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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

Printed for the use of the Committee on Energy and Commerce

(

Available via the World Wide Web: http://www.access.gpo.gov/congress/house

COMMITTEE ON ENERGY AND COMMERCE

W.J. ‘‘BILLY’’ TAUZIN, Louisiana, Chairman

MICHAEL BILIRAKIS, Florida

JOE BARTON, Texas

FRED UPTON, Michigan

CLIFF STEARNS, Florida

PAUL E. GILLMOR, Ohio

JAMES C. GREENWOOD, Pennsylvania

CHRISTOPHER COX, California

NATHAN DEAL, Georgia

RICHARD BURR, North Carolina

ED WHITFIELD, Kentucky

GREG GANSKE, Iowa

CHARLIE NORWOOD, Georgia

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES ‘‘CHIP’’ PICKERING, Mississippi

VITO FOSSELLA, New York

ROY BLUNT, Missouri

TOM DAVIS, Virginia

ED BRYANT, Tennessee

ROBERT L. EHRLICH, Jr., Maryland

STEVE BUYER, Indiana

GEORGE RADANOVICH, California

CHARLES F. BASS, New Hampshire

JOSEPH R. PITTS, Pennsylvania

MARY BONO, California

GREG WALDEN, Oregon

LEE TERRY, Nebraska

ERNIE FLETCHER, Kentucky

JOHN D. DINGELL, Michigan

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RALPH M. HALL, Texas

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, Jr., New Jersey

SHERROD BROWN, Ohio

BART GORDON, Tennessee

PETER DEUTSCH, Florida

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

TOM SAWYER, Ohio

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

KAREN MCCARTHY, Missouri

TED STRICKLAND, Ohio

DIANA DEGETTE, Colorado

THOMAS M. BARRETT, Wisconsin

BILL LUTHER, Minnesota

LOIS CAPPS, California

MICHAEL F. DOYLE, Pennsylvania

CHRISTOPHER JOHN, Louisiana

JANE HARMAN, California

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

FRED UPTON, Michigan

JAMES C. GREENWOOD, Pennsylvania

NATHAN DEAL, Georgia

RICHARD BURR, North Carolina

ED WHITFIELD, Kentucky

GREG GANSKE, Iowa

CHARLIE NORWOOD, Georgia

Vice Chairman

BARBARA CUBIN, Wyoming

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES ‘‘CHIP’’ PICKERING, Mississippi

ED BRYANT, Tennessee

ROBERT L. EHRLICH, Jr., Maryland

STEVE BUYER, Indiana

JOSEPH R. PITTS, Pennsylvania

W.J. ‘‘BILLY’’ TAUZIN, Louisiana

(Ex Officio)

SHERROD BROWN, Ohio

HENRY A. WAXMAN, California

TED STRICKLAND, Ohio

THOMAS M. BARRETT, Wisconsin

LOIS CAPPS, California

RALPH M. HALL, Texas

EDOLPHUS TOWNS, New York

FRANK PALLONE, Jr., New Jersey

PETER DEUTSCH, Florida

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

JOHN D. DINGELL, Michigan,

(Ex Officio)

(II)

2

C O N T E N T S

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)

(1)

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

2

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

3

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

4

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

5

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;

6

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

7

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

8

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 atVerDate 11-MAY-2000 11:29 Oct 03, 2002 Jkt 000000 PO 00000 Frm 00012 Fmt 6633 Sfmt 6621 80676.TXT HCOM1 PsN: HCOM1
9

tributed 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 cellbased 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 endstage 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.

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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.

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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.

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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.

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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:]

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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 costeffective 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

15

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 atrisk 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

16

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

17

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 techVerDate 11-MAY-2000 11:29 Oct 03, 2002 Jkt 000000 PO 00000 Frm 00021 Fmt 6633 Sfmt 6621 80676.TXT HCOM1 PsN: HCOM1
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nologies 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 FiveYear 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.

19

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-sponVerDate 11-MAY-2000 11:29 Oct 03, 2002 Jkt 000000 PO 00000 Frm 00023 Fmt 6633 Sfmt 6621 80676.TXT HCOM1 PsN: HCOM1
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sored 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

21

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

22

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

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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.

24

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.

25

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

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cent, 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.

27

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.

28

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 cerVerDate 11-MAY-2000 11:29 Oct 03, 2002 Jkt 000000 PO 00000 Frm 00032 Fmt 6633 Sfmt 6602 80676.TXT HCOM1 PsN: HCOM1
29

tainly 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?

30

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——

31

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

32

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.

33

[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.

34

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.

35

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 probVerDate 11-MAY-2000 11:29 Oct 03, 2002 Jkt 000000 PO 00000 Frm 00039 Fmt 6633 Sfmt 6602 80676.TXT HCOM1 PsN: HCOM1
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ably 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

37

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——

38

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

39

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. EdVerDate 11-MAY-2000 11:29 Oct 03, 2002 Jkt 000000 PO 00000 Frm 00043 Fmt 6633 Sfmt 6602 80676.TXT HCOM1 PsN: HCOM1
40

ward 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

41

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 investigatorinitiated 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.

42

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.

43

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.

44

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.

45

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.

46

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.

47

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

48

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’ con- certed 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

49

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, longVerDate 11-MAY-2000 11:29 Oct 03, 2002 Jkt 000000 PO 00000 Frm 00053 Fmt 6633 Sfmt 6602 80676.TXT HCOM1 PsN: HCOM1
50

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:]

51

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.

52

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 longterm 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?

53

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

54

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

55

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.

56

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

57

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.

State

Number of

Stroke

Deaths*

(1999)

Rank**

(Highest to

Lowest)

Rate***

(Deaths per

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

58

State

Number of

Stroke

Deaths*

(1999)

Rank**

(Highest to

Lowest)

Rate***

(Deaths per

100,000)

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 stand- ards.

**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 posttests) 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.

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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 strokeinfo@heart.org)

• 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 reopenVerDate 11-MAY-2000 11:29 Oct 03, 2002 Jkt 000000 PO 00000 Frm 00063 Fmt 6633 Sfmt 6621 80676.TXT HCOM1 PsN: HCOM1
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ing 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.

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ical 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.

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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,

63

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

64

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.

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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

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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.

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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.]