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26–657 PDF 2006

WOMEN AND CANCER: WHERE ARE WE IN PREVENTION, EARLY DETECTION AND TREATMENT

OF GYNECOLOGIC CANCERS?

HEARING

BEFORE THE

SUBCOMMITTEE ON CRIMINAL JUSTICE,

DRUG POLICY, AND HUMAN RESOURCES

OF THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

SEPTEMBER 7, 2005

Serial No. 109–128

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpoaccess.gov/congress/index.html

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

TOM DAVIS, Virginia, Chairman

CHRISTOPHER SHAYS, Connecticut

DAN BURTON, Indiana

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

MARK E. SOUDER, Indiana

STEVEN C. LATOURETTE, Ohio

TODD RUSSELL PLATTS, Pennsylvania

CHRIS CANNON, Utah

JOHN J. DUNCAN, JR., Tennessee

CANDICE S. MILLER, Michigan

MICHAEL R. TURNER, Ohio

DARRELL E. ISSA, California

GINNY BROWN-WAITE, Florida

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

——— ———

HENRY A. WAXMAN, California

TOM LANTOS, California

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

CAROLYN B. MALONEY, New York

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

DANNY K. DAVIS, Illinois

WM. LACY CLAY, Missouri

DIANE E. WATSON, California

STEPHEN F. LYNCH, Massachusetts

CHRIS VAN HOLLEN, Maryland

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

BRIAN HIGGINS, New York

ELEANOR HOLMES NORTON, District of

Columbia

———

BERNARD SANDERS, Vermont

(Independent)

MELISSA WOJCIAK, Staff Director

DAVID MARIN, Deputy Staff Director/Communications Director

ROB BORDEN, Parliamentarian/Senior Counsel

TERESA AUSTIN, Chief Clerk

PHIL BARNETT, Minority Chief of Staff/Chief Counsel

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY, AND HUMAN RESOURCES

MARK E. SOUDER, Indiana, Chairman

PATRICK T. MCHENRY, North Carolina

DAN BURTON, Indiana

JOHN L. MICA, Florida

GIL GUTKNECHT, Minnesota

STEVEN C. LATOURETTE, Ohio

CHRIS CANNON, Utah

CANDICE S. MILLER, Michigan

GINNY BROWN-WAITE, Florida

VIRGINIA FOXX, North Carolina

ELIJAH E. CUMMINGS, Maryland

BERNARD SANDERS, Vermont

DANNY K. DAVIS, Illinois

DIANE E. WATSON, California

LINDA T. SANCHEZ, California

C.A. DUTCH RUPPERSBERGER, Maryland

MAJOR R. OWENS, New York

ELEANOR HOLMES NORTON, District of

Columbia

EX OFFICIO

TOM DAVIS, Virginia HENRY A. WAXMAN, California

J. MARC WHEAT, Staff Director and Chief Counsel

MICHELLE POWERS, Counsel

MALIA HOLST, Clerk

RICHARD BUTCHER, Minority Professional Staff Member

(III)

C O N T E N T S

Page

Hearing held on September 7, 2005 ....................................................................... 1

Statement of:

Karlan, Dr. Beth, president, Society of Gynecologic Oncologists; Dr. Mark

Jay Rosenfeld, scientist/researcher; Sheryl Silver, sister of Johanna

Silver; and Kolleen Stacey, ovarian cancer survivor .................................. 71

Karlan, Dr. Beth ........................................................................................ 71

Rosenfeld, Dr. Mark Jay ........................................................................... 78

Silver, Sheryl ............................................................................................. 86

Stacey, Kolleen .......................................................................................... 94

Trimble, Dr. Edward L., M.D., M.P.H., head of the surgery section, Division of Cancer Treatment and Diagnosis, National Cancer Institute;

Dr. Ed Thompson, M.D., M.P.H., Chief of Public Health Practice, Centers for Disease Control and Prevention; and Dr. Richard Pazdur, M.D.,

Director, Division of Oncology Drug Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration ........................... 15

Pazdur, Dr. Richard .................................................................................. 33

Thompson, Dr. Ed ..................................................................................... 24

Trimble, Dr. Edward L. ............................................................................ 15

Letters, statements, etc., submitted for the record by:

Karlan, Dr. Beth, president, Society of Gynecologic Oncologists, prepared

statement of ................................................................................................... 74

Pazdur, Dr. Richard, M.D., Director, Division of Oncology Drug Products,

Center for Drug Evaluation and Research, U.S. Food and Drug Administration, prepared statement of .................................................................. 36

Rosenfeld, Dr. Mark Jay, scientist/researcher, prepared statement of ........ 80

Silver, Sheryl, sister of Johanna Silver, prepared statement of ................... 89

Souder, Hon. Mark E., a Representative in Congress from the State

of Indiana, prepared statement of ............................................................... 4

Stacey, Kolleen, ovarian cancer survivor, prepared statement of ................ 96

Thompson, Dr. Ed, M.D., M.P.H., Chief of Public Health Practice, Centers

for Disease Control and Prevention, prepared statement of ..................... 26

Trimble, Dr. Edward L., M.D., M.P.H., head of the surgery section, Division of Cancer Treatment and Diagnosis, National Cancer Institute,

prepared statement of ................................................................................... 18

(1)

WOMEN AND CANCER: WHERE ARE WE IN

PREVENTION, EARLY DETECTION AND

TREATMENT OF GYNECOLOGIC CANCERS?

WEDNESDAY, SEPTEMBER 7, 2005

HOUSE OF REPRESENTATIVES,

SUBCOMMITTEE ON CRIMINAL JUSTICE, DRUG POLICY,

AND HUMAN RESOURCES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The subcommittee met, pursuant to notice, at 10:45 a.m., in room

2154, Rayburn House Office Building, Hon. Mark E. Souder (chairman of the subcommittee) presiding.

Present: Representatives Souder, Burton, Cannon, Issa, Foxx,

Waxman, Cummings, Watson, Sanchez, Ruppersberger, and Norton.

Staff present: Marc Wheat, staff director and chief counsel;

Michelle Powers, counsel; Malia Holst, clerk; Kristin Amerling, minority general counsel; Tony Haywood and Naomi Seller, minority

counsels; Richard Butcher, minority professional staff member;

Earley Green, minority chief clerk; Cecelia Morton, minority office

manager; and Christopher Davis, minority investigator.

Mr. SOUDER. The subcommittee will come to order.

Good morning and thank you all for being here.

Today’s hearing will examine the Federal efforts targeting

gynecologic cancers, specifically where we are in the areas of education, research, prevention, and treatment. The hearing will also

provide an opportunity for medical and research specialists, patients, and family members to discuss the relevant issues involved

in gynecologic cancers and where more work is needed.

This month marks Gynecologic Cancer Awareness Month, as well

as National Ovarian Cancer Awareness Month. According to the

American Cancer Society, over 79,000 women are diagnosed every

year with cancers affecting the reproductive organs. If diagnosed in

the early stages, the survivability rate is as high as 95 percent.

Nonetheless, this year alone, more than 27,000 women will die

from gynecologic cancer.

Any woman is at risk for developing a gynecologic cancer.

The most deadly gynecologic malignancy is ovarian cancer. Patients with ovarian cancer often report that they had symptoms for

months before diagnosis, but early signs of this cancer are frequently mistaken for more common digestive disorders. As a result,

most ovarian cancer cases are diagnosed at an advanced stage,

where the chances of survival drop to only 20 percent. This year,

2

out of the more than 22,000 new diagnoses of ovarian cancer, more

than 16,000 women will die from the disease.

The most common gynecologic cancer is uterine cancer, which

will afflict more than 40,000 women this year and kill over 7,000

women. While there have been advances in therapy for uterine cancer, including the innovative new surgical treatments, women are

largely unaware of the risk factors contributing to this disease,

which include obesity, hypertension, diabetes, and inappropriate

estrogen use. However, if a women is diagnosed early, surgical

therapy is usually adequate for a cure.

Where there is effective screening, there has been a significant

reduction in deaths from certain gynecological cancers; over the

last 50 years, routine use of the pap test to screen for cervical cancer has reduced deaths from that disease by 74 percent. However,

there are no widely accepted and effective screening tests for other

gynecologic cancers. This leaves women vulnerable to late diagnosis, and lower chances of recovery.

Even with effective screening, the American Cancer Society estimates that cervical cancer will kill more than 3,700 women this

year. The primary cause of virtually all cervical cancers is human

papillomavirus [HPV], which is transmitted through sexual contact.

More women will die from this disease than from AIDS, among

non-injection drug users. Although Federal agencies are working on

vaccines developed to prevent HPV infection, current proposed vaccines do not address all strains of HPV.

Moreover, the FDA has yet to comply with Public Law 106–554,

signed by President Clinton in 2000, requiring that condoms be accurately labeled to reflect the fact that condoms do not protect

women from HPV infections. The Gynecologic Cancer Foundation’s

2005 State of the State Report on Gynecologic Cancers notes that

both women and men do not fully understand the association between HPV infection and its severe health consequences.

It is inexcusable that Federal agencies have yet to comply with

a law passed more than 5 years ago and, in the meantime, thousands of women continue to die from this preventable disease. The

cost to comply with the law requiring accurate condom labeling is

quite low. The benefit is measured in terms of women’s lives. There

is simply no justification for the FDA and the White House Office

of Management and Budget dragging their feet on this critical public health matter.

I am surprised that the FDA’s testimony today makes no reference to their progress in complying with this law since the FDA

last appeared before this subcommittee on this very issue on March

11, 2004. Perhaps the FDA witness is not prepared to address this

matter this morning, but I would ask that FDA provide a full explanation on this matter in 5 days, and we will be happy to forward FDA’s response to all subcommittee members. I hope the

other agencies represented here today will address these issues in

oral testimony.

There is an evident need to raise awareness among patient and

medical communities about all aspects of gynecologic cancers, including prevention, symptoms, screening, and treatment. A recent

poll commissioned by the Gynecologic Cancer Foundation found

that the majority of women believe that they are at risk for develVerDate 11-MAY-2000 13:12 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 D:\DOCS\26657.TXT HGOVREF1 PsN: HGOVREF1
3

oping gynecologic cancers, and fear them even more than lung cancer, which is the leading cause of cancer deaths among women.

More than a third of women say they have little knowledge about

gynecologic cancers, and in fact, a staggering 47 percent of them

could not name any symptoms of gynecologic cancers.

Parallel to the important education needs is the necessity for innovative research and therapy development.

I hope the outcome of this hearing is a better picture of what efforts the Federal agencies are making to raise awareness among

practitioners and among patient and medical communities of

gynecologic cancers, and where there are unmet needs. In particular, I hope the agencies address their critical role in protecting the

public from HPV infection and preventing more cervical cancer

deaths. I also hope we can learn the status of current funding

paths for innovative and cutting edge research for gynecologic cancers, and whether we are meeting the challenges to deliver new

therapies.

Finally, I hope the first-hand experience and perceived needs of

those who deal with gynecologic cancers as patients, family members, doctors, and researchers provide us with a better understanding of how to address gynecologic cancers.

I am now going to turn this hearing over to Congressman Cannon to chair the hearing. His daughter passed away from cancer

late last year at the age of 25, and he is particularly interested in

innovative research issues. I will be in and out of the hearing this

morning, and I appreciate his leadership in this field and his willingness to chair the hearing.

[The prepared statement of Hon. Mark E. Souder follows:]

4

5

6

7

Mr. CANNON [presiding]. Thank you, Mr. Chairman.

First of all, I would like to thank Chairman Souder for holding

this hearing today. This is an issue affecting millions of Americans

currently: 1 in 2 men and over 1 in 3 women will be diagnosed with

cancer. In 2000, more than 1.2 million new cancer diagnoses were

expected and 550,000 died from the disease. Nearly 10 million people in the United States alone were living with cancer in 2001, up

from 3 million in 1971, and the American Cancer Society estimates

that in 2005 nearly 1.4 million new cases of cancer will be diagnosed.

While we say that we are winning the war on cancer, the statistics don’t seem to represent that. Although I am pleased to hear

that we are making progress in the length of survival of those with

cancers, we need to eliminate the incidents of cancer and completely cure this illness. Tremendous strides in research and treatments are being made; however, there are numerous challenges in

getting those treatments to patients effectively and efficiently.

There are some serious gaps in research and failures to optimize

research to produce new treatments. Drug approval takes years,

withholding potentially life-saving drugs and treatments from patients.

We need to look at all of these areas and optimize research

among agencies, fill the gaps in research, and incentivize entrepreneurial research and produce life-saving treatments.

Today we will specifically hear from our witnesses regarding gynecological cancers, including the role of human papillomavirus and

cervical cancer. Most Americans are not aware that HPV is one of

the most common sexually transmitted diseases and that at any

one time approximately 10 percent of women have a cancer-causing

HPV infection. These HPV types cause nearly all cervical cancers,

and this year about 11,000 women will be diagnosed with cervical

cancer.

Additionally, as many of you may know, the Gynecological Cancer Foundation reported that men and women do not completely

recognize the association between HPV and its severe health consequences. We need to better educate the public on the health risks

of HPV and gynecological cancers. Although PAP test is the standard procedure to check for cervical cell changes, it is my understanding that it does not test for uterine or other gynecological cancers. I am anxious to learn how we are doing in developing tests

for these other cancers.

Many of us have been personally affected by cancer, unfortunately. We now have reached a time that I believe we can all say

we know someone who has been diagnosed with this devastating

disease.

I thank all of our witnesses for appearing today, and I look forward to hearing your testimony about where we are on cancer research and what we need to do to win the war on cancer.

I would now like to recognize Mr. Cummings for an opening

statement.

Mr. CUMMINGS. Thank you very much, Mr. Chairman. And I am

very pleased that we are holding this hearing.

Breast, lung, and colon cancers are the most frequently diagnosed cancers among women in the United States. The gynecologic

8

cancers, including cervical, ovarian, and uterine cancers, also account for a significant number and percentage of cancer diagnoses

and deaths among U.S. women.

The American Cancer Society reports that approximately 79,000

U.S. women are diagnosed with cancers affecting the reproductive

organs each year. Although the survivability rate is as high as 95

percent when these cancers are detected in the early stages, each

year 27,000 U.S. women die from gynecologic cancers.

Fifty years ago, cervical cancer was the leading cause of cancer

death among women in the United States and around the world.

Thanks to advances in cancer screening and treatment, most notably widespread use of the Pap test, the threat of mortality from

cervical cancer has been dramatically reduced in the United States.

Nevertheless, thousands of women are newly diagnosed each year,

and the American Cancer Society estimates that more than 3,000

women will die from it in 2005.

Unfortunately, despite improved screening rates, enabled by congressionally authorized CDC screening programs, unequal access to

screening remains a problem that contributes to significant disparities in cervical cancer death rates, along the lines of race, educational level, income, and age. Although racial and ethnic disparities have decreased sharply, there is more progress that must be

made.

Women who belong to racial and ethnic minority groups still are

disproportionately represented among the new cases of cervical

cancer. Asian, African-American and Hispanic women have significantly higher mortality rates from cervical cancer than White

women. Women with less than a high school education are less

likely to have testing than more highly educated women. And despite the peek incidents of cervical cancer among women 40 to 55

years of age, women in this age group are less likely to have been

screened than younger women. African-American women are 60

percent more likely to have cervical cancer and 33 percent more

likely to die from it, as compared to White women.

The great tragedy in the American Cancer Society’s estimates of

the thousands of lives that will be lost to cervical cancer is that

these deaths are avoidable. The Department of Health and Human

Services notes in its Healthy People 2005 Initiative that the likelihood of cervical cancer survival is nearly 100 percent if early detection is followed by appropriate treatment and followup. But costs

remains a barrier to access Pap tests and DNA tests for HPV.

Used together, these tests can accurately determine whether a

woman is or is not at risk for cervical cancer or precursor conditions. Genital HPV infection is a necessary precursor for cervical

cancer and the main cause of the disease. In recent years we have

seen vigorous efforts from certain quarters to force the FDA to

relabel condoms to indicate that condoms are ineffective in preventing transmission of HPV. These efforts, if they succeed, are likely

to undermine progress in preventing not only HPV infection and

the development of cervical cancer, but also the spread of other sexually transmitted diseases, including HIV.

The American Cancer Society specifically recognizes HIV and

chlamydia as risk factors for development of cervical cancer, and

condoms are widely recognized as a primary intervention for preVerDate 11-MAY-2000 13:12 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 D:\DOCS\26657.TXT HGOVREF1 PsN: HGOVREF1
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vention of HIV and chlamydia. The best available scientific evidence, moreover, supports the conclusion that condoms significantly reduce the risk of genital HPV infection and, therefore, development of cervical cancer.

In July of this year, a study entitled, ‘‘The Effect of Consistent

Condom Use on the Risk of Genital HPV Infection Among Newly

Sexually Active Young Women,’’ was presented to the International

Society of Sexually Transmitted Disease Research. The study found

that condoms significantly reduce the risk of HPV acquisition

among female university students who use them 100 percent of the

time, as well as among those who use them between 55 percent

and 99 percent of the time during the course of an 8-month study.

The bottom line, then, is that cervical cancer can be prevented,

detected, treated, and cured, and health screening and condom use

are essential components of a sound, realistic public health strategy for combating cervical cancer and the spread of sexually transmitted diseases. Unfortunately, ovarian, uterine, and other

gynecologic cancers are less susceptible to prevention and early detection, and mortality rates, as a result, are much higher.

But great progress has been made in developing treatments that

are highly effective when these cancers are detected at an early

stage. We must therefore support efforts to promote awareness of

risk factors for ovarian, uterine, and other gynecologic cancers, as

well as research that can lead to development of new and better

diagnostic and therapeutic tools.

That is precisely the aims of Johanna’s Law, legislation pending

the House and Senate named for the sister of Sheryl Silver, who

will tell her sister’s story during panel two of today’s hearing. I am

proud to be an original co-sponsor of this important bill in the

House, and I sincerely hope that this hearing serves to improve the

prospects for enacting this legislation.

Finally, Mr. Chairman, it is worth reiterating that we have made

enormous strides in reducing cervical cancer deaths over the past

few decades. Ensuring that cervical cancer death rates continue to

go down for women in all parts of American society and working

to duplicate that success with other gynecologic cancers are important objectives that we should fully support. Expanding access to

screening and treatment for women at risk should remain the foundation of a public health strategy that puts health and wellness before ideology and science, and before politics.

I want to thank you for holding the hearing. I sincerely hope that

it will lead to further advances toward eliminating gynecologic cancers as a cause of illness and death for women in these United

States.

With that, I yield back.

Mr. CANNON. Thank you, Mr. Cummings.

Let me just add that you point out that we want to solve this

for American society, and that is our goal. But if we solve it in

America, we solve it for large parts of the world, including the

many, many women who die of cervical cancer in Africa because

their partners and spouses have not only brought back AIDS and

other diseases, but HPV, and that ends up being a principal cause

of death in Africa. If we can solve some of these problems here in

10

America, it is cheap and easy to solve them in other parts of the

world, and that is why I think this is such an important hearing.

Are there other members who wish to make an opening statement?

Mr. ISSA. Yes, Mr. Chairman.

Mr. CANNON. Let me come over here.

Mr. ISSA. Thank you, Mr. Chairman. And I would ask that my

complete statement be placed in the record.

Mr. Chairman, I want to thank you on behalf of the thousands

of women fighting this fierce battle against gynecological cancer. As

you know, this bill has been previously introduced in early Congresses, it has been something that we wanted to get on the front

burner for 4 years plus, and I think your leadership is really making a difference in getting this bill moved and moved quickly. As

you know, there are 220 plus Members of Congress who have cosponsored this. As a general rule, that means that you have enough

votes to pass it on the House floor, and I am hoping that today is

an important step toward that.

I won’t repeat the good words that have been said by previous

speakers, but I would like to simply add a couple of items. First

of all, this is a cancer in which awareness can save lives. Cervical,

ovarian, and uterine cancer really is, to a great extent, about what

we don’t know and, to be candid, as we will hear in the second

panel, to a great extent what doctors don’t know.

The story of Johanna is the story of misdiagnosis. It is the story

not of an underserved population, a poor person or a minority; it

is somebody who had professional care, and that care failed to save

her life. And it has failed to save her life not out of malice, but out

of a lack of the kind of information that we hope the funding we

provide on a Federal level can do.

I do think that it is important. I was not an original cosponsor

of this in previous Congresses, but came on board as the principal

author, along with Sander Levin and others, because of an awareness that came into my office. If I may share this personally, last

year I discovered first-hand the importance of early diagnosis when

my legislative director, Paige Anderson, who is with us here today

because of early diagnosis. She is one of the lucky ones. She stands

here today a cancer survivor.

However, it was not until early diagnosis that she even learned

of HPV, cervical cancer, and the importance of early Pap smears

and pelvic exams. Unfortunately, her story is the story that is

going to repeat itself until this legislation not only passes, but that

we fully fund it and start bringing about the kind of awareness of

this cancer that, candidly, we have had success stories in other

areas.

This is a bipartisan bill, and I would particularly like to thank,

once again, Sander Levin, who was the author of it in a previous

Congress; Kay Granger; Rosa DeLauro; and Congressman Dan

Burton, who will speak in a few moments. They really made a difference in previous Congresses in moving this, and now, together,

we are very happy to be able to move this.

Last, but not least, I want to recognize Dr. Beth Karlan. Dr.

Karlan is the president of the Society of Gynecological Oncologists.

She practices medicine at Cedars Sinai Medical Center in my home

11

State of California. But beyond being a doctor, a researcher, a professor, and mother, Dr. Karlan has been an inspiration and

motivator in the fight for gynecological cancers, and she is also the

person whose efforts saved my staff person, Paige Anderson’s, life.

So I am looking forward to seeing the energy that she brings to the

Congress, just as the energy that she has brought to her practice.

And with that I yield back.

Mr. CANNON. Thank you, Mr. Issa.

Are there other Members who would like to make an opening

statement? Ms. Watson. The gentlelady is recognized for 5 minutes.

Ms. WATSON. Thank you, Mr. Chairman, for having this most

critical hearing. I too had cancer visited on my family: my sister,

18 months older than I, had cervical cancer and did not survive.

It reminds me of a discussion we had in our legislature maybe

20 years ago, when we were startled to learn in the 1980’s that

most of the cancer testing for breast cancer was done on men. So

about seven of the women in both Houses—I was in the Senate—

and my colleagues in the Assembly ganged together and we said

we will not vote for the budget in a block unless you put $28 million in for research on breast cancer on women.

And we got it in. We had to gang up; we had to terrorize. UCLA’s

Dr. Love worked with us and reported on the status of the research

over the years. The women—and particularly minority women—

who had breast cancer, by the time we finished up, were all dead.

So we really forged ahead.

I was heading Health and Human Services for 17 years, and we

forged ahead on the studies. But we required in the State of California that every woman over 40 have a mammogram yearly. We

had to drop that down to 20 because we found that breast cancer

was spreading faster among African-American women—we didn’t

know why—at an earlier age. And by the time we would get to

them and we would try to follow them and profile, they were gone

as well.

So in 2005 we cannot stress that we really have not made that

much progress. So I do hope, listening to the panels, that you will

encourage us—and particularly women—and let us know the intensity of the effort. Are we putting enough resources in? And what

are America’s priorities when it comes to fighting cancer? We have

new kinds of cancers appearing every day. And, particularly in my

State of California, skin cancer is becoming very prevalent. So we

must keep pace; we must keep focused; we must keep allotting the

necessary resources.

And I want to tie it in to the tragedy that we are all going

through in the Gulf Coast. We need to place a priority on health;

health of all Americans. And I just have to say this: When we talk

about homeland security, it is not the land I am worried about; it

is the people on the land. If they are weakened by disease, contagious diseases and cancer, we have no defense; we have no security. So I hope that our subcommittee will keep the focus going on

the health delivery system, and specifically on the prevention and

detection of cancer.

Thank you, Mr. Chairman.

Mr. CANNON. Thank you.

12

Other members who wish to make an opening statement? Mr.

Burton. The gentleman is recognized for 5 minutes.

Mr. BURTON. I have a very, very brief statement. First of all, I

want to thank Darrell Issa and Sander Levin for sponsoring this;

I think it is very important and you should be congratulated for

that. I want to thank Chairman Souder. He just added his name

as a cosponsor of the bill, so we are up to 221 or whatever it is,

so we should be able to get this passed. I want to also thank

Kolleen Stacey and Sheryl Silver for being here. They have been

doing yeoman’s service for this cause for a long time, and I personally really appreciate it.

My wife was misdiagnosed and died about 3 years ago because

of misdiagnosis on her cancer, and I just hope that part of the solution that we finally realize is making sure that the doctors across

this country are educated in how to deal with analyzing the various

kinds of cancer that women have. One of the big problems we have

right now is, unfortunately, some of the doctors misdiagnose, and

because of that the cancers spread too rapidly before we find out

about it, and that is what happened with my wife.

So I thank you very much for sponsoring this bill, Darrell, and

thanks for having this hearing. And I look forward to hearing the

testimony.

Mr. CANNON. The gentleman yields back. I want to thank the

gentleman. This is actually sort of a hard topic to talk about, isn’t

it, Mr. Burton?

Other Members who wish to make an opening statement? Mr.

Ruppersberger.

Mr. RUPPERSBERGER. Thank you, Mr. Chairman.

Mr. CANNON. The gentleman is recognized for 5 minutes.

Mr. RUPPERSBERGER. This is an extremely important issue, and

I hope this hearing today will really call attention to us and to

what we need to do to bring this issue to the forefront. As we all

know, gynecologic cancers, if detected early, can help the issue, and

it is very important to do this.

But we do need to understand that early detection is sometimes

not possible, where the symptoms demonstrated by afflicted women

are identified as something else. And we must continue to be at the

forefront of science and technology when it comes to diagnosing and

treating these types of cancers. If adequate resources, expertise,

and manpower exists, there is no excuse for delay.

I am looking forward to the testimony today from our witnesses

in an effort to again raise the awareness about this type of cancer

among patients and doctors, and how we, as Members of Congress,

can help.

Thank you, Mr. Chairman.

Mr. CANNON. The gentleman yields back.

Mr. Waxman. The gentleman is recognized for 5 minutes.

Mr. WAXMAN. Thank you very much, Mr. Chairman.

I welcome our witnesses today, and I am pleased we are holding

this hearing.

Over the last 30 years, the rate of lung cancer among women in

the United States has more than doubled. The rate of breast cancer

has increased by 20 percent. But the rate of cervical and uterine

13

cancers has dropped in half. And the racial disparities in diagnosis

of these cancers have also substantially narrowed.

Credit for progress against cervical cancer goes largely to a single preventive health intervention: the Pap smear. By diagnosing

precancerous lesions, this test permits eradication of the problem

before cancer develops. By any accounting, the Pap smear ranks as

one of the most major advances in women’s health of the 20th century. Yet, there is much more to be done to combat gynecological

cancers. Cervical cancer kills 4,000 women each year; ovarian cancer kills nearly 15,000.

The key to progress is to continue implementing sound public

health practices and supporting crucial research. To start, we must

make sure that all women have access to routine cervical screening. An estimated 60 percent of cervical cancer cases occur among

women who did not get routine Pap smears. We also must make

sure that women who screen positive for gynecological cancers have

access to needed medical treatment. This is not something to be

taken for granted. The President’s proposed cuts to the Medicaid

program threaten the basic access to care for women around the

country, and, if passed, they could expect it to lead to more suffering and death from cancer.

We must take advantage of new technology. And we will hear

today about vaccines that seem to be very, very promising and very

successful in their tests. We need to pursue progress at the same

time we resist calls to politicize policy decisions on women’s health.

And there are two ongoing ideological campaigns that could seriously undermine the progress that the public health system has

made. The first is the call to require warning labels on condoms

stating that they don’t protect against HPV. This policy makes no

sense.

The National Institutes of Health and CDC have both concluded

that condoms reduce the risk of cervical cancer. That is the benefit,

the health benefit outcome that we are all concerned about. In addition, the most recent scientific evidence indicates condoms do reduce the risk of HPV acquisition among women. In a carefully designed study of HPV and condoms by researchers at University of

Washington, consistent condom use reduced the risk of HPV among

young women by 70 percent.

A second attempt to politicize science involves early efforts to reject HPV vaccine. A spokeswoman from one right-wing group has

expressed concern that giving the HPV vaccine to young women

could be potentially harmful because they may see it as a license

to engage in premarital sex.

It is a good thing that this sort of reasoning did not prevail when

the Pap smear was invented. We would not have seen the major

decrease in cervical cancer rates over the last three decades. The

HPV vaccine offers the potential of saving thousands of lives. We

should follow the advice of experts, not ideologs, in determining

who should receive this intervention. After all, it is science that has

guided our success in cervical cancer, and science will lead the way

to continuing success.

I have looked at the list of witnesses. I think that we have a good

two panels before us. I particularly want to single out Dr. Beth

Karlan, who is my constituent, and welcome her to our hearing

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today, and also all of the witnesses that are here to make their

presentations.

Thank you, Mr. Chairman.

Mr. CANNON. The gentleman yields back. Thank you.

I would now like to recognize the Honorable Sandy Levin of the

12th Congressional District of Michigan, who will introduce Sheryl

Silver, the sister of Johanna Silver.

Mr. Levin.

Mr. LEVIN. Thank you. My thanks to everyone on the panel for

your eloquent statements.

My opportunity today is to introduce Sheryl Silver, who is on the

second panel, and I will do just briefly so you can move on to the

distinguished people here on the first panel.

Several years ago Sheryl Silver was in touch with us and in

touch with me. It was the aftermath of the death of her sister, and

she decided to take that tragedy in the life of her family and see

if she could impact the lives of others. And for these years that has

been, I think, her main preoccupation, as well as her mother, who

is here today, and other members of the family.

What she brought to our attention is what has been repeated

here, that wasn’t well enough known: that as to gynecologic cancers, early detection almost invariably works and late detection is

almost invariably fatal. So we introduced the legislation and there

was a lot of interest shown across the isle and across the Rotunda.

So I am here today to introduce Sheryl, who has been so dedicated

to this cause, Johanna’s Law, named after her sister.

Last session, Darrell Issa and I talked. He was very much moved

by the experience within his own office, and we set upon a course

to try to maximize the chances of passage of this legislation.

So let me just finish by suggesting the challenge here. One is for

us in this Congress to prove that one person in our country can indeed make a difference, and it is up to us to do that. And, second,

I think it is our charge to take personal experiences so eloquently

and personally expressed here, and take personal experiences and

place them into public action. And if we fail to do that, we have

failed in our responsibilities as elected officials.

I am glad you are holding this hearing. I think we all appreciate

the expression of personal backgrounds of personal experiences. We

appreciate the interest of the scientists who are here. And I hope

very much, to all of you, that the result of this hearing today will

be action on the floor of the Senate and the House. We have enlisted Senators in this effort, and I think now, after you hear this,

the responsibility will be ours.

Thank you for letting me proceed out of turn, and I wish you the

best of luck.

Mr. CANNON. Thank you, Mr. Levin. Let me just make a personal

note. I appreciate your initiative on this action, your support. I

truly believe that individuals make the difference, so I appreciate

your introduction, your initiative, and thank you for being here

with us.

Mr. LEVIN. Thank you very much. Thank you to all of you.

Mr. CANNON. I would just also add thanks to Mr. Issa. I am a

co-sponsor of this bill, and I think it is great legislation. Thank

you.

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A couple of procedural matters. I ask unanimous consent that all

members have 5 legislative days to submit written statements and

questions for the hearing record, and that any answers to written

questions provided by the witnesses be also included in the record.

Without objection, so ordered.

I also ask unanimous consent that all exhibits, documents, and

other materials referred to by Members may be included in the

record, and that all Members be permitted to revise and extend

their remarks. Without objection, so ordered.

Our first panel is composed of Dr. Edward Trimble, Head of the

Surgery Section, Division of Cancer Treatment and Diagnosis at

the National Cancer Institute; Dr. Ed Thompson, Chief of Public

Health Practice at the Centers for Disease Control and Prevention;

and Dr. Richard Pazdur, Director of the Division of Oncology Drug

Products, Center for Drug Evaluation and Research, U.S. Food and

Drug Administration.

It is our custom as an oversight committee to swear all of our

witnesses in. Would you mind rising while I administer the oath?

[Witnesses sworn.]

Mr. CANNON. You may be seated. The record should reflect that

each member of the first panel agreed in the affirmative to that

oath.

Dr. Trimble, thank you for joining us, and you are recognized for

5 minutes. Before you begin, let me just point out that, since we

are probably going to have quite a bit of questioning, the 5-minute

limit is not fixed, we don’t get lightening from heaven, but if it goes

beyond, I may tap just to remind you to draw your comments to

a conclusion. And then we may go a second round of questioning.

But for the panel members, I intend to enforce the 5-minute rule

fairly strictly, so that people who are waiting have a chance to ask

questions. But, again, we may go to a second round or more of

questioning if those here would deserve.

Dr. Trimble, you are recognized for 5 minutes.

STATEMENTS OF DR. EDWARD L. TRIMBLE, M.D., M.P.H., HEAD

OF THE SURGERY SECTION, DIVISION OF CANCER TREATMENT AND DIAGNOSIS, NATIONAL CANCER INSTITUTE; DR.

ED THOMPSON, M.D., M.P.H., CHIEF OF PUBLIC HEALTH

PRACTICE, CENTERS FOR DISEASE CONTROL AND PREVENTION; AND DR. RICHARD PAZDUR, M.D., DIRECTOR, DIVISION

OF ONCOLOGY DRUG PRODUCTS, CENTER FOR DRUG EVALUATION AND RESEARCH, U.S. FOOD AND DRUG ADMINISTRATION

STATEMENT OF DR. EDWARD L. TRIMBLE

Dr. TRIMBLE. I am honored to testify on the topic of gynecologic

cancer for the National Cancer Institute. Over the past century, we

have made major progress toward the defeat of cervical cancer in

the United States. Today I would like to talk to you about some

of the exciting work NCI is doing to eliminate the scourge of

gynecologic cancer in the United States and around the world.

NCI scientists developed a new vaccine approach to prevent the

transmission of HPV. We have licensed this technology to two large

pharmaceutical companies who have recently reported that the vacVerDate 11-MAY-2000 13:12 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00019 Fmt 6633 Sfmt 6633 D:\DOCS\26657.TXT HGOVREF1 PsN: HGOVREF1
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cines were almost 100 percent effective in preventing spread of the

virus. We have also been working to make screening for cervical

cancer less expensive, more reliable, and more available. Even with

the arrival of HPV vaccines, we will need to continue screening for

many years to come.

In one of our most exciting projects, NCI is working with the

CDC, the University of Alabama at Birmingham, and the Mississippi State Health Department to improve screening for cervical

cancer among poor rural women in the Mississippi Delta who have

had some of the highest rates of cervical cancer in the United

States for the last 50 years.

Again in collaboration with the CDC, as well as with the U.S.

Department of Agriculture and the American Cancer Society, NCI

is implementing TEAM-UP, a national pilot program to increase

cervical cancer screening among never or rarely screened women in

eight underserved Appalachian States.

We are also making major strides toward the elimination of

death and suffering from ovarian cancer. We are currently evaluating screening for ovarian cancer among 70,000 women through our

PLCO trial. Our laboratories are developing new screening tests for

ovarian cancer. One of the most promising is the identification of

proteomics, protein expression in the blood, as a screen for ovarian

cancer.

The NCI discovered and developed paclotaxol, or Taxol, which is

now one of the standard drugs used to treat ovarian cancer. We

have just completed the largest treatment trial, 5,000 women, ever

conducted in ovarian cancer with the help of investigators across

the United States, Canada, and five other international partner

countries.

We have established four specialized programs of research excellence to foster translational research in ovarian cancer.

We are also working to strengthen our research portfolio in

endometrial cancer, which is the most common female pelvic malignancy. The identification of new targets and treatments will lead

us to new strategies to prevent women from developing

endometrial cancer and to avoid the need for hysterectomy.

We have also developed an extensive educational program focused on gynecologic cancers. Our Cancer Information Service Partnership collaborates with local, State, and other Federal agencies

to conduct outreach on cervical cancer, particularly in medically

underserved populations. For example, NCI has joined with county

and local officials to raise awareness, provide education, and build

a community-based sustainable cancer control infrastructure for

urban American Indian women in Los Angeles. We also collaborate

with the CDC in addressing the needs of underserved populations

using our 1–800–4-CANCER number to refer thousands of eligible

women to low-cost and no-cost CDC services.

We have an extensive educational program focused on

gynecologic cancer, including Web sites and educational material

for both patients and medical professionals, available in English

and Spanish.

Ending pain and suffering from gynecologic cancer is among the

highest priorities of the NCI. We are working to implement the recommendations of the Gynecologic Cancer Progress Review Group.

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We have also undertaken, in partnership with the CDC, the American Cancer Society, the International Agency for Research on Cancer, the World Health Organization, the Society of Gynecologic

Oncologists, and the Gynecologic Cancer Foundation, a global initiative on women’s cancer so that we can lift the burden of

gynecologic cancer from women around the world.

That concludes my oral testimony. You have additional material

in my written testimony. I would be happy to answer any questions.

[The prepared statement of Dr. Trimble follows:]

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Mr. CANNON. Thank you, Mr. Trimble. And I note that the light

was still yellow when you finished. I appreciate that testimony.

The other members of the panel don’t have to be so careful. We

actually are interested in what you say.

Dr. Thompson, you are recognized for 5 minutes, or as much time

as you would like to use.

STATEMENT OF DR. ED THOMPSON

Dr. THOMPSON. Thank you, Mr. Chairman. I am Dr. Ed Thompson, a specialist in preventive medicine and Chief of the Public

Health Practice at the Centers for Disease Control and Prevention.

It is an honor to be in front of this committee again. We appreciate

the commitment of this committee to this important issue.

I would also like to thank Mr. Levin for referring to the members

of this panel as distinguished. But we are distinguished by the degrees that we hold and by the positions that we occupy. The next

panel will bring before you people who are distinguished by their

personal courage, by their commitment to this important cause;

and they are far more distinguished than we.

Gynecological cancers, cancers of the female reproductive organs—including, most importantly, those of the uterus, its endometrium, and cervix, the ovaries, and also, to a lesser extent, vaginal and vulvar cancer—are some of the most important cancers

that affect women in this country. According to the most recent

CDC and National Cancer Institute data—and as you have observed, Mr. Chairman—more than 71,000 women in the United

States were diagnosed with a cancer affecting the reproductive organs in 2002, and approximately 27,000 women in the United

States died from some form of gynecological cancer in that year.

Endometrial cancer may be the most common gynecological cancer; ovarian cancer the most deadly. Cervical cancer is the one cancer for which we currently have an effective and approved screening tool; and we will speak more about that in a moment as well.

At CDC, we are actively engaged in providing most current cancer prevention and control strategies at the community level, primarily through State and local health departments. These efforts

reach hundreds of thousands of women every year in the United

States. Our efforts are directed largely toward surveillance screening, where recommended, public education and awareness, health

care provider education, epidemiology, and behavioral research. I

would like to tell you about a few of our cancer initiatives, in particular those directed against cervical cancer. But by no means are

we limiting our activities to those against cervical cancer.

The CDC’s National Breast and Cervical Cancer Early Detection

Program, which was established by Congress in 1991, has received

growing support that helps low-income, uninsured, and underinsured women gain access to lifesaving screening programs. The

national program currently provides screening support in all 50

States, the District of Columbia, four U.S. territories, and to 13 Indian tribes.

Since 1991, this program has provided more than 2.9 Papanicolaou tests and detected more than 1500 invasive cancers. Testament to the benefit of prevention and early detection is the fact

that more than 74,500 cancer precursor lesions had been detected

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or treated since the program’s inception. The program represents

a national infrastructure of more than 22,000 health care providers

designed to reach those most in need.

Now, each year, between 10,000 and 12,000 women will be diagnosed with cervical cancer, and approximately 3,700 women will

die from cervical cancer in the United States in 2005. The sad

thing is that, in a very real way, every one of these 3,700 deaths

is preventable and every one represents a failure of our American

public health system.

We have achieved some success with cervical cancer mortality,

reducing it by more than 70 percent over the last five decades, so

that cervical cancer, once the No. 1 cause of cancer deaths among

U.S. women, is now 14th. This is in large part due to widespread

application of the Pap test to detect cervical abnormalities.

But as has been noted, approximately half of the cervical cancers

that are diagnosed today in this country occur in women who have

never received a Pap test. Another 10 percent occur in women who

have not been screened within the past 5 years. So we are still not

using this remarkable tool as effectively as it needs to be.

CDC also manages the National Comprehensive Cancer Control

Program, which provides supports to develop comprehensive cancer

control plans in all 50 States across the Nation. These plans serve

as blueprints for developing and implementing cancer control activities. As an example, the California and the Florida Departments of Health, through this program, have identified and implemented strategies in their Statewide cancer control plans to identify the burden of ovarian and/or cervical cancer in local communities, strategies which include promoting referrals of ovarian cancer patients to clinical trials, promoting education and awareness

within communities, and supporting ovarian cancer research.

In Alabama, the ovarian initiative focuses on enhancing the

public’s understanding of hereditary factors that increase the risk

of developing ovarian cancer. And West Virginia’s Raising Ovarian

Cancer Awareness Initiative enlists ovarian cancer experts to

speak with women in high-incidence counties about the symptoms

of ovarian cancer and the importance of gynecological exams. Since

implementing the program, the State has been able to demonstrate

a 40 percent increase in participants’ knowledge of the symptoms

and risk factors for ovarian cancer.

In addition, CDC’s national program of cancer registries collects

information about incidents, diagnosis, treatment, and mortality.

This data helps us to understand both the epidemiology of cancer

occurrence and, in some cases, our effectiveness in bringing women

to treatment.

In conclusion, gynecological cancers constitute a serious health

problem in this country that CDC, along with our fellow Federal

agencies, takes extremely seriously. Our role at CDC is focused on

risk reduction, early detection, identifying and improving barriers

to appropriate clinical practice, and to enhancing survivorship for

women. There is much work to be done in all of these areas. I look

forward to the opportunity to answer any questions that you may

have.

[The prepared statement of Dr. Thompson follows:]

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Mr. CANNON. Thank you, Dr. Thompson. We appreciate that.

Dr. Pazdur. Is that an appropriate pronunciation?

Dr. PAZDUR. Pazdur.

Mr. CANNON. Pazdur.

STATEMENT OF DR. RICHARD PAZDUR

Dr. PAZDUR. Mr. Chairman, members of the subcommittee, I am

Dr. Richard Pazdur, M.D., FDA’s Director of the Office of Oncology

Drug Products within the Office of New Drugs at the Center for

Drug Evaluation and Research [CDER]. I am pleased to be here

today to discuss prevention, early detection, and treatment of gynecological cancers.

The FDA’s mission is to promote and protect the public health

by helping to assure the safety and efficacy of human drugs and

medical devices. Let me begin by informing you of recent structural

changes within the FDA that are intended to provide a stronger

and more consistent approach to the review process for drugs used

to diagnose, treat, and prevent cancer.

In July 2005, the FDA created a new Office of Oncology Drug

Products. This office has three divisions that will review applications for safety and effectiveness: the Division of Drug Oncology

Products, Biological Oncology Products, and Medical Imaging and

Hematology Products. Also, the Office will develop and lead a comprehensive oncology program to facilitate coordination of oncology

activities across all FDA centers and ensure ongoing outreach and

collaboration between the FDA, the National Cancer Institute, and

other cancer-related organizations.

The Office expects to improve the consistency of review and policy toward oncology drugs and bring together a critical mass of

oncologists who will help guide the development of these new

therapies. Although many details of this new structure are still

evolving, I am pleased to be working with many talented and dedicated scientists who comprise this new office.

The access process for cancer drugs usually starts with a sponsor

seeking to develop a new cancer drug. A sponsor is usually a pharmaceutical company or a research scientist at the university or at

the National Cancer Institute at the National Institutes of Health.

Before clinical testing begins, researchers analyze the drug’s main

physical and chemical properties in the laboratory and studies its

pharmacological and toxic effects in laboratory animals. If the laboratory and animal studies show promise, the sponsor submits an

investigational new drug application to the FDA prior to initiating

testing in patients.

New therapies for the treatment of gynecological cancer are

being investigated. Hundreds of clinical trials in ovarian, cervical,

endometrial, and other gynecological cancers are publicly listed.

The FDA has several programs to expedite drug development and

expand access to unapproved therapies. All of these programs have

been instrumental in shortening the time to marketing approval for

cancer drugs and biologics.

Under the Accelerated Approval Rule, the FDA can approve

treatments for serious or life-threatening conditions that demonstrate the potential to address unmet medical needs on the basis

of a ‘‘surrogate endpoint’’ that is reasonably likely to predict clinical

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benefit. A surrogate endpoint is a measure of drug effect—for example, tumor shrinkage—that does not by itself show direct clinical

benefit such as decreased pain or longer survival, but is thought to

lead to such benefit.

Priority new drug applications and effectiveness supplements are

those that could have important therapeutic impacts. The FDA’s

goal is to review a priority product within 6 months, rather than

the standard review time of 10 months.

The fast track refers to a process for frequent and timely interaction between sponsors and the FDA during drug development.

The fast track programs are designed to facilitate the development

and to expedite the review of new drugs and biologics to treat serious or life-threatening conditions that demonstrate the potential to

address unmet medical needs.

We are currently in the early stages of planning a workshop for

oncology experts, radiation oncology, statisticians, industry representatives, and patient advocates to discuss endpoints related to

ovarian cancer, and hope to hold this meeting sometime in early

2006. A steering committee including representation from the FDA,

the NCI, the American Society of Clinical Oncology, and the American Association for Cancer Research is planning these workshops.

The FDA’s Office of Special Health Issues works with patients

with life-threatening diseases. Patients usually call to obtain information about unapproved treatments currently being researched.

We direct callers to public information about clinical trials for

which they might be eligible and provide additional sources of information to patients and their family members.

The formation of the NCI-FDA Interagency Oncology Task Force,

in 2003, was an important strategic step toward achieving FDA’s

goal of increasing availability and the use of safe and effective

treatments for cancer, and the NCI’s goal of eliminating pain and

suffering and death from cancer by 2015. The purpose of this Task

Force is to leverage the expertise and capabilities of both agencies

to help streamline and accelerate the overall development of the diagnostic, preventative, and therapeutic interventions of cancer.

Finally, we want to mention the FDA’s Critical Path Initiative.

There is growing concern that many of the new basic science discoveries made in recent years may not yield quickly more effective,

affordable, and safe medical products for patients because the current medical product development path is becoming increasingly

challenging, inefficient, and costly. During the past several years,

the number of new drugs and biologic applications submitted to the

FDA has declined. The number of innovative medical devices applications has also decreased. In contrast, the cost of product development has soared over the last decade.

A new product development tool kit—containing powerful new

scientific and technical methods such as animal or computer predictive models, biomarkers for safety and effectiveness, and new

clinical evaluation techniques—are urgently needed to improve predictability and efficiency along with all critical path from the laboratory to commercial product development. The FDA is in the

final stages of developing a critical path opportunity list based on

the input and ideas contributed both by external stakeholders and

the FDA reviewers.

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The FDA is working with the NCI, industry, academia, patient

and other organizations to ensure that cancer patients have timely

and important information about available cancer drugs, including

those for gynecological cancer indications.

Thank you for this opportunity to testify. I will be happy to answer any questions the subcommittee might have.

[The prepared statement of Dr. Pazdur follows:]

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Mr. CANNON. Thank you.

May I begin the questioning by asking you members of the panel,

generally, are you familiar with Abasian statistics or its evolving

cousin, complexity theory? Mr. Trimble. Are you experts in either

of those areas?

Dr. TRIMBLE. I am not expert. I do have statistical colleagues at

the NCI who are very qualified in those topics.

Mr. CANNON. Dr. Thompson.

Dr. THOMPSON. I can answer an unqualified no, I am not an expert in either of those, although, likely, we do have colleagues at

CDC who can provide additional information if needed.

Mr. CANNON. Dr. Pazdur.

Dr. PAZDUR. Likewise, I am not a statistician; however, the FDA

obviously has a complete cadre of statistical analysis.

Mr. CANNON. Are you all familiar with some of the concepts embedded in Abasian theory or complexity theory? Just generally familiar?

Dr. TRIMBLE. I would have to tell you, Mr. Chairman, that I am

sufficiently familiar with it to get myself into real trouble if I attempt to explain anything according to those lines.

Mr. CANNON. You are probably a lot better than I am. I ask that

question because it seems to me that we have the opportunity in

America today to make some dramatic changes in the way we do

things and improve things. Let me go through a series of questions

for each of you.

I met with Dr. Eschenbach from the National Cancer Institute.

I think he is a remarkably delightful, interesting person, but the

delightful part doesn’t extend to the gravitas that he brings to bear

on these subjects. He is highly committed and I have enjoyed my

conversations with him along these lines. NCI and NIH are to be

commended for the extensive database work they have done in developing databases on ongoing clinical trials. This is a terrific step

forward.

But, Dr. Trimble, is there any database you are aware of that

lists off-label use of currently approved drugs or devices for medical

treatment?

Dr. TRIMBLE. There is a compendium which lists the available

data to support off-label use of drugs in various clinical situations.

Mr. CANNON. Would that be like a study that somebody reported,

so it is a compendium of studies?

Dr. TRIMBLE. That is correct.

Mr. CANNON. Is there a centralized Internet database that physicians or patients can refer to that outlines current treatment protocols for a given medical condition?

Dr. TRIMBLE. The NCI’s PDQ database lists standard recommendations based on a comprehensive review of the literature

for cancer prevention, screening, treatment, treatment of symptoms, palliative of care and end of life care.

Mr. CANNON. Tell me a little bit about where that database

comes from, how it is developed, and how new protocols get into

the system.

Dr. TRIMBLE. The NCI convenes panels that are independent

panels. They include both representatives from academic institutions as well as from NCI and from other Federal agencies. They

52

review the current literature on a regular basis. Some panels meet

yearly, some meet every 3 months, depending on the volume of literature. They then draft statements which summarize the literature, which reference the literature, and those statements are

placed on the NCI’s PDQ Web site so that it is widely available.

Mr. CANNON. You know, we have this mammoth number of highly educated doctors in America. Sometimes they don’t actually recognize the problems. But when we have this huge group of people

that are well educated, tend to be academic, tend to be clinicians,

but with a creative mind-set, is it possible in your mind to capture

that capability, that academic ingenuity out there in some form

that would allow protocols that doctors are using to be brought into

a database so that other doctors could look at those protocols and

then develop sort of an Abasian context in improved treatments?

Dr. TRIMBLE. Well, as I said, the PDQ database makes or summarizes what is——

Mr. CANNON. Let me just make a distinction. The problem with

PDQ is that this is a bureaucratic and long process, as opposed to

a database process or a process that grows from practitioners up.

Is it possible to shift gears away from the long process that says

this is OK and to a process that says we would like to know what

you are doing out there, we would like to compare it to what other

people are doing, and we would like that information to be made

available to other doctors?

Dr. TRIMBLE. We have made an effort to reach out to the community in a pie project for certain cancers to find out how these cancers are being treated in the community, what is the effective

treatment upon outcome upon quality of life; and we are analyzing

that data currently to see how effective it is and to see whether we

should be expanding this program to other cancer sites.

Mr. CANNON. You are probably familiar with the development of

childhood cancer responses. When I was very young, my best

friend’s younger brother was found to have leukemia, and we

thought he would be dead within 3 months. It turns out there was

a treatment that somebody had identified, tried on the young boy,

and he wasn’t cured, but he didn’t die. This happened four or five

times in my childhood, where he became critical, was ready to die,

and then a new treatment came forward. As a result, I saw him

6 months ago; he has a family, he is happy and in his fifties now.

So we have a case of success.

What happened there—and I have talked to a number of people

throughout the pediatric world—is that there was so little focus on

pediatric medicine, especially oncology, that what we had was a

high level of communication. And that high level of communication

meant that it started out with telephones, later went to faxes and

to e-mail. It meant that people who discovered something that

might work communicated it to everybody else, everybody else tried

it, and those things that really worked tended to be focused on and

then became the base of treatment. That has been incredibly effective; not just in the single case that I am aware of, but the view

of all people involved in childhood oncology recognize that as a

great source of success.

We have the ability to communicate those things on all levels

and for all cancers much more rapidly. Is anybody looking at that

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at NIH or NCI that you are aware of, Mr. Trimble, to try and replicate with the massive increase in technology the great successes

we had in that one area?

Dr. TRIMBLE. Certainly, the progress that we have made in pediatric cancer has been tremendous, and we are trying to see if we

can replicate that progress. There are a number of things that the

pediatric oncology community has done which are admirable.

For example, probably 90 percent of children less than age 12 diagnosed with cancer are treated at pediatric cancer hospitals. This

is in contrast, for example, to adult cancers, where only 5 percent

or 10 percent of patients are treated at NCI-designated cancer centers. So the fact that the pediatric oncology community has been

able to concentrate the care of children with cancer in specialized

cancer hospitals has been tremendous.

They have also——

Mr. CANNON. Excuse me. The access to data is radically greater

today for all cancers, including adult cancers as opposed to child

cancers. In other words, I don’t want to understand why we are

successful with childhood cancers. I think I get that. The question

is is it possible to systematize access to data so that we do it much

more rapidly.

Dr. TRIMBLE. Well, another area which has made the pediatric

cancer world so successful is that more than 70 percent of children

with cancer go on clinical trials. So we capture data on how they

are treated, their response to treatment, and their quality of life.

We are trying to increase the number of adult patients going on

clinical trials. In addition, we are trying to extend our database so

that we can capture more information on all adults who are diagnosed with cancer.

Mr. CANNON. I apologize for that diversion. Have you finished on

that point?

Dr. TRIMBLE. Yes, I did.

Mr. CANNON. OK. In the case of my daughter—let me just ask

the panel of this generally.

I think we should do a second round of questions. On this committee there is a tendency to go longer for the chairman and the

ranking member. I am not going to abuse that too much.

But in the case of my daughter, she had a rare cancer that

maybe 30 young women typically a year get in America. I called

a friend of mine, as my daughter was going through the MRI, who

is a radiologist, and said after she is done, would you mind taking

a look at the pictures, and he said, hold on a second. And then he

said, OK, I am looking at them now.

I said, how could you be looking at them; she is in the MRI machine right now. And he was not at the same site. So he said, well,

the miracle of modern science. And then the next words out of his

mouth were, ‘‘Oh, this is bad.’’ Not exactly the kind of thing you

want to hear from a doctor.

Now, if he had been sitting—it was in her knee and he said it’s

involved in the tendons, and that is bad. Now, what she had was

clear cell sarcoma of the tendons and aponeurosis. But he didn’t remember the whole name; he just remembered having bumped into

this rare cancer that was associated with tendons. And if he typed

into the freaking machine that he had in front of him, if he had

54

a database that allowed him to type in sarcoma in tendons, the

treatment for my daughter would have been radically different.

Just a simple little information context there.

Now, we have done radical things in information. My favorite on

earth is Napster. You need to think about Napster, because that

was a peer-to-peer system that allowed anybody to get online and

identify information that was out there. In particular, it means

that a doctor can make information available.

You are telling me how you want to structure data so that it is

available and put people in clinical trials. We have people who are

essentially in clinical trials because they have cancer and they are

being treated by people who understand information and systems.

In my daughter’s case, she worked for the guy later on who actually did the MRI that I had mentioned earlier, so when the cancer

came back, she did a number of MRIs, because it didn’t cost anything and because her boss was a very gracious guy and a good

friend.

Now, in the course of her disease, there were no treatments. We

found one treatment of a person in Japan who had the disease and

had remission. But there are no accepted protocols for her disease.

That meant that we tried various different kinds of things with

medical guidance, including using the most standard or common

treatment for malaria throughout the world today, which is an

herb that the Chinese came up with.

Today, there are millions of people taking that herb with no side

effects, so we tried it on her. But we had no guidance; the idea of

how much to give her or how often to give it to her. So we experimented with it for 6 weeks. We didn’t really understand it, but

going back now we see that in her case the MRIs before she took

it and after she took it indicate that there was a dramatic slowing

of the growth of the tumor.

Now, that information seems to me to be quite important to

somebody else who has the same kind of disease. And the only way

you can get that information, the only way is by having access to

her records. So if you have a database that is like a Napster directory and you can find clear cell sarcoma of the tendons as

aponeuroses and see who has treated what and then say, wait a

minute, here is something that might have an effect, that could actually save people’s lives.

There is no way to get that data in our current system. You can

go online and you can see all the—well, I shouldn’t say that. There

are many people who have used this and they have their ideas

about how to use this, but there is no context where you can give

it scientific integrity, where people can build on the ideas.

What I am asking you—and let me just leave it at this point

with this panel and then we will go to Mr. Cummings—is does it

make sense to create in our data-rich environment a context for

practitioners, medical doctors, people who are trained in medicine,

to identify the best treatments that are out there, and then build

upon those and create a database as we did in pediatric oncology,

and move from that base forward? This is not, are your institutions

going to do it? The question is, does that make sense? Because we

probably have to make some changes here for you guys to be able

to do that. But does it make sense?

55

If I could ask the three of you to respond to that, I will then yield

back and defer to my friend, Mr. Cummings.

Dr. THOMPSON. Mr. Chairman, you have just identified one of the

primary reasons why Secretary Leavitt is committed for the Department of Health and Human Services to work toward developing an electronic patient record system in this country. It would

provide the sorts of database that would allow the sort of research

you are talking about to be done. It is not something that we now

have on a large scale basis.

You have identified one institution that had that aspect of it and

was able to use it very well, but we don’t yet have it standardized;

we don’t have it in enough places. We have not yet solved the problems of privacy and confidentiality that must be solved.

But if we can develop a common patient record that is electronic

and accessible in the ways you just described, it will not only provide better direct patient care with the medical knowledge that we

have now, it will allow the type of research you have just described.

Dr. PAZDUR. I think you hit on the head some really important

areas here, and one of them being treatment of patients that are

not on clinical trials. We do a great job, I think, of collecting data,

and perhaps too much data, on patients that are on clinical trials,

and one of the real issues is how does a drug work once it gets out

there in a post-marketing situation as well as in the treatment in

off-label uses such as in rare diseases where there are not going

to be large clinical trials.

So a database that reflects how the drug is actually used in the

intended indications as well as in off-label uses I think would be

an extreme important step to provide guidance, especially in areas

where you have relatively rare and unusual tumors, because considering the frequency of some tumors, they are very important tumors, but somebody is not going to do a large size clinical trial, just

due to the rarity of some of these diseases.

Dr. TRIMBLE. The only additional point I would add is that we

desperately need a system to track who has been screened for cancer, for example. We have no national database to tell us who has

had a Pap smear within the last 10 years, who has had a mammogram; do we know one place where we can capture the images of

those mammograms so we can compare them.

Mr. CANNON. Thank you. Let me make a distinction and a comment. The distinction is you are thinking in terms of clinical trials.

And what we have are many, many, many practitioners who use

protocols sometimes, who adapt protocols for the use of their patients, and who are accumulating huge amounts of data. The question is not how do we make this all fit into a clinical trial, but how

we capture the data from the practitioners. If you would think

about that.

Dr. Thompson, Secretary Leavitt is actually from Utah, interestingly, and he may not appreciate actually how good we are in

Utah, but there is a company in Utah that is the leading light in

these kinds of issues, and I am going to get you the name of it, it

is called NexLight, or sometimes eBridge. They have developed an

incredibly thorough system for managing patient data using all the

rules of HIPAA and other requirements and allowing the staff.

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And I am going to get you a card on that and ask for, in a written request, your response as to what that kind of a program could

do for allowing us in America to accumulate data on individuals

based upon their consent, their understanding of the law and their

consent, and giving access by those patients to people like doctors

or people running clinical studies or other scientists so that we can

actually move that issue forward.

I am going to ask some more questions, but I will save those

until the next round.

Mr. Cummings, if you have questions, you are recognized for 5

minutes.

Mr. CUMMINGS. Yes.

Dr. Thompson, in your opinion, what do we need to do to increase access to the existing interventions like Pap smears? You

know, the sad part is that we have people dying.

Dr. THOMPSON. It is. And what we need to do is to learn to use

the science we now have more effectively so that it reaches everybody. The Congress took an important step in 1991 in enacting the

legislation that created the Breast and Cervical Cancer Screening

Program, because what this does more than anything else is make

it true in this country that today no woman should be without cervical cancer screening or breast cancer screening simply because

she lacks the ability to pay for it, because any woman at or below

250 percent of the Federal poverty level qualifies for this program

and can receive screening services through it.

So cost should not be a barrier. And yet we know we are still not

reaching all of the women we should. The figures that I cited to

you I think are figures we should be proud of. We are reaching

many women and they are low-income women. But we know some

things that are troubling to us, and we want to work to make them

different.

This is not published information, it is simply what we have observed in looking at some of the States implementing it, but we

know, in the State of Ohio, for instance, that they tell us that although they are utilizing the program effectively, the women in the

upper half of that income range, 250 percent and below of the Federal poverty level, are the ones who seem to be taking advantage

of the program, and women in the lower half, the very lowest of

the low-income women, seem to be less often reached by the program. So we are looking and need to be looking at things that influence women’s choices as to how they use these programs, whether they know about them.

We have now gone passed the point where it is laboratory research that is needed. In these areas it is the sorts of behavioral

research that will help us learn why people do and don’t use medical programs and things that may be necessary to facilitate that.

That is the sort of research that CDC engages in along with our

colleagues at the National Institutes of Health. But the bottom

line, the answer to your question, we have simply got to learn how

to bring these techniques to the people that need the most and

often are the ones who know the least about them.

Mr. CUMMINGS. The program is one going back to 1991, so it is

about, I guess, 15 year anniversary. That is a long time. And I am

just wondering, do you know how that research is done? Is it focus

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groups? You know, one of the things that I do believe is that people

who have similar experiences in life probably shed the best light

on other people in like circumstances.

And I am just wondering. Sometimes I think what happens is

that, say, for example, if I wanted to know about why do women

in the lower economic rung of the ladder did not access, I would

go and talk to other women. I sure wouldn’t go to a man; I would

go to a woman. Sometimes I just find that a lot of our government

programs don’t do that. A lot of times we don’t go to people who

could probably help us with it.

For example, in my community there is a big glaucoma problem.

And my mother, having lost sight in one of her eyes with glaucoma,

I am in tune; I get it. So I am always talking to people about their

eyes. But some kind of way I think we also need to use people who

see the light, perhaps, to help spread the word. And I was just

wondering how much we do of that, too. That is, people who may

fall into those categories and have a relationship, therefore, and

can spread that word. You follow what I am saying?

Dr. THOMPSON. Yes, sir, I do. And this is an area in which we

in the medical professions maybe are coming a bit late to the idea

that we should ask those who we are trying to reach how best to

reach them. But we are doing that now. And at CDC in particular

we have established a new center, it is the National Center for

Health Marketing.

That doesn’t mean we are selling people things, it means we are

literally marketing health. And we are doing research by asking

people, both in studies and in focus groups, how it is that you make

your decisions about how you seek your health care of all sorts and

how we can improve your ability to do that. So we are beginning

to use those techniques of approaching the community we are trying to reach much more extensively.

Mr. CUMMINGS. Now, as far as doctors are concerned, they know

about these options that women have with regard to free

screenings and whatever. Do you think that plays a major role? Are

you following me? Somebody comes to the doctor. Do you think because they know this is something available, that they make

women aware of it?

Dr. THOMPSON. My colleagues can probably address this better

than I. But although we as doctors believe we know everything, the

truth is most of us don’t know enough even about our own specialties, and all have things that we can learn. So professional education is a part of CDC’s programs. I know it is also part of the

National Cancer Institute’s approach.

Mr. CUMMINGS. Dr. Trimble.

Dr. TRIMBLE. We have seen data showing that obstetricians and

gynecologists are the most likely to recommend that women undergo Pap smears and mammography. They are followed by family

practitioners. Unfortunately, many adult internal medicine specialists are less likely to do a pelvic exam or obtain a Pap smear.

So as Dr. Thompson mentioned, we need to redouble our professional educational efforts. In addition, the routine Pap smear

screening has now been instituted as a mark of quality in health

care provider organizations, so we think that this will increase the

recommendation of Pap smears for all women.

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Mr. CUMMINGS. Dr. Pazdur, you know that rising costs and a

lack of commitment to applied science in emerging various new

drugs and devices to treat cancer and other deadly diseases. What

can be done to encourage applied science research and technology?

Dr. PAZDUR. Well, I think this is one of the considerations that

the FDA had in establishing the critical pathway, because there is

a tremendous funding of discovery of drugs. But I think where we

have been lacking in the whole drug development area has been in

the clinical and the development of drugs after they may have been

initially discovered, and that is the clinical development of the

drugs and the preclinical development.

And that is why we are working with the NCI and have this

project. What are paradigms that can be shifted from conventional

evaluation of drugs to facilitate bringing drugs that are safe and

effective, not compromising safety and efficacy—we never want to

do that—but expedite drugs cognizant of the fact that they have to

be safe and effective; looking at new non-clinical ways to develop

in animal models.

For example, what would be a minimum data package that could

be accepted to bring drugs into a life-threatening situation; what

are different statistical tools that could be used to give us confidence that a drug is safe and effective, rather than the traditional

statistical methods that have been used? So I think this is an area

that is an extremely important area that we want to focus on, because we are cognizant of that and really need to work not only in

the FDA but with our external stakeholders, not only in government, not only in industry, but with the academic and patient community.

Mr. CUMMINGS. Thank you.

Mr. CANNON. The gentleman yields back.

Mr. Issa, did you have questions?

Mr. ISSA. Yes, Mr. Chairman.

Mr. CANNON. The gentleman from California is recognized for 5

minutes.

Mr. ISSA. Thank you.

Dr. Trimble, you mentioned in your opening statement the vaccine for HPV, and my understanding is there are 150 or so different strains, if you will. How many is it effective against?

Dr. TRIMBLE. Well, there are a variety of HPV subtypes. Only a

subset, perhaps 20 or 30, seem to be bad actors in terms of going

on to cause cancer. The two companies that are developing the vaccine have gone furthest with the prophylactic vaccine and have focused on the most common subtypes, 16 and 18, which are responsible for a majority of cervical cancers around the world and in the

United States.

Mr. ISSA. And I would like to concentrate my questions not on,

if you will, the new discovery side of it for a moment, because

Johanna’s Law really is about awareness, with $5 million going toward and $10 million per year going initially toward demonstration

projects to try to improve early diagnosis.

My first question—and I will take any of them, but I think, Dr.

Trimble, I would start with you—is it enough? Is this the amount

of money that you believe would start saving lives in large enough

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numbers, or are we kidding ourselves? And even with the

leveraging of public-private partnerships, will we need more?

Dr. TRIMBLE. Well, I concentrate my own work on promoting

gynecologic cancer research and developing trials in gynecologic

cancer, so obviously from my own perspective I always like to see

more money focused on gynecologic cancer. And it should be said

that about 5 percent of the NCI’s budget is, as we know, earmarked and goes toward gynecologic cancer research. And there is

a lot of basic science research as well that is specific to gynecologic

cancers, but may well influence us and help us develop new treatments, new screening tests.

So I think it is a very hard question for me to answer. Yes, I

would love to see more money going into gynecologic cancer; on the

other hand, we have a limited pot of money and there are a lot of

other cancers that we have to study as well.

Mr. ISSA. Dr. Thompson, maybe in your case, right now I would

say there are tens of millions of dollars a day worth of free air time

warning the people of New Orleans and the south, but particularly

New Orleans, not to drink the water and the contamination. I don’t

know how many people are going to heed that warning.

It does seem a little strange that we are all going to be aware,

unless of course, we are in the affected area, where we don’t have

a television. But maybe somebody will go in and tell the person

who doesn’t have a television or water what they need to do. From

your experience, is this a sufficient first step to have a real impact

both on the misdiagnosis side and on the need for testing side?

Dr. THOMPSON. Well, certainly we will never have spent enough

on cancer prevention and cancer detection until no one dies of cancer. But at the same time there are other priorities that we have

to balance back and forth.

I think certainly the concept of educating particularly providers

about the latest techniques, about the latest knowledge, about how

to appropriately screen, how to evaluate symptomotology is always

worth the effort. Whether this will accomplish the end I think we

will only know when we attempt it and then we evaluate whether

or not we have accomplished it, and if not, what is then required

to finally accomplish it.

Mr. ISSA. Last question, and I am staying on the same subject

of money. My understanding is it takes about three quarters of a

billion dollars to bring a new drug to market. Any one drug coming

to market, from your experience—and Dr. Pazdur might be the best

to answer this—any one drug probably would save, at a maximum,

3,000 to 5,000 deaths a year for nearly $1 billion, perhaps more;

$15, $20 million, would you say, any of you from your experience,

that an effective awareness campaign could save 3,000, to 10,000

lives a year between the three cancers? Would you say, on balance,

that this $15 million—as compared to the $1 billion of one new

drug—could save as many or more lives?

Dr. PAZDUR. The answer to your question is yes. Obviously, prevention and early detection of cancer is always better than the

treatment of advanced disease, even early stage disease. But especially when one takes a look at advanced disease, patients that

have metastatic disease, where most of the drugs in oncology are

60

being developed, most of those situations have to be considered palliative types of therapies, unfortunately.

So efforts to really eradicate cancer and to truly make an impact

on the burden of cancer really needs to be addressed in the early

stage awareness, getting the community to see their physicians.

Doctors know generally what to do; however, if the patients are not

coming to them, that is where the gap could be, and I think that

is a need for community recognition of the disease and the importance of getting screened, etc.

Mr. ISSA. Thank you, Mr. Chairman.

Mr. CANNON. The gentleman yields back.

Ms. Watson. The gentlelady is recognized for 5 minutes.

Ms. WATSON. Thank you, Mr. Chairman.

This question goes to Dr. Trimble. In your testimony you state

that an effective vaccine in combination with cervical cancer

screening is expected to reduce cervical cancer rates by 90 percent

in the United States.

I am finding out that there are those who began to oppose the

HPV vaccine. A spokesperson for the Family Research Council said

that giving the HPV vaccine to young women could be potentially

harmful because they might see it as a license to engage in premarital sex. So from a public health perspective, does the Government typically withhold vaccines because of the unsubstantiated

claims that they will affect people’s attitudes and behaviors?

Dr. TRIMBLE. Well, let me start by seeing if Dr. Thompson would

like to comment in terms of the—I know the CDC has a vaccine

advisory committee which carefully measures the risks and benefits associated with vaccines and makes recommendations, so perhaps Dr. Thompson——

Ms. WATSON. Fine.

Dr. THOMPSON. First, Ms. Watson, let me thank you for the imagery you used earlier about homeland security being not about the

land, but about the people on the land. With your permission, I am

going to use that with attribution, occasionally.

Ms. WATSON. Please do.

Dr. THOMPSON. As my colleague has said, CDC has a process for

evaluating the usage of vaccines. Now, the first issue is whether it

becomes licensed, and there my colleagues from the FDA must

make the decision. But once a vaccine is licensed, we have a committee, it is called the Advisory Committee on Immunization Practices, that meets regularly. It consists primarily of scientific experts, but also of public health practitioners.

I had the privilege of serving on that committee myself for 4

years before coming to CDC. And it also makes provision, extensive

provision, for public input and public comment. Based then on the

science and the policy implications of the use of a vaccine, they

make scientifically informed decisions recommending to CDC, and

from CDC thus to the Department of Health and Human Services,

what use the vaccine should be put for.

That process is ongoing now. The ACIP has already addressed

the issue of HPV vaccine in some of its meetings in anticipation of

licensure, and will be doing so again. So it is critically important

that persons interested in this issue bring their concerns to the

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committee through the public comment process and make sure that

their voice is heard.

Ms. WATSON. The encouraging words that you used were based

on science.

Dr. THOMPSON. That is correct.

Ms. WATSON. Not based on ideology or negative attitudes. We

have been accused in our public school system—I was a member

of the board in Los Angeles—when we passed out condoms upon request to block the spread of AIDS, we were accused of encouraging

young people to engage in sex.

I carried the needle exchange bill for 8 years—it was passed after

I left—and was accused and made to sit on the hot seat because

there were those attitudes out there that everything we did was encouraging people to have sex. So I am assured by your response

that you operate based on the facts and on empirical evidence

gained from your scientific research when you make these decisions, correct?

Dr. THOMPSON. I can assure you, both from having been on it

and knowing the people that are on it now, that the ACIP bases

its decisions on scientifically verifiable fact and will not deviate

from it.

Ms. WATSON. From a public health standpoint—and this is back

to Dr. Trimble—we in Government, we decisionmakers must put

policies out there that will help the public and reduce the risks

that they face, even if it goes against some people’s religious beliefs. I am a Roman Catholic, and I support choice, I support

condoms, I support all kinds of other things that will reduce the

risk to the public. So I just wanted to make that statement real

clearly. And I appreciate, Dr. Thompson, your response.

Thank you, Mr. Chairman.

Mr. CANNON. Thank you. Without objection, I think we will go

through another round of questioning.

Let me just followup on what Ms. Watson was just asking. What

rate of vaccination is that 90 percent figure you talked about predicated upon? In other words, what percentage of women and girls

does such an outlook presume will be vaccinated?

Dr. TRIMBLE. I am not sure where the 90 percent figure came

from. My impression is that we may well have said that the rate

of cervical cancer has fallen so dramatically in the United States

with the introduction of Pap smears, but I am not sure that we discussed in our testimony the projections for vaccine adoption and

implementation in the future.

Mr. CANNON. Thank you. Just along those lines, I am going to

ask a couple of questions that my colleagues wanted to ask but are

not here.

For the FDA, your testimony references cervical cancer only once.

This subcommittee informed your agency that we are very interested in issues that the FDA failed to address in our hearing on

cervical cancer last year. Your agency was provided with questions

that we expected to be addressed, specifically on the matter of the

agency’s failure to comply with Public Law 106–554, signed by

President Clinton in 2000, requiring that condoms be accurately labeled to reflect the fact that condoms do not protect women from

HPV infections. Why aren’t you addressing this issue?

62

Dr. PAZDUR. I personally can’t answer that issue. The condoms

are handled and the approval of condoms are handled by the Center for CDRH, so I do not have personal knowledge of that area.

We will provide to the committee a written response to this question within 5 days.

Mr. CANNON. Thank you.

Since Public Law 106–554 was enacted requiring accurate

condom labeling, more women have died of cervical cancer than

from AIDS among non-injection drug users. The FDA has still not

complied with this law. Can you tell this committee why it has

taken so long to act on this critical public health matter and require accurate condom labeling?

Dr. PAZDUR. Here again I will reference my previous answer,

that we will provide an answer to the committee in writing.

Mr. CANNON. Thank you. It is not a personal thing, but institutionally we did have a hearing, and we expect a response. Thank

you.

Now I would like to move on to other issues. Are any of you familiar with protein testing to identify whether a woman or, for that

matter, man has had HPV and which of the HPV viruses the individual has had?

Dr. TRIMBLE. There are currently approved by the FDA tests for

women to evaluate whether they have an active infection of HPV

and some subtyping of the various high-risk types is available for

that. In addition, we do have some serological studies which evaluate antibodies in blood that can show a history of HPV infection.

Mr. CANNON. Are those definitive; can you say to a woman you

have not had or you have had a HPV infection based upon those

studies?

Dr. TRIMBLE. Certainly the tests for active HPV infection does

have a false negative rate, so one would need to do a series of tests

over weeks to months to say for sure that a woman does not have

an active infection at this point in time. The serological tests can

fade over the years, so you may no longer have an immunological

memory of having HPV, although in one point in life you may have

had it.

Mr. CANNON. For you, Dr. Trimble, but also for CDC, it would

seem to be important that if you had a test that could identify

what HPV a person has had in his or her system, would that be

significant in the cost of identifying and treating people that may

have or get cervical cancer?

Dr. TRIMBLE. Certainly with the development of accurate HPV

tests, we have begun to study whether we should or could modify

the existing screening program so as to screen first with a HPV

typing and then only followup with Pap smears in people who were

found to have HPV infection. This might well work for women let

us say 25 and older in whom HPV is rare.

Among younger women, though, HPV infections are common, so

one would not want to start with a primary HPV screening test because there would be many false positives. And the vast majority

of individuals, both men and women, who are exposed to HPV

quickly resolve that infection and have no adverse health effects

from the HPV infection.

63

Mr. CANNON. But when you say no adverse health effects, doesn’t

it take years of the infection to create a cancerous lesion?

Dr. TRIMBLE. Well, we think that the average age of infection is

probably less than age 20, and the median age for diagnosing cancer is around 65. So, yes, there are years to decades.

Mr. CANNON. Thank you.

Dr. Thompson.

Dr. THOMPSON. We do currently, through CDC’s breast and cervical cancer screening program, provide for the use of HPV DNA

testing in certain clinical situations where it can be used as an adjunct to Pap testing. But at this point it has not yet been determined that it is a useful tool for across-the-board screening.

So we use it in very special circumstances, such as when a

woman has had a low-grade abnormality detected by a Pap smear.

And after a period of time she has had negative colposcopy, we can

then use HPV DNA screening and Pap screening to determine

what sorts of followup are necessary. So in some circumstances we

use it even today.

Mr. CANNON. You know, there have been some terrific transformations in science. I read 2 or 3 weeks ago in Time magazine

about Craig Ventner, who is traveling the world in a yacht and

testing the DNA set every 20 miles or so, and he is able to do this

because the cost of decoding DNA has fallen dramatically, from

about $10 a pair, when we started the Human Genome Project, apparently, now down to like less than a penny a pair to decode. So

it is cost-effective for him to do that even on his boat. And I think

there are new technologies that are going to bring that down by another order or two orders of magnitude.

It seems to me that this is an area where we need to change our

thinking about how we are looking at disease, because the cost of

decoding what is going on is so much, almost infinitely, lower than

it has been. Could the three of you respond to how your agencies

are dealing with the lowered cost of protein identification, DNA or

RNA and other proteins, and what that means for the future of

science? And what it might mean for complexity, how we ought to

start looking at these diseases in an environment of Abasian or

complex theory.

Dr. Trimble, Dr. Thompson, then Dr. Pazdur.

Dr. TRIMBLE. Well, certainly cost is an important issue. The

Gates Foundation, for example, has made a large contribution or

earmarked a large contribution of money to help develop inexpensive HPV diagnostic tests for use in the developing world. And we

have had some discussions with the Gates Foundation, as that research progress, as to whether we might be able to use some of

those inexpensive diagnostics in the public health sector.

At present, we only have a few tests which have been approved

by the FDA, and some individuals have commented that the prices

attached to them, prices placed on them by the companies which

market them, make them less than optimal for use in the public

health setting. But we obviously have no influence over the price

of a proprietary diagnostic.

Mr. CANNON. Thank you. I have a friend who complains that in

every other sector of the economy innovation means lower prices,

except in the medical sector, where prices skyrocket. That is an

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issue, but perhaps maybe the issue really is—and if I could skip

over you just for a moment, Dr. Thompson, because this is probably

an issue of most importance to you and what you are doing—but

what do we do about the cost of getting approval when the nature

of the ideas that are coming before the FDA is changing? In other

words, you know more about what you are dealing with when you

have decoded a protein than you do when you are dealing with a

substance which may be toxic, but it may also affect disease.

Dr. PAZDUR. I think what you are really talking about is a concept which we refer to as enrichment, and that could the fields that

you are referring to, proteomics and genomics, really identify a

population of patients that are more likely to respond to a therapy.

For example, if you have a DNA chip which identifies a subgroup

of cervical cancer patients or ovarian cancer patients that are more

likely to respond to a given therapy, that is a great step forward,

because obviously these drugs are toxic drugs, for the most part,

and you could spare people that have a very reduced chance of benefiting it from receiving drugs that they are not going to benefit

from. Likewise, you are going to select a group of patients that are

most likely to benefit.

Mr. CANNON. What you just said is perfectly agreeable, but what

I asked is slightly different. What are you doing at the FDA to encourage the identification of proteins and then your process for approving those proteins based upon what they are, as opposed to

what historically we have done with toxicity? In other words, you

may have a patient who responds better, as you have just pointed

out, because of proteins that he or she has.

On the other hand, you may have causative agents that you can

identify, like HPV viruses, for which you may have serological remnants, or you might have an active culture. What are you doing at

FDA to help speed up that process, where we are not dealing with

the likelihood of death, but we are dealing with the likelihood of

certainty that an agency is present?

Dr. PAZDUR. What we are doing in the area of genomics, we have

specific groups of people that are working on guidances on how this

data should be submitted to the agency. Obviously, this is an evolving field of science. So we are working with industry, inviting them

to come in, share their data with us. We are organizing conferences, discussing how this data will have an influence on subsequent clinical trials. We are well aware of the scientific advance.

It is an evolving science that has to really have a partnership with

the FDA and both the academic community as well as the commercial community.

Mr. CANNON. You call this an evolving area of science. It is not.

That is what you called a transition of understanding what germs

were over 100 years before we got vaccines that we actually understood why they worked. This is a revolution; this is an explosion;

this is a transformation. And what you are talking about is a process that makes it a lot more expensive and, by the way, impedes

the health care of Americans and people worldwide.

May I suggest that the FDA needs to think differently about

this? Because it is not the same as what has been, and much of

what has happened can be left up to practitioners who specialize

and who deal with the issues. So what I view the FDA here as is

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a big door, a big hurdle, a big cost increaser that needs some

thought.

I know you are thinking about it, but your answers are answers

that are in the context of a bureaucratic and outcome-oriented context, rather than how to help people’s health, which is what the

focus ought to be. You really need a transformation of thinking at

the FDA.

And I know you have done many things. I am a big fan of the

FDA. I have been a big opponent of reimported drugs and things

like that. But the FDA needs to evolve at a rate that is somewhat

maybe lagging, but at least near the rate that the transformation

in science is happening.

I don’t mean to lecture so much, but it is an area of deep frustration.

And, Dr. Thompson, clearly this is a matter of great importance

to you and your agency. Do you have some comments?

Dr. THOMPSON. Well, in public health it is really simple: the

lower the cost of a screening test or an intervention, the more people we can provide with the benefit of it. So it is up to our colleagues in the regulatory sector, in the research sector to develop

and certify these products, but once they reach our hands, the less

they cost, the more people we can serve with them.

Mr. CANNON. Thank you.

Mr. Burton, I have one more question, but did you want to ask

questions of this panel?

Mr. BURTON. I just have one question, but go ahead.

Mr. CANNON. Let me just point out what our discussion has been

and where I think, as a community, we need to be headed. Much

of the answering of the questions I have asked has related to controlled clinical trials, and I have continued to come back to what

a practitioner does with his patients and what his experience is,

and what we can accumulate from that process. It is a paradigm

shift. It is a dramatic paradigm shift, but it is a shift that makes

pretty significant sense, especially when you view the world from

the point of view of the tools we have that are capable of helping

us accumulate data.

Of course, I have to say my questions may have, at some times,

been harsh, and I apologize for that, but it is an awfully personal

thing. But your agencies are really wonderful agencies, and there

is no criticism of the agencies, it is just a road I hope you would

see to get to the next position. And all three of your agencies have

a piece of this and you are doing remarkable work, but the cost of

medicine is skyrocketing. The access to medicine is diminishing.

When I was elected to Congress, 65 percent of Americans had

employer-based health insurance; today, 45 percent of Americans

have that. And the answer is either we go to a controlled, socialized

single payer system, which 65 percent of Americans now want, by

the way, understanding that means socialism—as opposed to 45

percent when I first got elected; the numbers have inverted themselves—or we go to a system where the American way actually succeeds, and that is open markets, free access to information, choice

by consumers, choice based upon access to information. In some

cases that is a matter of cost; in the case of my daughter, it was

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a matter of life and death. It was an ignorant set of doctors who

prescribed badly, didn’t know what they were doing.

What happened to my daughter was an abomination, and it was

an abomination that I couldn’t fix. I mean, I am a Member of Congress; I was a Member of Congress then. I didn’t have access to the

information to figure out what was going on with my daughter.

Now, that has been ameliorated somewhat in recent times, but we

still have problems in that area.

Here, the three of your institutions are very different and represent different elements of the puzzle. But we have a huge cost

hurdle that is transforming the rights and choices of Americans in

a way that I think is wrong. So as you look at this, may I just suggest when a patient and his doctor or her doctor has access to information, they will make better decisions.

We have ways of massively expanding information, and one of

them, just to be thinking about, when we passed AHSEA, we had

2 million people in America that got involved in that act, that became activists. I suspect you have 5 or 10 million today, because

the number of people that are using nutritional supplements has

increased significantly. And if you go to the NNFA, which is the

National Nutritional Foods Association, Web site, nnfa.org, they

have an incredible presence. They reach many people.

And if the CDC said here is a set of questions we would like to

know about your health and here is how we will protect the data,

I suspect you would have millions of people who would respond. In

other words, if you think about how you get data, you can get it

much more cheaply than we have ever done before. The cost of obtaining data from individuals has plummeted, just like the cost of

decoding a DNA pair has plummeted.

So if you would think in those terms, I suspect you would see

that there are great opportunities for improved health in America,

for improved control by individuals of their health in America, and

for a system that protects without impeding, without causing death

and destruction, which in fact often happens with our medical system. That is probably not your fault, it is actually largely doctors

who are ignorant of what they are doing. But it would be nice to

allow patients to have some access.

And I have ranted here, but I would like you all to think about

that. We are going to followup with some written questions.

Now, Mr. Ruppersberger, I know that you are next, but I think

Mr. Burton only had one question. Would you mind if we go to him

for that question and then come back to you?

The gentleman from Indiana is recognized for 5 minutes.

Mr. BURTON. Thank you, Mr. Chairman. I will just be real brief

here.

First of all, I presume that you gentlemen would be supportive

of Johanna’s Law. That authorizes $15 million over 3 years for

public service announcements and $55 million over 3 years for

grants to establish local and national nonprofits and communitybased health centers to test different outreach and education strategies. I am sure you know all that.

Are our health agencies doing anything in this area right now?

Do they have any kind of an outreach program or educational program for gynecological cancers in women?

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Dr. TRIMBLE. The NCI does have an extensive educational program, both for the lay public as well as health professionals, focused on gynecological cancer. We work closely with our Cancer Information Service and the CDC in terms of disseminating that information.

Mr. BURTON. The reason I asked is when my wife was suffering

from cancer, I never saw any manifestation of that. Can you tell

me, real quickly, how much money is being put into that program?

Dr. TRIMBLE. I will have to get back to you with the amount of

money that we put into cancer information, but it is a large portion

of our budget and our activities.

Mr. BURTON. I would like to have that. Thank you.

Mr. CANNON. The gentleman yields back.

Mr. Ruppersberger. The gentleman is recognized for 5 minutes.

Mr. RUPPERSBERGER. Mr. Chairman, thank you.

There have been a lot of issues discussed here today. I think one

of the frustrations that we have sometimes in Congress is that we

raise some issues and then there is not implementation. And I

would hope that we could benefit from this panel, and I know that

the chairman feels very strongly about this issue because of some

of his unfortunate personal situations that we really implement

and move forward.

In order to avoid any repetition, there is one issue that I think

hasn’t been addressed, so I will just ask that to the panel and that

is all I have.

In the past, the NIH and CDC has found that there was evidence

that condoms can reduce the risk of cervical cancer, but there

wasn’t enough data to determine if condoms prevented the spread

of HPV. Earlier studies were insufficient to answer this question

because they asked people to recall past condom use, they didn’t

track people’s behavior over time or they didn’t know people’s STD

status before the study.

Now a recent study has addressed many of these issues. Researchers tracked young women over time and gathered precise

data on condom use and sexual behavior. The study found that consistent condom use reduced the risk of HPV acquisition among

women by 70 percent and reduced the risk of cervical HPV by 80

percent.

My question to anyone on the panel, if anyone has an opinion:

Do you think this is the kind of study that the FDA should take

into account when considering labels for condoms?

Dr. PAZDUR. Here again, I have not reviewed the study, but obviously I think we should take account of all information. I can’t

make a commitment to you on a specific study without obviously

seeing the data that is presented, but from your description of it

it is something that we would be very interested in looking at and

including into product labeling.

Mr. RUPPERSBERGER. I am not just saying looking at. I would

recommend that you look at the study and if we are going to have

momentum and move forward on this entire issue, I think these

are things that we just shouldn’t talk about at a hearing; we need

to get the research done and follow through.

Dr. PAZDUR. By ‘‘look at’’ I meant evaluate appropriately.

Mr. RUPPERSBERGER. And then deal with FDA.

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Dr. PAZDUR. Correct.

Mr. RUPPERSBERGER. Thank you.

Mr. CANNON. The gentleman yields back.

Mr. Issa, did you have further questions?

Mr. ISSA. Yes.

Mr. CANNON. The gentleman is recognized for 5 minutes.

Mr. ISSA. Thank you.

I would like to followup on a question Mr. Burton asked. If there

is a lot of money being spent on outreach, why is it that it doesn’t

get to the end of the pipeline? Because Johanna’s Law and this authorization for funding specifically is the result of an observation

that it doesn’t get to the end of the pipeline.

So where is it being spent if we can’t see it where we believe it

should end up? Is it just that it is being spent elsewhere or something? It is befuddling to both Mr. Burton and myself.

You could just not answer, and we will assume that is no, it isn’t

getting there, and we can move on. But go ahead.

Dr. THOMPSON. We can give you the figures as to how much CDC

spends on programs aimed at preventing or early detection in all

of the different kinds of gynecologic cancer. That is not going to answer your question, however; it will just tell you relative amounts

of dollars spent.

Our focus at CDC has been primarily on provider and patient

education, but it has been limited. It has been limited primarily to

demonstration projects trying to gain a little more knowledge about

how we can most effectively use those dollars. We do not yet have

a large-scale campaign that is population-based and nationwide. It

has been very focused.

Mr. ISSA. So, following up, should this bill become law, it would

enable you to take that next step; certainly not nationwide, but it

would give you the tools to do that, is that correct?

Dr. THOMPSON. Certainly from the standpoint at CDC, legislation

that provides resources to expand our programs would give us the

opportunity to expand them. But, at this point, HHS currently has

not established a position formally on this particular piece of legislation, but its provisions and the concepts embodied in it are certainly those that I think we could all support.

Mr. ISSA. OK.

I would yield to the gentleman from Indiana.

Mr. BURTON. Let me just say that I watch old movies and stuff

on television, and I see advertisements and stuff all the time, public service announcements saying, you know, prostrate cancer is a

growing thing; gentlemen, get tested for that. And I just can’t understand when I never—and when my wife was suffering from cancer, I never saw any ads, never saw any public service announcements, never saw anything.

And I was just talking to this young lady back here, who is a

cancer survivor, and she says she has a master’s degree, and when

she tried to go to the Web site to find information about the cancer

she was suffering from, she and her husband, they had to go

through all kinds of hoops to get the information. And it seems

that if our health agencies have money in the pipeline to educate

the public about these various forms of cancer, it would be manifested in television ads or newspaper ads.

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I just saw this ad in the Roll Call magazine that was paid for

by Angelina Jolie. You know, it just seems people would be educated to know, especially about the kind of cancer that is not readily discernible.

I mean, if you guys are spending money on telling people about

this, I sure haven’t seen it, and my wife died 3 years ago. So I

would just like to know, if you are spending the money, where in

the world is it going?

Dr. TRIMBLE. We would be happy to get you the information on

the budget that NCI spends on educating the public and professionals about gynecologic cancer. But, nonetheless, the size of that

budget is substantially less than that of, say, what major corporations use to promote new products. So in many cases we can’t afford to buy TV time on national network TV.

That said, I think we make a very energetic effort to make sure

that our Web site is as comprehensive as possible; that we have

publications which are available in low literacy form, both in

English and Spanish; that we have a 1–800–4-CANCER number

with cancer information services available around the country that

can help people find appropriate care, to find clinical trials, to find

contact for support organizations.

We know we need to do more, but we have developed a close

working relationship between NCI and CDC, between NCI and

CDC and the professional societies and advocacy groups so that we

can multiply our investments and make sure that the information

gets as widely as possible.

Mr. BURTON. Well, let me just say that maybe you need to hire

an ad agency or somebody to come up with some ads that could be

put in public service announcements so people could be made

aware of these things. My wife was misdiagnosed, and I think it

was because even the doctor didn’t have the kind of educational

background to tell her what she should do.

I just think if we are spending money in that area, and I hope

we pass Johanna’s Law to help augment this, but if we are spending money in that area, we ought to make sure the public can see

it in one way or another. So you should just take that back as a

recommendation. And I would like to see, if you could send it to

us, a list of the ways that you are spending the money to inform

the public, because I haven’t seen it, and I would like to see it.

Thank you.

Mr. ISSA. Mr. Chairman, I would ask unanimous consent for 1

additional minute.

Mr. CANNON. Without objection, so ordered.

Mr. ISSA. Mr. Chairman, I would yield to you for that minute.

Mr. CANNON. Thank you. If the gentleman would yield back, I

will just make my final comments. The gentleman yields back.

Thank you.

Mr. Trimble in particular, but others, have any of you been involved with the rulemaking relating to making federally funded

studies available? That is an issue for another time and another

panel, but of course goes right to the heart of access for information.

Just a final question. Actually, we want a commitment from each

of you on behalf of your agencies, so you have to be careful. You

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are not limited to what you are able to actually do, but you know

your internal circumstances. FED has made some commitment

along these lines that I am sure you are aware of.

I want from each of you a commitment, those of you who can give

it, on behalf of your agencies that you will work together and with

Congress, with my office, to work on the issue of making more information available, developing databases that appropriately can

have information available to doctors, researchers, and others, especially in the context of the lowered cost of database access and

the lowered cost of protein decoding.

If we could start with Mr. Trimble, whatever you could commit

to, I would appreciate.

Dr. TRIMBLE. Well, I know this is a high priority of Dr. von

Eschenbach, our Director, is making information more widely available, as well as building on the Nation’s expertise in informatics.

And as part of that he has established a cancer bioinformatics

project called CIBIG. And I think that there are a number of components to that, but one of them would include the emphasis that

you, Congressman Cannon, have put on, in terms of gaining data

from the way an individual doctor, an individual patient, their experiences so other people are aware of that and can learn from

that.

Mr. CANNON. Thank you. I appreciate the clarity of that commitment. I actually spoke to Dr. von Eschenbach about this. I believe

that he clearly understands the benefit of capturing data from

practitioners. So I appreciate that.

Dr. Thompson.

Dr. THOMPSON. As I mentioned earlier, the Department of Health

and Human Services is already solidly behind the development of

an electronic patient record which would facilitate many of the

things that you are describing. At the level of CDC, our commitment to this is, I think, demonstrated best by the establishment

only a few months ago of a new center called the National Center

for Public Health Infomatics, which will address this and other

needs for health information to be more readily collected and more

readily available.

Mr. CANNON. Thank you. And I assume that includes also a commitment to work with other agencies and to get clinical information

from practitioners available to others.

Dr. THOMPSON. Yes, sir, it does, particularly the electronic medical record effort is one that is cross-cutting throughout the Department of Health and Human Services, and all of the divisions of the

Department are potentially involved in this.

Mr. CANNON. Thank you.

Dr. PAZDUR. As I stated in my testimony, we have an Interagency Task Force that is a joint effort between the FDA and the

NCI, and I think that this is an excellent project for that task force

really to capitalize on. It is not solely an FDA problem; it is not

solely an NCI problem; it is not solely a CDC problem; but something for us to work on together. And I think that task force provides at last a framework to begin the process that you have outlined.

Mr. CANNON. And is this a fairly substantial commitment on the

part of FDA, from your perspective?

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Dr. PAZDUR. Yes, it is.

Mr. CANNON. Thank you.

I find myself sitting here frowning through this hearing. That is

because this is a rotten subject to be talking about, especially if you

have had the kind of loss that Mr. Burton and I have had. And I

hope that frown has not been viewed as negative. What your institutions are doing is incredibly important. You are remarkably effective. We don’t want to change the world, but we want to help you

all adapt and we want to create the legal context for that adaptation.

Let me just say finally, before we leave, Mr. Rosenfeld, would

you mind raising your hand? This is a molecular biologist over

here, a friend of mine and a brilliant human being. You may want

to meet him as you go out and get his card, or stay and listen to

his testimony, which I think is going to be remarkably interesting.

He was a molecular biologist before I think that was popular, and

has been a leader in some of these areas, particularly in cervical

cancer and the identification of proteins related to that.

So, with that, unless there are further questions, we appreciate

your time. This panel is dismissed.

If we could have the second panel join us.

We had a question from a witness regarding the appropriateness

of videotaping, that is, a family member videotaping the testimony.

Without objection, the chair is inclined to allow that. So, without

objection, so ordered. The family may videotape the hearing.

And, if you would like, without objection, Ms. Silver, you can

have her put a chair up here so she can videotape the table, if you

would like. Without objection, so ordered.

All right, now, if we could have you raise your right hands.

[Witnesses sworn.]

Mr. CANNON. The clerk will note that all members of the panel

have nodded in the affirmative.

We will just go member by member, starting with Dr. Karlan.

We appreciate your being here, and you are recognized for 5 minutes.

STATEMENTS OF DR. BETH KARLAN, PRESIDENT, SOCIETY OF

GYNECOLOGIC ONCOLOGISTS; DR. MARK JAY ROSENFELD,

SCIENTIST/RESEARCHER; SHERYL SILVER, SISTER OF JOHANNA SILVER; AND KOLLEEN STACEY, OVARIAN CANCER

SURVIVOR

STATEMENT OF DR. BETH KARLAN

Dr. KARLAN. Thank you, sir. Chairman Cannon and members of

the subcommittee, thank you for inviting me to testify at today’s

hearing. I am honored and heartened by the interest of this subcommittee in this important issue.

My name, as you heard, is Beth Karlan, and I practice medicine

at Cedar Sinai Medical Center in Los Angeles. There, I am the director of the Women’s Cancer Research Institute, the Division of

Gynecologic Oncology, and the Gilda Radner Hereditary Cancer Detection Program. I am also professor of Obstetrics and Gynecology

at the UCLA Geffen School of Medicine.

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This year I was elected to serve as the 37th president of the Society of Gynecologic Oncologists [SGO]. Our organization’s purpose is

to improve the care of women with gynecologic cancer by encouraging research and disseminating knowledge. Our overall effort is focused on raising the standards of practice in the prevention and

treatment of gynecologic malignancies through cooperation with

other organizations that share our interest in women’s health care,

oncology, and related fields. SGO members make us the leading organization of gynecologic oncologists in the United States.

At the outset, I want to clearly state my belief that Congress can

take action that in the immediate future will save the lives of thousands of women. Today in the United States, one women will be

diagnosed with a gynecologic cancer every 7 minutes. That is over

200 women just today and close to 80,000 women this year. If detected early, a majority of these cancers can be cured.

But, frankly, many women don’t know what symptoms to worry

about and, therefore, they are unable to ask the right questions of

their health care providers. Complaints such as bloating, abdominal or low back pain, or constipation may bother all of us occasionally. But when these symptoms are persistent and progressive for

as little as 2 weeks, they should alert a woman to see her physician

and ask about gynecologic cancer. With the help of the Federal

Government, we can make this happen. We can make this happen.

I would like to bring to your attention H.R. 1245, the Gynecologic

Cancer and Awareness Act of 2005, commonly referred to as

Johanna’s Law. This legislation would serve to increase the education and awareness about the early warning signs of gynecologic

cancer. That is the purpose of Johanna’s Law: so no woman has to

face a diagnosis of gynecologic cancer late in her disease just because she did not know the associated symptoms, risks, or where

to turn.

As a clinician and surgeon, I can recount hundreds of stories of

women who came into my care too late because they did not recognize the warning signs their bodies were sending to alert them to

the presence of cancer. These anecdotes, however, are validated by

a recent poll of 800 women across America that was conducted by

Research America in conjunction with SGO’s foundation, the

Gynecologic Cancer Foundation. This poll surveyed women about

their knowledge of gynecologic cancers and is submitted as an attachment to my written testimony.

Here are just a few of the astonishing statistics: 47 percent of

women surveyed could not name one symptom of a gynecologic cancer, not one; and almost 60 percent of women surveyed could not

name one step they could take to decrease their personal risk of developing a gynecologic cancer.

Mr. Chairman, these statistics do not lie. We need to make a difference, and we can make it now. We have achieved much, but

women are still dying. Congress’s commitment to expanding the

boundaries of medical research has been a vital weapon in our war

against gynecologic cancer, and for that we are immensely grateful.

However, there is still a tremendous gap between the science and

the realities of clinical care. All of our scientific advances are useless if women do not know when, where, or how to access care.

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Representatives Issa, Levin, Granger, and DeLauro have introduced Johanna’s Law, which is cosponsored by many members of

this committee. In fact, there are now 221 co-sponsors of this important legislation. Under Johanna’s Law, the Department of

Health and Human Services would conduct public education and

awareness programs to get facts about the early warning signs of

gynecologic cancer into the hands of women of this country.

I cannot over-stress the importance of arming women with the

basic facts about gynecologic cancers. Education is our front line

defense in the battle against these killers of women. Your support

will make this education and awareness possible.

Once again, thank you for the opportunity to testify here today.

I am constantly inspired and humbled by the strength and determination shown by women with cancer who are just trying to survive. I believe your leadership on this issue will give even more

women the full lives they so richly deserve.

Thank you, and I look forward to answering your questions.

[The prepared statement of Dr. Karlan follows:]

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Mr. CANNON. Thank you, Dr. Karlan. Among those women are

my five remaining daughters and wife who appreciate your testimony, and there are some startling statistics there.

Dr. Rosenfeld, you are recognized for 5 minutes.

STATEMENT OF DR. MARK JAY ROSENFELD

Dr. ROSENFELD. I am grateful to the subcommittee for the opportunity to discuss my professional experiences and opinions on

progress against gynecologic cancers. I come from a different perspective than most here. No. 1, I am a researcher; No. 2, most of

my work has occurred not only in the United States, but the bulk

of it in places like China.

Given the time constraints, I have made much of my presentation a written one, and covers such issues as the financial incentives that perpetuate inefficient and costly diagnostic methods; the

need for disruptive or analytic or diagnostic technologies to achieve

pervasive high-quality and inexpensive medical care; and whether

cervical cancer vaccines can actually achieve significant use in our

lifetime.

Perhaps not an intended topic at this meeting, but the ways in

which we have pursued cancer for several decades have, over all,

been a failure, in my opinion. There have been some clear successes. With the possible exception of Pap smears, gynecologic cancers are not blatantly prominent among these. Perhaps the greatest

improvement, as actually has been mentioned, has been treating

childhood cancers. Overall, our inability to lower the cancer death

rate, despite expensive efforts spanning more than 35 years since

the war on cancer began, shows the need for major change in strategy.

I am now going to somewhat digress—although it is in my written presentation—digress from what I had originally prepared because of comments made by people. For example, Dr. Thompson

talked about the 2.9 million Pap smears that had been done to

achieve the finding 1,500 patients with invasive cancers. That is

great, because that cost $75 million and an average of $40,000 to

$60,000 to find each of those cancers.

Now, I am happy that these people were discovered. I hope that

they were treated; I hope that it was successful. On the other hand,

that is a lot of money. And it is a lot of money that if we could

be more efficient in terms of the way in which we pursue our medicine and the way in which we pursue our diagnostics, then we

could reach more people.

This gets into questions such as we discussed a few minutes ago,

or actually throughout this entire proceeding, and that is how do

we reach people? We can only reach people if we have the kind of

technologies, if we have the kind of methods that will allow us to

reach them for a good economic price. Most of the democratic side,

in fact all are not here right now, but, on the other hand, they had

talked literally about that, the black community, and reaching the

black community.

I talk in my written work about the financial incentives that perpetuate inefficient and costly diagnostic methods. Look at the Pap

smear industry. It is a $7 billion industry. I am not condemning

Pap smears. But if something new, something revolutionary, someVerDate 11-MAY-2000 13:12 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00082 Fmt 6633 Sfmt 6633 D:\DOCS\26657.TXT HGOVREF1 PsN: HGOVREF1
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thing disruptive came along—and there are those things on the horizon as we speak—how do we contend with that? These people are

making a living.

So either consciously or subconsciously, they are going to buck the trend because they are spending $2 billion per gynecologic

exam in this country that leads to a Pap smear. There is $1.2 billion being spent on average each year now for Pap smears alone.

When you have a Pap smear that is questionable, you go to colposcopy. Colposcopy is a microscopic examination of the cervix; $3.6

billion is being spent there. Yet, over 80 percent of colposcopies,

fortunately for the patient, show that the patient has nothing

wrong. We just spend over $2 billion for nothing, in a sense.

Things need to be done. There is a need for disruptive technologies. Bringing down costs is mandatory. We have to shift in a

grander way to earlier detection and treatment. This is something

that I push very aggressively in China.

And I think that if you look at the war on cancer, speaking more

generally, but also to gynecologic cancers, we have to concentrate

more on less advanced states, where treatment effects may be better. For example, when we go to FDA approval and we are looking

at a new drug, what is happening with a new drug is that, typically, the patient that is being treated is the sickest patient.

Now, I am not saying sick patients should or should not be treated, but the sickest patient with a drug is oftentimes a patient that

won’t respond anyway; and maybe a person who is not as sick

could benefit more from that drug. This is something that really

needs to be looked at very, very seriously.

In any case, I am rather passionate about changing the system,

and hopefully during my question and answer period I can help you

in terms of what else I have to offer. Thank you.

[The prepared statement of Dr. Rosenfeld follows:]

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Mr. CANNON. Thank you for recognizing the light. We probably

wouldn’t have tapped you silent, given the kind of information you

were giving, but we will come back, I can assure you, with questions to give you more opportunity to explain some of these things.

Ms. Silver, you are recognized for 5 minutes.

STATEMENT OF SHERYL SILVER

Ms. SILVER. Thank you so much, Mr. Chairman, for your leadership, for holding this hearing today, for your passion for this issue.

I am so sorry for your loss, and I express my deepest condolences.

And to so many of you on this committee who have also been personally touched by cancer and who have led this fight for us, we

are so grateful to you, Mr. Issa, our lead sponsor in the 109th Congress; to Mr. Burton, who has been such an advocate for us; Mrs.

DeLauro; Mrs. Granger; and, of course, Mr. Levin, the original author of Johanna’s Law. We are just indebted to all of you for taking

up this fight for us, and for millions of American women at risk.

That is really the issue here.

And as the person who first proposed Johanna’s Law, I suppose

I should give my name: Sheryl Silver. I am the founder and president of Johanna’s Law Alliance for Women’s Cancer Awareness.

Most proudly, I am the younger sister of Johanna Silver Gordon,

after whom this legislation is named.

I feel a responsibility on behalf of millions of grieving family

members in this country who have lost hundreds of thousands of

their mothers, sisters, daughters, and other loved ones, to sound an

alarm today. I know everyone in this room is supportive, and we

are grateful for that, but there will be many who read and hear

this testimony.

So I want to go on record today as saying we have a national

tragedy that is not being addressed adequately. Unlike the tragedy

of September 11th and Hurricane Katrina, which thankfully have

only happened once in this Nation’s history, this is a tragedy that

is going on year after year in this country, as we lose, this year,

nearly 30,000 women to gynecologic cancers. Nearly 10 times the

number of Americans we lost on September 11th we are now losing

every single year.

In just the last 10 years we have lost over 250,000 of our mothers, sisters, daughters, and other loved ones. Although we are

grateful for its progress and absolutely for the 221 cosponsors in

the House, the time to act is now. In just the nearly 3 years since

I proposed it, over 75,000 more women in this country have run out

of time, run out of medical options and died, and left behind millions of us grieving for the rest of our lives.

And what magnifies the tragedy of these deaths, and all of them

from these cancers, is that they are not inevitable. A diagnosis does

not have to be a death sentence, as we have heard today. Diagnosed at the earliest stage, ovarian, uterine, and cervical cancer—

which account for over 90 percent of all new diagnoses in this country every year—these three cancers all have 5 year survival rates

greater than 90 percent, with women diagnosed early commonly

going on to live normal, long, healthy lives.

And yet thousands of women, tens of thousands are diagnosed

after this earliest stage every year in this country. With ovarian

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cancer, the problem is particularly common. Eighty percent of

women are diagnosed after the cancer has progressed to more advanced and less survivable stages.

And a common ingredient in those late-stage diagnoses are the

delays that occur simply because women don’t recognize or know

the symptoms of the disease or its risk factors, and so are not seen

quickly enough, appropriately enough. This is exactly the lifethreatening information gap that contributed to my sister’s late diagnosis and death.

Despite being the daughter of a physician, the sister yet of two

other physicians, and a health-conscious woman who saw her gynecologist annually for pelvic exams and Pap smears, who ate nutritiously, exercised regularly, did everything she knew of to live a

long, healthy life, despite that, the one thing my sister did not

know is that persistent heartburn, bloating, and constipation were

common symptoms of ovarian cancer. She assumed they were to do

with a minor gastric problem. She took antacids.

When the symptoms persisted, she made an appointment to see

a gastroenterologist; waited several weeks as a new patient for that

first appointment, never thinking the delay may be life-threatening. And by the time she saw her gynecologist and appropriate

tests were performed, she was immediately scheduled for major

surgery that led to the shocking diagnosis of stage 3C ovarian cancer, of only four stages, a late stage. She was only given a prognosis of 12 to 18 months to live; and with aggressive surgery, multiple surgeries, treatments, chemotherapy, different kinds of chemotherapy, clinical trials.

We searched for everything. She went to leading cancer centers,

she had great insurance, access to care at UCLA, MD Anderson.

But nothing helped because she was diagnosed so late. And she

spent the last 8 months of her life tethered to an IV pole for her

basic nutrition and hydration, and eventually pain medication 24

hours a day to dull her agony. This is a horrible way for a dynamic

and loving and health-conscious woman to lose her life.

But we are not here because my sister was an unlucky, uninformed woman. I didn’t propose Johanna’s Law 3 years ago because

of that. I proposed it because this tragedy is happening day after

day, year after year in this country, unchecked. And whatever we

are doing, it is not enough, because the death toll from this group

of cancers is not going down.

Two years ago the death toll from ovarian cancer went up. It

may go up further as this population ages. Our Nation is an aging

population, and women over 50 are at higher risk for both ovarian

and uterine cancer. So we have to do more to improve early detection and develop better treatments, all of it, or else we will see this

death toll continue to climb.

Last week—I am going to also cut my testimony short. I am already over that time. Let me just say the following, and I will submit, if I may, my written testimony in its entirety.

Last week our President said the Federal Government’s job is to

save lives because every life is precious. I absolutely agree. And we

have already lost too many of our precious mothers, daughters, sisters, and other loved ones and dear friends, simply because they

didn’t get the information in time.

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This is not the behavior of a compassionate Nation. We know

that acting quickly can spare needless suffering, just as we know

that acting quickly in the wake of Hurricane Katrina—and this

Congress can move quickly when it needs to, as it did last Friday

in granting major funding for relief. We know that moving quickly

in the case of natural disasters will spare needless suffering and

death.

And the coalition of doctors, nurses, cancer survivors, and family

members who have advocated for Johanna’s Law these last 2 plus

years, we do it because we all believe that we can improve early

detection; we can save lives by educating women. They will take action given the facts.

So I beg this Congress, we have the best chance we have ever

had because we have over half the members already co-sponsoring.

Please let the legacy of the 109th Congress be that in addition to

responding to the challenges of terrorism, homeland security, natural disasters, and other challenges facing this Nation, this was the

Congress that finally took the action so long needed and created

the urgently and desperately needed program of gynecologic cancer

education.

By doing that you will not only save lives by improving early detection, you will finally give a measure of healing to millions of us

in this country who grieve the loss of our loved ones and who will

know, by the existence and the passage of Johanna’s Law, that our

loved ones did not suffer and die in vain, but that their stories and

our retelling of their tragedies have finally been the catalyst to create this long overdue and urgently needed national program of

gynecologic cancer education.

I thank you for your patience and indulgence. Thank you.

[The prepared statement of Ms. Silver follows:]

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Mr. CANNON. Thank you.

Ms. Stacey.

STATEMENT OF KOLLEEN STACEY

Ms. STACEY. Good morning Chairman Cannon and committee

members. Good morning Mr. Burton, my Congressman. I want to

thank you, Mr. Burton, for everything that you have done for me

as a survivor. I am very honored to be here to speak to you about

something very dear to my heart, Johanna’s Law.

Last year I went to an advocacy training meeting and I heard

Sheryl Silver speak about her sister Johanna and her motives for

Johanna’s Law. That speech gave me hope that some day something will be done to make women and health care professionals

more aware of the signs and symptoms of gynecological cancers.

Sheryl, I want to thank you for taking the initiative to propose

a bill long overdue.

Johanna’s story and mine were so much the same that it gave

me cold chills. Unfortunately, thousands of other women have the

same story, caused in great part by a lack of knowledge of the

symptoms of ovarian cancer. The need for education and awareness

is crucial. Johanna’s Law will provide that campaign that will definitely save lives.

For the last 8 years I have suffered through numerous surgeries,

reoccurrences, countless hours of chemotherapy and radiation.

Why? Could this suffering have been prevented, or at least lessened?

I learned, after diagnosed, that I had all the symptoms. I wasn’t

aware that indigestion, heartburn, pressure on the bladder, unusual bleeding were symptoms of ovarian cancer. Nor did I know

that a Pap smear didn’t screen for ovarian cancer. I visited doctors

for each one of those symptoms, but no one put it all together.

It took an entire year for me to be diagnosed correctly. By then

the cancer was stage 3C, an advanced stage of ovarian cancer, with

only a 38 percent chance of a complete cure. Had it been discovered

in an early stage, I would have had a 90 percent chance of complete cure.

Today, 8 years later, nothing has changed. I still meet with

women who did not learn about the signs and symptoms until after

diagnosed. Together, Congress, we can do this. We can educate people until scientists come up with an early detection test.

I may look good to you today, at least I hope so, however, that

hasn’t always been the case. Time won’t permit me to go into all

the details of my experiences over the last 8 years, but let me tell

you what I have gone through just this year alone. I had a PET

scan last December that showed a tumor in my lymph node in my

neck. Surgery was scheduled for January to remove the tumor.

It turned out to be much worse than the doctors expected. On

January 7th I woke up with incisions up and down my neck, stapled. I had two drainage tubes coming out, six radiation catheters,

all hanging out my neck. I could tell people were frightened to look

at me. They were shocked by the way I looked. My friend said, you

have a good Frankenstein look going, Kolleen.

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Then I saw the fear in my family’s eyes and I was immediately

scared too. I was then told that my cancer had spread, and the surgeon had to remove two nerve clusters and my juggler vein.

Just 4 weeks after surgery and radiation treatments, a followup

PET scan was done. My cancer had spread again. We had no choice

but to be aggressive with treatment. I just finished chemo 2 weeks

ago. I felt like giving up. This isn’t fun.

My family is tired of seeing me with pain. I live with a terrorist

every day. I have multiple side effects that will be with me the rest

of my life. My quality of life has dramatically changed. I have an

equilibrium problem that makes me unable to walk in the dark.

I have numbness in my feet and hands, continuous pain, constant fatigue, and I was forced to go on disability. Being on disability affects my pride. This year, the 8th year, I wanted to give up,

but I knew I could not. I have to fight for my family and for other

women that are going through this horrible experience. Cancer

isn’t just a physical condition, but also an emotional roller coaster

for me, my family and my friends. I could not have done it without

their love and support.

In closing, I would like to leave you with a feeling of hope. As

children, we hope to grow up to be big and strong. As adults, we

hope to be healthy and live a long, happy life. If we are not

healthy, we hope that our experience will help the people around

us to make the right decision.

Congress, by passing Johanna’s Law, each of you has a chance

to make the right decision and give hope back to me, to women,

and grieving families that have been victims of this deadly disease.

This year, 28,000 women will die from gynecologic cancers.

Thank you.

[The prepared statement of Ms. Stacey follows:]

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Mr. CANNON. Thank you, Ms. Stacey. It is hard to believe all that

by talking about it or hearing about it. Thank you for sharing that

with us.

My sense is that we are going to make great progress with

Johanna’s Law. I am pretty sure the House will pass it. Unfortunately, we had to pass the bankruptcy bill eight times before the

Senate got around to it. In this case we may have more. I think

there is some kind of prohibition against speaking ill of the other

body, so let me just say we have high hopes that they will be reasonable on this issue and move relatively quickly.

I view Johanna’s Law as part of a larger context. You were all

here and listened to me talking with the people that control the

purse strings in America for much of what is going on here and

control, to a large degree, the research, so I would like your comments as we go through this on that research.

But, Dr. Karlan, if we could start with you. You are a practitioner. You run a research institute. You are one of those people

that is—I think most doctors really view themselves as scientists

anyway. But you really straddle both worlds; you treat people and

you run a research institute.

Can you comment on what we talked about, what the earlier

panel dealt with to some degree, about the role of practitioners,

what it would mean to health care generally if we had access to

more information from practitioners and their patients as to treatments, and how best practices could be spread and how new ideas

could be generated? Is that something you have thought about and

would you like to comment on that?

Dr. KARLAN. I clearly thought about it in the last 2 hours during

this panel, but I think previously we at times exchange the anecdotal observations that you described so clearly earlier with regards to your daughter’s response on the MRI to her Chinese herb.

I think sharing those observations are often seminal on the research side of things. One takes that observation and then asks

how and why, as well as sharing it with others.

I think that the information system that you described is one

that we do colloquially in our communities, we do it through the

society at our annual meetings where we talk about our patient experiences or the amazing survival or the things we have seen, and

exchange those stories. I think an information database as you described could perhaps allow us to collate those anecdotes, begin to

make observations that would have better power by seeing are they

consistent or is it anecdotal to that person’s immune system or

other aspects of her genetic makeup, and then translate that. As

a clinician-scientist, I look at those observations and try to understand the molecular biology as to why they occurred.

So, yes, that type of information, where every single patient, and

not to at all make patients’ experiences and take it out of the

human nature, but allow those data points to be captured so we

can learn more and more from every single patient’s experience, because I do think that is going to be our future. But individualized

care, molecularly directed and targeted care, and we are going to

need those data, that opportunity to move that forward.

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Mr. CANNON. Are you familiar at all with complexity theory or

Abasian statistics? That is a mean question, but I don’t mean it to

be.

Dr. KAPLAN. Not in any great detail, sir.

Mr. CANON. But from your point of view, having dealt with many

patients and with clinical studies, you get the sense of how, if you

had much data, you could sort that and bring a great deal of decision-enhancing information to bear on any given patient.

Dr. KAPLAN. Absolutely.

Mr. CANNON. Thank you.

Dr. KAPLAN. I think that is what we are all dealing with now

with genomics, proteomics, that we have enormous amounts of

data, but we need to mine that data so that we find those gold

cores, that ore that allows us to see the light, see how the dots are

appropriately connected. So we need all those patient——

Mr. CANNON. Exactly. That is exactly it. Thank you.

I wish the prior panel were all here. Thank you for staying with

us.

But, yes, thank you, that is exactly the point. And while I suspect all doctors may not be as smart or as attractive as you, almost

all doctors actually care about their patients and want to see better

processes, better treatment, better devices available for their

health.

And in the case of my daughter, by the way, there were like 100

studies, animal studies on the artemisinin that we used that

showed pretty dramatic success. But no bridge from those studies

to practice. How do you dose a human being? Whether that drug

would have worked or not, I don’t know. There was some obvious

evidence that it was working to some degree, but we are not building at all on that experience for other people who have this or similar diseases, despite the fact that there are some really very powerful, profound studies out there with animals, and yet no opportunity to translate that to others.

Thank you very much, Dr. Karlan.

Dr. Rosenfeld, we have talked somewhat about some of these

issues. Do you have other things you wanted to talk about in response to the other panel, or would you rather that I ask you questions?

Dr. ROSENFELD. I am used to questions from you. Ask me a question.

Mr. CANNON. You talked about disruptive technologies in your

presentation. And clearly, with the earlier panel, we talked about

the effect of the disruptive technologies that have resulted in a

much lowered cost of identifying proteins. Can you talk a little bit

about what has happened in that field, where we are headed, and

what that means for patients in America? Ms. Silver talked about

250,000 mothers and sisters in America. We are talking 20 or 30

times that many people worldwide. So if you would talk a little bit

about what progress in America means to the rest of the world, I

would appreciate that also.

Dr. ROSENFELD. Sure. Disruptive technology actually has its own

definition, it is an innovation that, due to its revolutionary nature,

can actually replace an existing or dominant technology. We already know of those things in other contexts. For example, everyVerDate 11-MAY-2000 13:12 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00103 Fmt 6633 Sfmt 6633 D:\DOCS\26657.TXT HGOVREF1 PsN: HGOVREF1
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body knows what a CD is. My kid doesn’t know what a vinyl record

is. So a point made there.

A disruptive technology oftentimes, also, if you read, for example,

Clayton Christianson, who has written extensively about that, from

the Harvard School of Business——

Mr. CANNON. And a good Utah boy, I might add.

Dr. ROSENFELD. You better believe it. You can tell I am from

Utah too.

A disruptive technology oftentimes also does several things. No.

1, it very frequently brings down costs. An example that comes to

mind, of course, is the computer industry. You get a lot more bang

for the buck today from a computer than the little 8088 that I

bought in 1981.

In any case, disruptive technologies are also interesting in the

sense that they have odd origins. Oftentimes they don’t come from

academia. For example, the CD, although it was from an MIT professor, it actually came through a private enterprise route. And the

reason is that academic institutions are oftentimes interested or

follow down a path which are called evolutionary technologies; that

is, you build A to B to C of the same technology. Where a disruptive technology is a revolution.

Now, with that in mind, what is on the horizon, what is actually

working now? And please realize that I am very, very interested in

health care delivery to rural populations, to developing nation populations. So, from my perspective, I want to see people everywhere

get the kind of health care that is only affordable now at some of

the big medical centers or the big reference laboratories.

But with regards to, for example, DNA and DNA analyses, right

now the current methods used to look at, for example, PCR DNA

to look at human papillomavirus in a laboratory, to set up that laboratory would cost you $100,000 for the device alone. Set up the

lab and so on, you are in for another $100,000. You have to run

it with specially trained personnel, etc., etc., etc.

There is now disruptive technology that will allow that same

DNA analysis to be done on a device that would retail probably for

a couple hundred dollars, for chemistries that will allow you to do

this for a couple pennies per patient. And that is the kind of disruptive technologies I am talking about. These technologies will

allow you to do things anywhere.

Mr. CANNON. So the common lab today, a current lab with PCR

technology, it costs something like a penny a pair to decode?

Dr. ROSENFELD. Well, it is not a penny a pair, but by the time—

I can actually, if you want me to produce this, I can actually give

you a spreadsheet; I have this broken down. But to do a patient

in a laboratory with all costs right now would probably cost in the

neighborhood of tens of dollars to do an analysis: do you have HPV;

do you have ovarian cancer. Those kinds of things would cost a lot

of money. And what I am talking about is now the technology is

in place for doing this for pennies; and away from offices and away

from laboratories.

Mr. CANNON. And when you say pennies, you are talking about

the whole analysis, not each pair.

Dr. ROSENFELD. Yes, I am talking the whole analysis.

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Mr. CANNON. So if you are decoding several pairs, you are talking about a fraction, a very small fraction of a penny per pair.

Dr. ROSENFELD. In fact, there is a meeting tomorrow at Johns

Hopkins University in that regard I will be participating in.

Mr. CANNON. So what does that mean for the FDA or for the

CDC or for NIH or for the National Cancer Institute in terms of

this massively plummeting cost of decoding proteins in comparison

with what should be available to Americans and the rest of the

world in terms of treatment? What should happen? How should

that transformation drive treatment technology?

Dr. ROSENFELD. Well, I mean, it is obvious. If it is disruptive

technology that has brought down cost, we should be able to deliver

whatever that is to the patient for cheaper. So, for example, if it

is to diagnose cervical disease, I should be able to diagnose cervical

disease for a couple of dollars instead of tens of dollars.

And, by the same token, if we are talking, though, the FDA,

CDC, I don’t hold them blameless, but the FDA, with regard to

that bureaucracy, they are going to have to start looking at things

differently. Things have to be done differently, because I don’t

think we can afford not only to neglect new technology, but we

can’t afford to approve technologies the way in which our infrastructure is set up as we speak.

Mr. CANNON. We have three people who have had a daughter or

a wife or a sister die of cancer here in the group and a cancer survivor with us, and we are talking about clinical testing and protocols that get set at a high level, when what you are telling me is

we have now in place technology that enables a physician at the

lowest level to be doing things that could only be done at the most

expensive labs on Earth less than a decade ago.

Doesn’t that seem to you—in fact, you, in your earlier testimony

said something—I made a little note somewhere. You are fairly

critical, I think, of the FDA and its reaction, and I suspect that the

key here is the historic context of the FDA versus the transformed

future of medicine.

Dr. ROSENFELD. It is time for the FDA to change. The world has

changed. It is time for them to change. They are operating on a

system that is predicated, in my opinion, on the way in which

things used to be done prior to the advent of molecular biology. The

FDA still has not even adjusted to molecular biology as a term.

There is one molecular biology test in the entire planet that is FDA

approved, one, with regards to gynecologic cancers.

Mr. CANNON. Wow.

Dr. ROSENFELD. And not only that, the technology for that one

HPV—it is an HPV test—is 20-year-old molecular biology technology. There is lots of new stuff, there is lots of good stuff. There

is molecular testing that could be done for ovarian as we speak,

and it is not in the pipeline.

Mr. CANNON. I want to explore this for a bit. But first I would

like to get some bona fides on the table. Would you mind giving us

your academic background, what you are doing in China, the committees you are serving on? I know that is a long list, but you don’t

have to do it all, just some of the high points.

Dr. ROSENFELD. OK, if I talk about China, remember I am a

loyal American.

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I have graduate degrees from both the University of Utah and

the University of British Columbia. I am a molecular biologist, also

a geneticist. I am former faculty at the University of Utah School

of Medicine. Our department used to be called the Cellular, Viral,

and Molecular Biology Department.

I went into private enterprise actually because I feel very strongly about the direction that I feel medicine needs to take, and have

been involved with innovative technologies as a consequence. I

have been involved predominantly with gynecologic cancers and, in

particular, cervical cancer, and I hold one distinction, and that is

that I actually sit on the China State Council on Medical Reform.

I am the only American.

And I am very proud of that because China has made great

strides with regards to reforming their medical system. They want

a system that really works for people, and that is something that

I think is, from my perspective, I am apolitical on that; if they

want to do it, I am willing to help. And just because it is fun, I

also breed giant pandas when I am in China. I am in charge of

giant panda reproduction at Peking University.

That is my background on reproduction endocrinology.

Mr. CANNON. Do you also work with the Mandalay? Do you also

work with the pandas——

Dr. ROSENFELD. Oh, the Mandalay Bay fiasco? Yes.

Mr. CANNON. I didn’t know it was a fiasco. That is because of the

trust that the Chinese have in your judgment.

Dr. ROSENFELD. Yes. I am also the English version—if you go on

the net, the English version of the China 5 year cancer policy, I am

actually the author.

Mr. CANNON. So you spend a lot of time in China. Why?

Dr. ROSENFELD. What?

Mr. CANNON. You spend a lot of time in China working on cervical cancer. Is there a reason for that?

Dr. ROSENFELD. Cervical cancer in particular, because China is

probably the epicenter for cervical cancer. Last year, for example,

over 90,000 died of cervical cancer. And I have been on wards

where I have seen, on a given afternoon, as many as 70 women

with terminal invasive cervical disease. So China is a place that is

necessary if one is to get a handle on gynecologic cancers, in particular cervical.

The other reason is that I really do have a true commitment to

taking technology and introducing it into rural and developing regions, and working with the Chinese has been good from that perspective. So, for example, I am down in Guangxi Province, which

is a remote area of China, and looking at whether or not we can

indeed deliver such things as molecular biology services in the middle of nowhere.

However, the spillover, I think, is great, and that is this, that the

commitment is that this be provided also here. So, for example,

when we heard discussions earlier today about the need for Black

populations to be able to achieve pervasive early detection screening, I believe that can only be achieved if we change the diagnostic

paradigm, and that is the kind of technologies that I work with.

Mr. CANNON. I know the Chinese Cancer Institute is among the

highest quality in the world, with highly trained people, and they

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are not compromising that at all. But China has a problem: they

don’t have the wealth that America has, so they can’t do things the

way America does them and still reach people in China, which is

really Johanna’s Law. How do we do things in America? Well, we

are going to spend a lot of money on it.

Dr. ROSENFELD. That is a plus.

Mr. CANNON. But the Chinese are different. Would you talk

about that, why that is a plus?

Dr. ROSENFELD. It is a plus because we are spoiled and they are

not. And the plus is this: again, I said it earlier, and that was 2.9

million people, we spend $75 million, $60,000 per cancer. We are

willing to spend that kind of money. We throw money left and right

in health care. That has been a problem here. We throw money out

for research, but where is the accountability in the end?

There is a wonderful article that I actually photocopied and put

in, called ‘‘Why We Are Losing the War on Cancer and How to Win

It.’’ Read that. That is what is wrong with cancer in the United

States, and that is why the Chinese don’t have that problem. You

know, they are very practical-minded. How did they deliver the

most to a country that is three or four times the size of our country, and for little money?

Mr. CANNON. It seems to me there are probably three disruptive

technologies or things that have happened in America.

And, Dr. Karlan, I would appreciate your comments on this as

well.

In the first place, you are talking about DNA decoding, that technology and how that has plummeted in price. That is dramatic. I

don’t know how you can state how dramatic it is, because everything that derives from it is unanticipated. You never thought in

terms of looking for a genetic marker for a disease when the cost

was tens of thousands of dollars. But now, if you are talking about

pennies, it means a different kind of thing; it is a whole new mindset.

In the second place we have what I call the Napster phenomenon, that is, I am a big fan of Napster, I wanted them to have a

model where people paid. We don’t want them to rob music. They

wanted a model where they paid. But that kind of peer-to-peer

technology is disruptive, I think it is fair to say. And when you add

that to the other kinds of database technologies we have, the

informatics approach, where you organize information, as opposed

to the peer-to-peer work, where information organizes itself, it

seems to me you have another two kinds of transformations.

And then the third kind of thing that is happening is that as people are aware of these transformations, wholly new ways of viewing

medical problems are arising. And those are principally coming, I

think, from medical practitioners, but they are also coming from a

lot of other folks, because as nutritionists, as dieticians, as people

that like nutritional supplements, as drug companies look at offlabel uses, you are getting this incredible increase.

So you take a drug that you know the toxicity of, that may be

very effective for one thing, and you say what are the molecules.

And, of course, we can tell what those molecules are better now because of these other technologies. Then you can look at what the

chain of reactions is within a body and do some significant predictVerDate 11-MAY-2000 13:12 Dec 04, 2006 Jkt 000000 PO 00000 Frm 00107 Fmt 6633 Sfmt 6633 D:\DOCS\26657.TXT HGOVREF1 PsN: HGOVREF1
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ing. In other words, as a derivative of these other things, you have

this massive number of people who are empowered then to do creative things.

Is it important to the two of you in particular that we create a

data context for that to happen? And if you are aware enough of

the difference between a database like the informatics database

that has been testified about earlier and a peer-to-peer database,

I would like your comments on that. And what else can we do to

help this tide or this dam that has broken and now is flooding

down, what else can we do to help that be channeled and effective

for improving treatments for people?

Let us start with Dr. Karlan, if you would, and then Dr.

Rosenfeld.

Dr. KARLAN. Thank you, Mr. Chairman. I think you have eloquently outlined the breakthroughs, the shifts in paradigm that

have resulted from the human genome project, and then the advances in informatics that allow us to look at gigabytes of data and

suddenly see the tree and get through it and see the next steps forward.

Johanna’s Law, though, processes and tries to take the disconnect between our breakthroughs in the laboratory and what we

see on the corner. Shoppers, come in and get your Pap smears now.

How do we bring these advances to all of our kitchen tables before

we get cancer? When you get cancer, then you start logging on, you

do extensive searches.

Mr. CANNON. Almost everybody in America uses Google. And to

the degree you can make information available—and there are

many forms of that—then you have the ability for people to educate

themselves, so you don’t have to suffer with four or five different

symptoms, you go to four or five different doctors, and way too late

you find out that you have one problem that is causing them all.

Dr. KARLAN. But I think Mr. Burton hit on it earlier. When you

start to have the symptoms, when you start to have the problems,

when you begin to ask those questions, then you go to Google.

Mr. CANNON. Right. Exactly.

Dr. KARLAN. But how do you process that information? How do

women——

Mr. CANNON. Let me make a suggestion. I understand what you

are saying, and I want Johanna’s Law to pass. But I want some

other transformations in the medical system, which I would like

your opinion on, because I believe, to your point now, to the degree

that people understand that there are transformations in medicine,

then they will look. Mr. Burton laid it out very well: The problem

is how do you look in the right place and know what you are actually looking for? But the transformations that derive, that is, as

you see from a database, from other sources, new treatments and

new opportunities, then people say, ‘‘What are my symptoms?’’ And

they will go back.

So I think it is actually an iterative process. In other words, I

am not just ignoring Johanna’s Law here. I am saying, how do we

make it all come together in a system?

Go ahead.

Dr. KARLAN. No. Again, as we get these new technologies, a better basic understanding, if you would allow me, why some people

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live and others do not survive their cancer, and we communicate

better that cancer is not a death sentence, we will then also open

up that door.

And I will digress, if you allow me, one moment. We did an outreach project in Los Angeles, in the inner city church system,

where the pastor was very much in support of Pap smears, and we

did see and treat; get your Pap before mass, go to mass, come out,

have your treatment. And we published those data about the findings of Pap smears. It was predominantly a Latina population.

Afterwards, the pastor was very interested in the women who did

not participate; came to church every single Sunday, but did not

partake in this problem. We did these focus groups in Spanish with

social workers, not with the physicians themselves. And there was

this pervasive fear of a passive coping mechanism of why do I want

to find out if I have cancer? Cancer is a death sentence.

So to your point again, informatics, genomics, targeted therapies,

when we can better use Johanna’s Law to communicate cancer is

a curable disease—the article that you referred to. When we look

at heart disease as the paradigm, where have we been able to see

the death rate from heart disease plummet? It is because we have

educated people so effectively about lowering your cholesterol, taking your aspirin, exercising, watching your weight, watching your

diet.

We need to do something similar for cancer; understand what we

need to do to prevent it. And the way we are going to get that information, the way we are going to be able to roll out the molecular

tests that are being developed is by integrating all these data effectively and seeing how to move forward.

Mr. CANNON. And you struck me with what you said earlier. You

talked about gigabytes of data. In other words, you are talking

about big, big, big numbers or data points that you are crunching

to identify this, which means you really have to have another paradigm shift, which is a paradigm toward complexity and toward the

kind of computing that is now so cheap, that will allow you to sort

the massive number of data points and come up with indicators of

where we should go.

Dr. KARLAN. Yes. And thank goodness our computational colleague scientists, who understand Abasian theory much better than

I myself, can put together these four-dimensional type of networks

that allow us to look at those massive volumes of data.

Mr. CANNON. We are actually looking now, as we speak, at trying

to get funded a complexity center in Utah, which is not just my

home State, but a place where a lot of this activity is going on. So

I am going to take that comment as in support of a massive computer that would be shared by University of Utah’s Medical Center

and various other places around the country.

We have talked a lot, but, Dr. Rosenfeld, do you want to followup

and comment on those things?

Dr. ROSENFELD. Yes. I actually have a couple comments. No. 1,

technologies are in place now, for example, for a lot of gynecologic

cancers, that you could, on your way into the mall, literally have

your finger pricked and an analysis instantly done. And from that

analysis you could find out such things as ovarian status; you could

find out such things as your Pap status, that is, whether or not you

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have not only HPV, but whether or not that has progressed to cervical dysplasia.

Now, that goes to what Dr. Karlan was saying, and that is why

some of these people who went to church did not participate. I contend a lot of them do not want to participate because a gynecologic

examination, whether you like it or not, means you have to get up

in stirrups, and it is very uncomfortable or discomforting for patients. And there is some good information on that.

So if we are able to diagnose new ways, and not only new ways

in terms of the technique, but new ways in the sense that you don’t

have to at least initially go for a gynecologic exam, then I think

that we are going to be able to obtain much broader reach of people

and get disease at its earliest stages.

I will say one last thing, and that is that we can get—and we

have done this already—we can get as little as one molecule and

find that one molecule, which means that we can find disease in

perhaps its earliest state. And if we find it in its earliest state, it

is the easiest to treat.

Mr. CANNON. Thank you.

Mr. Burton, would you like——

Mr. BURTON. Yes, Mr. Chairman.

Mr. CANNON. The gentleman from Indiana is recognized for 5

minutes.

Mr. BURTON. I am sorry, I have to leave in just a few minutes.

So I appreciate you yielding to me, Mr. Chairman.

First of all, I was reading part of this article that you referred

to, ‘‘Why We Are Losing The War on Cancer and How To Win It.’’

And I promise you I will read it all. But I wasn’t aware that in

2004 cancer will claim or did claim some 563,700 people. That is

an amazing figure to me.

I am glad Dr. Trimble is still here. Are you awake, doctor? Your

eyes are closed. I just want to make sure you are still with us.

The President signed a proclamation on August 29th making this

month National Ovarian Cancer Awareness Month, and he said because the early signs of ovarian cancer are easy to miss and often

resemble the signs of other conditions, it is important for women

to talk with their doctors about detection and be aware of the risk

factors and symptoms of this cancer. That is true of so many cancers, not just ovarian cancer.

And I would like to go back to what I said to you, doctor, a while

ago, and I am really glad you are still here. You know, it is one

thing to come up with technical advances that will help in the war

against cancers of various types. It is another thing for people to

know about them. There has to be some balance between the technology advances and the research that is taking place, and the people knowing what in the world to do.

It really bothers me from a personal standpoint—and, you know,

as I said, three members of the panel have had people die from

cancer, and we have people out here who have suffered from cancer

or had loved ones die from cancer, and they simply didn’t know the

signs.

There should be a significant part of the budget—we give our

health institutions billions and billions of dollars every single year

for research. That research amounts to nothing if the people who

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are affected by cancer don’t know that it works and don’t know how

to utilize it. And you say you don’t have money in there for public

service announcements and that sort of thing. That is nonsense.

I mean, if you could find that 90 percent of the people are going

to survive more than 5 years if they know how to deal with their

cancer and you don’t tell them about it, that is almost criminal. In

fact, I think it is criminal. Why are we spending these billions and

billions and billions of dollars, and people like my wife or these

other people we are talking about, aren’t even aware of what they

can do to protect themselves, or their doctor? Her doctor

misdiagnosed her, for God’s sake.

I should have sued her for malpractice, but when you are in politics, you can’t do that because it is all over the papers you are trying to take advantage of somebody. So we didn’t do that. But my

wife died. And everybody I have talked to said had she been aware

of her early signs, she would be alive probably today, 3 years later.

I just have to tell you—and I hope you will take this message

back, because I was looking at your background here. You are the

Head of the Surgery Section, Division of Cancer Treatment and Diagnosis at the National Cancer Institute. For God’s sake, go back

and tell them to spend some money on advertising and telling people what the hell is going on.

[Applause.]

Mr. BURTON. That is what Johanna’s Law is all about, and that

is why I am glad we are having this hearing today. And I wish

there were a lot more Members of Congress here. But to do all this

research and spend all these billions and billions of dollars—I don’t

want to beat a dead horse—and to not have public service announcements so people know that bloating and constipation, bleeding, and different kinds of things are signs of some form of cancer

so they can go get checked out, it just boggles my mind.

You know, there just has to be some balance there. So we have

talked about, just a minute ago, maybe introducing a resolution, a

congressional resolution saying that the National Institutes of

Health and National Cancer Institute should spend a certain percentage of their budget on advertising so people are aware of the

various kinds of cancer they may be subject to.

[Applause.]

Mr. BURTON. And I think we will probably introduce that legislation, but it is unnecessary, because all you guys have to do over

there is say, hey, look, we have to make sure the public is informed.

And I want to tell you, in my district right now we did some public service announcements this week about the hurricane, and

every television station was very anxious to put on public service

announcements informing people what was available to them to

help them survive. And with 563,000 people dying in 1 year from

cancer, you would think we would spend part of our budget telling

them what it is all about, especially since we are doing all this research.

Anyhow, that is all I have to say, Mr. Chairman, except I do

want to say one thing that is a little bit humorous. Your curriculum vitae, Doctor, is very impressive, but it is nothing compared

to the woman sitting right next to you. She has got 33 pages, and

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that is only since 1999. I am so impressed with you. Are you married?

Dr. KARLAN. Twenty-five years.

Mr. BURTON. I am just teasing. You tell your husband he is very

lucky to have such an intelligent woman at his side. I understand

he is a psychologist, too.

But let me just say, Mr. Chairman, I really appreciate your giving me the time to do this. And I hope that the people at our health

agencies and the National Cancer Institute will take this to heart.

Spend some money on telling people. And if you do public service

announcements, just get them produced. Get an ad agency to

produce them. I promise you, you get them to me in Indiana, they

will be shown. I will get them shown. You just get them produced.

Thank you.

Mr. CANNON. The gentleman yields back. Thank you for your

comments.

Mr. Issa, did you have questions?

Mr. ISSA. Yes, Mr. Chairman.

Mr. CANNON. The gentleman is recognized for 5 minutes.

Mr. ISSA. Thank you, Mr. Chairman.

Dr. Rosenfeld, you talked about the pin prick blood test. How

much is that per each examination?

Dr. ROSENFELD. Right now, the pin prick, just so you understand

what it is, Congressman Cannon had referred earlier to an immune

or protein test for cervical disease, and we have one actually working now. Our actual cost of doing it at the moment—realize that

we haven’t gone through the FDA hurdle. And, by the way, it is

$802 million, on average, for a drug or tests, not three-quarters of

a billion. So it is even higher.

Mr. ISSA. I have been in Congress for 5 years, so that is about

how far out of date I am on all my facts.

Dr. ROSENFELD. Oh. But, anyway, it is costing us 14 cents.

Mr. ISSA. What is it going to cost the patient if it becomes FDA

approved?

Dr. ROSENFELD. Well, in our discussions we are hoping a couple

bucks, literally. Again, realize that everything I do centers around

low resource settings, so that my eye is on the economy.

Mr. ISSA. I appreciate that. That sounds very promising, and we

look forward to—it is too bad we lost our FDA guy. We really could

have put him on the spot on that one.

Dr. Karlan, California is sort of the starting home of HMOs, and

health maintenance organizations were designed to do things early,

provide care early in order to spend less money, and the theory was

that you actually got less expensive health care by doing certain

things early.

How do you accomplish that in the—let me back up a little. In

order to accomplish that, which is a truism, I think, that we all understand from the last couple of hours here, in gynecological cancer, how can we take the dollars that we are authorizing in this

bill and leverage those in public-private partnerships to get that effect?

Dr. KARLAN. As you said, we have a lot of experience with the

prepaid health care system in California, and I go back to Mr. Burton’s impassioned words a few moments ago: we need to get the

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message out there. There was a recent study published a few

months ago in the Journal of the National Cancer Institute looking

within the Kaiser system.

They looked at specifically cervix cancer, and they looked at

women in the Kaiser system who had access to paid health care,

and if they had Pap smears in the 4 to 12 months prior to the diagnosis of cervix cancer. About two-thirds of them had been in the

system. Eighty percent of them had actually come in for an outpatient visit three times or more and did not get a Pap smear.

So I guess my comment about public service announcements, getting the information out there, new technologies is what they call

inreach. Instead of outreach, inreach assessment. When you come

in for your vision care—because you look at where gynecologic cancers hit in women, let us say, in the perimenopause, menopause,

and older, and you say what types of needs are those women accessing the health care for, and remind them to get a Pap smear.

At Kaiser it is almost a four vital sign. When you go in to get your

prescription checked, they will ask you, ‘‘Here is information about

gynecologic care, have you had your Pap smear?’’

There has to be this access, this education of both the women as

well as health care providers. I think we have heard over and over

again ob-gyns are more likely to think about gynecologic cancers,

but so many women, especially after they finish childbearing, their

primary care physicians are not their obstetrician-gynecologist, and

they may go misdiagnosed for months to years.

There was recently a study published out of California looking at

the Medicare records, and those women who were diagnosed with

ovarian cancer—and they looked at their doctor visits in the 4 to

12 months prior to the diagnosis of ovarian cancer, and 40 percent

of them went to the doctor. Forty percent of women with ovarian

cancer went to the doctor 4 to 12 months before their diagnosis

with a complaint of one of the main symptoms, bloating, abdominal, low back pain, or constipation, and never had it worked up. So

that is an enormous impact we can make right there.

Lower cost. If you make an early diagnosis, costs a lot less to

cure someone with stage 1 disease. And then not only the financial

cost, the human cost: they live a full life, they are cured of their

disease.

Kolleen was very brave today both to come here and to take the

time to share with us her story. If she was diagnosed at stage one,

it would have been 8 years ago, she would have been cured.

So I think that is an enormous way to lower cost: find them

early; we don’t have to pay for the lengthy treatments. And for that

we do need continued research, continued focus on newer technologies.

Mr. ISSA. Mr. Chairman, I will put most of the rest of my questions in for the witnesses to answer, but could I ask just one more

on the record?

Mr. CANNON. Certainly.

Mr. ISSA. Thank you, Mr. Chairman.

Dr. Karlan, you and I, as Californians, but you as a health care

professional, have been in California during this entire period after

we mandated a woman’s right to get to an Ob-Gyn directly. Can

you give me—because even though it is not in this law, but it is

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an area of concern—how much has it accomplished? It was very

controversial at the time.

General practitioners, among others, said, ‘‘Hey, we can handle

this, we can handle the referral; we can prescreen.’’ And, of course,

the HMO—which used to be a nice word and now is pejorative normally—fought it, but it became law. How has that impacted in

California, for the benefit of those who may be in States that don’t

have this?

Dr. KARLAN. The legislation that Mr. Issa is referring to, of

course, is that every woman in the State of California has the right

to see her obstetrician-gynecologist as her primary health care provider. And I will have to go back and look at actual numbers, because I don’t know how it has enhanced the use of mammography

screening, Pap smear screening, and early detection, because those

would be the benchmarks that I would look at. We know that obstetrician-gynecologists are more cognizant of those screening practices.

I think when we look at the roll-out of Johanna’s Law and making sure that we get the right information into women’s hands before they have symptoms, I think that opportunity in California,

that when you come in for your prenatal care there is information

already out there, that while you are sitting there waiting in doctors’ offices it is inevitable, that these are things, and whether it

is a PSA loop, I mean, there are many ways people learn, whether

it is visually, auditory, or the written word that we can use that

opportunity by working with the American College of Ob-Gyn, the

Society of Gynecologic Oncologists and its foundation, the

Gynecologic Cancer Foundation can help put together the messaging that would be the ability to be accessed.

But I don’t have actual benchmark numbers, to answer the question, at this time, but I will look into getting that for you.

Mr. CANNON. Thank you. The gentleman yields back.

Let me just wrap up, and after I go through a list of things, if

any of the panel members want to comment, I would appreciate

that.

It seems to me that we have come to the conclusion that there

are some disruptive technologies. I have described them as protein

decoding, cost declining dramatically, and as databases with the capability of making information available in either the structured

form like the informatics kind of database or the peer-to-peer kinds

of databases. And then, finally, those two things lead us to a point

where scientists and MDs and other people can be freed to be

innovators because they have more information available to innovate.

We have other things going on in the world today that I think

are important as it relates. For instance, we have the availability

of information. NIH just withdrew a rule that would require federally funded research to be available publicly. I suspect what we

need to do there is—and the reason they did that is because the

publishers of those journals had to pay the cost of preparation.

So what we probably need to do is increase the Federal funding

for research to include the cost of publication so those publications

can be made available. And then hopefully a Napster type micropayment system could be set up so that they can make money on

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selling their information and people in America and worldwide

have the ability to access that information.

In addition, we need a kind of patient information environment

where a patient can make—and this is what the CDC is working

on, and Secretary Leavitt at HHS—his information available, subject to certain rules, to certain types of people, M.D.s and scientists, so that it is a controlled environment. That is just a technological breakthrough that we need and we need to put in place. In

fact, I mentioned there is a company in Utah that is doing that

called NexLight.

I think, in addition to that, Dr. Karlan, you were talking about

the gigabytes. You need the kind of computers to drive the issue

so that you can come up to, even in the cases of an individual who

may have a problem, to go through gigabytes of data to come up

with the data points that may help him is well within our reach.

The cost of supercomputing has plummeted, but we need to probably focus on a center for complexity studies that would provide

that kind of availability.

Finally, we need public awareness so that people can identify

their problems and then, in my view, in addition to that, drill down

themselves to find out the kind of information that would be available in this world where we make information available so that an

individual can find more and more about his or her particular problems.

And in that world of changes that have happened around us or

that need to happen, it seems to me that the FDA needs to come

up with new processes to accommodate how we do that. That

means physicians need to have the ability to treat patients with

best practices that they learn online; they need to be able to innovate and come up with, based upon their own analysis and based

upon a context rich in information and rich in analysis, they need

to be able to come up with their own innovations; and they have

to be able to do that relatively quickly so that their individual patients can be treated as opposed to creating protocols and tests that

were fine in an earlier time.

Because when you have an $800,000 to $1 million cost for a new

drug, that means you have massive interests who all have a huge

reason to keep the threshold high and to keep alternatives that

may be cheaper, that may be more readily available, that may be

innovated by a doctor with access to information. You want to keep

those people out, you want to keep the thresholds up. And what

that means is worse health for Americans, worse health for people

all over the world, a stifling of creativity instead of an improved

safety. And safety was the purpose of the FDA at a time when we

were doing a lot of guessing.

And I think, Dr. Karlan, you were talking about following the

chain of reactions that a protein causes. We know a lot about those

chains, and in a complex environment where we have lots of information, we can have much better guessing. So the nature of what

FDA does has to change. The nature of what the National Cancer

Institute does has to change. The nature of what NIH does and the

CDC does all have to change to accommodate these disruptive technologies.

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I want to thank you all for being here. The suffering caused by

cancer is phenomenal and personal, and I appreciate the roles that

you all have played in this hearing today and in the cause of transforming our system so that we get the kind of treatments we deserve in America. Thank you all for being here.

The committee is now adjourned.

[Whereupon, at 2:10 p.m., the subcommittee was adjourned.]

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