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THE HEART DISEASE EDUCATION,

ANALYSIS RESEARCH, AND

TREATMENT FOR WOMEN ACT

HEARING

BEFORE THE

SUBCOMMITTEE ON HEALTH

OF THE

COMMITTEE ON ENERGY AND

COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDRED TENTH CONGRESS

FIRST SESSION

ON

H.R. 1014

MAY 1, 2007

Serial No. 110–37

(

Printed for the use of the Committee on Energy and Commerce

energycommerce.house.gov

COMMITTEE ON ENERGY AND COMMERCE

JOHN D. DINGELL, Michigan, Chairman

HENRY A. WAXMAN, California

EDWARD J. MARKEY, Massachusetts

RICK BOUCHER, Virginia

EDOLPHUS TOWNS, New York

FRANK PALLONE, JR., New Jersey

BART GORDON, Tennessee

BOBBY L. RUSH, Illinois

ANNA G. ESHOO, California

BART STUPAK, Michigan

ELIOT L. ENGEL, New York

ALBERT R. WYNN, Maryland

GENE GREEN, Texas

DIANA DEGETTE, Colorado

Vice Chairman

LOIS CAPPS, California

MIKE DOYLE, Pennsylvania

JANE HARMAN, California

TOM ALLEN, Maine

JAN SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

CHARLES A. GONZALEZ, Texas

JAY INSLEE, Washington

TAMMY BALDWIN, Wisconsin

MIKE ROSS, Arkansas

DARLENE HOOLEY, Oregon

ANTHONY D. WEINER, New York

JIM MATHESON, Utah

G.K. BUTTERFIELD, North Carolina

CHARLIE MELANCON, Louisiana

JOHN BARROW, Georgia

BARON P. HILL, Indiana

JOE BARTON, Texas

Ranking Member

RALPH M. HALL, Texas

J. DENNIS HASTERT, Illinois

FRED UPTON, Michigan

CLIFF STEARNS, Florida

NATHAN DEAL, Georgia

ED WHITFIELD, Kentucky

BARBARA CUBIN, Wyoming

JOHN SHIMKUS, Illinois

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

VITO FOSSELLA, New York

STEVE BUYER, Indiana

GEORGE RADANOVICH, California

JOSEPH R. PITTS, Pennsylvania

MARY BONO, California

GREG WALDEN, Oregon

LEE TERRY, Nebraska

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

SUE WILKINS MYRICK, North Carolina

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff

GREGG A. ROTHSCHILD, Chief Counsel

SHARON E. DAVIS, Chief Clerk

BUD ALBRIGHT, Minority Staff Director

(II)

(III)

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman

HENRY A. WAXMAN, California

EDOLPHUS TOWNS, New York

BART GORDON, Tennessee

ANNA G. ESHOO, California

GENE GREEN, Texas

Vice Chairman

DIANA DEGETTE, Colorado

LOIS CAPPS, California

TOM ALLEN, Maine

TAMMY BALDWIN, Wisconsin

ELIOT L. ENGEL, New York

JAN SCHAKOWSKY, Illinois

HILDA L. SOLIS, California

MIKE ROSS, Arkansas

DARLENE HOOLEY, Oregon

ANTHONY D. WEINER, New York

JIM MATHESON, Utah

JOHN D. DINGELL, Michigan (ex officio)

NATHAN DEAL, Georgia,

Ranking Member

RALPH M. HALL, Texas

BARBARA CUBIN, Wyoming

HEATHER WILSON, New Mexico

JOHN B. SHADEGG, Arizona

STEVE BUYER, Indiana

JOSEPH R. PITTS, Pennsylvania

MIKE FERGUSON, New Jersey

MIKE ROGERS, Michigan

SUE WILKINS MYRICK, North Carolina

JOHN SULLIVAN, Oklahoma

TIM MURPHY, Pennsylvania

MICHAEL C. BURGESS, Texas

MARSHA BLACKBURN, Tennessee

JOE BARTON, Texas (ex officio)

(V)

C O N T E N T S

Page

Hon. Frank Pallone, Jr., a Representative in Congress from the State of

New Jersey, opening statement .......................................................................... 1

Hon. Nathan Deal, a Representative in Congress from the State of Georgia,

opening statement ................................................................................................ 2

Hon. Lois Capps, a Representative in Congress from the State of California,

opening statement ................................................................................................ 3

Hon. Michael C. Burgess, a Representative in Congress from the State of

Texas, opening statement .................................................................................... 4

Hon. Anna G. Eshoo, a Representative in Congress from the State of California, prepared statement ...................................................................................... 5

Hon. Joe Barton, a Representative in Congress from the State of Texas,

prepared statement .............................................................................................. 5

Hon. Barbara Cubin, a Representative in Congress from the State of Wyoming, prepared statement ................................................................................... 6

Hon. Marsha Blackburn, a Representative in Congress from the State of

Tennessee, prepared statement .......................................................................... 6

Hon. Edolphus Towns, a Representative in Congress from the State of New

York, prepared statement .................................................................................... 8

H.R. 1014 to amend the Federal Food, Drug, and Cosmetic Act and the

Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. . 11

WITNESSES

Susan K. Bennett, M.D., clinical director, Women’s Heart Program, the

George Washington University Hospital, Washington, DC .............................. 23

Prepared statement .......................................................................................... 26

Janet Wolf, Santa Barbara County supervisor, Santa Barbara, CA ................... 32

Prepared statement .......................................................................................... 34

(1)

H.R. 1014, THE HEART DISEASE EDUCATION,

ANALYSIS RESEARCH, AND TREATMENT

FOR WOMEN ACT

TUESDAY, MAY 1, 2007

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON HEALTH,

COMMITTEE ON ENERGY AND COMMERCE,

Washington, DC.

The subcommittee met, pursuant to call, at 10:08 a.m., in room

2123 of the Rayburn House Office Building, Hon. Frank Pallone

(chairman) presiding.

Members present: Representatives Capps, Schakowsky, Solis,

Hooley, Deal, Murphy, Burgess, Barton, and Blackburn.

Staff present: William Garner, Bobby Clark, John Ford, Jesse Levine, Melissa Sidman, Carrie Annand, Lauren Bloomberg, Lyn

Walker, Chad Grant, Ryan Long, and Katherine Martin.

OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE IN CONGRESS FROM THE STATE OF NEW JERSEY

Mr. PALLONE. Today we have a hearing on H.R. 1014, the Heart

Disease Education, Analysis Research, and Treatment for Women

Act. I recognize myself initially for an opening statement.

I first of all should thank the sponsor of the bill, the gentlewoman from California, Lois Capps. She has been a leader on so

many healthcare issues. I often think of the nursing aspect because

you talk to me about it so often but also on women’s issues in general. It is no surprise that she has introduced this bill that is the

subject of our hearing today. It is about coronary heart disease

which occurs of course when the arteries that supply blood to the

heart muscle become hardened and narrowed due to a buildup of

plaque on the arteries in the walls. As plaque continues to build

up in the arteries, blood flow to the heart is reduced, which can

lead to a heart attack. There is a common misperception that exists

today that heart disease is a man’s disease, but this simply is not

true. In reality, heart disease has a deadly impact on both men and

women. In fact, I think most people would be surprised to learn

that heart disease is the No. 1 killer of women in the United States

followed by cancer and stroke. One in four American women die

from heart disease each year, while one in 30 by contrast dies of

breast cancer.

There are a number of risk factors that might lead a person to

develop heart disease including cigarette smoking, high blood presVerDate 11-SEP-98 09:56 Feb 29, 2008 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 Q:\DOCS\110-37 SCOM1 PsN: SCOM1
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sure, high blood cholesterol, overweight, physical inactivity, and diabetes. Research shows that more than 95 percent of those who die

from heart disease have at least one of these major risk factors.

But many of the risk factors are within our control. We have the

ability to decrease our chance of developing heart disease through

diet, exercise, and medication therapy.

Education is obviously the key. Knowing what the risk factors

are and how to change them is crucial to decreasing your chance

of suffering from heart disease, and that is why this bill is so important. Under Mrs. Capps’ legislation, a new program would be

authorized to educate health care professionals and older women

about unique aspects of care in the prevention, diagnosis, and

treatment of women with heart disease. But these risk factors don’t

tell the whole story. The interaction between age and sex also plays

a significant role in developing heart disease. Starting around age

50, women are at increased risk of developing heart disease. For

those women, ensuring access to screening services is vital to survival. Without a way to receive an appropriate screening test,

many women who suffer from heart disease will go undetected and

be unable to receive proper treatment. Needless to say, those who

are uninsured are disproportionately impacted by heart disease because of their inability to access screening services and follow-up

treatment. And even when there are no barriers to accessing care,

determining the most appropriate treatment is crucial.

The final component of Mrs. Capps’ bill deals with treatment

service and encourages better research into the most effective

treatments for women who suffer from heart disease. Although coronary heart disease causes more than 250,000 deaths in women

each year, much of the research and clinical trials in the last 20

years on CHD has either excluded women entirely or included only

limited numbers of women. That is incredible to me that those are

the facts.

This bill would change that by improving the availability of gender-specific information on drugs and devices designed to treat

heart disease and the risk factors that lead to it.

Again, I want to thank Mrs. Capps for all her efforts in this area

and for leading the charge in so many women’s health issues. As

a husband and father of two girls, I know how important it is that

we tackle this issue. I want to thank you, Lois, really for all that

you do.

I would now recognize our ranking member, Mr. Deal.

OPENING STATEMENT OF HON. NATHAN DEAL, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF GEORGIA

Mr. DEAL. Thank you, Mr. Chairman. I got him beat. As the husband and father of three girls, I am certainly interested in hearing

what we have to say today about educating women about the dangers of heart disease and cardiovascular disease and learning about

the risks it imposes.

Many women, of course, consider the cancers, breast cancer in

particular, as being the primary focus and say, ‘‘well, heart disease

is a problem relegated to men’’ but as it has been pointed out, it

is the leading cause of deaths among women. And in fact, while

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nearly 450,000 died of coronary heart disease in 2004, nearly

220,000 of those were in fact women.

Another portion of the bill that we will be looking at is the provisions that take steps to ensure that drug, device, and biological

product applications submitted to the FDA include safety and efficacy data broken down by sex, race, and ethnicity. This information

certainly has a useful role to play as doctors and patients determine the best course of treatment, and I support providing the

FDA with these statistics. However, I think the committee should

look very closely at the legislation to ensure that those provisions

do not prevent or delay needed medications from reaching patients,

and I am glad and we are given the opportunity today to evaluate

those portions of the bill as well.

I look forward to the testimony of the witnesses and thank them

for being here today and hope that as we address the issue of heart

disease among women and the role of the FDA in this effort that

we will have the opportunity to have other testimony from people

such as you, and we thank you for your presence today.

Thank you, Mr. Chairman.

Mr. PALLONE. Thank you, Mr. Deal. And now I recognize the

sponsor, the gentlewoman from California.

OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA

Mrs. CAPPS. Thank you, Chairman Pallone. I appreciate very

much that you are holding this hearing today. I think it is appropriate timing that we are having this hearing just before Mother’s

Day. What greater gift could this Congress give to mothers and

daughters this holiday than the tools to combat the No. 1 health

crisis for women in the United States? I am so proud to have introduced H.R. 1014 in the House with Congresswoman Barbara Cubin

and to work with our colleagues in the Senate, Senators Stabenow

and Murkowski on companion legislation that they have introduced.

Unfortunately, Congresswoman Cubin has been detained in Casper, Wyoming, due to a family health situation; but I want to

thank her and her staff for her commitment to this bill. As many

of our colleagues know, Congresswoman Cubin is a heart disease

survivor herself, and I am happy to share that this legislation is

on the Women’s Caucus priority list for the 110th Congress boasting the co-sponsorship of over 50 women members in the House

and all 16 women Senators. We felt it was necessary to introduce

this legislation because of the substantial knowledge gaps that

exist in diagnosing and treating heart disease in women.

Heart disease kills more women than the next five causes of

death combined. Most Americans don’t know this, and unfortunately, many health professionals don’t know this either. Though

awareness has been increasing, we simply must do more to improve our Nation’s ability to fight heart disease. H.R. 1014 would

accomplish this in three main ways: one, by initiating awareness

campaigns about cardiovascular disease for women and also health

professionals; second, requiring that healthcare data be reported to

the Federal Government and that it be stratified by gender, race,

and ethnicity; and third, expanding the CDC’s WISEWOMAN proVerDate 11-SEP-98 09:56 Feb 29, 2008 Jkt 000000 PO 00000 Frm 00008 Fmt 6633 Sfmt 6633 Q:\DOCS\110-37 SCOM1 PsN: SCOM1
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gram which provides screenings to low-income women from 14

States currently to all 50 States.

Today I am so happy to welcome two terrific witnesses to testify

on this subject. County Supervisor, Janet Wolf, from my district in

Santa Barbara, will discuss her own experiences stemming from a

heart attack at age 50. Supervisor Wolf has been a leader on a

number of important health issues in my district, and I am very

proud to have her here today. Dr. Sue Bennett, whose full credentials are way too long to list, is a cardiologist and a spokeswoman

for the American Heart Association. She has dedicated herself to

improving the treatment of heart disease in women and was instrumental in the writing of this legislation.

As the subcommittee will hear from these two witnesses, too

many women are unaware of the symptoms of heart disease as

they manifest themselves differently in women than in men. And

when women present these symptoms to a health professional, they

too often go unrecognized.

I am very excited to discuss this issue further with our colleagues today, and I am sure that we are going to learn valuable

information that I hope we will all share with the women in our

lives. Thank you.

Mr. Chairman, I yield back.

Mr. PALLONE. Thank you. Dr. Burgess.

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS

Mr. BURGESS. Thank you, Mr. Chairman, and I will be pretty

brief this morning. These are both very worthwhile bills. I think

our witness from the American Heart Association sums it up best

with the phrase an alarming lack of awareness in her testimony,

and if there was one constructive criticism I might make to you to

this bill dealing with heart disease is making section VI a more robust section as far as getting the information out to healthcare providers because the awareness seems to come in ways that are not

direct pipelines from the NIH; and that has been one of my disappointments up here is learning about all the good things that go

on at the NIH and realize that for 25 years in clinical practice I

was barely aware of the NIH’s existence and I don’t think that was

just inattentiveness on my part. I think it is more widespread than

that.

And the other reason this bill is worthy of support is Texas is

not one of the States that is colored in, and that is a shame; and

we ought to expand the program to at least include Texas, and if

some other States are looped in as a byproduct of that, then I guess

that is ultimately a good thing.

H.R. 20 which I have co-sponsored with subcommittee Chairman

Rush for the last two Congresses is also a good bill. I would make

the same comments about that as far as disseminating the information. The legislative language is good and it is sound, but the

research doesn’t deliver on the promise if we don’t get the information and the tools into the hands of the clinicians; and largely that

is the primary care physician, the family practice doctor, the pediatrician, and the OB/GYN who are going to be on the front lines of

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making the diagnosis and at least initiating the cascade of treatment.

Thank you, Mr. Chairman, for bringing these two bills up. I look

forward to some lively interchange today, and I will yield back.

Mr. PALLONE. Thank you, Doctor, and I believe that concludes

our opening statements. Any other statements will be accepted for

the record at this time as well as the text of H.R. 1014.

[The prepared statements of Members and H.R. 1014 follows:]

PREPARED STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF CALIFORNIA

Mr. Chairman, thank you for holding this important hearing on H.R. 1014, the

HEART for Women Act.

Heart disease, stroke, and other cardiovascular diseases are the leading cause of

death among women. Despite being the No. 1 killer, only 13 percent of women are

aware that cardiovascular diseases are their greatest health risk. Cardiovascular

diseases disproportionately affect minority women, and statistics show that unfortunately, these populations are less likely to know of their risk.

During 2004 in California, nearly 128 women died every day from cardiovascular

diseases, making them the No. 1 killer of women in the State. Stroke accounted for

10,049 female deaths in California that same year, ranking as the No. 3 cause of

female deaths in the State.

Heart disease, stroke and other cardiovascular diseases are preventable and treatable when women are aware of their risk factors and are appropriately screened by

health care professionals.

Under H.R. 1014, the highly successful WISEWOMAN heart disease and stroke

prevention screening program would be expanded from 14 States to all 50. This

CDC-funded programs helps women with little or no health insurance gain access

to screening and lifestyle interventions that can reduce their risk for heart disease,

stroke, and other chronic diseases.

The bill also authorizes grants to educate healthcare professionals about the prevalence and unique aspects of care for women in the prevention and treatment of cardiovascular diseases. It also authorizes Medicare to conduct an educational awareness campaign for older women about the risks of heart disease and stroke.

H.R. 1014 has been endorsed by has been endorsed by the American Heart Association/American Stroke Association, the American College of Cardiology, and the

American College of Obstetricians and Gynecologists (ACOG).

I’m proud to be a cosponsor of the bill, and want to thank Rep. Lois Capps for

sponsoring this very important legislation which will go a long way toward preventing unnecessary illness and death.

I look forward to hearing from our witnesses today and I urge my colleagues to

support this bill.

PREPARED STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN CONGRESS FROM

THE STATE OF TEXAS

Mr. Chairman, thank you for holding this hearing on H.R.1014, the Heart Disease

Education, Analysis Research, and Treatment for Women Act. Often times we move

forward on legislation that is well-intended but fails to fully examine the policy

ramifications of the substance of the legislation. I hope that today’s hearing will provide us with a better understanding of the goals of H.R. 1014 and what effects the

legislative text will have on the programs at the Centers for Disease Control and

the Food and Drug Administration.

The legislation has several notable goals including raising awareness among

women and their health care providers regarding the prevention and treatment of

cardiovascular diseases, calling for gender and race-specific information for clinicians and researchers, and improving screening for low-income women at risk for

heart disease and stroke. Additionally, the legislation would authorize the expansion

of the Centers for Disease Control’s WISEWOMAN program.

As several of you know, I recently suffered a heart attack and thanks to a wonderful team of medical personnel and the research that has gone into heart disease,

I have made a full recovery. I undoubtedly understand the need for research and

treatment of heart disease.

However, some of the provisions of the bill relating to the Food and Drug Administration may be well intentioned, but may not provide a significant public health

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benefit. As I understand much of the information required to be reported under the

bill for New Drug applications is already being given to the agency. Additionally,

the provisions related to Abbreviated New Drug Applications and Investigational

New Drugs would not improve the safety of these products but could needlessly

delay the approval of generic drugs and disrupt the development of clinical trials

for investigational drugs.

Thank you again Mr. Chairman for holding this hearing. I hope we can work together to examine the ways in which we can improve the legislation before us today.

PREPARED STATEMENT OF HON. BARBARA CUBIN, A REPRESENTATIVE IN CONGRESS

FROM THE STATE OF WYOMING

Heart disease, stroke and other cardiovascular diseases are the leading causes of

death in Wyoming. Nationwide, these diseases claim the lives of over 480,000 American women annually. To give perspective to that number, it amounts to the death

of one American woman every minute. Though long perceived as a ‘‘man’s disease,’’

more women than men die from heart disease annually. The lives of American

women may depend on correcting that faulty perception.

That is why I joined Representative Lois Capps in introducing H.R. 1014, the bipartisan, bicameral Heart Disease Education, Analysis, Research, and Treatment

for Women Act, or HEART for Women Act. Representative Capps has demonstrated

tremendous commitment and leadership on this issue. I am proud to partner with

her on H.R. 1014, not just as a colleague and friend, but as a heart attack survivor

myself.

Unfortunately, there is a startling lack of understanding about the threat of heart

disease among women. A recent survey conducted by the American Heart Association found that only 21 percent of women believed heart disease to be the greatest

threat to their health. Many women are also unaware of heart disease risk factors

and symptoms, which tend to be more subtle than those manifested in men.

Even worse, the same survey revealed that less than 10 percent of primary care

physicians recognize that heart disease kills more women than men each year, a

fact that has been established since 1984. If doctors fail to realize women are at

risk, they are less likely to refer them for the necessary screening and treatment.

Even after a diagnosis, treatment options may not be as effective for women as men.

Women are also less likely than men to receive certain diagnostic testing and treatment, such as angioplasties and stents.

H.R. 1014 takes a three-prong approach to reducing the death rate in women from

cardiovascular disease. The legislation will raise awareness about cardiovascular

disease among both women and the healthcare providers they rely on. It accomplishes this through grants for provider education regarding the prevalence and

unique aspects of care for women in the prevention and treatment of cardiovascular

diseases. It also authorizes the Medicare program to conduct an educational awareness campaign for older women about their risk for cardiovascular disease.

To improve the quality of healthcare data already being collected by the federal

government, H.R. 1014 requires stratification by sex, race and ethnicity. This includes pharmaceutical and medical device approval data, medical errors data, hospital quality data, and quality improvement data. This information will assist clinicians and researchers as they seek to determine best practices relating to screening,

diagnosis, and treatment for women with cardiovascular disease.

Finally, the legislation authorizes the expansion to all 50 States of the

WISEWOMAN program administered by the Centers for Disease Control and Prevention. The program provides heart disease and stroke prevention screening, such

as tests for high blood pressure and high cholesterol, to low-income uninsured and

underinsured women. Fourteen states currently benefit from the program. My home

state of Wyoming is not one of them. Expanding WISEWOMEN nationwide would

give women in Wyoming the number one tool in fighting any disease—early detection.

I am very grateful that our panelists have joined us today to share their own personal experiences with cardiovascular disease. I am hopeful their testimony will

help this committee realize the gravity of this issue and the need to take up and

pass the HEART for Women Act for the health of our Nation’s women.

PREPARED STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN

CONGRESS FROM THE STATE OF TENNESSEE

I would like to thank the chairman for holding this hearing today and welcome

our witnesses. Heart disease is ranked as the No. 1 killer of women in the United

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States and the No. 3 killer of women in my home State of Tennessee. Heart disease

and stroke accounted for nearly 36 percent of all female deaths in Tennessee in

2003. Further, heart disease alone is the leading cause of death in Tennessee, accounting for 8,052 female deaths in 2003.

As we all know, Congress determines funding for the National Heart, Lung, and

Blood Institute for medical research on heart disease, as well as funding for heart

disease prevention and education programs. Last year, Congress provided almost $3

billion to the National Heart, Lung, and Blood Institute and almost $45 million for

cardiovascular prevention and health promotion. Other federal laws and regulations

promote cardiovascular health by discouraging smoking, promoting physical exercise

and nutrition education, and establish food labeling requirements.

As a cosponsor of H.R. 1014, I appreciate the intent of the HEART for Women

Act to increase the focus on cardiovascular disease in women. I would hope that this

legislation will further enhance our knowledge and research, and not be duplicative

of existing programs. I also hope that personal responsibility and maintenance will

play a role in reducing the number of cardiovascular-related deaths. It is imperative

that a balance exist between the bureaucratic role and personal responsibility when

addressing this very serious health issue.

I look forward to hearing testimony from today’s witnesses. Thank you Mr. Chairman and I yield back the balance of my time.

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Mr. PALLONE. I will turn to our two witnesses. First of all, thank

you for being here today, and let me introduce first, Dr. Susan Bennett who is clinical director of the Women’s Heart Program at

George Washington University Hospital, and next to her is Ms.

Janet Wolf who is the second district supervisor for the county of

Santa Barbara in Santa Barbara, CA. Thank you both for being

here today.

We have 5-minute opening statements. They become part of the

hearing record, but each of you may, in the discretion of the committee, submit additional brief or statements in writing for including in the record. And I will start now by recognizing Dr. Bennett.

Thank you again.

STATEMENT OF SUSAN K. BENNETT, M.D., CLINICAL DIRECTOR, WOMEN’S HEART PROGRAM, THE GEORGE WASHINGTON UNIVERSITY HOSPITAL, WASHINGTON, DC

Dr. BENNETT. Well, thank you, Congressman Pallone. It is a

pleasure to be here, and Representative Capps, thank you for sponsoring this bill.

My name is Susan Bennett, and I am a practicing cardiologist;

and I think first and foremost, I am one of the doctors in the

trenches. I see patients 5 days a week, and I see men and women.

About 70 percent of my practice is women, and that is primarily

what I do. I am a clinical assistant professor of medicine and director of the Women’s Heart Program at George Washington University Medical Center. I am also a volunteer and national spokeswoman for the American Heart Association and president of the

Association of Women’s Heart Programs and I also serve on the Advisory Board of Women Heart which is the national coalition for

women with heat disease.

On behalf of the American Heart Association, or AHA, and its

more than 22 million volunteers and supporters, I appreciate the

opportunity to testify today on H.R. 1014 known as the HEART for

Women Act. We wish to thank this House Committee on Energy

and Commerce, Subcommittee on Health, for holding today’s hearing on this Act which we strongly support along with many other

non-profit health organizations.

Heart disease, stroke, and other forms of cardiovascular diseases

are the No. 1 killer of American women, claiming more than

460,000 lives each year or about a death a minute. That is more

female lives than the next five causes of death combined, including

deaths from lung and breast cancer. An estimated 42 million

women, about one in three, are living with the chronic affects of

heart disease, stroke, or some other form of cardiovascular disease.

In 1984, women achieved equality and then surpassed men in

one area where they don’t want it, heart disease mortality. Every

year since then, more women than men have died of cardiovascular

disease, or CVD. During that time we have made good progress in

reducing CVD mortality for men but the same cannot be said for

women. Although mortality rates have gone down for women, the

decline is not nearly as steep as it is for men.

The HEART for Women Act is intended to help close that gap by

focusing on three strategies to improve diagnosis, treatment, and

prevention of heart disease and stroke in women. Part of the probVerDate 11-SEP-98 09:56 Feb 29, 2008 Jkt 000000 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 Q:\DOCS\110-37 SCOM1 PsN: SCOM1
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lem is that there is not enough women nor their physicians who

recognize heart disease as a serious health threat that it truly is.

Efforts like the AHA’s Go Red for Women movement and the

NHLDI’s Heart Truth campaign have helped to increase awareness

among women about their risk of heart disease, but much more

work remains.

The latest American Heart Association survey tracking women’s

awareness of heart disease found that 43 percent of women are still

not aware that heart disease is the leading cause of death for

women. Women of color are even significantly less likely to know

this important fact despite being at greater risk for cardiovascular

disease.

Even more alarming especially to me is the pervasive lack of

awareness about women and heart disease among physicians. According to an American Heart Association sponsored survey published in 2005, fewer than one in five physicians surveyed recognized that more women than men die of heart disease than other

cardiovascular disease each year. Astoundingly, only 8 percent of

primary care physicians knew this basic fact.

Healthcare professionals treat what they perceive to be a problem; and partially as a result of the above statistics, we see that

women are often treated less aggressively. For instance, women are

more likely to die within a year of their first heart attack, but are

less likely to be referred for diagnostic testing ahead of time that

could have caught the disease early in the preventive phase. And

according to the Agency for Health Care Research and Quality’s

2006 National Healthcare Disparities Report, female Medicare patients who suffer from a heart attack are less likely to receive the

recommended care compared to their male counterparts.

The Heart for Women Act would help to increase awareness

among populations for which there are still gaps, particularly older

women and healthcare professionals. For healthcare professionals,

the bill authorizes the Health Resources and Services Administration to conduct an education campaign to increase professionals’

understanding about the prevalence and unique aspects of care for

women in the prevention and treatment of forms of CVD.

The bill also authorizes the Secretary of Health and Human

Services to develop and distribute educational materials to women

65 years and older to educate them about a woman’s risk for heart

attacks and strokes, risk factors, and symptoms.

Another problem that I struggle with every day in my practice

is the lack of information available to us about the safety and efficacy of heart and stroke treatments for women. When a new therapy comes on the market, one of the first things I want to know

is how does it work in women compared to men, and all too often

that information is simply not available.

For far too long we have simply assumed that if a new drug or

medical device works for a man, then it must work for a woman.

Thanks to reports such as the National Institute of Medicine’s

landmark 2001 report, Does Sex Matter?, we know that sex really

does make a difference from womb to tomb. Researchers are learning that sex differences play an increasingly important role in prevention, diagnosis, and treatment. For instance, we have learned

from the National Heart, Lung, and Blood Institute funded WISE

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study that coronary artery disease may manifest itself differently

in women than in men which suggest that treatment testing regimens that work in men may not work as well in women.

Diagnostic tests, prescription drugs, and medical devices may

work differently in women than men. These differences are likely

due to a variety of reasons. The presence of the excess chromosome

which is in all cells may change the pharmacology of the drug and

cells certainly change——

Mr. PALLONE. Dr. Bennett, I would just ask you to summarize

because we are over by about 30 seconds.

Dr. BENNETT. There are several drugs that I can talk to you

about in regard to differences and their response to women, and

certainly the WISEWOMAN program needs to be expanded to all

50 States, and I can talk to you later if you need to know any information about the effectiveness.

So in summary, for me as a practicing clinician, it is absolutely

important for this Act to be passed so I can take care of women

better. Thank you.

[The prepared statement of Dr. Bennett follows:]

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Mr. PALLONE. Thank you, Doctor. Ms. Wolf.

STATEMENT OF JANET WOLF, SANTA BARBARA COUNTY

SUPERVISOR, SANTA BARBARA, CA

Ms. WOLF. Thank you very much, Mr. Chairman, and members

of the committee. I want to thank you for holding this hearing and

in particular I want to thank my beloved Congresswoman, Lois

Capps who is highly respected in our district, and it is truly an

honor to be here and to be asked to come here and to tell my story.

I am not a physician, so the story I have to tell you is about my

personal experience, and I also just want to point out that my husband is here with me. I have three daughters as well. This has

been an incredible experience for me and my entire family and

friends and relatives, and so it is an honor to be able to tell you

my story as well in the hope that it will help and educate other

women and husbands.

On December 7, 2004, I suffered a massive heart attack. I had

a 100 percent occluded left anterior descending artery. I was 50

years old and considered myself to be very healthy and incredibly

blessed. I had a wonderful family and great friends. I ran a successful business. I had just finished serving 11 years as a school

board member. I played on a roller hockey team, and I exercised

fairly regularly at the gym. I am 5’4′′ and at the time of my heart

attack I weighed 155 pounds. I was told that I carried it very well.

I had annual medical exams which included EKG’s, blood work,

mammograms, and I even had a colonoscopy. I felt that I had covered all of my bases.

My experience began on a Friday evening when after going out

to dinner with friends, I experienced extremely painful heartburn

which felt as if a hole was burning in my esophagus. When I returned home, I took over-the-counter heartburn medication. As the

weekend progressed, the heartburn sensation continued intermittently.

By Monday morning, the pain was worse and I noticed that it became more intense after slight exertion. I became concerned that

it was more than just heartburn and that it might be cardiac related. I called my internist and I told him that I thought I was either

having a heart attack or a very bad case of heartburn. He listened

to my symptoms and prescribed medication over the phone for

heartburn. I rushed to the pharmacy to get the prescription filled

and took the first pill before leaving the pharmacy.

I went to bed that evening and woke up at 2:00 in the morning

with what I thought was continued horrible heartburn. Because I

couldn’t get back to sleep, I went on the Internet to find out what

I could do to ease my discomfort. By 4:00 in the morning, the pain

was even more severe and I went back to the Internet. This time

I went to WebMD and I compared the symptoms of heartburn with

a heart attack. At that time it didn’t appear that I had any of the

symptoms of a heart attack. And then at 5 o’clock I started to feel

clammy, a feeling that was described as a heart attack symptom.

I decided to wake up my husband. He soon realized as my pain was

getting worse and I was hanging over our kitchen counter that we

should go to the hospital.

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When we arrived at the ER and after what seemed like eternity,

which actually was about 15 minutes, I had an EKG and was immediately told I was having angina.

After having a chest X-ray and finding out that I was also experiencing congestive heart failure, they told me that indeed I had and

was having a massive heart attack. The doctors immediately performed an angioplasty and inserted a medicated stent in my artery.

Approximately 2 weeks later I began cardiac rehab at the hospital

three times a week and completed it after 8 weeks.

Since my heart attack, I have modified my lifestyle. I currently

work out at the local gym about five times a week. I stopped drinking coffee and I have altered my eating habits by adopting a version of the Mediterranean diet, and I have cut my portions of food

in half. I have lost 25 pounds that the hospital dietician recommended that I lose.

Many people have experienced a degree of confusion as to how

it was me who had a heart attack. The answer to that question remains somewhat elusive, but I am told that in my case, heredity

played a big factor. My father at the age of 52 had coronary bypass

surgery and at the age of 65 he had a heart attack and additional

coronary bypass surgery.

As for my current health status, my cardiologist states that my

laboratory results are superb and my exercise, weight control, and

medication program are paying huge dividends. I consider myself

very lucky to have received the excellent medical care that I did,

but in retrospect I wish I had a greater understanding of my own

risk factors so that I could have been more proactive.

I am very hopeful that the HEART for Women Act will increase

the educational and medical knowledge to a greater number of

women who might otherwise not be aware of their risks of heart

disease and how to prevent it. The Heart Act will also result in an

important education and awareness campaign for physicians and

other healthcare professionals about the prevention, diagnosis, and

treatment of cardiovascular disease in women. I urge your committee to support the passage of this bill, and I thank you for the opportunity to testify before you today. Thank you.

[The prepared statement of Ms. Wolf follows:]

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Mr. PALLONE. Thank you, Ms. Wolf, and that concludes our opening statements. We are going to have some questions, and I will

start by asking some questions myself.

I just wanted to ask Ms. Wolf, I know that this bill is primarily

education oriented, and I guess the conclusion I can come to from

your statement is because you were relatively young and in good

health that you just didn’t think that you had a problem and that

is one of the reasons that you didn’t go to the hospital so quickly.

In other words you say you have lost a lot of weight, you talk about

the Mediterranean diet, all this. I think many of us just don’t think

that we have to worry about it if we are in relatively good health.

I mean, was that a factor? I mean, is part of the purpose here to

educate people that even though they may think that they are in

pretty good shape they are not?

Ms. WOLF. I think, yes. When I was in the hospital and I think

most of us know what we need to do to lead a healthier lifestyle,

and sometimes we don’t because we feel like we are kind of sliding

along and we are doing OK. Just like I said, I was very active but

I knew I needed to lose weight. I also knew that my diet was not

what it should be, although my cholesterol level was fairly low. It

was 170. But I also knew that I had these risk factors related to

my family, but I never took any proactive measures. For me it was

just a little too hard to lose 20 pounds. But I will tell you, a motivating factor is having a heart attack. And one of my messages to

people is to not wait until you have a heart attack, that there are

certain things you can do. And it takes time. I knew and wanted

to lose weight, but I wanted to lose it in a week. It took me a long

time to lose the weight, and I think that’s also a message that

needs to get out to people is that eating healthier, eating better,

eating smarter, and also making time to exercise is very important.

And so while I may have appeared healthy, certain things can happen; and I think at this point I would do everything I can to make

sure that I have a healthier lifestyle.

Mr. PALLONE. Sure. Now, you said you were 50 at the time, but

the bill is I guess mainly targeted for women aged 65 and older;

so I guess I would ask Dr. Bennett, what is the reason for that targeted audience of over 65? I mean, why not target women age 64

and younger, Ms. Wolf being a good example?

Dr. BENNETT. Well, certainly the Act has several components to

it. I think the over 65 was the Medicare portion of the Act. The

FDA certainly is a big part of that, and getting data to understand

how heart disease functions in women who are age 50 is very important. It turns out that family history, especially for women, is

a huge risk factor. It increases risk by about 1.7 fold, so there are

some things potentially that could have been done ahead of time.

And when we look at women who have heart attacks in their 50’s,

they do far worse than men who are the same age; and we don’t

really know why. Research, in looking at the FDA research especially, in that age group, men versus women, is going to be very

important to gain a better understanding of what medical treatments might make people better off.

Mr. PALLONE. OK. You started to talk about the WISEWOMAN

program, Dr. Bennett, that has been a big factor in providing these

pre-cardiovascular disease screenings for low-income, uninsured

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women. You want to talk about how this bill would expand it? Apparently now it is in 14 States and this bill would expand it to 50

States. I know you were starting to talk about that maybe when

I cut you off, so why don’t you tell us why it is important or what

you see with this expansion.

Dr. BENNETT. The WISEWOMAN program really targets those

women that are underinsured or not insured at all, and that turns

out to be a very high risk factor group. In fact, when they screened

women in the existing 14 States, they found that almost 75 percent

had some risk factors that needed attention. And it really makes

a difference. Not only is it saying, hey, you are at risk, it actually

provides a venue for them to get some training in regards to smoking cessation which is critical, looking at weight loss, exercise, medical management of blood pressure; and it really does make a difference. Cardiovascular risk in women who participated in these

programs for a year declined anywhere between 51⁄2 to 8.3 percent,

and smoking rates, which as you know, are very tough to get people to quit smoking, smoking rates decreased about 5.9 to 10 percent. So that parlays out into a huge benefit, and that of course

should be expanded to all 50 States because at-risk women are of

course in all 50 States.

Mr. PALLONE. OK. And then the last thing I wanted to ask the

doctor about, what was the rationale for including an increased

data collection requirement for abbreviated new drug applications.

Doesn’t that add a regulatory burden on the abbreviated new drug

applications?

Dr. BENNETT. I think the burden is nothing compared to the burden that women are suffering right now from lack of information.

The data that is collected for research studies, and I am very familiar with industry-related studies, they always collect gender. So it

is there. It is just a matter of getting it tabulated. And even more

importantly, once it is tabulated and put in the new application,

whether abbreviated or not, the FDA reviewers really need to include that as an important issue because once the FDA reviewers

collate their data and it goes to panel, if it is missed at some point

in the line there, it is not going to be an important item that is

discussed. And there are treatments no doubt that respond the

same in men and women, and that is great, we should know about

that. But I think we can’t assume that drug is going to pharmacologically be the same as in men and women. We have a very

strong blood thinner call glycoprotein inhibitors that is used if you

came in with a heart attack or near heart attack, and we know

that it is great for men. It really is very effective and should be

used. For women, sometimes the data is a little more equivocal as

far as benefit, and we know that it causes a lot more bleeding. And

of course, we would like to know, how do I deal with that when I

have a woman who is coming in with a heart attack? How can I

better administer that drug to decrease the side-effects and maximize the benefit?

Mr. PALLONE. All right. Thank you. Thank you both. Mr. Deal.

Mr. DEAL. Thank you, Mr. Chairman. I certainly agree on the

education side of it. I failed to say that while I have three daughters, I also have four granddaughters, the oldest of whom is in first

grade. On the education side of it, one of the things that I am conVerDate 11-SEP-98 09:56 Feb 29, 2008 Jkt 000000 PO 00000 Frm 00045 Fmt 6633 Sfmt 6633 Q:\DOCS\110-37 SCOM1 PsN: SCOM1
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cerned about is that childhood obesity, which of course is leading

to more childhood diabetes and then ultimately to heart disease as

they become older, so the education component certainly I think

needs to spread all of the age groups and include both sexes, of

course.

One of the areas of concern that I have is the part that relates

to the FDA. Dr. Bennett, let me ask you just a couple of questions

about that. There are two parts of the bill, one that deals with new

drug applications and another one that deals with investigational

new drug applications. Both of course require that information be

stratified by sex, race, and ethnicity. Now, the information I have

is that the current Code of Federal Regulations requires that already. Am I incorrect and if I am not incorrect, are you simply saying by this bill they are not doing what the Code of Federal Regulations requires currently?

Dr. BENNETT. No, you are correct that there are regulations that

state that the data needs to be collated on that basis and reported

on that basis. The problem is it is just not done, and it doesn’t

come out in the final review. In about a third of the cases, the trial

participants’ sex was unknown which seems astounding since——

Mr. DEAL. That is getting to be more and more a problem now.

Dr. BENNETT. It is pretty easy to defer them, and most of us are

pretty good at it.

Mr. DEAL. Ethnicity is a problem, too, obviously.

Dr. BENNETT. Ethnicity is a problem, too. When ethnicity is determined and collated for trials, it is the participants’ self-declared

ethnicity which is pretty much across the board, how we collect

that particular set of data.

Mr. DEAL. So you are simply saying there needs to be more attention paid to what is already the current requirement of making

sure that it is enforced in terms of breaking it down in all of these

various categories, is that what you are saying?

Dr. BENNETT. In the HA’s conversations with the Office of Women’s Health at the FDA, we really felt that having an across-theboard methodology of approaching this and having a set way that

all this information needed to be collected and tabulated by the reviewers was essential and unifying that and making that mandatory and having a little more teeth in it with the statutory law was

really the best solution to this.

This data is really essential, and I don’t think anybody—it is a

difficult position for me to be in when I see a woman in the ER

and I just don’t know if the drugs I am going to give are as safe

and effective as I know they are for men.

Mr. DEAL. OK. The question that Mr. Pallone asked with regard

to the abbreviated new drug applications, I just generally think

those as generic drugs; and we are all trying to make sure that we

get generics on the market and to the consumers’ hands because

of the cost factors that make them more available to constituents.

But as I read the bill, it requires that they go through a new set

of providing safety and efficacy of their product instead of being

able to rely on the patented holder of the product, which is the way

generics currently operate. That seems to me is going to place a

time and cost burden on generics and will prevent many of them

from getting to the market as soon as we had hoped that they

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would and as they do now under the current system. Do you see

that as a potential problem?

Dr. BENNETT. Yes, I am personally not that familiar with the abbreviated portion of it and the regulations that the FDA has to go

through, generics versus non-generics. I mean, I certainly agree

that generics are a big benefit for women in particular because

they often are not covered by insurance, and we want that to be

offered. And I would say that in general, stratifying results by gender is a pretty easy thing to do mechanically. It is one little statistical run and one hit of the computer. So if it truly is not that burdensome, having that information available is important.

Mr. DEAL. But if they can do that for the approved drug, then

the biologic should be able to piggy-back on that, wouldn’t you

think, if it has already been done?

Dr. BENNETT. It sounds reasonable.

Mr. DEAL. That is the way we get them to the market quicker,

obviously. Finally, Dr. Bennett, do you have any examples of adverse effects of drugs currently on the market as it relates to heartrelated problems that have had adverse effects on women?

Dr. BENNETT. There is a medication called digoxin which is widely available in treatment of heart failure and is quite commonly

used. In 1997, that was really the first prospective randomized clinical trial showing that digoxin was helpful in heart failure patients

across the board, men and women, and decreased hospitalizations.

Five years later in 2002, a post-hack analysis or an analysis of the

data looking at gender was published raising the issue that digoxin

was not as helpful in women as in men; and in fact, it may be

harmful and may have led to more mortality in women. That could

be explained by higher serum levels, but that kind of information

would have been extremely helpful to a physician’s daily practice

in the treatment of heart failure. And my concern is why did it

take 5 years later to come out, and I think starting with the FDA

and having that information available before it is released to the

general public to at least start that dialogue of how can we maybe

treat women better remains essential.

Mr. DEAL. Thank you.

Mr. PALLONE. Thank you. Mrs. Capps.

Mrs. CAPPS. Thank you. Ms. Wolf, I think it is important that

you mentioned what happened when you first called your primary

care physician. I think we were all hanging on your words at that

moment. And he, as we might have guessed, prescribed you medication for heartburn. I understand this is a very common misdiagnosis of heart disease in women, and I wondered if you ever

had the chance to discuss this with this primary provider afterward

or do you think he or she would have benefited by being exposed

to an awareness campaign earlier?

Ms. WOLF. Thank you. He did come to the hospital the first night

when I was there, and that was the last time I had seen him. I

chose to, because of everything that had happened, I chose to

change doctors. There is this sense, I think we grow up with this

appropriate sense that we trust our doctors. And so when I called

and got the information from him, I trusted him as though he had

the right answer for me. And I have subsequently come to feel that

had my husband called and said the same thing, that I am experiVerDate 11-SEP-98 09:56 Feb 29, 2008 Jkt 000000 PO 00000 Frm 00047 Fmt 6633 Sfmt 6633 Q:\DOCS\110-37 SCOM1 PsN: SCOM1
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encing chest pains, I think I may be having a heart attack or

maybe indigestion, that—I would think that most physicians would

say because my husband, being a man, would say either come into

my office and let me evaluate you or go directly to the ER. And

that didn’t happen. And I think that one of the reasons that I think

this is so valuable is to make physicians aware that this is certainly a possibility and a likely possibility and they shouldn’t just

tell women, which I have heard that it is anxiety or it is heartburn.

At least give us the direction to take care of ourselves. And I think

one of the reasons it is the No. 1 killer of women is because we

don’t have time, and I was lucky and fortunate to get to the hospital on time. And I was told even with that, I should have called

an ambulance because time was of the essence. And so it is critically important that physicians have an understanding of what the

potential of risks are for women. And I also think that women bear

the responsibility, too, to be a little bit more proactive and to understand when our—I knew that something was wrong. After having three children, I know what labor is like; and having a heart

attack was pretty close to that, if not more so. So I should have

listened to my body as well and taken initiative on my own.

Mrs. CAPPS. Let me follow up without interrupting you because

you are Supervisor Janet Wolf, as well. You have a responsibility

for the county of Santa Barbara, and you know how many people

don’t have the wherewithal or the resources that you had to follow

up, to get on the Internet, and do all the things that you did, even

though it was late. Do you want to comment briefly? I want to ask

Dr. Bennett a quick question, too, but what does it feel like to have

gone through what you have gone through knowing how many

women in the county that you serve don’t even have what you have

to get themselves treated.

Ms. WOLF. Right. Well, it is not a great feeling, and I think it

goes back to Mr. Deal’s question about education. After my heart

attack—and I didn’t know this, that it is the No. 1 killer of women.

I went to a Heart Association meeting and found that out. I subsequently went through training through Women Heart which is a

program that trains women to become spokespeople to go back to

their community and talk about their personal stories. And having

gone through that program, it has given me an opportunity to talk

to different groups of people, from churches, synagogues, I have

gone into high schools, just any group that will listen to me, I talk

to them about my experience. And so that is a little piece of what

I do. And of course, healthcare in our community and our society

is not what I believe it should be; so I am trying to do my part to

educate as many women as possible. And again, going to Mr. Deal

with the question about obesity in children, when you have a

healthy mom, it kind of flows to the children; and I think that is

so important. If I didn’t die from having a heart attack, I almost

died seeing my kids in my hospital room because it was very sad.

And I think as a woman, as a mother, and as a politician, as a

school board member, we know how important it is to take care of

our children. It is just not that tough. We just need to be educated

and work on it a little bit more.

Mrs. CAPPS. I will have to save my questions.

Mr. PALLONE. Thank you. Dr. Burgess is recognized.

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Mr. BURGESS. Thanks, Mr. Chairman. Let us stay on the concept

of making sure that physicians and practitioners are aware. I will

just share with you an experience I had where I almost by serendipity came across the symptom of unrelenting fatigue as perhaps warranting further investigation as to the possibility of underlying heart disease, and I think I came across that in something

as mundane as the Reader’s Digest, and then when confronted with

the patient within the next couple of weeks who presented with

such symptoms, she thought I was nuts for making her go see the

cardiologist. And she went from the treadmill to the cath lab to the

operating room in the space of an afternoon, but it would have

been fairly easy to just check the box, yes, fatigue, 50 years old,

what else is going on in your life. So it is not always easy to come

to those conclusions, and sometimes I recognize my practice, it was

better to be lucky than good.

On the educational initiatives, Dr. Bennett, what are some of the

paths we should take to improve the provider education; and let me

just ask specifically, what are you doing at George Washington to

get the information into the hands of the people on the front lines?

Dr. BENNETT. It is interesting that you ask. The Association of

Women’s Heart Programs is actually taking this on nationally, and

we have decided that our first target audience is going to be those

first-line physicians, the OB/GYN’s, the primary care physicians,

the nurse practitioners and PA’s who work in those organizations.

And we did a very in-depth audit of about 40 thought leaders

across the country, and we basically got back information that, as

you know, primary care physicians are just overwhelmed with patients, overwhelmed with time constraints. And basically they

thought, hey, this is a difficult area, the research is somewhat

murky at times. We basically just want to know the three things

that we need to keep in our minds when that door closes and we

are talking with the woman behind that door. And we want to

know when do we need to refer her to a cardiologist, when should

we initiate blood pressure and cholesterol treatment. So having

those standards of care from what is derived from the American

Heart Association, the American College of Cardiology Guidelines,

making those guidelines livable, breathable, and usable I think is

one of the key pieces that we can do for those first-line providers.

And then the usual, continuing medical education and motivation.

Mr. BURGESS. Do you key in on what questions should be asked

during the history, during the interview?

Dr. BENNETT. We are actually going to be holding a summit on

June 28 in regard to that and starting that dialog about how that

process should be done, how best to reach those primary care physicians. It might be a simple checklist. We don’t have a mammogram equivalent in cardiovascular disease——

Mr. BURGESS. That is what I was going to ask you.

Ms. BENNETT. Yes.

Mr. BURGESS. C-reactive protein or are there any other screening

tests quite there yet?

Dr. BENNETT. I wish we were there, but it still boils down to Framingham risk score which we think is the best global approach,

and we all do it in our heads as physicians. We kind of, hey, you

don’t look like you got heart disease, your blood pressure is not

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that high. But it turns out we do a pretty bad job of that, and gender is one of those things that sort of knocks down the risk in our

minds unfortunately. So maybe it is just as simple a thing as

screening form that physicians need to do and that extra work

needs to be recognized.

Mr. BURGESS. Ms. Wolf, let me just ask you, did you seek a second opinion for WebMD. Did you fire WebMD also?

Ms. WOLF. Well, actually, it was through WebMD that I was actually able to have the symptoms of heartburn next to the symptoms of heart attack. No, I didn’t fire them. I think that they in

some ways saved my life because the symptom of being clammy

was on the heart attack side and——

Mr. BURGESS. But in fairness you did not share that information

with your internist because that information developed later in the

course of the disease?

Ms. WOLF. That is true, but what I did share with my physician

was what I was feeling. And because I had had Rolaids or whatever it was at home, I had had heartburn in the past. But when

I called him and said—I used the word heart attack. I said, something is going wrong. I said, like I said, I am either having a heart

attack or really bad heartburn.

Mr. BURGESS. Yes, I can’t quarrel if the wrong decision was

made.

Ms. WOLF. Well, I do know again——

Mr. BURGESS. I used to instruct my nurses in labor and delivery,

never give me an option in the middle of the night because if it is

an option to go back to sleep, that is what I am going to take. Just

tell me, you need to come to the hospital, and I will figure out the

reason why when I get here.

Let me just ask you, too, in retrospect, were there other milder

symptoms you could share with this panel that you may have encountered earlier that in retrospect could have been a harbinger of

something more serious just around the corner?

Ms. WOLF. No.

Mr. BURGESS. So there was absolutely symptom-free days up

until the bad heartburn or the bad cardiac pain started?

Ms. WOLF. Right. Yes, it basically started on that Friday. Otherwise, I would never have known. This was in November, in the

summer we went to Greece and I remember climbing the Acropolis

and I said, it is a good thing it didn’t happen then. And back then

I felt fine. So it can just happen like that.

Mr. BURGESS. Thank you.

Mr. PALLONE. Thank you, Doctor. The gentlewoman from Illinois.

Ms. SCHAKOWSKY. Thank you. I thank the witnesses, and I also

thank Congresswoman Capps. Before women came to the United

States Congress, the clinical trials that were done on heart disease

were only done on men; and some of the differences that have since

emerged were never found. And so I think it is another example

of why it is very important to have everyone at the table so that

these kinds of gender differences are recognized and attended to.

And I thank our witnesses very much for pointing that out.

I wanted to ask Dr. Bennett, while more women die of heart attacks than men, is cardiovascular disease also more common or is

it just that we are not treated appropriately for it?

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Dr. BENNETT. More women than men die of cardiovascular disease so including heart attacks and strokes and other forms of cardiovascular disease, and they have done so since 1984.

Ms. SCHAKOWSKY. We die more from it but is that because it is

not recognized, we are not treated, or that we have it more than

men?

Dr. BENNETT. It is multi-factorial, no doubt, as to why women

are dying more so than men. I think it has to do with——

Ms. SCHAKOWSKY. Is it more common in women? Is the disease

more common in women?

Dr. BENNETT. It depends on what age group you are talking

about. Based on the NHAIN survey, which is a national survey,

when women get in their 50’s and 60’s, the prevalence of the disease so those living with disease is about the same. And that is different than about 10 years ago where the prevalence started to become equal when women were more in their 70’s. So it appears

that more women are living with cardiovascular disease.

Ms. SCHAKOWSKY. I see. I wanted to ask the question actually

that Mrs. Capps was unable to ask because of time. The question

was for Dr. Bennett to follow up on a statement you made regarding the fact that more than one-third of the time information about

demographic data isn’t being provided to the FDA and clinicians.

And I was wondering if you could elaborate on that and tell us how

you think this legislation could help improve on that statistic.

Dr. BENNETT. I think it is critical, and I think there is enough

differences between men and women from a biologic standpoint,

from a societal standpoint, from a stress and anxiety standpoint

that all plays into how well we take our medicines, do our doctors

give them to us early enough, that we just can’t assume that the

next drug X works equally well in men as in women. We can’t necessarily say the same thing as far as race and ethnicity.

So going on that premise, which I think for me is true, we need

that data to make that determination; and you mentioned earlier

that women weren’t allowed in cardiovascular trials a while ago. It

has certainly changed. In NIH sponsored trials, women represented

about 38 percent of trial participants. Most of the information that

I use in daily practice comes out of industry-sponsored trials as far

as new medications. And in those trials, women represent about 25

percent. And what happens when you only have 25 percent of the

population studied, when you go to look at statistics, those statistics are often weakened. So they don’t achieve statistical significance. So it may trend toward a positive effect in women. It may

be helpful in women, but we don’t definitively, we can’t statistically

say that it is effective in women. And we have been living with

that for a while. I think what this FDA portion of the act does is

allows us to at least see what is going on. In a recent trial that

looked at over 600 studies done fairly recently in major medical

journal, cardiovascular trials, only 24 percent of those studies reported results by gender. We knew how many women were in the

trial, but when it came to prevents heart attacks, men versus

women, that data was not listed in 75 percent of the trials.

Ms. SCHAKOWSKY. And what was the proportion of women to

men in those trials?

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Dr. BENNETT. Approximately 25 percent, sometimes a little more,

sometimes a little less.

Ms. SCHAKOWSKY. Now, what is the justification for that?

Dr. BENNETT. Well, I don’t know if there is a justification. It is

what it is. Having done trials——

Ms. SCHAKOWSKY. Well, it doesn’t have to always be.

Dr. BENNETT. No, it doesn’t. I am aware of one trial that was a

government-sponsored trial called the BEST trial. That was a heart

failure trial, and it was mainly based in the VA. And of course,

they had to get more women in those trials. And one of the things

they did to more heavily recruit women was to pay the investigators a higher reimbursement for enrolling women, and that seemed

to be fairly effective. Other barriers to enrolling women is that I

don’t have the time, I got to take care of my husband, I don’t have

the time, I have to take care my kids, I don’t have transportation.

And sometimes it is a little bit of I am concerned. I don’t want to

expose myself to risk or my husband says I shouldn’t do this because there is some risk in the study. I think that is changing as

sort of the our bodies, ourselves generation grows up to the point

where we are enrolling in trials ourselves and I think we are willing to take those risks because we know that it is a benefit to everyone.

Ms. SCHAKOWSKY. But in essence though what you are saying is

that often it is the fault of the women themselves, that there aren’t

more women in trials, and that may be true; but is there not a

need for more increased effort to make sure that it is more balanced than just a quarter of those that are in these trials are

women?

Dr. BENNETT. I certainly wouldn’t place all the reasoning on the

women themselves. There have been several NIH symposia and

conferences about how to recruit more women. In Women’s Health

Initiative they did a great job recruiting women. So I think a lot

of this just needs to be propagated and discussed more about; and

certainly there is always an analysis that needs to be done in people who decide, hey, I don’t want to participate in this trial. I think

there is a wealth of information in that in determining why and

how we can correct that.

Ms. SCHAKOWSKY. That seems to me a major point. I hope that

particularly women in the profession will work on that.

Mr. PALLONE. Thanks. I recognize our ranking member, Mr. Barton.

Mr. BARTON. Thank you. Mr. Chairman, I would be happy to

yield a minute of my time to the gentle lady from Illinois if she still

has a question. I support this Act. Obviously, as somebody who has

had a heart attack I am very sensitive to doing things to help prevent others having heart attacks. My only concern is the reporting

requirements, require reporting by ethnicity. And I am not sure

that that might not cause more problems than it solves. So my

question to you, Dr. Bennett, I certainly understand the need to report by gender but why do we need to report by ethnicity?

Dr. BENNETT. I would say the first reason is that that is where

America is right now, and if we are going to be releasing a drug

to the general population, we should release it to or we should

know how it performs in what I am typically going to be seeing in

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the emergency room. All ethnicity data is typically self-reported

data. There are certainly examples even in the cardiovascular literature where African-Americans, Asian-Americans respond differently to medications as far as the pharmacology and serum levels. So there may be some important biologic understanding of

that. There was just a drug that the FDA approved for AfricanAmericans for heart failure that was an old drug combination of

more than 10 years ago that on a post-hack analysis many years

later, lo and behold it looked like these old-fashioned drug combinations were very helpful in African-Americans. So I think from

a clinician, when I sit across the table from a patient, I am trying

to tailor therapy to that patient; and I use every bit of information

I possibly can to try to maximize my effective treatment for that

patient.

Mr. BARTON. What is the difference to reporting by race and reporting by ethnicity because as I understand it this legislation requires both, although it gives some discretion to the Secretary?

Dr. BENNETT. I couldn’t tell you the strict definitional differences

between the two. I don’t know.

Mr. BARTON. And if we are going to require that, would you support putting in a safeguard that the person requesting the information can’t be accused of a civil rights violation for requesting it?

Dr. BENNETT. I think on the basis that it is self-reported data,

so the individual who is participating in the trial doesn’t want to

discuss that information, there should certainly be a box saying unavailable data.

Mr. BARTON. OK. That is all my questions, Mr. Chairman. I support the legislation. I just hope we can work in a bipartisan basis

to fine tune it to prevent unanticipated problems.

Mr. PALLONE. I appreciate that. Thank you. I recognize Ms. Solis.

Ms. SOLIS. Thank you, Mr. Chairman. I apologize for coming in

late. I also want to commend Congresswoman Capps for introducing this legislation. We have been talking about disparities for the

last week. We were celebrating National Minority Health Month,

and something that we talk about often with the tri-caucus, Congressional Hispanic Caucus, Congressional Black Caucus, and the

Congressional Asian Pacific American Caucus, is healthcare disparities. When the question is asked, how do we deal with those

communities of color, oftentimes we don’t have adequate information. How can you prevent and detect diseases when you don’t have

access to information? As I understand it we do see higher incidence of heart disease in the African-American and Latino population, especially Mexican-American. Thirty four point four percent

of Mexican-American women, have cardiovascular disease while

Anglo women have 32 percent and African-American have 45 percent. It is very important that we move in a direction where we can

actually collect the data and do a better analysis and outreach, particularly to those communities that have different cultural barriers.

Language is also a barrier, not just for Latinos, but for Asian communities, Asian-Pacific Islanders, and other immigrant groups that

may not understand what the difference is between having, for example, problems with heartburn over time and telling your doctor

that and him just prescribing Zantac and knowing later that you

49

may have ended up developing a cancer which has happened so

often in our community.

There is a provision in the bill that I am particularly interested

in hearing more about. That is the Centers for Disease Control Prevention Program , the WISEWOMAN Well-Integrated Screening

Evaluation across the Nation. I understand there are projects in 14

States. This bill would carry it to 50, and I would like for you to

elaborate on why we need to expand the program.

Dr. BENNETT. The women that the WISEWOMAN program targets are those that are underinsured, uninsured, and often those

are the women with the highest risk factor profiles, so really, the

women that would stand most to benefit from early intervention

and prevention. We know that if we are able to get all our health

ducks in a row or control all those risk factors that lead to cardiovascular disease, we can reduce the burden of death, disability,

need for bypass surgery and angioplasty in over 82 percent; and

this is the perfect population to target. The WISEWOMAN program combines screening and education. The education has an impact in smoking cessation and reducing overall cardiovascular risk

in a very vulnerable population. And I really appreciate your comments in regards to the cultural competency because there is nothing that will tear down a physician/patient relationship than not

listening and understanding. Communication and ability to convey

the importance of testing, the importance of weight loss and exercise, the importance of taking your medications all breaks down if

you don’t find that common bond in communication.

Ms. SOLIS. Last week we had a special orders hour on healthcare

disparities, and we had a discussion about tobacco and the high incidence of young Latinos picking up that habit and that fact that

we are seeing a larger number of our pre-teens smoke, so I am

wondering if programs like this can also reach down and work even

with some of the young women who are already starting with these

bad habits. Many of those cases are going to affect us later on. For

Latinos, our nutritional values may be a little different because of

cultural differences. Early detection is equally important as being

aware of how to balance your diet and if you know, maybe you

could speak on that.

Dr. BENNETT. There are certainly some of my colleagues who

have accrued a bit of cynicism across their years for practicing

medicine, for all us adults it is too late for us. We don’t listen and

that going after primordial prevention or prevention in pre-teens

and teens is where we are most likely to get our bang for our public

healthcare buck. There is nothing that would replace early education; and being the mother of two sons that are 10 and 13, when

I have to shush my 10-year-old from saying, boy, that man is smoking over there. Isn’t that horrible? I know that the education is

working.

Mr. PALLONE. Thank you. Mr. Murphy.

Mr. MURPHY. Thank you, Mr. Chairman. I thank both of you for

being here, and I am sorry I was running late as well. But I just

wanted to ask a couple of questions with regard to this because I

am a psychologist by training and I think back when I was in graduate school how little information was emerging back in those

olden days about gender issues and race issues, ethnicity, age. I

50

still think we are far, far behind where we need to be in understanding age issues, true, but let me just ask, Doctor, in terms of

your knowledge that has emerged over the years, the significance

of what we are learning in terms of what gender has taught us

about clear biological differences and its impact upon medical

issues, and I would also add, too, that if you could comment on

some of those things, if we have some other knowledge on things

like ethnicity and age as well to that sort of complicates or at least

makes it that we can be more specific in our treatment. Can you

comment on those issues?

Dr. BENNETT. Certainly age is one of those risk factors that increases the complexity of treatment. Oftentimes drug levels get

fairly high in somebody whose renal function is not as good, kidney

function is not as good, and then ensues complications. There is almost always more concomitant disease of high cholesterol, diabetes,

there may be lung disease and liver disease. That always complicates the medical therapy. And there are also significant barriers

to exercise and weight loss when it comes to our older patients. I

think it is interesting that you mention the psychological aspects

of it because I think that that really has a tremendous impact on

cardiovascular disease for both men and women. We know that

anxiety and depression puts people at increased risk for cardiovascular disease. If somebody develops anxiety and depression after

a diagnosis of heart disease, their outcome is worse. So it is very

mixed together as far as its negative effects. We know that women

are more depressed after bypass surgery than men. We know that

women are less likely to be referred to cardiac rehab, and that may

involve some depression and anxiety. I would have to say in my

practice that one of my most common referrals is to licensed clinical social workers to help deal with the issues of weight loss that

are often tangled up in stress and anxiety and depression.

Mr. MURPHY. In fact, to elaborate on what you are saying, I believe that some of the numbers are that persons who have anxiety

and depressive disorders, it doubles some of the risks for other

problems such as heart disease; and I believe once they have a diagnosis of heart disease, it doubles the cost of their healthcare if

these things are not dealt with. Along those lines, do you see some

differences as well with regard to not only the present psychological issues but if you add this to a large spreadsheet would also

affect gender issues as well? You mentioned a couple, but then add

the other element of age as well. You are saying not only the risk

for heart disease with age goes on but also some of the other risks

for some of the psychological issues that exacerbate that?

Dr. BENNETT. Well, certainly there is higher rates of depression,

whether it is reactive depression or more serious depression after

a diagnosis of heart disease and stroke. Women tend to be more debilitated after a stroke, so it is certainly possible, although I don’t

know that there is higher rates of depression after a stroke. I think

that a lot of this is not as well-clarified and as known as we would

like it to. Also, response to medications. There has been some recent studies that look at certain drugs that could be used to treat

depression safely after heart disease has been diagnosed, and to my

knowledge I don’t know of a significant look into age relation to

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that, as far as response to treatment or gender relationship to that

treatment.

Mr. MURPHY. I think I have seen some other studies that talk

about response to medication that some of the errors are sometimes

made in prescribing as people assume that you give the same dose

to a 17-year-old as to a 70-year-old, and that is not the case. Similarly that we have medication issues where the same medication

dosage or type may have different responses to women as to men

would you say?

Dr. BENNETT. In regard to treatment of depression and anxiety

or cardiovascular disease?

Mr. MURPHY. Cardiovascular disease.

Dr. BENNETT. Certainly there has been with the glycoprotein inhibitors as a good example. That is an intravenous drug we give

just around the time of an acute coronary syndrome or heart attack, and we know that that leads to higher bleeding complications

in women. There is no doubt about it. That has been shown across

many, many studies with that class of drugs. There is also the

question raised as to whether they have the same effectiveness.

Some of those studies actually pointed out that perhaps rates of

mortality, morbidity were increased with use of those drugs. The

data is mixed. That sort of thing needs a big discussion. I have to

say in my cardiology community, we are not discussing that as

heavily as I think we should.

Mr. MURPHY. Let me close with this thought, too, because passed

recently out of here is the Genetic Information Act which prohibits

employers and others from discriminating on the basis of genetic

information. One of the things that will come from this as we develop more knowledge of gender differences, age differences, racial

ethnicity issues, I think it helps us better to read patients and target diagnosis and treatment to the individual. One of the things we

have to make sure is we do not use any of that as a basis for discriminating against people and saying because this group is more

risk, we won’t hire them. So I am hoping what comes out of all this

legislation is some research that tells us how to better treat patients, how to open doors and not close doors to them; but I thank

you for your testimony today.

Mr. PALLONE. Thank you. Ms. Hooley.

Ms. HOOLEY. Thank you, Mr. Chairman. And again, I too apologize. I had another hearing before this. I have just a few question,

and I would like to ask Dr. Bennett. The bill requires a clinical

hold to be placed on manufacturers when they fail to submit sexspecific data. From your perspective, do you believe the clinical

hold is an appropriate tool to ensure compliance with the bill’s statutory requirements?

Dr. BENNETT. Right now the FDA has that ability to do that anyway at their own discretion. Gender data is a very-easily collectible

piece of data, and having personally run trials for industry on

many occasions, it is one of the first pieces of demographic data

that you collect. So the data is there, and I think it is just very

easy to transmit. Personally, I don’t think that imposes a great

burden considering all the bits of data they have to transfer to the

FDA anyway.

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Ms. HOOLEY. The larger question that was a follow-up question

from Ms. Schakowsky is how do we ensure that we have women

in the clinical trials?

Dr. BENNETT. By talking about it is certainly one, impressing

upon women before they may be asked to be in a trial that this is

an important issue for them that we will never know unless they

make a really big sacrifice of being in a trial and it often is a sacrifice because there is often a risk. They may not get the drug they

want, they may end up getting the drug they didn’t want. I think

encouraging the investigators to create an environment that would

be better able for women to participate in trials would be essential.

With the Women’s Health Initiative, I know people were very creative organizing van pools and the like to make sure that women

could come for their visits and go back to their home. So we just

need to think a little bit outside the box.

Ms. HOOLEY. I firmly believe in the importance of educating

women and providers about strokes, about heart attacks. What information do you have on the effectiveness of such educational efforts? I mean, have they worked? Have we really penetrated into

the greater population?

Dr. BENNETT. The National Heart, Lung, and Blood Heart Truth

campaign has been going on for now 5 years, and we looked at

awareness levels of do you recognize the red dress symbol, do you

know that heart disease is the No. 1 killer, and it has definitely

gone off. As that has gone off and achieved levels of greater than

50 percent in the general population, we have data that shows that

those women are going in and getting their issues addressed as far

as cholesterol and blood pressure. So women are taking steps based

on this information. What I would have to say from the medical

community’s standpoint, we don’t get the red dress campaign. We

need a red coat campaign or something because the medical community in general is less aware about some basic facts of women

and cardiovascular disease, for instance, that more American

women have died of heart disease than stroke. Only 8 percent of

primary care physicians knew that. We did a recent survey of 1,000

Americans, 500 men and 500 women; and 22 percent of American

men knew that heart disease killed more women than men. So the

red dress campaign works, and it really motivates women to

change. And not only does it reach women, but it reaches the men

that love those women.

Ms. HOOLEY. What is it, do women and men have different symptoms for a heart attack?

Dr. BENNETT. They can. Sort of the classic symptoms of an elephant on my chest, tremendous pressure, tightness, heaviness, it

doesn’t have to be pain, are fairly common for both men and

women. Women can have more shortness of breath. Dr. Burgess

mentioned that he had a patient with unrelenting fatigue. That can

be a symptom in women. Pain between the shoulder blades is a little more characteristic for women. The bottom line is that women

are often embarrassed to come to the emergency room if it is just

a case of indigestion, and I think far better to be in the ER with

a bad case of indigestion, be sent home with a clean bill of health,

than to wait too many hours and perhaps lose heart tissue that

could be never be regained again.

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Ms. HOOLEY. Thank you. Again, I just think we have to be relentless in our campaign to educate not only our doctors but both

men and women about the disease. Thank you.

Mr. PALLONE. Thank you. Mrs. Blackburn.

Mrs. BLACKBURN. Thank you, Mr. Chairman, and thank you to

our witnesses, and thank you for your patience while we run out

and meet school groups and jump back in. Ms. Wolf, I want to

thank you for coming in, for sharing your story as openly as you

do. I am certain that you are a great advocate for the Heart Association and for the programs that they have in place and being

someone who, in my private life before coming to Congress, I have

been on the boards for heart and lung and cancer and arthritis and

children’s hospital and all of these things. My husband laughingly

says sometimes that we have a disease ball of the month going on

at our house as we work to raise funds for this.

Dr. Bennett, just a couple of kind of little wrap-up points that

I want to make. We have talked a lot about the data that you gather, and I thought you might want to provide some kind of a framework around this. Many times in my role as a volunteer, we would

talk about data collection when we were working on a program

with a grant at Vanderbilt or St. Jude’s or somewhere. People

would be fearful if they were going to be transparent in the system

with that data being collected, and it may be an insurance company or an employer would find out more than they wanted them

to know. Would you like to explain the anonymity that is allowed

to individuals when they participate in trials or when their data is

collected and used for ongoing research? You want just maybe 30

seconds or a minute on that?

Dr. BENNETT. There are some pretty big firewalls that are put

up and that are mandated. The data is delinked as far as identifying demographic information. When we collect information in something called a case report form, that information is delinked with

that person. There can’t be any tracing back. So when the industry

comes in to review the CRF’s or when the FDA reviews the CRF’s,

there is no identifying information on them.

Mrs. BLACKBURN. OK. So women who are participating or in

some way know that data is being held and used, they can have

the confidence that they are helping to find an answer to the problems and that they are not exposing themselves to the system?

Dr. BENNETT. That is correct.

Mrs. BLACKBURN. Thank you so much for that. Now, a couple of

other things. As I mentioned, working on the volunteer side and

then coming to the public sector side, or the not-for-profit side and

then the public sector side, grants are always so very important to

us; and when we look at the prevention and treatment and education, can you give me an idea of when you are looking at grant

dollars, what percentage are you pulling from the public sector and

what percentage is coming from the private sector on the research

work that is done?

Dr. BENNETT. I would estimate at least from a clinical trial

standpoint that Federal dollars and government dollars that actually funnel into how we practice medicine on a daily basis represent maybe a fifth to two-fifths of what we utilize in treating patients. A vast majority of the information that we know and underVerDate 11-SEP-98 09:56 Feb 29, 2008 Jkt 000000 PO 00000 Frm 00058 Fmt 6633 Sfmt 6633 Q:\DOCS\110-37 SCOM1 PsN: SCOM1
54

stand and incorporate in our practice comes through the industry

side, and as you know with cardiovascular disease it is a very fast

river of new information with new medications, with new ways to

use those medications, and a vast majority of that does come

through the private sector.

Mrs. BLACKBURN. So the private sector really is leading the way

and then the public sector is supplementing that in this arena.

FDA. As we look at the programs, on cardiovascular education

and prevention, and we have talked a good bit about heredity, exercise, weight control. The times that I have been here, educating

children has been mentioned looks like five or six different times.

Do we have anything there that is being done to address educating

children on health heart programs, on obesity, on a wellness lifestyle? One of the things that amazes me, my children are out of

high school, have been out of high school for a long time now, but

when you go in and visit middle school and high school, all of your

life skills classes have been eliminated. Many of your physical education classes have been eliminated, and I know that some of our

not-for-profits are trying to do teacher training curriculums and

help fill that void and put some of that back in. But we have talked

about the FDA and their participation. What are they coordinating

in the education realm, and are they backing it up enough to get

to those children to start that education early enough that bad habits are not formed?

Dr. BENNETT. I am not at all sure what educational programs the

FDA has for the community. I know the CDC certainly has the

WISEWOMEN program. I am personally just not aware of all the

other programs that they have for teens and preteens and elementary school children. I am sure there are. I know the American

Heart Association does Jump rope for Heart and Hoops for Heart

which at least gets it on their radar screen, and I know that Congress has worked fairly extensively on lunch programs and things

like that.

Mrs. BLACKBURN. I think we are all painfully aware of Jump

rope for Heart right now. My 7-year-old niece tried to have me participate. It was entertaining.

Thank you. My time has expired. I appreciate you all. Thank

you, Mr. Chairman.

Mr. PALLONE. Thank you. That concludes all questions, and I

just want to thank both of our witnesses again. This is a very important hearing and of course thank Mrs. Capps as well for sponsoring the bill. I just would remind members that you may submit

additional questions for the record to be answered by the witnesses, so you may get additional questions in writing. We should

get those within the next 10 days, but expect that you may get

those additional questions.

But thank you again. I know we have another hearing at 12:00

so we are going to take a half-an-hour break here. And without objection, this meeting of the subcommittee is adjourned. Thank you.

[Whereupon, at 11:30 a.m., the subcommittee was adjourned,

subject to the call of the Chair.]