[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]


 
          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

                    U.S. GOVERNMENT PRINTING OFFICE
38-951                      WASHINGTON : 2008
_____________________________________________________________________________
For Sale by the Superintendent of Documents, U.S. Government Printing Office
Internet: bookstore.gpo.gov  Phone: toll free (866) 512-1800; (202) 512ï¿½091800  
Fax: (202) 512ï¿½092104 Mail: Stop IDCC, Washington, DC 20402ï¿½090001


                    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)
                         Subcommittee on Health

                FRANK PALLONE, Jr., New Jersey, Chairman
HENRY A. WAXMAN, California          NATHAN DEAL, Georgia,
EDOLPHUS TOWNS, New York                 Ranking Member
BART GORDON, Tennessee               RALPH M. HALL, Texas
ANNA G. ESHOO, California            BARBARA CUBIN, Wyoming
GENE GREEN, Texas                    HEATHER WILSON, New Mexico
    Vice Chairman                    JOHN B. SHADEGG, Arizona
DIANA DeGETTE, Colorado              STEVE BUYER, Indiana
LOIS CAPPS, California               JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine                     MIKE FERGUSON, New Jersey
TAMMY BALDWIN, Wisconsin             MIKE ROGERS, Michigan
ELIOT L. ENGEL, New York             SUE WILKINS MYRICK, North Carolina
JAN SCHAKOWSKY, Illinois             JOHN SULLIVAN, Oklahoma
HILDA L. SOLIS, California           TIM MURPHY, Pennsylvania
MIKE ROSS, Arkansas                  MICHAEL C. BURGESS, Texas
DARLENE HOOLEY, Oregon               MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York          JOE BARTON, Texas (ex officio)
JIM MATHESON, Utah
JOHN D. DINGELL, Michigan (ex 
    officio)


                             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

 
    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 pressure, 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 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 program 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 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 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 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.
                              ----------                              

[GRAPHIC] [TIFF OMITTED] T8951.001

[GRAPHIC] [TIFF OMITTED] T8951.002

[GRAPHIC] [TIFF OMITTED] T8951.003

[GRAPHIC] [TIFF OMITTED] T8951.004

[GRAPHIC] [TIFF OMITTED] T8951.005

[GRAPHIC] [TIFF OMITTED] T8951.006

[GRAPHIC] [TIFF OMITTED] T8951.007

[GRAPHIC] [TIFF OMITTED] T8951.008

[GRAPHIC] [TIFF OMITTED] T8951.009

[GRAPHIC] [TIFF OMITTED] T8951.010

[GRAPHIC] [TIFF OMITTED] T8951.011

[GRAPHIC] [TIFF OMITTED] T8951.012

[GRAPHIC] [TIFF OMITTED] T8951.013

[GRAPHIC] [TIFF OMITTED] T8951.014

[GRAPHIC] [TIFF OMITTED] T8951.015

    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 problem 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 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:]
    [GRAPHIC] [TIFF OMITTED] T8951.016
    
    [GRAPHIC] [TIFF OMITTED] T8951.017
    
    [GRAPHIC] [TIFF OMITTED] T8951.018
    
    [GRAPHIC] [TIFF OMITTED] T8951.019
    
    [GRAPHIC] [TIFF OMITTED] T8951.020
    
    [GRAPHIC] [TIFF OMITTED] T8951.021
    
    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.
    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:]
    [GRAPHIC] [TIFF OMITTED] T8951.022
    
    [GRAPHIC] [TIFF OMITTED] T8951.023
    
    [GRAPHIC] [TIFF OMITTED] T8951.024
    
    [GRAPHIC] [TIFF OMITTED] T8951.025
    
    [GRAPHIC] [TIFF OMITTED] T8951.026
    
    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 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 5\1/2\ 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 concerned 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-the-board 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 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 heart-related 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 experiencing 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.
    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 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?
    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?
    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 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 African-Americans 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 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 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 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 sex-specific 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.
    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.
    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 understand 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.]


