[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
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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
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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
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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.
----------
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Mr. Pallone. I will turn to our two witnesses. First of
all, thank you for being here today, and let me introduce
first, Dr. Susan Bennett who is clinical director of the
Women's Heart Program at George Washington University Hospital,
and next to her is Ms. Janet Wolf who is the second district
supervisor for the county of Santa Barbara in Santa Barbara,
CA. Thank you both for being here today.
We have 5-minute opening statements. They become part of
the hearing record, but each of you may, in the discretion of
the committee, submit additional brief or statements in writing
for including in the record. And I will start now by
recognizing Dr. Bennett. Thank you again.
STATEMENT OF SUSAN K. BENNETT, M.D., CLINICAL DIRECTOR, WOMEN'S
HEART PROGRAM, THE GEORGE WASHINGTON UNIVERSITY HOSPITAL,
WASHINGTON, DC
Dr. Bennett. Well, thank you, Congressman Pallone. It is a
pleasure to be here, and Representative Capps, thank you for
sponsoring this bill.
My name is Susan Bennett, and I am a practicing
cardiologist; and I think first and foremost, I am one of the
doctors in the trenches. I see patients 5 days a week, and I
see men and women. About 70 percent of my practice is women,
and that is primarily what I do. I am a clinical assistant
professor of medicine and director of the Women's Heart Program
at George Washington University Medical Center. I am also a
volunteer and national spokeswoman for the American Heart
Association and president of the Association of Women's Heart
Programs and I also serve on the Advisory Board of Women Heart
which is the national coalition for women with heat disease.
On behalf of the American Heart Association, or AHA, and
its more than 22 million volunteers and supporters, I
appreciate the opportunity to testify today on H.R. 1014 known
as the HEART for Women Act. We wish to thank this House
Committee on Energy and Commerce, Subcommittee on Health, for
holding today's hearing on this Act which we strongly support
along with many other non-profit health organizations.
Heart disease, stroke, and other forms of cardiovascular
diseases are the No. 1 killer of American women, claiming more
than 460,000 lives each year or about a death a minute. That is
more female lives than the next five causes of death combined,
including deaths from lung and breast cancer. An estimated 42
million women, about one in three, are living with the chronic
affects of heart disease, stroke, or some other form of
cardiovascular disease.
In 1984, women achieved equality and then surpassed men in
one area where they don't want it, heart disease mortality.
Every year since then, more women than men have died of
cardiovascular disease, or CVD. During that time we have made
good progress in reducing CVD mortality for men but the same
cannot be said for women. Although mortality rates have gone
down for women, the decline is not nearly as steep as it is for
men.
The HEART for Women Act is intended to help close that gap
by focusing on three strategies to improve diagnosis,
treatment, and prevention of heart disease and stroke in women.
Part of the 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:]
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Mr. Pallone. Thank you, Doctor. Ms. Wolf.
STATEMENT OF JANET WOLF, SANTA BARBARA COUNTY SUPERVISOR, SANTA
BARBARA, CA
Ms. Wolf. Thank you very much, Mr. Chairman, and members of
the committee. I want to thank you for holding this hearing and
in particular I want to thank my beloved Congresswoman, Lois
Capps who is highly respected in our district, and it is truly
an honor to be here and to be asked to come here and to tell my
story. I am not a physician, so the story I have to tell you is
about my personal experience, and I also just want to point out
that my husband is here with me. I have three daughters as
well. This has been an incredible experience for me and my
entire family and friends and relatives, and so it is an honor
to be able to tell you my story as well in the hope that it
will help and educate other women and husbands.
On December 7, 2004, I suffered a massive heart attack. I
had a 100 percent occluded left anterior descending artery. I
was 50 years old and considered myself to be very healthy and
incredibly blessed. I had a wonderful family and great friends.
I ran a successful business. I had just finished serving 11
years as a school board member. I played on a roller hockey
team, and I exercised fairly regularly at the gym. I am 5'4"
and at the time of my heart attack I weighed 155 pounds. I was
told that I carried it very well. I had annual medical exams
which included EKG's, blood work, mammograms, and I even had a
colonoscopy. I felt that I had covered all of my bases.
My experience began on a Friday evening when after going
out to dinner with friends, I experienced extremely painful
heartburn which felt as if a hole was burning in my esophagus.
When I returned home, I took over-the-counter heartburn
medication. As the weekend progressed, the heartburn sensation
continued intermittently.
By Monday morning, the pain was worse and I noticed that it
became more intense after slight exertion. I became concerned
that it was more than just heartburn and that it might be
cardiac related. I called my internist and I told him that I
thought I was either having a heart attack or a very bad case
of heartburn. He listened to my symptoms and prescribed
medication over the phone for heartburn. I rushed to the
pharmacy to get the prescription filled and took the first pill
before leaving the pharmacy.
I went to bed that evening and woke up at 2:00 in the
morning with what I thought was continued horrible heartburn.
Because I couldn't get back to sleep, I went on the Internet to
find out what I could do to ease my discomfort. By 4:00 in the
morning, the pain was even more severe and I went back to the
Internet. This time I went to WebMD and I compared the symptoms
of heartburn with a heart attack. At that time it didn't appear
that I had any of the symptoms of a heart attack. And then at 5
o'clock I started to feel clammy, a feeling that was described
as a heart attack symptom. I decided to wake up my husband. He
soon realized as my pain was getting worse and I was hanging
over our kitchen counter that we should go to the hospital.
When we arrived at the ER and after what seemed like
eternity, which actually was about 15 minutes, I had an EKG and
was immediately told I was having angina.
After having a chest X-ray and finding out that I was also
experiencing congestive heart failure, they told me that indeed
I had and was having a massive heart attack. The doctors
immediately performed an angioplasty and inserted a medicated
stent in my artery. Approximately 2 weeks later I began cardiac
rehab at the hospital three times a week and completed it after
8 weeks.
Since my heart attack, I have modified my lifestyle. I
currently work out at the local gym about five times a week. I
stopped drinking coffee and I have altered my eating habits by
adopting a version of the Mediterranean diet, and I have cut my
portions of food in half. I have lost 25 pounds that the
hospital dietician recommended that I lose.
Many people have experienced a degree of confusion as to
how it was me who had a heart attack. The answer to that
question remains somewhat elusive, but I am told that in my
case, heredity played a big factor. My father at the age of 52
had coronary bypass surgery and at the age of 65 he had a heart
attack and additional coronary bypass surgery.
As for my current health status, my cardiologist states
that my laboratory results are superb and my exercise, weight
control, and medication program are paying huge dividends. I
consider myself very lucky to have received the excellent
medical care that I did, but in retrospect I wish I had a
greater understanding of my own risk factors so that I could
have been more proactive.
I am very hopeful that the HEART for Women Act will
increase the educational and medical knowledge to a greater
number of women who might otherwise not be aware of their risks
of heart disease and how to prevent it. The Heart Act will also
result in an important education and awareness campaign for
physicians and other healthcare professionals about the
prevention, diagnosis, and treatment of cardiovascular disease
in women. I urge your committee to support the passage of this
bill, and I thank you for the opportunity to testify before you
today. Thank you.
[The prepared statement of Ms. Wolf follows:]
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Mr. Pallone. Thank you, Ms. Wolf, and that concludes our
opening statements. We are going to have some questions, and I
will start by asking some questions myself.
I just wanted to ask Ms. Wolf, I know that this bill is
primarily education oriented, and I guess the conclusion I can
come to from your statement is because you were relatively
young and in good health that you just didn't think that you
had a problem and that is one of the reasons that you didn't go
to the hospital so quickly. In other words you say you have
lost a lot of weight, you talk about the Mediterranean diet,
all this. I think many of us just don't think that we have to
worry about it if we are in relatively good health. I mean, was
that a factor? I mean, is part of the purpose here to educate
people that even though they may think that they are in pretty
good shape they are not?
Ms. Wolf. I think, yes. When I was in the hospital and I
think most of us know what we need to do to lead a healthier
lifestyle, and sometimes we don't because we feel like we are
kind of sliding along and we are doing OK. Just like I said, I
was very active but I knew I needed to lose weight. I also knew
that my diet was not what it should be, although my cholesterol
level was fairly low. It was 170. But I also knew that I had
these risk factors related to my family, but I never took any
proactive measures. For me it was just a little too hard to
lose 20 pounds. But I will tell you, a motivating factor is
having a heart attack. And one of my messages to people is to
not wait until you have a heart attack, that there are certain
things you can do. And it takes time. I knew and wanted to lose
weight, but I wanted to lose it in a week. It took me a long
time to lose the weight, and I think that's also a message that
needs to get out to people is that eating healthier, eating
better, eating smarter, and also making time to exercise is
very important. And so while I may have appeared healthy,
certain things can happen; and I think at this point I would do
everything I can to make sure that I have a healthier
lifestyle.
Mr. Pallone. Sure. Now, you said you were 50 at the time,
but the bill is I guess mainly targeted for women aged 65 and
older; so I guess I would ask Dr. Bennett, what is the reason
for that targeted audience of over 65? I mean, why not target
women age 64 and younger, Ms. Wolf being a good example?
Dr. Bennett. Well, certainly the Act has several components
to it. I think the over 65 was the Medicare portion of the Act.
The FDA certainly is a big part of that, and getting data to
understand how heart disease functions in women who are age 50
is very important. It turns out that family history, especially
for women, is a huge risk factor. It increases risk by about
1.7 fold, so there are some things potentially that could have
been done ahead of time. And when we look at women who have
heart attacks in their 50's, they do far worse than men who are
the same age; and we don't really know why. Research, in
looking at the FDA research especially, in that age group, men
versus women, is going to be very important to gain a better
understanding of what medical treatments might make people
better off.
Mr. Pallone. OK. You started to talk about the WISEWOMAN
program, Dr. Bennett, that has been a big factor in providing
these pre-cardiovascular disease screenings for low-income,
uninsured 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.]