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55–315 PDF 2008

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 

COMMITTEE ON ENERGY AND COMMERCE 

JOHN D. DINGELL, Michigan, Chairman 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chair 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi 

VITO FOSSELLA, New York 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff 

GREGG A. ROTHSCHILD, Chief Counsel 

SHARON E. DAVIS, Chief Clerk 

DAVID CAVICKE, Minority Staff Director 

(II)

(III) 

SUBCOMMITTEE ON HEALTH

FRANK PALLONE, JR., New Jersey, Chairman 

HENRY A. WAXMAN, California 

EDOLPHUS TOWNS, New York 

BART GORDON, Tennessee 

ANNA G. ESHOO, California 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

Vice Chair 

TOM ALLEN, Maine 

TAMMY BALDWIN, Wisconsin 

ELIOT L. ENGEL, New York 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

JOHN D. DINGELL, Michigan (ex officio) 

NATHAN DEAL, Georgia, 

Ranking Member 

RALPH M. HALL, Texas 

BARBARA CUBIN, Wyoming 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

STEVE BUYER, Indiana 

JOSEPH R. PITTS, Pennsylvania 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas (ex officio) 

(V) 

C O N T E N T S 

Page 

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

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

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

opening statement ................................................................................................ 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 

Page

VI 

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 

(1) 

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 

2 

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. 

3 

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. 

4 

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. 

5 

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 

6 

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 bareVerDate Nov 24 2008 10:51 Oct 08, 2010 Jkt 037690 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-121 SCOM1 PsN: JIMC
7 

ly 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 

8 

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. 

9 

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 fundVerDate Nov 24 2008 10:51 Oct 08, 2010 Jkt 037690 PO 00000 Frm 00015 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-121 SCOM1 PsN: JIMC
10 

ing 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 81⁄2

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. 

11 

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. 

12 

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. 

13 

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 decisionbased 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 

14 

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 

15 

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. 

16 

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. 

17 

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 

18 

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. 

19 

[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. 

20 

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 

21 

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 coauthor 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. 

22 

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? 

23 

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 

24 

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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29 

30 

31 

32 

33 

34 

35 

36 

37 

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. 

38 

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 

39 

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. 

40 

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 famiVerDate Nov 24 2008 10:51 Oct 08, 2010 Jkt 037690 PO 00000 Frm 00046 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-121 SCOM1 PsN: JIMC
41 

lies 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? 

42 

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 

43 

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 sciVerDate Nov 24 2008 10:51 Oct 08, 2010 Jkt 037690 PO 00000 Frm 00049 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-121 SCOM1 PsN: JIMC
44 

entific 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. 

45 

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 

46 

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. 

47 

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 

48 

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. 

49 

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. 

50 

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 

51 

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 

52 

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 

53 

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 

54 

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 

55 

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 

56 

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. 

57 

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 posiVerDate Nov 24 2008 10:51 Oct 08, 2010 Jkt 037690 PO 00000 Frm 00063 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-121 SCOM1 PsN: JIMC
58 

tive 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 

59 

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 

60 

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 

61 

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— 

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veloping 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 

63 

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. 

64 

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 

65 

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 

66 

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, 

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ture, 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 

68 

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. 

69 

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 broadbased, 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, 

70 

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 antiEGFR 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 

71 

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 21⁄2-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 

72 

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 

73 

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. 

74 

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 

75 

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 

76 

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 

77 

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?’’ 

78 

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, 

79 

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, ConVerDate Nov 24 2008 10:51 Oct 08, 2010 Jkt 037690 PO 00000 Frm 00085 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-121 SCOM1 PsN: JIMC
80 

gresswoman 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. 

81 

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-yearold 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 

82 

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 

83 

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. 

84 

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 

85 

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? 

86 

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. 

87 

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—— 

88 

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. 

89 

Ms. WILLIAMS [continuing]. Two or three weeks ago when we 

walked for Relay for Life we walked together. And she said I want 

to show you my caregiver who emptied my drains, and it was her 

12-year-old son who was approximately 10 years old when he had 

to do that. 

Mr. CAPPS. So as recently as 2 years ago—— 

Ms. WILLIAMS. Yes, ma’am. 

Ms. CAPPS [continuing]. This procedure of a surgery center or a 

free-standing center is or was, or maybe it still is, is offering services for mastectomies in your—— 

Ms. WILLIAMS. Yes, ma’am. 

Ms. CAPPS. I am out of time. I thank you very much. 

And I appreciate again, Mr. Chairman, we are having this hearing today. Thank you. 

Ms. WILLIAMS. Thank you. 

Mr. PALLONE. Thank you. I know that we haven’t spent as much 

time on this bill, but I certainly think that the two of you have 

made a very strong case. And we have been able to get to the bottom of this even in the limited time that we have. So thank you 

again, and again we are going to be trying to move on this legislation. And we appreciate your being here. Thank you very much. 

Dr. ZARFOS. Thanks for hearing us. 

Ms. WILLIAMS. Thank you. 

Mr. PALLONE. Sure. Let me just remind our members that you 

can submit additional questions for the record. They should be submitted to the clerk within the next 10 days, and the clerk will then 

notify the witnesses if we have additional questions. 

And without objection this meeting of the subcommittee is adjourned. 

[Whereupon, at 3:25 p.m., the subcommittee was adjourned.] 

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