[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]
H.R. 1157, BREAST CANCER AND ENVIRONMENTAL RESEARCH ACT OF 2007 AND
H.R. 758, BREAST CANCER PATIENT PROTECTION ACT OF 2007
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED TENTH CONGRESS
SECOND SESSION
__________
MAY 21, 2008
__________
Serial No. 110-121
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
JOHN D. DINGELL, Michigan, JOE BARTON, Texas
Chairman Ranking Member
HENRY A. WAXMAN, California RALPH M. HALL, Texas
EDWARD J. MARKEY, Massachusetts FRED UPTON, Michigan
RICK BOUCHER, Virginia CLIFF STEARNS, Florida
EDOLPHUS TOWNS, New York NATHAN DEAL, Georgia
FRANK PALLONE, Jr., New Jersey ED WHITFIELD, Kentucky
BART GORDON, Tennessee BARBARA CUBIN, Wyoming
BOBBY L. RUSH, Illinois JOHN SHIMKUS, Illinois
ANNA G. ESHOO, California HEATHER WILSON, New Mexico
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York CHARLES W. ``CHIP'' PICKERING,
GENE GREEN, Texas Mississippi
DIANA DeGETTE, Colorado VITO FOSSELLA, New York
Vice Chair ROY BLUNT, Missouri
LOIS CAPPS, California STEVE BUYER, Indiana
MIKE DOYLE, Pennsylvania GEORGE RADANOVICH, California
JANE HARMAN, California JOSEPH R. PITTS, Pennsylvania
TOM ALLEN, Maine MARY BONO MACK, California
JAN SCHAKOWSKY, Illinois GREG WALDEN, Oregon
HILDA L. SOLIS, California LEE TERRY, Nebraska
CHARLES A. GONZALEZ, Texas MIKE FERGUSON, New Jersey
JAY INSLEE, Washington MIKE ROGERS, Michigan
TAMMY BALDWIN, Wisconsin SUE WILKINS MYRICK, North Carolina
MIKE ROSS, Arkansas JOHN SULLIVAN, Oklahoma
DARLENE HOOLEY, Oregon TIM MURPHY, Pennsylvania
ANTHONY D. WEINER, New York MICHAEL C. BURGESS, Texas
JIM MATHESON, Utah MARSHA BLACKBURN, Tennessee
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
_________________________________________________________________
Professional Staff
Dennis B. Fitzgibbons, Chief of
Staff
Gregg A. Rothschild, Chief Counsel
Sharon E. Davis, Chief Clerk
David Cavicke, 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
DIANA DeGETTE, Colorado JOHN B. SHADEGG, Arizona
LOIS CAPPS, California STEVE BUYER, Indiana
Vice Chair 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..................................... 3
Hon. Henry A. Waxman, a Representative in Congress from the
State of California, opening statement......................... 4
Hon. Tim Murphy, a Representative in Congress from the
Commonwealth of Pennsylvania, opening statement................ 5
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 5
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 6
Hon. Hilda L. Solis, a Representative in Congress from the State
of California, opening statement............................... 7
Hon. Marsha Blackburn, a Representative in Congress from the
State of Tennessee, opening statement.......................... 8
Prepared statement........................................... 9
Hon. Darlene Hooley, a Representative in Congress from the State
of Oregon, opening statement................................... 10
Hon. Sue Wilkins Myrick, a Representative in Congress from the
State of North Carolina, opening statement..................... 11
Hon. Tammy Baldwin, a Representative in Congress from the State
of Wisconsin, opening statement................................ 12
Hon. Joe Barton, a Representative in Congress from the State of
Texas, opening statement....................................... 13
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 14
Prepared statement........................................... 15
Hon. John D. Dingell, a Representative in Congress from the State
of Michigan, prepared statement................................ 16
Hon. John B. Shadegg, a Representative in Congress from the State
of Arizona, opening statement.................................. 17
Hon. Edolphus Towns, a Representative in Congress from the State
of New York, opening statement................................. 18
Prepared statement........................................... 19
Hon. Mike Rogers, a Representative in Congress from the State of
Michigan, opening statement.................................... 19
Hon. Jim Matheson, a Representative in Congress from the State of
Utah, opening statement........................................ 20
Hon. Lois Capps, a Representative in Congress from the State of
California, opening statement.................................. 20
Hon. Jan Schakowsky, a Representative in Congress from the State
of Illinois, opening statement................................. 21
Witnesses
Deborah Winn, Ph.D., Associate Director, Epidemiology and
Genetics Research Program, National Cancer Institute........... 22
Prepared statement........................................... 25
Fran Visco, President, National Breast Cancer Coalition.......... 50
Prepared statement........................................... 52
Sheryl Crow, singer-songwriter and breast cancer advocate........ 56
Prepared statement........................................... 58
Kim Lyerly, M.D., George Barth Geller Professor of Research in
Cancer; Director, Duke Comprehensive Cancer Center, Duke
University Medical Center...................................... 59
Prepared statement........................................... 61
Kristen Zarfos, M.D., FACS, Assistant Clinical Professor,
University of Connecticut School of Medicine; Director, St.
Francis Comprehensive Breast Health Center, Saint Francis
Hospital....................................................... 74
Prepared statement........................................... 76
Alva Williams, a breast cancer survivor.......................... 80
Prepared statement........................................... 81
Submitted Material
Georgia Cancer Coalition, letter of May 20, 2008, to Mr. Deal.... 90
Breastcancer.org, letter of May 20, 2008, to Ms. DeLauro......... 93
Oncology Nursing Society, letter of March 3, 2008, to Ms. DeLauro 94
Cancer Action Network, letter of May 16, 2009, to Ms. DeLauro.... 95
Connecticut Breast Cancer Coalition Foundation, letter of May 19,
2008, to Ms. DeLauro........................................... 96
Lifetime Networks, letter of May 21, 2009, to the Subcommittee... 97
Breast Cancer Network of Strength, letter of May 15, 2008, to Ms.
DeLauro........................................................ 99
Families USA, letter of May 16, 2008............................. 100
Susan G. Komen for the Cure Advocacy Alliance, letter of May 19,
2008, to Ms. DeLauro........................................... 101
.................................................................
H.R. 1157, BREAST CANCER AND ENVIRONMENTAL RESEARCH ACT OF 2007 AND
H.R. 758, BREAST CANCER PATIENT PROTECTION ACT OF 2007
----------
WEDNESDAY, MAY 21, 2008
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 11:07 a.m., in
room 2123 of the Rayburn House Office Building, Hon. Frank
Pallone (chairman) presiding.
Members present: Representatives Pallone, Waxman, Towns,
Eshoo, Green, Capps, Baldwin, Engel, Schakowsky, Solis, Hooley,
Matheson, Deal, Shadegg, Pitts, Rogers, Myrick, Murphy,
Burgess, Blackburn, and Barton (ex officio).
Staff present: Ryan Long, Chad Grant, Brandon Clerk, Amy
Hall, Jessica McNiece, Bobby Clark, Melissa Sidman, Hason
Sarsour, Lauren Bloomberg, Brin Frazier, and Jodi Seth.
Mr. Pallone. The meeting of the subcommittee is called to
order.
Today we are having a hearing on two bills, H.R. 1157,
``The Breast Cancer and Environmental Research Act of 2007,''
and H.R. 758, ``The Breast Cancer Patient Protection Act of
2007.''
OPENING STATEMENT OF HON. FRANK PALLONE, JR., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. I will recognize myself initially for an
opening statement.
These bills obviously are very important. According to the
Centers for Disease Control and Prevention, or the CDC, breast
cancer is the second most common form of cancer in women. Each
year in America approximately 182,000 women are diagnosed with
breast cancer, of which 41,000 lose their lives. Undoubtedly,
many of us know some of these women. They are our mothers, our
grandmothers, wives, sisters, daughters, co-workers, and
friends. Families across the country are confronted with this
terrible disease every day. In fact, breast cancer has hit
close to home for me and my family after my mother-in-law was
recently diagnosed with the disease. So I can personally attest
to the struggle these families have to face. And as a son, a
husband, and the father of two girls I want to ensure that we
are doing everything we can to beat back this terrible disease.
While improved access to screening and treatment services
have helped reduce breast cancer death rates over the past
couple of decades, significant challenges still remain.
For example, we are still unsure about what causes breast
cancer or how to prevent it. While there have been a number of
studies that have looked at various risk factors, we have not
been able to draw a solid conclusions about what specifically
causes breast cancer. H.R. 1157, ``The Breast Cancer and
Environmental Research Act of 2007,'' introduced by
Congresswoman Nita Lowey, is intended to address the need for
more research in the hopes of discovering the causes, possible
preventative measures, and one day a cure. Let me also
acknowledge the work of my colleagues on the Committee, Ms.
Capps and Ms. Myrick, who have also been tireless advocates on
behalf of this legislation.
H.R. 1157 would authorize a research program at the
National Institutes of Health to study the potential links
between breast cancer and the environment. Specifically the
bill would authorize the National Institute of Environmental
Health Science to aware grants for the development and
operation of centers for the purpose of conducting research on
environmental factors that may be related to breast cancer.
This bill has strong bipartisan support and 268 members of the
House have cosponsored the bill, including the majority of the
members on this committee. A number of organizations have also
endorsed H.R. 1157 and have called upon Congress to implement a
broad research strategy as outlined in the legislation.
Clearly, this bill is a priority for many people, and I am
looking forward to hearing testimony from a few of them today.
In addition to H.R. 1157 we will also hear testimony on
H.R. 758, ``The Breast Cancer Patient Protection Act of 2007,''
introduced by my good friend and colleague from Connecticut,
Congresswoman DeLauro. H.R. 758 would require that health plans
provide coverage for minimum hospital stays for mastectomies,
lumpectomies, and lymph node dissection for the treatment of
breast cancer. I call it the drive-through bill. It would also
require coverage for radiation treatment for women undergoing
lumpectomies and coverage for secondary consultations when the
patient requests one.
Presently 21 states have implemented minimum stay
requirements to varying degrees. As a result, some people may
question why this legislation is necessary. But this bill is
not for the women who live in those states or have insurance
policies that provide these protections. It is for the women
who do not. For these women a federal remedy is their only
hope. Having access to appropriate medical care should not be
dependent on the state that you live in.
Once again, I want to thank my colleagues who have worked
so hard on both of these bills. I assure you that not only
Congressman DeLauro and Congresswoman Lowey, but many other
members have been pushing, I guess is the best to say, over the
last few months to bring up these bills and have a hearing. It
is really because of their efforts and the efforts of the
people that they represent that we are here today. And I also
want to thank out witnesses for being here today. We look
forward to hearing from your testimony.
And I now recognize the 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.
Diagnosis of breast cancer is certainly a devastating blow
to any woman, and also to the sons, the daughters, and the
husbands or a mother or a wife who is faced with this life-
threatening disease. You have mentioned your family. I have
three daughters as well, and four granddaughters, and certainly
have a personal interest in this matter.
Fortunately, great strides have really been made in the
treatment of breast cancer, and as a result the number of
breast cancer survivors continues to increase. However, we must
learn more about the causes and the treatments of this disease
through continued research. Already the National Institutes of
Health devotes considerable resources to breast cancer research
in evaluating the environmental causes of this disease. As we
pursue new treatments for all diseases it is important for us
to always be considering the causes for the disease that we are
trying to treat. By knowing the causes we can do more to
prevent disease, rather than simply treating it.
These efforts of prevention will save lives, but to get to
that point we must be learning more about the triggers of the
disease. I applaud the ongoing efforts of the NIH to research
breast cancer, so that we can continue to make life saving
advancements. I signed on as a cosponsor of H.R. 1157 to show
my support because I believe it is important for us to continue
research into the causes of breast cancer. I also strongly
supported efforts last Congress to fundamentally reform the
NIH, which I believe was a vital step in improving research
into all diseases. It is all too easy, I am afraid, for the
political process to interfere with research funding questions
which should be guided by science and medicine. My hope is that
the NIH has been better able to coordinate their efforts
between the various institutes since the passage of the NIH
Reform Act.
Mr. Chairman, it would be my hope that we would have an
opportunity in the remaining months of this Congress to hold a
hearing on the NIH Reform Act to evaluate its success and find
ways to further improve the research efforts at NIH.
I want to thank our distinguished witnesses for their
attendance today, and I look forward to hearing not only about
the work being done at NIH on breast cancer, but also hearing
suggestions from our other witnesses about how those efforts at
NIH could be made more effective.
And, Mr. Chairman, at the conclusion I have a letter from
the Georgia Cancer Coalition outlining a project that they have
undertaken as it relates to coordinating of information about
breast cancer, and I would ask unanimous consent that it be
made a part of this record.
Mr. Pallone. Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Deal. I yield back my time.
Mr. Pallone. Thank you, Mr. Deal. Thank you.
The gentleman from California, Mr. Waxman, is recognized
for an opening statement.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Mr. Chairman, for holding
this hearing on two important bills dealing with breast cancer
issues, which have broad bipartisan support. In fact, both
bills have a majority of the House of Representatives as
cosponsors of the legislation. I think it is important that we
hold this hearing and move these bills forward.
Breast cancer kills so many people, strikes so many. It is
a tragedy. And what is so troubling is that we are learning
more and more about environmental causes of breast cancer. We
don't know the cause of breast cancer. We are trying to figure
out how to treat the disease. But wouldn't it be great if we
could stop the disease and prevent it? And we can't figure out
how to do that unless we can see if there is an environmental
cause for breast cancer itself.
There has only been limited research on environmental
factors, and in many cases the studies have raised, rather than
settled these important questions. So it is critical that we do
all we can to understand the links between the environment and
cancer. Obviously, we need to do more research to do that. The
Breast Cancer and Environmental Research Act would establish a
peer review program at NIH to fund collaborative research
across institutions, across disciplines, and with community
organizations to study the environmental factors that cause
breast cancer.
I hope that we could reach a consensus and move these bills
right away. They should have been enacted into law in the last
Congress. It was unfortunate that this particular bill did not
go through.
I want to address one additional critical point. Some will
say it is not the business of the Congress to tell the NIH what
their research priorities should be. And I say nonsense. Of
course we shouldn't micromanage the work at NIH, or we
shouldn't make scientific judgments, or select specific
projects, but it is our business to establish broad priorities.
If we had not taken that role in the past we would not have
seen the tremendous progress in AIDS research. We would not
have changed the policies to ensure that women were involved in
clinical trials. And we would not have been able to push for
addressing racial disparities in health care. It is appropriate
that we establish a priority for examination of environmental
affects in breast cancer, and that is why this bill is so
important. It has 268 of our colleagues as cosponsors. More
than enough to pass the House.
I look forward to hearing from our witnesses today, and
working with all of my colleagues to get this job done.
Mr. Pallone. Thank you, Mr. Waxman.
Next for an opening statement the gentleman from
Pennsylvania, Mr. Murphy.
OPENING STATEMENT OF HON. TIM MURPHY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA
Mr. Murphy. Thank you, Mr. Chairman.
I am particularly interested in this hearing today to
gather some information not only because of the importance of
continuing on with research and an extended understanding of
breast cancer, but like so many people in this room knowing it
has also touched my life with sisters who have suffered from
breast cancer. And what I want to know is what else we can do
to prevent it, and what else we can do to treat it and make
sure that it is an acute illness and a preventable illness.
I also want to make sure that as we review the bills in
front of us today that we are getting important information on
what decisions doctors and patients need to make in hospitals.
When I was the state senator I was the author of Pennsylvania's
Patient Bill of Rights Law. And in so doing there were many
times we thought it was important to review procedures that
insurance companies had to make sure the decisions could be
made by physicians and patients in cooperation in making
important decisions about their care. And that decisions were
not just made on a financial basis of saying how long and what
patients should have as treatment.
I am hoping today to also gather information on this with
regard to patient stays. Making sure we are not standing in the
way of medical decisions of what is in the best interest of the
patient's treatment, and quite frankly, sometimes the best
interest of the patient's mental health in terms of their
length of stay.
There is so much we can be doing, and I know so many folks
in this country have dedicated themselves to raising money
independently for things like the Susan Komen breast cancer
research through NIH funding--NIMH funding. We have to continue
to do that. All of us have to continue to be dedicated to
eradicating this disease and finding the best ways of treatment
and prevention of it.
And with that I yield back.
Mr. Pallone. Thank you, Mr. Murphy.
Next for an opening statement our vice-chair, Mr. Green,
the gentleman from Texas.
OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Green. Thank you, Mr. Chairman, for holding the hearing
on these two very important pieces of breast cancer
legislation.
As a cosponsor of both bills I am pleased that we are
moving them through the committee process. Breast cancer is the
second most common cancer among women in the U.S. from 1973 to
1998. Breast cancer incident rates increased by more than 40
percent. Today a woman's lifetime risk of getting breast cancer
is one in eight. The National Cancer Center Institute estimates
that over 182,000 women, and more than 1,100 men will be
diagnosed with breast cancer, and that over 40,000 women and
450 men will die as a result of breast cancer.
Research has shown that cancer can be linked to
environmental causes. While some research is being conducted by
the National Cancer Center Institute and the DOD in these areas
we still have not discovered why some people get breast cancer
and others do not. The Breast Cancer and Environmental Research
Act of 2007 will allow the National Institute of Environmental
Health Science to make grants available for the development and
operation of research centers specifically designed to study
the link between environmental factors and breast cancer.
Some people would get breast cancer due to increased
genetic risks. However, others who have no genetic
predisposition for breast cancer will be diagnosed with it.
This piece of legislation will allow for research to be
conducted to possibly uncover the link between environmental
factors and breast cancer. The Breast Cancer Patient Protection
Act of 2007 will require group health insurance providers to
provide coverage for no less than 48 hours of hospital care to
mastectomy patients.
Texas already has a state mandate requiring minimum length
of stays following the breast cancer surgery, but it is only
one of 20 states to have this protection for cancer patients.
Patients who have mastectomies are at risk of developing
infections and need medical care from trained medical
professionals following their surgery. Both these bills should
have passed years ago, and I am pleased that we are having this
legislative hearing today.
Mr. Chairman, I yield my time.
Mr. Pallone. Thank you.
Next is the gentleman from Texas, Mr. Burgess, for an
opening statement.
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 brief because I am anxious to get on to our
witnesses.
We all recognize that medical research, scientific research
is lengthy and tedious and expensive. Many years of training
for the young scientist who wants to spend a lifetime in
research. They have to spend long years before even beginning a
career in research, which adds to the expense. For certain non-
governmental sources such as corporations and philanthropic
organizations there is a great deal of money that they put
forward, but the expense is too much for the private sector to
bear alone. And we are fortunate to have the National
Institutes of Health, which is truly a national treasure to
really get the ball rolling on a lot of the very basic research
that likely would not be borne by the private sector. And it is
by partnering these elements the Federal Government does its
best work and helps us motivate the innovation and keep the
edge in technology and knowledge that truly makes America the
envy of the world.
I am a believer that scientific research is important. I am
not necessarily a believer that--I do part company a little bit
with what Chairman Waxman says about us being in charge of
making the decisions about the direction of the research. True
enough, broad priorities should be set by bodies such as this,
and committees such as this. But we also gave the NIH broad
powers with their translational research in December of 2006.
And we are barely past that reauthorization bill, and I do
think we need to give Dr. Arhunee and the scientists at the
National Institutes of Health the freedom to explore where that
translational research will take them.
Oftentimes I find myself in some difficulty because I don't
know that I always know how to tell the American family how to
budget their expenses. I don't know how to always tell the
generals how to fight the battles. And I think we all need to
be careful about being those micromanagers that Chairman Waxman
said we should not be, and trying to direct at a micro level
the NIH and other federal research entities, and telling them
what to study and when to study.
This is well-intentioned legislation. At the end of the day
I may well vote for it. I am grateful to have this hearing as a
learning exercise. Again, I am concerned about prescribing a
specific way of conducting federal research and the unintended
consequences. We live in a time it used to be your unintended
consequences might not happen for a generation. Now they happen
in a matter of months. So we do need to be careful about the
unintended consequences.
The NIH has established four standards of excellence for
breast cancer and environmental research. That is a good thing.
Nearly three-quarters of $1 billion are devoted to the research
of breast cancer and environmental factors. The NIH Reform Act
was devised to give the NIH more authority to conduct a
multitude of disciplinary research and establish priorities
that were previously dominated by more political talk and not
scientific action.
In my 25 year medical career I treated thousands of
patients, and breast cancer was a daily specter over my
practice. It has certainly visited me and my family in a
personal way as well. I understand the importance of getting
the upper hand on this disease. But I also think we need to
acknowledge that the NIH is already doing good work, and we
must be careful that what we do today doesn't further constrain
their ability to do the correct kind of research.
And I will yield back the balance of my time.
Next for an opening statement the gentlewoman from
California, Ms. Solis.
OPENING STATEMENT OF HON. HILDA L. SOLIS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Solis. Thank you, Mr. Chairman, and thank you for
holding this very important hearing to discuss two very
important bills that will help millions of women and families
affected by breast cancer.
I have been a proud supporter of both of these pieces of
legislation for many years, and I am very pleased that finally
the subcommittee is moving to address the breast cancer issue
in a comprehensive way.
You know, it is estimated that about 180,000 women will be
diagnosed this year with breast cancer. And for women of color,
particularly minority women, Latinas, breast cancer is often
diagnosed later with fewer treatment options resulting in
increased risk of death. Only 38 percent of Latinas over the
age of 40 have regular mammograms. And even though Latinas have
lower rates of breast cancer than white or African-American
women breast cancer continues to be the leading cause of death
for Latinas.
H.R. 1157, The Breast Cancer Environmental Research Act
would provide important research on the links between our
community's environment and its impact on breast cancer risks.
I have long advocated for increased awareness for the inherent
links between our environment and our health. In Los Angeles
County, for example, poor air quality and pollution have
incredibly damaging affects on everyone, especially our
children who develop asthma. We owe it to the millions of
American women who have fought this terrible disease to
comprehensively study how our environment may have contributed
to their breast cancer. This research we know could provide
promising prevention strategies so that future generations of
women are not impacted by breast cancer.
The second bill that we will be discussing today, The
Breast Cancer Patient Protection Act, is long overdue. A piece
of legislation will be provide basic standards that health
insurers must adhere to for breast cancer patients. Twenty
states, including mine in California, have already enacted
minimum length of stay requirements for breast cancer
surgeries, which is a key provision in H.R. 758. Both H.R. 758
and H.R. 1157 are important bills that grass root activists
from across the country have worked tirelessly to champion for
many, many years.
I look forward to hearing the testimony from our witnesses,
and I yield back the balance of my time.
Mr. Pallone. Thank you.
Next is the gentlewoman from Tennessee, Ms. Blackburn.
OPENING STATEMENT OF HON. MARCIA BLACKBURN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TENNESSEE
Ms. Blackburn. Thank you, Mr. Chairman. I thank you for the
hearing.
I want to welcome our witnesses, and I want to welcome the
young women that I am seeing here in the hearing room today for
this hearing.
I am a cosponsor of H.R. 1157, The Breast Cancer
Environmental Research Act. I also cosponsored this in the
109th session of Congress, when I was in the state senate in
Tennessee. This is an issue that I started working on then and
have continued to follow.
One of the interesting things is that one in every three
cancers diagnosed in women is breast cancer. And the way this
affects us in Tennessee, in 2006, we had 4,400 new breast
cancer cases and the lives of 1,000 Tennesseans were claimed
that year. And the impact of the environmental conditions is
something that has not been lost on us, and that we are
continuing to follow, so I appreciate that legislation.
All in all, Tennessee is home to some stellar cancer
research. We have the University of Tennessee Cancer Institute.
We have the Vanderbilt-Ingram Cancer Institute, which is
dedicated to breast cancer research.
We also have one that I know, our witness and my
constituent who I welcome, Ms. Crow. Thank you for being here.
I know she has been involved, as I have been very supportive,
of the Minnie Pearl Breast Cancer Center at Centennial Medical
Center in Nashville. And I thank you for that support, and I
thank you for all you do to bring awareness to the issue.
The Tennessee Breast Cancer Coalition continues to work
towards eradication of the disease through both education and
advocacy on the state and national level. In fact, the
coalition has raised over $1.2 million since '95, and donates
100 percent of those funds to efforts within the state of
Tennessee. We are serious about this issue.
We have had some talk this morning about the NIH, and their
responsibility. It is our responsibility to continue to fund
the NIH. I do think, however, the NIH rather than Congress
should set those research priorities. We are going to talk more
about that.
But, Mr. Chairman, I thank you for the opportunity to bring
these issues forward, to bring attention to them. I welcome our
guests.
I yield the balance of my time and will submit a longer
statement for the record.
[The prepared statement of Ms. Blackburn follows:]
Statement of Hon. Marsha Blackburn
Today, the Subcommittee will discuss two important bills
regarding breast cancer. I am a cosponsor of H.R. 1157, the
Breast Cancer Environmental Research Act, and also cosponsored
this legislation in the 109th Congress.
Since my days in the Tennessee State Senate, I have been
interested in the link between breast cancer and environmental
factors, and secured funding to research the relationship
between the two issues in Tennessee.
One in every three cancers diagnosed in U.S. women are
breast cancer diagnoses, making it the most common diagnosed
cancer in women. Approximately 4,400 new breast cancer cases
were diagnosed in Tennessee women in 2006, claiming the lives
of 1,000 Tennesseans that same year.
Tennessee is home to stellar cancer research institutions,
including the University of Tennessee Cancer Institute, the
Vanderbilt-Ingram Cancer Center, and the Minnie Pearl/Sarah
Cannon Cancer Center at Centennial Hospital in Nashville
dedicated to breast cancer research. I would also like to
recognize Sheryl Crow, a constituent testifying on the second
panel today, who has been very involved with the Minnie Pearl/
Sarah Cannon Cancer Center.
In addition, the Tennessee Breast Cancer Coalition (TBCC)
continues to work towards eradication of the disease through
education and advocacy on the state and national level. In
fact, the TBCC has raised over $1.2 million dollars since 1995,
and donates 100% of raised funds to efforts within the state of
Tennessee.
I also maintain a strong record of support for breast
cancer research. I have cosigned multiple letters and
cosponsored legislation in support of breast cancer, such as
the National Breast and Cervical Cancer Early Detection Program
Reauthorization Act which was signed into law last year.
Throughout my experience in the Tennessee State Senate and
in Congress, I have met with all kinds of disease-specific
groups advocating for additional research funding. Every
disease is important and with the growth of entitlement
programs consuming the federal budget, research dollars are
scarce.
It is the responsibility of Congress to provide funding to
the National Institutes of Health (NIH). As the agency
developed in size and complexity, the Committee completed NIH
Reauthorization last year to assist with the growing need for a
more efficient inter-agency coordination and best practices.
The NIH continues to formulate specific scientific directions
and priorities, as well as operational oversight of its
institutes and centers.
However, the NIH--rather than Congress--should set its
research priorities. While I support continued research,
Congress must be careful not to set NIH funding priorities and
cherry-pick the most ``worthy'' diseases for research funds.
Even with the best of intentions, it is irresponsible for
Congress to micromanage NIH.
While I appreciate the focus of this hearing on important
public health programs, I believe this committee could use this
time to work on more critical and time-sensitive issues, such
as reform of the Medicare physician payment formula.
I have met with doctors from all over Tennessee regarding
their concerns about the impending 10 percent pay cut for
physicians under Medicare, scheduled to go into effect July 1,
2008.
I have repeatedly supported congressional efforts to
provide physicians with Medicare payment relief. It is
unfortunate that this committee is not taking any action to
prevent the looming payment cut from going into effect.
As health care providers in my district have stated time
and time again, many Tennessee physicians have already stopped
taking Medicare patients. With this cut, a critical number of
doctors will cease to serve Medicare beneficiaries completely
if a solution is not implemented to fix the physician payment
reduction.
It is imperative that this committee and Congress act on
this critical issue immediately. The alternative could be
disastrous for this nation's seniors.
I thank the Chairman and yield back the balance of my time.
----------
Mr. Pallone. Thank you, Ms. Blackburn.
Next for an opening statement the gentlewoman from Oregon,
Ms. Hooley.
OPENING STATEMENT OF HON. DARLENE HOOLEY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Ms. Hooley. Thank you, Mr. Chair.
As I prepared for this hearing I went back to my files to
refresh my memory on the various bills and letters I signed
onto in support of breast cancer research and funding. I found
a draft letter written in 2000 in response to a constituent
asking for my support for the Breast Cancer Environmental
Research Act in the 106th Congress, which I am proud to say I
did cosponsor.
In part, Mr. Chairman, the letter references a July 2000
article in the New England Journal of Medicine reporting on a
new study showing that environmental factors are more important
than gene factors in causing many types of cancer. Specifically
the study reported that on average environmental factors caused
about twice as many cancers as inborn genetic factors. The
study also stated that researchers are unsure which
environmental factors are cancer causing, which clearly shows a
need for research in this area. The Breast Cancer and
Environmental Research Act of 2007, of which I am proud to be a
cosponsor is as relevant today as it was 8 plus years ago.
Mr. Chair, the constituent letter I referred to was written
8\1/2\ years ago. I understand that in the greater scheme of
things here in Congress 8 years may be hardly any time at all.
However, not to the people who have been diagnosed with cancer.
Since that time 1.5 million people have been diagnosed with
breast cancer, and the American public shouldn't have to wait
any longer for action on this issue.
I could make a similar statement about the need to act on
the Breast Cancer Patient Protection Act of 2007. In Oregon we
passed a minimum standard for mastectomy patients. I think it
is only fair to give folks that are not fortunate enough to
live in the great state of Oregon similar care in treatment.
Mr. Chair, I yield back the remainder of my time. I look
forward to asking questions of the witnesses, and I think we
need to get on with the business and not wait any longer for
this. Thank you.
Mr. Pallone. Thank you.
Next is the gentlewoman from North Carolina, Ms. Myrick.
OPENING STATEMENT OF HON. SUE WILKINS MYRICK, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NORTH CAROLINA
Ms. Myrick. Thank you, Mr. Chairman. Thank you for calling
the hearing. I appreciate it, and for all of our witnesses who
are going to testify. And, of course, I am delighted Dr. Lyerly
is from North Carolina. We always like to have North Carolina
people here.
But this is a really important hearing, and I appreciate
the fact that we have got the opportunity today, and all of you
are here to do this.
I have been an early cosponsor on the Breast Cancer and
Environmental Research for several years, because of course I,
like every other person basically, including men, not just
women, believe it is critical to examine those potential
environmental triggers that cause breast cancer incidents. And
of course, as has already been mentioned, I too am very
troubled by the growing number of young women who are diagnosed
with aggressive, often deadly, forms of breast cancer. And I
believe that dedicated medical research is the most effective
way to figure out why this happens.
As a strong supporter of NIH reform in the NIH Reform Act,
I understand the importance of encouraging the efficient,
effective research at NIH. Congressional restraint in the
disease-specific realms are important because none of us wants
to unintentionally limit the effectiveness of any cross
institutional research by being too prescriptive with
legislation, and not letting science drive the research agenda.
And I was pleased to see the compromise language on the
bill emerge from the Senate HELP Committee earlier this year,
because I believe that this revised language improves the
efficacy of the bill, and appropriately reflects the intent of
its supporters to assist and improve scientific research on
breast cancer's environmental links.
I am also supportive of the Breast Cancer Patient
Protection Act to limit instances when women are forced to
leave the hospital shortly after a mastectomy. It, of course,
was supported by my dear friend, Joanne Davis, who tragically
succumbed to the disease last year. We all still miss her a
lot. The State of North Carolina has passed legislations other
states have already mentioned to require a minimum hospital
stay for mastectomies, which applies to health plans under the
state's jurisdiction. This bill would extend the requirement to
a ERISA plans and group and individual plans within the
jurisdiction of the Public Health Service Act. And naturally
this requirement does not apply if a medical decision includes
sending a patient home will not hamper her recovery.
I again thank the Chairman for holding this hearing, and I
look forward to hearing from our witnesses.
And as a breast cancer survivor myself, why it always has
extra importance to me, because fortunately I am still here.
Thank you all for being here, and I yield back my time.
Mr. Pallone. Thank you, and thank you in particular for all
that you have done to bring attention to the issue. I know you
have talked to me many times, and I appreciate that.
For an opening statement our next member is the gentlewoman
from Wisconsin, Ms. Baldwin.
OPENING STATEMENT OF HON. TAMMY BALDWIN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF WISCONSIN
Ms. Baldwin. Thank you, Mr. Chairman, and I very much
appreciate your holding this hearing today, and our witnesses
for joining us.
I am, like a number of my colleagues, proud to be a
cosponsor of both H.R. 1157, which seeks to move us closer to
identifying and understanding the causes of breast cancer, and
H.R. 758, which seeks to ensure that breast cancer patients
receive adequate care.
I was delighted last year to partner with my colleague,
Representative Myrick, who we just heard speak, in authoring
the reauthorization of the National Breast and Cervical Cancer
Early Detection Program. And it was great to work with you, Mr.
Chairman, and many other members of this subcommittee and the
Full Committee in passing that important reauthorization.
I know that many of my colleagues on this subcommittee
share my commitment to strengthening the federal role in
fighting breast cancer. And I am glad that we are continuing
that commitment by considering the two bills that we have
before us today.
Mr. Chairman, unfortunately nearly all of us are touched by
breast cancer in some form. Either as a patient, a daughter, a
friend, a sister, a brother, a son, a father, or mother of
somebody who has been diagnosed with breast cancer. The
National Cancer Institute estimates that this year alone some
nearly 200,000 women and men will be diagnosed with breast
cancer, and they also estimate that over 40,000 women and
nearly 500 men will die as a result of breast cancer.
I view these bills as important steps that cover both ends
of the spectrum. In the case of H.R. 1157 we are strengthening
the commitment that our Nation's health researchers are making
to discover the cause of breast cancer and the environmental
factors that play a role in the disease. And once we discover
the cause, then we can work to improve prevention and treatment
of breast cancer. In the case of H.R. 758 we are strengthening
patient protections to ensure that breast cancer patients are
receiving appropriate medical care. We are also ensuring that
medical treatment decisions are being made by a patient and her
doctor and not by the insurance companies.
While I am glad that a number of states have already
enacted state level reforms to ensure minimum lengths of stay
requirements for breast cancer surgery, I note that my home
state of Wisconsin is not one of those states. So establishing
a federal standard would certainly benefit the people that I
represent in the state of Wisconsin.
Again, Mr. Chairman, I am a strong and enthusiastic
supporter of both of the bills before us today, and I am
looking forward to today's discussions. Thank you.
Mr. Pallone. Thank you, Ms. Baldwin.
Next is the ranking member of our Full Committee, the
gentleman from Texas, Mr. Barton.
OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS
Mr. Barton. Thank you, Mr. Chairman. Thank you for the
hearing.
I want to start out by thanking the Susan G. Komen Breast
Foundation for their tireless dedication to breast cancer
research. I have been associated with the leaders of that
organization for a number of years and I am very proud of the
work that they have done.
I want to say something about this specific bill. We have
been talking a lot in this Congress about earmarks, mostly in
the appropriation bills, but there are earmarks that can pop up
in other places too. And the bill that is before us today is
one of those bills. It is a disease-specific bill for earmark
research at the National Institutes of Health. For more than a
decade Congress and this committee on a bipartisan basis has
been trying to make decision-based decisions on both policy--we
have tried to fund each of the major institutes and centers
that compromise NIH with a single appropriation line item. I
had my staff look and we can't find one instance in the last 5
or 6 years where the appropriators of the House of
Representatives funded a research project to benefit one
specific disease.
Disease-specific earmarks are bad policy. They are bad for
science. We shouldn't do it. Having said that, every year there
are literally dozens of bills that are filed in this committee
that designate disease-specific research activities. And I will
say that all these disease-specific research activities are
positive, that they are noble, they need to be done. So it is
not the issue of whether we should be doing in this case breast
cancer research or not. The issue is how do we instruct the
National Institutes of Health to use the research dollars that
we appropriate for the best possible good for all Americans.
If a patient advocacy group is looking for more attention
for a specific disease it seeks out a member to sponsor a bill
who does it with the noblest of intentions, signs up
cosponsors, and who can be against breast cancer research, and
pushes forward. I understand that that is good politics for the
member that is introducing the bill, our members, and I know it
is always helpful to show interest in a specific disease, and
it is definitely good for the association that is pushing that
particular bill. However, as I have said earlier, it is not
good science and it is counterproductive in my opinion for
Congress to politically micromanage the National Institutes of
Health.
In the last Congress, on a bipartisan basis, we made a
major effort to reform and improve the National Institutes of
Health. It was one of the top priorities of my chairmanship.
And the bill that I am most proud of in the 24 years that I
have been in the Congress is the National Institutes of Health
Reform Bill which passed in the last Congress. We held dozens
of hearings. We consulted with every major scientific society.
We sat down with all the major research universities and
medical colleges. We talked to all the institute directors at
NIH. We talked to the director of NIH himself. We moved heaven
and earth to put together a consensus package, and we passed
it.
With the Breast Cancer and Environment Research Bill that
we are discussing today, it is a bill that has been in the last
several Congresses. It always has several hundred cosponsors,
and the top cosponsors are very, very good people and good
personal friends of mine. This bill would require the NIH to
coordinate research activities between the Cancer Institute and
the Environmental Health Institute. That makes sense. The
problem is it is already being done. We don't need the bill
before us today to make that happen.
In addition, in the NIH Reform Bill that is now the law of
the land we have set up a common fund that any, any
investigator that wants to work across the silos at the NIH can
form a coalition with other investigators and other institutes
and apply for research grants through this common fund. And the
Common Fund has been funded by the appropriators. So again, the
problem that this bill is addressing has already been
addressed.
I could go on and on, Mr. Chairman, but my time is about to
expire. Let me simply say this. It is good public policy for
members of this committee and this Congress to be interested in
research to find cures to all the various diseases, whether it
be breast cancer, Alzheimer's, Parkinson's disease, you name
it. But we should try to have a policy where we fund research,
put priorities on certain research, and then let the NIH under
this new reform package that we just passed find the best way
to allocate the available resources. I hope that we don't go
back to the way we used to do business, where whichever
advocacy group has the most political clout in a specific
Congress, they get their research funded at the top of the
list. That is not the way, in my opinion, to do health-based
scientific research.
With that, Mr. Chairman, I yield back.
Mr. Pallone. Thank you, Mr. Barton.
Our next member for an opening statement, the gentlewoman
from California, Ms. Eshoo.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Eshoo. First, Mr. Chairman, thank you for having this
hearing on the bills. Thank you to our witnesses.
I see a real honor roll of great advocates sitting in the
rows looking up at us. And I hope that you will respect what
comes out of this as you are sitting there.
I want to thank our colleague Sue Myrick because she has
been steely and gentle at the same time, and has inspired a lot
of us. And I want to salute her for the work that she has done.
I paid special attention to what the ranking member of the
Full Committee just said. I have worked with Joe Barton for
years. We like each other. We have trusted each other. And it
is--I think he outlined where the Committee is and what we
honored in all of these things. But, Joe, I want to say to you
that life is not tidy. This is really more a competition for
dollars, than it is for anything else. And so that is how I
think that whole architecture has been set down about specific
diseases and specific disease bills and whatever.
I for one think that this committee should just break
through all of that and say as great as the United States is we
can be greater and we are going to declare war on all of these
diseases. We have the capability and the capacity to do this.
We just haven't set forward the political will to fund these
things, and so we have the DOD funding, breast cancer
research--you know why we have that there? Because that is
where the money is, and that Congressman Murtha took that call
up years ago.
And so we are here today with two good bills. I don't think
they deliver the world on this issue, but in terms of the
research it is very important. Just in this last week four of
my friends--actually two of my friends were diagnosed with
stage II, and each one of their daughters was diagnosed with
stage II. And that is in one week's time.
So there is work to be done here. This is as serious as it
comes. Women, men, their families can't go to Macy's, they
can't go to Neiman Marcus to get their problem solved on this.
They come to us. They come to us. The least we can do is to put
these bills on the books. They are important bills, but they
are not the end-all. So let us do ourselves proud by doing the
right thing, but understanding that, as Auntie Mame said, we
have miles to go and places to see. And I hope all of my
colleagues will consider breaking out of the pack, and saying
let us declare war on a whole list of diseases and set the
resources there. Set the resources to the task. There isn't
anything that our researchers and our scientists in this
country can't do if we are willing to fund it.
So thank you for starting out with this. I am proud to
cosponsor them. I look forward to the people that are going to
testify. And I am especially proud of the advocates and the
breast cancer coalition advocates that never tire of knocking
on our doors.
Thank you, Mr. Chairman.
[The prepared statement of Ms. Eshoo follows:]
Statement of Hon. Anna G. Eshoo
Thank you Mr. Chairman for holding this hearing on two very
important breast cancer bills, the Breast Cancer and
Environmental Research Act and the Breast Cancer Patient
Protection Act which I'm proud to cosponsor.
Breast cancer affects hundreds of thousands each year and
is the most common cause of cancer among women. There's still
so much we don't know about breast cancer but there are strong
clues that the environment is playing some role. How big a role
is what we need to learn.
The Breast Cancer and Environmental Research Act is
supported by the National Breast Cancer Coalition. It would
establish a national strategy to study links between the
environment and breast cancer and to bring us closer to
learning what these exposures are, possibly unlocking new
treatments and cures.
The Breast Cancer Patient Protection Act would guarantee
mastectomy and lumpectomy patients a minimum hospital stay of
48 hours, and 24 hours for a woman undergoing a lymph node
removal. It's important to note that this bill does not mandate
a 48-hour hospital stay if a patient chooses to go home sooner,
nor does it set 48 hours as a maximum amount of time a woman
can stay in the hospital. The bill only ensures that any
decision in favor of a shorter or longer hospital stay will be
made by the patient and her doctor, and not an insurance
company.
I look forward to hearing from our witnesses today and I
thank the Chairman for holding this hearing. We do not yet know
what causes breast cancer or how to prevent it and that's why
these bills can make important contributions to our
understanding of this all-too-frequent disease.
----------
Mr. Pallone. Thank you, Ms. Eshoo.
I would like to request that the statement of our Full
Committee Chairman, Mr. Dingell, be inserted into the record.
Without objection, so ordered.
[The prepared statement of Mr. Dingell follows:]
Statement of Hon. John D. Dingell
I am pleased that Chairman Pallone is holding this hearing
to provide the Subcommittee on Health an opportunity to learn
more about H.R. 1157, the ``Breast Cancer Research and
Protection Act of 2007'', and H.R. 758, the ``Breast Cancer
Patient Protection Act''. Breast cancer is the second most
common type of cancer among women in the United States, and
this Congress should closely examine how best to prevent and
treat it.
One of the hopeful messages from cancer research is that
most cases of cancer are linked to environmental causes and, in
principle, can be prevented. Environmental factors such as
exposure to excessive sunlight or to chemicals, cigarette
smoking, diet and lifestyle can all contribute to an
individual's chances of developing cancer. While it is known
that certain genetic and environmental factors increase the
risk of developing cancer, it is not known exactly which
combination of factors is responsible for a person's specific
cancer.
H.R. 1157 would provide for the development and operation
of collaborative, multi-institutional centers for the purpose
of conducting research on environmental factors that may be
related to the etiology of breast cancer. Additionally, this
legislation would establish a Breast Cancer and Environmental
Research Panel at the National Institutes of Health. This Panel
would be responsible for developing innovative approaches to
study unexplored or underexplored interactions between the
environment and the occurrence of breast cancer and outline the
key knowledge gaps.
I look forward to taking a closer look at issues related to
breast cancer and environmental research, and I am very
interested in exploring how best to accomplish the goals of
this legislation.
The other bill that is the subject of today's hearing is
H.R. 758. This legislation is included as a part of the
Patients Bill of Rights, which I have championed over the past
decade. I was also a lead cosponsor when it was originally
introduced as a freestanding bill.
H.R. 758 would ensure that women undergoing mastectomies
would be guaranteed 48 hours of hospital care unless the
provider and patient determine a shorter stay is appropriate.
The legislation would also protect physicians who provide
quality care for breast cancer patients from retaliation by
health maintenance organizations (HMOs) and other insurance
companies seeking to maximize profits at the expense of patient
care.
Guaranteeing that treatment decisions are made by the
provider in consultation with the patient, taking into account
the patient's unique medical needs, is the cornerstone of good
medical care and an important part of what makes H.R. 758 a
good bill.
One of my own staff from Michigan, Connie Shorter, was
victim of these unscrupulous insurance company practices when
she was sent home after a mastectomy in considerable pain with
no support to manage her condition. Connie ultimately succumbed
to her cancer, but the heartless way her insurance company
treated her was an outrage.
I am pleased the Subcommittee is shining light on these
issues of great importance to women and their families and look
forward to the testimony of today's witnesses.
----------
Mr. Pallone. And our next member for an opening statement
is the gentleman from Arizona, Mr. Shadegg.
OPENING STATEMENT OF HON. JOHN B. SHADEGG, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ARIZONA
Mr. Shadegg. Thank you, Mr. Chairman, and I want to thank
you for holding this hearing. I want to compliment my friend
Sue Myrick for her tireless advocacy of the cause of breast
cancer and dealing with the issue.
I hadn't intended to make a lengthy opening statement but
just to insert my opening remarks, but I think in light of the
discussion we are having I would like to deliver my
perspective.
My life has been touched directly by breast cancer. My
oldest sister, who when I was young and before I was married
was my best friend, is now a 20-plus year breast cancer
survivor. And I thank God for that every day. She remains a
very close friend.
In addition, I think in prior hearings many of you have
heard me tell the story of my son, who in his young education
needed tutoring assistance. He had a tutor that was with him
for years and years. He grew phenomenally close to her, and
tragically her life was taken by breast cancer.
There are valid merits to both of the arguments we have
just heard. Both Mr. Barton's argument that the political
allocation of research funds has drawbacks to it. That means
that those with the greatest political power can get that
legislation passed and perhaps that is not how we ought to
allocate resources. At the same time, my colleague on the other
side did a great job of articulating that sometimes it is
appropriate to rise above that.
What I would like to say is something that people don't
understand because it is a civics lesson, and that is often it
is appropriate to introduce a bill and to hold a hearing on a
bill whether that bill becomes law or not. The American people
need to understand the importance of going after and allocating
research dollars to go after breast cancer. And whether we
enact these bills as they are written, or amend them and change
them, or whether we remain with the current policy where NIH
decides the allocation of these resources, this hearing is
appropriate. Bringing these knowledgeable people forward,
reminding the American people of the need for research dollars
in this area, making people aware of the dire consequences of
cancer on so many lives. The numbers show one in eight American
women will be a victim of breast cancer in their lives. I think
there is no amount of attention that you could pay to this
issue that would be too great.
I simply want to say that I applaud, as again, my friend,
Sue Myrick, for her tireless advocacy and all of the advocates
of this legislation. We need to continue to focus on this
fight. It is vitally important. I know that we need to find a
cure, and if we ignore it, if we don't look at it, if we don't
examine it, we won't get there.
I want to conclude with one last point. When I first got
here to Congress, HMOs, I believed, were abusing people rather
dramatically. They were failing to pay for services that people
need. They were denying coverage, not based on medical reasons,
but based on money. And so I became a champion of patient
advocacy legislation. Sadly, we never passed that legislation.
But I believe that just the legislative hearings, and the
pressure Congress put by looking at that legislation, put
pressure on the HMO industry to quit denying people care for
reasons other than legitimately they didn't need the care,
rather than just to get rich off of their premiums. And I think
this could be viewed in the same way. I believe it is important
to hold these hearings and to focus on these issues, and to
debate them and resolve whether or not we need to fund this
particular legislation at this level or some other level, or
follow the course that Joe was talking about.
But I compliment you, Mr. Chairman, and all involved.
Mr. Pallone. Thank you.
Next for an opening statement the gentleman from New York,
Mr. Towns.
OPENING STATEMENT OF HON. EDOLPHUS TOWNS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW YORK
Mr. Towns. Thank you very much, Mr. Chairman. I would like
to thank you and, of course, Mr. Deal for holding this hearing.
This is a giant step in the right direction. I want to
commend the gentlewoman from North Carolina for her work. And
to say that I would agree with the fact that it might not be a
total solution, but I think that it is moving in the right
direction. And I support both H.R. 1157 and also H.R. 758. I am
a sponsor of both of the bills. And the reason I am a sponsor
of both is that the fact that my situation is that I come from
a family of four. Mother, father, and a brother. All of them
died from cancer. And to listen to some of the comments being
made on the other side bothers me, because I think that we
cannot sit back and not do everything that we can do to find a
cure.
And let me just sort of pause and say that I want to extend
my best wishes to a true health care advocate, the Honorable
Senator Ted Kennedy, who has been fighting this battle for more
than 40 years. I want to extend my best to him and to his
family during this very difficult period.
I look forward to hearing from the witnesses, because I
think that there is so much that we can learn from the
witnesses. And, of course, through this process I hope we move
forward with an open mind. That we really, really understand
how important it is to put the resources wherever to be able to
come up with a cure.
So I want to thank the witnesses for coming and sharing,
and I want to thank the members for being here to listen. And I
hope that through this process that we will be able to fund the
research, do whatever is needed to be able to come up with a
cure.
And I would like to associate myself with remarks made from
the gentlewoman from California. Yes, we are piecemealing, but
when you are frustrated and you know that something needs to be
done, you are prepared to do whatever you can do at the time
that you can do it. I agree with her. I think that we should
fund all of that, and to be in a position to do--I think we can
do it. But the point of the matter is that do we have the will?
It is not a priority. And once we make it a priority then I
think we can come up with the solution.
So I would say to you, Mr. Chairman, I think that you are
doing the right thing by having a dialogue, and that hope out
of this dialogue will come a solution.
Thank you so much for having this hearing.
[The prepared statement of Mr. Towns follows:]
Statement of Hon. Edolphus Towns
Thank you, Chairman Pallone and Ranking Member Deal for
convening this hearing on H.R. 1157 and 758, recognizing the
importance of breast cancer and environmental research, and
breast cancer patient protection to enable longer hospital
stays for women who undergo mastectomies. I am a proud
cosponsor of both bills. Breast cancer is the most frequently
diagnosed cancer among women, but it disproportionately affects
African American women. Environmental research includes the
ability to examine the health disparity aspects and better
positions us for finding a cure. I am greatly motivated to find
a cure because I lost my mother, father, and brother to cancer.
Lastly, I extend my best wishes to a true health care
advocate--the honorable Senator Ted Kennedy and his family
during this period.
Thank you, Mr. Chairman, I yield back.
----------
Mr. Pallone. Thank you, Mr. Towns.
Next for an opening statement, the gentleman from Michigan,
Mr. Rogers.
OPENING STATEMENT OF HON. MIKE ROGERS A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Rogers. Thank you, Mr. Chairman, for having the
Committee.
As a 24-year cancer survivor myself I certainly understand
the impact that the disease has on families across the country.
I couldn't imagine that there aren't that many people in
America whose lives who have not been touched by cancer in any
way.
When it comes to breast cancer we have seen the lives of
grandmothers, and mothers, daughters, wives, and friends all
torn apart by the deadly disease, including my sister-in-law.
But we also have witnessed tremendous stories of courage, and
importantly, victory over cancer. I remember when I first ran
in 1994 the folks were saying whatever you do don't tell people
you survived cancer. We have come a very long way, because so
many people with courage have stood up and said yes, we can
beat this disease and yes, we can continue on with long and
productive lives.
Finding a cure for cancer is a national priority. Last year
alone the Federal Government spent over $5.6 billion on cancer
research. In fact, last year the National Cancer Institute
spent $500 million on breast cancer research alone. Along with
support for this research I have been working on issues
impacting cancer care and treatment. As a matter of fact, in
2005 a good friend of mine, Anna Eshoo from California, and I
cofounded the Cancer Care Working Group here in Congress to
educate members and staff about exciting new developments and
challenges facing oncology.
It is my hope that through a strong federal commitment to
cancer research we will soon find cures that will offer new
hope to millions of people throughout the world. I hope this
committee, and I hope this serves as an opportunity for us to
address some concerns with H.R. 1157, just as the Senate HELP
Committee has done in order to ensure that breast cancer
research dollars are spent on actual research. Not overhead,
not administration or duplicate efforts.
Again, thank you, Mr. Chairman, for holding this hearing
today, and I look forward to working with you on this important
issue as we move forward.
Mr. Pallone. Thank you.
Next I recognize the gentleman from Utah, Mr. Matheson, for
an opening statement.
OPENING STATEMENT OF HON. JIM MATHESON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF UTAH
Mr. Matheson. Thank you, Mr. Chairman.
I am a cosponsor of H.R. 1157. As my colleagues have
stated, this bill would invest in research still necessary to
determine the potential links between breast cancer and the
environment, so that we can cure it and eventually eradicate
this terrible disease.
Our best weapon against cancer is research. Everyday the
headlines reveal new information that cancer patients, their
families, and their doctors can use in their battle against
this disease. The national investment in cancer research has
yielded, and will continue to yield, substantial returns in
terms of lives saved and suffering lessened. Through that
research these scientists are making advances in the causes,
diagnoses, and treatments of cancer and are on the front lines
in the quest for prevention and cure.
In my state of Utah nearly 1,000 people will be diagnosed
with breast cancer this year, and it is anticipated over 200
will die from this disease. I am continually saddened by the
fact that a woman in the United States has a one in seven
chance of developing invasive breast cancer during her
lifetime. This risk was one in 11 in 1975. Breast cancer
remains the second leading cause of cancer death among women,
second only to lung cancer.
I am committed to continue fighting for increased research
into the potential links between the environment and breast
cancer. And I have joined many of my colleagues on this
committee in encouraging increased funding for NIH. Because we
don't know what causes breast cancer I look forward to hearing
from the panel of experts on this bill in ways that this
committee should tackle the question of how our environment may
affect breast cancer.
Mr. Chairman, I yield back my time.
Mr. Pallone. Thank you.
And next is the gentlewoman from California, Ms. Capps. I
thank her again. She has also been a tireless advocate for the
environmental research bill.
OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Capps. Thank you, Mr. Chairman. And particularly I want
to give some thanks this morning in my opening statement. Thank
you first of all for holding this hearing. I fully believe that
this hearing is long overdue and welcomed and needs to lead to
passage of legislation. It is not just a showplace for
discussion today.
In saying that, I give the utmost praise to our tireless
advocates who are here yet again on the topic of breast cancer.
As it is an epidemic in our country today with the numbers of
one in eight women--that is astounding when you think of the
number of women who have had cancer or will expect to be
diagnosed with cancer during their lifetime. And all of the
people who will be affected by that.
I want to single out our celebrity, Sheryl Crow, because
you are not coming today as a celebrity as much as a survivor,
and you don't give just token status to this. I have watched
you here on the Hill time and time again, advocating also
around the country. I am putting a face, a human life, to this
topic in ways that are very appreciated by women around the
country as well, and the many other advocates.
I want to speak on behalf of the Caucus for Women's Issues
in the House of Representatives. Seventy-four of us strongly
support these two pieces of legislation, determined that these
will pass and be adequately funded.
And then to the two authors of the Breast Cancer and
Environmental Research Act. Nita Lowey, who will, I believe,
join us shortly. But, Sue Myrick, my dear friend and survivor,
and co-chair along with me and our friends, Deborah Pryce and
Steve Israel of the Cancer Caucus. And this is a high priority
for this Caucus as well.
We have also the opportunity now to have this hearing on
the Breast Cancer Patient Protection Act. And I just want to
say that I came to Congress as a spouse over 11 years ago. And
one of the first things I heard about was the so-called drive-
by mastectomy. That this famous person I hadn't met yet, Rosa
DeLauro, was working tirelessly to eliminate that possibility
that some of the insurers were making it so difficult for
someone to go through a horrendous surgery and then be sent
off, back home again so quickly.
And I think it is very, very important to acknowledge, and
perhaps others have already, that along with Rosa DeLauro, the
co-author of this legislation in this Congress, is our dear
departed colleague, Jo Ann Davis. And it is with great
determination that we need to pass this bill in her memory.
So I am going to yield back, and look forward very much to
the testimony of our witnesses today. Thank you.
Mr. Pallone. Thank you, Ms. Capps.
And next for an opening statement the gentlewoman from
Illinois, Ms. Schakowsky.
OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Ms. Schakowsky. Thank you, Mr. Chairman.
This is a great way for us really to close this legislative
work period before returning home to our districts for a week.
As you have heard everybody has a personal story. I was
proud when I was in the state legislature that we were able to
pass legislation that stopped these drive-through mastectomies
in Illinois. Give women a period of time to get the care that
they need in the hospital. And several states have actually
done that. And I have been with women, talked with women, who
were shuffled out of the hospital before they felt ready to go.
And unfortunately, too many women experienced those kinds of
things, because their insurance companies don't do what is
really needed and appropriate. And so I am so glad we are going
to be making progress on H.R. 758 today.
And I also want to express my thanks to Congresswoman Rosa
DeLauro for her tireless work on this. And I want to thank the
cosponsors of the Breast Cancer and Environmental Research Act,
H.R. 1157, Congresswomen Nita Lowey and Sue Myrick. And I am
proud to be one of the cosponsors of that bill.
We know far too little about what causes breast cancer, but
without a doubt we know that it affects far too many of our
mothers and daughters and sisters and friends. And this bill
will take a huge step toward learning more about the etiology
of breast cancer by establishing a research panel, encouraging
multi-disciplinary and multi-institutional research on the
environmental factors that may be related to breast cancer and
authorizing appropriations for these purposes.
I am particularly interested in finding ways to learn more
about the relationship between chemical exposures from everyday
products and the occurrence of breast cancer. I look forward to
hearing our witness from the NIH, Dr. Winn, who I believe will
discuss this area of research. I believe this is something that
we can do in the United States of America with the kind of
expertise that we have. That we can actually provide answers to
some of these health care challenges. And I look forward as a
member of Congress to be part of that effort to make it happen
sooner, rather than later.
Thank you, Mr. Chairman. I yield back.
Mr. Pallone. Thank you, Ms. Schakowsky.
I think that concludes our opening statements by the
members, so we will now turn to our first panel, which actually
has one witness.
Welcome, Dr. Winn. Let me introduce and give everyone your
official credentials here. You are the associate director--this
is Dr. Deborah Winn, who is associate director of Epidemiology
and Genetics Research Program at the National Cancer Institute
in Bethesda.
You know the ritual here. We have a 5-minute opening
statement. It becomes part of the record. But we may, as
Committee members, submit additional briefs or pertinent
statements in writing and ask you to get back to us later in
writing.
So I now recognize you. Welcome again, and thank you for
being here.
STATEMENT OF DEBORAH WINN, PH.D., ASSOCIATE DIRECTOR,
EPIDEMIOLOGY AND GENETICS RESEARCH PROGRAM, NATIONAL CANCER
INSTITUTE
Dr. Winn. Thank you very much for the opportunity to speak
with you today. I am Deborah Winn, the associate director for
the Epidemiology and Genetic Research Program at the National
Cancer Institute, NCI, within the National Institutes of
Health, NIH, an agency of the Department of Health and Human
Services.
Mr. Pallone. I think Dr. Winn--do you want to bring that
mic closer and make sure it is on?
Dr. Winn. Sure.
Mr. Pallone. You might have to bring it closer.
Dr. Winn. OK. I specifically oversee research seeking----
Mr. Pallone. I don't know. It seems to be something wrong.
Is the light on?
Dr. Winn. Yes, the light is on.
Mr. Pallone. Maybe just bring it closer.
Dr. Winn. OK. OK.
Mr. Pallone. That is good.
Dr. Winn. How about that? Sorry. I specifically oversee
research seeking to identify environmental and genetic factors
involved in the etiology of breast cancer, which H.R. 1157 is
intended to address.
We at NIH believe that the current Public Health Service
Act provides sufficient authority to address this area of
research, as well as others. As science advances through
discovery it increasingly converges. We know that the answers
to the most vexing scientific questions involving one disease
often comes from areas of unrelated research. As scientists we
know that it would be a mistake to focus on one disease without
understanding the underlying biological mechanisms that affect
multiple diseases. And this is one of the great lessons that we
are learning from some of the recent advances in genomics and
molecular biology.
In general, prescribing a specific way of conducting
federal research could have the unintended consequences of
narrowing the field of inquiry, and promoting an unwise use of
precious resources. This morning I would like to share with you
information about our progress in understanding the role of the
environment and the development of breast cancer. The research
activities that I describe were planned and carried out using
our existing authority.
As you have noted it is estimated that approximately
180,000 women will be diagnosed with breast cancer in 2008. I
certainly know about this, having been one of them diagnosed
with breast cancer at age 42. Known risk factors include
increasing age, family history, reproductive history, obesity,
heavy alcohol intake, and hormone replacement therapies. We
know less about possible environmental causes of breast cancer,
but we recognize that breast cancer is a complex disease caused
by multiple interacting factors including genes, hormones, and
environmental exposures that interact across the lifespan and
may share common etiologic pathways with other diseases.
NIH estimates that it will fund about $705 million in
breast cancer research in fiscal year 2008; almost $100 million
will be spent focusing specifically on the role of the
environment in breast cancer. Despite this substantial
investment, well-conducted studies of adult women have revealed
little in the way of findings of possible environmental causes.
One new approach is to study ``windows of susceptibility.''
These are the prime events over the lifespan where exposures to
environmental factors can directly or indirectly affect a
person's risk of developing breast cancer. This approach stems
from the knowledge that there are specific windows of time and
physiologic changes in the mammary gland that may be important.
And narrowing in on these time periods could be very important
in our understanding.
To uncover the links between early environmental exposures
and cancer risks, NCI partnered with the National Institute of
Environmental Health Sciences, NIEHS, in 2003 to fund four
Breast Cancer and the Environment Research Centers. We call
these BCERCs. These BCERCs are specifically focusing on
exposures during early life and during puberty because they are
important windows of susceptibility for breast cancer. The
centers are headquartered at four sites across the U.S., but
each center is a consortium and has many research partners. The
BCERCs were designed to include breast cancer advocates as
foundational parts of each center and as formal members of
various steering committees and an advisory working group. Each
center includes basic scientists, clinicians, population
scientists, and advocates. They conduct research into the role
of the environment in breast cancer by using both animal models
and studies in human populations.
The animal models allow investigators to examine the entire
reproductive span and breast cancer. The research also includes
the study of young girls going through puberty to look at
environmental, psychosocial, dietary, and other determinants of
breast development.
My written testimony includes details about a number of
other research efforts we have in the area of breast cancer and
the environment. In conclusion, NIH funds research that takes a
diverse approach to studying breast cancer and the environment.
This approach includes identifying specific chemicals which
change the structure and function of the mammary gland, or
breast, during different windows of susceptibility,
understanding gene environment interactions in the etiology of
breast cancer and other associated physiological milestones
that are associated with breast cancer risks.
In addition, our research is focused on identifying common
pathways across a number of different types of cancer. While
more research is needed and with continued collaborations of
scientists, advocates, and Institutes, we are well equipped to
continue to support and enhance this area of breast cancer and
the environment research.
And I would like to thank you for the opportunity to
testify today and welcome any questions.
[The prepared statement of Dr. Winn follows:]
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Mr. Pallone. Thank you, Dr. Winn, and thank you for all
that you and your colleagues do at NIH.
We are going to have questions now, and I will start with
myself for questions.
In your testimony you talk about a lot of the research that
is already ongoing at NIH or being funded by extramural
research grants. The proponents of this legislation, as you
know, believe that the research strategy outlined in the bill
before us will help supplement research efforts currently
underway. Do you think that the provisions of this bill will
help build upon current research efforts and lead to a better
understanding of the linkages between the environment and
breast cancer, and basically why or why not?
Dr. Winn. Well, NIH already has the existing authorities to
pursue this area of research through the Breast Cancer and the
Environment Research Centers as well as many other
opportunities. For example, through the Common Fund and through
the Genes and Environment Initiative, we have ample
opportunities to study breast cancer and the environment.
Mr. Pallone. Well, how does the research strategy outlined
in the bill compare or contrast from the efforts currently
under way at NIH or being funded through NIH through extramural
grants?
Dr. Winn. The bill would include a panel that would direct
the funding of the research, as well as having a very specific
disease focus. Our general approach at NIH that has worked very
well for us is to use our existing peer review system that is
really considered to be a gold standard across the world for
its fairness and its focus on scientific merit. Also, our
approach at NIH with respect to breast cancer and the
environment takes a number of different routes through, for
example, use of the Common Fund, use of various funding
mechanisms, and use of workshops that include the advocacy
community.
Mr. Pallone. Now, there is a Senate equivalent of this
bill.
Dr. Winn. Yes.
Mr. Pallone. I try not to mention the other body too often
here, but there is one.
Dr. Winn. Yes.
Mr. Pallone. And I understand that NIH has--well, I
understand that our colleagues in the Senate made some changes
to the legislation when the HELP Committee marked up its
version. Can you explain the concerns that NIH has with the
House bill and tell me if the changes that the Senate made
adequately addressed your concerns, or are there any other
changes that NIH would like to see made?
Dr. Winn. Yes. Well, certainly from the scientific
perspective the issue regarding the funding panel, as well as
the single-disease focus, are concerns that we have because it
circumvents the existing peer review system, and because a
single-disease focus can actually constrain us in terms of the
research that we can do and our ability to let the science
direct the research agenda. Specifically, regarding the Senate
bill, the Senate bill as amended is not opposed by NIH.
However, the Administration does not have a position on the
bill.
Mr. Pallone. But you obviously had some input into the
changes. Is there anything else? I mean I understand your basic
concern----
Dr. Winn. Yes.
Mr. Pallone [continuing]. With any of these bills, but you
have obviously had some input on the Senate bill. Is there
anything additional, other than the basic concern that you
would like to see addressed here?
Dr. Winn. I think I will defer to my colleagues on that.
Mr. Pallone. This is----
Dr. Winn. The changes in the Senate bill are very
satisfactory to the National Institutes of Health.
Mr. Pallone. OK. Let me ask you one more question, and then
we will move on. You testified that advocates play an active
role in the governance of the Breast Cancer and the Environment
Research Centers, and its formal members--I guess they are
formal members of various steering committees and then advisory
working group. Can you, please, explain why you believe it is
important for advocates to play an active role with respect to
these issues?
Dr. Winn. Because they are the ones who are listening to
the community. The advocates in our group have played a number
of key roles in addition to participating in the overall
scientific management and oversight. Some of these roles
include our ability to help recruit and retain the young girls
and their families who are part of the epidemiologic study.
They also have an incredibly large role in developing materials
that try and explain what it is that we do know about breast
cancer and the environment that can be used both with the study
participants and their families, as well as the broader
communities. Each of the advocacy groups that is part of the
Breast Cancer and the Environment Research Centers are local to
that particular center and are very well aware of the issues
that differ between the California, Ohio, Michigan, and New
York City areas where the young girls are located.
Mr. Pallone. OK. Thank you very much.
Mr. Deal.
Mr. Deal. As I understand it you currently work with
outside advocacy groups in determining the direction of the
research that NIH is conducting. Is that correct?
Dr. Winn. Yes, that is true.
Mr. Deal. All right. Could you give us an idea how under
the NIH Reform Act this collaboration of information across
institute lines works in terms of, perhaps, advancing the cause
of dealing with this specific area of breast cancer?
Dr. Winn. Well, I can give you one example, which is the
Genes and Environment initiative, and that is the trans-NIH
effort that comes out from the Common Fund. One major part of
that is the environmental exposure area. We are really way
behind in terms of our ability to monitor individual's
environmental exposures and in the development of biomarkers
that would indicate environmental exposure or early damage. And
one of the particular projects that is being supported under
that is looking at biomarkers for estrogen-like compounds in
biological fluids that could be used as a future biomarker for
example. So that is one area where the Common Fund has directly
impacted the breast cancer and the environment issues.
Mr. Deal. As I read your testimony one of the concerns that
you express is that if we try to statutorily be too specific in
designating what you must do or should do that we run the risk
of having unintended consequences. Is that a general
summarization of one of your concerns?
Dr. Winn. Yes. So, for example, with this bill, were this
bill to pass, we would have to fund it given the current fiscal
environment. We would have to redirect funds from some other
research area. This is what typically happens at NIH with a
disease-specific requirement.
Mr. Deal. I believe I have the figures right, that you
currently spend about $705 million on breast cancer research.
Is that about right?
Dr. Winn. Yes.
Mr. Deal. How does that compare with other cancer research
activities?
Dr. Winn. Well, it is extremely high. For example, in the
area of brain cancer research the estimate is $148 million in
fiscal year 2007. So that would compare with $705 million for
breast cancer research in 2007.
Mr. Deal. All right. Thank you, Mr. Chairman. I yield back
my time.
Mr. Pallone. Thank you, Mr. Deal.
The gentlewoman from California, Ms. Eshoo.
Ms. Eshoo. Thank you, Mr. Chairman, and thank you for being
here today with us.
The area that I would like to examine is--and I obviously
don't know the answer to this. Is there research being done in
other countries today to study the links between environmental
factors and breast cancer?
Dr. Winn. Yes. In fact, the National Cancer Institute,
through the intramural program, is funding what is called the
Polish Breast Cancer Case Control Study. The study is focusing
on--like many studies of breast cancer on many risk factors
including occupational exposures. We sometimes like to look at
occupational exposures because workers tend to have greater
exposures, and it allows us to look at potential environmental
factors better. So that is an instance where we are using a
special opportunity to focus on environmental factors.
Ms. Eshoo. How big is that study in Poland?
Dr. Winn. My understanding is several thousand women with
and without breast cancer. I can find out more information
about the numbers.
Ms. Eshoo. And other countries?
Dr. Winn. With respect to environment and breast cancer
research?
Ms. Eshoo. Yes.
Dr. Winn. We have a number of studies in China that are
cohort studies that involve tens of thousands of people that
have some environmental components. Usually they are focused on
multiple factors.
Ms. Eshoo. And those are the two that come to mind? Are
there many more? Is it widespread? Is it small? Would we be in
the lead by doing this?
Dr. Winn. Would we be the lead in breast cancer and the
environment research? I would have to get back to you on that.
There are some countries that are particularly strong in
environmental research.
Ms. Eshoo. Yes.
Dr. Winn. For example, Scandinavian countries where record
linkage is much more common, which enables certain types of
research more than others.
Ms. Eshoo. Well, I am particularly interested in the nexus
between environmental factors and breast cancer because that is
what one of the bills directs itself toward. Are women in other
countries, do you know, getting breast cancer at the same rate
as in the United States? The one in eight figure?
Dr. Winn. The probability of developing breast cancer can
be very high in many parts of the world. It is likely to be
higher in more developed countries than in less developed
countries in general.
Ms. Eshoo. And can you speak to the enthusiasm that you
have for these bills? Do you recommend any additions or
subtractions or tweaking? You are an expert in the field and
that is what a hearing is for. We want to hear, listen, build,
make better.
Dr. Winn. Yes. We all appreciate the goal of the
legislation, but NIH already does----
Ms. Eshoo. I mean on the specifics.
Dr. Winn [continuing]. Have authorities that would allow us
to pursue these areas. We are, of course, from a scientific
perspective concerned about the peer review aspect and the
single disease focus. And the Senate bill is not opposed by
NIH.
Ms. Eshoo. Why are you concerned about that?
Dr. Winn. We are concerned about the peer review system
because the NIH peer review system is set as a gold standard
with respect to its overall fairness and its overall focus on
scientific merit. It is a very finely tuned instrument for that
purpose. And the comparable safeguards with respect to the
panel that is proposed would not ensure that same level of
scientific overview expertise on the panel and the scientific
merit focus.
Ms. Eshoo. Yes.
Dr. Winn. It also creates a parallel organization separate
from the----
Ms. Eshoo. So the peer review process is what you believe
should be in the----
Dr. Winn. The peer review process has worked very well for
us.
Ms. Eshoo. Yes. And what was your other concern?
Dr. Winn. The other concern is the single disease focus----
Ms. Eshoo. Yes.
Dr. Winn [continuing]. In terms of boxing us in with
respect to the types of research that could be undertaken.
Ms. Eshoo. Well, it seems to me though that this is one of
the biggest question marks relative to breast cancer. I mean
women in the Bay area where I come from have much higher rates.
There have been--and when I think of all of the women and their
families that run and walk and we sponsor them, and the dollars
from selling cupcakes to go into research, this seems to me to
be an area that we need to really be pouring some efforts into.
So I am more attracted to a bolder statement that, yes, we are
going to take this on and not be so tied to--if we had
succeeded with what you just stated I would say, hey, we have
won. We have already discovered. We have made the
breakthroughs. Amen. Let us move on to something else. But I
don't think we have, so I don't understand why you would be
essentially driving with an emergency brake on and be kind of
hanky about research that is specific, and the nexus between
the environment and breast cancer. That is my observation, so
now you can't really respond because I am 29 seconds over time.
Thank you.
Mr. Pallone. OK. Thank you, Ms. Eshoo.
Dr. Winn, would you get back to us in writing, though, with
some of the things that Ms. Eshoo mentioned about the----
Dr. Winn. I certainly will.
Mr. Pallone [continuing]. Studies in Poland and the E.U.
and----
Dr. Winn. Yes.
Mr. Pallone [continuing]. How these compare in terms of
funding?
Dr. Winn. Absolutely.
Mr. Pallone. Thank you.
Next for questions is the ranking member, Mr. Barton.
Mr. Barton. Thank you, Mr. Chairman.
Let me start out by putting a few things on the record I
didn't in my opening statement. I have an aunt that died of
breast cancer, and I have a sister that is a breast cancer
survivor of 15 years. I also have a brother that died of liver
cancer, a father that died of complications from a heart
operation caused by diabetes, and my mother is in an early
stage of Alzheimer's victim. My problem with this bill is not
that we shouldn't do all we can do to combat breast cancer. My
problem with the bill is that once again we look like we are
going down the path of picking winners and losers and who gets
the most research. You know, where does that leave liver cancer
or breast cancer or bone cancer, leukemia, lung cancer, skin
cancer, brain cancer, prostate cancer, pancreatic cancer? What
about Alzheimer's? What about Parkinson's? What about autism?
What about diabetes? So that is my problem.
Let me ask you, Doctor, right now in the National Cancer
Institute we have four centers of excellence for breast cancer
research. Is that correct?
Dr. Winn. Yes, we have four Breast Cancer and the
Environment Research Centers.
Mr. Barton. OK. Do we also--now, in the environmental--in
the National Institute of Environmental Sciences, which is a
separate institute from National Cancer Institute, does the
National Institute of Environmental Sciences have centers of
excellence for environmental research, and if so how many?
Dr. Winn. Well, first of all I would like to ask if Mr.
Chairman would permit my asking my colleague, Gwen Collman,
with the National Institute for Environmental Health Sciences,
NIEHS, to join me at the table?
Mr. Pallone. Sure. Let me introduce her. It is Dr. Gwen
Collman from the National Institute of Environmental Health
Sciences, Chief of Disease, Susceptibility and Population
Branch.
Dr. Collman. Thank you very much for the opportunity to
answer the question directly. The NIEHS has 25 centers of
excellence in environmental health sciences distributed across
the country. Many of them are actively involved in research on
breast cancer and environment, but of course the field of
environmental health sciences is quite broad. They support
research in basic science, toxicology, exposure assessment in
human studies related to a host of environmental exposures as
causes of a variety of different diseases.
Mr. Barton. Now, the bill before us would require the
creation of collaborative multi-institutional centers of breast
cancer and environmental research in addition to what we
already have. In the opinion of you--both of you expert
witnesses--is that directive in the pending legislation
necessary or helpful?
Dr. Winn. Well, we already have Breast Cancer and the
Environment Research Centers that fall within what you
described in that they are transdisciplinary, multi-center, and
geographically distributed.
Mr. Barton. OK. As I understand the pending bill it would
require the creation of additional multi-institutional centers.
And my question is, since we have 25 centers of excellence for
environmental research and four centers of excellence for
breast cancer research, are those currently collaborating and
cooperating, and is it necessary to create these additional
centers of excellence?
Dr. Winn. So my personal opinion on this is that there are
lots of different mechanisms available to us at NIH to bring
small projects together with larger projects and to create
consortia around issues of importance. We have tackled some of
these questions using a center mechanism, but we are concerned
that we would not be able to tackle these pressing problems
using other mechanisms with the language in the current bill.
Also, we routinely bring center members together for joint
meetings that are focused on synergizing the science. We have
broad authority and ability to do that and do that all the
time.
Mr. Barton. Now, am I not correct that under the new common
fund that has just been created, and has been funded by the
appropriation process, if any of the scientific leaders,
research directors, at the existing centers of excellence and
your two institutes wanted to collaborate on a specific
research project they could put together an application, submit
it to the Common Fund, and it would be peer-reviewed by experts
and if it was of merit it would probably be funded. Is that not
correct?
Dr. Collman. The investigators at our centers do
collaborate and they have submitted applications that leverage
the resources that we have given them in the original projects.
An example is the study that Dr. Winn mentioned before in our
genes environmental health initiative where two--three
collaborators from different centers in our Breast Cancer
Environment Research Centers submitted an application to the
genes environment and health initiative and was funded through
the Common Fund to develop new markers of exposure to
disrupting chemicals. We can fund studies collaboratively right
now both from institute funds and other ways. So this is part
of the authority that NIH already has.
Mr. Barton. Mr. Chairman, my time is expired. I think I
have made my point that people like myself are not opposed to
doing everything we can for breast cancer research.
Mr. Pallone. Thank you.
Mr. Barton. Having just gone through the expert witnesses,
though, this bill is not necessary from a scientific research--
in my opinion.
Mr. Pallone. Thank you.
You may as well stay up there, Dr. Collman.
Next is the gentlewoman from California, Ms. Capps.
Ms. Capps. Thank you, Mr. Chairman.
Dr. Winn, I understand that prior to markup in the Senate
HELP Committee, the NIH indicated it would lift its opposition
to this bill if certain changes were made, and that those
changes were in fact made. Is that correct?
Dr. Winn. Yes, that is correct.
Ms. Capps. Now, this hearing today is on the legislation as
originally introduced, and not the version that was passed by
the Senate HELP. But I just want to be sure that the NIH's
position would remain neutral if the House were to accept the
Senate's changes. I want to get you on record as to your
statement about that.
Dr. Winn. Yes, that is correct.
Ms. Capps. And oftentimes in a conference committee or,
perhaps, even in the House this is a possibility that we would
have is to accept the language in the Senate, particularly
knowing that it would be something that you would not object
to. And so you are now on record as saying that if that is
something the House wishes to do that the NIH would not oppose
it, or would remain neutral on that topic?
Dr. Winn. That is correct. NIH would not oppose it.
Ms. Capps. Thank you. Dr. Winn, you also testified that
advocates play an active role in the governance of the Breast
Cancer and Environmental Research Centers as formal members the
various steering committees and as an advisory working group.
Now, would you explain for us, please--and I know you have
referenced this, but to get it specifically on the record why
you believe it is important for advocates to play an active
role? And I believe that is your phrase, active role, with
respect to these issues?
Dr. Winn. I believe that it is important they play an
active role, once again, because of their closeness to the
ground and to the community. One example of how valuable they
have been with respect to this particular project, the Breast
Cancer and Environment Research Centers, is that they have been
critical in developing, together with the scientists, the list
of chemicals that we are actually going to look for. They have
specifically listened to their communities to identify what
chemicals might be of greatest concern. The list is being
combined with lists that we are creating based on what may be
found in animal models to create a master list that
hypothetically and theoretically might be the most important
chemicals to study. So that is one example. They are also very
critical in the recruitment and retention of the young girls in
communicating with the communities and in working with us on
our annual scientific conference that includes a wide range of
advocates. We also are fortunate in having support from the
Avon Foundation which is contributing to the BCERCs as well.
And their support has been very important to us.
Mr. Capps. So even though they are not necessarily
scientists, these are advocates and many of them are breast
cancer survivors or loved ones of those who have not maybe
survived. They are very mighty, powerful forces in my
communities I know. But that you are able even to use their
data collections in a fairly scientific way to help identify
possibilities in the kinds of ways that research will go on. I
want to ask one final question of you, because it has come up
already today among many of the opening statements. We hear
from critics of H.R. 1157 that the legislation is too disease-
specific. But isn't it true that research on any cancer can
often lead to progress in all cancers? And, in fact, isn't
research in many other fields than cancer sometimes applicable
to cancer cures or cancer treatments that may be beneficial?
Dr. Winn. Yes, it is true that one disease can inform
another. But also what we are finding is that there is a lot of
convergence of our understanding about diseases. We learn from
one disease about another, and we are learning something about
all of them that suggests common pathways. The best example I
think I can give for that is the very recent findings in 2007
from genome-wide association studies that look at hundreds of
thousands of places along the genome. And when you compare
thousands of women with breast cancer and thousands of women
without we find that a certain area that is implicated in
breast cancer is the same area that has been found for prostate
and colon cancer. So we are looking forward to finding out more
about that and how environmental, life style, behavioral and
dietary factors may influence all of these cancers by looking
at them together.
Ms. Capps. So you would agree that--this is not a question,
but a summary, Mr. Chairman. That even though this legislation
is modeled to study the effects of environmental factors on the
etiology of breast cancer, the structure that it puts in place
has the potential to yield results relevant to all cancers and
perhaps even other diseases, and could be used for that?
Dr. Winn. That could be an off-shoot.
Ms. Capps. Yes.
Dr. Winn. Certainly it is not directly intended to focus on
that.
Ms. Capps. Understood. Thank you very much.
I yield back.
Mr. Pallone. Thank you.
The gentlewoman from North Carolina, Ms. Myrick.
Ms. Myrick. Well, in the interest of time I want to hear
the other witnesses and I would just simply like to ask the
Chairman's permission to put the letter from the Collman
Foundation, that you have a copy of, into the record and then I
will wait for the second panel.
Mr. Pallone. Without objections, so ordered. And thank you.
[The information was unavailable at time of printing.]
Mr. Pallone. And next is the gentlewoman from Illinois, Ms.
Schakowsky.
Ms. Schakowsky. Dr. Winn, in your testimony you mentioned
that investigators are looking at so-called windows of
susceptibility, which are considered prime events over the
lifespan where exposures to environmental factors can directly
or indirectly affect a person's risk of developing breast
cancer. This approach, as you have explained, recognizes that
there are specific windows of time that physiological changes
to the mammary gland occur, including gestation, puberty,
pregnancy, and lactation. I am very interested in this, because
knowing what we do about early puberty and the risk of breast
cancer and first menstruation before age 12 apparently raises
the cancer risk by 50 percent I think we most certainly need to
be examining the causes of the falling age of puberty. And you
touched on the recent stories we have all seen about the
plasticizer BPA and its possible affects on female development.
I wondered if you would expand on these comments and include,
for example, where BPA is found in the environment and if
ongoing studies find a negative association between BPA and
female health, and what your recommendations might be for
reducing the risks? For example, should we ban BPA?
Dr. Winn. Well, the NIEHS supported research on BPA in a
number of different ways, not only in our Breast Cancer and the
Environment Research Centers. But I think over the last decade
or so information has come out that low levels of this chemical
are commonly found in the environment in plastics, such as in
plastic baby bottles, plastic water bottles, plastics that are
used to store food. Many plastics manufacturers have been using
BPA to make those products strong and hard. Softer plastics do
not have as high of levels of BPA.
Ms. Schakowsky. So is that water bottles? I mean, you know,
we all drink water and carry them around. That has BPA?
Dr. Collman. Right. So some of them--the more rigid water
bottles have higher levels of BPA than the ones that have--are
more pliable.
Dr. Winn. Low doses have been implicated now to show
toxicity in the mammary gland as well as the prostate gland,
and so that is why several review committees that are
associated with NIEHS have reviewed the evidence recently and
have concern about that particular chemical in our products.
Dr. Collman. So in the Breast Cancer and the Environment
Research Centers program investigators have been looking at the
mammary glands in the animal models and looking at exposure
during pregnancy of the animals, looking at the mammary gland
changes during puberty and are finding areas that we are
concerned about. We have also done some pilot work measuring
BPA in the blood--in the urine, excuse me, of the girls that
are in our study, and we do find detectable levels of BPA in
these girls. That there are some other data from CDC that also
suggests that BPA levels in urine are quite ubiquitous in the
human population. So we are just starting to try to pull all of
this together to understand whether the exposures that we are
finding in our bodies are necessarily related to factors--what
makes somebody have a higher level of BPA versus a lower level,
and then did that change the time window for when breast
development first occurs? Does it affect the age at
menstruation? Because we believe that if you extend that window
of estrogenicity in a young girl that go all the way through
her adult years she may be at higher risk of breast cancer
later. And, of course, that is the biggest concern that we
have.
Ms. Schakowsky. Are we at the point yet of discouraging
this ubiquitous water bottle among young girls?
Dr. Winn. Several companies that have been using BPA in
their products have voluntarily taken them out, and so now
there will be more choices for the consumer of products that
will not have BPA.
Ms. Schakowsky. And how will we know?
Dr. Winn. They are being labeled as such in the stores.
Ms. Schakowsky. Thank you. Oh, I do have one more question.
You also mentioned chemicals that have been shown by the
National Toxicology Program to be endocrine-disrupting
chemicals, and therefore associated with increasing
susceptibility to breast cancer. You cite a list of 40 such
chemicals that are mammary gland carcinogens and possibly
estrogenic and mutagenic. Where are these chemicals found in
our environment? Do they have common names? How prevalent are
they?
Dr. Winn. There are quite a wide range of chemicals that
have these effects on the various components of our hormone
systems and interact with them in animal models. NIEHS is
conducting research to understand the prevalence of those
chemicals in human populations as well. There are consumer
products, the chemical group called phtalates which have been
found in products that have fragrances. and in shampoos and
soap. There are carcinogens on that list including benzene,
which is, of course, found in gasoline that have been shown to
be a mammary gland carcinogen in the animal model systems that
the National Toxicology Program.
Ms. Schakowsky. My time is expired. Thank you very much.
Mr. Pallone. Thank you.
The gentleman from Arizona, Mr. Shadegg.
Mr. Shadegg. Thank you, Mr. Chairman.
Fascinating testimony and I think that highlights how it is
useful to do this kind of a hearing, and for us to learn. I
mean those of us who can't concentrate all of our time on this
issue.
Dr. Winn, I just want to walk through a clearer
understanding of the progress of this legislation on the Senate
side. As I understand it as that bill went to committee on the
Senate side there were discussions between NIH and the
proponent to the bill about the structure of the bill, and
particularly about the fact that it was disease-specific and
very prescriptive in what would occur under the legislation as
introduced. Is that correct?
Dr. Winn. Yes, that is correct.
Mr. Shadegg. And as a result of those discussions a number
of amendments were agreed to, to make it less prescriptive?
Dr. Winn. Yes, that is correct.
Mr. Shadegg. But it still remains disease-specific?
Dr. Winn. It still remains disease-specific.
Mr. Shadegg. Do you know if the House sponsors of the bill
were consulted in those negations? Sometimes the Senate
includes us and sometimes they choose not to include us.
Dr. Winn. No, they were not.
Mr. Shadegg. OK. Have those kinds of discussions gone on
here on the House side?
Dr. Winn. No, they have not.
Mr. Shadegg. OK. I might encourage you as this legislation
progresses to have those discussions, because we all know that
senators are very smart, but sometimes we think we are equals
in the process and Ms. Myrick might want to have a discussion
with you about the changes that were agreed to in the Senate
amendment process. You might have different ideas about the
amendments that might be agreed to.
Dr. Winn. We would be happy to.
Mr. Shadegg. Great. Disease-specific legislation, I presume
there are disease-specific bills introduced on thousands or at
least dozens of different diseases every year here in Congress?
Dr. Winn. Yes, there are.
Mr. Shadegg. And your concern about this bill being
disease-specific would apply to all of those bills as well I
take it?
Dr. Winn. Yes, it would because the passage of one bill
would require that we reprogram funds from some other research
area or disease condition to the one that is called upon by the
bill.
Mr. Shadegg. So as a general policy matter NIH would say it
had concerns about any disease-specific bill?
Dr. Winn. Yes, that is correct.
Mr. Shadegg. OK. And those are the kinds of concerns that
were aired in your discussions----
Dr. Winn. Yes.
Mr. Shadegg [continuing]. On the Senate side? And I take it
NIH has had that position through the years? Republican
Administration, Democratic Administration, Republican Congress,
Democratic Congress?
Dr. Winn. Correct.
Mr. Shadegg. Mr. Barton made a passionate plea for not
enacting disease-specific legislation and for following the
requirements of the NIH Reform Act. Many of us as an obligation
to represent our constituents have a duty to listen to them and
to be concerned about their concerns. One of the questions I
have had about this--and this whole topic of disease-specific
legislation relating to NIH has been around since I got elected
in 1994. As you might recall, one of our former speakers wanted
to double the NIH funding year after year after year. That was
his goal, and he did that. How would someone concerned about
this issue, breast cancer, or someone concerned about
Alzheimer's or any other topic, express their concern to NIH
and to its policy makers, and is there an avenue for open
public input? And is that a factor that you would consider as
opposed to just talking to scientific direction?
Dr. Winn. Yes. There are often calls in the NIH Guide for
Grants and Contracts that request information from the public.
It would say something on the order of the NIH is very
interested in this area; what do you think? And we often get
public input in that way. We also often as staff members get
calls from the public and then try and respond to those issues.
With respect to being able to follow the progress of all that
input, something like the scientific management review board
that was established in the NIH Reform Act in 2006 gives the
public a way of finding out exactly where the money went and
what disease areas it has been focused on. It is sort of a
post--way of monitoring what funds went into which particular
area of scientific endeavor.
Mr. Shadegg. Well, I thank you very much for your
testimony. It has been very helpful, and I would encourage you
to talk with Ms. Myrick and the other sponsors of this
legislation, and at least have them better understand how the
bill was modified by the Senate amendments. Maybe they are
willing to go with those. Maybe they have different ideas that
might add to that discussion.
Thank you very much, and I yield back.
Mr. Pallone. Thank you.
The gentleman from Pennsylvania, Mr. Pitts. Passes.
And then the gentleman from Michigan, Mr. Rogers.
Mr. Rogers. Thank you, Mr. Chairman, and I won't take long.
I am just trying to understand it, Dr. Winn, if I can.
There is a--they put in place a panel that oversees the
senator, but there is no NIH person on the panel as I read the
bill. Wouldn't that make----
Dr. Winn. That is correct.
Mr. Rogers. Doesn't that make it far more difficult to
coordinate activities through the NIH if there is no NIH
representative on the panel?
Dr. Winn. Well, it is my understanding that the panel would
be making decisions about who would get funded, so that one
could not get funded without the approval of the panel. That is
the primary concern about the bill, and that the panel would
establish the scientific directions that NIH would have to go
into in this area.
Mr. Rogers. Yes, I understand. But don't you try to take
those into consideration at the NIH now based on resources
available versus where you might be on a certain disease set?
Dr. Winn. Well, normally staff has a very important role to
play. With the Breast Cancer and the Environment Research
Centers staff was on the steering committee, and it has a lot
of direct input into the nature of the research and how it is
conducted. Does that address your question?
Mr. Rogers. Yes. I guess it just didn't--the one part that
doesn't make sense to me is that to try to separate it out, but
still try to obligate NIH funding with no direct coordination.
And I kind of scratch my head thinking is that the--I am a big
believer in this research and other cancer research obviously.
And it is never for me--we shouldn't be mad at the dollar that
isn't spent as much as we should be mad at the dollar that is
misspent. And we are appropriating a lot of taxpayer dollars,
and I want every dollar we could possibly get on the bench.
Some researcher spending valuable time doing that versus any
other effort we might have. And I am a little concerned as I
look at this that we may be creating more of a problem for you
than we are a solution for you when it comes to trying to solve
what I think is a critically important problem.
Dr. Winn. Yes. Normally what happens in NIH is that each
Institute has an advisory committee that is composed of experts
in their particular field of endeavor that provides oversight
to projects that are proposed being considered for refunding
and evaluation of them. The bill, 1157, calls for an exception
to NIH's normal procedure.
Mr. Rogers. And not only does the singular exception of
disease--because sometimes we--it may pay to rush in like the
cavalry and solve a problem. I am not a big believer in that.
But this kind of takes it out of what is a--we all have been
pretty hard on you in the last 2 years. Not you personally, but
the NIH, about coordinating your efforts, taking waste out of
the system, getting dollars to the bench. And as I look at
this, and I am not decided where I am going on this yet, but it
seems to me the more I understand it the more I think maybe it
is creating another level of a problem for you versus trying to
solve a problem for you. And I just want to make sure I am
understanding that correctly.
Dr. Winn. Correct.
Mr. Rogers. And tell me--can you just talk real briefly
about some of the things you have been doing to do better
coordination on all disease research projects? And what you
have been doing to streamline your efforts so that less money
is wasted, more money is put on the bench for research?
Dr. Winn. Well, I think at the highest levels of NIH, as
well as at the Institute levels, transdisciplinary efforts are
encouraged, and sharing and partnerships are encouraged. For
example, the National Institute of Environmental Health
Sciences, NIEHS, and NCI have any number of programs where we
are sharing either the funding for a particular project or
responsibility for development of initiatives. The way that the
Common Fund is being spent through the NIH Roadmap Initiatives
provides for extensive input from all of the Institutes into
what areas of science are going to be focused on. And if an
area is deemed to be a high priority, it provides for how that
money is spent. This is happening at trans- and NIH levels.
Mr. Rogers. How long have you been involved with NIH
medical research? Obviously you have spent a lot of time and
talent and energy becoming a doctor, but----
Dr. Winn. Between being at the Centers for Disease Control
and Prevention and the National Institutes of Health, 28 years.
Mr. Rogers. So you have really committed your life to
trying to find solutions for diseases. You have tried to find
cures for 28 years of your life. Is that correct?
Dr. Winn. Yes.
Mr. Rogers. Is that fair?
Dr. Winn. Looking on the prevention side, yes.
Mr. Rogers. And so there is no disease I could bring to you
that you wouldn't be anxious and stay awake at night trying to
solve. Is that----
Dr. Winn. That is correct.
Mr. Rogers. And if I understand you correctly--and don't
let me put words in your mouth. But you are a little concerned
that this effort may make what you have spent 28 years trying
to accomplish a little bit more difficult? Not because you
don't care, but maybe it is just not the best way to do it.
Maybe we can find another good way to do what I think the
author's intent is. Is that fair? Is that a fair assessment?
Dr. Winn. Our particular focus is on balancing the broad
range of conditions and diseases that influence the burden of
disease in the U.S. population.
Mr. Rogers. Well, I will join Mr. Shadegg's hope that maybe
you can sit down with the House members and we can maybe find a
solution here that works for everybody. And more importantly,
doesn't work for us in this room, but works for the researchers
and the scientists and the doctors who have committed their
lives to trying to fix this problem, and give them some value
added versus maybe taking a little time away from their bench
time. And I appreciate you being here. Thank you for your
presence today.
I yield back.
Mr. Pallone. Thank you, Mr. Rogers.
I think we are done with our questions for Dr. Winn and Dr.
Collman. Thank you very much, and we look forward to working
with you on this legislation as we move to markup. And thank
you.
And I will ask the second panel to come forward now. OK. I
want to welcome our second panel. Let me introduce each of the
individuals. From my left is Ms. Fran Visco, who is president
of the National Breast Cancer Coalition. Next is Ms. Sheryl
Crow, who is a famous singer and songwriter, and a breast
cancer advocate from Nashville, Tennessee. And again, thank you
for being such an advocate. I know you visited my office and
many of the others in order to try to get this hearing today
and move this bill, and we appreciate your advocacy. And then
there is Dr. H. Kim Lyerly, who is the George Barth Geller
Professor of Research and Cancer and director of the Duke
Comprehensive Cancer Center at Duke University Medical Center
in Durham, North Carolina. I think you probably heard what I
said before that you each have a 5-minute opening statement.
They become part of the record. And we may submit additional
statements in writing or additional questions for you that you
would respond back to later. But for now we will begin, and we
will start with an opening statement from Ms. Visco.
STATEMENT OF FRAN VISCO, PRESIDENT, NATIONAL BREAST CANCER
COALITION
Ms. Visco. I thank you, Chairman, for----
Mr. Pallone. I think you have got to turn that on or move
it closer.
Ms. Visco. OK. Thank you, Chairman Pallone, and Ranking
Member Deal, and members of the subcommittee for holding this
hearing. I want to thank Nita Lowey, of course, the lead
sponsor of the legislation for her leadership over the years,
as well as our other lead sponsor and fellow survivor, Sue
Myrick, and Congresswoman Lois Capps.
I am Fran Visco. I am a 20-year breast cancer survivor, and
I am president of the National Breast Cancer Coalition. And the
coalition is an umbrella of more than 600 member organizations
across the country who come together to work on public policy
and breast cancer.
I want to make clear at the outset before I get into my
actual discussion that this legislation, which I will discuss
in a few moments, is not about making centers happen. It is not
about reprogramming funding at NIH. It is not about vacating
the peer review process, which we are very strong believers in.
And it is also the same bill that was introduced in the Senate
that you have in front of you that NIH and we negotiated on and
came to decisions. It is not a different bill. It is now a
different version in the Senate.
Now, I was diagnosed with breast cancer in September 1987.
My son David was 14 months old, and I had no family history of
the disease. I had two overriding questions. One, would I live
to see David grow up? And two, why? What gave me breast cancer?
I am happy to be here today. And the first question has
obviously been answered in the positive. But the second--it is
20 years later. We didn't know then what caused my breast
cancer. We don't know now.
I have had the honor of meeting thousands of breast cancer
survivors over the past years of my involvement in this
movement, and with the National Breast Cancer Coalition there
are millions of us. More each year actually. More than 250,000
women who are diagnosed each year. We have daughters,
granddaughters, sisters, friends, partners, and we don't know
what to tell them to do to prevent breast cancer. We can sit by
and wait and watch and hope the scientific community finds the
answers. We can hope that these women do not also join our
club, or we can fight as hard as we can to find the answers,
find the cause and end this disease.
As you are all very well aware the National Breast Cancer
Coalition chose the latter course. We have advocated for
increased funding for breast cancer research. We have
collaborated with researchers around the world on breast
cancer. We have launched unique training programs to educate
ourselves so that we can understand and engage in the science
and help set the agenda.
In the beginning of the coalition we launched our 300
million more campaign, which resulted in working with you, the
DOD program. We made new models of research happen, new
collaborations. We worked on the first targeted therapy in
breast cancer, which has had an impact well beyond breast
cancer. The NIH report on what they are doing is exciting. It
happened because advocates advocated for increased funding for
research. We made that happen with you.
A lot of the research focuses on treatments, on new drugs.
And that is very important, but these drugs bring with them
life changing and often life threatening toxicities, incredible
financial costs and results in most cases of modest impact on
the disease. It is extremely important that we continue that
research because each year 40,000 women die of breast cancer. A
number of the founders of NBCC have died of their disease. We
need to have better treatments and hopefully some day cures.
But how much better if we can prevent this disease? Our
daughters not live in fear of getting it, not face life
threatening breast cancer, not suffer toxicities of treatment
and the incredible financial and emotion drain on them and on
this country?
We as advocates recognize how real the complexities are. I
remember when I co-chaired a subgroup of the National Active
Plan on Breast Cancer with Francis Collins, and he and I talked
about how complex and very difficult this was. And I remember
his words. We cannot let that be a reason not to do this. We
know there is no magic bullet, no easy answers. Scientists over
the years have told us, and we have seen, how they work in
silos. How there is competition. Whose perspective is right?
Whose idea of what it is? How can I get funded? We can continue
along those paths, or we can take this extraordinary
opportunity to harness the incredible scientific abilities
across the country working with engaged advocates and community
groups and complete what has been happening. Building on the
very real advances and the resources we have put into the
investments we have made in breast cancer research.
You have heard some from NIH of what is going on in
different pockets. There is other work being done in this
arena, but there are many different approaches. What we need to
do is bring all of this together to work in tandem. No one
institution, no one institute, no one approach, no one
individual has the answers. If they did we wouldn't be here. We
need to work on many diseases. Yes, that is important. This is
one of them. We need a balance. It is not enough to simply let
scientists or administrators determine what they should focus
on. We need to build on the science we have already invested in
and the knowledge that we have in breast cancer. That is what
this bill will do. I listen carefully and read carefully, and I
am very happy that the NIH centers are helping and the model is
one they like. They are not exactly what this bill
contemplates. They are one small step toward that. The
questions for those were chosen by NIH, but you have to
remember that they are doing that because of the National
Breast Cancer Coalition advocacy around this bill, and our
working with Congress to get it in the report language and tell
NIH to do that. So it is a great example of why this bill
before you now is important. How it will work and how it must
move forward.
So what is the bill going to do?
Mr. Pallone. I am going ask you--you are a minute over.
Ms. Visco. Right. I am going to----
Mr. Pallone. And we also have votes, and I would like to at
least get one more witness in. So if you could summarize.
Ms. Visco. I just want to summarize by saying that the bill
is not going to hurt the peer review process. The bill is going
to let collaborative grants, peer review collaborative grants--
the extended bill provides that the secretary will take into
account the recommendations of the panel. The panel doesn't
direct. The worldwide, nationwide, scientific community decides
what the research questions are. Those questions will go
through peer review. It is something that builds on
reauthorization. It enhances the work that is being done. It is
a strategic approach, which is what we need. It doesn't
replicate, duplicate. It doesn't take money away. It is not
intended to do that. We did our homework 16 years ago when we
began advocating on behalf of breast cancer research, and we
are here today to say it is time to take this next step.
Seventy senators, 268 members of the House, two-thirds of the
Committee are sponsors of this bill. And I look forward to this
year when this bill becomes law.
Thank you very much.
[The prepared statement of Ms. Visco follows:]
Statement of Fran Visco, J.D.
Thank you Chairman Pallone, Ranking Member Deal and Members
of the Subcommittee for holding this hearing on such crucial
legislation, the Breast Cancer and Environmental Research Act,
H.R. 1157. I want to also thank Representative Nita Lowey, the
sponsor of this legislation, for her leadership throughout the
years on this critical bill, as well as our other lead
sponsors, Representatives Sue Myrick and Lois Capps. I am Fran
Visco, a 20-year breast cancer survivor, wife and mother, a
lawyer, and President of the National Breast Cancer Coalition
(NBCC).
NBCC is a grassroots organization dedicated to eradicating
breast cancer. The Coalition includes hundreds of organizations
and tens of thousands of individual members, many of whom you
have heard from often over the past years to express their
strong support for H.R.1157. In fact, as you know, we now have
70 Senate and 268 House cosponsors of this legislation.
NBCC's main goals are to increase federal funding for
breast cancer research and collaborate with the scientific
community; to increase access to high quality treatment and
care for everyone as well as access to quality clinical trials;
and to increase the influence of women living with breast
cancer in all areas of decisionmaking that impacts breast
cancer.
Purpose and Summary of the Legislation
Background
As you know, the causes of breast cancer have not yet been
determined. We simply do not know what to tell women to do to
prevent breast cancer. We have identified some factors
associated with increased risk of breast cancer. Yet, about 70%
of breast cancers are not associated with known risk factors.
Less than 10% of breast cancers can be attributed to an
inherited genetic predisposition. We know it is not solely a
genetic question, nor is it solely a question of environment.
Rather, it is a complex interaction between genes and
environment that is at the core of this problem. Yet, the
environmental influences remain largely unexplored and
unexplained.
It is especially disturbing that we do not know the causes
of this disease since the chances of a woman developing the
disease have increased over time. Today, a woman in the United
States has a one in eight chance of developing invasive breast
cancer in her lifetime. In 1975, that chance was one in eleven.
Recent reports of a decline and stabilization in incidence
among some groups of women have been linked to the findings of
the Women's Health Initiative and a decrease in use of hormone
replacement therapy. It remains to be seen if this association
between HRT and breast cancer is one of cause and effect or
delayed diagnosis. In any event, it accounts for a small
percentage of new cases.
The three million women living with breast cancer and all
women at risk, which is all women, want to know what causes
breast cancer. They want to know how to prevent this disease,
so that they, their daughters, other family members and friends
will not suffer from it.
There is no doubt this is a complex problem. Ten years ago
NBCC held the first of two environmental summits, bringing
together scientists, trained consumers, policymakers and other
stakeholders to help us determine how best to address the issue
of environmental links to breast cancer. The consensus was
then, and is now, that little is known and little is done in
this area of research. The participants had different
perspectives on the problem, including what is encompassed in
``environment'' in this context. Some working on this issue
believe that ``the environment'' should encompass external
exposures (e.g., pesticides) only, and not ``internal'' (e.g.,
age of menarche, circulating hormone levels, etc.). Some want
to exclude voluntary exposures (e.g., diet). NBCC defines
environment broadly, for all its work in this arena and for
this proposed legislation. All agreed that these issues are
exceedingly complex and must be addressed on many different
levels from many disciplines and perspectives, with a strategic
approach that respects scientific freedom and public input. It
was clear that this is not a question that can be addressed
solely by government, or by advocates, or by scientists. This
diverse input from all stakeholders was one element that led to
the proposed legislation. There are many ways to look at this
problem and no one institute, institution or individual has the
answers. Of course, if they did we would not be here today.
After an initial significant increase 15 years ago, we have
seen annual funding for breast cancer research in both the
private and public sectors remain the same or perhaps increase
slightly. We know that certainly in the private, and to a
lesser extent in the public sectors, much of that research is
invested in a search for the next new drug, or the next
combination of existing drugs. Technology has increased,
looking for biomarkers of disease, primarily so that a therapy
can then be found to attack that biomarker. Yet drugs and other
technology have made a modest overall impact in breast cancer.
The majority of drugs that result from research result in
incremental improvement over existing therapies, often adding
toxicity and great financial cost. While it is extremely
important to find out how best to treat and hopefully to cure
this disease, we must invest significant resources into
figuring out how to prevent it. That would be the ultimate and
optimum result of our research investments. And government
funding is the primary source of support for this approach
since there is little commercial incentive.
Why this bill?
NBCC developed this approach as it has many others. As
described above, we brought together all stakeholders involved
in this issue on several occasions to look at and discuss the
issues surrounding the environmental links to breast cancer.
NBCC has watched as Congress has funded studies looking at
possible breast cancer ``hot spots''. States have legislated
pesticide and other registries. Given what we learned from our
summits, from working with and looking at the Department of
Defense peer-reviewed Breast Cancer Research Program, from our
work with scientists around the world, we concluded that
continuing to ask specific questions and funding isolated
approaches is not enough. A piecemeal approach to this very
complex area is not a good use of resources, nor is it in the
best interest of the public. The decisions about which
questions to research should not be made in a vacuum, rather
they should be made as part of a national strategy that takes
into account past research, research underway and prioritizes
the gaps that still exist.
We see excellent research being done, such as the Sisters
Study and other studies at the National Institute for
Environmental Health Sciences, and the technological advances
brought about in part through the Human Genome Project that
underlie the Genes, Environment and Health Initiative at the
National Institutes of Health (NIH). We are not suggesting nor
would we want that this bill take the place of these or any
other studies. This bill will enhance and complement those
efforts. The approach contemplated by this legislation would
allow the scientific community across the country to identify
gaps in our knowledge, design ways to address those gaps and
collaborate on the best research needed to respond. It will
allow the research community throughout the country to set the
agenda, to come together in multi-disciplinary, multi-
institutional collaborations including the public, to decide
questions to be asked, and to work together to launch a
strategic, national approach incorporating all aspects of this
problem.
What would the bill do?
With this country's investment in biomedical research, we
have learned a great deal about how science works best in
addressing complex questions that require the attention of the
full range of scientific expertise.
It is most important to recognize that this bill will allow
the scientific community to decide how the funds should be
spent and will require that they be spent through a peer review
process and a programmatic review that is based on proven,
successful research programs.
The legislation would authorize $40 million a year for 5
years for the National Institutes of Health to develop a
collaborative, peer-reviewed grant program to study
environmental factors that may contribute to breast cancer.
This number was based on analyses of existing research
mechanisms and the input of many researchers across the country
who are experts in this area.
The grant-making model in this bill is based on the
successful and internationally acclaimed structure of the
Department of Defense (DOD) peer-reviewed Breast Cancer
Research Program, which has been replicated in other areas of
research. The model was originally recommended by the Institute
of Medicine at the National Academy of Sciences (IOM/NAS). The
IOM has twice reviewed the DOD Breast Cancer Research Program
and lauded its innovative and effective structure. There are
several features of the DOD peer-reviewed Breast Cancer
Research Program that are included in the legislation we are
discussing today
The Breast Cancer and Environmental Research Act
would establish a Breast Cancer and Environmental Research
Panel made up of experts in the field and trained consumers.
(The Senate version includes an NIH representative also). The
Panel would develop mechanisms based on the intent of the
legislation, and a Request for Proposals will be published to
the scientific community. The bill contemplates a strategic,
broad approach to the issue that would be shaped by the
scientific collaborations' response to the Request for
Proposals. Scientists working with community groups are free to
decide the critical questions to ask and the scientific
approaches to be taken. The request will be for proposals
looking at broad approaches to a broad definition of
environmental links to breast cancer.
After scientific and technical peer review is
conducted, the Panel would review the proposals to make certain
they, as a whole, address in a non-duplicative, strategic way,
the fundamental questions necessary to look at the issue. The
Panel would then make recommendations for allocations of funds
to the grantees. This critical step will prevent unnecessary
duplication of research and ensure consistency with an
overarching strategy as contemplated by the bill.
Trained consumer advocates are included on the
Panel. We believe the perspective of informed, educated breast
cancer advocates must be present everywhere that breast cancer
research decisions are made. A true partnership between
advocates and scientists is the most efficient and effective
way to reach the mutual goal of eradicating breast cancer,
because both parties bring distinct and valuable knowledge to
the process. Trained advocates have been included on the
Integration Panel and at all other levels of the DOD Breast
Cancer Research Program since 1993. This unique feature has
been hailed as a success by the scientists, the advocates and
the Institute of Medicine.
This bill includes a broad definition of the environment--
from contaminants to lifestyle factors such as diet and
exercise, stress levels, socio-economic status and other
endogenous factors. Multi-disciplinary and multi-institutional
groups of researchers receiving the grants would look at the
factors that may contribute to breast cancer development from
different angles. A main feature of the research model proposed
in this bill is flexibility. It is the grantees themselves, the
researchers, who would identify the area to be studied--the
science would not be dictated to them.
Collaboration is a key component of this legislation. The
bill envisions that the best and brightest scientists and
trained advocates from different institutions and different
disciplines would come together to apply for a grant, studying
a complex question of the relationship between breast cancer
and the environment, and breaking down the traditional silos of
research. In turn, all the grantees would then collaborate with
each other as well as with community groups representing a
breast cancer constituency. This would prevent duplication of
research, encourage new ideas and dynamic thinking, and with
the involvement of community groups and trained consumers,
ensure that the research is innovative and meaningful.
History of the Legislation
This bill was first introduced in 1999 by Representative
Nita Lowey. I remember discussing the contents of the proposed
legislation with then acting director of NIH, Dr. Ruth
Kirschstein. As a result of those discussions, the content of
the bill changed before it was actually introduced, as we
wanted to address some of NIH's questions. We came to an
agreement with NIH on the content and approach of the bill at
that time. In 2000, Senators Lincoln Chafee and Harry Reid
introduced the bill in the Senate. Since then the bill has had
incredible bipartisan support and political momentum. Over two-
thirds of the Energy and Commerce Committee Members are
cosponsors.
The Senate Environment and Public Works Committee held a
field hearing on this bill in the 107th Congress. In 2002, the
Senate Labor-HHS Appropriations Subcommittee agreed that a
strategic approach like the one taken in this legislation was
necessary. They included language in their Committee Report
urging the National Institute of Environmental Health Sciences
(NIEHS) ``to establish centers to conduct multi-disciplinary
and multi-institutional research on environmental factors that
may be related to breast cancer.'' The following year, the
Labor HHS Conference Report included similar language.
In response, NIEHS established four research centers to
focus on the environmental determinants of puberty and mammary
gland development that may increase a woman's risk of breast
cancer. These centers do not address an overall national
strategy for researching the possible links between the
environment and breast cancer, and they focus on a narrow
question. They are important, but are not what is envisioned by
this legislation.
The Senate HELP Committee approved S. 579 in February of
this year. Prior to that mark-up, changes in the bill were
negotiated to respond to concerns expressed by NIH. As a result
of those changes, NIH no longer opposes the Senate version of
the bill. We hope that this committee will approve the Senate
version of the bill.
The Senate Version
The bill was clarified by removing references to centers.
The intent of the legislation was never to establish brick-and-
mortar centers, but rather, as I have said, the grantees would
be a collaboration of scientists and consumers from various
disciplines and institutions. The reference to centers in the
language was confusing and distracted from the true intent of
the legislation.
A peer review protection clause was added. The bill was
never intended to override or otherwise interfere with the peer
review process at NIH. The Panel takes the peer-reviewed
research and makes recommendations for funding based on the
strategy that has been developed, to make sure that not only
the most scientifically important research is funded, but also
the research that will have the most impact.
Changes were made to the Panel at the request of NIH.
First, an NIH representative was added to the panel, and
language was added so that the selection of the Chairperson of
the Panel is subject to the approval of the NIH Director.
Finally, language regarding how the HHS Secretary adopts the
recommendations of the Panel was changed at NIH's request.
The bill has evolved over the years, taking into account
concerns raised by not only Members of Congress but also by the
National Institutes of Health. I am hopeful that this committee
will mark up this bill promptly following this hearing, and
include the changes made to the Senate version.
Public Support
The National Breast Cancer Coalition has educated its
grassroots membership across the country on the purpose and
content of this bill. They in turn have worked very hard to get
support from their Senators and Representatives for this bill.
We are very proud of the fact that we now have 70 Senators and
268 Members of the House as cosponsors for this bill. We have
had several negotiations with Committees and with the National
Institutes of Health, to revise the bill and address concerns,
while retaining the integrity and vision of the bill. The NIH
has withdrawn its opposition to the Bill.
Now the public is looking to you. We have done all that you
ask, with this level of bipartisan support for the bill, with
no administrative opposition. Women's lives depend on your
actions. It has been 8 years since this legislation was first
introduced. Women can't wait any longer.
In summary, this bill offers a strategic approach to
researching the potential links between the environment and
breast cancer. It would establish a proven model for conducting
this critical research. It would enhance and complement work
that is ongoing at NIH. It leaves the scientific community and
the public impacted by the disease free to decide, within the
strategic approach of the legislation, what and how to
research. Innovative thinking and meaningful research that gets
us closer to finding the answers about the causes of breast
cancer is critical to the eradication of this disease. The
current research is not enough. We need to not only do more
research, but we need to spend our precious federal dollars
more efficiently and effectively. The approach this bill
envisions does just that.
----------
Mr. Pallone. Thank you, Ms. Visco.
Let me explain where we are. We have six votes, which could
take as much as 45 minutes, maybe more. But we have time for
one more, because we still have 12 minutes left, so I am going
to ask Ms. Crow to give her opening statement. And then,
Doctor, you will have to wait until after if you don't mind.
And then we will have questions after, so we are hoping that
you can all stay around.
But I will recognize Ms. Crow now.
STATEMENT OF SHERYL CROW, SINGER-SONGWRITER AND BREAST CANCER
ADVOCATE
Ms. Crow. Thank you, Chairman Pallone, and Ranking Member
Deal, and members of the Senate--or the House subcommittee for
holding this hearing.
And I just want to say I am honored to sit in the presence
of Sue Myrick, who is a rock star as far as I am concerned in
the breast cancer advocacy community.
I appreciate the opportunity to testify before you today on
the Breast Cancer and Environmental Research Act. As a breast
cancer survivor and advocate I am very passionate about getting
this bill enacted this year. In 2006 I was diagnosed with
breast cancer. Needless to say, I was absolutely devastated.
Before my diagnosis I had been helping raise awareness and
funds for breast cancer for years. Concerts, events, whatever I
could do because I knew it was an important issue. So when I
was diagnosed this really hit home. And I have the dubious
honor because I am a singer of having a large female fan base,
and I have become sort of a spokesperson for early detection.
But as I look to my right and I see these young women over here
as they embark on their adulthood and they are asking questions
about whether the lipstick they are using, the shampoo they are
using, whether they are drinking from a water bottle and not be
a factor, and they are being the one in the seven. With breast
cancer I don't have the answers to that, but I think it is a
question that needs to be answered, and now is the time.
I know awareness is not enough. We need real strategic
action, and so I am joining with Fran Visco and the National
Breast Cancer Coalition, because I believe that what they are
doing is good for all of us. About a year ago Fran asked me to
learn about this bill and I did, and I am not here lightly. I
know what this bill will do, and I am certain that it is the
right approach. Why is this bill important to me? Because I
know--because I want to know what causes this disease for me
and for 2.3 million others who share this diagnosis with me,
and especially for those of us who are at risk or putting
themselves at risk without even knowing. Like the vast majority
of women diagnosed with breast cancer I have no known risk
value, including no family history. I have no idea why I got
breast cancer, or what I can say to others on how to prevent
it. But what I do know is we need more resources and to figure
out what the environment has to do with breast cancer. And we
need to do that through the government funding, because there
is little financial incentive for anyone else to do this
research.
I have spent a great deal of time out talking to people
about the environment, obviously. I have traveled throughout
the country to try to raise awareness about what we are doing
to the environment and what we can do to help save it. And I
know these issues are even more complex than that, especially
when it comes to associations between environment and disease.
And I know this bill and the National Breast Cancer Coalition
includes a broad definition of environment to include not just
exposures but lifestyles and the interaction between genes and
the environment inside and outside of our bodies.
I can tell you that the public deeply cares about the
environment. We are talking about it every day. It is no longer
third page stuff in the newspaper. It is on the front page.
Women are talking about it on a daily basis on every talk show
and about how they can live healthier lives and prevent
diseases. We are talking about how to live green in order to
prevent disease. This is a question that everyone wants
answered. And I will say that I understand the concerns of
Congressman Burgess and Congressman Barton about this bill. But
this bill establishes an opportunity for setting precedence
where the environment is concerned for other diseases. I would
hate to think that the benefits of today's vaccinations would
not be possible because the research done on finding the polio
vaccination was considered disease-specific.
Would it not be possible that any findings in this area for
the environment affects disease be beneficiary to other
diseases? For instance--in the instance of what Dennis Slamon
did at the Revlon Cancer Center at UCLA where he did research
on the HER2 positive and created the treatment that now is a
targeted treatment that actually is benefiting brain cancer and
other diseases.
And I want to say that I don't live in the political world
and while this might be a political--seem like a political
discussion until you are the one in seven women diagnosed with
breast cancer. You will never know how not political this is.
Now is the time. We have been talking about this for a long
time, and thank God for Senator Edward Kennedy, who I love and
adore and idolize, who took this to the Health Committee and
has been pushing this through and has been a strong advocate.
And I feel like we have had so much support on this that now is
the opportunity to make this happen, to do the right thing, and
to show the American people that we are concerned about what is
happening, and that we are not going to let the brake stay on,
as was alluded to earlier. We are going to keep driving this
thing forward.
And I look forward to celebrating this with the good people
here on Capitol Hill and being able to take good news back to
the small towns in America as I go out and tour.
Thank you.
[The prepared statement of Ms. Crow follows:]
Statement of Sheryl Crow
Thank you Chairman Pallone, Ranking Member Deal and Members
of this Subcommittee for holding this hearing. I appreciate the
opportunity to testify before you today on the Breast Cancer
and Environmental Research Act. This bill is responsible public
policy calling for research to move us closer to understanding
the causes of breast cancer and how to prevent it. As a breast
cancer survivor and advocate I am very passionate about getting
this bill enacted this year.
In 2006, I was diagnosed with breast cancer. I knew I
wasn't going to sit back and let breast cancer control my life.
Before my diagnosis, I had been helping raise awareness and
funds for breast cancer for years. Concerts, events, whatever I
could do because I always knew it was an important issue. Then
it really hit home. And I knew awareness wasn't enough; real,
strategic action was needed, so I joined with Fran Visco and
the National Breast Cancer Coalition (NBCC) because I believe
in what they are doing for all of us.
About a year ago, Fran asked me to learn about this bill
and I did. I am not here lightly. I know what this bill will do
and I am certain it is the right approach.
Why is this bill so important to me? Because I want to know
what causes this disease--for me, for the 2.3 million others
who share this diagnosis with me, and especially for all those
who are at risk, or putting themselves at risk without even
knowing it. Like the vast majority of women diagnosed with
breast cancer, I have no known risk factor, including no family
history. I have no idea why I got breast cancer, or what I can
say to others who want to prevent it. Here's what I do know: we
need to put more resources into figuring out what the
environment has to do with breast cancer. We need to do that
through government funding, because there is little financial
incentive for anyone else to do this research.
I have spent a great deal of time working on environmental
issues. I have traveled the country to raise awareness about
what we are doing to our environment and what we can do to help
save it. I know the issues are even more complex than that,
especially when it comes to the associations between
environment and disease. And I know this bill--and NBCC--
includes a broad definition of environment, to include not just
exposures, but lifestyle and the interaction between genes and
the environment in and outside of our bodies. Looking at these
issues in such a strategic, global way needs federal funding
and oversight. But it also needs the input of researchers and
advocates throughout the country and from every perspective.
I can tell you this: the public cares deeply about the
environment and about breast cancer. And they look to you to
help solve these problems. Don't let us down.
Breast cancer continues to be a puzzle. Rather than just
continuing to invent new treatments, I believe we need to focus
on prevention. And we are unlikely to prevent breast cancer if
we do not know what causes it. The Breast Cancer and
Environmental Research Act calls for a national, strategic
approach to address the question of what in our environment--
inside and outside our bodies--may be related to breast cancer.
It doesn't dictate the science. It doesn't tell scientists what
to do. But it does give them the resources and the focus to
address these issues. It will bring the best and brightest
researchers together to work in collaboration with trained
advocates and with community-based organizations. So, the
scientists across the country, working with the community most
at risk and impacted by this disease, working together to solve
the problem seems like a great way to deal with such a
difficult issue. It is a wise investment that our Federal
Government must make. It is a small investment relative to the
size of this problem that affects millions of Americans.
It is frustrating to me that this bill has been around for
so long, with so much support, and it still has not been
enacted. I know that this bill was developed after years of
analysis by the National Breast Cancer Coalition, with the
input of scientists, policymakers, consumers, and all the key
stakeholders. It was developed after much thought and based on
experience with different research models.
I can't imagine there are many bills with the level of
bipartisan support this bill has. Advocates like me worked very
hard to get 268 cosponsors here in the House, and 70 in the
Senate. As a member of the public I must assume each and every
one of those cosponsors supports the approach taken by this
bill. And I have heard about the tremendous support from the
scientific community. So, scientists support this, the public
supports it, and the majority of both the House and Senate
support it. A majority of this very committee supports it. My
understanding is that after negotiations and discussions with
the National Breast Cancer Coalition, the National Institutes
of Health (NIH) does not oppose the Senate version of this
bill. Those facts alone should support enactment.
Last April, I was up here on Capitol Hill with Fran and the
National Breast Cancer Coalition, meeting with a number of you,
and with Members of the Senate, to talk about this bill.
Frankly, I thought after all the support, after all the
promises I got last Spring, after 8 years of Congress
supporting this bill, by now it would be law. Yet, here we are.
It's time.
I am so glad you are holding this hearing today. I
understand it is a necessary step before your committee can
actually approve the bill. And I hope that will happen very
soon, perhaps today? I urge you to take action on this
legislation--the time is long overdue. All across the country,
women and their families are demanding that Congress act now to
pass the Breast Cancer and Environmental Research Act.
We are looking to you for your leadership and your support.
----------
Mr. Pallone. Thank you, Ms. Crow.
Now, as I said we have six votes. That is about 45 minutes.
We will come back and hear from Dr. Lyerly, and then we will
take questions. Hopefully you can stay.
So the subcommittee is now in recess for about 45 minutes.
[Recess.]
Mr. Pallone. This subcommittee will reconvene. I apologize.
I think there was some confusion on the part of the members as
to when we were going to begin again, so they will probably
start coming in. But I want to keep going, because I know you
have some time constraints too.
So we left off with Dr. Lyerly.
STATEMENT OF H. KIM LYERLY, M.D., GEORGE BARTH GELLER PROFESSOR
OF RESEARCH IN CANCER; DIRECTOR, DUKE COMPREHENSIVE CANCER
CENTER, DUKE UNIVERSITY MEDICAL CENTER
Dr. Lyerly. Thank you, Chairman Pallone.
Mr. Pallone. I think you got to turn that on and bring it
closer, or both.
Dr. Lyerly. Thank you, Chairman Pallone, and thank you for
holding this hearing on such an important legislation.
I am Dr. H. Kim Lyler, director of the Duke Comprehensive
Cancer Center. I am a breast cancer researcher and a member and
former chair of the Department of Defense Peer Review Breast
Cancer Research Program integration panel, and I am grateful
for the opportunity to testify today.
I was going to focus a lot of my comments about specific
issues regarding H.R. 1157 that have been described, and I can
say that I find this to be an innovative approach to address
this issue of breast cancer and the environment. I agree it
should be done through the NIH due to the complexity of the
collaborations contemplated, and I would echo the sentiment
that has been expressed, that NIH is the crown jewel in the
world of biomedical research. Clearly the engine that drives
much innovation and the place in the world that the U.S. holds
in advancing medicine and the biotechnology industries. The
design of the proposed program is based on the model supported
now by the Department of Defense Peer Review Breast Cancer
Search Program, which actually compliments and extends the NIH
model. As a scientist and as a past chair of this integration
panel I can tell you firsthand why this model has been so
successful, and how it extends the thoughtful and
groundbreaking reforms that the NIH has recently made.
No less than the Institute of Medicine recommended the
existing structure that includes both sides of the peer review
and programmatic review by integration panel is so-called two
tiered approach. The integration panel of the Department of
Defense includes scientists and breast cancer advocates. This
panel recommends research investment strategies, reviews the
scientific peer review results, deliberates and compares
scoring across the multiple panels, and recommends applications
to be funding as well as assisting in overall program
evaluation.
The integration panel reviews proposals with the mission
and the strategic investment strategy in mind looking at not
only what proposals have scientific merit, but also at which
proposals meet the stated goals. Scientific merit is always
considered and weighted appropriately and this is consistent
with the strengths of the scientific peer review process that
we heard earlier this morning.
It is extremely important that the ongoing programs
exploring the link between cancer and the environment use
innovative approaches to include all potential contributors.
These include contributors outside of the National Institutes
of Health. Consider the role of the Centers for Disease
Control, tumor registries maintained by the American College of
Cancer, American College of Surgeons Cancer Program, and other
environmental research centers supported by the National
Science Foundation. Without a broad umbrella to incorporate
these research centers they may be in fact excluded for
research linking cancer and the environment.
The panel proposed and the Breast Cancer Environmental
Research Act would act much like the integration panel at the
DOD Breast Cancer Research Program. And this panel has a proven
12 to 13 year track record of successfully enabling peer review
research and providing insight and empowering individual
investigators to develop broad based, far reaching and
inclusive research strategies. Mechanisms for funding would be
developed and then released to the scientific community with a
request for proposals. And the idea here is not to determine
the specific scientific question to be asked. This would be
allowed to be the purview of the scientists, but the idea would
be to create funding mechanisms which could be populated by the
best and most innovative scientific ideas moving forward.
Again, this is an exciting and innovative strategy that
allows the best scientific ideas to rise to the top, and allows
the most potentially fruitful collaborative strategies to be
engaged.
Let me finish by just commenting about how this approach
has affected research at my own institution. As you may know
Duke is one of the most outstanding schools of environmental
research in the United States, as well as an outstanding
medical center. Policies requiring cross-disciplinary
approaches that have been promoted by the DOD mechanisms have
led investigators at the cancer center to actively meet and
engage in collaborations with the Nicholas School of the
Environment. This is a first-time event even though both of the
institutions have been in existence for a number of years.
Environmental scientists, molecular epidemiologists, and basic
scientists work together with breast cancer specialists to
explore how environmental exposure can increase women's risk to
breast cancer. And traditional forms of support would tend not
to support these types of interactions. What one specific
example is that one of the most prominent strategies to
identify environmental exposures in environmental toxins is to
look at fish models of accumulation of toxins within the lipid
deposits of fish, and these fish in fact develop liver cancers.
But the insight gained from these fish that are populating
pools and rivers and streams downstream of environmental events
informs us as to what potentially could lead to the type of
developmental changes, the changes occurring within the
development of the breast in young women.
Finally, there is an emerging opportunity for science to
engage in a discovery process in which we look at the
epigenome. And that means your genetic fingerprint is stable,
but there are changes that are occurring outside of your genes
that are influenced by the environment. For example, we now
know that in animal models the diet of the mother can influence
the genetic expressional genes in offspring, and these
offspring will have inherited traits like obesity and cancer
susceptibility that can be passed onto their offspring. You
know, this epigenetic imprinting and get a--understudied area
of environmental toxicology wouldn't actually be developed or
sought by the traditional DNA sequencing methods, and you have
to use specialized epigenetic types of inquiry to find these
things.
Let me finish by again really applauding this committee and
the work done in bringing this incredibly important issue to
the forefront. Thanks very much for allowing me the opportunity
to present.
[The prepared statement of Dr. Lyerly follows:]
Statement of H. Kim Lyerly, M.D.
Chairman Pallone, Ranking Member Deal and Members of the
Committee, thank you for holding this hearing on such important
legislation, the Breast Cancer and Environmental Research Act.
I am Dr. H. Kim Lyerly, Director of the Duke Comprehensive
Cancer Center. I am a breast cancer surgeon, researcher, and a
member and former Chair of the Department of Defense peer-
reviewed Breast Cancer Research Program Integration Panel. I am
grateful for the opportunity to testify today.
We all know how serious the problem of breast cancer is.
Unfortunately, it is difficult to find a person who has not
been touched in some way by breast cancer--either themselves or
through friends or family members. A woman's chances of
developing breast cancer have increased over the years. It is
estimated that more than 250,000 women and nearly 2,000 men
will be diagnosed with breast cancer in 2008. Sadly, more than
40,000 women and 450 men will die of the disease this year.
Despite some progress, we still do not know what causes most
breast cancers, how to prevent them or how to cure breast
cancer for any individual woman.
Finding the cause or causes of breast cancer could be the
key to unlocking this and other diseases--finding ways to
prevent the disease from occurring in the first place, and also
helping to better treat the disease and eventually cure it.
While it is clear that traditional genetic studies can help us
understand the etiology of a small fraction of cancers, it was
demonstrated in this decade that identical twins, those who are
essential genetic duplicates of each other, have only a 10-15
percent chance of having breast cancer if their twin had breast
cancer. Clearly, something other than your inherited genes, as
we know them, is leading to breast cancer in the majority of
women. It is important to focus significant resources on these
issues and doing so will have ramifications beyond breast
cancer.
Breast Cancer and the Environment
Breast cancer is a complex and heterogeneous disease.
Research into the causes of breast cancer is a difficult area
to study, particularly when examining environmental links. To
date, any efforts in this arena have been fragmented.
Laboratory and epidemiologic research may give some clues to
the possible carcinogenicity of chemicals and other
environmental exposures. Some resources have been put into
genetics programs at the National Institutes of Health (NIH) to
look at genetic variation in groups of patients with specific
illnesses. Some resources have been put into the National
Institute of Environmental Health Sciences (NIEHS) to develop
environmental technology to validate exposures. These are
nascent areas of research that are necessary. While this
research is ongoing, we are far from determining the clinical
utility of these relationships.
Some resources have gone to analyze clusters of cancer
cases to generate hypotheses about potential risk factors.
Unfortunately, the identification of a cluster does not
necessarily reveal the exposure, or whether an individual
exposure is responsible for the elevated rate of disease. An
added challenge is the measurement of exposures over a
lifetime, as exposures are intertwined and may be confounded by
socioeconomic, occupational and reproductive factors. Studies
such as the Sisters' Study at NIEHS look into these areas. In
addition, recent data has demonstrated the maternal exposure
can influence risk. For example, dietary supplements in
experimental animal models can cause ``epigenetic'' changes, or
changes in the ability of genes to be expressed. Theses
epigenetic changes can then be passed on from generation to
generation and increase cancer susceptibility in offspring.
Clearly, new knowledge and new concepts of what constitutes
environmental exposure, are being brought to light at an ever
increasing pace.
While biomarker, other genetic research, and cohort studies
are important, these are only a few aspects of the needed
research into this area. We need to fund scientific freedom to
determine different approaches to this problem and a cohesive,
strategic program. Supporting different approaches is a
hallmark of great research. We cannot presuppose which
discipline or which approach has the answers. We must support
collaboration among all with the expertise to address a health
problem, especially one that poses such a complex scientific
dilemma.
The DOD Breast Cancer Model
The examples I discuss above are just a few examples of how
trying to determine what in our environment causes breast
cancer is so challenging. It requires an innovative and
strategic approach, with many different scientific disciplines
working together. I have carefully reviewed the approach that
H.R. 1157 describes and I can say it is the right and the best
approach in this context. And it should be done through NIH
because of the complexity of the problem and the collaborations
contemplated. This legislation moves beyond fragmented
approaches to a broad, innovative approach that fosters
scientific freedom and public input to work in collaboration on
a compelling national public health problem. I have seen the
framework suggested by this bill work so well. The design of
the program in this legislation is based on the model at the
Department of Defense peer-reviewed Breast Cancer Research
Program. As a scientist and past Chair of the Integration
Panel, I can tell you firsthand why this model has been so
successful.
The Department of Defense (DOD) peer-reviewed Breast Cancer
Research Program has established itself as a model medical
research program, respected by the military and throughout the
cancer and broader medical community for its innovative and
accountable approach. The DOD Breast Cancer Research Program is
meant to challenge the research community to work together to
design innovative research that will foster new directions in
breast cancer research.
The Institute of Medicine recommended the existing
structure that includes scientific peer review and programmatic
review by an Integration Panel (IP). The IP of the Department
of Defense peer-reviewed Breast Cancer Research Program is made
up of scientists and breast cancer advocates, including experts
in basic, transitional, clinical, psychosocial, and public
health research. The Integration Panel recommends a research
investment strategy; reviews the results of the peer review
panels' deliberations and comparison of scorings across panels;
recommends the applications to be funded; and assists in
overall program evaluation.
The IP's overarching role is to ensure the Program remains
focused on its mission: eradicating breast cancer. The Panel is
there to guarantee scientific freedom and minimize duplication.
Once the scientific and technical peer review has been
completed, the Integration Panel reviews the proposals with the
mission and the strategic investment strategy in mind--looking
at not only what proposals are scientifically meritorious, but
also at which are the most meaningful. This step is critical.
It is extremely important to note that, unlike most traditional
funding programs, the DOD Program--and the structure proposed
by the pending Breast Cancer and Environmental Research Act--
does not tell the scientific community what to do, or what
specific study to perform. The scientists are free to use their
best judgment to decide what questions they will ask and what
areas their proposals will address. And they do so with input
from the consumer advocate community.
Another aspect of the proposed legislation has been
validated by the DOD Program. It is extremely important that
the program require grantees to be multi-disciplinary, multi-
institutional, and to collaborate with community-based
organizations. As I said earlier, environmental research is
complex and difficult. It requires the best minds working
together. We cannot stay within the silos of science if we want
to unravel the secrets of how our environment is related to
breast cancer.
The DOD Breast Cancer Research Program has been a model in
this area. It has spearheaded concepts such as team science
that proposed combining expertise to address significant
issues, by promoting funding mechanisms that require disparate
disciplines and/or investigators to communicate, cooperate and
jointly address problems. These collaborative grants encourage
not just individual scientists but also institutions to work
together. I have seen the results of promoting team science and
interactions through the multi-disciplinary and multi-
institutional model, and I fully support inclusion of this
model in the Breast Cancer and Environmental Research Act.
Team-oriented science can work, it is especially critical for
complex environmental research, and it requires novel funding
mechanisms to ensure that teams are both recognized for their
successes and accountable for their shortcomings.
Specific Application to the Proposed Legislation
The Panel in the Breast Cancer and Environmental Research
Act would act much like the Integration Panel at the DOD Breast
Cancer Research Program. The Panel would determine the
mechanisms necessary to address the overarching goal of the
legislation. Those mechanisms would be released to the
scientific community with a request for proposals in response.
The plan ensures that we do not restrict but rather foster
scientific freedom, creativity, and innovation. The idea is not
to predetermine for the scientific community what specific
research areas are to be addressed. The idea is to create a
framework for scientists and consumers to fund scientifically
meritorious research related to the environment and causes of
breast cancer--research that is meaningful and will get us
closer to finding the answers we need, in a strategic,
collaborative way.
The Importance of Consumer Involvement
Breast cancer is not just a problem of science, but it is a
problem of people. The inclusion of trained consumers at every
level is critical to the success of the DOD Breast Cancer
Research Program. The Program is a collaboration of the
critical stakeholders--scientists, clinicians, the military,
and trained consumers with a connection to breast cancer.
The consumers play a key role in ensuring that the research
that is funded is responsive to needs of both the scientific
and patient communities. Their perspective is necessary to
ensure that the grants funded are meaningful and will have
impact. Consumer advocates bring a vitally important
perspective to scientific research. And they keep the
scientists on task. Together, they can look at the current
state of knowledge, and then design appropriate and necessary
mechanisms to allow scientists, in collaboration with
advocates, to develop proposals to research the most important
questions.
I have quotes from several of my colleagues in the
scientific community who have worked on the Integration Panel
or in other capacities in the DOD Breast Cancer Research
Program. Many of the scientists who have participated in the
Program have said that the Program--and working with the
advocates--has changed the way they do research. This has a
profound impact on the way scientists approach their work.
For example, Dr. George Sledge of Indiana University said,
``Of the many advances in breast cancer research over the past
decade, among the most important is the role of advocates in
furthering and focusing the research agenda.''
Dr. Regina Resta of New York said, ``I served as a
scientist on a DOD breast cancer study section [peer review
panel]. The idea of the `consumer reviewer' frankly, struck me
as somewhat forced and potentially unhelpful in the review
process. I was WRONG. These women added immeasurably to the
process.''
Finally, Dr. Michael Diefenbach of Mount Sinai School of
Medicine wrote, ``I have served as a reviewer for the
Department of Defense's Breast and Prostate Cancer Review
programs and I am a member of the behavioral study section for
the National Cancer Institute. I find survivors or advocate
reviewers as they are sometimes called bring a sense of realism
to the review process that is very important to the selection
and ultimately funding process of important research. Both
sides bring important aspects to the review process and the
selected projects are ultimately those that can fulfill
scientific rigor and translatability from the research arena to
clinical practice. I urge that future review panels include
advocate reviewers in the review process.''
In addition to these scientists, and many others who have
praised the DOD Breast Cancer Research Program, the IOM has
reviewed the Program twice and has praised the design of the
Program. In its 1997 review of the Program, the IOM stated:
The program fills a unique niche among public and private
funding sources for cancer research. Among the most outstanding
features of the program are the flexible approaches for setting
priorities annually [and] the involvement of breast cancer
advocates (consumers) in the peer review process.
The report goes on to state, ``The Integration Panel, along
with the USAMRMC, is responsible for a breast cancer program
viewed as successful by this committee.'' In 2004 a report by
the IOM reiterated these remarks.
Finally, I would just like to talk a bit about how this
approach has affected my research in my own institution. As you
may know, Duke University has one of the most outstanding
schools of environmental research in the United States, as well
as an outstanding medical center. Policies of required cross-
disciplinary research promoted by the DOD, led a number of
investigators in the Cancer Center to actively meet and engage
in collaborations with the Nicholas School of the Environment,
an event that had not taken place previously. Environmental
scientists, molecular epidemiologists, and basic scientists
work together with breast cancer specialists to explore how
environmental exposures can increase a woman's risk of breast
cancer, and possibly inhibit current strategies to prevent
cancer. In addition, we have seen rapid increases in breast
cancer in parts of the world undergoing rapid economic growth,
which must be explored. Traditional forms of support could not,
and did not support interactions reflecting these
collaborations in the past. It is imperative that mechanisms
that will enable these types of interactions be supported
In conclusion, the approach used by the DOD peer-reviewed
Breast Cancer Research Program has changed the world of breast
cancer research. We now need to apply the same model to
investigate the causes of breast cancer. And it is our hope
that this research model might inspire new approaches in other
areas of scientific inquiry. As I said earlier, if we know what
causes the disease, we can learn how to prevent it, how to
better treat it and even to cure it. It is time that we take a
fresh look at the environment and breast cancer. This proven
approach will bring innovation and new thinking to the problem,
will best use our resources and will complement ongoing work at
NIH and elsewhere.
----------
Mr. Pallone. Thank you, Doctor, and thank you to all of
you.
We will now have some questions. I know that you may not
all be able to stay for the whole time, but we will start out.
And I wanted to ask Ms. Crow a question. First of all,
thank you for coming to meet with me and the other members,
because I know you are a strong advocate on this legislation.
You testified that the bill before us gives scientists the
resources and the focus to address issues pertaining to breast
cancer and the environment. And you stated that the bill would
bring researchers together to work in collaboration with
trained advocates and with community based organizations. Can
you tell me what impact you think the legislation will have on
determining the linkages between the environment and breast
cancer, and how that will help us develop a cure or preventive
measures?
Ms. Crow. Well, obviously I think Fran could probably
answer that more efficiently. But I would say that this bill
has been set up very thoughtfully with the exchange of
information between researchers and with the grants being peer-
reviewed and information being just submitted through that.
That hopefully a lot of questions will be answered. I would
have to defer to you on that. I can tell you from my
perspective because I am not a scientist and have not been
involved in actually writing the bill, but what I understand of
it is that it is very efficient and will by no means tie up
anybody's arms as far as what they can and can't do, but that
it creates opportunity for research to go forward. And if I
can, I would love to defer that to Fran.
Mr. Pallone. Sure. I mean either one of you really. What I
am trying to get at obviously is how the provisions of this
bill would help us understand these linkages better than the
current research efforts. So Ms. Visco or Ms. Crow, either one
of you.
Ms. Visco. Well, Chairman, this bill is meant to look at
these issues in a strategic way. The NIH has devoted resources
to this issue. We have worked with, over the past 10 years, we
have met with and collaborated with research who have devoted
decades of their lives to looking at this particular issue. And
what happens is we look at these issues in silos, and to some
extent in a vacuum. There is very good important work going on,
but what isn't happening is a really broad overarching
strategic approach to looking at the links between the
environment and breast cancer.
What this bill will do is it will compliment and enhance
the ongoing work at NIH and it will allow researchers across
the country, again many of whom who have devoted their lives to
these issues, to work in collaboration and to submit their
ideas and their questions to the NIH. And looking across all of
those ideas the NIH has the ability to make certain that there
is going to be a strategic approach. So it is complementing and
enhancing and increasing scientific freedom and a strategic
approach to this question.
Mr. Pallone. Now, you said, Ms. Visco, that the annual
funding for breast cancer research, both private and public,
has remained relatively stagnant for the past 15 years. Do you
know why that is true, and do you think that this--I mean one
of the purposes of this legislation was to increase the public
investment.
Ms. Visco. Yes. Well, we recognize that first of all this
is an authorization bill. This is not an appropriations bill.
It is not our intent that NIH take the limited funding that
they have to fund this bill. It is our intent to bring the
power of advocacy and working in collaboration with you to
increase the appropriations to make certain that this bill has
an appropriation so NIH can do the work.
So here we have a situation where you have scientists
around the country who are eager to see this happen. You have
advocates and the political will to make it happen. We have
incredible sponsorship all behind, looking at this issue and
taking an innovative, new, exciting approach that will
compliment everything that is ongoing. They----
Mr. Pallone. Did you want to talk--I mean my time is
running out. Did you want to talk about the Senate bill? What
do you want? We don't like to follow the Senate just so you
know, but----
Ms. Visco. Well, actually what we are doing is following
the NIH. Because the bill that was marked up in the committee
in the Senate and was a result of negotiations with NIH taking
into account their concerns with the bill and coming to an
agreement on what they would agree to, and then withdraw
opposition to the bill, so the bill makes clear that the peer
review----
Mr. Pallone. Would you be satisfied if we amended this to
conform with the Senate?
Ms. Visco. Yes, yes, we would very much like to see that.
Mr. Pallone. And you think that would still accomplish your
goals?
Ms. Visco. Yes, we think that would retain the integrity of
the approach and of the legislation. Yes.
Mr. Pallone. OK, thank you. Mr. Rogers.
Mr. Rogers. Mr. Chairman.
One of the things that concerns me most about when we weigh
in on these issues is--as I said I am a 24-year cancer
survivor--is that we keep partisan politics out of them.
Because if it seeps in in any way we end up fighting about
things that are ridiculous when we have people who have
committed their lives to solving this problem for real people
who are going through some pretty horrible events in their
life. And, you know, I had heard some expressed concern, at
least through Senate negotiations, that there has been some
strong rhetoric on this. Ms. Visco, you don't believe that this
is a partisan issue do you?
Ms. Visco. Well, this is without question not a partisan
issue, and the bill itself has incredible bipartisan support.
Mr. Rogers. And my understanding is you support the Senate
bill as amended.
Ms. Visco. Yes, we do.
Mr. Rogers. OK. You know, that is reassuring to me, because
I think that we will probably, if we can get close to that
Senate bill, we are going to have very--excuse me--broad
bipartisan support for this bill, and you would support that.
Ms. Visco. Yes.
Mr. Rogers. Wow. That is--I mean that is good to know, Mr.
Chairman. And I hope that we put that in our calculus here as
we move forward, because I think the concerns are actually
legitimate concerns. As I said I really don't want to take away
a doctor's time doing research to fill out a form to talk about
a grant that isn't quite coordinated to find out if it is
duplicative is not a good use of time, I don't think. So I am
glad to hear you say that and that----
Ms. Visco. Can I just----
Mr. Rogers. Sure.
Ms. Visco [continuing]. Address one of those issues? And,
in fact, one of the purposes of the structure, which mirrors
the DOD structure, is to make certain there isn't unnecessary
duplication. So the scientific peer review is--maintains its
integrity. We don't have unnecessary duplication, and at the
same time we have a strategic approach to the problem, and that
is what the Senate bill underscores.
Mr. Rogers. Right. And I--you are talking about the Senate
bill. And this bill, that panel--when I went back and tried to
read that language I just felt, boy, I think there is a better
way that we can do this that gets the result that we all want
to have, I think, at the end of the day. So I appreciate you
working with them and your note that this is not a--or this is
a bipartisan effort, and that you do support the Senate version
of it, which is a little different from this. So I don't think
any members here, including some of my good friends who had
some objection to it, were doing it in any other way other than
somebody saying, hey, there might be a better way to do this.
Thank you for that.
And Ms. Crow, I want to thank you for something. When I was
a young army lieutenant--and I had suffered cancer prior to
getting in the military--I had gone through all my military
stuff and I got a very shocking call one day. And this was back
in the 80's when it was still not really--it was uncouth to
talk about having cancer at any time in your life. They called
me into the office and said, we went through the medical review
and found out that you had cancer. Before I had completed all
the training by the way. So I had completed the training. And
said, we don't think you are eligible to be an officer in the
United States Army. And after a very long process of going--
getting through the notion of that is the most ridiculous thing
I have ever heard--and the reason that happened is because
there weren't a lot of people having--willing to have the
courage and commitment to stand up and say, hey, wait a minute,
I am a cancer survivor. I am leading a productive life.
Ms. Crow. Yes.
Mr. Rogers. And there are a lot of great things and a lot
of great days ahead. And one of the things I want to compliment
the doctor for, and others, is we have made such strides in
survivability in cancer. That is--we haven't found a cure
necessarily yet, but we have found a lot of ways to keep people
alive. Earlier prevention, catching it early, the treatment
regimens, the next generation of treatment regimens that are
going to be less harmful in their side affects is all right
here. It is all coming down the pike. And I think this a very
exciting time to be in research, and it is an exciting time to
be involved in cancer research for you doctor. And so, you
know, there are a lot of things you could do with your time, to
spend your time doing that, and letting people know that,
listen, you can survive it and you can move on and you can
still do great things.
I look forward to your next album, by the way.
Ms. Crow. Thank you.
Mr. Rogers. Yes, you are welcome.
One of the things that the Senate did--and maybe I can get
a comment from all of you--is they moved back the grant
process. Rather than create that center they wanted to do
grants. And I thought that was a pretty good idea, so that we
don't do--and I think it would be easier to get to the
research. Did you agree with that portion of the Senate bill?
Instead of having that dedicated center with a panel funding it
that they would go to a grant structure to do the research, the
very research that you are talking about accomplishing?
Ms. Visco. That was actually the intent of the legislation
from the beginning. It was simply using an inartful word--
center--to describe it. But we very much--that is the approach
that we are interested in. We are not interested in the bricks-
and-mortar or rigid structure. We are interested in a grant
program that will respect scientific freedom.
Dr. Lyerly. Thank you. And I would concur with that. It is
really, you know--probably the more contemporary term would be
a social networking type of support that allows the type of
communication, the non-duplicative events, the ability to
engage. And, again, I think this idea that, you know, in the
past centers have excluded others and supported only those
within it, and the exact opposite intent. And I think the
language does improve that to develop a policy in which
information is pushed out, the ideas are brought in, and
respectfully and thoroughly considered, and so forth. And I
think the DOD track record in establishing that is it provides
an assurance that that type of template, that type of thinking,
will move forward.
Mr. Pallone. The gentleman's time is expired.
Mr. Rogers. Just a comment for Ms. Crow. You had--in your
testimony you said this was the bill, but you would be, as an
advocate, willing to get to where we are all going I would
assume----
Ms. Crow. Absolutely. And I think one of the strongest
arguments for that is seeing this young group of women over
here, and not having--they were here earlier. And they are
working tirelessly on behalf of this bill as well to not be
able to dictate, at this point, while they are coming into
their maturity earlier than in the past, and what kind of
correlation that has to the uprising statistic in young women
who are being diagnosed with a much more advanced kind of
cancer that is more difficult to treat. And as, obviously, a
person who is in the media I get all kinds of e-mails about
don't use this kind of lipstick, don't use that kind of
shampoo. A lot of it is misinformation. A lot of it is
information that has not been investigated. These young women
are living with that every day, with having the kind of
information that I am getting as well, knowing that is this
going to be a factor in my getting an early diagnosis with
breast cancer, or any other disease. And to me this bill,
instead of having a cannonball shoot at a fly, it creates a
much more, I think, directed opportunity to look at breast
cancer with the hope and the knowingness perhaps that will
correlate not just breast cancer but cancer across the board,
and to these diseases outside of cancer as well.
Mr. Pallone. Thank you, gentleman.
Mr. Rogers. For the record, Mr. Chairman, my staff warned
me--I am the big Sheryl Crow fan--that I was not allowed to
faun over the----
Ms. Crow. Please, faun away. If it means getting the bill
passed, faun, faun, faun.
Mr. Pallone. Thank you, Mr. Rogers.
The gentlewoman from California, Ms. Capps.
Ms. Capps. Thank you, Mr. Chairman.
You know, a lot of people hear that this bill is about
research on breast cancer and the environment. They may only be
thinking of things like pollution in air or tainted water,
things like that. And I know, Ms. Crow, you elaborated a little
in your opening statement that the use of the word environment
can be very broad-based, and you mentioned the lifestyle and
stress as environmental issues that may clearly affect a
woman's health or a person's health. I am going to start with
Ms Visco, and ask--because I know you have some strong opinions
about this as well, or beliefs, and ask you to start this
conversation. And I hope Ms. Crow will chime in. But I also--
just to lay out my 5 minute time I do want to ask Dr. Lyerly
the same question that I asked Dr. Winn in the previous panel
just to get some information on the record, so please, Ms.
Visco.
Ms. Visco. Well, I will say quickly that we do, as an
organization, and this legislation would define environment
very broadly. It is not just about chemical exposure. It is
about lifestyle. It is about endogenous environmental
influences, what is happening in our body, outside out body, so
it really is a broad strategic, a broad look at the issues and
the links between the environment and breast cancer. Sheryl,
did you want to----
Ms. Crow. Well, and I would go one step farther and say
that as anybody who has been diagnosed knows that you sort of
become a student of cancer, and you learn a lot more than
probably what you want to know. And one of the things that is
really interesting with regard to the environment is in the
correlation in different places such as China that never had
cancer before 1950, and what is the correlation now to
lifestyle, to environmental exposures that is causing a rise
in--does that apply to us in America? I think we work together
as a complete scientific community, but America is so much at
the forefront of research and we know it and we do it so well.
And this to me is a great opportunity in the fact that everyone
right now is concerned about the environment, and as we watch
it move into our personal space and affect our personal lives
we know that there is a correlation. We don't know what it is,
and it creates and incites a lot of fear in us. And when we are
talking about what kind of plastics we are drinking out of--I
have a 1-year-old who is still drinking out of a baby bottle. I
want to know if later on that is going to cause some sort of
cancer, some sort of disease, that could have been prevented.
So I agree with Fran that the environment is difficult to
define or to narrow, but this is a great starting place for us
to tackle.
Mr. Capps. Thank you. And I will ask my question of you,
Dr. Lyerly, in a minute. But, Ms. Crow, while you were speaking
a group of young women that you were referencing in an earlier
comment came back in. And I know that we are all impressed with
the girl power, soon to be women power, that is----
Ms. Crow. Yes.
Ms. Capps [continuing]. Going to really take leadership in
the areas that we are talking about today, and you are going to
have plenty of material to work with. Let us put it that way,
because as much as we want to pass this legislation there is
certainly more to come, and the advocacy groups can hardly
wait. And as I said, as I shook a few hands earlier some of
them are going to be sitting back here one day too, so that is
a very good strategy that you are embarking upon.
Dr. Lyerly, I asked this question before, but I want to
have your take on it as well. We have heard from critics of
H.R. 1157 that the legislation is too disease-specific. Isn't
it true that research on any cancer can often lead to progress
for all cancers? In fact, doesn't research for one condition
often to lead to a cure for another?
Dr. Lyerly. Thank you for that question. I think there is
clear evidence that inside into how cancers are diagnosed and
treated can lead to very clear advances and treatment for other
diseases. One example that stands out for breast cancer
specifically is the idea of targeting the Epidermal Growth
Factor Receptor type II or ERBE II and developing strategic
therapies against this pathway was widely thought as not going
to be effective, was demonstrated to be highly effective in
breast cancer, and this has lead to anti-EGFR or Epidermal
Growth Factor Receptor therapies that are proven to be
affective in lung cancer. They are proven to be affective in
colorectal cancer. They are proven to be affective and very
promising in pancreatic cancer, and a very interesting, but yet
unproven approach for the treatment of malignant brain tumors.
Something that is very near and dear to many of our hearts at
this point, because again EGFR mutations are found in brain
cancers, and we can imagine that insight developed in the
development of therapies and insight into why breast cancer is
developed could now be applied.
I do think breast cancer has led the way in forming
collaborations, forming networks for tissue acquisition, for
research approaches. So I do think there is a--like everything
in life one foot has to go first. Breast cancer has lead the
way in many examples in advancing the entire field of cancer,
as well as helping us understand fundamental biological
principals like metabolism of cancer cells, and how that
metabolism can affect weight gain or weight loss or myocardial
function, and so forth and so on. So broad implications for
even this narrowly defined starting point.
Ms. Capps. Thank you. And interesting that you would say
what you just said next to two of the real leaders in this
advocacy movement that have highlighted that breast cancer has
shown the way in many areas. And it is a lot because of the
advocates, and many of them are survivors. I just have to give
credit where credit is due.
Thank you so much.
Mr. Pallone. Mr. Deal.
Mr. Deal. Thank you. I want to thank all of you for being
here today.
I hear a great deal of commonality of concern, even though
different points of view have been expressed. And I think that
the issue of whether we know best, or whether the scientists
and the experts at NIH know best, we probably lose in that on
every basis, and I think that is the concern we have heard
expressed.
And, Ms. Visco, I understood you to say in your earlier
testimony that you are supportive of the Senate version of the
bill. And, of course, it does address some of the concerns that
were expressed by the NIH representatives in terms of the
issues that they thought were somewhat troubling. Is that your
understanding as well?
Ms. Visco. Yes, we do support the Senate bill, and it did
come about as a result of negotiations with NIH to address
their concerns.
Mr. Deal. OK. Dr. Lyerly, I understand that you are the
director of the Cancer Treatment Center there at Duke, and I
assume you treat all sorts of cancers, not just breast cancer.
Is that correct?
Dr. Lyerly. We do.
Mr. Deal. Yes. And one of the things that causes us concern
about trying to put everything back in the old silo approach is
that, as you probably know better than I do, the non-melanoma
cancers and the bronchial cancers and lung cancer. Those are
taking substantial number of women's lives as well. In some
cases maybe even exceeding the breast cancer deaths. So the
fact that we may not all agree that everything needs to be
focused in one area I think we are all saying that we need
research, because it does overlap, does it not, as to what you
find out in one area, as you have already elaborated?
Dr. Lyerly. It really does. And I think the emphasis here
is imagining a complementary and potentially open extension of
the really elegant model for NIH funding, and allowing
scientists and the science to drive the opportunities for it.
So I think--what I think that I found most comforting in long
discussions about this opportunity is to hear and open and not
to look at plastics or to look at specific toxins or a specific
industry, but to allow the science to really drive the
opportunity. But what I think is really important is that it
creates a overarching strategy to move forward, and it allows
engagement of investigators that perhaps may not have been
traditional environmental scientists to be involved. And this
is really where great opportunities abound. Having people with
deep insight into computational models, nano-technology,
environmental scientists at the Environmental Protection
Agency. These are investigators that traditionally would not be
engaged in any NIH-funded research, and this opportunity allows
and opens up and creates the sort of power of persuasion to get
them onto the table to have those discussions. So I concur with
the sentiment that we don't want to be exclusive, but as we are
beginning to start innovative models that address the
fundamental problems in cancer we have to have some focus,
otherwise we will be a mile wide and an inch deep.
Mr. Deal. But I think you understand the concerns some have
expressed here that we don't want to undo the good we think we
did in the NIH reform model that did some of those very same
things of breaking down the silos and allowing cross institute
sharing of information. Things that really needed to be done
for a very long time. I think that is the concern that you have
heard expressed by a lot of people.
I will conclude, Mr. Chairman, with a personal reference,
and my daughter probably will not like this. But our family has
just gone through a real traumatic experience of my 2\1/2\-
year-old granddaughter suffering strokes. And that has been one
of the most traumatic situations, and fortunately they live
close to Eggleston's Hospital there in Atlanta and she has been
treated there and is out of the hospital now. But I understand
the importance of research because currently we don't know the
cause, we don't know how to treat it, and that is one of the
most frustrating experiences anybody could have is that
uncertainty. So all of us hold great hope for scientific
research and to a lot of different areas, and this of course
being one of the ones that all of us are empathetic with. And I
think you will find that we will have the support necessary to
move this legislation forward. Personally, I hope it is the
model that the Senate has adopted. I think it does eliminate a
lot of the controversy that we would otherwise encounter.
Mr. Chairman, thank you for your time and I thank all the
panel members for their presence today. Thank you.
Mr. Pallone. And you have to leave? That is OK.
Ms. Crow. I do have to leave.
Mr. Pallone. Oh, please.
Ms. Crow. I sure do appreciate your allowing me to give my
testimony----
Mr. Pallone. Sure.
Ms. Crow [continuing]. Today.
Mr. Pallone. Thank you very much. We appreciate your
advocacy.
Ms. Crow. And I will--thank you.
Mr. Pallone. Take care.
The gentleman from New York, Mr. Engel.
Mr. Engel. Thank you. Thank you, Mr. Chairman.
Having lost my mother last year to pancreatic cancer it
certainly opens your eyes in terms of all kinds of cancers. And
certainly I think that the Congress ought to be doing
everything we possibly can, not only for research, but the
ability to have people diagnosed, see doctors as well.
I want to--I understand we have a lot of young women here
from Georgetown Visitation High School, and on behalf of myself
and our colleague, Ed Towns, I would like to welcome them
because I know they worked hard on this bill through student
advocacy. So thank you very, very much, ladies, for coming and
for being great advocates.
This, of course, should be bipartisan and is bipartisan,
but I think that I would be remiss if I didn't say that the
levels of funding, the Administration's levels of funding, for
NIH for breast cancer has been inadequate. And we had a
doubling of monies directed to cancer research, and then in
2003 that doubling was sort of left by the wayside and kind of
flattened out. And NIH has lost more than 13 percent of its
purchasing power as a result. So I think that we need to keep
pushing for more funding. Money doesn't cure everything, but it
sure helps, and I think we ought to keep doing that.
And I was glad that people mentioned environmental issues,
because--Ms. Capps did. And I think it is very important,
because it is not a coincidence that cancer is just multiplying
in leaps and bounds from what it was only a few short years go,
so we know that the environment is certainly a major factor in
this as well.
I would like to ask Dr. Lyerly a couple of questions.
Doctor, based on your work with DOD, Department of Defense's
Peer Reviewed Breast Cancer Research Program, can you enlighten
us as to why you believe that that approach is the right
approach for looking at the environmental causes of breast
cancer? And also in conjunction with that if you could explain
why getting consumers involved as the DOD research program does
is beneficial for the research process.
Dr. Lyerly. Yes, thank you. Well, in my experience on the
DOD integration panel I was able to see that the process was
slightly different than the NIH process. And the NIH process in
general allows for investigators to come up with their own
ideas. But usually if there is an idea that it wants to be
promoted by the NIH they will send out a request for
applications and they will say we want to study broadly
pancreatic cancer or nano-technology or imaging, and that
creates opportunities for people to apply for funds to look at
cancer imaging. The DOD approach is different in that it really
begins to allow a completely clean slate and allow the
scientists to say what are the fundamental issues, the most
pressing issues, in breast cancer research today, and we will
not begin to apply for funds to address those issues.
We also think, as we have heard earlier, that many of the
opportunities involve collaborative research where we don't try
to have everyone replicate themselves, but in fact, partner,
develop relationships, and leverage scientific input. So we
wanted to promote mechanisms that facilitated that and provided
incentives for investigators to work together within their own
institution, but even with other institutions. Something
typically not promoted by the usual structures in which deans
or other center directors are rewarded for accumulating as much
as they can in their own center. And so the DOD approach was,
how do we address this question and who are the players in the
world that need to be on the team to address that question? And
we are going to promote those interactions by providing funding
mechanisms, and those teams would self-assemble and say we want
to understand why women don't respond to hormonal therapies, or
we want to understand why mammograms don't detect all breast
cancers, or we want to understand why triple negative breast
cancers are so lethal. And that is the question. It is not we
have three investigators working on breast cancer and we want
to form a center because we have three people. It is what are
these fundamental questions?
And I think that mechanism and the intent of that mechanism
requires advocacy involvement, because I don't think the
scientists--and I include myself in that population--in a
vacuum can really know what are the most pressing issues in
breast cancer research without really understanding what are
the most pressing issues in breast cancer.
Mr. Engel. Thank you.
And, Mr. Chairman, before I yield back I just want to add
my voice to all our colleagues who have mentioned Senator
Kennedy and wish him Godspeed and the very best in his battle
against cancer. Thank you.
Mr. Pallone. Thank you, Mr. Engel.
And I think we are done with our questions for this panel.
Thank you both really for really providing some worthwhile
testimony to us. And I think we are well on our way to moving
this legislation based on this hearing today. So thank you
again.
Ms. Visco. Thank you.
Mr. Pallone. And I will ask the third panel to come
forward. Now, this panel is going to focus on the second bill,
H.R. 758, ``The Breast Cancer Patient Protection Act.'' And
thank you for being here. Let me introduce the two of you.
First, on my left is Dr. Kristen Zarfos who is assistant
clinical professor at the University of Connecticut School of
Medicine, and director of the St. Francis Comprehensive Breast
Health Center at St. Francis Hospital in Hartford, Connecticut.
And then we have Ms. Alva Williams from Jacksonville, North
Carolina. Thank you for being here.
You probably heard me say before that we are going to hear
5-minute statements from each of you, and that we may have
additional questions that we would ask you to get back to us in
writing.
And I will start by recognizing Dr. Zarfos.
STATEMENT OF KRISTEN ZARFOS, M.D., FACS, ASSISTANT CLINICAL
PROFESSOR, UNIVERSITY OF CONNECTICUT SCHOOL OF MEDICINE;
DIRECTOR, ST. FRANCIS COMPREHENSIVE BREAST HEALTH CENTER, SAINT
FRANCIS HOSPITAL
Dr. Zarfos. Thank you. Good afternoon all of you and thank
you for those of you who are here. I appreciate you this
afternoon being here. We thank you Congressman Pallone for
bringing this bill to hearing, and we thank you certainly for
the honor of being here today.
As Congressman Pallone has said, my name is Kristen Zarfos.
I am a general surgeon with a specialty in breast care in
Hartford, Connecticut.
A little background information. A mastectomy is one of two
surgical procedures used to remove breast cancer. It is a 2-
hour operation, usually under general anesthesia, where all the
breast is dissected off the chest wall removing most of the
overlying skin, sampling some of the lymph nodes under the
adjacent arm. And as you might know, because I hear many of you
on the Committee have personally experienced a family member
with breast cancer, or at least you might expect it is painful,
accompanied by nausea many times, compounded by the need for
rubber tubes to drain blood from under the remaining skin. It
is deforming and it comes under the shroud of a woman facing a
potentially life-threatening disease, possible chemotherapy,
radiation, therapy. And uppermost in her mind the fear of
impact on her children and husband.
Until 1996 the average hospital stay for a mastectomy was 2
to 4 days for basic physical health care needs. And in 1996
exclusively patients paying for private health care insurance
were suddenly being told that they would have to leave the
hospital a few hours after their mastectomy, regardless of any
underlying complex medical problems they might have. This
unilateral decision on the part of several health care
insurance companies was made without any perspective clinical
research showing that it was safe.
Women, as consumers, earlier in the year before they knew
they would be diagnosed with breast cancer had purchased health
care insurance policies based on their reputation and the track
record of what services the company provided. These consumers
paid for and assumed they would receive what basic care they
had contracted for during the time of that contract. Yet, in
mid-1996 without informing the patients, the insurance
customer, several insurance companies changed the provision of
their contracts. Thus, women with newly diagnosed cancer who
had previously known other women who had stayed in the hospital
2 to 4 days after a mastectomy now are shocked to be sent home
within a few hours despite contracted services that they were
still paying premiums for. They were facing a breach of
contract for services at a time when they were sorely needed.
Imagine first being told you had breast cancer and that
conjures in your mind. And you are told then you are going to
lose your breast, and then you are told you cannot stay more
than just a few hours after surgery. To be certain, fighting a
consumer issue would be far from the foremost in your mind.
Government data showed that women with Medicare, Medicaid, or
no insurance at all were given the length of hospitalization
that they needed. Yet, women paying health care premiums were
denied that.
Following the precedent Congress set in the mid-1990s of
legislation to prevent mothers and newborns from being
discharged prematurely, a few hours after delivery, drive-
through delivery legislation, U.S. Congresswoman Rosa DeLauro
introduced The Breast Cancer Patient Protection Act in 1997 and
annually thereafter. This legislation does not mandate
hospitalization, but instead restores a right for a woman to
choose whether she be hospitalized 24 to 48 hours if she needs
basic care. Without protective legislation women and their
spouses will continue to pay double digit increasing health
care premiums, yet be denied care when they need it.
Now, women who have had adverse consequences from being
sent home a few hours after a mastectomy question what had
their insurance premiums that they paid for done for them. It
had not covered their physical needs. And indeed, 22 million
people who signed the Lifetime TV online petition asked the
very same question and share the outrage. In addition, many of
the 40,000 women who call the Breast Cancer Network of Strength
each year have echoed the concern. In 1997, 21 states responded
to the issue by passing legislation in various forms. Yet,
American women in 29 states and many still in the 21 states
with legislation where there is ineffective law face what has
been coined as a drive-through mastectomy. Sixty-five percent
of 125,000 women having mastectomies across America today face
leaving home in a few hours.
Now, remember none of us want to be in the hospital at all.
And I have had patients determined, the morning of their
surgery, that they want to go home that night, and yet most of
those women choose to stay for 24 hours. Indeed, women who are
ready to go home the same day, who are well enough to go home
the same day and choose to go home the same day, have the right
to do so. And so shouldn't women who post-operatively have
physical needs requiring hospitalization have the right to
receive the care that they paid for? It is not a woman's issue.
It is a family issue. In the last decade nearly a million
families had to face this, and their caregivers most of the
time are not health care professionals. But most important is
hearing the voices of women who face this, which you will hear
from Alva.
Now, included in the supplement given to you are
testimonies from women taken from the Lifetime TV petition, and
I would ask you please to look at those, because they are more
important than what I have to say. But there is a common
denominator. Pain, intractable vomiting, and infection, which
was rarely seen when we did inpatient mastectomies, emergency
room visits, and readmissions. And I can say in my 20 years of
practice, covering over 30 surgeons during the course of my
career, I have never had to see a patient in the ER shortly
after their surgery, or readmit them.
I must also tell you that despite being immersed in this
issue daily for over a decade I am still shocked at what
happens outside of Connecticut. And just 6 weeks ago I was
called from a woman in New Hampshire. A woman in her 50s
partially paralyzed and on blood thinners for clots who would
told she would have to go home a few hours after surgery. Now,
not to bore you with details, but if you are paralyzed your
mobility is limited to handle the drains, and being on blood
thinners it makes it very tricky for handling hemorrhage from
the standpoint of a surgeon. Yes, she had to fight to get one
night in the hospital. And what this says to me is that
unilaterally denying hospitalization says that each woman in
this country needs to be treated individually and not as a
faceless procedure.
Mr. Pallone. I am going to have to ask you to summarize.
Dr. Zarfos. I shall.
Mr. Pallone. Because it is over a minute.
Dr. Zarfos. I believe, as do most Americans, that our
legislators have served the consumer rights and health
protections rights of American people when we bring issues to
you as in the drive through delivery issue. We turn to you to
do that as you have done before. To help American families
faced with breast cancer in a way that brings no additional
cost to the American taxpayer and adds no burden to the health
care premiums, because after all, patients have already paid
for basic care.
I also want to--before introducing Alva I would like to
also acknowledge the several young women, who I have met before
joining us today representing the 150 members of the Think Pink
Society. It is a student-run organization at Georgetown
Visitation Preparatory School who have been working diligently
to raise awareness and garner support for The Breast Cancer
Patient Protection Act. We are pleased to have you join us for
this important issue today.
I would like to recognize the statement that the co-
president of Think Pink, Kaley Costino, has submitted for
record. And I echo what our Congressman said. I will be
delighted when they are running this country, and they are the
future doctors of this country.
Thank you.
[The prepared statement of Dr. Zarfos follows:]
Statement of Kristen A. Zarfos, M.D, FACS
Good morning Congressmen Pallone and Deal, along with the
entire Subcommittee on Health of the Energy and Commerce
Committee. It is an honor to come before you to share
information on one aspect of breast cancer care of women and
their families in America today.
My name is Dr. Kristen Zarfos, fellow in the American
College of Surgeons. I am a general surgeon with a focus in
breast cancer care. I am an assistant professor of surgery at
the University of Connecticut School of Medicine, as well as
Director of the St. Francis Comprehensive Breast Health Center
in Hartford, Connecticut.
Until 1985, almost all women who were diagnosed with breast
cancer underwent a surgical procedure called a mastectomy. It
is likely that someone in your family has had this procedure.
It is a 2-hour operation, usually under general anesthesia
where all of the breast is dissected off the chest wall,
removing most of the overlying skin and approximately half of
the lymph nodes under the adjacent arm. As you might know, or
at least expect, it is painful, accompanied by nausea many
times, compounded by the need for rubber tubes to drain blood
from under the remaining skin. It is deforming and comes under
the shroud of a woman facing a potentially life threatening
disease, possible chemotherapy, radiation therapy, and
uppermost in her mind--the fear of the impact on her children
and husband.
The good news is that federally funded prospective clinical
research showed in 1985 that not all women with breast cancer
need have a mastectomy, but could have a lumpectomy with
radiation therapy. The even better news is that each year since
the early 1990s, because of early detection, fewer American
women have mastectomies each year. Yet each year, more women
are diagnosed with breast cancer--now over 200,000 each year.
And still, because of certain individual characteristics (which
I would be glad to share with you in more detail if you wish)
approximately 125,000 American women require mastectomies to
give them the best possible chance that the cancer will not
recur.
Until 1996, the average hospital stay for a mastectomy
based on data collected by a hospital association, was 2-4
days. This hospitalization was for the basic health care needs
of pain control, nausea control for the needed pain medication,
management of the necessary tubes draining blood from the chest
wall, overcoming the effects of anesthesia, and nurses teaching
the patient, after she is awake, and her caregivers how to
dress the wounds and handle the drains. Rarely were infections
seen in the mastectomy incisions. Even more rare was a patient
seen returning to the emergency room with a problem or being
readmitted. In fact, in the 20 years of my practice, I have
never had a patient of my own or the surgeons who I covered
return for these needs.
In 1996, exclusively patients paying for private health
care insurance were suddenly being told that they would have to
leave the hospital a few hours after their mastectomy--
regardless of any underlying complex medical problems they
might have, such as diabetes requiring close monitoring and
adjustment of insulin shots because of the stress of surgery,
severe heart disease, or being on blood thinning medication.
Under no consideration was if the patient had a prior history
of adverse reactions to anesthesia, post-operative pain that
oral medications would not control, how far they needed to
travel home still groggy, in pain and nauseated , or if they
even had an adult to care for them at home. This unilateral
decision on the part of several health care insurance companies
was made without any prospective clinical research showing it
was safe.
As the Commerce Committee, you should be aware that as
consumers, earlier in the year, before knowing they would have
to face breast cancer, women had purchased health care
insurance policies based on the reputation and the track record
of what services the company provided. These consumers paid for
and assumed they would receive what basic care they had
contracted for during the time period of that contract.
In mid 1996, without informing the patient, i.e., the
insurance customer, the several insurance companies changed the
provision of their contracts. Thus, women with newly diagnosed
breast cancer, who had previously known other women who were
admitted for 2-4 days after a mastectomy, now were shocked to
be denied even 24 hours in the hospital, despite the contracted
services they were still paying for. They were facing a breach
of contract for services that they now so badly needed.
Imagine first being told that you have breast cancer, and
all that conjures in your mind. Next you are told you would
lose your breast, and the impact that has on you. Then you are
told that you could not stay in the hospital but for a few
hours after losing your breast. To be certain, fighting a
consumer issue would not be the foremost thought on your mind.
The questions that women ask when faced with breast cancer are,
``Am I going to die?'' (over 40,000 women die each year in the
US from breast cancer); ``Am I going to leave my children?'';
``How painful and deforming will the surgery be?''; Will I be
able to return to taking care of my family or working?''
This denial of care was faced primarily by women paying for
private insurance. Government data showed that women with
Medicare or Medicaid or no insurance at all, were given the
length of hospitalization after a mastectomy they needed.
Following the precedent Congress set in the mid 1990s of
legislation to prevent mothers and newborns from being
discharged prematurely a few hours after delivery (know as the
Drive-Through Delivery legislation), your colleague, U.S
Congresswoman Rosa DeLauro introduced the Breast Cancer Patient
Protection Act in 1997 and annually thereafter. This
legislation does not mandate hospitalization, but instead
restores the right for a woman and her doctor to choose whether
she be hospitalized 24-48 hours if she needs hospitalization
she has paid for through premiums for basic health care.
Without protective legislation, women and their spouses will
continue to pay double digit increasing health insurance
premiums, yet be denied basic--not embellished, superfluous or
elective--health care at a time of the crisis of being told the
diagnosis of breast cancer. There is consensus that pain
control, alleviation of the physical act of vomiting against a
painful chest wall, control of rubber tubes draining blood from
a fresh surgical area fit the definition of basic health care.
Women who have had adverse consequences from being sent home a
few hours after their mastectomies ask what have they paid
insurance premiums for if their basic physical needs were not
covered.
Please do not rely on what I am telling you, but refer to
the many testimonies gathered on the Lifetime TV online
petition of 20 million people, in which many women tell their
own stories of being sent home within a few hours of their
surgery. What they tell makes even me, a seasoned surgeon of
two decades of practice, cringe at the consequences they
endured. (A condensed list of testimonies is provided.) The
Breast Cancer Network of Strength (formerly the Y-Me National
Breast Cancer Organization) fields over 40,000 a year from
breast cancer patients. On many occasions the hotline has
received calls from patients told that their insurance will not
cover a hospital stay after their mastectomy--stories about
women forced to leave the hospital shortly after surgery
without proper recovery time have surfaced--many forced to
leave while still under anesthesia.
In 1997, 20 states responded to this issue by passing
legislation in various forms--some truly protective, others
just token--as you will hear. Yet, American women in 30 states
and many in the 20 states where there are ineffective laws face
what has been coined as ``drive-through mastectomies.'' Sixty-
five percent of the 125,000 women having mastectomies across
America today leave the hospital within a few hours of their
surgery, regardless of their physical health needs. Remember
that nobody wants to be in a hospital at all. Even the most
determined patients I have had who preoperatively request going
home the same day, after having surgery have requested staying
at least 24 hours. Many women have the resources and they
choose to go home the same day of their mastectomy. They have
the right to do so. And, so shouldn't women who postoperatively
have the physical needs requiring hospitalization should have
the same right to receive the care they need and have paid for.
But, let me pause here to clarify that this is not solely a
woman's issue. This is a family issue. 125,000 American
families face this each year. Approximately 975,000--nearly 1
million families have faced this over the last decade since
this practice started. This is a family issue, which I am sure
many of you may have experienced. As husbands or sons hearing
this information today, you may be thinking what it would be
like for you to take care of your wife or mother in pain and
frightened. The entire family--husbands, young children,
elderly parents--have become caregivers, most often with no
previous medical experience.
These are the background facts. Following is the most
important perspective from women with breast cancer who had
outpatient mastectomies. These American voices from across the
country will tell you what happened to them with the
treatment--or lack thereof--of their breast cancer.
Today in this audience is Alva from North Carolina. Alva
came to Congress to share her story at a press conference to
announce the introduction of the Breast Cancer Protection Act
in 2006. Alva has asked me to share her and her husband's story
in her words to help you understand the real impact of being
sent home a few hours after a woman loses her breast.
Alva was 65 at the time of her diagnosis of breast cancer.
Her health care insurance was covered by her husband's
insurance along with their contribution. Her insurance company
mandated that she have a surgeon who performed her surgery in
an outpatient facility 1 hour away by back roads from her home.
Alva was sent home directly from the recovery room a few hours
after her surgery, still groggy from the general anesthesia.
She was given pain and nausea medication to take by mouth,
neither of which worked. She vomited, causing more pain in her
chest wall, and of course preventing the pain medication from
being absorbed. Her husband, a washer-dryer technician, with no
prior medical experience, was her caregiver. She developed a
Staphylococcal infection, causing her mastectomy incision to
pull apart, and drain. The open wound required weeks and weeks
of antibiotics, dressings and packings, which delayed her much
needed chemotherapy for 6 weeks.
Alva was so moved by her diagnosis that she has embraced
helping other women diagnosed with breast cancer in many ways.
Through her advocacy, she has met two other women who underwent
outpatient mastectomies in her state, despite the fact that
North Carolina has a state law to prevent this. One woman is a
widow in her 40s with 3 children she is raising by herself. She
went home to be taken care of by her eldest son who is 10 years
old, being the only person to help her with bandages and the
draining tubes. As a city employee, her employer was not self-
insured, so that even ERISA was not an excuse for her being
sent home a few hours after her surgery. A third woman who Alva
met has insurance with a very well respected company. She, too,
was denied hospitalization the day of her surgery.
In Alva's words, ``No person should be treated like an
animal; even my Cocker Spaniel with breast cancer was kept
overnight when she had surgery.''
Let me share yet more personal stories from women across
the country--all of which have the common themes of pain,
intractable vomiting, infection (something rarely seen before
outpatient mastectomies), emergency room visits shortly after
surgery, re-hospitalizations, and even a fatal postoperative
heart attack at home. These are included in the supplement to
my testimony taken from the on-line petition. I will stratify
those from the states which already have laws, with additional
compelling reports.
But first, I must again tell you that despite my being
immersed in this issue day in and day out for two decades, I am
still shocked at what is going on outside Connecticut. I was
called by a women in New Hampshire just 6 weeks ago. She is a
woman in her 50's, partially paralyzed and on blood thinning
medication for blood clots, who was told she would have to go
home a few hours after her surgery. Her paralysis limits her
mobility; managing the blood thinners can be tricky to prevent
her from hemorrhaging. The thought she would be unilaterally
denied hospitalization says that each woman in this country
needs to be treated individually, not as a faceless procedure.
These are facts from the people who matter--American women
and their families across the country and in ever increasing
numbers. What they say is the reality. This is a major obstacle
to the treatment of 125,000 women with breast cancer each year.
The purpose of the Breast Cancer Patient Protection Act is
simple and straightforward:
1. To restore consumer services of basic health care that
women have paid for, but is being withheld.
2. To restore a right to the basic health care of a choice
of the services of a 24-48 hour hospitalization. This is not a
mandate for hospitalization, but rather quite the contrary, a
restoration of the individual patient's rights based on her
physical needs for care she has paid for.
3. To provide uniform protection to all American women and
their families across the country rather than the current
disparity in the care of women with breast cancer in the United
States.
Shouldn't all American women and their families have the
right to having basic health care they have paid for the day
they face mastectomy?
I believe, as do most Americans, that our legislators have
served the consumer rights and health protection rights of the
American people when we have brought issues to you attention,
as with the Drive-Through Delivery legislation. We turn to you
to do as you have before to help American families faced with
breast cancer in a way that brings no additional cost to the
American taxpayer, and adds no burden to health care premiums,
as the services of basic health care the patient has already
paid for.
We turn to you to help us. Pass the Breast Cancer Patient
Protection Act.
Thank you.
----------
Mr. Pallone. Thank you.
Let me ask unanimous consent to enter into the record
several statements including the one you mentioned from the
Think Pink Society of the Georgetown Visitation Prep School,
Lifetime Television Network statement, a statement from the
Breast Cancer Network of Strength, a statement from the sponsor
of the bill, Congresswoman Rosa DeLauro, and a number of
letters of support from various organizations. Without
objection those will be entered into the record.
[The information appears at the conclusion of the hearing.]
Mr. Pallone. And now let me ask Ms. Williams to give us
your opening statement. I forgot to mention that you are
actually a patient and you are here representing other
patients. Thank you for being here.
STATEMENT OF ALVA WILLIAMS
Ms. Williams. Thank you so much for having me. It is a real
pleasure to be here.
I have quite the story to tell and I will try to tell it
within 5 minutes. I am the mother of five children, four sons,
and one daughter, and have a wonderful husband. So I am
fortunate on that side.
But when I went in and had to have a mastectomy I found out
I had to go straight home from the recovery room. Well, to add
insult to injury my insurance was not accepted by a surgeon in
the town we live in, so we had to go to a town about 40 miles
away. And a two lane road at that, and they were working on it
to make it four lanes. So it took a little over an hour each
way.
But anyway, we left early that morning. I went in for
outpatient surgery. I was home before the sun went down. I
barely remember the trip home. We were like a caravan. My
sister--excuse me--my sister and my 82-year-old brother-in-law
who was a Naval corpsman in World War II, Korea, and Vietnam
came from Georgia to take care of me. And my sister drove me in
her car and my husband and brother-in-law were behind them, and
my children in the third car. And the reason we did that is we
didn't know the shape I would be in after the surgery. Perhaps
I would have to lie on the back seat of the car.
And anyway, we got back home. Everyone is worn out. I am
terrified. I have tubes--excuse me--hanging from my chest to my
knees. And my sister comes at me and she says here is two
pills, please take these pills. I said what are the pills for?
She said I really don't know, but the doctor said take them. I
said I am not taking them until you tell me what I am taking.
So she came back and she said one is for pain and one is for
nausea. And I said I will take the one for nausea, because I
really was sick. And she insisted on the second pill so I took
it to satisfy my sister. Well, then I really got sick.
You see if I had been in a hospital I would have been
getting this medication through my veins, not through pills
that I ended up throwing back up. And it was a horrible night.
Everyone went to bed. They were worn out, but me, I just
couldn't lay down. I was so afraid. And for the first time in
my life I talked to God out loud. And I promised God--excuse
me--if he would just make me well I would do everything in
power to help one other woman to never, ever have to go through
what I am going through.
And the tubes--I was so afraid of the tubes, getting them
caught on something that I decided to put on my husband's
pajama bottoms, because they were big and roomy and I could fit
the tubes down into my pajamas. And my husband is retired now,
but at that time he was still working, and he is a washer/dryer
technician. This man had to drain my tubes, measure, and
record. And we find out when we got back to the surgeon several
days later Larry had drained the tubes just fine, but he had
not measured correctly. He was to measure the drainage from
each tube separately, and he had just combined the two. But we
lived through it.
But I ended up with a staph infection. I don't know if you
have the photographs of my chest. They are available if you
would like to see them. And that caused me to be 6 weeks late
getting my chemotherapy. But I never lost faith in God that he
would bring me through it, and I have never forgotten what I
promised God that night. If he would help me to get well I
would everything in my power to help one other woman. And I was
so lonely that night and I needed someone to talk to, and it
was 2 or 3 o'clock in the morning. I got on my computer and I
found Lifetime for Women, and up pops a survey. I took
Lifetime's survey on breast cancer, and at the bottom it wanted
my story, which I wrote my story. That is the way I vented that
night. That was who I talked to was my computer.
I forgot all about it. It helped me. Six months later my
phone is ringing and it was Lauren from Lifetime in New York.
Since September of '06 I made my trip to Washington D.C., my
first trip, and spoke at a congressional press conference. And
I am so honored to be here to speak to you today to ask you to
please help us. My damage is done. Nothing can repair my
damage, but I want to help other women, your wives, your
daughters, your cousins, your nieces, whoever in your life to
never, ever have to go through what I have been through.
And I thank you very much.
[The prepared statement of Ms. Williams follows:]
Statement of Alva Williams
A Breast Cancer Survivor from North Carolina Speaks Out Against
``Drive-Through'' Mastectomies
About 2 years ago, I had a ``drive-through'' mastectomy. I
left my house for my surgery at sunrise and was back home
before sundown. I was not given the option of staying in the
hospital. When I went to schedule my surgery, I was told by my
surgeon's office that my health insurance would not cover a
hospital stay. So my mastectomy was scheduled as an outpatient
procedure at the New Bern Surgical Center in New Bern, North
Carolina.
My older sister, Nell, who is 73 years old, and her
husband, Charlie, an 80-year-old retired Chief Hospital
Corpsman who served in WWII, Korea, and Vietnam, live in
Georgia and came to take care of me. On the morning of my
surgery, Nell drove me to the surgery center, approximately 37
miles from my house. We didn't know how I would feel after the
surgery and if I would need to lay down in the backseat, so
Charlie and my husband, Larry, as well as three of my children
followed us. We joked that we were a caravan.
My surgery seemed to go well. When I got home, I stayed on
the sofa in our den. I didn't want to be away from my family. I
had never been so scared in my life and I didn't want anyone to
know how terrified I was. I was used to always taking care of
them, not the other way around. I was in shock--my God, my
entire breast had just been removed! I felt like a butchered
animal. And though my family really wanted to be there for me,
they really couldn't understand all of the feelings that I was
going through. I just wished that I had been in the hospital,
so I could have shared my fears with a doctor or a nurse.
Even though I was lucky enough to have my family there to
take care of me and they tried their best, I really needed
expert medical care, especially during the first couple of days
following my surgery.
The worst part was emptying the drainage tubes. These tubes
hung from my chest to my knees. Terrified that I'd catch them
on something, I ended up wearing my husband's pajama pants and
tucking them into there. We had to empty the drains and then
measure and record the bloody fluid. Though Charlie was a
retired Navy medic, he couldn't handle doing this. That left my
husband Larry, a washer and dryer repairman without a medical
bone in his body, to try. God bless him. As he struggled to get
the gloves over his big hands, he proceeded to empty the
drains. However, we later found out that poor Larry had been
combining the amount of fluid, rather than measuring each drain
individually.
I ended up getting a staph infection and had to seek
medical help from Dr. Turlington, my primary care physician in
Jacksonville. He cleaned the site, taught my husband how to
change the dressings and put me on heavy antibiotics. In about
2 weeks, the infection started to heal. My oncologist told me
he could not begin the chemotherapy treatments until the
infected site was completely healed. In the end, I was 6 weeks
late starting my chemotherapy.
I just thank the good Lord everyday for Dr. Turlington;
this man saved my life! He is not only my family doctor, but
also a very close friend who lives just up the street. Not
everyone in my situation is fortunate enough to have a doctor
close by.
I never thought this could happen to me. It's not right for
an insurance company to dictate how a physician must treat a
patient. I pay for health insurance to protect myself, in case
the worst happens. And when it did happen to me, I found out
just how little coverage I really had. And I didn't know the
right questions to ask. I just found out from Lifetime that my
state, North Carolina, has a law on the books to prevent
``drive-through'' mastectomies, but unfortunately, it did not
protect me.
I hope that my story makes a difference. I really want to
help other women and make sure that they get the expert medical
care and attention they need and deserve. I signed Lifetime's
petition to end ``drive-through'' mastectomies. I know now that
I am not alone. My signature is just one of more than 20
million Lifetime has collected. That means that I am not the
only one who cares and has had this happen to them. I urge
Congress to pass the Breast Cancer Patient Protection Act of
2007. Unfortunately, one in eight women will be diagnosed with
breast cancer in her life. Please make sure that others don't
have to experience a ``drive-through'' mastectomy.
----------
Mr. Pallone. Thank you, Ms. Williams. I appreciate the way
you explained your situation and how many others would be
impacted in the same way.
We are going to have questions now, and I will recognize
myself.
You know, I went through this I don't know how many years
ago now with the drive-through deliveries for babies. And, of
course, everyone--well, I shouldn't say everyone, but you know,
the naysayers say that we shouldn't be mandating these things.
You know, it should be up to the insurance companies. And I
don't agree with obviously, and I went through the situation
where my son was released after he was born, very quickly. He
ended up going home, having jaundice, and had to go back to the
hospital again. So I mean it is different circumstances, but a
lot of the same rationale as to why we would pass this kind of
bill.
But let me ask Dr. Zarfos a couple questions. Would you
agree that physicians should make the decision as to when to
discharge a woman after surgery based on their medical needs,
and not what is in the best interest of the insurance company?
And is there any reason to believe a woman would want to stay
in a hospital if it isn't in her best interest?
Dr. Zarfos. No. I think, yes, the patient-doctor
relationship is really a very special relationship. It is one
on one. It is face to face. It really can't be legislated by a
faceless physician a distance away who has never looked into a
patient's eyes or understood their circumstances.
The second part of your question, of course, nobody wants
to be in the hospital. And, indeed, for women who have
resources and support and feel well, aren't having pain or
nausea, they should have every right to go home with the
supportive care they need. A visiting nurse or whatever.
But two patients come to mind to me in the last 2 weeks.
And one is a personal trainer who is in the most robust shape I
have ever seen anyone, who if you thought anybody would have
wanted to go home the same day. And she had pain, significant
pain. And this is someone who is not a wimp by any stretch of
the imagination. And a patient I just operated on Monday who
had had a thyroid operation 2 years. Who had a lousy roommate
and was awake all night and really hated the idea of being in
the hospital, and needed to be in for 2 days for nausea and
pain. So your question is right. We have to individualize care
whether we have no insurance, private insurance, Medicare, or
Medicaid. The sanctity of the patient-doctor relationship
cannot be ignored or we are going to be nothing but machines.
Mr. Pallone. I don't know anybody who wants to stay in the
hospital by the way.
Now, in Connecticut you have this on the books, but
obviously a lot of states haven't enacted the laws in this
area, so that is why we are talking about a national bill. But
opponents of the bill say that the legislation is unnecessary.
It would raise costs. What was the experience in Connecticut
after the protection was enacted? Did the costs spiral out of
control as a result of the state legislation? And to your
knowledge did Connecticut's law cause small businesses or any
other employers to drop health insurance?
Dr. Zarfos. Well----
Mr. Pallone. Because that is another criticism we got.
Dr. Zarfos. In Connecticut we can give patients
individualized care, and sometimes we aren't aware of what is
going on around the country except for people like Alva and the
Lifetime TV petition.
No. Now, let us think about this. The average length of
stay in Connecticut in 1996, based on Connecticut Hospital
Association statistics, not my personal experience, was 2 to 4
days. So if insurance companies are paying for 4 days, which
would cost the premiums to be at a certain level, this
legislation is asking for 1 to 2 days as necessary. So there,
in fact, is the cost savings for the insurance company.
Number two, we have looked at data about--there are
concerns about nosacomial infections that occur while in the
hospital. That is why a person shouldn't stay in. There is no
perspective data looking at breast cancer surveys that says
that women are more likely to have an infection if they stay 1
night or 2 nights versus not at all. And indeed, women are
really pretty bound and the wounds are very covered, and the
drains are covered when in the hospital.
Mr. Pallone. Well, is it also true that if the doctor
suggests you leave and you want to leave you still would be
able to after----
Dr. Zarfos. Absolutely.
Mr. Pallone [continuing]. This bill?
Dr. Zarfos. But the issue of infection I think we really
need to address where everyone says you stay in the hospital
you will get an infection. I have to reiterate that in my
experience in 20 years I never had anybody with an infection
that had to be readmitted. Yes, if you look at the Lifetime TV
petition testimony it is a recurrent theme across the country.
Now, I did a little research on numbers, and in my hospital if
you stayed overnight, if one stayed overnight, for basic care
it would be about $860. The literature, on the other hand, says
that for a readmission for an infection after a mastectomy,
with or without reconstruction, the cost is $4,600. Let us say
a patient has an infection and gets IV antibiotics using one
drug called Vancamycin for 3 weeks. It would be $6,000. So to
answer your question in a circuitous way, indeed, it is less
expensive for the insurance company to pay if a patient wants
to stay 1 night, than the consequences of infection
readmission. So, no, to the best of my knowledge no businesses
have gone out of--no small businesses have gone out of business
because of that, gone into bankruptcy, nor have premiums gone
up because of this particular issue.
Mr. Pallone. OK. And there is also the issue of dropping
health insurance. We have no evidence that any businesses
dropped health insurance because of it either in your state.
Dr. Zarfos. Well, across the country we have seen double
digit increases----
Mr. Pallone. Right.
Dr. Zarfos [continuing]. Every year since 2000, including
the 30 states that don't have the legislation.
Mr. Pallone. Yes, so that would be very difficult to make
any conclusions.
Dr. Zarfos. I think so. I think to blame those few states
that have patients, and if we could say that those states
didn't have increasing premiums and the others did, but indeed,
it is across the country. The premiums continue to rise.
Mr. Pallone. OK, thank you.
Mr. Deal. Thank you.
I agree with both of you that we need some reforms in our
health delivery system and in our health care system in
general. And I think it applies to the health care insurance
companies, the physicians, the hospitals, the government. And
in that end let me ask you just a--Dr. Zarfos, I guess I will
ask you these questions.
Do you think a patient who is facing breast cancer should
have access to more quality and price information on the
different health care providers that are available and the
options that are available to them?
Dr. Zarfos. I think if you look at quality as defining it
as the individualization of care, access to antibiotics not
necessary. If you want to look at physicians, on how much they
spend, let us not judge us only by that. Let us look at the----
Mr. Deal. Well, do you think patients are entitled to more
information? That is what I am asking.
Dr. Zarfos. Well, but also how much time the doctor spends
with a patient as well as not the amount of money they spend on
the doctor.
Mr. Deal. All right. Let me ask you some specifics about
that. If a lady has breast cancer and she is trying to choose
between hospital A and hospital B. And hospital A has a higher
infection rate than hospital B, is that the kind of information
that this patient should have access to before she decides
where to go for a mastectomy?
Dr. Zarfos. Well, I think breast cancer is such a personal
issue that one has to take that into consideration. But you
know what I tell patients to do? Always get a second opinion.
Go try on a doctor like a shoe, because one--a hospital might
have an infection rate, but a particular surgeon may not. So I
think there are a lot of criteria that every woman and her
spouse should take into consideration before choosing their
surgeon.
Mr. Deal. So you would even dissect it down to the
individual information about the individual surgeons ought to
be available?
Dr. Zarfos. Well, indeed, when I do conformed consent for
any patient I tell them what my infection rate is or
complication rate. The American College of Surgeons sort of
mandates it if you are a fellow in the American College of
Surgery that when you do informed consent you should be telling
patients that.
Mr. Deal. Should the patient have that information maybe on
the Internet before they go make that decision?
Dr. Zarfos. You know, I am sure that it is true in the
political realm too that all sorts of misinformation can be on
the Internet. I am not sure the perfect way of how to get----
Mr. Deal. Well, if it is a sanction----
Dr. Zarfos [continuing]. Those profiles on----
Mr. Deal. If it is a sanctioned Web site for the particular
purpose of disseminating information so consumers will be well-
informed you wouldn't have a problem with that would you?
Dr. Zarfos. I think that as long as we do it in a
sensitive, professional way with dignity.
Mr. Deal. So if hospital A has a 25 percent lower success
rate in the breast cancer arena than hospital B, that might be
something that the patient might also want to know.
Dr. Zarfos. But you always have to look at those numbers
based on the type of hospital. For example, I am in the inner
city hospital and the biggest other hospital in town is inner
city. So we have more patients without insurance, co-
morbidities, so indeed, our patients present with a later
stage, certain micro-populations. If you were to look at that
population of my hospital and also Hartford Hospital, the two
big hospitals, we would look like our patients have a higher
recurrence rate, but they present. So I guess what I want to
say to you is when that information is presented as long as it
is stratified and qualified as Medicare is doing now with the
gravity of illness of a patient and the stage. So you get--you
are comparing--I hate to say apples to apples when we are
talking about surgery, but you are getting all the information
without it being skewed, because of taking care of more ill
patients..
Mr. Deal. And if those two hospitals had a $5,000
difference in what they charged you for the very same procedure
do you think a prospective patient ought to have that
information before they make a choice as to where to go?
Dr. Zarfos. But let us hope they don't choose it just on
cost, but where they get the best kind, comprehensive,
individualized care.
Mr. Deal. But if they have got all that other information I
just asked you about coupled with price they would be a better
informed patient as to where they should go wouldn't they?
Dr. Zarfos. I spend about an hour with each of my patients
before we even entertain whether I am going to be their
surgeon, so informing----
Mr. Deal. But we know you are the----
Dr. Zarfos [continuing]. Patients is number one.
Mr. Deal. We know you are the exception to the rule.
Dr. Zarfos. No, I am not.
Mr. Deal. Don't you think patients ought to have this kind
of information?
Dr. Zarfos. I think patients should have what information
is going to help guide them to make the decision as long as the
information is valid.
Mr. Deal. OK. And since you support this H.R. 758, which we
are talking about in your testimony today, don't you think that
if we are going to mandate certain things we ought to give
patients with breast cancer this kind of specific information,
so that they can be better informed and make better choices?
Dr. Zarfos. Well, but Congressman Deal, this is not a
mandate. This is restoring a choice to patients. This is not a
mandate to the----
Mr. Deal. No. Well, it is a mandate. I mean for those 30
states that don't have any legislation. And your state and Ms.
Williams' state and my state already have legislation on this
issue. But for those 30 states it is a mandate, and if we are
going to draft a mandate bill, then why don't we mandate the
kind of information about quality, infection rates, costs, the
kind of things that I would think patients would want to know?
Dr. Zarfos. I think as long as you mandate then the
insurance companies give people what they pay for. Let us make
it an equal playing field for insurance industry and the
medical profession.
Mr. Deal. This would be for everybody. You have no problem
with that do you?
Dr. Zarfos. Well, I would like to see equal transparency in
the insurance industry. I feel bad for these women who in
January signed up for one company, really good company, and in
August when she had breast cancer that transparency became
foggy.
Mr. Deal. But you can't--as a physician you can't say you
want to mandate things on the insurance industry, and then as a
physician shy away from giving patients the kind of information
that they need to know about the----
Dr. Zarfos. I agree with you.
Mr. Deal [continuing]. Treatment part of it.
Dr. Zarfos. I think transparency----
Mr. Deal. OK.
Dr. Zarfos [continuing]. For all components of the health
care field is very important.
Mr. Deal. I think we agree. Thank you.
Mr. Pallone. Thank you.
Ms. Capps.
Ms. Capps. Thank you again, both of you, for--our witnesses
for your testimony.
I want to ask--give each of you a chance to respond to a
question. I have a couple of questions for Dr. Zarfos, if you
would, and that implies a brief response, please.
Your state of Connecticut and my state of California are
two states that do have patient protection laws in place
already. Would you discuss the affect of these laws on patient
outcome? You did in your testimony, but I want to see if we can
draw contrast with states that have these patient protections
and some states that don't.
Dr. Zarfos. Most of the states have different working of
their laws, so some of them are affected and some are not. And
so when you--I hate to be redundant, but when you look at the
testimony----
Ms. Capps. Yes.
Dr. Zarfos [continuing]. Of those patients you will see
patients having horrific experiences in states that have
legislation. Even in my state of Connecticut. So certainly how
the physicians interact with the patients is important, though
we have to at least give that opportunity for the physician and
the patient to work together on it. So there are some states
with great laws and some with no so great, and then of course
the states without.
Ms. Capps. So if there is federal legislation it shouldn't
preempt the states with stronger laws, but it should be then a
floor for states that have bad or weak laws now----
Dr. Zarfos. It should----
Ms. Capps [continuing]. Or no law?
Dr. Zarfos. It should--the disparity across the country.
Ms. Capps. I hear you. So you are kind of implying then
that despite 20 states or more having protection laws that many
of them are not adequate enough in each state. Thank you.
And that this bill that we are discussing could help to
eliminate the disparities among the states, which is one of our
goals as the Federal Government. Thank you very much.
Ms. Williams, as a patient your very eloquent testimony to
your experience, and I want to thank you for providing a really
insightful sort of personal glimpse into what must have been a
very terrifying experience for you. And I just have to say that
the promise you made to God when you prayed out loud certainly
seems that you have lived--you have met your pledge, probably
multiple times now, at least certainly today, in what you are
doing because your statement is now part of the permanent
record of the U.S. Congress.
I want to--and it may seem like we are repeating some, but
I want to get it really clear about some of what is driving
this legislation. You noted that when you had your mastectomy
you didn't have the option of staying. In fact, you got up
literally from the recovery room?
Ms. Williams. Yes, ma'am.
Ms. Capps. You never did go into a patient room. And the
recovery room is quite a different place from the normal
patient room.
Ms. Williams. I never went into a patient----
Ms. Capps. So you got right up off the--and oftentimes one
is feeling quite groggy at that point.
Ms. Williams. Very groggy.
Ms. Capps. And not even very clear-headed about it. So you
maybe were given some instructions that hopefully some other
people were writing down or could remember. Your sister was----
Ms. Williams. Yes.
Ms. Capps [continuing]. Your interpreter? OK.
Ms. Williams. If I may tell you this----
Ms. Capps. Sure.
Ms. Williams. For some reason--it is a rural area where we
are from and----
Ms. Capps. Yes.
Ms. Williams [continuing]. For some reason all I can
remember from the hospital home was a herd of goats in a field.
I don't know why, but it was goats, and the next thing I knew
we were home.
Ms. Capps. Well, you probably were having even some of the
affects of the anesthesia still wearing off.
Ms. Williams. Yes, but I made sure they were real goats.
Ms. Capps. Oh, I am not saying they weren't real goats. I
am not----
Ms. Williams. I really saw the goats.
Ms. Capps. You may have missed some other things though
along that way home. May I ask you, when you signed up to be a
patient in the hospital was it your goal of leaving the
hospital early? Was this something your doctor recommended or
did you have to leave because of your insurance plan?
Ms. Williams. I wasn't in a hospital. It was done in an
outpatient---
Ms. Capps. Oh, so you didn't even----
Ms. Williams [continuing]. Surgical center.
Ms. Capps [continuing]. Go to a full fledged hospital?
Ms. Williams. Ma'am, I was in a surgical center. And I fell
through the cracks in the state of North Carolina. How I don't
know, but----
Ms. Capps. Is this done as procedure, as far as you know,
in North Carolina to have----
Ms. Williams. I have found four other--well, I am the
fourth one in my county. There is about 150,000 in our county,
and through me being out and speaking to different groups----
Ms. Capps. Yes.
Ms. Williams [continuing]. And being known I had found four
others that the same thing has happened to.
Ms. Capps. That they have had their surgeries in the----
Ms. Williams. They have had the drive-through mastectomies
and----
Ms. Capps. In places where there were no--the doctors and
nurses all went home at 5 or 6 o'clock or----
Ms. Williams. That is right. And this one lady----
Ms. Capps [continuing]. Whatever time the surgery center
closed.
Ms. Williams. May I tell you about one lady?
Ms. Capps. Sure.
Ms. Williams. She is in her early 40s and she has two
little boys. Her husband had passed away from cancer when was
diagnosed with breast cancer. And we walked 2 or 3 weeks ago in
the Relay for Life. We walked as buddies.
Ms. Capps. So this story you are telling is 2 or 3 weeks
ago that you heard about it?
Ms. Williams. Her--no, no. I knew about her story, but----
Ms. Capps. OK.
Ms. Williams [continuing]. Two or three weeks ago when we
walked for Relay for Life we walked together. And she said I
want to show you my caregiver who emptied my drains, and it was
her 12-year-old son who was approximately 10 years old when he
had to do that.
Mr. Capps. So as recently as 2 years ago----
Ms. Williams. Yes, ma'am.
Ms. Capps [continuing]. This procedure of a surgery center
or a free-standing center is or was, or maybe it still is, is
offering services for mastectomies in your----
Ms. Williams. Yes, ma'am.
Ms. Capps. I am out of time. I thank you very much.
And I appreciate again, Mr. Chairman, we are having this
hearing today. Thank you.
Ms. Williams. Thank you.
Mr. Pallone. Thank you. I know that we haven't spent as
much time on this bill, but I certainly think that the two of
you have made a very strong case. And we have been able to get
to the bottom of this even in the limited time that we have. So
thank you again, and again we are going to be trying to move on
this legislation. And we appreciate your being here. Thank you
very much.
Dr. Zarfos. Thanks for hearing us.
Ms. Williams. Thank you.
Mr. Pallone. Sure. Let me just remind our members that you
can submit additional questions for the record. They should be
submitted to the clerk within the next 10 days, and the clerk
will then notify the witnesses if we have additional questions.
And without objection this meeting of the subcommittee is
adjourned.
[Whereupon, at 3:25 p.m., the subcommittee was adjourned.]
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