[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

                              ----------                              
                                                                   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.]
    [Material submitted for inclusion in the record follows:]

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