patients could prevent as many as 40,000
strokes a year in the U.S., and save nearly $600 million a year in
health care costs.
Other studies supported by the Institute, such as the Warfarin
Antiplatelet Recurrent Stroke Study, the Vitamin Intervention for
Stroke Prevention study, the African-American Antiplatelet Stroke
Prevention Study, and the Women's Estrogen for Stroke Trial, build on
these earlier findings, and continue to add to our knowledge about
medical interventions that can affect the incidence of stroke in
different at-risk groups.
The NINDS has also supported several major studies of surgical
approaches to the secondary prevention of stroke. This work has
particular significance for people with carotid artery stenosis, a
narrowing of the major blood vessels that supply the brain. One
definitive study in the late 1970s examined a procedure called
extracranial/intracranial (EC/IC) bypass. EC/IC bypass had been used
for several years as a means to restore blood flow to the brain. The
NINDS-funded study of the procedure's effectiveness found that the data
did not support its continued use in medical practice to prevent
stroke. These findings were of significant benefit to patients, who
could avoid the risks and costs of this surgery, and to researchers,
who used this information to redirect their attention to other
promising approaches. As a result, investigators explored an
alternative surgical strategy, called carotid endarterectomy, which
involves the removal of fatty deposits, or plaque, in the carotid
arteries. In two NINDS-funded trials--the North American Symptomatic
Carotid Endarterectomy Trial (NASCET), and the Asymptomatic Carotid
Atherosclerosis Study (ACAS)--this approach was examined more
extensively.
The results of the 12-year NASCET trial were reported in two
stages. The investigators' early data led to a radical change in the
recommended treatment for severe (70-99 percent) carotid stenosis, or
blockage, when it was determined that, together with appropriate
medical care, carotid endarterectomy for patients with severe blockage
prevented more strokes than did medical treatment alone. NINDS
responded to this finding by halting the part of the study involving
patients with severe blockage, and issuing a nationwide alert to
physicians asking them to consider the study results in making
recommendations to their patients. The rest of the study focused on
determining the efficacy of this surgery for symptomatic patients with
moderate carotid stenosis (30-69 percent blockage). Those results
showed that patients with the higher grades of moderate stenosis (50-69
percent) clearly benefit from surgery. There was no significant benefit
for patients with less than 50 percent stenosis. As a result of the
NASCET trial, patients with moderate stenosis are better able to decide
whether to risk surgery in order to prevent possible future strokes.
In the ACAS trial, carotid endarterectomy was found highly
beneficial for persons who are symptom-free, but have a carotid
stenosis of 60 to 99 percent. In this group, the surgery reduces the
estimated 5-year risk of stroke by more than one-half, from about 1 in
10 to less than 1 in 20.
To the long list of studies contributing to improvements in
secondary stroke prevention, we can add a more recent NINDS-funded
trial, which resulted in the first FDA-approved acute treatment for
ischemic stroke, in 1996. This therapy--tissue plasminogen activator or
t-PA--dissolves blood clots and restores blood flow, if given
intravenously within the first three hours after an ischemic stroke.
Patients must be screened carefully before receiving t-PA, since it is
not appropriate for use in treating hemorrhagic stroke, and should not
be given beyond the three-hour window. However, in carefully selected
patients, use of t-PA can achieve a complete recovery. Unfortunately
many, indeed most, stroke patients do not receive t-PA because they do
not arrive at the hospital in time to be evaluated and treated within
the crucial three-hour window of effectiveness. Or, in many cases,
hospitals are not prepared to rapidly identify and treat these
patients. It is this dual challenge that NINDS is actively pursuing
through the development of model systems and through education and
outreach efforts that are discussed later in my testimony.
recent advances
Within the framework of these historical successes, NINDS continues
to build its basic science and clinical stroke programs, and to reap
the rewards of past investments. A sampling of these recent advances
includes:
The use of medical therapy to prevent recurrent stroke in people
without cardiac risk factors
As described above, past clinical studies provided important
information about preventing recurrent stroke in people with cardiac
arrhythmias. However, it has been difficult for physicians to choose
between aspirin and warfarin for patients who do not present with
cardiac risk factors. To help address these questions, another large
clinical trial--the Warfarin versus Aspirin Recurrent Stroke Study
(WARSS) was initiated with NINDS support. More than 2000 individuals
with a history of stroke unrelated to cardiac problems participated in
this study, with equal groups receiving aspirin and warfarin. After two
years of treatment, there was no significant difference in the
prevention of recurrent stroke or death, or in the rate of brain
hemorrhage, in the aspirin and warfarin groups. This finding will
likely have a major impact on the standard of care for this group of
stroke survivors, since aspirin is considerably less expensive, safer,
and easier to administer than warfarin.
The use of the ``warning signs'' of stroke to aid in prevention
Recently, NINDS-funded researchers evaluated the risk of stroke
after a transient ischemic attack (TIA), or ``mini-stroke.'' The
symptoms of TIAs pass quickly, within a day or even hours, and are
often ignored. After following 1700 people with a TIA, the study found
that these episodes warn of a dramatically increased likelihood of
experiencing a stroke within the subsequent 90-day period. Other risk
factors, such as advanced age, other health conditions, and severity of
the TIA, also helped to predict stroke risk, and may be useful in
determining whether patients should be hospitalized immediately and/or
receive preventive interventions following a TIA.
The development of clinical tools that can be used to predict stroke
recovery
In order to offer clinicians the best possible methods for
evaluating patients after a stroke, intramural investigators at NINDS
have explored the types of clinical measurements and diagnostic tools
that might be used to predict how well a person will recover from a
stroke. They found that the combined use of a unique type of magnetic
resonance imaging, the score on the NIH Stroke Scale--a diagnostic tool
developed at NINDS for evaluating stroke patients, and the time from
the onset of symptoms to the brain scan, can effectively predict the
extent of stroke recovery. Future studies will focus on the potential
of computerized tomography (CT) scanning to predict recovery as this is
a technology more commonly available in most hospitals. We expect that
all of these tools will help physicians manage patients more
efficiently and reduce distress and anxiety among patients and their
families.
Brain plasticity
Over the last several years research has revealed the remarkable
extent of brain plasticity--that is, the capacity of the brain to
change in response to experience or injury. Scientists are now using
brain imaging techniques that reveal the activity of brain cells, as
well as structure, to understand why some patients recover lost
abilities following stroke and others do not. In other efforts,
researchers are trying to apply what has been learned about brain
plasticity to encourage stroke recovery through a method called
``constraint-induced therapy.'' This therapy involves constraining an
unaffected extremity while actively exercising the affected one,
thereby inducing use-dependent brain reorganization.
The use of stem cells to treat stroke in animal models
Stem cells are immature cells that can multiply and form more
specialized cell types. Recent animal studies have provided evidence
that transplanted stem cells can help restore brain function after
stroke. Other animal research suggests that the adult brain may itself
have a latent capacity to regenerate new cells following stroke, which
might be encouraged in efforts to repair the brain. The continuing
efforts to develop these approaches to restoration of function in
survivors of stroke build on active NINDS support to understand the
basic biology of animal embryonic stem cells and adult human stem
cells. Within the President's policy guidelines, the Institute is
encouraging research to evaluate the capabilities of human embryonic
stem cells.
current stroke initiatives
The generous appropriations provided by Congress have made it
possible for us to expand our programs in stroke, and we are grateful
for the opportunity. Since the doubling of the NIH budget began in FY
1999, the Institute has initiated many new clinical and basic science
projects. Currently, the Institute is supporting 14 Phase III clinical
trials in stroke, eight of which have been initiated since the start of
the doubling effort. Even more importantly, the doubling effort has
enabled NINDS to fund 17 Phase I and II clinical trials in stroke.
These numbers are impressive and indicate that many novel prevention
strategies, therapeutic interventions, and rehabilitation techniques
for stroke are closer to the clinic as a result of the significant
investments in NIH over the past several years. Areas of clinical
research that are under exploration include the use of hypothermia to
improve outcome following aneurysm surgery, the use of magnesium to
treat stroke, and improvements in stroke imaging techniques. Several
studies, including research in the NINDS intramural program at the NIH
Clinical Center, are examining various strategies for rehabilitation
after stroke including the use of constraint therapy, exercise,
anesthesia, and electrical stimulation to improve functional recovery.
NINDS also continues to be committed to exploring stroke at the
basic science level, and has provided funding for many new projects
since the doubling effort began. These include studies of procedures
and drugs that may protect the brain against further injury, a possible
vaccine for stroke, the role of inflammation, the expression of genes
and proteins in response to stroke, and pre-clinical testing of
therapies--just to name a few. Cellular ``communications'' between
blood vessels, neurons, and glia, and the role of the blood-brain
barrier, are also subjects of intense interest. In addition to studies
specifically targeted to stroke, NINDS also provides support for many
areas of basic neuroscience research that have broad applicability to
stroke and other brain injuries. These include mechanisms of cell
survival and death, neural growth factors, stem cell therapy, neuronal
plasticity, and glial cell biology.
In addition to the investigator-initiated projects that make up the
core of our grant programs, NINDS is constantly looking for
understudied areas in stroke research that the Institute could address
through the use of targeted initiatives. Several years ago, NINDS
identified a need for acute stroke centers, and in May 2001, we issued
a grant solicitation for Specialized Programs of Translational Research
in Acute Stroke (SPOTRIAS). The goal of the SPOTRIAS program is to
reduce disability and mortality in stroke patients, by promoting rapid
diagnosis and effective interventions. It will support a collaboration
of clinical researchers from different specialties whose collective
efforts will lead to new approaches to early diagnosis and treatment of
acute stroke patients. In its report language for the Institute's
FY2001 appropriation, the Senate also encouraged the creation of acute
stroke research or treatment research centers to provide rapid, early,
continuous 24-hour treatment to stroke victims, and noted that a
dedicated area in a medical facility with resources, personnel and
equipment dedicated to treat stroke, would also provide an opportunity
for early evaluation of stroke treatments. The SPOTRIAS program is
responsive to the recommendation highlighted by the Senate.
Institutions supported under this program must be able to deliver rapid
treatment for acute stroke and to conduct the highest quality
translational research on the diagnosis and treatment of acute ischemic
and hemorrhagic stroke. They will also help to recruit and train the
next generation of stroke researchers. The SPOTRIAS initiative will
facilitate the translation of basic research findings into clinical
research, and ultimately, the incorporation of clinical research
findings into clinical practice. The first two centers have recently
been approved for funding under this program, and as more centers are
added, it is expected that they will form a national network that will
lead to significant changes in the care of stroke patients.
On a more local level, NINDS is also developing the ``Acute Brain
Attack Research Program'' in the Baltimore-Washington Area. This effort
has already established a 24-hour stroke research program in diagnosis
and treatment at Suburban Hospital in Bethesda, Maryland, and our plan
is to replicate this program in other medical facilities in the
Baltimore-Washington metropolitan area, next targeting those serving
predominantly inner city minority populations.
stroke research planning
While a significant knowledge base about stroke has been amassed
through research supported by the NINDS, continually emerging
discoveries and new technologies create constantly increasing research
needs and scientific opportunities. Coupled with the increases in the
NINDS budget as a result of the recent NIH doubling effort, it is
necessary to identify clear scientific priorities, so that the
Institute can determine the best uses for its resources. Such
priorities will also serve as benchmarks for the broader scientific
community against which progress can be measured. NINDS convened a
Stroke Progress Review Group (Stroke PRG) to identify priorities in
stroke research. The Stroke PRG had its origins in Fiscal Year 2001
report language from the House and Senate Appropriations Committees to
the NINDS urging us to develop a national research plan for stroke.
Following on the success of the Brain Tumor Progress Review Group, a
joint collaboration between NINDS and the National Cancer Institute to
identify priorities for research on brain tumors, NINDS decided to use
a Progress Review Group to develop a plan for stroke research. Members
of the Stroke PRG include approximately 140 prominent scientists,
clinicians, consumer advocates--including leaders from the American
Stroke Association and the National Stroke Association, industry
representatives, and participants from other NIH Institutes. Together,
these individuals represent the full spectrum of expertise required to
identify and prioritize scientific needs and opportunities that are
critical to advancing the field of stroke research.
At the Stroke PRG Roundtable meeting in July 2001, and in many
subsequent discussions, the Stroke PRG report was developed--a
comprehensive document that identifies the national needs and
opportunities in the field of stroke research. The final draft of this
report was submitted for deliberation and acceptance by the National
Advisory Neurological Disorders and Stroke Council in February, and the
final report was published in April 2002. The PRG report will be widely
disseminated to the stroke community, and is available online at
www.ninds.nih.gov (Search: Stroke PRG); copies were provided to the
Committee earlier this week.
Several areas of scientific need are identified in the Stroke PRG
report, but five consensus priorities emerged from the PRG:
bIdentification of the genes and proteins that contribute to
stroke;
An improved understanding of the relationship of blood, blood
vessels, and brain tissue;
A better appreciation of how blood flow is regulated and how
it can be improved after stroke;
The development of combination therapies based on molecular
and cellular pathways of injury; and
A better understanding of the neural mechanisms that regulate
recovery after stroke.
Participants also identified a number of scientific resource needs
including:
Access to new technologies that allow for large numbers of
genes or proteins to be analyzed simultaneously;
Improved animal models of stroke that better simulate the
human disease;
Improved methods of imaging the brain;
Improvements in clinical trial design and methods;
Development of a network of stroke centers;
A national database that would capture information on the
burden of stroke; and
Better education and training for clinicians in the care of
stroke patients.
The full PRG report expands on all of these issues, and provides
in-depth analysis of the status of 15 different fields of stroke
research. As we move forward from the planning process into the
implementation phase, the Stroke PRG members will work with NINDS staff
to ``map'' the Institute's current stroke research efforts to the
recommendations of the report. Using this approach, we will be able to
identify existing research gaps and resource needs, and to incorporate
these into a formal implementation plan.
health disparities in stroke
NINDS recognizes that stroke is one of several neurological
disorders that has a disproportionate effect on minority and
underserved populations. For example, African Americans are twice as
likely to die of stroke or complications from stroke as people in any
other racial or ethnic group in the country, and Hispanics have a
stroke rate two times higher than that of Caucasians. For this reason,
we have identified stroke as a critical health disparities issue in
several Institute planning efforts: health disparities in stroke was
considered as an over-arching issue by the Stroke PRG panel; stroke is
one of the top research priorities in the NINDS Five-Year Strategic
Plan on Minority Health Disparities; and the Institute is also in the
process of establishing a planning panel that will specifically address
health disparities in stroke.
The NINDS is also working to establish prevention/intervention
research networks throughout the extramural community, particularly in
regions of the ``Stroke Belt,'' an area in the Southeastern U.S. with
stroke mortality rates approximately 25 percent above the rest of the
nation. The goal is to foster stronger linkages between investigators
at minority and majority institutions and community-based organizations
in order to improve minority recruitment and retention in clinical
studies--as one way of addressing health disparities. As part of this
program, NINDS, working with the National Heart, Lung and Blood
Institute (NHLBI) and the National Center for Research Resources, is
developing the ``Stroke and Cardiovascular Prevention-Intervention
Research Program.'' The pilot phase of this program is at the Morehouse
School of Medicine in Atlanta, Georgia.
In addition to these programs, NINDS supports a number of ongoing
clinical projects that specifically address stroke in minority
populations, including a new study that will examine the phenomenon of
the ``Stroke Belt.'' In this study, the role of geographic and racial
differences as contributors to differential mortality rates will be
examined and risk factors estimated. We are also engaged in targeting
special public education efforts to minority populations, as I will
describe later in my testimony.
stroke in women
In addition, we recognize that stroke is a major health problem for
women. To address this critical research area, NINDS is supporting
studies that will help us to better understand gender differences in
stroke. Specific projects include a clinical study to determine if
hormone replacement therapy affects stroke severity, and a study
examining blood flow in the brain and the role of female hormones in
protecting brain tissue during ischemia. In all clinical trials, we
ensure that appropriate numbers of women are enrolled, and many of
these trials involve specific analyses to examine the effects of the
intervention tested in the female participants. For example, we are
currently supporting a clinical study that is comparing the efficacy of
two procedures--carotid endarterectomy and carotid stenting--that
unblock a clogged carotid artery in the neck, a significant risk factor
for stroke. Previous research has shown that women may not benefit from
carotid endarterectomy as much as men do, so one facet of the trial
will examine gender differences in these procedures.
education and outreach programs
NINDS recognizes that supporting research into new prevention
strategies and treatment options is only part of the battle in reducing
the health burden of stroke. Helping people to recognize that they are
having a stroke, so that they can seek help immediately, is a critical
first step. To address this problem, the NINDS directs an extensive
health promotion effort to raise awareness of the signs and symptoms of
stroke, the need for urgent action if experiencing a stroke, and the
possibility of a positive outcome with timely hospital treatment.
In May 2001, the NINDS launched the ``Know Stroke. Know the Signs.
Act in Time'' campaign, a multi-faceted public education campaign to
educate people about how to recognize stroke symptoms, and then to call
911 to get to a hospital quickly for treatment. The campaign's target
audiences are those most at-risk for stroke--primarily people over the
age of 50--and their family members, caregivers and health care
providers. Because stroke attacks the brain, a stroke patient often
cannot act alone to call 911 and seek medical treatment, so bystanders
are integral to acting quickly and getting stroke patients to the
hospital. For this activity, the NINDS developed a wide variety of
public education materials including airport dioramas jointly sponsored
with the National Stroke Association, billboard displays, an award-
winning eight minute film, consumer education brochures, exhibits, and
new radio and television public service announcements (PSAs). All
indications are that the ``Know Stroke'' campaign has been extremely
well-received and effective. The television PSA garnered more than 87
million viewer impressions and hundreds of thousands of dollars worth
of free broadcast time; the radio PSAs received more than 46,000
broadcasts on 272 stations; the airport dioramas received more than 800
million annual impressions; and thousands of nursing homes, hospitals,
senior centers and other organizations have received consumer education
materials.
All of our public education strategies are designed to increase
awareness of stroke. However, since the problem of stroke is even more
acute in the African American and Hispanic communities, some are
targeted to specific at-risk minority communities. These campaigns
started with outreach to the media in May 2002 for Stroke Awareness
Month and, in the coming months and years, will include public service
advertising and grassroots community education components. NINDS also
co-sponsored a ``Stroke Sunday'' program in October 2000, with the
American Stroke Association and the Black Commissioned Officers'
Advisory Group of the U.S. Public Health Service. This program was led
by the former U.S. Surgeon General, Dr. David Satcher, and I
participated on behalf of the NINDS. Held at a Rockville, Maryland
church, the event was designed to bring attention to the major impact
of stroke in the African American community and to help inform
participants about reducing their stroke risk.
NINDS also participates in ``Operation Stroke,'' a coalition of
health care professionals, allied health providers, civic leaders and
representatives of community organizations for stroke education. This
effort is being coordinated by the American Stroke Association, and is
aimed at the public as well as medical professionals. An intramural
investigator at NINDS, who is a stroke clinician, is chairing this
coalition in the greater D.C. and Maryland suburban areas.
Finally, NINDS has held several meetings and workshops to help
educate health care professionals about advancements in stroke
research, like t-PA. For example, our Institute held a major national
scientific meeting after the publication of the t-PA study that
involved more than 400 medical professionals. We plan to convene
another conference later this year to revisit stroke treatment, and to
explore how more people can be encouraged to recognize stroke as an
emergency medical situation. The Institute hopes to use this symposium
to educate healthcare professionals about the benefits of early
treatment for all stroke patients. In addition, NINDS scientists speak
at medical meetings all over the country in order to educate physicians
about effective stroke care, and our grantees produce educational
videos and offer continuing medical education courses on proper
administration of t-PA. To complement these efforts, NINDS also
distributes free copies of the NIH Stroke Scale.
partnerships
As part of our ongoing prevention efforts, we have formed
collaborative relationships with other NIH Institutes and federal
agencies, and numerous voluntary organizations. NINDS coordinates the
Brain Attack Coalition--a group of professional, voluntary, and
government groups dedicated to reducing the occurrence, disabilities,
and death associated with stroke--to increase awareness of stroke
symptoms. To encourage improvements in stroke care, the Brain Attack
Coalition published an article in June 2000 designed to help physicians
and hospitals set up stroke centers.
In February 2001, the NINDS signed a memorandum of understanding
(MOU) with NHLBI, the Centers for Disease Control and Prevention (CDC),
the HHS Office of Disease Prevention and Health Promotion, and the
American Heart Association to foster cooperation in reaching the heart
disease and stroke goals for the nation articulated in the Healthy
People 2010 initiative. These goals include: the prevention of risk
factors for cardiovascular disease (CVD) and stroke; the detection and
treatment of risk factors; the early identification and treatment of
CVD and stroke, especially in their acute phases; and the prevention of
recurrent CVD and stroke, and their complications.
In order to achieve these goals, we will work with the
participating partners on focused initiatives such as population- and
community-based public education and health promotion programs;
activities to bring about improvements in the nation's cardiovascular
health care delivery systems; media-based public awareness campaigns
about the warning signs and symptoms of heart attack and stroke;
promoting professional education and training, and other activities.
CDC has already used our public education materials in cooperation with
their networks, and we are enthusiastic about this partnership, and
anticipate that it will continue for the next several years.
NINDS is also participating in the development of a comprehensive
National Action Plan for Cardiovascular Health--A Comprehensive Public
Health Strategy to Combat Heart Disease and Stroke. This planning
process was initiated last year by the CDC. It will chart a course for
the CDC with the states, territories and other partners--including
public health agencies, health care providers, and the public--for
achieving national goals for heart disease and stroke prevention over
the next two decades. The pillars of this public health strategy
incorporate the three core functions of public health: assessment,
policy development, and assurance.
conclusion
NINDS has made, and continues to make, significant contributions to
the achievements in stroke prevention, treatment, and rehabilitation,
and we are extremely proud of our accomplishments. However, the
incremental nature of progress in stroke prevention has confirmed that
there is no easy route to success. There are still difficult challenges
to be addressed, and we have invested more than a year in gathering
recommendations from the best clinicians and researchers in the field,
as well as our committed partners in the advocacy community, in order
to help us make the best use of our resources.
Our planning efforts tell us we must continue to pursue, in
parallel, several areas of basic, translational, and clinical research
that may have an impact on stroke. We must find better ways to prevent
strokes before they occur. We must improve upon and encourage
acceptance of pioneering diagnostic tools and acute treatments for when
stroke happens. We must capitalize on the prospect, for the first time,
of actually repairing the brain damaged by stroke and recovering
function. The broad portfolio of NINDS research on stroke offers a
glimpse of what the future might bring--the possibility of vaccines,
genetic tests to tailor preventive measures for each individual,
studies that may link infections or inflammation within blood vessels
to stroke, biological markers that could aid in the identification of
stroke risk, and new information about how chronic stress and hormones
may affect susceptibility to stroke damage. Encouraged by the recent
progress in neuroscience, guided by extensive and inclusive planning,
and enabled by the support from Congress, I assure you that NINDS is
committed to pursuing all of these opportunities to alleviate the
devastating effects of stroke on our society.
Thank you again for the opportunity to speak with you today. I
would be happy to answer any questions you may have.
Mr. Bilirakis. Thank you very much, Dr. Penn.
I will start off the questioning. First of all, by the way,
the bookmarks that you referred to are back at that rear table.
Ms. Penn. Yes.
Mr. Bilirakis. They are in English also? The one that is
available up here is in Spanish.
Ms. Penn. Yes, there should be two sets.
Mr. Bilirakis. Good enough.
I guess this question may be for both of you: The
Department of Defense, as we know, has also invested, Dr.
Lenfant, significant dollars in blood research. So they are
conducting blood research also. We have represented here today
by the two of you two institutes, the Institute of National
Heart, Lung, and Blood Institute, your institute as well as Dr.
Penn's institute.
So I guess my question goes to coordination. It is
something that has always concerned me. Maybe I am placing too
much emphasis in my own mind on that, but there's Veterans'
Administration research, Department of Defense research,
similar type of research by your two institutes. My question
goes to coordination.
Is much duplication taking place? Is that duplication, if
it is taking place, necessary? In order to reach the ultimate
result, is some duplication a necessary evil, if you will, if I
can call it that? What coordination takes place among the
institutes with other departments of the government, et cetera,
university research, all that? Yes, sir?
Mr. Lenfant. I think the varieties of cooperation and
collaboration are many, and I would say ideal. First of all,
Mr. Chairman, we are all on the same campus. We bump into each
other all day. So we have this free-wheeling discussion about
topics and whatever.
But there are, as Dr. Penn mentioned to you, some formal
ways to do it. For example, a few months ago, our two
institutes signed a Memorandum of Understanding to assure our
corroboration and cooperation in areas of mutual interest. But,
furthermore, not only do we do it with the two of us, but we
worked with the American Heart Association and other agencies
of the government such as CDC. There was also the Office of
Prevention from the Department, and we discuss things.
If you are looking at the initiatives which are issued by
NIH, that is, new programs which are initiated, you probably
would be amazed to see that there may be as many as 10
institutes sponsoring one program. We all contribute the
technical contributions, technical support, but also monetary
support.
Mr. Bilirakis. How do you tie into other departments, the
VA, the Defense, the universities?
Mr. Lenfant. I will go into that. With the VA, we have many
cooperations. In fact, we have a number of joint studies in our
institute with the VA. You mentioned blood safety earlier. We
do have exchange of information. In fact, I believe--and I
would have to verify that--but I believe that we have a project
on blood safety and substitutes that is, quote/unquote,
artificial blood. We have programs which are jointly supported
between our institutes and the Department of Defense. So there
is a lot of cooperation.
The idea is that you want enough in the open so that people
know about it. We cannot, with the rules of NIH, we cannot
issue a new program, initiate a new program, without posting it
for, I believe it is, 2 weeks for anyone to see it, and to
indicate its intents, that is, another institute or somebody
else. That happens all the time.
We could probably do more.
Mr. Bilirakis. Does that information get to the other
departments in some way? Does it become known to the
universities?
Mr. Lenfant. The NIH publishes widely on the Internet and I
believe also on paper all the things which are being developed.
You also asked about the academic community. Most, not to
say all, of the things which are initiated, new programs, by
the National Institutes of Health, and certainly by our two
institutes, are actually the result of deliberations and
discussions and debates, I should say sometimes, with the
scientific community. In fact, we do have an obligation, either
by rule or legislation--I must admit I don't know which one it
is--but to basically seek the support of our national advisory
council, which is made up of representatives of the public as
well as the scientific community, before we can start the new
programs.
Mr. Bilirakis. Well, my time has expired.
Mr. Lenfant. I'm sorry.
Mr. Bilirakis. Dr. Penn, if you wanted to take 30 seconds
or a minute to maybe expand upon what Dr. Lenfant said?
Ms. Penn. I would say it depends somewhat on what kind of
science or medicine you are trying to drive. In the case of
issues actually of a particular type of therapy for Parkinson's
disease, we are working with the Veterans' Administration, also
through a Memorandum of Understanding between the two agencies,
because they have patients that the general academic health
centers don't have. They started this, and they asked us to
work with them. We helped design this large clinical trial of
deep brain stimulation. So that is one example.
Another example depends somewhat, as Dr. Lenfant just said,
on who the investigators are, and the investigators really do
work both through the Department of Defense, some of them are
in the VA system; some of them are coming to us for grants. We
just have to--you know, we know who is getting support from
whom. In some cases, such as the prion diseases that Mr. Brown
referred to, we have an action plan in the Department, which
involved all the institutes as well as several other units of
HHS. That really did require collaboration, and that was not
overlap. The prion diseases are a major problem or potentially
a major problem.
Mr. Bilirakis. So I am unduly concerned then? I am unduly
concerned about that problem? There isn't that much
duplication?
Ms. Penn. Well, we do talk to each other first, is what I
am getting at.
Mr. Bilirakis. Thank you.
Mr. Brown?
Mr. Brown. Thank you, Mr. Chairman.
I think that probably Members of Congress, when they look
at NIH and look at CDC, they think of, first of all, they fund
NIH to the tune of about $4, $5 for every dollar that Congress
funds CDC, and there are a lot of reasons for that. One of
them, I think, is that all of us know people that have awful
diseases in our families, our friends, our constituents. NIH is
a terrific agency responding to those challenges.
Most of us don't know, frankly, because of the way we live
our lives and run our offices, don't know a lot of people that
are poor, where CDC, which is not an agency only for the poor,
but an agency that seems to be that to many people in this
body. I think of NIH, I think of both CDC and NIH as public
health agencies. I am not sure you would characterize
yourselves that way, but you are a public health agency in the
sense that you respond to health demands, to public health
demands, in terms of basic research, sometimes in the case of
Taxol more than simply basic research.
But your charge in many ways, in my mind, is that when
neither the private sector in terms of antibiotics, as an
example perhaps, and a host of other awful developing world
illnesses where there is not much money for private
pharmaceutical--not much monetary incentive for private
pharmaceutical companies to respond, or in the sense of
sometimes the public where we didn't respond publicly quickly
enough, to the public sector, on something like coming up with
responses to the awful AIDS epidemic.
So my questions is, how does NIH respond when it is clear
that a medical need is not being sufficiently addressed? Do you
see your model in part the way that the Department of Defense's
Walter Reed took it upon themselves, with little private
involvement and private money, simply to develop malarial drugs
and not exactly go to market with them, but really develop them
almost in toto--do you see your role fulfilling a public need
in that way?
How poorly we have done developing antibiotics, how we
haven't done well enough in malarial vaccines, how we haven't
done well enough for--I know less about this--but river
blindness and various awful Third World diseases that none of
our constituents will have, and certainly nobody that dresses
the way I do will probably have.
Not that I dress that well. I have heard from several
people how ugly this tie is, but because it is from Children's
Hospital I get a break on it.
Go ahead.
Ms. Penn. The mission of the National Institute of
Neurological Disorders and Stroke is to apply research in basic
neuroscience to solving our major disorders. We, obviously,
focus on disorders of the central and peripheral nervous
system, and to some degree muscles. So muscular dystrophy is in
there.
So we look for opportunities by looking, on the one hand,
at the scientific opportunities that are there that our basic
scientists and our clinical scientists are providing us, and
then saying, okay, how can we move this into the clinic? We
don't go so far, necessarily, as to start by saying--well, we
do say we want to treat this. This is underserved or not
treated well or it has got way too many side effects. We could
do that.
But we concentrate really--and it is becoming increasingly
clear to all of us--that we have to do the translational
research. So that we are right in the middle of taking the
mechanisms and saying, okay, if you tweak this or you do that,
you are going to get a therapy. Then we have to least start to
work out the therapy and say, it's safe; it isn't safe; how
much do you need, and all of this.
At some point in there we do have to talk, and we often do,
to small or large pharmaceutical companies because they are
going to finally make this drug and market it. I am really not
into what they do. We leave it a lot to the NIH Office of
Technology Transfer, as you mentioned.
But we do look, and sometimes get a little concerned, as
all citizens do, about how things are being done in terms of
delivery of care and all of that, but we are really into taking
the science, making sure the science is done, making sure the
science--some of our science is really purely at the bench and
purely doesn't seem to be related to anything, but sooner or
later it is. It is amazing how much it is. We think that is the
key, to figure out where, all of a sudden, okay, that
breakthrough is going to work on that.
Mr. Brown. But the other key is when there is not private
sector incentives. There apparently hasn't been in antibiotics,
and with multi-drug resistance. Was NIH taking--not your
institute, but NIH as a whole--taking on that public burden?
Ms. Penn. I would just say this is not something we think
of first; we really don't. But, I mean, sooner or later, we do
have to consider that.
Mr. Brown. But your charge as a public health agency needs
to be broad enough, as we have just piled on money for you--to
think of doubling the budget over 5 years, when of course there
are untold number of scientific opportunities and thoughts and
proposals and ideas and ideals, but we need not you and
necessarily your institute, but the NIH as a whole needs to
think what ultimate, not just basic scientific research, but
what ultimate public goals do you have.
When you see antibiotic resistance, you see what happens
with TB, you see we are going back to the 1940's and 1950's
antibiotics, which have terrible side effects, that people have
to take for 2 years to treat multi-drug-resistant TB, as it is
getting worse and worse, there is a public need there that the
drug industry probably won't address, and who else will if not
you with a doubled budget? Just comment.
Mr. Bilirakis. Yes, a brief comment to that.
Mr. Brown. Dr. Lenfant, if you----
Mr. Lenfant. Yes, I would like to add to what Dr. Penn has
said. I cannot speak about antibiotics because that is not
something that we are doing and are involved with. But what I
can say to you, Mr. Brown, is that there are medications which
have the potential to have an effect on disease. Well, let me
put it this way: on diseases which basically are not on the
label of the medication. You can be sure that the
pharmaceutical industry will not engage in exploring the whole
possibilities that one medication may offer.
In our institute we initiate many clinical trials, and the
reason we do it, it is basically because we know that industry
will not do it, either because, if it is done, it may not have
enough impact and the business aspect is small to get into
that, but we take it. In effect, we know that there are some
significant benefits which are given to the public and the
patients by this kind of approach to explore what it is and
investigate what it is that is not being done by the industry,
for whatever reason they may have, which may be business, which
may be--I don't know what it is, sometimes liability issues. We
have the capability to do it, and we do it.
Mr. Bilirakis. Would you say that you speak for the NIH as
a whole?
Mr. Lenfant. I believe--well, you know, I can tell you at
least one institute that I know a little bit better than most,
it is the Cancer Institute. I know that the Cancer Institute
has a drug development program which is extraordinarily active.
Basically, I suppose if the industry would do it, they would
not have that program. I am sure that there are many other
examples with regard to NIH.
Mr. Bilirakis. Well, thank you. I am not sure that Mr.
Brown is completely satisfied, but we've really got to go on.
Mr. Brown. Thank you.
Mr. Bilirakis. But it is a good start.
Mr. Deal, to inquire?
Mr. Deal. Thank you, Mr. Chairman.
As I understand it, each of you represent 27 institutes or
centers under the umbrella of NIH. I would like to find out how
the operational activities take place within each institute.
Could you give me an idea, first of all, as to what percentage
of the research is done through extramural grants as opposed to
in-house research? And what process do you use to determine to
whom those extramural grants will be given? Do you have a
review panel within each institute, I assume? Is that review
panel made up of people from the outside who are recognized
experts? Would you elaborate on those two areas? First of all,
how much is done in-house versus grants, and how do you decide
how the grant process is going to work?
Mr. Lenfant. Well, okay, let me take it. These are very
important questions.
Let me say that, as a rule, the amount, the fraction of the
total NIH budget which is for intramural research is pretty
much fixed. I think the average for the NIH as a whole is 11
percent. Eleven percent of the total is intramural. It varies
greatly. My institute is the one with the smallest intramural
budget. It is, I believe, 6 percent, but of course it is 6
percent of $2.7 billion. So it is a significant amount of
money.
It varies. It may go up and down a little a bit, but not
significantly. But years ago there was a review of the
intramural programs, and the decision was made by all of us
that we would pretty much limit our intramural research to that
amount for the corporation.
Now the extramural research is, indeed, all decided by a
peer review process. Applications for grants are all coming
into a central place at NIH. That place has two
responsibilities. The first one is to assign them to one of the
institutes. Say, for example, something comes on strokes,
depending on what it is going to be specifically, it may go
here or it may go here.
Now once the application is assigned, it does not come to
my institute until it has been reviewed, evaluated
independently of me and my staff. The people who are going to
do that are people from the institutions which are in all of
the States that you are from. So it is a independent peer-
review process.
What they do, they give a numerical score, 100 being the
best, 500 being the worst. By and large, these things are
funded on the ranking of the score that you have received.
Ms. Penn. Right. We have to follow the NIH guidelines for
the intramural program. It has its own review committee made of
external experts that come in three times a year to look at--
the same cycle as extramural--how 4 years of work has
proceeded. It is at least as tough as any academic tenure
committee or worse. So people really have to show that they
have done good work, really good work, and that they are
fulfilling the mission of the institute in what they are doing.
Our intramural program has a set of units, laboratories,
that have to do with clinical research and another set that
have to do with basic laboratory research, all in related
neuroscience aspects. The extramural is exactly as Dr. Lenfant
described. We receive, following assignment by the Center for
Scientific Review, grants that will then--we just know they are
there, and we monitor until they have gone through the review
process.
Study sections are the review process. That is the other
name for these committees. The set up and the organization of
the Center for Scientific Review has recently been looked at by
a star committee of outside experts, looking at whether they
have the proper sets of science covered. I would say we all,
all the institutes, through central NIH, contribute to the
funding of the Center for Scientific Review. But it is critical
that they are peers, but they are not in any way run by our
institute or Dr. Lenfant's institute.
Mr. Deal. Just a real quick question: During the course of
the 4-year grant period--as I understand, it is usually 4-year
grant periods--what oversight is exercised by the respective
institutes over what is being done in these research projects?
Could you give us some idea of what percentage may be renewed
after an initial 4-year period?
Mr. Bilirakis. Please try to answer the question, but try
to be as brief as you can.
Ms. Penn. Be as brief as possible.
Mr. Bilirakis. I will tell you why. We are going to have
another, I will call it, nonsense vote in a few minutes. So we
are trying to get through----
Ms. Penn. Quickly, both institutes have a group of
extramural persons who are all scientists, or who are
physicians themselves, who work on different parts of this
program and are experts, pretty expert in the topics. They keep
an eye on their particular set of people with grants. They are
charged to review the progress every year to sort of let them
know when they are not doing anything, and then to decide
whether they possibly would get some kind of monetary
supplement or not. But it is really monitored very carefully.
Mr. Lenfant. Yes, I can only echo what has been said. There
are some instances where actually your progress is not deemed
to be satisfactory, and there are some consequences which may
be from reducing the budget to in some instances, very rare, I
have to say, but sometimes to basically closeing the grant.
Ms. Penn. It varies, but it is somewhere between, I guess,
25 and 40 percent are successful on the first pass on their
renewal. This is, I think, your question.
Mr. Deal. Thank you.
Mr. Bilirakis. I thank the gentleman. Mr. Stupak?
Mr. Stupak. Thank you, Mr. Chairman.
In the NIH, you are required to transfer new biomedical
technologies to the private sector for further research and
commercialization and development. Also, Congress intends that
NIH research will lead to new products such as diagnostics and
vaccines.
My question is, how far along do you go in developing new
vaccines? Do you work with the pharmaceutical companies? Do you
say, ``Look, we have an idea that this is where we think it
should go. Here's the idea. Take it from here.''? How do you do
it?
Ms. Penn. The vaccine program, all of it pretty much, is
under--except for very unusual new cases in Alzheimer's and
potentially even in stroke--but most of the vaccines for
infectious agents are in the hands of the National Institute
for Allergy and Infectious Disease and the Vaccine Program,
including the one for HIV/AIDS.
When something is developed, we do talk to industry, or
industry may be developing something also. There comes the NIH
Office of Technology Transfer. I mean, we do monitor, they do
monitor, they do come in and talk at various of our committees.
They are always involved in all these groups that I talked
about because they are very interested, obviously. I mean they
are really interested in fixing diseases, too.
Mr. Stupak. Okay, you say, well, here comes your Office of
Technology, and you work with them. You transfer that to, let's
say, the pharmaceutical company----
Ms. Penn. Yes.
Mr. Stupak. [continuing] to develop whatever the vaccine
may be, correct?
Ms. Penn. Yes. I mean, they are the group that handles
things like intellectual property, things like, you know, we
don't always take brand-new ideas because the brand-new ideas
are really--our investigators have developed the brand-new
ideas most of the time.
Mr. Stupak. Okay.
Ms. Penn. But it is a very active component of our
intramural program, where our investigators really are us, and
they are developing new technologies, diagnostics, and drugs.
Mr. Stupak. Okay. Then in response to Representative
Brown's question, you mentioned clinical trials. Are you
involved in the clinical trials as these new vaccines are
developed?
Mr. Lenfant. I would assume that the answer to that is yes,
but again----
Mr. Stupak. Well, I don't want you to assume.
Mr. Lenfant. Neither our institute nor Dr. Penn's institute
are involved with vaccine and drug developments, especially
antibiotics. So it is a bit difficult for us, at least for me,
to tell you what another institute is doing.
Mr. Stupak. Okay. If we assume for the sake of discussion
here this morning that you do do the clinical trials, do you do
post-marketing surveillance on drugs then after they have been
on the market?
Mr. Lenfant. I mean, if I understand the question, if
clinical trials were said to assess the possibility of a new
application of a medication of some sort, we work very closely
with the FDA. Basically, any event, good or bad, that may occur
during that process is reported to the FDA.
Mr. Stupak. Sure. Well, we all are painfully aware up here
that FDA doesn't do post-marketing surveillance on drugs, or
very little, if any. So my question, I was wondering if you did
then.
Mr. Lenfant. Post-marketing?
Mr. Stupak. Yes.
Mr. Lenfant. No, not post-marketing. We don't have the
authority to do it. We are not a regulatory agency.
Mr. Stupak. Pardon?
Mr. Lenfant. We are not a regulatory agency. We do not have
the authority to do it.
Mr. Stupak. Oh, I agree, but you are also a public health
agency, as we established earlier. It would seem to me, if you
helped to produce a vaccine or a drug an do clinical trials,
you would really want to know what happens once it is out in
the real world, and would probably do some post-marketing
surveillance or work with the drug company, whoever it may be,
who is making this vaccine, to make sure that the good
intentions that you had in producing or going down this route
is actually being fulfilled in the real world.
Mr. Lenfant. Well, these events are not reported to us.
Ms. Penn. Not in that way.
Mr. Lenfant. If you ask about adverse events that are in
the post-marketing phase, I think they probably appear in the
newspaper long before they come to us actually. I am not being
flippant about it.
Mr. Stupak. I just think of the recent publicity around the
drug Lariam which they indicated that NIH helped to develop.
That is to fight malaria. There's been some side effects on it,
mental health, especially some suicide. In the articles I read,
NIH was more or less protecting the quality of this drug.
But if you are telling me you don't do the post-marketing
surveillance and it is not really your job, and it is not
important, I certainly would think it would be important to all
those people who may have been harmed by a drug. While it might
help you out with malaria, but Lariam also has some side
effects that, if the FDA isn't doing the post-marketing and you
are not doing the post-marketing, who in the heck is?
Ms. Penn. Now I would add that, of course, we work with our
investigators in academic medical centers who are then using
this drug. Not only will it come out in the newspapers, it will
come out in medical journals. We certainly would hear.
Now the question then is still, who's got the
responsibility? We really don't. We don't like what is
happening. Actually, our best drugs have a lot of side effects.
Mr. Stupak. Yes, they have a lot of side effects, and they
are out in the general public. They are not in the academic
world or the research world anymore, and the people who are
suffering are the people who don't have the scientific
background, medical expertise, and we look to NIH when we
double your budget and FDA to do it. If you don't do it and FDA
doesn't do it, the pharmaceutical companies aren't doing it,
who has to do it then?
Ms. Penn. I hear you.
Mr. Bilirakis. The gentleman's time has expired.
Dr. Penn, following up, you say it is not part of your
responsibility, but if you wanted to do it, could you do it? I
realize you don't have the regulatory authority.
Ms. Penn. Yes, we simply don't have the authority.
Mr. Bilirakis. You don't have the authority to do it even
if you wanted to?
Ms. Penn. No. Our Program Director certainly and our staff,
we are all aware when something that we have invested a lot of
time and effort, and we think it is going to work, and then it
goes out--this is true, for instance, of some anti-convulsants,
anti-epilepsy agents, and we have a big program for that. If
something goes out, the best possible studies we thought were
done, and then a side effect occurs, then we would get the
investigators to look at it again. Actually, we found out why
Felbamate gave a hepatic effect, that kind of thing.
Mr. Bilirakis. Dr. Norwood, to inquire.
Mr. Norwood. Thank you very much, Mr. Chairman. I would
like to state at the outset that probably NIH is one of our
most important national resources, and I am happy to be part of
the group that doubled your funding. I know ever since I have
been here we have increased NIH funding almost every year, but
that does, then, lead us into the realm of being responsible to
some degree for that funding.
I just want to follow up on some of the questions that have
been asked. For example, Congressman Deal asked you the
question of what percent of your research is done in-house, and
I would like to know the answer to that.
Mr. Lenfant. Well, Mr. Norwood, as I indicated, for the NIH
as a whole, it is 11 percent of the budget, 11.
Mr. Norwood. Percent of the budget goes for in-house
research?
Mr. Lenfant. Correct. Correct. And that varies from
institute to institute.
Mr. Norwood. But, in general, the average is 11 percent?
Mr. Lenfant. Correct.
Mr. Norwood. I understand. Would you describe for me,
briefly, because I think I have lost my way, not you, what is
the simple mission statement of NIH?
Mr. Lenfant. It is to do research to improve the health of
the American people.
Mr. Norwood. I have always labored under the thought that a
lot of your research was basic science.
Mr. Lenfant. Well, the research process begins with basic
science.
Mr. Norwood. I understand.
Mr. Lenfant. From basic science, it moves to applications,
and applications means clinical research.
Mr. Norwood. I know it does move to that, but does it move
to that at NIH? Is that part of your mission----
Mr. Lenfant. I would say yes. I can speak for our
institute. We spend a lot of our budget to basically carry into
clinical practice the basic research that is conducted either
from us or from Dr. Penn, or from any of the institutes.
The beauty and the problems with clinical research is that
you address an idea, but you don't know for sure where it is
going to take you. Our job, my job, is to identify things which
appear to be promising and important and move them into the
next step. The end of all these steps is basically the practice
of medicine, what is going to happen between the physician and
the patient.
Mr. Norwood. So you do, then, a lot of clinical research--
--
Mr. Lenfant. Oh, yes.
Mr. Norwood. [continuing] as well as basic science?
Mr. Lenfant. Yes.
Mr. Norwood. Do you think Congress emphasizes enough the
need to conduct basic scientific research? Do we imply that to
your agency in different ways, how important we think basic
science research is?
Mr. Lenfant. Yes. Mr. Norwood, you know, I have been at the
NIH for 32 years and the Director of this Institute for 20. I
am not aware that the Congress ever said to us and to our
institute, ``You shall do this much clinical research or this
much basic research,'' or whatever. What the Congress has done,
and I would say in its wisdom, is to say, ``You have to address
them all.'' Sometimes it is going to be more of this; the next
time it is going to be more of that.
Mr. Norwood. Do you define yourself as a public health
agency? Is that how you think of yourself?
Mr. Lenfant. Absolutely. I can tell you that, I mean
speaking for myself, I am entirely committed to the public
health mission of our institute.
Mr. Norwood. Let me just conclude with a last questioning
sort of thought about it. Dr. Penn, you said that many, if not
most, of our best drugs have side effects.
Ms. Penn. Yes, sir.
Mr. Norwood. Actually, most drugs have side effects, don't
they?
Ms. Penn. Yes, they do. Well, I'm thinking----
Mr. Norwood. Isn't it also true that the side effects don't
occur the same in each and every patient? Some may have them;
some may not. Some may have drastic side effects; some may not.
Ms. Penn. Yes. I am thinking of the big drugs. I am
thinking of penicillin. I am thinking of aspirin and all of the
ones that we do use and sometimes we absolutely have to use
them, side effects or no side effects. But they do have side
effects, and you are absolutely correct, it has to do with the
genetic makeup of the individual to some degree. It has to do
with how it is given in some cases. But everybody tries. What
you need to do, again, is the doctor-patient communication, as
soon as something happens. You hope it doesn't happen
seriously.
Mr. Norwood. Because anaphylactic shock may occur with
penicillin, it is probably not a wide decision to conclude from
that that we shouldn't use penicillin?
Ms. Penn. Yes, sir, because some bacterial infections are
best treated with penicillin. So you do your best.
Mr. Norwood. And that is what I am trying to get you to say
here.
Ms. Penn. Yes.
Mr. Norwood. I think we all do our best that we possibly
can, and there are sometimes some very drastic outcomes, but
these drugs are very important to many other people.
Ms. Penn. But I would say that part of our mission, as Dr.
Lenfant just said, is to say, okay, if we change one chemical
part of penicillin, can we get a better penicillin?
Mr. Bilirakis. The gentleman's time has expired. Ms. Capps,
and then we are going to break right after her inquiry.
Ms. Capps. Thank you, Mr. Chairman. Thank you for holding
this very important hearing. I was frustrated by being detained
on the floor and didn't get here for opening statements. I
understand that you spoke to the importance of a particular
bill that my colleague, Mr. Chip Pickering, and I are working
on on Stroke Treatment and Ongoing Prevention Act of 2001.
Thank you for your support of that legislation.
I am sorry I didn't get your opening testimony either, but
I am so appreciative that you are both here. I have three
questions I am going to wrap into one. They have to do with the
report that came recently from your group, Dr. Penn, I think.
This is about stroke.
You have written a report that will serve as a blueprint
for a long-range strategic plan on stroke research. I want to
hear from you about it. I know you have talked about it some,
but I want to focus on the cost, the breakdown of cost, the
aspects of it that will address women's health in perhaps a
reinforced way, and also some concerns that I have that the
doubling of the NIH budget has meant the Heart and Stroke
Coalition is concerned in the House that the stroke and heart
disease budget has not kept pace as it should have, and that
there is a letter that I have signed, written and signed on
with 80 of my colleagues, to see if we can fix this
discrepancy.
Ms. Penn. I said in my opening statement----
Ms. Capps. Yes, I'm sure.
Ms. Penn. [continuing] that we really do spend more on
stroke than any of our other major disorders at NINDS. Part of
what we did at the Stroke Progress Review Group meeting was to
prioritize the kinds of science and medicine that they felt, as
over 140 of our investigators thought should be done as we move
ahead, as we implement this plan.
Ms. Capps. I am actually not----
Ms. Penn. I have a summary here for you, but I don't know
if it is back there. You have the book.
Ms. Capps. But I want to clarify that.
Ms. Penn. Yes.
Ms. Capps. I am not talking about within your agency. I am
talking about within NIH as a whole.
Ms. Penn. NIH. Well, we do work, as we said this morning
with Dr. Lenfant, with all the other institutes----
Ms. Capps. Yes.
Ms. Penn. [continuing] at NIH that could impact on, not
only figuring out what stroke really is, but treating it. I
haven't even mentioned the hemorrhagic strokes this morning.
Ms. Capps. Yes, exactly.
Ms. Penn. So I believe that we have an excellent plan. We
know roughly where we have to go, and we will fund it. We are
very grateful for the help that we have gotten in funding it.
Ms. Capps. So you see that the ability that you have to
work among other institutes, that----
Ms. Penn. We are definitely talking to other institutes,
and we are talking, again, to the FDA. We can talk to them when
the time comes about some of the things because we have to be
concerned about safety. We talked, as we said before, to the
Veterans' Administration about some of the things.
Ms. Capps. Right.
Ms. Penn. I mean, we do interact and we know the folks.
Ms. Capps. Then your blueprint, we can expect that it
really is going to----
Ms. Penn. It will go forth. It won't all go forth at one
time.
Ms. Capps. Right.
Ms. Penn. We would like to get grants in on some of the
issues here, right, and set up new clinical trials, the whole
thing.
Ms. Capps. Then how much do you think it is going to cost
and how much do we need to be prepared to address?
Ms. Penn. We are going to do this in the context of the
budgets that we think, and we think that----
Ms. Capps. What would you like?
Ms. Penn. I am not even going to try. Just to say, again,
that stroke is extraordinarily important.
Ms. Capps. Yes.
Ms. Penn. We, of course, are hearing from a lot of other
disorders because we have some really major and disabling
disorders, but we will fund this.
Ms. Capps. Thank you.
Ms. Penn. You're welcome.
Mr. Bilirakis. I thank the gentlelady.
We are going to break to make this vote. I plan, Mr. Brown
and I, I think, plan to get back immediately, and then we
will--I am just not going to discharge the panel. I apologize
again. You are going to have to just wait a few more minutes.
Thank you.
[Brief recess.]
Mr. Bilirakis. I think Mr. Brown is on his way, is he not?
There must be some Greek blood in Mr. Brown because he is
always late.
Until he comes and others, Mr. Pickering is here. I think I
will yield to Mr. Pickering at this point.
Mr. Pickering. Mr. Chairman, I want to thank you for
holding this hearing today, and I want to thank you for calling
attention to legislation that I have introduced with my
colleague on the committee and from the other side of the
aisle, Mrs. Capps, the Stop Stroke Act.
I want to commend both Dr. Lenfant and Dr. Penn for their
institutions and the great contributions that they are making
and efforts across the board. I wanted to ask them for their
comment on how important this legislation is, if they have had
a chance to review the legislation, any recommendations they
may make. What difference do you think this legislation may
make and add to your ongoing efforts, as we try to take it one
step up in trying to get the grants, the resources, and the
information out to both our physician and medical community,
but also to individuals who need to know what the signs are,
how they can get treatment, what are the medical and
technological and pharmaceutical breakthroughs that have really
made a tremendous difference as we look at how to treat and
effectively prevent strokes.
With that, Dr. Lenfant.
Mr. Lenfant. Mr. Pickering, with your permission, I would
defer to Dr. Penn whose institute is overseeing the stroke
program at NIH.
Ms. Penn. We feel that we have made a start with this, and
we have several campaigns that will fit right into the Stop
Stroke Campaign, which are the public service announcements. We
are trying to get a network out, so that in some communities we
work through the churches, in some communities through
professional societies.
The Stroke Progress Review Group report will certainly
address some of the issues that are in the Stop Stroke Act. It
is extraordinarily important still to make sure that everybody
knows the signs of stroke, and we finally think we have a
therapy, which can intervene immediately. So people really have
to get to the hospital.
So we are foursquare behind this campaign. As I said, we
have started, but this can only help. The bookmarks in the back
are to address our populations in a bilingual way.
So in terms of the idea, it is just terrific.
Mr. Pickering. Let me follow up. What is your current
spending at NIH as it relates to strokes? As you know, it is
the third leading cause of death, approximately $50 billion in
economic impact to our country on an annual basis. What I would
like to know is, what is the research commitment that we are
making as a country, given that tremendous loss of life or the
quality of life of victims of stroke and to their families,
their community, and to our economy because of strokes? What is
our research commitment in NIH?
Ms. Penn. NIH-wide, it is for fiscal year 2001, it is $239
million. We, as an institute, we are spending more on stroke
than any of our other disorders at the moment, and that is over
$117 million.
Everything, of course, is relative, but we are getting done
what needs to be done. I just answered your colleague in terms
of mobilizing the resources and using them to fulfill what is
in the plan.
Mr. Pickering. Again, just putting it in context, if it is
the third leading cause of death, how would you say that $239
million is in the priority at NIH, as we look at other diseases
and research? Would you be able to put it into, what are the
leading five areas of overall spending at NIH on research?
Ms. Penn. On research, I would have to get you those
answers for the written record.
In terms of our own priorities, as I said, we are spending
more on stroke. The rest of NIH has, obviously, institute-per-
institute--I mean, we've got cancer; we've got AIDS; we've got
diabetes. So they have their own priorities. The diabetes
impacts strokes. So there you go.
Mr. Pickering. If you could, I would just like, as a
policymaker, to understand where we are putting our resources
and our priorities, and to put it in context to both the
medical and the economic impact of our communities, of our
families, of individuals, and to make sure that our priorities
are right.
Ms. Penn. Yes. Well, I think everybody, including all the
people at NIH--it is just that you don't know exactly what is
going to strike, but I did this on ``Stroke Sunday.'' I asked
the audience, you know, ``How many of you have hypertension or
high blood pressure?'' It was well over half the congregation.
I mean, you could do that with stroke. Most of them had had
relatives with stroke. That was the second question. So we all
know the impact and we all know that it is a major, major
problem.
I think we are doing something for it, though, and I
think----
Mr. Pickering. I want to commend you and congratulate you
for what you are doing. I would just like to know as to our
research budget on AIDS, cancer, diabetes, hypertension,
stroke, where we are in the allocations.
Ms. Penn. Right. I can give you stroke, and I did, numbers,
but I will have to get the relative amounts for you.
Mr. Bilirakis. There will be a series of questions that
will be presented to you after the hearing in writing which you
would be asked to respond to in writing. So that certainly
would be one, Chip.
Mr. Lenfant. If I may add something, Mr. Pickering, our
institute, the National Heart, Lung, and Blood Institute has
spent approximately over $60 million in research on stroke,
either basic but mostly clinical research. But, as you know,
one of the main risk factors of stroke is elevated high blood
pressure. Our institute supports $120 million in high blood
pressure, and we have an extensive program of public and
professional education and dissemination of what we know. It is
called the National High Blood Pressure Education Program,
which has been in existence for 30 years.
I believe that we can fairly say that it has been a great
contributor in the decreasing prevalence and, more importantly,
in the control of high blood pressure. See, the issue is,
again, to be sure that what we know is used, in this case that
people who have high blood pressure are treated and controlled;
that is, that we keep their blood pressure low.
I think these programs do that, and I think that jointly
with our colleagues we endeavor to do that with much increased
intensity now, because we do realize the importance of that
significant problem, especially in the Stroke Belt that was
mentioned before you came this morning. But we are beginning to
see some significant successes.
Mr. Bilirakis. Thank you. Mr. Green, to inquire.
Mr. Green. Thank you, Mr. Chairman. Again, I apologize to
the panel for lots of us coming and going. We actually had
votes scheduled, and some of us didn't know when we would vote
on the House floor.
I have one question of both witnesses. It is great
following up my colleague from Mississippi. One of the most
common concerns, I guess, with the NIH is that funding
allocation is not proportionate with the burden of the certain
diseases. For example, diabetes, which affects 17 million
Americans and costs our Nation more than $100 billion in
medical costs each year, actually receives only about $769
million in research funding at the NIH. This amounts to about
.7 of 1 percent of the cost of the treating the disease.
The NIH is probably the only agency I know that Congress is
reluctant to micromanage, simply because none of us have the
expertise. But it seems to me the NIH would be emphasizing
those diseases that have the largest burden both physically and
economically on our society. If each of you could comment on
that?
Mr. Lenfant. Yes. First of all, I would like say, sir, that
the diabetes research is not precisely in the purview of our
two institutes. There is an institute where they do that.
Having said that, it is a sad state of affairs that most
diabetic patients suffer development of vascular disease which
often leads to arteriosclerosis and then to death eventually,
coronary heart disease and what have you.
Our institute has a very significant program. In fact,
yesterday I spent the day in New York discussing the
development of a program which is precisely for the prevention
of cardiovascular disease in diabetes.
So if you take this commitment in addition to the basic
research and the work that has been done by our colleague who
is not here today whose responsibility is diabetes, we almost
doubled, not quite, but we certainly had a very solid amount of
money to the research, not only of the disease, but of the
consequences of the disease.
Mr. Green. Okay.
Ms. Penn. Yes, sir, I was thinking somewhat of consequences
of some of our disorders. You can talk about numbers. You can
also talk about consequences because some of our disorders kill
people sort of slowly. We have things like amyotrophic lateral
sclerosis in our portfolio. We have the dystrophies where the
kids are going to die by the age of 25. Now Parkinson's
certainly and MS, and, therefore, what we look for are ways to
make breakthroughs. We really want to go after the mechanisms
of these, so we can figure out how to fix them.
So sometimes small diseases can give you information on big
diseases. We have a small disorder, very rare, genetic, which
is probably giving us ideas on how to treat some major diseases
that have to do with loss of balance.
So it isn't just always dollars. It is how the whole
package is coming together. If I really thought that, if I just
added more and more dollars to some of these, something would
happen tomorrow, I would probably do it. But I'm not always
sure of that.
We need to get the scientists involved. We need to train
more to look at these disorders. We need to look at all of our
disorders. We've got like 300 genetic diseases with some 5 or
10, or 20 patients, but they are children. Again, these are
very important also.
So it is a balance. We have to balance the disorders in our
mission, and we certainly consider burden. As I said, we all
have--the more common the disorder, the more likely all of us
will have somebody around who's got the disorder.
Mr. Green. I guess I understand, hopefully, there is better
correlation in NIH between your institutes than we have between
our intelligence agencies.
I hope that is the case. When we look at the loss, for
example, in my home State of Texas with diabetes and juvenile
diabetes--in fact, the House passed a resolution 2 days ago
encouraging increased investment in diabetes research in
juvenile diabetes.
But I appreciate the correlation, and, hopefully, that will
happen, because you are right, one success in one research area
or one illness may also turn into something else.
Ms. Penn. And I don't want to say that we aren't--you know,
and Dr. Lenfant, too, we are a working--we have, again, a
Memorandum of Understanding with the Juvenile Diabetes Research
Foundation to deal with the complications in the nervous system
for diabetes. So we do talk to people.
Mr. Green. Thank you, Mr. Chairman.
Mr. Bilirakis. Well, and just if I may, and Mr. Green has
basically said it, really sometimes the toughest part of our
job is having witnesses come here and pleading for additional
funding for research for their particular diseases. Muhammad
Ali has been here, just so many others.
We try to stay on the path of not interfering with NIH
because we are an ivory tower and don't really know, and we
like to think that the funding is going where maybe they are
closer to a particular cure and emphasize that sort of thing,
but it is frustrating sometimes when we feel strongly, as Mr.
Green does about diabetes, and don't see maybe a little more
funding going that way.
That is something that I don't want to take the time here
now because I would really like to be able to excuse you in a
few minutes, after Mr. Buyer has asked you questions, but that
is something you might want to give a little thought to, giving
us a little more rationale to sort of stay on the path that we
are on, rather than to press NIH to allocate so much funding to
a particular disease versus any others. You might want to think
about doing that in writing to us.
Mr. Buyer, to inquire.
Mr. Buyer. Thank you.
Dr. Lenfant, I am new to this Health Subcommittee. This is
my first term. I am more challenged than I was before I walked
into this hearing 2 hours ago. I am more challenged because
maybe it is my logical reasoning; I can follow methodologies; I
don't follow things very well if it is said, well, it is not
always about dollars. I must interpret, then, that you are
asking for great deference.
I then hear your testimony in response to a very good
question by Mr. Deal, and I know that you didn't mean to be
flippant, but you said, well, we've spent a little more here
and we've spent a little more there, and makes it sound like
this or that, which then I must interpret that you like being
capricious. It is a strong word, ``capricious.'' So if
Congress--let me pause for a second. Mr. Pickering asked a very
simple question: What are the five leading areas for which you
do funding? And, Dr. Penn, you wouldn't even answer that. You
said, ``Well, I want to answer that on the record, give you a
written answer.'' Well, excuse me, I am almost challenged here
at the moment.
If this Congress is going to double the investments into
NIH, please, we are not being intrusive into your territory. We
would like you to be responsive because this Member here is
challenged at the moment.
So let me ask Dr. Lenfant, please respond to Mr.
Pickering's question, what are the five leading areas in which
you invest in your research? You ought to be able to do this
off the top of your head. Thirty years, what are they?
Mr. Lenfant. Well, I am going to let Mr.--would you allow
me to----
Mr. Buyer. I will allow you to say what are the five
leading areas. What are they?
Mr. Lenfant. Okay. In heart disease, congestive heart
failure, coronary heart disease, and congenital heart disease.
In----
Mr. Buyer. Those are your five leading areas?
Mr. Lenfant. That is three in our cardiovascular area. Our
institute is the National Heart, Lung, Blood, blood resources,
that is, blood safety, sleep, these are all areas, sir. So I
could give you examples for each of these areas.
Mr. Buyer. All right. No, that's fine.
Now let me ask this question: I am trying to understand,
quote, ``methodology.'' If you know this answer, what are the
percentage of applications that receive funding compared to the
total applications received?
Mr. Lenfant. That's very easy, Mr. Buyer. In our institute
during the last2 or 3 years, it has been between 30 and 33
percent.
Mr. Buyer. All right. Is it fair for us--I am looking at
this chart by the American Stroke Association that uses some of
your statistics here on funding. It shows the investments. It
lists cancer, AIDS, heart disease, and stroke. I can understand
why we doubled your budget, we've got this huge increase in
cancer, but I don't understand this large increase in AIDS
funding relative to a flat line in stroke and a minimal
increase with heart disease. So could you explain it to me?
Let me ask, before you jump to this, what can you tell me
about the death rates of cancer versus AIDS versus heart
disease and versus stroke? Is that a fair question for me to
say?
Mr. Lenfant. It is a fair question. I do not know, Mr.
Buyer, whether you have in front of you a copy of my written
statement. If you would turn on page 2----
Mr. Buyer. No, I don't want to go to your written
statement.
Mr. Lenfant. Okay.
Mr. Buyer. I want you to answer this question without----
Mr. Lenfant. The answer is that half of the people who are
here in this room will die from heart disease.
Mr. Buyer. All right.
Mr. Lenfant. That is a fact. That is a fact. Now why the
budget is higher than for heart disease? If I was in a position
to make that decision, I would probably take half of the budget
of the institute, of the NIH, for heart programs, but I am not
the one to make that decision. So I just cannot answer your
question.
Mr. Buyer. So must I interpret, then, by your answer that
we have a disproportionate in funding for AIDS as compared to
the illnesses out there?
Mr. Lenfant. No, no. I would say that the----
Mr. Buyer. Wait a second. You just said that if you were
the decisionmaker, that you would prefer this investment to be
in heart disease. If you think half of us in this room are
going to die from heart disease and not from AIDS, why do we
have the funding increases for that as compared to AIDS?
Nothing on AIDS--it is just that there are four things on
this chart.
Mr. Lenfant. Well, if you look at cancer, that is a
condition where you see a steady increase today of the death
rate, whereas in cardiovascular disease you see a steady
decline. I suppose that people who are making these decisions
say, here we have an emergency, a situation which is becoming
more serious year after year, and that probably influences the
decision.
With regard to AIDS, that is an infectious disease. An
infectious disease always leads to a sense of emergency. I
think that is why you see that situation. It may be that fewer
people die from AIDS than from heart disease, but AIDS is a
global emergency which can affect any one of us almost at any
time.
Mr. Buyer. Mr. Chairman, I am going to yield back to you,
but I think Mr. Green asked a great question, along with Mr.
Deal and Mr. Pickering. I think what we have here is sort of an
invitation for greater scrutiny. I yield back.
Mr. Bilirakis. All right, the gentleman's time has expired.
Mr. Brown?
Mr. Brown. I have two things. Thanks for the extra time.
Mr. Bilirakis. I will ask consent for an extra 30 seconds.
Mr. Brown. That is a unanimous consent request. I would
like to submit questions. I specifically want to raise one, and
we will submit it in writing and ask for your response in
writing. But I just wanted to mention a brief moment the status
of the graduate training and clinical investigation award,
which has not yet been implemented and the eligibility
requirements for the Clinical Research Loan Repayment Program.
Researchers at Case Western University near my district near
Cleveland and Ohio State tell me these criteria are effectively
excluding many qualified students. I will submit that as a
question for your response.
I want to make one more point. This is not the time to
debate this in length, but I had a physician that was in my
office, who works in international health, the day before
yesterday. He said unequivocally that the AIDS epidemic is the
worst epidemic in human health for 600 years.
For us to question funding because, for whatever political
agenda people have, to question the funding when we are
doubling the NIH budget, to question any commitment, any
expenditure we have on AIDS, not that we shouldn't do
oversight, and I wish this agency would take more leadership,
as I mentioned two or three times earlier, on things like
vaccines and antibiotics.
But the politics of this issue disgusts me, frankly, the
politics of the AIDS issue, when it is an epidemic, not nearly
as big in this country, but the epidemic in Africa, the
epidemic when AIDS and TB intersect in India, in China, in
Russian prisons, in Estonian prisons, in Latvian prisons, and
millions, 1100 people, as I said, a day in India die of TB.
That number is going to skyrocket when AIDS hits India and
China in the way that it almost inevitably will. We simply
can't do enough.
We spend less than .1 percent of our GDP on foreign aid and
we should be ashamed of ourselves.
Mr. Bilirakis. Well, you can see the reasons why we would
rather not interfere in terms of the use of----
Mr. Brown. Thank you, Mr. Chairman.
Mr. Buyer. Mr. Chairman, I would like a chance to respond
to that.
Mr. Bilirakis. Well, this----
Mr. Buyer. Mr. Chairman----
Mr. Bilirakis. I don't think we ought to get into debate.
This is a hearing.
Mr. Buyer. No, he's--Mr. Chairman, he's pulling me into an
area in which I was not going. For him to interpret my words as
though he's personally disgusted, as though I was attacking
AIDS insults me.
I am referring to a chart right here, Mr. Brown. And Mr.
Green asked some very good questions. Mr. Deal asked good
questions. Mr. Pickering asked good questions. This is not a
debate about AIDS. Diabetes was a very good thing to go over. I
asked a very pertinent question here. So please don't pull me
into your political disgust into some other form of agenda----
Mr. Brown. My disgust----
Mr. Buyer. [continuing] which I find personally insulting.
Mr. Bilirakis. Without objection, the opening statements of
all members of the subcommittee will be made a part of the
record, and, as I have indicated earlier, there will be written
questions submitted to you. We would appreciate a relatively
prompt response to those.
I thank you both very, very much. Again, I apologize for--I
thank you for your patience, but that is the kind of a day we
are going through here, is running back and forth. Thank you so
very much, Doctors.
Mr. Lenfant. Thank you, sir.
Mr. Bilirakis. The second panel consists of Dr. Robert O.
Bonow, President-Elect, American Heart Association, Goldberg
Distinguished Professor of Medicine, and Chief, Division of
Cardiology, Northwestern University, Feinberg School of
Medicine; Mr. Eric Hargis, President and CEO of the Epilepsy
Foundation; Dr. Edward Sanchez, Commissioner of Texas
Department of Health, and Dr. Daniel Jones, whom Mr. Pickering
would like to introduce.
Would you like to do that at this point?
Mr. Pickering. Yes, Mr. Chairman. Thank you for giving me a
point of personal privilege and honor to introduce Dr. Daniel
Jones from Jackson, Mississippi, who is the Vice Chancellor of
the University of Mississippi Medical Center.
But he is also a family friend. He had a private practice
in my home town of Laurel, Mississippi, where he treated my
family as well as me as I was growing up. Not only did he
practice in a small town in Mississippi and contribute to the
community, I grew up attending the same church as he, but he
also went overseas to Korea as a medical missionary for 7
years. For his humanitarian contributions and leadership and
example, we are always very proud to point to his role in
giving back not only to the community, but going overseas to
help those in Korea.
We also are very proud as he now is leading the effort in
Mississippi at the University of Mississippi Medical Center in
a number of different areas, especially in research and in
hypertension and in stroke, as he has been published and is a
leading figure and voice in that area, not only for our State,
but around the country.
So it is my great privilege today to introduce him, and I
look forward to his testimony and the testimony of the rest of
the panel.
Mr. Bilirakis. Thank you. Thank you, Mr. Pickering.
Mr. Green would like to add to my very brief introduction
of Dr. Sanchez.
Mr. Green. Thank you, Mr. Chairman. I would like to welcome
Dr. Sanchez, our Texas Commissioner of Health. Having served 10
years in Congress, I have worked with four different Texas
Health Commissioners, and 20 years in the legislature before
that, many dedicated people. Dr. Sanchez, he has been there 7
months or a little more than 7 months, but he brings an
aggressiveness and innovation, I think, to the department.
I had a chance to meet him, and our staffs have worked
together. So I am glad he is here today.
Thank you, Mr. Chairman.
Mr. Bilirakis. Thank you, Mr. Green.
Gentlemen, your written statements are a part of the
record. We will set the clock at 5 minutes. I would appreciate
it if you would stick as close to it as you possibly can.
Dr. Bonow, is that correct, sir?
Dr. Bonow. Bonow.
Mr. Bilirakis. Bonow. All right, Dr. Bonow, please proceed.
STATEMENTS OF ROBERT O. BONOW, PRESIDENT-ELECT, AMERICAN HEART
ASSOCIATION; ERIC R. HARGIS, PRESIDENT AND CEO, THE EPILEPSY
FOUNDATION; EDUARDO J. SANCHEZ, COMMISSIONER, TEXAS DEPARTMENT
OF HEALTH; AND DANIEL JONES, VICE CHANCELLOR, UNIVERSITY
MEDICAL CENTER, UNIVERSITY OF MISSISSIPPI
Mr. Bonow. Thank you, Mr. Chairman. Members of the
committee, it is my great pleasure to participate in this
discussion this morning. My name is Robert Bonow. I am
Professor of Medicine and Chief of Cardiology at Northwestern
University. I did serve 16 years as a commissioned officer in
the National Heart, Lung, and Blood Institute at the NIH in
Bethesda. As a volunteer member of the American Heart
Association, I now serve as its President-Elect.
I would like to first thank the committee for its
leadership in including the Community Access to Emergency
Defibrillation Act in the bioterrorism legislation. Your action
will reduce cardiac arrest deaths by providing grants to
purchase AEDs and to train first-responders in their use.
Our association is devoted to fighting heart disease,
stroke, and other cardiovascular diseases which are America's
leading cause of death. Nearly 62 million Americans suffer from
cardiovascular diseases, at an estimated cost this year of $330
billion in medical expenses and lost productivity, more costly
than any other diseases.
Since Dr. Jones will focus on stroke in his testimony, I
will address heart disease. Heart disease remains the number 1
killer of Americans and is the leading cause of premature,
permanent disability among American workers. Our association
works to increase the number of Americans who receive
immediate, high-quality care for sudden cardiac arrest, heart
attack, and stroke by raising awareness of their warning signs
and risk factors, and the need to seek immediate medical help.
These efforts touch Americans throughout the country.
We are particularly concerned about the elderly who suffer
disproportionately from these diseases, yet benefit from
preventative strategies. So we are leading the charge to add
preventative cholesterol screening to Medicare benefits, which
currently are not covered.
Our association also invests in medical research. We are
unique in that our local and national research programs for
investigator-initiated research are supported wholly by
publicly donated money, and our programs emphasize the support
of investigators in the early stages of their careers, as they
strive to become successful and become competitive for NIH
grants.
We do not accept Federal funds, but we do enjoy a
productive relationship with the government in advancing our
mission. For example, as mentioned by both Drs. Penn and
Lenfant, our association has signed a Memorandum of
Understanding with the Centers for Medicare and Medicaid
Services, NHLBI, NINDS, and the Centers for Disease Control and
Prevention. Through this partnership with the Department of
Health and Human Services, we strengthen and enhance the
information and services provided to the public to reduce the
impact of heart disease and stroke.
Also, we work with the NIH to coordinate and enhance vital
research activities by participating mutually in each other's
conferences, research committees, and advisory councils. For
example, I now serve on the NHLBI's Board of Extramural
Advisors, and our chairman of the board serves on the NIH
Directors' Council of Public Representatives.
Our association, including our extensive grassroots network
and affiliates, actively advocates for the completion of the 5-
year, bipartisan congressional initiative to double the NIH
budget. We applaud this committee's visionary leadership in
this historic effort, and we urge you to complete this
initiative in fiscal year 2003. Your action will benefit the
health of all Americans for decades to come.
Thanks to your investment in NIH, exciting medical advances
have benefited countless Americans suffering from heart disease
and those at risk. Major advances include: cutting-edge, life-
extending drugs that help prevent heart disease, including
drugs to control blood pressure and cholesterol. Your
investment has also produced revolutionary diagnostic tools,
including exciting new imaging technologies to diagnose heart
disease in its early and advanced stages, and simple blood
tests that can rapidly diagnose even the smallest heart attack.
Your investment in NIH has resulted in major changes in the
heart patient care. Revolutionary clot-buster drugs can reduce
disability from heart attack by dissolving the blood clots that
cause the attack. Small, wire-mesh stents, now used in nearly
80 percent of the 1 million angioplasty procedures performed
each year to widen narrow arteries of the heart, greatly
increase the success rate of these procedures.
Other breakthrough technologies include pacemakers,
implantable cardiac defibrillators, AEDs, and minimally
invasive surgical techniques. Advances have clearly been made
in the control and treatment of heart disease and its risk
factors.
However, as has already been mentioned, heart disease
remains America's number 1 killer, and there still is no cure.
An American dies from cardiovascular disease every 33 seconds.
Much more needs to be done to address these challenges and
their opportunities.
Now is the time to capitalize on our potential to
understand the fundamental causes of heart disease and to
develop exciting new treatments. For instance, NHLBI research
has shown the strongest evidence yet that human heart muscle
cells may regenerate after a heart attack. This finding opens
entirely new avenues in future investigation and clinical
trials for treatment of failing hearts weakened by heart
attacks.
Also, implantable left ventricular assist devices and even
artificial hearts show promise as replacement therapy for end-
stage heart failure. Promising breakthroughs for this and other
heart conditions are on the horizon with the potential to
improve the quality of life for all Americans and to reduce
health care costs.
Unfortunately, the NIH budget for heart disease and stroke
has not kept pace with the doubling initiative, and NIH heart
and stroke research remains disproportionately underfunded
compared to the burden and to the many promising scientific
opportunities. I will take some risk here by referring you
again to the chart on page 5 of the brochure attached to my
testimony. The point of my testimony is not whether or not this
is disproportionate funding, but only as we double the NIH
budget, we are currently not on track to double the amount of
funding for heart-related research. The point is we would like
the NHLBI to also share in the doubling effort for this very
important disease.
Importantly, these opportunities include research into
improved health care delivery systems, not just basic science
or clinical trials, but developing research to deliver the
health care, to allow all Americans access to our current and
future research advances. We urge Congress in the last year of
this effort to provide funds necessary to ensure the NIH budget
for heart disease and stroke also doubles over this 5-year
period.
Thank you very much for the opportunity to be with you
today.
[The prepared statement of Robert O. Bonow follows:]
Prepared Statement of Robert O. Bonow, President-Elect, American Heart
Association
Good morning, I am Robert Bonow, Goldberg Distinguished Professor
of Medicine and Chief of the Division of Cardiology at Northwestern
University Feinberg School of Medicine. Before joining Northwestern, I
served 16 years as a commissioned officer in the U.S. Public Health
Service at the National Institutes of Health's National Heart, Lung,
and Blood Institute as Chief of the Nuclear Cardiology Section and
Deputy Chief of the Cardiology Branch. I currently serve on the NHLBI's
Board of Extramural Advisors. As a volunteer, I am President-Elect of
the national American Heart Association and President of its Chicago
Metro Board. The Association is the largest voluntary health
organization fighting heart disease, stroke and other cardiovascular
diseases.
Before I begin my discussion on NIH, I would like to thank the
Committee, on behalf of the American Heart Association, for its
leadership in including the Community Access to Emergency
Defibrillation Act in the bioterrorism legislation awaiting the
President's signature. Your action will help reduce deaths from cardiac
arrest by providing grants for the purchase and placement of AEDs where
cardiac arrests are likely to occur and train first responders in their
use.
american heart association: fighting heart disease and stroke
The Association, with 22 million volunteers and supporters, is
devoted to reducing disability and death from heart disease, stroke and
other cardiovascular diseases, which kill nearly 960,000 Americans each
year. Cardiovascular diseases account for more than 40 percent of all
American deaths. Nearly 62 million Americans suffer from cardiovascular
diseases, many of whom are permanently disabled. Cardiovascular
diseases cost Americans more than any other disease--an estimated $330
billion in medical expenses and lost productivity this year.
Since Dr. Jones will focus on stroke in his testimony, I will
address heart disease--still the No. 1 killer of Americans across
racial and ethnic groups, killing more than 725,000 people of all ages
each year. Nearly 23 million Americans live with the often disabling
effects of heart disease. Heart disease is the leading cause of
premature, permanent disability among American workers, accounting for
nearly 20 percent of Social Security disability payments.
Our Association works to increase the number of Americans who
receive immediate, high-quality care for sudden cardiac arrest, heart
attack and stroke by raising awareness of the warning signs, risk
factors and the need to seek immediate medical attention. Our awareness
and educational efforts touch Americans in every area of their lives--
at home, work, school, church and in the hospital. For example, our
national, community-based initiative, Operation Heartbeat, seeks to
improve the sudden cardiac arrest survival rate. Search Your Heart is a
faith-based program, involving approximately 3,000 places of worship
and community-based organizations. It is a prevention program that
teaches at-risk Hispanics, African-Americans, and Asians to recognize
and control heart disease and stroke risk factors, such as high blood
pressure, high cholesterol, obesity and diabetes. Another example is
Get With The Guidelines, an acute-care, hospital-based program that
helps manage risk factors in heart disease patients. It strives for
long-term behavioral change to help prevent subsequent heart attacks.
Also, we invest in medical research. In fiscal year 2000-2001, we
expended nearly $135 million on research to increase knowledge of heart
disease and stroke. Even this amount places us a distant second to the
National Institutes of Health in the amount of research funding in
these critical areas. However, we are unique in our research by
providing both local and national resources for investigator-initiated
research projects wholly supported by publicly donated money. In
addition to sponsoring the highest meritorious research, we place
emphasis on supporting beginning investigators as they progress to
become competitive for national funding sources, such as the NIH.
partnering to advance our mission
Our Association cannot accomplish our life-saving mission alone, so
we join forces with the federal government. We do not accept federal
funds, but enjoy a productive relationship with the government in
advancing the battle against heart disease and stroke. For example, in
February 2001, the Association and four federal health agencies signed
a Memorandum of Understanding. An important example in public and
private sector cooperation, this agreement creates a working
partnership with the Department of Health and Human Services, including
the Centers for Medicare and Medicaid Services, a Centers for Disease
Control and Prevention component and two NIH institutes--the National
Heart, Lung, and Blood Institute and the National Institute of
Neurological Disorders and Stroke. Through this partnership of shared
community-based education, health promotion programs, public awareness
campaigns, media information and data collection, we strengthen and
enhance the information and services provided to the public to
significantly reduce the exorbitant impact of heart disease, stroke and
other cardiovascular diseases on our nation.
Also, we work with the NIH to coordinate and enhance vital research
activities by participating in each other's national conferences,
research committees and advisory councils. For example, I serve on the
NHLBI's Board of Extramural Advisors and other Association volunteers
have participated on the National Heart, Lung, Blood Advisory Council.
Our Chairman of the Board serves on the NIH Director's Council of
Public Representatives.
NIH-supported research plays an essential role in advancing the
fight against heart disease. So, our Association, including our
extensive grassroots network, our affiliates nationwide and more than
32,000 scientific council members, actively advocates for the
completion of the five-year bipartisan congressional initiative to
double the NIH budget. We laud this Committee's visionary leadership in
this historic effort and urge you to complete this initiative by FY
2003. Your action will benefit the health of all Americans for decades
to come.
heart disease research advances
Thanks to your investment in NIH, exciting medical advances benefit
Americans suffering from heart disease and those at risk. Several major
advances follow. Cutting-edge, life-extending drugs help prevent and
treat heart disease, including drugs to control blood pressure and
cholesterol. Now, a simple blood test can diagnose even the smallest
heart attack within six hours of symptoms. When prevention fails,
revolutionary ``clotbuster'' drugs, such as tPA, can reduce disability
from heart attack by dissolving blood clots causing the attack.
Your investment in NIH has resulted in major changes in heart
patient care. For instance, stents--wire mesh tubes used to prop open
an artery--are now used in nearly 80 percent of the more than 1 million
angioplasty procedures performed each year to widen narrowed arteries
to the heart. The use of stents as part of the angioplasty procedure
significantly reduces the incidence of artery renarrowing within six
months.
Also, your investment in NIH has revolutionized imaging technology
to diagnose heart disease and surgical techniques to treat heart
disease. You probably know someone who has benefited from the research-
breakthrough of heart bypass surgery--355,000 Americans under-went this
procedure in 1999. Patients who experience conventional bypass surgery
to improve blood flow to the heart require several weeks to recover,
but those who experience the new ``minimally invasive heart bypass
surgery'' need a much shorter recovery period. Other amazing
technologies include pacemakers, implantable cardiac defibrillators,
and automatic external defibrillators.
During our Association's recent lobby day, I teamed up with
numerous heart disease and stroke survivors who traveled to Washington,
D.C. asking you to make America's No. 1 killer, your No. 1 health
priority. Many of them are alive today due to your investment in the
NIH. They are living with stents, pacemakers, implantable cardiac
defibrillators, or heart transplants or have benefited from other
state-of-the-art procedures.
heart disease: still america's no. 1 killer
Thanks to research made possible by your Committee, great strides
have been made in the control of heart disease risk factors and in the
treatment of heart disease. However, heart disease remains America's
No. 1 killer and there is still no cure for this devastating disease.
Much more needs to be done to address the mounting challenges and
numerous unanswered questions about heart disease.
Now is the time to capitalize on a century of progress in
understanding the causes of heart disease and in developing new
treatments. According to a national expert panel supported by Congress,
America's progress in reducing the death rate from cardiovascular
diseases has slowed, suggesting the need for new strategies against
these killers. Also, the panel reported striking differences in
cardiovascular disease death rates by race/ethnicity, socio-economic
status and geography.
heart disease research opportunities
Promising, cost-effective breakthroughs are on the horizon, with
the potential to reduce health care costs and to improve the quality of
life for all Americans, including the 1.1 million who will suffer a
heart attack this year and the nearly 5 million who live with the
effects of heart failure. For instance, NHLBI-supported research has
shown the strongest evidence to date that human heart muscle cells may
regenerate after a heart attack, challenging previous beliefs that
heart muscle damage from a heart attack remains permanent. Implantable
left ventricular assist devices show promise as replacement therapy for
end-state heart failure. This year, several patients received the first
completely implantable artificial heart. Imagine what could be
accomplished with more resources.
Unfortunately, despite the tremendous advances and burgeoning
opportunities, the NIH budget for heart disease has not kept pace with
the doubling initiative. Heart research receives 8 percent of the NIH
budget. We urge Congress in the last year of this historic effort to
provide funds necessary to ensure that the NIH budget for heart disease
also doubles over the five-year period. NIH heart research remains
disproportionately underfunded compared to the enormous burden heart
disease places on our nation and the abundant promising scientific
opportunities that could advance the fight against heart disease.
preventing heart disease
Research findings must be translated into effective prevention
programs. More resources should be made available to bring research
advances to Americans. We support the conviction of Dr. Elias Zerhouni,
Director of the National Institutes of Health, who noted during his
United States Senate confirmation hearing on April 20, 2002 that ``we
still have to make discoveries to perhaps facilitate the way we deliver
healthcare.'' For example, two separate independent panels, one
convened by NHLBI, agreed that it is never too late to substantially
lower heart attack risk by aggressively reducing cholesterol levels.
So, we lead the charge to add preventive cholesterol screening to
Medicare benefits. Now, Medicare covers cholesterol screenings only if
beneficiaries already suffer from diseases associated with elevated
cholesterol, such as heart disease, but does not cover screening of
apparently healthy individuals to prevent heart disease.
Thank you for this opportunity to speak with you today. I will be
happy to answer questions.
Mr. Bilirakis. Thank you so much, sir.
Mr. Hargis?
STATEMENT OF ERIC R. HARGIS
Mr. Hargis. Thank you, Mr. Chairman and distinguished
members of the subcommittee, for the opportunity to be here
this morning, or actually this afternoon, and talk about NIH
research and the efforts to prevent and cure disease. My name
is Eric Hargis. I am the President and Chief Executive Officer
of the Epilepsy Foundation. This is a topic of critical
importance to the 2.3 million Americans who live with epilepsy.
Advances in medical treatment have enabled many people to
live normal lives, free of seizures, and to achieve personal
and professional success. These advances would not be possible
without an aggressive public and private research effort. Yet,
one in four of all newly diagnosed people will have persistent
seizures despite treatment. More than 1 million Americans
currently live with uncontrolled epilepsy.
The Epilepsy Foundation is an aggressive advocate for the
doubling of the NIH budget, for an expanded epilepsy public
health program, and for quality and affordable health care for
all Americans. Families are desperate for a cure for epilepsy
and hopeful that in the short term research will provide new
and more effective treatments.
While much about the research program at NINDS could be
praised, I want to single out a very successful joint effort of
the NINDS and the epilepsy community. Our work together on the
Curing Epilepsy Focus on the Future Conference illustrates
several important principles that we believe have widespread
application.
First is the value of having the institutes collaborating
with professional organizations, lay organizations,
individuals, and family members affected by the condition.
Second, the importance of Federal interagency coordination
and cooperation.
And, third, the value of creating measures to hold the
various agencies accountable for their activities and their
progress.
This conference drew together experts from all parts of the
scientific world, representatives of different agencies within
NIH, and people with epilepsy to review the status of our
current understanding of the epilepsies and to develop a
framework for future directions in research. As a result of
that conference, the research community has reached a dramatic
turning point, and we are now able to talk about a potential
cure for epilepsy.
The next step was the community's creation, under the
auspices of NINDS, of the Scientific Benchmarks Implementation
Plan for the next 5 years. This will guide research activities
and should serve as the springboard for the development of
measurable goals both for the agency itself and for other
affected agencies within the NIH. However, a shortcoming of
these benchmarks was the failure to do funding projections for
what would be needed to accomplish this research.
One of the important aspects of the Conference on the Cure
was NINDS's concerted effort to bring together multiple
agencies within NIH to participate. NIH should ideally develop
an interagency coordinating body to address epilepsy and its
impact on all aspects of life. While we know that NINDS staff
members do work with members of other agencies within NIH, this
is on an informal basis, and this activity should become more
formalized and systemized among the agencies.
It is also important that the Federal Government be able to
account for how it has spent the large increases in funding for
research that has occurred over the last 5 years. While NINDS
has been helpful in answering our questions on epilepsy
funding, we do not know how much the NIH has spent overall on
epilepsy research. Apparently, there are no cross-agency
accounting systems for making that determination.
Within NINDs, further detail and information describing and
explaining the research that is being funded is needed to
better educate the public about the work of NIH. This morning
when we visited the NIH website to gather updated information
about the level of funding, we found that, unfortunately, while
there were 60 conditions listed with dollar amounts, epilepsy
was not included.
NINDS should also be recognized for another innovative
program that fosters partnership between the public and the
private sector. The Anti-Convulsant Screening Program was begun
in recognition that private industry would not pursue research
for products that addressed the needs of a limited number of
people. This Federal program has now had a successful history
of identifying promising compounds that develop into
medications for seizures. In fact, most of the medications that
have been introduced in the last decade have been developed as
a result of this research.
Thus, NINDS must overall be congratulated for its work and
achievements in understanding of the brain and its support of
research toward an ultimate cure. At the same time, NINDS needs
to better address the continuing medical treatment issues of
this population whose needs will not go away while cures are
being sought.
NINDS very recently funded a multi-center clinical trial on
early surgical interventions for temporal lobe epilepsy. We
urge NINDS to do more of these types of studies, including
research on bioequivalence and bioavailability among various
anti-epileptic drugs, or doing research to compare the outcomes
of the various new treatments to help define best practices.
These are but a few examples of clinical research projects
that NIH could and should fund to a far greater extent than it
does today. Again, our recent work with NINDS is really a model
for bringing stakeholders together to address the future of
research. That is a practice that must continue to ensure a
close relationship between the needs of American citizens and
the work of Federal agencies.
We congratulate NINDS for the progress they have made and
look forward to being a key partner in the efforts to prevent
and cure epilepsy. Again, thank you for the opportunity to
testify.
[The prepared statement of Eric R. Hargis follows:]
Prepared Statement of Eric R. Hargis, President & Chief Executive
Officer, Epilepsy Foundation
Good Morning. Thank you Mr. Chairman and Distinguished Members of
the Subcommittee for the opportunity to be here this morning to talk
about research at the National Institutes of Health and the efforts to
prevent and cure disease. I am Eric Hargis, President and Chief
Executive Officer of the Epilepsy Foundation. This is a topic of
critical importance to the 2.3 million Americans who live with
epilepsy.
The Epilepsy Foundation is the national organization, formed in
1968, that works for children and adults affected by seizures through
research, education, advocacy and service. Approximately 181,000 new
cases of seizures and epilepsy occur each year; 10% of the American
population will experience a seizure in their lifetimes; 3% will
develop epilepsy by age 75.
Advances in medical treatment have enabled many people to live
normal lives free of seizures and to achieve personal and professional
success. These advances would not be possible without an aggressive
public and private research effort. Yet one in four of all newly
diagnosed people will have persistent seizures despite treatment and
more than one million Americans currently live with uncontrolled
epilepsy. For them, epilepsy remains a formidable barrier to normal
life, affecting educational attainment, employment and personal
fulfillment. People with epilepsy are at risk of brain damage and
increased mortality when seizures resist control. Despite a decade of
economic boom and record employment, 25% of people with epilepsy are
unemployed, the majority a result of their epilepsy. Stigma remains a
fact of life for many with epilepsy fueling discrimination and
isolating them from the mainstream of American life. Epilepsy can
strike at any age but tends to impact the very young and old, often the
most vulnerable segments of our population. Epilepsy can produce
developmental delays and brain damage in children that can lead to a
lifetime of dependence on others and continually accruing costs to the
health care system and society at large.
The Epilepsy Foundation is an aggressive advocate for the doubling
of the NIH budget, for an expanded epilepsy public health program, and
for quality and affordable health care for all Americans. Spending time
with families who live with frequent and persistent seizures
underscores the need to address each of these areas. Families are
desperate for a cure for epilepsy and hopeful that in the short-term,
research will provide new and more effective treatments.
While much about the research program at NINDS could be praised, I
want to single out a very successful joint effort of NINDS and the
epilepsy community. Our work together on the 2000 Curing Epilepsy:
Focus on the Future conference illustrates several important principles
that have widespread applications:
The value of working with people with epilepsy, their family
members and the organizations that represent their interests
The importance of federal interagency coordination and
cooperation
The value of creating measures to hold the various agencies
accountable for their activities and progress.
This conference drew together experts from the all parts of the
scientific world, behavioral experts, representatives of different
federal agencies within NIH, and people with epilepsy and family
members to review the status of current understanding of the epilepsies
and to develop a framework for future directions in research.
As a result of that conference we are now able to talk about a
potential cure for epilepsy--a turning point in the general approach
that had been taken to epilepsy since the first medications were
introduced sixty years ago. The conference identified important areas
where continuing research may indeed lead to a cure in the course of
the next twenty years. These include advances in genetics,
understanding the plasticity of the brain and epileptogenesis, insights
from new imaging and electrophysiology, the potential for cell therapy,
and surgical and other mechanical interventions in the brain.
After that conference, the NINDS again pulled together all
stakeholders and created an epilepsy research benchmarks implementation
plan for the next five years. This document will be used to guide the
NINDS' activities, and should serve as the springboard for the
development of measurable goals, both for the agency itself and for
other affected agencies within the NIH. It is also important that
progress towards these goals be assessed periodically, but certainly at
least every five years, through future reviews with the participation
of expert community, government and consumers. One shortcoming was the
failure to do funding projections for what would be needed to
accomplish the research.
One of the important aspects of the Conference on the Cure was
NINDS' concerted effort to bring together multiple agencies within NIH
to participate. This is an effort that needs to continue in future work
of the NINDS and NIH. Coordination of activities among the various
agencies must be fostered and institutionalized so that each hand knows
what the other is doing and a systematic cross agency approach to
epilepsy research can be implemented. NIH should ideally develop an
interagency coordinating body to address conditions like epilepsy and
the many neurological and other diseases that impact one in all aspects
of life, so as to prevent needless overlap, inconsistency, and promote
optimal research among the agencies. While we know that NINDS staff
members do work with members of other agencies within NIH, this is on
an informal basis, and this activity should be more formalized and
systemized among the agencies.
It is also important that the federal government be able to account
for how it has spent the large increases in funding for research that
have occurred over the last five years. While NINDS has been helpful in
answering our questions on epilepsy funding, we do not know how much
NIH has spent overall through all the agencies on epilepsy research,
because apparently there are no cross agency accounting systems within
NIH for making that determination. Within NINDS, further detail and
information describing and explaining the research that is being funded
would be helpful. The Epilepsy Foundation is a logical partner that can
assist NINDS in getting the word out about their good work, but we need
more information from the agency.
NINDS should also be recognized for another innovative program that
fosters partnerships between the public and private sector. Over the
last twenty years, NINDS has made considerable progress in the
identification of compounds that affect seizure generation by
interfering with various channels and receptors within the brain. This
has occurred through the NINDS Anti-Epileptic Drug Development program,
a program begun in response to federal recognition that the private
marketplace would not invest in research for products which affect
limited numbers of people. The Anti-Epileptic Drug Development program
has led to the introduction of multiple new drugs for the treatment of
epilepsy and has made a real difference in the lives of people with
epilepsy by adding more treatment options.
The program, now called the Anticonvulsant Screening Program, has
identified many compounds that should continue to be explored for their
potential to treat seizures and other conditions, and we urge Congress
to continue its support for this activity. An interesting and difficult
side issue is whether the private marketplace will be willing and
equipped to explore these risky new potential treatments. Congress
should consider a broader public role in the exploration and
development of new treatment, particularly for conditions that affect
only a limited segment of the public. That is a discussion for another
time, but we raise it here because the federal government is sitting on
a potential goldmine of treatment options for a variety of conditions
that should not be lost.
Thus NINDS must overall be congratulated for its work in
understanding of the brain and its support of research towards a long
term cure. At the same time, NINDS needs to address the continuing
medical treatment issues of this population, whose needs will not go
away while cures are sought. For example, NINDS recently funded a
multi-center clinical trial on early surgical intervention for temporal
lobe epilepsy. We urge NINDS to do more of these types of studies.
Other types of outcomes research are also needed, such as a study of
the efficacy of the various treatment modalities, including comparisons
among them in terms of best outcomes; studies on bioequivalence and
bioavailability issues among various products which are based on the
same chemical compounds but which clinicians and patients will swear
are different in their effectiveness in treating seizures. These are
but a few examples of clinical research projects that NIH could and
should fund. The private sector is generally not capable of funding
this type of research, and in our view NIH could do much more to
sponsor research that informs best medical practice.
I would like to conclude this morning by again stating how
critically important it is for the general public to understand what
NINDS is doing. Too often, the work of the NIH is a mystery to the
public. NIH and its agencies could do a better job of presenting itself
simply and clearly to the public, and of reaching out to stakeholders
for input and guidance on its activities. As discussed earlier our
recent work with NINDS is really a model for bring stakeholders
together to address the future of research. That is a practice that
must continue to ensure a close relationship between the needs of
American citizens, and the work of the federal agencies. We
congratulate NINDS for the progress they have made and look forward to
being a key partner in the efforts to prevent and cure epilepsy.
Again, thank you for the opportunity to testify this morning, I am
happy to answer any questions.
Mr. Bilirakis. Thank you very much, Mr. Hargis.
Dr. Sanchez, please proceed.
STATEMENT OF EDUARDO J. SANCHEZ
Mr. Sanchez. Good afternoon, Mr. Chairman and members of
the Subcommittee on Health. It is an honor to appear before you
today to testify about the Texas Department of Health's efforts
to disseminate public health interventions that reduce the
health effects and related costs of cardiovascular disease, the
leading cause of death in our country.
My name is Eduardo Sanchez. I am the Texas Commissioner of
Health with the Texas Department of Health.
I want to thank you, Mr. Chairman and members of this
subcommittee, for your support to help improve our Nation's
health and for holding this hearing. As Texas State Health
Officer and family physician experienced in community-based
care, I know that are many who have yet to benefit from
available research on effective prevention of cardiovascular
diseases and other chronic illnesses. Getting research and
proven public health interventions off the shelf and into
communities is vital for all Americans.
First, I want to explain why cardiovascular disease
prevention is one of the Texas Department of Health's top
priorities. Death, long-term illness, disability,
hospitalization, and rising costs related to treatment and lost
productivity are quite literally breaking the heart and
breaking the bank of our State and of this country.
Heart disease and stroke kill nearly 1 million men and
women each year in the United States. This number represents
more than 40 percent of all annual deaths. Sixty-one million
Americans, almost 25 percent of our population, are living with
some form of cardiovascular disease. Almost 6 million
hospitalizations each year are due to cardiovascular disease.
As you heard, the estimated annual cost of cardiovascular
disease is $330 billion.
The good news is that we know how to reduce this burden,
but we must put this knowledge into action. I want to share
with you one example of translating research into positive
public health outcomes.
We know the primary risk factors for cardiovascular disease
are tobacco use, poor nutrition and obesity, and physical
inactivity. These risk factors begin to have negative effects
at a young age. Texas is 1 of 4 States that participated in a
National Heart, Lung, and Blood Institute trial specifically
designed to reduce these risk factors.
The Child and Adolescent Trial for Cardiovascular Health,
or ``CATCH,'' is the largest school-based health promotion
study ever conducted in the United States that has
scientifically documented positive changes in children's
physical activity and dietary habits. Now it is a research-
based model, and TDH is providing curricula and training for
teachers, cafeteria workers, and other school personnel.
Our program evaluation shows that behavioral changes have
continued 3, 5, and 7 years after the first Texas schools
implemented the CATCH program. Former CATCH students have
continued to eat diets low in fat and to exercise vigorously.
CATCH-trained schools are still serving healthier meals than
those not in the program.
CATCH is a demonstrated success, and we have renamed the
program a Coordinated Approach to Child Health, still
``CATCH.'' It has been adopted by over 1,000 Texas elementary
schools with support from public and private partnerships.
Although schools are already challenged with developing optimal
curricula for the basics, the CATCH curriculum can integrate
important life-long health lessons with those already in
teachers' lesson plans.
At present, few States have comprehensive cardiovascular
disease programs. If all States of the United States had
comprehensive cardiovascular disease programs, then successful
models such as CATCH might be introduced in schools across the
country.
Preventing cardiovascular and other chronic diseases
increases our quality of life and life expectancy and might
help lower health care and related costs. CATCH is an example
of a solidly researched public health intervention strategy
that needs nationwide funding and implementation to make a real
difference in Americans' lives.
Thank you for the opportunity to testify before you today.
[The prepared statement of Eduardo J. Sanchez follows:]
Prepared Statement of Eduardo J. Sanchez, Commissioner of Health, Texas
Department of Health
Good morning. Mr. Chairman and members of the Subcommittee on
Health, it is an honor to appear before you today to testify about the
Texas Department of Health's ongoing efforts to disseminate public
health interventions in communities to reduce the health impact and
related costs of cardiovascular disease--the leading cause of death in
our country. With your permission, I would like to submit my written
testimony for the record.
My name is Eduardo Sanchez, and I am the Texas Commissioner of
Health. I want to thank you, Mr. Chairman, and the members of this
Subcommittee for your support for improving the cardiovascular health
of our nation and for holding this hearing. As the State Health Officer
and a family physician experienced in community-based care, I've
treated many who have yet to benefit from the available research on
effective prevention of cardiovascular diseases and other chronic
illnesses. Getting research and proven public health interventions
``off the shelf'' and into communities is vital--for all Americans.
First, I want to explain why cardiovascular disease prevention is
one of the Texas Department of Health's top priorities: death, long-
term illness, disability, hospitalization and rising costs related to
treatment and lost productivity are, quite literally, ``breaking the
heart'' and breaking ``the bank'' of this country. Heart disease and
stroke are the leading causes of death in the U.S.: together, these
cardiovascular diseases kill nearly one million men and women each
year--this number represents more than 40% of all annual deaths in this
country. Almost 25% of our population is living with some form of this
disease--61 million Americans. More than 1 million Americans are
disabled every year by stroke; and almost 11 million persons over age
65 report such disabilities as loss of speech or mobility--caused by
heart disease and stroke. Almost 6 million hospitalizations each year
are due to cardiovascular disease. For 2001, the costs--in both health
care expenditures and lost productivity--are estimated at $298 billion
(CDC, 2002). Both the human and economic costs are enormous. The good
news is: we know how to reduce this burden; but we must put this
knowledge into action. I want to share with you one example of
translating research into positive public health outcomes.
We know that the primary risk factors for cardiovascular disease
are: tobacco use, poor nutrition and obesity, and physical inactivity--
these same risk factors also underlie the development of diabetes,
cancer and other chronic diseases. Texas is one of four states that
participated in a trial program specifically designed to reduce these
risk factors. (The others are California, Louisiana and Minnesota.) The
National Heart, Lung, and Blood Institute (NHLBI) conducted this 4-year
trial of the most effective concepts and strategies distilled from
previous studies that intervene on the three risk factors I mentioned
earlier: sedentary lifestyle, poor dietary choices, and tobacco use.
Appropriately named ``CATCH'', this method ``catches'' both the
opportunity to develop healthy habits and prevents cardiovascular
disease--at the earliest possible time, early childhood.
During the trial period, this acronym stood for the ``Child &
Adolescent Trial for Cardiovascular Health''. We not only helped
demonstrate the effectiveness of the research-based interventions, the
Texas Department of Health is helping to disseminate this program into
communities across the state. The program has garnered international
attention. When results showed clear success, Texas renamed it to
reflect what really happens: a ``Coordinated Approach To Child
Health.''
Briefly, CATCH is the largest school-based health promotion study
ever conducted in the United States that scientifically documented
positive changes in children's physical activity and dietary habits. It
is a research-based model that has proven results. The Texas Department
of Health is helping diffuse this model statewide by providing
curricula and training for teachers, cafeteria workers and other school
personnel.
CATCH is a comprehensive, coordinated school health program for 3rd
through 5th graders that introduces healthy behavior through four
components: classroom curriculum, physical education, school food
service, and family involvement. Though focused on those three grade
levels, CATCH teaches our children what healthy food choices are, what
healthy activity levels are and models other healthy behaviors for
life. Three years after CATCH was implemented in Texas, students in the
program reported lower fat intake and more vigorous physical activity
than those in the control group. Five to seven years down the road,
schools that received CATCH training were still serving meals
significantly lower in total fat and saturated fat than schools not
introduced to this program. Former CATCH students were also spending
the same amount of time in moderate-to-vigorous physical activity as
when they were in the program.
This program's effectiveness is linked not only to its
comprehensive design, but with how seamlessly it fits into existing
school curricula, addresses the need for physical activity, raises the
health status of all school children, involves parents, cafeteria
workers and entire communities, and has demonstrated long-term
effectiveness. CATCH has been adopted by over 1,000 Texas elementary
schools with support from local public health departments and
professional and community organizations. Other states as well as 350
Department of Defense schools worldwide are piloting their own CATCH
programs. All components of this program have been cited
internationally as examples of ``best practices.''
We know that schools are already challenged with developing optimal
curricula for ``the basics'' and ensuring that students are prepared to
demonstrate their knowledge on standardized tests. The CATCH curriculum
fits seamlessly into that knowledge base, and it includes a number of
methods for teachers to integrate these important life-long health
lessons with those already planned. One teacher commented that the
curricula ``. . . are very user-friendly (and) easy for any teacher to
modify or--enrich (what he or she already has planned). It allows for
individuality in each classroom.'' So while the program is specific in
its design, it doesn't tell teachers how to teach--CATCH provides the
tools that teachers need and want to help our kids grow up healthy and
strong.
One of the greatest success stories in Texas comes from El Paso, an
example of community investment. Collaborative efforts among school
districts, the Texas Education Association, the Texas Department of
Health, the American Cancer Society, the American Health Association,
universities and other private and public partners have resulted in
such important accomplishments as translating materials into Spanish
and otherwise adapting them to be more culturally appropriate for that
community. The original, 4-year initiative has grown into a 7-year
program that reaches an estimated 52,000 students and their families
through 83 schools in 13 school districts. Grant funds from the Paso
del Norte Health Foundation (PNHF) are supporting this expansion, with
an evaluation component funded by PNHF and the American Heart
Association. Parents, teachers, and school principles have volunteered
testimonials on the changes in children's health.
One Texas parent, ``Will's mother,'' wrote that ``(w)hen--Will was
first enrolled in the program, he was a chubby guy who regularly
overate. Today, his eating habits are the best of our whole family. Now
Will is slender and very active. At the age of 13, he plays football,
baseball, and basketball and works out with weights twice a week.
Thanks for your part in this healthy metamorphosis.'' This statement
reflects the kind of changes needed in one of ``the nation's fattest
cities''; Texas has 5 of the country's 50 fattest cities, according to
Men's Fitness magazine. The alarming increase in childhood obesity
demonstrates the urgent need for programs like CATCH--to intervene
early, preventing disease before it strikes down our citizens, often in
the prime of their lives.
Much of this devastation on our people, on our economy, on our
quality of life--can be prevented. We know what causes cardiovascular
disease; and we have solid, tested methods for helping people make wise
decisions to reduce their risk for these chronic diseases, as well as
improve their overall health status. Right now, few states have
comprehensive cardiovascular disease programs, yet all Americans
experience these health problems. Research reveals that young people,
members of racial and ethnic minorities, women, and people of low
socioeconomic status are most at risk for developing these problems and
suffering the greatest effects (CDC, 2002). The Texas Department of
Health validated that the CATCH curriculum, as implemented in Texas
communities, is flexible enough to ensure cultural appropriateness and
is a good, comprehensive strategy for child health.
If all states had comprehensive cardiovascular programs, then
successful models--such as CATCH--can be taken directly to communities.
We've known the risk factors for cardiovascular disease for over 50
years--the result of the NHLBI's long-term research on cardiovascular
health, the Framingham Heart Study. We've known how to prevent the
development of these risk factors for over 10 years. Preventing
cardiovascular and other chronic diseases increases the quality-of-life
and life expectancy. It also lowers health care and related costs.
CATCH is an excellent example of solidly researched public health
intervention strategies that need adequate funding to make a real
difference in people's lives.
Thank you for the opportunity to testify before you today. I will
be happy to answer any questions you may have.
Mr. Bilirakis. Thank you very much, Doctor.
Dr. Jones?
STATEMENT OF DANIEL JONES
Mr. Jones. Mr. Chairman, I would like to express my
appreciation to you and the members of the subcommittee for
holding this hearing on this very important issue, and thank
you, Congressman Pickering, for your kind introduction and for
your continued leadership.
I am here today to tell you about the enormous impact of
stroke, our Nation's number 3 killer, and the opportunity to
advance the fight against stroke through research. The American
Heart Association and our American Stroke Association Division
applauds Congress for its commitment to double the budget of
the National Institutes of Health over 5 years by fiscal year
2003. Fulfillment of this commitment will help us to develop
new knowledge and tools to more effectively prevent and treat
stroke and other cardiovascular diseases.
Together, NIH and the stroke community have advanced our
knowledge of stroke. Stroke was once viewed as an untreatable
disease, but important new information shows promise for
improved stroke diagnosis, treatment, rehabilitation, and
prevention. Research during the last decade provided physicians
new resources to prevent, diagnose, and treat stroke.
For example, NINDS-sponsored clinical trials showed the
effectiveness of a clot-busting drug when administered to
appropriate patients within 3 hours of the onset of symptoms of
a clot-based stroke. Another series of trials found that
aspirin or warfarin reduced stroke risk to 80 percent in
victims of atrial fibrillation and irregular heart beat
associated with 70,000 strokes each year. NHLBI-sponsored
clinical trials confirmed the benefit of treatment of high
blood pressure and high cholesterol as ways to prevent stroke.
The bad news is, despite this progress, stroke remains the
Nation's third leading cause of death and, importantly, a major
cause of disability. We must make a commitment to do more. With
the aging of the population, the number of stroke patients in
the United States will substantially grow in the coming
decades.
Despite the overall effort to double the NIH budget, stroke
research, as has been pointed out, remains disproportionately
underfunded in view of the enormous burden this disease places
on our Nation and the numerous scientific opportunities in the
future. Presently, only 1 percent of the NIH budget is invested
in stroke research and related programs.
We urge Congress to ensure that the NIH budget for stroke
also doubles over the same 5-year period. An appropriation of
$316 million for fiscal year 2003 is needed to accomplish this
goal.
Each year over 600,000 Americans suffer a stroke, and
167,000 of them die. This devastating disease touches the lives
of nearly all Americans. There are currently 4.6 million stroke
survivors living in the United States, and as many as 30
percent of survivors are permanently disabled, requiring
extensive and costly care. My home State of Mississippi, which
is in the Stroke Belt Region, has the seventh highest stroke
death rate in the Nation.
Stroke is a costly disease. Nationally, stroke is expected
to cost our Nation $49.4 billion in 2002, including $30.8
billion in direct medical costs. Since a large share of these
costs are paid for by public payors like Medicare, these
programs should be modernized to better address stroke.
For example, Medicare should cover the cost of preventative
cholesterol screening in order to better detect stroke risk.
The American Heart Association and its American Stroke
Association Division has set a bold goal to reduce stroke and
risk of stroke by 25 percent by the year 2010. The association,
which does not accept government funding, plans to reach this
goal through its continued efforts to fund stroke research,
educate the public about stroke, and implement successful
community-based programs.
We can reach this goal, but it will take commitment, hard
work, a continued close relationship with Federal agencies like
the National Institutes of Health and public and private
resources. The American Stroke Association applauds the
National Institute of Neurological Disorders and Stroke at the
NIH for recognizing the need to do more in this area and for
developing a road map for the next decade of stroke research.
We are pleased that several of the critical priorities
identified by NINDS include the development of stroke center
networks with sufficient infrastructure to deliver quality
stroke care, improvement of data bases for collection and
analysis of stroke data, and expansion of efforts to raise
public awareness and train medical professionals about stroke.
Accomplishing these goals will require a shared responsibility
on the part of Congress and the public health community.
We encourage the members of this subcommittee to actively
join our fight. We are pleased that the members of this
subcommittee are committed to funding stroke research and
ensuring that this research is translated into effective care.
For example, we particularly want to thank Congresswoman
Lois Capps and Congressman Chip Pickering for introducing the
Stroke Treatment and Ongoing Prevention Act, or Stop Stroke
Act, and the chairman for his support stated today. This vital
legislation will ensure that stroke is more widely recognized
by the public and treated more effectively by health care
providers. The Stop Stroke Act unanimously passed the Senate
and currently has strong bipartisan support from 175 co-
sponsors in the House.
Last, I want to take a moment to congratulate Dr. Lenfant
and the National Heart, Lung, and Blood Institute on the 30th
anniversary of their National High Blood Pressure Education
Program that was mentioned earlier. This is one of the most
successful public awareness programs in existence, and it has
helped dramatically increase the interest and awareness of
hypertension or high blood pressure, one of the leading risk
factors for stroke.
Thank you, and I would be happy to answer any questions,
and look forward to ongoing dialog with the subcommittee.
Thanks.
[The prepared statement of Daniel Jones follows:]
Prepared Statement of Daniel Jones, American Stroke Association, a
Division of the American Heart Association
Thank you Congressman Pickering. I appreciate your leadership on
this issue. I would also like to thank Chairman Bilirakis and the
members of the Subcommittee for holding this hearing.
I am Dr. Daniel Jones, the Associate Vice Chancellor for Health
Affairs and Associate Dean, School of Medicine at the University of
Mississippi Medical Center. I am also the Herbert G. Langford Professor
of Medicine, the Co-director of the Division of Hypertension and
Associate Director of the Center for Excellence in Cardiovascular-Renal
Research. In addition, I am also an active volunteer for the American
Heart Association and its American Stroke Association Division. In this
capacity, I serve on the NIH National High Blood Pressure Education
Program Coordinating Committee and am the chairman of the AHA
International Committee.
I am here today to tell you about the enormous impact of stroke--
our nation's number three killer--and the opportunity to advance the
fight against stroke through research.
significant advances in the last decade
The American Heart Association and our American Stroke Association
division applaud Congress for its commitment to double the budget of
the National Institutes of Health (NIH) over five years--by Fiscal Year
2003. Fulfillment of this commitment will help us develop new knowledge
and tools to more effectively prevent and treat stroke and other
cardiovascular diseases.
Together, NIH and the stroke community have advanced the knowledge
of stroke. Stroke was once viewed as an untreatable disease.
Importantly, new information shows promise for improved stroke
diagnosis, treatment, rehabilitation and prevention.
Research during the last decade provided physicians new resources
to prevent, diagnose and treat stroke. Highlights of selected National
Institute of Neurological Disorders and Stroke (NINDS) supported stroke
studies follow.
A clinical trial showed that when administered to appropriate
patients within three hours of the onset of symptoms of a clot-
based stroke, tissue plasminogen activator (tPA), the only FDA-
approved emergency treatment for stroke, can restore blood flow
and reduce the chances of permanent disability by 33 percent.
It is estimated to save $4.5 million to $5 million for every
1000 patients treated.
A series of clinical trials found that aspirin or warfarin
reduced stroke risk by up to 80 percent in victims of atrial
fibrillation, an irregular heart beat that is associated with
70,000 strokes each year. Either aspirin or warfarin treatment
could prevent up to 30,000 strokes each year with an annual
savings of $200 million. For many atrial fibrillation victims,
the less expensive, less complicated aspirin can provide
sufficient protection from stroke.
A clinical trial is evaluating medications, ticlopidine and
aspirin, to prevent recurrent stroke in African-Americans.
Importance of prevention and early risk factor treatment are
stressed.
Clinical trials sponsored by the National Heart, Lung and
Blood Institute (NHLBI) confirmed the benefit of treatment of
high blood pressure and high cholesterol as ways to prevent
stroke.
stroke is still the nation's number three killer
The bad news is, despite this progress, stroke remains the nation's
third leading cause of death, and importantly, a major cause of
disability. We must make a commitment to do more. With an aging
population, the number of stroke patients in the United States will
substantially grow in the coming decades.
Despite the overall effort to double the NIH budget, stroke
research remains disproportionately underfunded in view of the enormous
burden this disease places on our nation and the numerous scientific
opportunities. Presently, only 1 percent of the NIH budget is invested
in stroke research and related programs.
We urge Congress to ensure that the NIH budget for stroke also
doubles over the same five-year period. An appropriation of $316
million for Fiscal Year 2003 is needed to accomplish this goal.
Each year, more than 600,000 Americans suffer a stroke and 167,000
of them die. This devastating disease touches the lives of nearly all
Americans. There are currently 4.6 million stroke survivors living in
the United States, and as many as 30 percent of the survivors are
permanently disabled, requiring extensive and costly care.
My home state of Mississippi, which is in the stroke belt region,
has the seventh highest stroke death rate in the nation. Mr. Chairman,
I have included as part of my testimony a chart that illustrates the
impact of stroke on each state.
Stroke is a costly disease. Nationally, stroke is expected to cost
our nation $49.4 billion in 2002, including $30.8 billion in direct
medical costs. Since a large share of these costs are paid for by
public payors like Medicare, these programs must be modernized to
better address stroke. For example, Medicare should cover the cost of
preventive cholesterol screening in order to better detect stroke risk.
the american heart association--we're putting our heart behind fighting
stroke
The American Heart Association and its American Stroke Association
division have set a bold goal of reducing stroke and risk of stroke by
25 percent by the year 2010.
The Association, which does not accept government funding, plans to
reach this goal through its continued efforts to fund stroke research,
educate the public about stroke and implement its successful community-
based programs. The Association leverages credible science, a strong
reputation and a nationwide infrastructure of Affiliates to advance its
mission.
We can reach this goal, but it will take commitment, hard work, a
continued close partnership with federal agencies like the National
Institutes of Health and public and private resources.
nih sets roadmap for the future of stroke research
The American Heart Association and its American Stroke Association
division applauds the National Institute of Neurological Disorders and
Stroke (NINDS) at the NIH for recognizing the need to do more in this
area and for developing a roadmap for the next decade of stroke
research.
NINDS assembled leaders in the stroke field to form the Stroke
Progress Review Group to develop the strategic plan, which was released
in April, 2002. Our Association plays an active role in this group. The
report identifies five research priorities for the next five to ten
years as well as seven priorities needed to implement this important
research so that patients benefit in a meaningful and timely manner.
Several of the critical priorities identified in the NINDS report
include the development of stroke center networks with sufficient
infrastructure to deliver quality stroke care, improvement of databases
for collection and analysis of stroke data and expansion of education
and training.
translating research into improved stroke care and prevention
Accomplishing these goals will help ensure that stroke research
advances are translated into practice, but their fulfillment will
require a shared responsibility on the part of Congress and the public
health community.
We are pleased that Members of this Subcommittee are committed to
funding stroke research. We ask that the Subcommittee also help ensure
that this research is translated into effective stroke care and
prevention by advancing legislation like the Stroke Treatment and
Ongoing Prevention Act (STOP Stroke Act).
We thank Congresswoman Lois Capps and Congressman Chip Pickering
for introducing this vital legislation (H.R. 3431/S.1274), which will
help ensure that stroke is more widely recognized by the public and
treated more effectively by healthcare providers.
The STOP Stroke Act addresses a number of barriers that prevent
stroke patients from accessing quality care. These barriers include low
public awareness, lack of awareness among medical professionals, lack
of infrastructure and lack of data collection. Many of these barriers
were also identified as priorities in the Report of the Stroke Progress
Review Group, and their removal is critical to the translation of NIH
stroke research advances into practice.
For example, the legislation addresses the critical need to better
educate the public about stroke. Despite being the nation's number
three killer, the public knows very little about stroke. Only 68
percent of the general public can name the most common stroke warning
sign--sudden numbness or weakness on one side of the body. Even more
alarming, those at the greatest risk--seniors, minorities and women--
know the least about the stroke warning signs.
Stroke is a medical emergency and must be treated rapidly.
Unfortunately, since many Americans do not recognize the stroke warning
signs, stroke victims frequently wait as long as 22 hours before
seeking medical attention. The treatment window for most strokes is as
short as three hours from the onset of symptoms.
We look forward to continuing to work with Representatives Capps
and Pickering to advance this legislation.
The STOP Stroke Act unanimously passed the Senate and currently has
strong bipartisan support from 175 co-sponsors in the House, including
21 Members of this Subcommittee.
Lastly, I want to take a moment to congratulate Dr. Lenfant and the
National Heart, Lung and Blood Institute on the 30th anniversary of the
National High Blood Pressure Education Program. This is one of the most
successful public awareness programs in existence and has helped
dramatically increase awareness of hypertension, or high blood
pressure, one of the leading risk factors for stroke.
Thank you. I have included as part of my testimony several
documents that provide additional background information about stroke
as well as information about the American Heart Association and its
American Stroke Association division, including what we are doing to
fight this devastating disease.
I would be pleased to answer any of your questions and look forward
to an ongoing dialogue with the Subcommittee as you address these
important issues.
stroke in your state
In 1999, stroke was the number 3 killer in every state but Colorado
(number 4), Nevada (number 4), New Mexico (number 5) and Wyoming
(number 4).
The following chart shows the number of stroke deaths in your
state, your state's stroke death rate (number of deaths per 100,000
people), and your state's rank.
------------------------------------------------------------------------
Number of
Stroke Rank** Rate***
State Deaths* (Highest to (Deaths per
(1999) Lowest) 100,000)
------------------------------------------------------------------------
Alabama.......................... 3,148 11 68.1
Alaska........................... 171 20 63.7
Arizona.......................... 2,600 44 56.2
Arkansas......................... 2,255 2 85.4
California....................... 17,962 26 61.5
Colorado......................... 1,834 43 56.5
Connecticut...................... 1,933 46 52.1
Delaware......................... 365 47 51.8
District of Columbia............. 297 33 60.4
Florida.......................... 10,560 48 51.3
Georgia.......................... 4,416 6 73.8
Hawaii........................... 762 39 58.9
Idaho............................ 771 17 65.1
Illinois......................... 7,714 23 62.3
Indiana.......................... 4,057 9 68.8
Iowa............................. 2,317 28 61.1
Kansas........................... 1,841 24 62.0
Kentucky......................... 2,710 13 67.6
Louisiana........................ 2,684 14 67.2
Maine............................ 879 42 57.0
Maryland......................... 2,892 35 60.0
Massachusetts.................... 3,548 51 49.3
Michigan......................... 6,041 22 62.7
Minnesota........................ 2,997 27 61.4
Mississippi...................... 1,854 7 69.9
Missouri......................... 3,950 18 64.5
Montana.......................... 595 31 60.6
Nebraska......................... 1,176 37 59.6
Nevada........................... 882 21 63.0
New Hampshire.................... 669 29 61.0
New Jersey....................... 4,122 50 50.1
New Mexico....................... 817 45 53.1
New York......................... 8,124 52 42.9
North Carolina................... 5,626 4 77.8
North Dakota..................... 513 25 61.5
Ohio............................. 7,235 34 60.2
Oklahoma......................... 2,481 12 68.0
Oregon........................... 2,799 5 77.2
Pennsylvania..................... 8,600 38 58.9
Puerto Rico...................... 1,814 40 58.5
Rhode Island..................... 633 49 51.2
South Carolina................... 2,974 1 86.0
South Dakota..................... 547 32 60.5
Tennessee........................ 4,103 3 78.3
Texas............................ 10,414 16 66.3
Utah............................. 869 30 60.9
Vermont.......................... 344 41 58.4
Virginia......................... 4,110 8 69.3
Washington....................... 3,718 10 68.1
West Virginia.................... 1,323 36 59.6
Wisconsin........................ 3,869 15 66.3
Wyoming.......................... 265 19 63.9
------------------------------------------------------------------------
*Source: National Center for Health Statistics: National Vital
Statistics Reports for 1999. Age adjustments are based on the 2000
standards.
**The rank is based on the state death rate and is listed from highest
(1) to lowest (52). For the purposes of the chart, the District of
Columbia and Puerto Rico are listed and ranked as states.
***Source: National Center For Health Statistics compressed mortality
file for the years 1996 to 1998.
As a division of the American Heart Association, the American
Stroke Association's mission is to reduce disability and death from
stroke through research, education, fundraising, and advocacy. The
American Stroke Association leverages credible science, a strong
reputation, and a nationwide infrastructure of Affiliates to advance
its mission. The American Stroke Association's goal is to reduce stroke
and stroke risk by 25 percent by the year 2010.
programs, products and services
The American Stroke Association's initiatives are delivered through
three primary categories:
I. Primary Prevention of Stroke
The American Stroke Association produces educational
materials, including brochures and videos, for both
professional and consumer audiences, with a high level of focus
on women, African Americans and seniors.
Search Your Heart is an educational program designed to reach
African Americans in a church setting, which encourages church
members to change their lifestyles in order to build heart-
healthy bodies. The program contains several activity kits,
including a module called Stomp Out Stroke, that are designed
to educate people about risk factors and warning signs.
II. Acute Care/The Acute Event
Operation Stroke--Created in 1997, Operation Stroke is a
comprehensive community initiative that pulls together local
resources necessary to provide optimal care for those
experiencing a stroke.
Acute Stroke Treatment Program (ASTP)--This implementation
resource was developed as the tool for the Brain Attack
Coalition's Guidelines for Primary Stroke Centers, published in
the Journal of the American Medical Association (JAMA), which
the American Stroke Association co-authored. Since its launch,
more than 3,000 kits have been distributed to hospitals across
the United States, and the ASTP is considered the premier
resource for implementing primary stroke centers.
The need for rapid action is communicated to consumers through
national media and call-to-action campaigns, radio public
service announcements and national alliances with other
organizations that can impact care at the time of an acute
event.
Stroke: When Minutes Matter, is a senior education program
designed to help seniors identify the stroke warning signs and
to respond promptly by calling 9-1-1. Pilot results showed 10-
15 percent improvement (between pre- and post-tests) in senior
recognition of stroke warning signs.
III. Secondary Prevention and Post-Stroke Rehabilitation
Get with the Guidelines is a Web-based initiative delivered at
the hospital level to develop hospital-based protocols to
implement primary and secondary prevention guidelines for
cardiovascular disease and stroke. The stroke module is
currently in pilot with the Patient Management Tool (a Web-
based data collection tool also used to support some states in
the Paul Coverdell stroke registry pilot).
The American Stroke Association provides valuable resources
for stroke survivors and caregivers, including:
1. Stroke Connection magazine;
2. A toll-free ``Warmline'' (888-4-STROKE) staffed by
stroke survivors and caregivers; and
3. Support Group Registry of more than 2,000 support
groups nationwide.
professional resources
Attended by more than 2,400 people, the American Stroke
Association's International Stroke Conference provides an
educational experience for neurologists, surgeons, physicians,
nurses and allied health professionals. The conference, which
highlights major advances in fundamental and clinical stroke-
related research, is considered among the most successful and
prestigious stroke conferences in the world.
Stroke: A Journal of the American Heart Association is the
premier scientific journal for those involved in the care of
stroke patients.
The Stroke Trials Directory is a one-of-a-kind Web site that
contains descriptions of completed and ongoing stroke
therapeutic trials, positive and negative.
The Satellite Broadcast on Acute Stroke, one of a series of
live, interactive satellite professional education broadcasts,
reached more than 4,500 healthcare professionals
simultaneously. The Emerging Science broadcast reached more
than 8,600 health care professionals simultaneously. Future
topics may include Secondary Prevention and Comprehensive
Stroke Centers.
Healthcare professionals and others interested in stroke can
sign up to receive a quarterly email communication, the Stroke
Information Alliance, to keep up with the latest activities and
initiatives of the American Stroke Association (by sending
email information to [email protected])
Stroke volunteers and alliances may also keep up-to-date
through our Extranet community located at
www.strokecommunities.org
national strategic alliances
In order to align goals and strategies at a national level to fight
against heart disease and stroke, the American Heart Association and
American Stroke Association recently signed an historic Memorandum of
Understanding, considered a milestone in public and private sector
cooperation, with:
Centers for Disease Control;
National Heart, Lung and Blood Institute;
National Institute of Neurological Diseases and Stroke;
Office of Disease Prevention and Health Promotion; and
Centers for Medicare and Medicaid Services
These collaborative efforts, coupled with the organization's
ability to work through more than 2,000 local offices, provides a
strong basis for delivering stroke messages to consumers and
professionals across the United States.
american heart association/american stroke association identified
stroke research opportunities
Improved Treatments for Stroke
Blood clots or bleeding into the brain can cause strokes. tPA use
has dramatically improved treatment of clot-caused strokes when
administered within three hours of the onset of stroke symptoms. Using
coils, balloons and stents in arteries in the brain has dramatically
prevented bleeding and strokes in small numbers of patients. However,
many challenges to improving treatment remain. Strokes often are not
recognized quickly. They can start with mild or confusing symptoms, or
in the middle of the night. Also, techniques for treating strokes,
other than using tPA, require extensive training for safe and effective
use and so are often not available. Therefore, a compelling need exists
to develop medications, devices and techniques to accomplish three
specific but broad goals: 1) more effective stroke treatment; 2) safer
treatment than is now available that can be administered later after
stroke onset than is possible now; and 3) treatment that can be used
more widely, in more patients, by more doctors.
Limiting Damage Due to Interruption in Blood Flow and Restoration of
Blood Flow
Strokes damage the brain by depriving affected areas of blood and
oxygen. If blood flow is restored quickly after a stroke occurs--for
example, by using tPA--this damage is prevented. Even if certain areas
are not completely deprived of blood, or are only without blood for a
few hours, they may not recover when blood flow is restored. Much
research has focused on damage caused when parts of the brain do not
receive blood. But so far there has been little practical progress.
Further research is needed to develop ways to 1) prevent damage to
cells around the area deprived of blood, 2) prolong the time that areas
of the brain can be partially deprived of blood and still recover and
3) help damaged brain cells recover. This will require a better
understanding of how brain cells respond to injury and developing new
drugs to help in prevention, preservation and healing. Treatments based
on reopening brain blood vessels are often complicated by bleeding into
the brain, when blood flow is re-established. Studies are needed to
understand why such bleeding occurs and how best to prevent it.
Brain Imaging Techniques
To be considered for tPA, a patient must undergo imaging studies
within three hours of the onset of stroke symptoms to 1) confirm that
the symptoms stem from a stroke and 2) determine that the stroke
results from a blood clot, not bleeding. Thus, an imaging technique
must quickly provide information about stroke. Efforts must be directed
toward 1) advancing the technology of imaging techniques to reduce the
time to obtain images and improve image quality, and 2) investigating
and expanding imaging to other applications that directly impact stroke
care, such as telemedicine. Telemedicine is implementing radiological
and communications technology to facilitate treatment of stroke
patients in communities without immediate access to adequate emergency
care.
Stroke Risk Factors
The devastating impact of stroke will continue until proven methods
and techniques prevent its long-term debilitating effects. After
researchers identify and understand how risk factors predispose someone
to stroke, more people at high risk for stroke can be identified,
evaluated and treated to prevent a future stroke.
Stroke and Dementia
Research on dementia has focused on Alzheimer's disease, but some
of dementia in the elderly stems from stroke. Dementia remains a
contributing factor in the overall outcome and quality of life of
stroke survivors and of patients with high blood pressure. Lesions in
the brain and some of its blood vessels can cause dementia either by
producing multiple strokes (multi-infarct dementia) or by producing
lesions in the white matter of the brain (leukoaraiosis). More research
must define risk factors for multiple strokes, its underlying causes
and effective preventive measures. Furthermore, more clinical and basic
research is needed to characterize the risk factors for leukoaraiosis
and to define its causes and potential treatments.
Functional Recovery from Stroke
More Americans are expected to suffer from stroke as the ``baby
boomer'' population ages. Managing high-risk patients and evaluating a
stroke in progress must continue to focus on predicting and improving
functional recovery from stroke.
Stroke Education and Awareness
Studies underscore the importance of comprehensive and effective
educational efforts to increase public awareness of stroke. They
emphasize three important steps in improving stroke outcome: educating
the public about stroke risk factors, recognizing stroke warning signs
and seeking emergency medical attention. Several audiences must be
targeted: the public, especially high-risk populations (blacks,
elderly, diabetics), stroke survivors, healthcare professionals,
emergency medical personnel, hospital administrators, civic leaders and
government officials. Primary stroke center recommendations published
by the Brain Attack Coalition in the June 21, 2000 Journal of the
American Medical Association clearly define recommendations for
hospitals to implement stroke centers, teams and other programs to
improve stroke treatment.
Genomics and Proteomics in Stroke
The factors that predispose someone to stroke are complex. They are
influenced by multiple genes interacting with each other and the
environment. Recent advances in genomics and proteomics help identify
genes and their protein products involved in developing brain blood
vessel disease and stroke. Knowledge of these genes will help
scientists and physicians use an individual's genetic makeup to
identify subgroups of the population at risk for stroke, establish
which groups are most likely to benefit from specific treatments, and
provide the scientific basis for developing innovative approaches to
treat and prevent stroke. Important opportunities for research include
1) developing new technologies for studying the differing patterns of
gene expression of normal and diseased cells and tissues and 2)
measuring interactions between genetic variants and specific
environmental changes to identify genes that modify the impact of the
environment on brain blood vessel disease.
Proteomics builds on and complements knowledge gained from genomics
and genetic screening approaches. It helps provide a functional
understanding of how genes regulate the blood vessels. It also allows
investigators to identify alterations in protein structure and function
that lead to brain blood vessel disease and stroke. Genomic and
proteomic studies are often complex and require sophisticated
analytical tools to store and analyze data. So studies involving
multiple investigators and centers and ways to share data among
investigators should be encouraged.
frequently asked questions
What is a stroke?
Stroke is a cardiovascular disease that affects the blood vessels
supplying blood to the brain. A stroke occurs when a blood vessel
responsible for supplying the brain with oxygen and nutrients bursts or
becomes excessively clogged by a blood clot or some other particle.
What are the types of stroke?
There are two main types of stroke: ischemic strokes and
hemmorrahagic strokes.
Ischemic strokes are caused by blood clots that form and block
blood flow to the brain. Ischemic strokes are most common and
account for 80 percent of all strokes.
Hemmorrahagic strokes are caused by a break in an artery in
the brain, causing blood to fill the area and damage the
surrounding tissue.
What is a TIA (transient ischemic attack) or ``mini stroke''?
A TIA is a sudden but temporary interruption of the blood supply to
the brain resulting in symptoms that last from several minutes to
several hours, but not more than 24 hours.
What are the effects of stroke?
Strokes affect people in different ways, depending on the type of
the stroke, the area of the brain affected and the extent of the brain
injury. Strokes can cause devastating disability, including:
Paralysis or muscle weakness
Difficulty in speaking or swallowing
Blindness
Cognitive impairment or memory loss
Incontinence
How can stroke be prevented?
The American Heart Association has identified several factors that
increase the risk of stroke. The more risk factors a person has, the
greater the chance that he or she will have a stroke. The best way to
prevent a stroke is to reduce the controllable risk factors, which
include:
High blood pressure
Tobacco use
High cholesterol levels
Obesity
Physical inactivity
There are also a number of uncontrollable risk factors for stroke
including age, gender, race, family history of heart disease, stroke or
diabetes.
What are the stroke warning signs?
The most common warning signs of stroke include the following:
Sudden numbness or weakness of the face, arm or leg, often on
one side of the body.
Sudden confusion, trouble speaking or understanding.
Sudden trouble seeing in one or both eyes.
Sudden trouble walking, dizziness, loss of balance or
coordination.
Sudden severe headache with no known cause.
Not all of these warning signs occur in every stroke. If some signs
begin to occur, don't wait. Get help immediately. Stroke is a medical
emergency.
How is stroke currently treated?
Depending on the type and severity, stroke can be treated through
surgery, drugs, acute hospital care and rehabilitation. If the stroke
is caused by a blood clot (ischemic stroke), clot-busting drugs can
sometimes be used to dissolve the clot. This treatment, which was
approved by the Food and Drug Administration in 1996, is a significant
advance in the war against stroke.
For clot-busting drugs to be effective, treatment must be started
within three hours of the onset of the stroke. Therefore, it's critical
that care1ivers, medical professionals and the public recognize stroke
as a medical emergency and respond immediately. Unfortunately, for a
number of reasons, only 3 to 5 percent of patients who could benefit
from these drugs actually receive the treatment.
Can stroke survivors be rehabilitated?
Besides being the third leading cause of death in the United
States, stroke is a leading cause of serious, long-term disability.
Many survivors are left with mental and physical disabilities of
varying severity, and nearly all stroke survivors can benefit from an
appropriately structured and comprehensive rehabilitation program.
People with the least impairment are likely to benefit from
rehabilitation the most. Sometimes even modest gains can mean the
difference between staying in an institution and returning home. The
goal of rehabilitation is to increase independence and improve physical
abilities. Rehabilitation is most successful if initiated early.
In addition to current treatments and therapies, there are many
promising medical advances on the horizon. What is the goal of
these new treatments?
A number of new stroke technologies are in development. The primary
objectives of these medical advances are to more effectively remove
blood clots that cause stroke and to extend the therapeutic window.
New drug therapies are under development that would, like
current treatments, dissolve blood clots. Physicians hope to
improve the performance of these drugs by delivering them
directly to the blood clot through small tubes threaded
directly into arteries or the brain itself. Researchers are
also trying to develop very small mechanical devices that can
be delivered through these small tubes to break-up or remove
blood clots.
Once a blood clot occurs and a portion of the brain is starved
of blood, a series of chemical reactions take place. Many of
these chemical reactions occur in the first few hours of a
stroke and actually cause most of the damage to the brain. This
short time frame means that many patients are not able to
receive treatment in time to prevent significant brain injury.
Researchers hope to develop drugs that stop or delay these
chemical reactions, prevent permanent damage to the brain and
expand the therapeutic window so that there is more time to
provide treatment.
Mr. Bilirakis. Thank you. Thank you very much, Dr. Jones.
Dr. Bonow, certainly because of your past experience on the
research staff at the institute, you're more than anybody here,
I guess, in a unique position to explain to us how NIH research
activities translate to patients and their providers. In the
process of formulating your answer, I wish you would maybe
expand my question, so that you can expand your answer, to go
into the public advocacy organizations such as your
organization, such as Mr. Hargis' organization, in terms of
their relationship with NIH, in terms of interacting with NIH,
and their having difficulty interacting with NIH, et cetera.
Please proceed, sir.
Mr. Bonow. Thank you, Mr. Chairman. I do have a unique
perspective, both on the inside and outside, as a researcher
and currently as somewhat of an administrator over a large
number of cardiologists who are seeking NIH grants.
I do believe that I can reassure the committee that, from
my perspective, the administrative components of the National
Institutes of Health are doing a good job. There is a large
attention to basic research, but basic research is vital,
getting to some of the issues raised in the previous panel. New
drug development only comes when there is an understanding of
the fundamental mechanisms of disease. You can develop a whole
new class of drugs when you know what is going on in the cell,
on the cell membrane. If we have cell regeneration, perhaps
there are drugs that can be developed to simulate this. So the
basic science is critically important.
Translating that to clinical research is equally important.
Intramurally, getting back to one of the questions I believe
from Mr. Deal this morning, much of the research done in
Bethesda is patient-based research. My 16 years there was
spent, at least 14 years, involved in clinical trials in
patients with either new drugs, new diagnostic tests, new
indications for surgical advances, and so forth. I believe that
is vitally important to continue this focused research in a
very heady research environment, unencumbered by the rest of
the issues that someone in a medical school environment must
deal with in trying to accomplish research.
On the other hand, one needs to be able to translate
research in a protected environment like the NIH into the real
world, and this is where the clinical trials become very
important. In the current year of cardiovascular disease
research, much of the clinical trials are being performed by
drug companies. This is very important. This is the way we
advance our understanding of drugs.
But I believe the federally funded clinical trials are
preeminent in their objectivity, their research
accomplishments. Negative results are published equally with
positive results without bias. These trials are fundamentally
important.
I do believe that the process by which clinical trials get
developed and approved and implemented is a good one with
appropriate peer review by external reviewers. So, therefore, I
think that component is fine.
The other component you raise of how this now gets
implemented into outcomes and improvement in patient care is
something the NIH does focus on, perhaps could focus on more,
and perhaps better. But it can only do so in partnership with
other agencies, I think, like CDC, or perhaps at the state
level with state departments, such as Dr. Sanchez mentioned,
partnerships with NIH and public health groups.
Mr. Bilirakis. Is that being done on an adequate basis?
Mr. Bonow. Well, as has been discussed in the first panel,
the Memorandum of Understanding I think is critical. This is an
official liaison between these Federal agencies. We in the
American Heart Association are part of this as well, and we are
proud to be. It does help to translate things beyond the
research arena into outcomes or outcomes-based research, and
then perhaps it can actually improve care nationwide.
The CDC I believe should be focused on. I know it is not
the topic for today's discussion, but CDC's chronic disease
program, which can address cardiovascular disease and stroke at
the state level, would require more funding to implement this
nationwide. Currently, only six States are receiving full
support from CDC to implement chronic disease programs,
including cardiovascular disease and stroke. I would like to
see more funding going to the CDC chronic disease components to
do this.
My district in Chicago for African American men has the
third worst mortality rates in the country for cardiovascular
disease. We are not doing enough to translate what we already
know works. It is not new research; it is old research. What
already works, but to implement that effectively and at the
community level. To answer your question, I don't believe we
are focusing on this enough.
This also leads, I guess, to your final question, which is
how the private agencies or groups before you today could help
because we are focusing on this, too. We can't do it alone. We
need to have partnerships with other peer groups. We work with
the American College of Cardiology, the American Diabetes
Association, but in partnership with the Federal agencies, I
believe we can get the job done.
Mr. Bilirakis. My time has expired, and we have a series of
votes coming up. So we should finish up, would like to finish
up, because I don't want to keep you that long.
Mr. Hargis, I intended to ask you basically the same
question, and consider that question asked, but will you
respond in writing to us----
Mr. Hargis. Certainly.
Mr. Bilirakis. [continuing] regarding it? I would like to
know your experience with NIH in terms of your relationship
with them. Can you interact with them? Do they listen to you?
You know, things of that nature.
Obviously, we think the world of them in general, but we
also want to make sure that they are spending the taxpayers'
dollars the right way, and that the organizations such as
yours, since you spend so much time on these particular
epilepsy and heart and all these other diseases, we want to
make sure that they listen; if not necessarily go along with it
all the time, at least are listening.
All right, I will now yield to Mr. Brown.
Mr. Brown. Thank you, Mr. Chairman. I will do better than I
did the last time you yielded to me. Thank you.
Dr. Sanchez, just one pretty simple question: We have
talked at length about translating basic research into basic
health through both panels, in large part through the
development of prescription drugs and antibiotics. I was
interested in your discussion about translating basic research
into prevention.
Tell us, if you would, in my State of Ohio we have, I
believe Columbus has some of the highest diabetes mortality
rates in the country. Diabetes is a serious problem, obviously,
everywhere. Ohio, you are at the top of the list by most
measurements.
Tell us, if you would, a little more about what you have
done through the Texas Department of Health in terms of obesity
and exercise and diet, and all the issues that clearly make the
diabetes probably the worst.
Mr. Sanchez. Sure. As was stated, I have been Commissioner
of Health for about 7 months, and one of the first things that
we did at TDA when I came on board was to have a discussion
internally and with external partners about what might be Texas
Department of Health priorities. The top five priorities for
the Texas Department of Health are fitness promotion, in other
words, obesity prevention, improving our immunization rates in
our State, eliminating health disparities in our State, not
just racial and ethnic but geographic disparities--we have
great geographic disparities in our State--enhancing our public
health preparedness, and then, last, as a State agency whose
charge is to dispense public funds, look at improving our
business practices.
So far as obesity goes, we've got a number of programs.
CATCH, which you heard about, is one. We feel that focusing at
least some of our attention on children is very important in
terms of the continuum and the upstream benefits of addressing
lifestyle issues early on in life, before they become so
ingrained as in someone like me, and try to get people early in
life.
We have a Texas Diabetes Council in Texas that works in
collaboration with the Texas Department of Health. It is a
legislatively created entity. That is entity that is doing
interventions at the community level and at the practice level
to try to improve our ability to prevent diabetes and our
ability to improve the management of diabetes by physicians.
Those programs are tailored for the community. A program in
the Lower Rio Grande Valley, where 90 percent of the population
is Hispanic and a substantial percentage of the population
speaks Spanish, is going to look very different from a diabetes
community program based in Dallas, for example.
With regards to physical activity, the Texas Department of
Health is now a part of the Governor's Council on Physical
Fitness, and we are in the very initial stages of defining an
agenda with regard to physical fitness.
We also have a Cardiovascular Council that has created a
State plan that was only published May 2002. We can provide
that for this committee. That sets out a short-term and long-
term agenda to address cardiovascular disease in our State.
One thing that I will say is obesity is one of our
priorities because we feel that obesity prevention, if we were
to do it properly, we would be preventing cardiovascular
disease, diabetes, some forms of cancer, arthritis, and the
list literally goes on and on. Our sense is that we should try
to promote fitness, and in so doing we would address some of
these more disease-specific issues, not to say that they aren't
important, but at the Texas Department of Health we are trying
to take of an upstream primary prevention approach in
conjunction with already-existing secondary prevention
approaches.
I hope that answered your question.
Mr. Bilirakis. I thank the gentleman. Mr. Pickering?
Mr. Pickering. Mr. Chairman, I know our time is running
short, and I want to submit for the record to Dr. Jones some
questions for the record, to make sure that we get the full
benefit as a committee from the very important research that
you are doing at the University of Mississippi Medical Center
as it relates to these issues of heart, cardiovascular,
hypertension, stroke, and what that means for the Stroke Belt,
what it means for a State like Mississippi, and especially in
the African American community. We know that those findings can
be very important not only to Mississippi, but for the rest of
the country.
But I would like to ask you a couple of different things.
You stated in your testimony a very aggressive objective of
reducing stroke incidences by 25 percent by the year 2010.
Without the legislation that has passed the Senate unanimously,
has 175 co-sponsors in the House, introduced by Mrs. Capps and
myself here in the House, can you meet that objective? If you
do not have the resources that that legislation calls for, can
you meet that goal?
Mr. Jones. No, we can't. As I said in my statement, this
will take a partnership, and all of us need to work together.
You have unique resources that we need to raise awareness both
at the public level and at the professional level about stroke.
There has been a true revolution in the management of stroke in
the last few years, but we really must move forward to
implement that. We can stop the devastating effect of stroke in
individuals if they can receive modern treatment in an
appropriate time fashion, but we have a lot to do in public
awareness, in professional awareness, and in changing access to
health care to make that happen.
Mr. Pickering. Let me follow up. One of the key components
of meeting that objective as well is to have the physicians
that can treat stroke, In Mississippi we are in a state of
crisis as it relates to the availability and the number of
neurosurgeons. Now that has several components, but one of the
key causes to the flight of neurosurgeons from Mississippi and
the inability to recruit neurosurgeons to Mississippi is the
condition that we now face in the tort or medical malpractice
arena.
Another piece of legislation that is coming before this
subcommittee and before this committee and Congress in the
coming days will be an effort that I co-sponsored, that
Congressmen Cox and Greenwood and others have sponsored, that
would limit medical malpractice liability. We are seeing in
Mississippi 400 doctors leave our State. We are not being able
to recruit others. We have seen 14 medical malpractice insurers
go down to one insurance. We are seeing a quadrupling of
insurance premiums for our small rural hospitals.
Would you also support that effort, and how critical is
that to your overall effort to bring good health to Mississippi
and to make progress on heart and stroke disease?
Mr. Jones. Thank you for that question and for your
interest. The word ``crisis'' is overused sometimes, but this
is a true crisis. It is a crisis in several States now, 5, 6,
10, depending on how you define it, but it is a crisis that is
spreading across our country.
I would like to couch this in terms of what we are talking
about today for cardiovascular disease management and
particularly stroke management. Access to care is a critical
issue. You have heard testimony from several that we have new
treatments that are effective if they are implemented within 3
hours. In a rural state like Mississippi, like Texas, where
people have to go to receive that wonderful new treatment is
really important. As part of a comprehensive stroke team,
neurosurgeons are a vital part.
In Mississippi the Mississippi Neurosurgical Association
has on the public record said that 30 percent of the
neurosurgeons have left Mississippi. Now that is beginning with
a total of 38 neurosurgeons. That is a scarce resource in a
State that has the seventh highest stroke rate in the country.
There are parts of Mississippi now where on some evenings and
on some weekends, if you experience a problem where you need a
neurosurgeon, you may have to travel 200 or 300 miles to have
that. If you add up that 3 hours, it is a magic 3 hours for the
initiation of treatment of stroke.
Our patients are confused about what they should do, about
where they should go when they get to hospitals and they don't
have adequate coverage. It is a real crisis in health care.
Access to care is an important part of this issue of
improving the treatment of stroke, and I thank you for your
interest in that. I plead with you to bring some solution to
that. If you don't care enough about physicians, and physicians
are not always easy to love, care about our patients and
providing access to care for our patients.
Mr. Pickering. Mr. Chairman, let me just close real quick
with, in my earlier questions----
Mr. Bilirakis. We don't want to miss these votes.
Mr. Pickering. I know. In my earlier questions I did not
intend to set up any type of competition on research among the
various priorities that we have. I simply want to find
consensus on a very important issue that is important to my
State, and from a personal point of view, having both a
grandmother die of heart disease and a grandfather who passed
away after a series of strokes. This affects all of our
families.
We just want to get the resources and the priorities and
objectives to be able to give you the resources you need. Thank
you for coming here today.
Mr. Bilirakis. Hopefully, we can do that, and are doing
that, on a bipartisan basis. This increase of funding, doubling
the funding for NIH over 5 years, we make an awful lot of
promises from up here, and many of them we just can't fulfill,
but that is one we did, and we are very proud of it.
The hearing now is terminated. I very much appreciate your
being here. We have learned a lot from you. I know if we had
more time, we would probably learn even more from you, but
there will be a series of questions. We would like to hear from
you. We would like to hear from you on this, particularly the
one that I had asked. Again, anything, even if it hasn't been a
question that has been asked, if you feel that you have
anything to offer that might be helpful in these regards,
please feel free to submit that information to the committee.
Thank you very much.
[Whereupon, at 12:59 p.m., the subcommittee was adjourned.]