U.S. GOVERNMENT PRINTING OFFICE

64–044 CC WASHINGTON : 2000

FIGHTING PROSTATE CANCER: ARE WE DOING

ENOUGH?

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

FIRST SESSION

SEPTEMBER 23, 1999

Serial No. 106–112

Printed for the use of the Committee on Government Reform

(

Available via the World Wide Web: http://www.gpo.gov/congress/house

http://www.house.gov/reform

(II)

COMMITTEE ON GOVERNMENT REFORM

DAN BURTON, Indiana, Chairman

BENJAMIN A. GILMAN, New York

CONSTANCE A. MORELLA, Maryland

CHRISTOPHER SHAYS, Connecticut

ILEANA ROS-LEHTINEN, Florida

JOHN M. MCHUGH, New York

STEPHEN HORN, California

JOHN L. MICA, Florida

THOMAS M. DAVIS, Virginia

DAVID M. MCINTOSH, Indiana

MARK E. SOUDER, Indiana

JOE SCARBOROUGH, Florida

STEVEN C. LATOURETTE, Ohio

MARSHALL ‘‘MARK’’ SANFORD, South

Carolina

BOB BARR, Georgia

DAN MILLER, Florida

ASA HUTCHINSON, Arkansas

LEE TERRY, Nebraska

JUDY BIGGERT, Illinois

GREG WALDEN, Oregon

DOUG OSE, California

PAUL RYAN, Wisconsin

HELEN CHENOWETH, Idaho

DAVID VITTER, Louisiana

HENRY A. WAXMAN, California

TOM LANTOS, California

ROBERT E. WISE, JR., West Virginia

MAJOR R. OWENS, New York

EDOLPHUS TOWNS, New York

PAUL E. KANJORSKI, Pennsylvania

PATSY T. MINK, Hawaii

CAROLYN B. MALONEY, New York

ELEANOR HOLMES NORTON, Washington,

DC

CHAKA FATTAH, Pennsylvania

ELIJAH E. CUMMINGS, Maryland

DENNIS J. KUCINICH, Ohio

ROD R. BLAGOJEVICH, Illinois

DANNY K. DAVIS, Illinois

JOHN F. TIERNEY, Massachusetts

JIM TURNER, Texas

THOMAS H. ALLEN, Maine

HAROLD E. FORD, JR., Tennessee

JANICE D. SCHAKOWSKY, Illinois

———

BERNARD SANDERS, Vermont

(Independent)

KEVIN BINGER, Staff Director

DANIEL R. MOLL, Deputy Staff Director

DAVID A. KASS, Deputy Counsel and Parliamentarian

CARLA J. MARTIN, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

(III)

C O N T E N T S

Page

Hearing held on September 23, 1999 ..................................................................... 1

Statement of:

Dole, Hon. Bob, former Senator of the U.S. Congress; Hon. Randy ‘‘Duke’’

Cunningham, a Representative in Congress from the State of California; and Mrs. Betty Gallo, vice president, Dean and Betty Gallo Cancer

Research Foundation .................................................................................... 43

Geffen, Jeremy, M.D., Geffen Cancer Center and Research Institute;

Konrad Kail, M.D., Phoenix, AZ; Sophie Chen, Ph.D., Brander Cancer

Research Institute, New York Medical College; Allan Thornton, M.D.,

Indiana University; Richard Kaplan, M.D., National Cancer Institute,

accompanied by Jeffrey White, M.D., Director, NCI’s Office of Cancer

Complementary and Alternative Medicine; Andrew C. von Eschenbach,

M.D., American Cancer Society; and Dr. Ian Thompson, COL.M.C.,

University of Texas Health Science Center at San Antonio ..................... 73

Letters, statements, et cetera, submitted for the record by:

Biggert, Hon. Judy, a Representative in Congress from the State of

Illinois, prepared statement of ..................................................................... 40

Burton, Hon. Dan, a Representative in Congress from the State of Indiana, prepared statement of .......................................................................... 5

Chen, Sophie, Ph.D., Brander Cancer Research Institute, New York Medical College, prepared statement of .............................................................. 112

Cunningham, Hon. Randy ‘‘Duke’’, a Representative in Congress from

the State of California, prepared statement of ........................................... 56

Dole, Hon. Bob, former Senator of the U.S. Congress, prepared statement

of ..................................................................................................................... 49

Gallo, Mrs. Betty, vice president, Dean and Betty Gallo Cancer Research

Foundation, prepared statement of ............................................................. 67

Geffen, Jeremy, M.D., Geffen Cancer Center and Research Institute, prepared statement of ........................................................................................ 76

Kail, Konrad, M.D., Phoenix, AZ, prepared statement of ............................. 85

Kaplan, Richard, M.D., National Cancer Institute, prepared statement

of ..................................................................................................................... 135

Thompson, Dr. Ian, COL.M.C., University of Texas Health Science Center

at San Antonio, prepared statement of ....................................................... 155

Thornton, Allan, M.D., Indiana University, prepared statement of ............. 126

von Eschenbach, Andrew C., M.D., American Cancer Society, prepared

statement of ................................................................................................... 146

Waxman, Hon. Henry A., a Representative in Congress from the State

of California, prepared statement of ........................................................... 13

(1)

FIGHTING PROSTATE CANCER: ARE WE

DOING ENOUGH?

THURSDAY, SEPTEMBER 23, 1999

HOUSE OF REPRESENTATIVES, COMMITTEE ON GOVERNMENT REFORM, Washington, DC.

The committee met, pursuant to notice, at 10:05 a.m., in room

2154, Rayburn House Office Building, Hon. Dan Burton (chairman

of the committee) presiding.

Present: Representatives Burton, Morella, Shays, McHugh, Horn,

Mica, Barr, Terry, Biggert, Vitter, Waxman, Owens, Maloney, Norton, Cummings, Kucinich, Turner, and Schakowsky.

Staff present: Kevin Binger, staff director; Daniel R. Moll, deputy

staff director; James Wilson, chief counsel; David Kass, deputy

counsel and parliamentarian; Carla J. Martin, chief clerk; Lisa

Smith Arafune, deputy chief clerk; Heather Bailey, legislative assistant; Robert Briggs and Michael Canty, staff assistants; Robin

Butler, office manager; S. Elizabeth Clay, professional staff member; Mark Corallo, director of communications; Corinne Zaccagnini,

systems administrator; Phil Schiliro, minority staff director; Phil

Barnett, minority chief counsel; Kristin Amerling and Sarah

Despres, minority counsels; Ellen Rayner, minority chief clerk; and

Jean Gosa, minority staff assistant.

Mr. BURTON. The committee will come to order, and a quorum

being present, the Committee on Government Reform will start its

business.

I ask unanimous consent that all Members’ and witnesses’ written opening statements be included in the record. Without objection, so ordered.

I ask unanimous consent that all exhibits and materials referenced to be included in the record. Without objection, so ordered.

And if our first panel, Senator Dole, if you would like to come

forward, sir, and our good friend, the great Congressman from California and, Mrs. Gallo, would you come forward. Duke, I am surprised you are not out flying a plane this morning.

Mr. CUNNINGHAM. Tomorrow.

Mr. BURTON. You are going to fly tomorrow? For those of you

who don’t know, Duke was an Ace in Vietnam. And of course we

know that Senator Dole was not only a great Senator but a war

hero as well.

We are here this morning to talk about a disease that will affect

over 175,000 men this year, prostate cancer. In fact, unless we

change course, one in five men will develop prostate cancer during

their lifetime. Today, 101 Americans will die each day from prosVerDate 11-SEP-98 11:23 May 16, 2000 Jkt 000000 PO 00000 Frm 00004 Fmt 6633 Sfmt 6633 C:\DOCS\64044.TXT HGOVREF1 PsN: HGOVREF1
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tate cancer. That is 37,000 men this year that will be killed by this

dreaded disease.

Prostate cancer affects more men than any other cancer except

skin cancer, and it is the second leading cause of cancer-related

deaths in men. We have a slide that shows this.

The National Institutes of Health reports to Congress, and they

state that despite advances over the past decade our treatments for

prostate cancer are inadequate, the side effects of treatment are

unacceptable, and troubling questions remain about the relative

benefit of early detection for the disease.

We are here today to talk about what the current level of knowledge is in preventing prostate cancer. We will also talk about current treatment options and research that will develop better and

more compassionate treatments for men to choose. It is a travesty

for a man to be forced to choose to save his life by choosing a treatment that has a good chance of leaving him impotent or incontinent for the rest of his life.

I am pleased to have three colleagues and friends joining us for

the first panel today. Senator Dole is a true American hero. He was

elected by the people of Kansas to the House of Representatives in

1960. He retired in 1996 after serving four terms in the House and

five terms in the Senate and being elected Senate Majority Leader

in 1984. He has continued as one of the Nation’s leaders now as

an advocate saving the lives of men with early detection testing for

prostate cancer and access to better care.

After testifying, Senator Dole will be visiting the confidential

prostate specific antigen screening that is taking place here in the

Rayburn Building this morning and on the Senate side this afternoon. I hope all of my colleagues and the staff will take the time

for screening today.

Most of us keep a close eye on our cholesterol levels and on our

blood pressure, but are we watchful about our PSAs? This is a simple blood test which has been shown to be a valuable indicator to

the possibility of prostate cancer and we should all pay attention

to this.

Congressman Randy ‘‘Duke’’ Cunningham was re-elected to the

House of Representatives in 1998 for his fifth term. Gosh, has it

been that long? Five terms? I understand that Duke may have to

leave early since he is a member of the Appropriations Subcommittee on Labor, Health and Human Services and Education, one of

the cardinal committees. We do not want him to miss the markup

that is happening concurrent with our hearing. We will benefit

greatly by Duke sharing his personal story of dealing with prostate

cancer, and we look forward to working with Duke on prostate legislation.

Additionally, we are delighted that Mrs. Betty Gallo, whose husband Dean was a friend of mine, is joining us to share her perspectives as the wife of a prostate cancer victim, Congressman Dean

Gallo. She will share their story and discuss the work of the Dean

and Betty Gallo Prostate Cancer Institute of New Jersey, including

the role of nutrition in preventing prostate cancer.

Dr. Jeremy Geffen, board certified in medical oncology and internal medicine and executive director of the Geffen Cancer Center

and Research Institute, will lead the second panel. In addition to

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his extensive training in oncology and hematology, Dr. Geffen is

also trained in the medical and spiritual traditions of the East. He

will share with us his perspectives in the reality of treating prostate cancer in a compassionate manner. In politics there is more

than one philosophy or school of thought. This freedom to be diverse is one of the greatest benefits of democracy and the same is

true in medicine.

Dr. Konrad Kail is a naturopathic physician from Phoenix, AZ

and a member of the new Advisory Council on Complemental and

Alternative Medicine. He will discuss natural approaches to treating cancer and interactions between the naturopathic medical community and conventional oncologists.

Dr. Sophie Chen is an associate professor at the New York Medical College and will discuss Chinese botanicals and their use in the

treatment of prostate cancer. Dr. Chen patented PC SPEC, a Chinese botanical that research indicates may slow the growth of cancer cells.

Dr. Alan Thornton is the chief advisor to the Midwest Proton Radiation Institute at Indiana University in the great State of Indiana, and he will provide testimony on the benefits offered prostate

cancer patients by proton therapy. Dr. Richard Kaplan, a leading

expert on prostate cancer, will present testimony on behalf of the

National Cancer Institute. Dr. Andrew von Eschenbach of the Anderson Cancer Treatment Center will present testimony on behalf

of the American Cancer Society. And Dr. Ian Thompson from the

University of Texas Health Science Center at San Antonio will testify about research in preventing prostate cancer.

There has been a lot of progress in prostate cancer. Today we

will hear about that progress. But are we doing enough and are we

spending enough?

Is the funding of research at the National Institutes of Health

adequate and properly focussed to get viable, effective, and compassionate treatments for prostate cancer? Are we looking enough into

the natural approaches to healing? Are we looking closely enough

at the emotional and psychological-physiological issues that arise

as men and their families face prostate cancer? Are we moving forward in getting real answers about the nutritional aspects of cancer prevention, including organic and plant based diets and the role

of dietary supplements? Are we looking at the role of pain management issues, including complementary approaches like meditation,

guided imagery, acupuncture, aroma therapy, and music therapy?

Is the spending on prostate cancer in line with the spending for

other diseases that affect the comparable number of individuals?

This is very interesting, and I want to put this slide up there

right now. I hope everybody can see this. When we calculated this,

the disparity was shocking. I was not aware of this and I don’t

think any Member of Congress is. In fiscal year 1999 for HIV/

AIDS, the National Institutes of Health is spending on average

$44,960 for each new case of AIDS in the United States this year

just for research alone. That is almost $45,000 for research on

AIDS for each case. And that is not talking about all the treatments, just for research alone.

In cardiovascular disease the National Institutes of Health is

spending $2,019.69 per new case, and in the case of prostate canVerDate 11-SEP-98 11:23 May 16, 2000 Jkt 000000 PO 00000 Frm 00006 Fmt 6633 Sfmt 6633 C:\DOCS\64044.TXT HGOVREF1 PsN: HGOVREF1
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cer, that is going to affect 175,000 men this year, they are devoting

$941. Now, I want you to know that I think AIDS is a tragic thing

for anyone to have to deal with, and we should pay attention to

that and we should appropriate money for research, but the disparity is unconscionable. We have a lot of other diseases that are extremely important to the American people and to spend $45,000 for

each new case of AIDS on research and less than $1,000 on research for prostate cancer just does not make any sense.

In our June hearing we asked the National Cancer Institute to

provide us a list of all the new drugs, devices, and treatments

available in Canada and Europe that are not currently available

here. Just yesterday, we received a letter that lists six chemotherapy drugs available and an explanation that so far they haven’t

been able to compile the rest of the requested information. We were

told at the June hearing that the National Cancer Institute staff

stays in communication with international experts. If they cannot

even provide a list of the existing international alternative advances in cancer detection and treatment, how can they be taking

advantage of these advances in research and moving to increase

America’s access to them? The Congress and the American taxpayer have entrusted the National Cancer Institute with over $3

billion to fight cancer this year alone. I said in the past that the

less than 1 percent of the NCI budget that is being spent on complementary and alternative medicine is not enough considering

that over 50 percent of cancer patients use these therapies. I will

reiterate my request again to the National Cancer Institute to step

up to the research plate and set aside a larger percentage of research funds for this necessary research.

The time for watchful waiting in prostate cancer research is over.

We as a government have to join organizations like CapCURE, the

National Prostate Cancer Coalition, Men’s Health Network, U.S. 2,

and the American Foundation for Urologic Disease to get answers

to the questions of how to prevent cancer, how to detect cancer as

early as possible, and how to treat prostate cancer with effective

compassionate treatments. Then we must empower men with this

knowledge so that 101 men do not die each day from prostate cancer.

The hearing record will remain open until October 7th for those

who would like to make some statements in addition to what they

are going to say today. Let me end up by saying that I hope those

who are here from the National Cancer Institute and the National

Institutes of Health will address this disparity in funding for HIV

and prostate cancer. And we are talking not about overall; we are

talking about $45,000 per HIV patient, new HIV patient for research alone, not for the cure or helping those people. And less

than $1,000 for prostate cancer. That just doesn’t make any sense.

I now recognize my colleague from California.

[The prepared statement of Hon. Dan Burton follows:]

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Mr. WAXMAN. Thank you, Mr. Chairman. I am pleased that we

are having a hearing on the important issue of prostate cancer. Except for skin cancer, prostate cancer is the most commonly diagnosed cancer in American men, and this year alone an estimated

37,000 American men will die of the disease.

We face many challenges relating to prostate cancer. Questions

remain unresolved about the causes and biology of prostate cancer

and about why there are racial differences in the incident rates. We

must concentrate our efforts on developing the most effective prevention, detection, and treatment approaches. We must also work

to ensure that all men have access to appropriate treatment and

to accurate information about their treatment options.

As we face these challenges, it is important that we keep an open

mind about innovative and unconventional approaches to prostate

cancer treatment and prevention. At the same time, we must promote thorough testing and review of these approaches to avoid unnecessary harm and expense to consumers.

Some of today’s witnesses will share their personal experiences

with prostate cancer. Others will highlight ongoing efforts to advance prostate cancer prevention, detection, and treatment. This

discussion will increase our understanding of the options currently

available to men who are diagnosed with prostate cancer and of the

research efforts we should continue to explore.

I look forward to their testimony. I want to explain to witnesses

that many of us have conflicts in our schedule, and I know I won’t

be able to be here for the full hearing but I will have an opportunity to review the record and the statements that will be submitted. So, while many of our colleagues are not present, we are making an important record today that will be shared with all of our

colleagues and others interested in this field.

I particularly want to recognize and welcome Senator Dole. He

and I have had an opportunity to work together over the years, and

he has been a tremendous champion for research and trying to

fight this and other diseases, and for making sure that people have

access to care. He has my undying admiration and respect for the

work he has done in this and many other areas.

I am pleased we have our other colleague and spouse of our

former colleague with us as well.

Mr. Chairman, I appreciate the fact that we are holding this

hearing. It is important that we pursue this issue and I look forward to the testimony.

[The prepared statement of Hon. Henry A. Waxman follows:]

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Mr. BURTON. Thank you, Mr. Waxman. Do any other Members

have a comment they would like to make an opening statement?

Mrs. Morella?

Mrs. MORELLA. Thanks, Mr. Chairman. I want to thank you for

holding this hearing today to examine the current status of prostate cancer issues, including prevention, early detection, treatment,

and research.

As you listen to the compelling statements of our panels, particularly Senator Dole, our colleague Duke Cunningham, and Mrs.

Gallo. I served with your late husband and have great, great respect and love for him, I appreciate the three of you coming to discuss this with us. Indeed we must keep in mind that prostate cancer is the most frequently diagnosed nonskin cancer, the second

leading cause of cancer deaths among men, second only to lung

cancer. In fact, prostate cancer is the most common type of cancer

in men in the United States.

The statistics are one out of every six men will develop prostate

cancer at some point during his life. African-American men have

the highest incidence of prostate cancer in the world. There are

many parallels I find between prostate cancer in men and breast

cancer in women. Like breast cancer in women, the risk of having

prostate cancer increases with age. The American Cancer Society

estimates that 180,000 new cases of prostate cancer will be diagnosed in 1999. It kills 37,000 men each year. Breast cancer kills

over 46,000 women. Prostate cancer is the second leading cause of

cancer death in men. Breast cancer is the second leading cause of

death in women after lung cancer.

Although testing for early detection for prostate cancer has become more common, too many lives are still lost to this disease,

and I think it is critical that American men use every means available to fight prostate cancer, including regular testing and medical

examinations.

I know Senator Dole is going to be chairing a luncheon panel in

the Senate at noon as part of Prostate Cancer Awareness Week to

further educate men about this disease. Free, confidential prostate

cancer screenings will be offered immediately after the luncheon

until 3:30 this afternoon. I encourage the men in this room and

others to take advantage of this opportunity because it was

through a similar Capitol Hill screening that I eventually discovered that I have osteoporosis. So one never knows.

In conclusion, Mr. Chairman, I have been a strong supporter of

increasing the Federal Government’s commitment to biomedical research. In particular, I was leading an effort to double the funding

for the National Institutes of Health over the next 5 years and we

are working toward that goal. Funding biomedical research

through the NIH is today’s investment in America’s future. We

must continue our commitment now if we are to find better ways

to fight prostate cancer and to ensure the future health of our Nation.

Recently, I attended the opening of an expanded Department of

Defense Prostate Cancer Research Center in Rockville, MD. This is

a wonderful partnership with NIH in Bethesda, and will also work

with other departments and even the private sector in prevention,

early detection, and a cure for prostate cancer.

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I just want to mention one comment, Mr. Chairman, and that is

I would be very much against pitting one disease against another.

I mean, I think you have to be very careful when you look at the

kind of money that goes into AIDS and you don’t want it to be in

combat with breast cancer, prostate cancer, whatever it may be.

But I really look forward to the discussion today and the testimony of our witnesses. Thank you very much.

Mr. BURTON. Before I yield to my next colleague, let me just say

that they are spending $2,700 for every new case of breast cancer

research, and I have had that happen in my family. And while you

cannot make everything equal and you should not, I think that we

ought to seriously look at why some are getting a great deal more

attention, huge quantities more of money per case for research

than others. I think it is a question that at least needs to be answered.

Mr. Horn.

Mr. HORN. Thank you, Mr. Chairman. I appreciate you setting

up this hearing. My wife has had breast cancer and I have had

prostate cancer, and I have a daughter who heads an anticancer

foundation. So the family is deeply involved.

And I think Senator, you and I had the same doctor, Dr. McLeod,

who is an outstanding surgeon. We are very lucky that we had his

talents work on both of us and a lot of other Members of the

House. We have an alumni group, a McLeod alumni group. They

ought to make him a General with all the lives he has saved.

I thank you for being here, you and Mr. Cunningham, and, Mrs.

Gallo, I had great affection for your husband. He was a wonderful

Member. Thank you very much and we will maybe get results as

a result of this hearing.

Mr. BURTON. Thank you, Mr. Horn. I neglected to alternate back

to our colleagues on the other side of the aisle, so I will yield to

two of them in a row. First, Mr. Kucinich.

Mr. KUCINICH. Thank you very much, Mr. Chairman. I want to

begin by stating my appreciation to the Chair and to our ranking

member, Mr. Waxman, for their ongoing commitment on matters of

health, and over the years I think we have seen great leadership

from many members of this committee on health issues and our

American community, and we see our congressional community

represented here by Senator Dole, Congressman Cunningham, and

Mrs. Gallo.

It takes great courage to share your experience with us and to

share with the people of the United States the things that can be

done to protect their families through early protection through perhaps raising health issues to a higher priority on this Nation’s

agenda through addressing it with funding and new strategies.

So thanks to all of you, to my good friend Senator Dole for his

willingness to come forward and to Mr. Cunningham for his neverending insight into matters, which makes all in Congress very

grateful, and to Mrs. Gallo for sharing your husband’s career with

this Congress and for your willingness to come back here and talk

about what can be done to help other Americans who have struggled with this. Thanks to all of you and again thanks to the Chair.

Mr. BURTON. Thank you. Mrs. Maloney.

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Mrs. MALONEY. Thank you, Mr. Chairman. And thank you very,

very much for having this hearing and for our distinguished guests,

distinguished panel. And until we come up with a cure, the only

thing that we really have is preventive screening and early detection. And all of your speaking out on this disease, particularly Mr.

Dole, have hopefully brought more people to doctors for screening.

As we sit here today, Supreme Court justice Ruth Bader

Ginsberg, who is just 66 years old, is undergoing colon cancer

treatment and, like many other women and men, she was

misdiagnosed for several months. Very often, women and men over

age 50 are not advised to get tested for cancer despite their risk.

Routine screening really should be taking place between ages 50

and 65.

I am glad that we are focusing on prostate cancer, but really it

should be interrelated with all cancers, many cancers are interrelated. And I want to mention a bill, along with the cochair of the

Women’s Caucus Sue Kelly, we have put forward, and it is a cancer

screening bill.

One of the bills that I authored with Mrs. Morella and others

that was part of the balanced budget amendment was the Breast

Cancer Early Detection Act, which allowed for annual mammograms for women on Medicare, and we are pleased that this became part of the law of this country. But what about men and

women who are at threat for prostate cancer—prostate cancer for

Medicare was also covered but what about below the age of 65, at

the age of 50, when most cancers could begin and when screenings

should likewise be taking place?

Our bipartisan bill, the Cancer Screening Coverage Act, would

help ensure preventive care—that it becomes, you know, part of

our routine health care and it would have insurance coverage for

prostate cancer, breast cancer, cervical cancer, and colorectal cancer. And we do not need to or we shouldn’t be looking at cancer

with a body part by body part perspective.

I am glad that we are focussing on prostate cancer here today,

but how many of you are aware that colon cancer is the second

leading cancer killer just behind lung cancer. And so I just want

to say that the American Cancer Society and many others have endorsed this bill and they say that people who do not receive screening tests because their doctors do not encourage it, and if you ask

doctors why is it not encouraged it is because it is not covered. So

it is important that screening, when it is advisable or necessary,

is covered.

I thank the chairman for organizing this and our distinguished

panel for being here.

Mr. BURTON. Thank you, Mrs. Maloney. Mrs. Biggert.

Mrs. BIGGERT. Thank you. I am particularly eager to hear from

our distinguished witnesses, particularly Senator Dole and our colleague Congressman Cunningham, so I would ask unanimous consent to submit my opening statement for the record.

[The prepared statement of Hon. Judy Biggert follows:]

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Mr. BURTON. Without objection, so ordered. Mr. Turner.

Mr. TURNER. Thank you, Mr. Chairman. I want to commend you

on organizing this hearing. It is a very important subject. And I

want to thank Senator Dole for his leadership. It took a lot of

gutsiness to make those commercials, Senator. It meant a whole lot

to the cause that you spoke out on behalf of.

Our second panel has two distinguished professionals from Texas

today, so I think we have a good second panel, Dr. von Eschenbach

and Dr. Thompson.

Mr. BURTON. There is one from Indiana as well.

Mr. TURNER. So we are in for a good hearing today. Thank you,

Mr. Chairman.

Mr. BURTON. Thank you. Mr. Terry, do you have any comments?

Mr. Cummings.

Mr. CUMMINGS. Thank you very much, Mr. Chairman. I want to

just take this moment to thank our panel for being here. In my district, we have one of the greatest hospitals in the world, Johns

Hopkins, and some of probably the greatest experts in this area in

prostate cancer, whom I have gotten to know very well. But at the

same time, we have one of the highest death rates from prostate

cancer.

I have said it often, when I go to the bank on Saturdays it is not

unusual for me to run into someone, Mr. Chairman, who is about

to undergo some type of prostate surgery or has just come through

it or is recovering from it.

And so I want to thank our panel for what you are doing. So

often, I think what happens is that we in government and those

not in government who speak out on these issues wonder what effect what we do has. I mean we always wonder. But I can tell you

that it has had a profound impact to raise this issue to a level

where people can talk about it. I think it was Congresswoman

Maxine Waters who said: ‘‘Secrets kill. Keeping things hidden and

not dealing with them and not bringing them out kill.’’

And so, I too join the voices of my colleagues to say thank you,

simply thank you, for those you will never meet. For those who

have been touched by seeing you on C–SPAN or hearing you all

testify at a hearing like this. But touching their lives because when

you open the door and break down the walls of discussion, then you

also break down the walls so that people can get the kind of diagnosis and treatment that they need.

And so I thank you. Thank you, Mr. Chairman.

Mr. BURTON. Mr. Vitter, no comment? Ms. Norton.

Ms. NORTON. Thank you, Mr. Chairman. May I thank you for organizing this hearing about a form of cancer that I think needs

very special awareness.

If I may, I would like to thank Senator Dole first for his work

on behalf of the District as head of the Federal City Council. The

Senator was most gracious as the District was coming out of crisis

to offer his extraordinary and unique leadership. That leadership

has been felt and the District, its residents, and its elected officials

are most grateful to you for your work.

I share with the Senator what has been his lifelong habit of not

speaking much about his own personal life and struggles. I am

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selves and what they have gone through physically or mentally, but

I must say that I have come to believe that there are some conditions where to hear from a person who is very distinguished and

very admired is to render a unique service. To talk about a disease

like prostate cancer to people, I have in mind men who are reluctant even to go to the doctor, is to do something that doctors cannot

do, that Members of Congress cannot do, that only someone whom

they respect, whom they know would not be inclined to simply

speak about himself for the sake of hearing—telling about himself,

that person gets the attention in a way nobody else does, and that

person can save lives.

And I submit to you without being able to document it that I believe that Senator Bob Dole has saved lives by having the guts to

go on television and talk personally about prostate cancer.

And I must thank you, Senator, as well because not only is that

the case for men in general who go only at the last minute and perhaps because they think it is a sign of weakness even to go to the

doctor when they have a cold, but for many men, especially African-American men where prostate cancer is out of control, the

whole notion of going about this disease simply was off the radar

and off the table. To hear a man whom they regard as manly speak

about this disease has had an effect which I think we will never

know, but I think all of us should be grateful for, and I want to

express my gratitude personally to the Senator here this morning.

Thank you, Mr. Chairman.

Mr. BURTON. Thank you, Ms. Norton. Well, without further ado

we will start with Senator Dole. We really do appreciate you being

here. We appreciate all of you being here. I would just like to say

that I have known a lot of people who had some kind of prostate

problems that led to prostate cancer and they were very reluctant

to even talk about it to anybody. And I think because of you and

others like you, Mr. Cunningham, Mrs. Gallo, and others, I think

that people are now willing to talk about it and look into it. And

thanks to you very much, Mr. Dole.

STATEMENTS OF HON. BOB DOLE, FORMER SENATOR OF THE

U.S. CONGRESS; HON. RANDY ‘‘DUKE’’ CUNNINGHAM, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF CALIFORNIA; AND MRS. BETTY GALLO, VICE PRESIDENT, DEAN AND

BETTY GALLO CANCER RESEARCH FOUNDATION

Senator DOLE. Well, thank you, Mr. Chairman and members of

the committee. I really appreciate this opportunity. It is good to be

back on the Hill. And I know the experts are lined up behind us.

We are here to sort of set the stage and then they can make very

appropriate statements.

But I think it is true that not many people like to talk about

their own problems, whether it is an illness or anything else. We

go through life and some people have some problems, some people

have other problems, and that is all a part of life. But this is Prostate Cancer Awareness Week, and for the past 8 years, I have been

speaking out on prostate cancer.

When it was diagnosed, I recall some difference in my staff.

Maybe I should just have it done quietly and nobody would know

about it because it might make people think that I wasn’t going to

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be able to carry out my job and all these things. But it occurs to

me that maybe just sending a signal might encourage others to do

the same. And since that time, I have literally talked to hundreds

of men—in fact I was coming out of the hotel this morning, we are

living there temporarily while they are fixing up our apartment,

the doorman stopped me and said, ‘‘You know, I have prostate cancer.’’ This was less than an hour ago. And can we talk about it?

And I said, yes, I am going to be here for a couple of months. And

so he has some good new theory that he doesn’t have to have an

operation. Maybe there is an option that I am not aware of.

The point is that it is out there. It is every day. It affects Republicans and Democrats, liberals, conservatives, black, white, yellow,

brown, whatever. It doesn’t spare anybody. And the case that I remember is Senator Sparky Matsunaga, who was one of my colleagues. We served together in the House and then in the Senate,

and then of course he died of prostate cancer, which spread

throughout his body.

I remember talking to Dean shortly before his death, and I must

say he was a man of great courage. His spirits were good. He understood what was about to happen. And it is great that Betty is

carrying on with the foundation to help others.

One thing that we have done, and I found it to be very good policy and might also be good politics, but at the Kansas State Fair,

we have a screening booth, the Bob Dole screening booth. We have

mammograms and PSA tests and we got the cooperation of the

State Urological Society and generally some of the drug companies

to help underwrite part of it. That ended as soon as I left the Senate, I might add. But we are still doing that. We are still finding

the funds. It is a good way because some people will not go to the

doctor, particularly men. It takes about two laps around the midway to get them in that little booth there for that blood test, which

is painless, and we discovered even in our small state we do about

3,000 PSAs during that week and maybe 100 cases of cancer, prostate cancer that could be treated because there is early detection.

We hope to do this at both national conventions next year in

Philadelphia. We are working with some doctors to see if we can,

because we will have a lot of opinion makers there, there will be

a lot of people at the Democratic Convention and Republican Convention that people will listen to and we think it is a great opportunity just to spread the word. We did it at the Republican Convention in 1996. There wasn’t much else going on. About the most exciting thing that happened were the PSA tests. But in any event,

we think it is an opportunity and I know there is certainly enough

support for it there.

I think it is fair to say that almost every family in America has

been touched by cancer. And when you hear the word ‘‘cancer,’’ it

scares a lot of people, and men are not any different than women.

As I said, I think I have talked to, I don’t know, hundreds of men

because their son asked me to call or the wife asked me to call or

the mother, whoever, and just say that there is life after prostate

cancer, as Cliff knows and others in the Congress. Suddenly your

whole perspective changes when you hear the word, and again

when it is determined by biopsy after the PSA test, what the cancer may be. I share the view that it is not just prostate cancer, it

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is cancer across the board. Great progress is being made and I commend those who are making that progress. But it seems to me that

early detection is, of course, the key.

As I said, it was about 8 years ago and I have been in great

health since that time. I have made a commercial or two and I

must say I got a lot of ridicule for one. But I think when you look

at the 30 million men that may be benefited, you have to take a

little heat sometime. Most of it came from the misinformed media.

They are generally misinformed when it comes to some of these

issues, and it seemed to me a little unfair, because there are 30

million men and their wives who would be affected by the message

I was trying to send without endorsing any products. I don’t endorse any products and don’t intend to endorse any products and

I didn’t keep any money. There was no monetary motivation. But

I must say some of the reaction, not from the people but from the

media, was a little distressing.

But so what I think some of us can do is encourage others, as

Eleanor said, and others have said, encourage others to see their

doctor. For some reason men just don’t want to see their doctor. If

you look at percentages of men versus women, and you are the experts, doctor visits are much higher among women, and they do it

on an annual basis. For some reason, men, they don’t want to go

to the doctor, they don’t think they are ever going to be sick and

so they put it off and put it off and put it off. My father was a good

example of that. He would go to our little hospital and maybe

spend all night with a patient, but he would never want to go to

the hospital himself. And I am sure there are others like that and

some women like that too, but primarily men.

I think the early detection message is the important one. It is

like anything else. If you find what the problem is early, you can

deal with it. And I think the options are changing. You are going

to hear some of the new options available. Eight years ago, when

I went out to see Dr. McLeod, a fantastic and a very good person,

a good surgeon, I was told there were two options: Surgery and radiation. And I explored both, because I didn’t know much about

what was happening. And none of this sounded very appealing to

me, but I finally decided and I was 68 years old at the time—so

to get to the point where maybe watchful waiting, maybe you don’t

do anything—but I was in good health physically and I finally decided to do the radical prostatectomy. But other men, 68, 70, and

older, may have other health problems and doctors don’t want to

chance surgery. If you have got other health problems you may not

want surgery. My point is that the more effective treatment options

available, the more men will be cured of prostate cancer, and that

is where the role of Congress and the administration come in.

And I might say just looking at the figures that are over there,

I think about 9 years ago, maybe 7 years ago, Mr. Chairman, the

amount spent for prostate cancer on a Federal level was hardly

anything. And I must say that Senator Stevens, who has gone

through the same procedure at Walter Reed Hospital, is on the Appropriations Committee, sort of made it a crusade to see that we

couldn’t spend a little more for prostate cancer research. And that

is why we have, even though it is not as high as some of the others,

certainly much higher than it was just a few years ago.

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Now the way our system works, at least the way it worked when

I left here 3 years ago, is that if Medicare adequately reimburses

a treatment, it is widely available. If you are going to get treatment, going to get paid for it, it is going to be there. And every day

there is a scientist looking for the cure for cancer or looking for a

new treatment option. Companies invest large sums of capital in

this endeavor, and we all hope that there will be a cure. We all

hope the government will have the wisdom to recognize it when

they see it. Is our government prepared to take the necessary steps

so that when a new technology for treatment becomes available,

patients with the disease can have access to it?

I mean, if you have a new treatment option that has been demonstrated effective and safe and you can’t get access to it because

you don’t have the money and Medicare doesn’t cover it, of course

that is a problem. Brachytherapy is an example where the role of

Medicare reimbursement is critical. It is an innovative treatment

option for prostate cancer where radioactive seeds are implanted in

the prostate to destroy the cancer. For some patients it is a minimally invasive procedure done on an outpatient basis. You are in

and out of the hospital. You don’t stay as you do with the surgery

and all the other things. It has shown to treat some forms of prostate cancer. Now, I am not here advocating. I am just saying this

is one new option.

This procedure is reimbursed by Medicare currently, but a proposed change in the regulation will reduce the rates of reimbursement dramatically, in effect making this treatment unavailable.

And I agree with everybody here, you have to find a way to stop

some of the increased costs and you have to make certain changes.

But I think this is one area that at least ought to be addressed.

You have to determine how it is going to affect patients who could

benefit from this procedure. Is this really the type of decisionmaking which the government needs to involve itself? Maybe it

ought to be left to physicians and others to make that choice.

There is another new treatment—there are probably others we

are going to hear about, ones that I haven’t heard about, later from

the other panel. Cryosurgery is another treatment option where the

prostate is frozen to prevent the growth of cancer. And again this

is a sort of noninvasive procedure. I think you maybe stay overnight in the hospital. There is no blood shed. It is just frozen and

it took over 3 years to receive Medicare reimbursement for that

procedure. And again you kind of wonder, well, maybe if you are

too old or your health is not good enough for surgery, you reject radiation, are these other options available? And if so, are they covered and should they be covered? That is a decision that doctors

and patients and the marketplace have to make. As I said, I am

an advocate for solvency of Medicare, but I think our health care

system continues to change with all this new technology. We have

to keep up with it. Medicare was passed originally in 1964, so

maybe we haven’t kept abreast of all the technology and I think

we do need to take a look at these options.

The private sector is always looking for new therapies and new

options because they are more cost effective in many cases and you

could go back and look at some of the options here that are probably more cost-effective and less demanding on the patient.

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I know that Congress is considering a number of Medicare reforms. I am not here lobbying for anything except we have got to

keep in mind in 11 years we are going to have 77 million baby

boomers descend on us and there is going to be a big, big demand

out there and the money has to come from somewhere and we have

got to have priorities. I am certain there are people in this committee on a bipartisan basis who are going to be looking at that very

carefully.

I think a successful Medicare program will mean that when an

individual receives a diagnosis of cancer or any other serious disease, his life doesn’t have to flash in front of him. He or she will

understand that there is going to be some protection, some way

they can receive treatment. I am just here to underscore the importance of communication. The thing that I have learned over the

years as sort of a spokesperson for prostate cancer, and there are

a number of them, but is that most people do not understand, they

do not know what to do.

It is pretty hard for somebody to do the right thing if they do not

know what the right thing is. The right thing obviously is to see

your doctor, and even some doctors there is not enough communication between the doctor and the patient. I have been speaking to

medical groups urging doctors to be more forthcoming. If you don’t

ask the patient the right questions you are not going to find out

what the problem is because sometimes patients, we all tend to be

very shy. We don’t go in there and lay out our soul because we are

in a doctor’s office. The doctor has to sort of draw it out of some

of us, and I think that is very important.

Last week or in fact this past Sunday, my wife was off somewhere doing what she’s doing, and so I was reading the Washingtonian, and I just happened to read a story, which probably should

be made part of the record—that costs money, but it is called

‘‘Under the Knife.’’ You may know David Dorsen. I don’t know

David Dorsen, but I called him on the telephone after I read the

story. It is the story of a 62-year-old man—I think that is the right

age—who discovers he has prostate cancer and he doesn’t know

how to deal with it. He is in a state of denial. He doesn’t think it

is real. He doesn’t understand the different options and they go

through the options. He keeps it from his wife. He does not discuss

it with his wife. And of course that leads to a rather tense situation, until he finally faces up to reality that this has to be dealt

with.

And then the story sort of goes on in how he dealt with it and

how successful it was, and so he feels very good about it. But I

think it is the kind of story that if all men could read it, they would

be a little more apt to go visit their doctors. So I would at least

call it to the attention of the committee and I told Mr. Dorsen it

is the kind of thing that ought to be circulated at State fairs, anywhere people have a chance to pick up information.

Again, I want to thank all the committee and the chairman for

holding this hearing. I hope in 10, 20 years, we may not have prostate cancer, many of these diseases will be gone. And those of us

who have had the successful operation, radiation, cryosurgery, or

Brachytherapy, whatever, I think have some responsibility to encourage our friends and encourage our neighbors.

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I think that is just the way it is, and I think most of us will do

that and by spreading the word and getting good information, not

trying to prescribe anything, I think we will be able to reach out

to more and more men. So thank you very much and I appreciate

this opportunity.

[The prepared statement of Hon. Bob Dole follows:]

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Mr. BURTON. Well, thank you very much, Senator Dole. I know

there are great demands on your time and we appreciate it.

Senator DOLE. I am unemployed.

Mr. BURTON. Give our regards to your wife. I understand she is

doing some important things right now.

Senator DOLE. Send money. Thank you.

Mr. BURTON. One of my heroes is Duke Cunningham. He was an

Ace in Vietnam and has been a hero here in the Congress as well.

Duke would you like to go next?

Mr. CUNNINGHAM. Thank you, Mr. Chairman and Mr. Waxman

and panel.

Mrs. Gallo, unlike Strom Thurmond, I didn’t know Abraham Lincoln, but I did know your husband and he reminded me a lot of my

dad. He was a big, assuming guy and I can still remember his

smile. We all miss him. And I would say to my former colleague,

Senator Dole, the day after I found out I had prostate cancer, I

called Bob Dole. I think that the amount of information that we

put out and the knowledge and that call was probably the most

helpful that I had, because today there is not a day goes by that

I don’t have somebody call me and say Duke, can I talk to you

about prostate cancer because they don’t know. You become an

automatic expert on the issue because you read, you study, you do

everything that you possibly can.

We are having a markup in Labor-HHS and I am proud to say

that last year we increased medical research by 15 percent. This

year, medical research is going to exceed 8.5 percent. I believe in

it. I would invite each of you to sit in on a panel. Actually it is very

difficult. John Porter, the chairman, asked me to chair a couple of

the hearings and I told him I would never do it again because we

had about 16 children that had exotic diseases and one of them

looked up and said, ‘‘Mr. Congressman, you are the only person

that can save my life.’’ I had to shut down the hearing. It is just

too hard. So medical research is very, very important.

While we talk here today, four men will die, just in the time that

we talk, an equal number of breast cancer surgeries. I don’t know

why I am teary. I am happy. I am the luckiest guy in the whole

world. But it is very—something that happens and it is difficult.

On May 10, 1972, I was coming down in a parachute over North

Vietnam and it is something that always happens to the other guy

that gets shot down. It is not Duke Cunningham. I am invincible.

And the realization that you are coming down over North Vietnam

and going to die or be a prisoner, there was no white scarf and no

Bentsen and Hedges coming out. But the most scared individual

you would ever imagine, that is not second to a doctor looking you

in the face and saying, Duke, you have got cancer.

The first is denial, no, it can’t be me. You have the wrong test.

I am invincible. It happens to the other person. I can’t have cancer.

I am Duke Cunningham; I just can’t have it. And the next thing

is to find out everything you can and say, OK, Doc, what do I have

to do?

I called two people. I called Father George from Georgetown University, a good hunting buddy of mine, and I called my friend, Senator Dole. And I want to tell you some of the things that you go

through in this.

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First of all, early detection, as Senator Dole has talked about, is

the most important thing. Dr. Christiansen, my surgeon, told me

about a lady that had four lumps in her breast. All were benign.

She was a soccer mom and she got a fifth lump. She, like most

moms, are busier than we are, they are taking their children to

school, they are taking them for soccer, the piano lessons, cooking

dinner, and all the other things. She let it go for over a year.

This lady is now going through chemo, she had a mastectomy,

and they don’t know if she is going to exist anymore. She is fighting for life itself. Not just life, but the quality of life and what those

people can be giving back to their children.

In my case, I had an annual physical. Dr. Christiansen, who—

I am very fortunate, Bob, the Navy, and we are going to beat Army

this year in football, but the Navy doctors have been in the Capitol

for the history of Congress, and Dr. Eisold is no exception.

I had my annual physical. I had a prostate check. They found no

cancer. But because of a blood test called a PSA, there had been,

and it really wasn’t that high, but there was a delta between what

it was last year and it had gone up slightly, Dr. Eisold said, ‘‘Let’s

do a sonogram.’’ They found no cancer on the prostate.

They then said, ‘‘Let’s do an MRI.’’ They found no cancer. Dr.

Eisold said, ‘‘Duke, we want you to go out to Bethesda and have

a biopsy.’’ I would tell the panel, I would rather fly over Hanoi

again and get shot down again than get a shot. You can imagine

when the doctor said he was going to use a needle that big in my

prostate, I said ‘‘Doc, I ain’t going. You told me I don’t have cancer.’’ Probably, like Steve went through, the night before, I am a

coward when it comes to shots, and I sweated bullets thinking,

man, this thing is going to hurt so bad.

I want to tell the panel, first of all, it doesn’t hurt. You sit there

and you wait, and it sounds like a cap gun goes off, and you say,

is that all there is to it? You say, I know the next one is going to

hurt. But it doesn’t. You go through. But unfortunately when Dr.

Eisold called me and said, Duke, I have some bad news for you, he

said, in two of the eight biopsies you have a low-grade cancer.

The next that I had never heard, he said Gleason. I said who is

that? Jackie Gleason? He said no, Gleason is the aggressiveness of

a cancer, a 10 being the highest and the lower numbers the least

aggressive. I had a 4. He said, well, Duke, you can go for years by

just observing this and watching it, and you don’t have to have surgery or the other things for a while.

I said wait a minute, Doc, you told me I have an enemy inside

of me, an enemy more deadly than any MIG that I ever shot down,

that this guy is going to try to sneak up on you. I said, is it in the

lining of the prostate? Is it in the center? He said, statistically you

can go for a long time.

The next thing is to find out the information and the different

options that you have. Is it cryogenics? There had not been enough

information at that time, so I chose not to. What about radiation?

And then the doctor goes through the different side effects—incontinence, where you can’t control your bladder because when they

remove the prostate, they have to detach the urethra and reattach

it to the bladder. Sometimes you end up incontinent. The next

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thing is impotence, a pretty serious thing for a man and for his

family.

You go through the different choices of what you have, and I

chose, like Senator Dole, to go through the surgery. I said, I want

it out. I told Dr. Christiansen, I don’t care if it takes you 40 hours,

you protect those nerves.

And I am happy to say I don’t need Viagra. I appreciate your

calling. This was one Member of Congress that saluted, what you

did on TV, and didn’t criticize Senator Dole because—for us that

are trying to get the information out and know that it is important

to do that.

The second thing that Senator Dole mentioned that I think is

very, very important, it is very, very difficult to go to your wife and

say, sweetheart, I may be impotent after the surgery. I may be incontinent, and we may have to live with that.

My wife looked at me and said, sweetheart, I will support you

all the way. She supported me 100 percent whatever those decisions were, and you need to bring in the family as well. Those

things are very, very important.

But something else that I found in my studies, Mike Milton, who

was famous for another reason, has invested millions of dollars into

prostate cancer. I met with Mike and he has put out a diet book.

And I spoke—I see Mrs. Holmes Norton—I spoke the day before

yesterday at a hospital in D.C. right down by the air force base

there, Bolling Air Force Base. D.C. has the highest prostate cancer

rate in the United States, and among African Americans, it is even

higher, prostate cancer. And they have done studies, and the reason I bring it up, on diet, that people that are African Americans

that come directly from the continent have a less incidence of prostate cancer. But once they come to the United States, and the same

is true with Asians, once they come to the United States, their incidence goes up.

There are a lot of studies that say it is diet, the fatty foods and

so on. So my mom was right, you need to eat your veggies and

those things. But that kind of information, is very, very important.

I would like to address another subject real quickly. I think it is

a good question to ask as far as the disparity between the amount

spent on prostate cancer versus other diseases, but I want to tell

you something. Many of us went out with Dr. Varmus and Dr.

Klausner—Dr. Varmus, head of NIH, and Dr. Klausner in cancer

research. I saw an African American lady that had Parkinson’s,

that they implanted an electrode into her brain. She had been in

a wheelchair, couldn’t eat and walk, had been taken away from her

family. We asked what happened to her, because the film ended.

She ran down the center of the aisle, jumped in front of us and

started talking to us. That kind of medical research in those things.

I met an AIDS patient that contacted AIDS in 1989. He said,

Duke, the only thing I thought about was death. Every morning I

woke up, I only thought about dying.

You know that since they have had some of these new research

techniques, that he has bought stocks and bonds, he has bought a

new home, that he has hope?

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Ovarian cancer, I know Mrs. Ginsburg, you talked about, with

colon cancer, for the first time NIH is identifying PSA-type markers for ovarian cancer, and they have never had that before.

So support the medical research that comes in. I would say that

Senator Stevens and Jerry Lewis on the House side, we have put

more money into breast and prostate cancer in the military. We

have a captured force there, and we can look and make those kinds

of studies. It is important.

I would say, also, I think it is time that many of us do believe

that we need HMO reform, because some HMOs don’t do PSA’s and

the other things. Some of the veterans hospitals don’t have those,

Mr. Waxman. I would tell you there are two bills out there—Norwood is one bill, and the other one is, I think, Dr. Coburn—but

take a look at them. It is time to put doctors in charge of our

health care again. But it is not time to put trial lawyers into the

driver’s seat, in the Democrat bill, which is why we oppose that

kind of HMO reform. Unlimited lawsuits is just not going to work,

and it will drive more people out of the issue.

But I want to thank the panel for having this hearing, and Senator Dole, and also Mrs. Gallo. Thank you.

Mr. BURTON. Thank you, Duke.

[The prepared statement of Hon. Randy ‘‘Duke’’ Cunningham follows:]

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Mr. CUNNINGHAM. Can I mention one other thing real quick?

This stamp on cancer awareness, breast cancer, this stamp right

here, does not add to medical research for cancer. We have a bill

that does. Like in breast cancer, we would like to propose, this is

a 4-year committee, and you can act on it, Mr. Chairman—that we

would like to bring forward a stamp that actually—I think we have

to get every Member of Congress in their campaigns to use that

stamp, the breast cancer stamp, that goes for medical research. I

know I would.

Mr. BURTON. We will see if we can’t talk to the Postmaster General about that.

Mrs. Gallo, we have about 12 minutes, I think, before the vote.

Would you like for us to come back after the vote to hear your testimony, or you would like to do it now?

Mrs. GALLO. Whatever is easiest for the committee.

Mr. BURTON. Why don’t we recess for the vote and come back,

and then—we appreciate it.

Senator Dole, will you be able to stick with us for a while or do

you have to leave?

Senator DOLE. I will be here for a while.

Mr. BURTON. We will be back as soon as the vote is over because

we have some questions for you. Thank you.

[Recess.]

Mr. BURTON. If we could get the witnesses to once again take

their seats, we will have witnesses coming back. We just finished

our second vote. Because we have that good-looking Senator Robert

Dole with us—I know he has some time constraints, as well as the

other panelists—I thought we would go ahead and get started.

While we are waiting on Mrs. Gallo, let me just ask Senator Dole

a question or two, if it is all right, Senator.

You spoke about the emotional side of facing cancer, the disbelief, fear, hope and so forth. How did you and your wife cope with

this when you first found out about it?

Senator DOLE. Well, I think a little like Duke Cunningham said.

First of all, you think it must be a mistake. It can’t be my biopsy,

because I don’t have prostate cancer. But then there is the realization that it is there and then you have to decide how to deal with

it. So we went to—I learned a lot more about it since the operation

than I knew before the operation. I am not saying I might have

picked a different route, but I don’t know. We were a little panicky,

and we went out to Walter Reed Hospital, and they talked to both

of us about side effects and all the other things.

But once you make a decision, that is it. Then you just do the

best you can.

Mr. BURTON. It sounds like you handled it pretty well. Was it

kind of like when you realized all the severity of your wounds when

you were in World War II?

Senator DOLE. I guess I had great faith in medicine and doctors,

and I think they certainly played a major role in my life from way

back when I was 19 years of age.

But I think the important thing is—we were just visiting here

while you were voting—how do we get the information out there?

How do we get the average guy on the street, who may be walking

around with a PSA of 10, 12—and that is not foolproof, it may not

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make any difference, but how do we get him to understand that it

is important to go to the doctor?

We have all the experts here today, and they can tell us about

all the options, but there has to be some way for that information

to leave this room and get out to the average guy on the street in

Indiana or Kansas or California or wherever.

Mr. BURTON. I wish we had a lot more coverage today than we

have. We have print media here that will probably be talking about

it. We need to really work on getting the message out.

You have been very helpful in that regard. We will see if we can’t

be of assistance too.

Senator DOLE. I need to speak at noon.

Mr. WAXMAN. I thought the Senator had mentioned he had to be

at this luncheon at noon. Would you allow me to ask a question or

two?

Mr. BURTON. If Mrs. Gallo doesn’t mind, would you mind if we

ask a few questions of the Senator?

OK.

Mr. WAXMAN. Senator Dole, you have been a very important

force in raising awareness, public awareness, about prostate cancer

and all the related problems; and I want to congratulate you and

express my appreciation to you in that regard.

You are also spokesman for the product Viagra. That product

was approved by the Food and Drug Administration where they

evaluated numerous randomized placebo controlled trials involving

more than 3,000 men; and then FDA published information on potential side effects of this product and other interactions Viagra

might have with other substances.

But there are some herbal products being advertised on the

Internet, and they are being called alternatives to Viagra. One

product, for example, says they are 100 percent herbal sensation,

touted as the herbal Viagra, and they make a number of claims

that the product will relieve lack of desire, impotency, orgasm dysfunction. Additionally, they state it will help relieve prostate problems, lower cholesterol, help urinary function. They say you don’t

need a prescription. There are no side effects; there are only positive things from using this drug.

If Pfizer were to make some of these claims, they would have to

extensively prove them to protect the public health, but for some

of these herbal products, there are no FDA approvals, because it

is not a drug, they say, and they cite no clinical studies to support

their claims. There is only testimony, always of users.

I would like to know how you feel about that and whether it is

a concern and whether we ought to have more scrutiny over these

kinds of products?

Senator DOLE. I must say I think the first part of this, I almost

got into this by accident. I was talking to Larry King one time in

the Green Room, I learned not to do that since, just visiting before

the show, and I was telling him about this trial I was in, this protocol, and it turned out to be Viagra. Of course, Larry made a mental note of that and raised it publicly on the show about 2 minutes

later.

So, with you, I have had people send me these things. They have

heard about what I have been doing; this is better, do this, do this,

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do this. It seems to me there ought to be some basis for all the

claims that are made. At least it ought to say at the bottom it may

not help, but it won’t do you any harm. There ought to be something there.

Mr. WAXMAN. What assurances would you want to have before

you would feel comfortable in promoting any kind of product like

that?

Senator DOLE. I don’t promote that product. I have some stuff

called Macho Man, somebody sent me a case of it in the mail. I

would be happy to bring it up here and distribute it.

Mr. BURTON. You think we need that, do you?

Senator DOLE. They make a lot of claims, but I don’t have any

information at all, whether it is, because they don’t have to comply

with any regulation. They don’t have to satisfy that it is safe and

effective.

Mr. WAXMAN. Do you think the Congress and the regulators

should require some substantiation before claims to consumers are

made about the effect of these products?

Senator DOLE. I think it would be helpful. I know it is a very

tough issue when you get into vitamins and everything else and

herbal remedies. At least there ought to be some determination

that it is not going to hurt someone. I don’t know how you do that.

Aside from whether it is doing all the things you read off, I think

that is probably mostly hype, would be my guess.

They also had different herbal remedies for brain power. I got a

case of that the other day. Just take a couple of drops a day and

your brain functions, which is different than it has been.

Mr. WAXMAN. The way the Congress decided to deal with the

issue is, we said if it is a claim about just your general good health,

you can go ahead and make it. But if it is a claim you are going

to cure a disease, there automatically should be more substantiation because then it gets to be close to a drug.

Senator DOLE. I agree.

Mr. WAXMAN. You agree with that kind of distinction?

Senator DOLE. We are talking about health and new technology,

new options for all these different things, not just cancer, but everything else. We have to be very careful. We are dealing with consumers, a lot of people that don’t have information, are not sophisticated; and they pick up some magazine, they will read all these

things and they are going to head for the store.

In fact, there was one last night on TV that I am going to check

out myself, not about any of this, but about your general energy.

We will see what happens.

Thank you.

Mr. WAXMAN. Thank you very much.

Mr. BURTON. Mr. Horn, do you have any questions briefly for the

Senator?

Mr. HORN. Well, let me make one point. We named some colleagues that really have helped in getting the money for cancer research—you, Senator Stevens and so forth on your side. I want to

say Jack Murtha, when he was the chairman of the Defense Appropriations Committee pumped millions of dollars into the Defense

Department to face up finally to both breast cancer and prostate

cancer, and he felt with the military having women in the services

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and breast cancer being the plague that it is, that that ought to

be done. I think he can take great pride in what has happened in

the grants over there.

One of them I am aware of, at UCLA, the person had been denied a grant by NIH, and why? Because they had never had a

grant from NIH. Now, if that wasn’t a catch-22, I don’t know what

is. But the military has made some real progress in research with

the grants given to the Department of Defense.

Senator DOLE. Steve, I appreciate that. I think it is fair to say

the record is pretty clear, this is a nonpartisan-bipartisan area,

where you have got, in this case, men on both sides of the aisle who

have had the problem.

I remember getting a very irate letter from a lady in Kansas

after we appropriated money for prostate cancer research. This is

after my operation, but she concluded this was to help me, and I

advised her that it was too late to help me, but it might help her

grandson. So there is misinformation or noninformation or whatever. But certainly in the Congress, it has had across-the-board

support.

Mr. BURTON. Mr. Turner.

Mr. TURNER. No questions.

Mr. BURTON. Mr. Ose.

Mr. OSE. I do want to say hello to the Senator.

Senator DOLE. Good to see you again. Good to see you here.

Mr. BURTON. Mr. Owens, do you have a comment?

Mr. OWENS. No.

Senator DOLE. I watch him on the Late Show. I watch C–SPAN

at night.

Mr. BURTON. You do? I may have to get on there more often.

Mr. Barr.

Mr. BARR. No questions. No, thank you, Mr. Chairman.

Mr. BURTON. I had a lot of questions for you, Senator, but I think

you covered just about everything. We really appreciate you and

your wife and how you represent all these issues to the country.

You are a real credit to America.

Senator DOLE. On Sunday, for example, I will be in Des Moines,

IA. I am not a candidate——

Mr. BURTON. Are you sure?

Senator DOLE. But there is going to be a Walk for Prostate Cancer to raise money for prostate cancer.

So it is happening. All these things are happening, so there is

more awareness. A lot of it is being done by men who have been

through the process, radiation, whatever treatment they might

have had. So I think the word is getting out.

But certainly this hearing will be helpful and what you do individually will be helpful as you go back to your districts, town meetings, whatever. Thank you.

Mr. BURTON. Thank you, Senator.

Mrs. Gallo, thank you for your patience. Once again we really appreciated your husband, serving with him and traveling with him.

He was a fine fellow. We appreciate what you are doing by carrying

on his memory with this Institute.

Mrs. GALLO.

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Mrs. GALLO. Thank you very much, Mr. Chairman. I want to

thank the committee for allowing me to testify today, especially before the people who knew and worked with Dean in Congress. That

is why it is nice to be here, because I am talking to people who

really knew him. So if I can use him as ‘‘a poster child’’—for prostate cancer, I think that is very important. You put a face with the

disease, and this is exactly what I am trying to do.

I want to give you a little background on what happened to Dean

with regard to prostate cancer. Back in March 1991, he had his

normal physical in Congress, and about August 1991, he started

with a backache. Of course, as is typical of men, they don’t go to

the doctor, and I kept bugging him. Finally, in February 1992 he

went to an orthopedist, who gave him cortisone shots. Didn’t work.

They gave him a bone scan, and he called me up and said, ‘‘Honey,

I have got prostate cancer.’’ I responded, ‘‘What? What is prostate

cancer?’’ Not knowing what I was getting myself into and how my

life was going to change at that point. He said his bone scan lit up

like a Christmas tree.

I am not sure if everyone is aware of the PSA test. A normal

PSA, the prostate specific antigen, is usually 1 to 4. Dean’s PSA

was 883. He was already in the advanced stages of prostate cancer;

it had already metastasized to his bones.

His prognosis was only 3 to 6 months. This was back in 1992,

and, as you all know, he was in Congress until 1994.

Dean went to his urologist where we lived in Morris County. He

said, what can you do for me? The doctor said they could remove

his testicles, because the testosterone is what causes the cancer

cells to grow. I said to him, I think before we go to that extreme,

I would like to look at other options.

Because he was down here in Washington most of the time and

we did not have a cancer institute in New Jersey, he decided to go

to the National Institutes of Health. Dean was treated by Dr.

Charles Myers and was actually one of the first two people on a

protocol called suramin, which—I don’t know if you remember Bill

Bixby, they tried it on him when he had prostate cancer, but unfortunately, it had already advanced to his organs.

With that, Dean’s PSA did come down between 1992 and 1993.

In January, it was 3.5. People in Congress at the time did not realize Dean was sick with prostate cancer. In fact, Senator Dole made

a comment: Do you say anything? Will people look at you differently? And that is what Dean’s concern was. He loved his constituents and didn’t want them to feel sorry for him because he was

going through this process of dealing with cancer.

So for the following couple of years he seemed to be doing OK.

He was on different protocols. One of the things you live by is the

PSA. He would get it checked every month, and sometimes it would

be up, sometimes it would go down; and then you have to decide,

if it went up, what were you going to do next.

I am sorry, I am just trying to gather myself here.

Finally, what happened was, toward the fall of 1994, as you all

recall, Dean had decided to retire from Congress. He had very bad

bone pain, and it couldn’t be controlled at that point. So he decided

not to run for re-election in November.

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When Dean left Congress, he decided to try to work harder on

the cancer, which he did, but unfortunately, the pain was so much

out of control that there wasn’t too much more they could do for

him. Unfortunately, in October 1994, he fell and broke his shoulder, which put him in the hospital.

The bone pain was so excruciating, it was very difficult to treat

it. Most of the time, they treat bone pain with morphine, and from

what I understand, that doesn’t always take the pain away like it

should.

Unfortunately, the cancer was so well advanced that he died on

November 6, 1994. All I can say is that Dean and I had the best

21⁄2 years of our 8-year relationship when he had the cancer. It

brought us much closer together and created a love that I may

never know again. I saw a very warm and loving side of Dean that

I may have never known had he not had cancer.

When Dean was diagnosed, we started going to church and we

believed that the Lord would get us through the tough times. Dean

was a wonderful, strong individual, and he put up an incredible

fight. I truly believe the support system was part of what helped

him through that tough time.

If the PSA had been available when Dean had his yearly physical, maybe Dean would have been diagnosed in the early stages

rather than the advanced stages in 1992. If we had had more funding for prostate cancer at that point, and research, perhaps Dean

would have survived.

We do need more money for prostate cancer research. If we don’t

have the funding, we can’t attract the scientists to come and do research in this field. Prostate cancer, as Chairman Burton had remarked, has the highest incidence rate in the Nation.

We need the funding, to be able to prevent or possibly cure this

disease. We need the FDA to find a better approach to move the

approval process which affects the public. We also need to focus on

research for pain management. As I said before, the bone pain is

horrible. We need to look at how to improve the quality of life, not

always the quantity of life.

We need more studies and funding for complementary and alternative medicines. I have seen that people that have been on some

kind of complementary or alternative medicines, along with standard chemotherapy, seem to do a little better.

I feel nutrition is a very important part, of prevention and the

treatment of prostate cancer. I feel it helps to build the immune

system and keep it healthy when the body is being fed the toxins

to destroy the cancer cells.

Dean had a nutritionist come in before he passed away, and unfortunately, I wish I had done it sooner. I think it would have

helped him to survive or possibly do better with his chemotherapy

treatments.

Unfortunately, the other point with nutrition is, our foods do not

have the nutrients like they used to because we process the foods

for shelf life. We lose a lot of our nutrients, so that is why the supplements are so important.

Today, prostate cancer is no longer an older man’s disease; 30 to

40 percent of men over 50 will be diagnosed with prostate cancer.

A prime example is my husband’s doctor, Dr. Charles Myers, who

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treated my husband. To me he was my hero because he kept Dean

alive for 21⁄2 years and Dr. Myers was just diagnosed a couple of

months ago with prostate cancer.

Since Dean’s death, I have become a prostate cancer advocate. I

have worked with the American Cancer Society and developed a

prostate task force to educate the community. I have worked with

the American Foundation of Urologic Disease. I am also a founding

and present board member of the National Prostate Cancer Coalition, and I also work with the Men’s Health Network.

I have also testified at the State level for two bills. One was to

name June as Prostate Cancer Awareness Month in memory of

Dean, and the other was for insurance coverage for the PSA and

the digital rectal exam.

One concern which is important that Senator Dole mentioned before, is the funding for medication for the patients. I think Congressman Cunningham referred to that also—that the medications

are so expensive and even some of the treatments they have to go

through, the patients can’t always afford them. I think that is one

area we need to have more money available to them, whether it be

through Medicare or their own insurance companies.

I know the patients that come to the Cancer Institute where I

work, there are certain parts that are not always paid for, like

some of their visits and whatnot. It becomes very costly when you

are treating any kind of cancer or any kind of disease.

I am currently working at the Cancer Institute of New Jersey,

which is the State’s only NCI-designated center. I am director of

advocacy and fund-raising for the Dean and Betty Gallo Prostate

Cancer Center, which was just recently created in memory of Dean.

Dean was very helpful in getting the initial funding to build the

Cancer Institute of New Jersey. I am also on the scientific review

board at the Cancer Institute.

With regard to the Prostate Cancer Center, our intention is to

create more programs, bring in more research funding, and do education and awareness. We want to make this a premier center in

memory of Dean.

One of the programs I am involved with that I am bringing on

board to the Prostate Cancer Center which, I am vice chair of, is

the 100 Black Men Prostate Cancer Initiative. We are planning to

screen the underserved population in the 21 counties of the State

of New Jersey by the year 2001. We are doing an educational part

to educate the underserved on prostate cancer, and are doing

screenings.

Advocacy is really important. Part of what when Senator Dole

mentioned is getting out there to get out the word. It is groups like

the National Prostate Cancer Coalition, the ‘‘us too’’ groups, and

the grassroots that gets out there and tells people how important

it is to have early detection and education on prostate cancer. That

is the only way you are going to stop it from going into the advanced stages like Dean.

It has been almost 5 years since Dean’s death. My mind knows

time, but my heart doesn’t. My goal is to prevent others from suffering from prostate cancer the way Dean and his family did. This

is a family disease.

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I want to advocate the importance of early detection, awareness,

and education. In doing so, I know when I leave this Earth, I will

have made a difference, as Dean had, and I know we will be together again.

Thank you.

[The prepared statement of Mrs. Gallo follows:]

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Mr. BURTON. Thank you for that very moving testimony. We

really appreciate it. I know it was difficult for you.

You mentioned the incredible pain that Dean was suffering, and

it was treated, I guess, by morphine primarily?

Mrs. GALLO. Primarily. They also put him on this protocol called

strontium, which unfortunately I have a very tough time with, because most of the men on it die from it. I think that is what happened with Dean, it hits the immune system.

Mr. BURTON. Were you offered anything as an alternative, like

acupuncture, or any other complementary treatments that might

have helped?

Mrs. GALLO. Not at that time. Unfortunately, I wasn’t that well

educated to realize that may have been very helpful. I think now—

as time has gone on, I realize patients are beginning to use that.

I think it is helping a lot of patients.

Mr. BURTON. I see. I don’t know, do you know if any of that is

paid for by any of the insurance plans?

Mrs. GALLO. Probably not. I think most of them are not. A lot

of patients try to do something to help their chemotherapy. I think

some of the complementary medicines out there you have to be concerned about, such as the herbal medicines. One of our scientists,

doctors, had done research on the PC SPES, which is used to bring

the PSA down. It does work, but the only problem is you have to

monitor it.

I do believe you need some kind of regulations when it comes to

any kind of herbal medications. You don’t want the person to get

really ill if it is not monitored. I think it is important to have alternative medicines cancer patients, because they feel it does help to

heal the good cells and keep them going. I have seen people who

have done that and they have done very well with their chemotherapy.

Mr. BURTON. Let me just ask you one or two more questions. Did

the spirituality that you were active in with Dean, did that really

help?

Mrs. GALLO. The spirituality with Dean and me was incredible.

I didn’t really touch on that as much. I put it in my testimony. But

Dean and I did start going to church, every Sunday, I had never

given up hope that Dean was going to survive. Up until the week

before he died, I was not going to let this man die. I was going to

do everything humanly possible.

On that Sunday I had said to my pastor that I had spoken to the

Lord 2 years ago and he promised he was going to heal Dean. He

said to me, the Lord doesn’t always heal physically, he heals spiritually. That is exactly what he had done with Dean.

I will give you a for-instance. We had been engaged a year. I

wanted to give Dean something for our anniversary of being engaged, and I bought him this cross. He had been in the hospital

at this time because he had a hip replacement. I went in and gave

him the present, and he opened it. I didn’t buy him a chain because

I didn’t know if he would wear it. He was not a real big jewelry

person. Dean started to cry. He put the cross around his neck, and

he wore it until the day he died.

Another thing, along that note was, he died on Sunday, but on

the previous Thursday he was in excruciating pain. I went in, and

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he said, honey, I can’t do this anymore. I want to die and be with

the Lord. I just looked at him. I had no clue what was happening

at that point. I am sure, knowing Dean you knew he wanted to

know what was going on next. So finally he looked at me 2 hours

later and he said, honey, how long is this going to take? I am looking at him, I don’t know. Do I have a heavenly contact somewhere?

I had no clue what was happening at this point.

On that Friday, one of the last things he said before they put

him into a comatose like state, which is when they brought up his

morphine count and also gave him Ativan to relax him, he said,

Jesus, please take me now.

So my pastor was right in the fact God had healed him spiritually, and I guess that is what I felt my mission to him was, to

bring him to the peace he had when he passed away.

Mr. BURTON. Did you get any nutritional advice from the

oncologist that was working with Dean?

Mrs. GALLO. I actually got a nutritionist to come in to evaluate

Dean. She gave a regimen of different vitamins he should be taking

and some changes in his diet. This was toward the end. Again, I

was learning so much in the process of dealing with this disease.

I really wish I had done it sooner, because I think it really had

some good merit to it.

I think one of the interesting parts is green tea which seems to

be helpful in even preventing cancer, and when you have cancer,

it supposedly helps to maybe not let it spread further. There are

still some studies being done with that. Green tea seems to be one

of the areas that they are saying has some credence to it.

Mr. BURTON. But the oncologist wasn’t one of those who recommended any kind of nutrition?

Mrs. GALLO. No.

Mr. BURTON. I see my colleague is on the phone here. Let me ask

him one more question and then yield to him and then go to the

next panel.

Did anybody ever talk to you about why African American men

get—you said you worked with them a little bit—get and die more

from prostate cancer?

Mrs. GALLO. Part of it is, I think, the culture. Part of it is the

fact a lot of them don’t have insurance and their fear of medical

community. These are the three areas. One of the reasons I have

gotten involved with the ‘‘100 Black Men,’’ is because they do have

the ability to bring us into the community to educate them so they

are not as afraid of the medical community and are willing to get

tested for prostate cancer.

Mr. BURTON. Mr. Barr, do you have any questions?

Mr. BARR. No, Mr. Chairman. I appreciate the testimony.

Mr. BURTON. I want to thank you very much, Mrs. Gallo, for

being with us. Continue your good work. If we can be of any help,

let us know.

Mrs. GALLO. If I can be of any help, I am here to help.

Mr. BURTON. And we all miss Dean.

Mrs. GALLO. I do too. Thank you.

Mr. BURTON. Would the next panel come up, the experts. We appreciate your being so patient. We will try not to keep you too long.

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I can’t recall when we have had so much knowledge and talent

at that table at one time. I only regret that more of my colleagues

are not here. I am sure there will be more coming back and forth,

running from different meetings. So I apologize for that.

Dr. Geffen, I have been instructed to ask you if you have an

opening statement and let you start off, if you would like.

STATEMENTS OF JEREMY GEFFEN, M.D., GEFFEN CANCER

CENTER AND RESEARCH INSTITUTE; KONRAD KAIL, M.D.,

PHOENIX, AZ; SOPHIE CHEN, Ph.D., BRANDER CANCER RESEARCH INSTITUTE, NEW YORK MEDICAL COLLEGE; ALLAN

THORNTON, M.D., INDIANA UNIVERSITY; RICHARD KAPLAN,

M.D., NATIONAL CANCER INSTITUTE, ACCOMPANIED BY JEFFREY WHITE, M.D., DIRECTOR, NCI’S OFFICE OF CANCER

COMPLEMENTARY AND ALTERNATIVE MEDICINE; ANDREW

C. VON ESCHENBACH, M.D., AMERICAN CANCER SOCIETY;

AND DR. IAN THOMPSON, COL.M.C., UNIVERSITY OF TEXAS

HEALTH SCIENCE CENTER AT SAN ANTONIO

Dr. GEFFEN. Good afternoon. I am honored and privileged to be

here today and to have the opportunity to speak with you about a

subject that I care very deeply about, namely the journey through

cancer in general, and prostate cancer specifically.

Like so many others, I have been touched by this disease in

many ways, including through members of my own family. I spent

14 years studying and training to become a medical oncologist at

some of the finest universities and medical centers in the United

States, and have also been fortunate to have studied medical and

spiritual traditions in other parts of the world. For the past 10

years, I have also had the privilege of serving as physician, guide,

mentor, coach, and friend to thousands of cancer patients and their

family members, many of whom were dealing with the often formidable challenges associated with prostate cancer.

Along the way, I have learned one lesson over and over and over

again that I believe lies at the heart of what patients and families

experience on their journey through cancer. That lesson is very

simple, yet profound, and it is this: Cancer often challenges the

mind, heart, and spirit of patients and their family members, as

deeply, if not more deeply, than it challenges the physical body.

Unfortunately, even tragically, this simple lesson is often overlooked in the compelling search for newer and better ways to diagnose and treat cancer.

The urgent drive to eradicate illness has caused Western medicine, which we are so richly blessed to have, to focus almost exclusively on the physical dimensions of disease, rather than on caring

for the whole person who has the disease. This is especially true

in the field of oncology.

With respect to prostate cancer, for example, as we have heard

today, we typically speak of incidence and mortality rates, PSA

screening programs and Gleason scores. We talk of radical versus

nerve-sparing prostatectomies, external beam versus seed implant

radiation therapy, and things like simple versus total androgen

deprivation therapy. In recent years, we have also started to talk

about the role of diet, nutrition, and alternative and complementary therapies in cancer prevention and treatment.

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This is the language of prostate cancer, and it is also the language that physicians, researchers, and legislators tend to use

when we talk about where the field is today and where it should

be going in the future. If we listen carefully to all of this language,

however, and if we have the courage to really hear, we will notice

something that is almost always glaring in its omission: namely,

the mind, heart, and spirit of the men who are going through the

nightmare of prostate cancer, and the spouses and family members

who are going through it with them.

Make no mistake, aggressively pursuing all avenues of research

in early diagnosis, prevention, and treatment of cancer is a vitally,

critically important task. However, technological breakthroughs in

science and medicine, no matter how breathtaking or spectacular,

will never fully resolve the enormous spectrum of challenges encountered by people with cancer.

And in a similar vein, as valuable as they are—undoubtedly valuable—neither will diets, herbs, vitamins, antioxidants, exercise

programs or other similar regimens. Focusing primarily on treating

the physical body ignores the profoundly important mental, emotional, and spiritual dimensions of this disease, and it also ignores

the important inner healing potential that lies within all of us.

Thus, as radical as it may seem, I have one simple message that

I would like to bring to this committee. I believe it is time for our

medical and health care system to make a firm, uncompromising,

and unwavering commitment to honor and embrace every single dimension of who we all are as human beings, particularly in the

care of people with cancer. At our cancer center in Florida, we have

implemented a unique program which, along with high-tech conventional medical cancer treatments, is designed explicitly to accomplish this very goal. The program, which has seven levels, addresses each and every aspect of the healing process that patients

encounter on the journey through cancer.

Very briefly, the seven levels are as follows: First is education

and information, which is designed to give patients answers to the

urgent, pressing questions which they have about their disease and

treatment options.

Next is psychosocial support, which focuses on the need and benefits of having a strong support network on the journey through

cancer as well as the journey through life.

Third is what we call the body as garden, which encourages patients to think of their body as a garden that can be cultivated and

nurtured rather than as a machine that is simply to be fixed by

the doctor. This level of the program is where we also explore the

vast array of alternative and complementary therapies which can

definitely help facilitate this process.

The fourth level of the program is called emotional healing, and

here we help patients and family members deal with the difficult

and at times overwhelming emotional challenges encountered on

the journey through cancer.

Fifth is the nature of mind, which helps patients gain an understanding of how their own thoughts and beliefs, and the meaning

they give to events, including cancer, profoundly influences their

day-to-day experience of life and their treatment process.

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Sixth is life assessment, which helps patients understand and

connect more deeply to their life’s deepest meaning and purpose

and to their most important goals and priorities for the coming

year.

And last, No. 7, is the nature of spirit, which teaches patients to

connect with the nonphysical, timeless, dimensionless, and profoundly healing spiritual aspect of life that we all share.

Years and years of experience have proven to me that these are

the seven areas of care that all patients need, in addition to the

very best that high-tech conventional medicine has to offer. I believe that our challenge and our opportunity is to find a way to

make them available to every man, woman, and child in America

who has cancer. Thank you.

[The prepared statement of Dr. Geffen follows:]

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Mr. BURTON. Thank you, Doctor. We will take a look at your

book. I presume what you just talked about is in your book.

Dr. GEFFEN. That is right.

Mr. BURTON. Hopefully it will help give us a more in-depth understanding of how to deal with it. My mom and dad died of cancer

last October and November, and my wife has had breast cancer for

5 years, so this is the kind of literature that we have in the house

all the time.

Dr. Kail, would you like to go next, sir?

Dr. KAIL. I want to thank Chairman Burton and the members of

the committee for holding this hearing on one of the leading forms

of cancer affecting U.S. males. I am a licensed naturopathic physician and a physician’s assistant.

Mr. BURTON. Doctor, this is going to be for the record and it will

be disseminated to the Congress. So we need you to talk straight

into the microphone.

Dr. KAIL. I have a private practice in Phoenix, AZ, and serve as

the chairman of the board of the Southwest College of Naturopathic Medicine and Health Sciences. I am here as a representative

of the American Association of Naturopathic Physicians. I formerly

was on their board of directors and I participate in several other

alternative medicine organizations. I am currently a naturopathic

physician representative to the advisory council of the newly created NIH Center for Complementary and Alternative Medicine,

and I am serving as the first NCCAM advisory council liaison to

the National Institutes of Health advisory panel as well.

I attended the last NCAP meeting and was pleasantly surprised

at the high level of interest among conventional cancer specialists

with alternative medical therapies. Admittedly, they had little

knowledge about how they worked, but they were interested in the

outcomes that they were observing.

I hope that this will eventually become part of the day-to-day

course of medical events, but as of this reading, most alternative

treatments are not even considered as an option in looking at the

list of medical events that can happen in regard to this.

My written statement refers to several things: The similarities

and differences in the training of naturopathic and allopathic physicians, the medical philosophy that is different and why that creates barriers to integrating this into care, and we are also going

to talk about some of the things you can do to deal with prostate

cancers and what we can do to get by the barriers to care.

I had some slides prepared. This first slide looks at some of the

differences in training as far as specifics and some of the softer

areas of clinical science that we have specific education in.

Next slide.

The next slide shows more equivalence of our education. If you

look at the top three schools, they are all naturopathic colleges and

the bottom three schools are well-known medical universities. The

main information here is that our total number of hours is basically the same in basic sciences and clinical sciences. You can see

that in allopathic medical sciences we are just a little bit short and

of course the naturopathic medical sciences, if you will, don’t show

any representation at all in the allopathic venues.

Next slide.

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This is even a bigger discrepancy when you look at some of the

things that were allowed to counseling and therapeutic nutrition.

The other differences that come other than our education involve

philosophy and the types of therapeutics. Natural therapeutic modalities include five basic types: Nutrition, botanical medicine, energy medicine, physical medicine, psychological medicine, and

minor surgeries, which sometimes includes home birthing. And in

some jurisdictions, naturopathic physicians can write prescriptions

and dispense medications as well.

As to our philosophy, the next slide please, one of the concepts

that we hold as naturopathic physicians is the concept of the vital

force, that each person has in them a force that innately tries to

optimize conditioning and functioning. We view health as more

than the absence of disease but a balance of a variety of forces

moving toward the optimal condition.

Next slide.

Toxification is one factor that opposes this natural inclination toward optimal. Toxification is the concept that dysfunction of metabolic processes to detoxify internally generated or ingested

xenobiotics is a progenitor and aggravator of disease and this is an

event that can be measured. Internal cleansing via detoxification

protocols to simulate liver and other organ functions result in a

lower level of internal toxic burning and hence facilitate healing.

Next slide, please.

There are basic tenets of care that are shared by most healing

traditions. The healthy lifestyle and treating the whole person in

the context of their environment are the things that might be

unique to us.

Next slide.

Naturopathic health care services are focused in a different area.

Our fortes are treatment of preclinical disease and chronic disease

management.

Next slide, please.

Diagnosis is around health risks, tissue function, and finally gets

to pathology. But we think it is very important if you want to look

at prevention that you look at the things that precede disease.

Your risk goes up; your function goes down.

Next slide.

Outcomes are based—hopefully, therapeutics are based on outcomes. We review the medical literature. We develop the protocol.

We track our outcomes. We refine the protocol.

Next slide.

Studies have shown potential savings could be great. And this is

looking at naturopathic patients who were 50 percent lower or discontinue conventional medication; 16 percent forgo a surgery procedure, 96 percent get educated well at home, and 92 percent as a

result of that change their lifestyle.

Next slide, please.

If you look at likelihood of use of therapies when conventional

therapies fail, of course supplements and diet lead the pack, but increase likelihood when other things fail.

Epidemiology, there are a couple of points on here that are important. First, that 80 percent of cancers are slow growing and 20

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percent of prostate enlargement is cancer. The rest of the demographics you are familiar with.

Next slide.

If you look between 1983 and 1991, new cases increased dramatically. But if you look at deaths due to cancer and percentage of

deaths, they are actually modest increases and actually decrease in

percentage of deaths. This reflects earlier intervention due to better diagnosis. This is the result of people getting those PSA tests

out there.

Next slide.

This is probably the most dramatic slide I can show you, and

that is that this cries for conservative treatment. In one study that

is treated here only 8.5 percent of the people followed for over 10

years died from their cancer, 47 percent of those people died from

other causes. The survival rate was 86.8 percent with no treatment

at all compared to survival rates of 65 and 83 percent with irradiation and prostatectomy. The mean survival time of 10 years was

found in 85 to 90 percent of the patients involved. This cries for

conservative treatment.

Next slide.

Some basic approaches that are different between allopathic and

alternative medicine. Allopathic medicine with regards to cancer focuses on decreasing the cancer mass while alternative methods focuses on increasing host survival. Allopathic usually are single modality. There are some multimodality uses, but by and large all alternatives are multimodality. The agents are noninvasive and conventional agents reduce host defenses where CAM agents build

them. The best I can say is that the best outcomes are an integration of both.

If we can go through the next slide quickly. If you look at utilization of therapies, chronic conditions basically are treated better by

alternative medicine than possibly conventional medicine. If you go

to the next slide you will see efficacy. With cancer in particular,

you find that alternative methods are on a par with conventional

methods. In other words, alternative treatment alone doesn’t do

any better than conventional treatment alone. It is when you do

both together that you get a synergistic effect and actually do better.

Next slide.

Primary cancer therapy for alternatives is avoidance xeno biotics,

lifestyle modification, detoxification, energy balancing, optimizing

function, relaxation, and visualization.

Secondary therapies include antioxidants, immune modulation,

endocrine modulation, and specific therapy as to tissue types.

Next slide.

Nutrition is a big part of that. This is also part of prevention as

well as treatment. There are several things listed there that are

very useful. The big ones of course are modified citrus pectin seems

to prevent metastases, and IV vitamin C seems to be very promising.

Botanical medicines have specific indications for treating prostate cancer. They either block estrogen or follow stimulating hormone or somehow have a direct effect.

Next slide.

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There are a whole bunch of other agents that have indirect effects, or are more suited for specific treatment of symptoms.

Next slide, please.

There are also other therapies that are less formal and secondary

that are also very usual. As you can see there is a wide variety.

Homeopathic medicine is very noninvasive and we have reviewed

some cases at the NIH which are very dramatic in homeopathic response to cancers. Dendritic cell therapy and some others are very

important.

Next slide.

Basically our modalities are inexpensive, they are easily managed at home, they have less side effects, and do result in better

outcome than conventional medicine, and they do result in better

quality of life for patients that have them.

Next slide.

Barriers to integration. There are two big barriers. One is 46 percent of HMOs actively discourage patients from using alternatives.

This makes it real hard for people to go see a doctor of their own.

Another big barrier that is not stated here is Federal policy and

this has to do with entitlements. If you are not entitled—if you look

at the language of entitlement of virtually every Federal program,

there is no language that enables alternative participation.

Other barriers to integration—next slide. This has to do with the

practitioners in the allopathic community. There is lack of information about training of the providers in the alternative community.

There is lack of information about alternative therapeutic modalities. There is lack of information about interaction with allopathic

therapeutics. And in general there is a fear of liability with conventional physicians comanaging patients with alternative physicians.

Part of this is due to the training that they receive. The next

slide please. You will see that a survey that I did of conventional

medical colleges that were training in alternative methods we

found that out of 26 schools we surveyed, 9 responded. But as you

can see the quality of the courses here were less than desirable.

They are basically survey courses. There is no place where conventional physicians can get formal information that is quality information about alternative modalities without going to school.

Some things to facilitate integration. I will be brief. This is my

last slide. Public demand for CAM health care services is forcing

these things. The public is driving this boat. I think that is why

we are all sitting here. Inclusion of CAM providers into third-party

reimbursed multispecialty care networks forces communication. I

am in many of these. I have to communicate with the primary care

doctors as part of my consultation, and as a result of that, we are

getting to know each other and we trust each other’s therapeutics

more and we interact more for the benefit of the patient.

Integration training. There is a leg that can be done on both

sides of the fence to help people understand each other better. The

NIH, of course, National Center for Complementary and Alternative Medicine is a big step forward; however I want to put this

in context. Even though their funding went from approximately

$19 million to $50 million last year it still represents only one-third

of 1 percent of the total NIH budget. I think that is a very dramatic place to state where alternative medicine is in the convenVerDate 11-SEP-98 11:23 May 16, 2000 Jkt 000000 PO 00000 Frm 00086 Fmt 6633 Sfmt 6633 C:\DOCS\64044.TXT HGOVREF1 PsN: HGOVREF1
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tional community, certainly within the research community. It is

the smallest, tiniest little consideration out there. I think if you

look at the Federal Government in general that reflect business,

the same attitude.

Potential cost savings is so great, and the plan for integration is

so necessary, that there are several alternative medicine organizations that have been working on a national plan to address the

Federal public policy issues in regards to this. I have a copy of the

plan that has been put together by these organizations here with

me. I would like to see it entered into the record. I would also ask

that you and other members of the committee or committee staff

review the document and submit comments, criticisms, and suggestions for improvement to the organizations who are leading this effort.

I think if you read this, the magnitude of this document will suggest there are some very solid and good ways without a lot of funding, with just entitlement and other things, that we can do to

greatly accelerate this process of integration which I believe again

shows the best outcomes for all those concerned. I thank the committee for your time.

[The prepared statement of Dr. Kail follows:]

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Mr. BURTON. Thank you. We will review that followup on that

and I have some questions for you too on the record when we get

to that.

Dr. Chen.

Dr. CHEN. Mr. Chairman, and members of the committee, thank

you for your invitation to testify today. It is my honor to present

to you information on scientific research on botanicals for treatment of prostate cancer.

I appear before you today as a medical researcher. I got into this

field because of personal experience with family members who had

prostate cancer. In the past 10 years, we have learned that the

fight against cancer requires multiple interventions and efforts.

The good news I can say today is there are botanicals that can be

beneficial for cancer treatment and for prevention. The bad news

is we do not have enough clinical studies and there is still a long

way to go.

One role for botanicals is that they can serve as complementary

medicine to enhance the conventional therapies. They will not be

a replacement for cancer therapy at this point. There are large

numbers of botanical components that have been identified as antioxidants, immune stimulants, and others and are shown to be preventive for prostate cancer. These include selenium, vitamin E,

green tea extract, lycopene from tomatoes, soy products, and PC

SPES.

It is postulated that the reason Asian men and women have a

lower incident rate of prostate and breast cancer is because their

diet is rich in botanicals.

I feel the more we study these compounds, the better we can utilize them to help patients. Here I would like to discuss PC SPES,

which has been studied at many different prestigious laboratories

and hospitals across the United States. To my knowledge, more

than 1,000 men are taking PC SPES at the recommendation and

suggestion of their physicians. PC SPES is a standardized botanical

formulation composed of seven purified Chinese herbs and one

American herbal extract. The preparation is based on a patented

formulation which I developed. The laboratory data so far has

shown that it can inhibit prostate cancer cell growth in a test tube.

It can also induce them to go suicidal.

Two different animal studies confirm the laboratory finding and

show a 50 percent reduction in prostate tumor incident rate, in

tumor volume and in metastasis.

At the present time there are several clinical trials in phase two.

Two of them have been reported recently. Dr. Eric Small from the

University of California San Francisco found that 61 advanced

stage prostate cancer patients responded to PC SPES; 27 of them

belong to the group of hormone sensitive and they responded 100

percent. The other 34 hormone failure patients responded with 57

percent. He also found some reduction in the pain of those patients.

A separate study by German physician Dr. Ben Pfeifer with a

team studied 16 hormone refracture patients. They also had failed

the conventional therapy and were at the end of their life. The response rate among this group was about 70 percent and the quality

of life was found to be profoundly improved. Those data were preliminary. There are some side effects that need to be investigated.

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We need more funding and more studies to conclude these exciting

results and hope we can help more prostate cancer patients using

this new approach with multiple components based on scientific

studies.

In conclusion, I would like to suggest that Congress consider

fully refunding and expanding the budget for the National Center

for Complementary and Alternative Medicine and the Office of Dietary Supplement at the NIH to undertake clinical studies on

botanicals which show promise for prostate cancer treatment. I also

would like to suggest that the Congress can promote and encourage

more clinical research on botanicals by the NCI. Thank you for

your time.

[The prepared statement of Dr. Chen follows:]

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Mr. BURTON. Thank you, Dr. Chen. We will have some questions

for you and NIH about your findings in just a little bit.

Dr. Kaplan, would you rather someone else go first?

Dr. KAPLAN. I thought that Dr. Thornton was going ahead of me.

Mr. BURTON. Dr. Thornton.

Dr. THORNTON. Thank you, Congressman Burton, for the opportunity to speak before you and your committee this morning. I

serve as the chief advisor for the Midwest Proton Radiation Institute, and my current faculty position is as a member of the Department of Radiation Oncology at Massachusetts General Hospital

and a member of the Harvard Medical School. I have prepared a

brief summary of prostate cancer and then I will focus on proton

therapy.

In general, cancer of the prostate is common in men of developed

countries second only to lung cancer in incidence. The current incidence is greater than 75 per 100,000 with an annual incidence of

new cases of 120,000 in this country. The tumor is more common

in men of African-American ancestry and increases in incidence

with age.

Most cases of prostate cancer are composed of what is known as

adenocarcinoma cells, a pattern that is seen on pathologic specimens under the microscope. A small percentage of these cells are

transitional tumors, which are much more aggressive.

Importantly, the degree of differentiation of the tumor as seen

under the microscope when the tumor is first diagnosed is the single most important factor to determining survival and how aggressive the tumor will be.

The cancer of the prostate usually spreads, that is metastasizes,

by passage through the lymph system to lymph nodes, that is one

mechanism; second, by direct extension to tissues around the prostate gland; and also by direct invasion into the blood vessels and

thereafter into other organs throughout the body. The tumor may

spread to bones, which we have heard about today, where severe

pain and fracture may occur, as well as to the liver, to the lungs,

but rarely the brain. Patients often live for significant periods of

time after the tumor has spread subject to prolonged pain and compromise of quality of life due to these bone and organ metastases.

Fortunately, many prostate tumors are now detected at an early

age due to the development of PSA antigen test which we have

been hearing about today, which was developed in the 1980’s. Formerly, patients were not diagnosed until changes in either the

urine stream or frequency prompted a rectal exam. With sensitive

PSA screening, a significant number of patients, now thought more

than 50 percent, present with early stage disease, which represents

a clear pattern shift, disease diagnosed prior to the likely spread

of the tumor. This offers potential for long-term control and cure

to increasing numbers of American people if the control of the

tumor in the prostate gland can be realized.

The current therapeutic options as standardly recognized include

surgery, radiation, and we have heard cryotherapy for very early

stage disease. Hormonal therapy alone is effective therapy only for

very early cases in elderly men who are thought too senior for either radiation or surgery. Chemotherapy has thus far been relatively unsuccessful in affecting this tumor. Surgery is reserved for

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men with tumor confined to the prostate gland and it is usually designed for men with lower grade—that is less likely to spread—

types of tumors. Men must be healthy in order to tolerate the surgery and they must recognize that over 50 percent of the time they

will lose sexual function and may lose control of their bladder function.

Radiation is an effective alternative to surgery for prostate cancer supported by the consensus development conference of the NIH

in 1988. Radiation has the advantage of less toxicity with greater

likelihood of preservation of sexual function and bladder function.

It is also used widely for men with more advanced tumors, those

who have a higher likelihood of spread of their tumors, or those

who are thought not suitable for surgical rejection.

However, conventional radiation, which is known as photon or xray radiation, that is available in most community hospitals and

most university hospitals, cannot be aimed to selectively treat only

the prostate gland and not the adjacent rectum and bladder. Therefore, the doses that can be safely delivered with conventional photon radiation are limited.

Proton therapy involves the precise delivery of high doses of radiation with particle beams from hydrogen atoms, the hydrogen atom

nuclei, designed to treat only the prostate gland and involved tissues around the gland. This therapy for prostate patients is predicated on the knowledge that prostate cancer remains localized for

a significant length of time in the earlier stages of the disease.

However, we know from very elegant Canadian studies by Juanita

Crook in 1987 that over 38 percent of men will still harbor tumor

cells within their prostate glands after conventional radiation.

Of great significance is the knowledge that patients whose biopsies are positive after this treatment will have over a 70 percent

likelihood of going on to develop metastatic disease. However this

represents an incurable situation for these patients. However, if

the biopsy is negative after radiation, then only 25 percent of the

patient will develop metastatic disease and will likely be cured.

Therefore, effective control of the tumor within the prostate is the

key to long-term control and the cure of this otherwise relentless

disease.

Proton therapy has been used for many years, since 1962, for the

treatment of tumors at the base of skull, inaccessible to neurosurgeons. Cure rates with tumors at the base of brain have been

increased by 35 percent at the Massachusetts General Hospital in

Boston, working in conjunction with the Harvard Cyclotron Laboratory. The physics and computer dosimetry of proton therapy has

been developed to a very sophisticated degree, spurring increasing

elegance of conventional therapies as well.

Figure 1—and I have but one slide here—graphically demonstrates the high degree of concentration of protons in the prostate gland as viewed horizontally on a CT scan, which is known as

computerized tomography scan. The concentric colored lines represent the areas treated by the protons with very high degrees of

concentration. Volumes outside these lines receive only 20 percent

of the prescribed dose. If you look carefully, you will see a crescentshaped white line which represents the anterior wall of the rectum,

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which is a very sensitive structure and this is largely untreated

and spared with protons.

Currently only two centers exist in the United States to treat patients with proton therapy: Massachusetts General Hospital in Boston and Loma Linda Medical Center in Los Angeles. No center exists to treat patients in the Midwest, who must travel great distances and stay for an average of 2 months of proton treatment in

either Boston or L.A.

The Midwest Proton Radiation Institute, a consortium of Midwest universities led by Indiana University, is seeking to convert

an existing accelerator at the Indiana University Bloomington campus into a facility for the treatment of prostate cancers using proton therapy. Recognizing the need to provide access to this type of

cancer treatment to patients in the Midwest, the House Labor,

Health and Human Services, Education Appropriations Subcommittee in the 1999 committee report accompanying the appropriations

bill, encouraged the NCI to assist with the conversion of an accelerator for proton therapy treatments in a location not currently

served by two existing facilities. The MPRI clearly fits this outline

and MPRI sponsors, led by Indiana University, submitted an application to the NCI earlier this year to seek assistance with the conversion of this accelerator at the cyclotron facility for proton therapy treatments. To date, NCI has not reviewed the application.

I ask your committee to inquire of the agency its plans for responding to the language in the House report supporting the establishment of a proton therapy facility in the Midwest and how that

agency plans to specifically address the proposal put forth by Indiana University. It is our hope that congressional support for prostate cancer will include assistance to the Midwest Proton Therapy

Institute so that the proven benefits of proton therapy may be

available to patients throughout the United States with more equitable regional access.

We appreciate the opportunity to review the effectiveness of proton therapy for prostate cancer with this committee. Thank you.

[The prepared statement of Dr. Thornton follows:]

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Mr. BURTON. That was one of the slickist bits of lobbying I have

ever seen, it was well done.

Dr. Kaplan, are you next?

Dr. KAPLAN. Congressman Burton and members of the committee, I coordinate NCI’s extramural clinical research on prostate

cancer treatment. I am accompanied by Dr. Jeffrey White, who is

directly behind me, the Director of the NCI’s Office of Cancer Complementary and Alternative Medicine. I am pleased to appear before you to describe NCI’s prostate cancer research program and

our interest in complementary and alternative approaches to prostate and other cancers.

The Congress has asked NIH to make prostate cancer a top priority in allocating funding increases to accelerate spending on prostate cancer and to consult closely with the research community. We

have undertaken a vigorous effort to respond in all of these areas.

Prostate cancer has risen in clinical and research importance in

the last decade faster than any other neoplasm. Some of the many

factors responsible for this are greatly improved methods to identify the disease before it causes symptoms; major public awareness

campaigns, including the sorts of things that Senator Dole has had

such an impact on; some modest improvements in surgery, radiation, and hormonal therapy that have rendered management options more acceptable; and important new research opportunities.

When Dr. Klausner assumed leadership of the NCI he envisioned

a new strategy of evaluating the entire research portfolio for a particular disease from the ground up and structuring future efforts

according to the insight and advice of the entire extramural research community and of stakeholders, including patients, advocacy and patient support organizations, and professional societies.

This new process called a Progress Review Group [PRG], was initiated in prostate cancer and breast cancer and it was extremely

productive. The Prostate Cancer PRG laid out a framework for

planning and identified a number of particularly important problems and potentially productive areas of research. There are about

20 new NCI initiatives outlined in the reports that we have provided, but I would like to go through some examples.

The following sequence of three initiatives taken together should

speed the development of new interventions, that is to say treatments, of any type from initial work in the laboratory, or animal,

all the way into definitive testing in men with cancer. The RAID

and RAPID programs, as they are called, are intended to expedite

new agent development by moving novel molecules toward clinical

trials. Often there is a catch-22. Many scientists don’t have the resources to do all the required animal testing or drug formulation

before tests in humans can begin. At the same time it is not easy

to get a pharmaceutical or biotech industry partner to commit such

resources until an agent is further along.

This is where RAID and RAPID can step in. Independent investigators are given access on a competitive basis to NCI’s own preclinical drug development resources and expertise. They are assisted with necessary development steps to enable investigational

new drug application filing with FDA and initiate proof-of-principle

trials. Then NCI steps back out and the investigators are free to

develop industry collaborations.

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The next step is to actually carry out preliminary patient clinical

trials to find out how best to apply the new intervention and

whether it actually does appear to do something useful in patients.

These studies are time consuming and personnel intensive and

may require sophisticated tests. And it is increasingly difficult in

today’s medical care system to do such trials without grant funding. But it is challenging to get a conventional grant with little preliminary data and there can be frustrating and unsatisfactory

delays.

For this reason, we developed the Prostate Cancer Quick Trials

program, a process for rapid approval and funding of early trials

of new agents. We feel we can increase the number of early clinical

trials and the number of patients participating by two to threefold.

If the Quick Trials approach works the way we anticipate it will,

we want to make a similar mechanism available to researchers

working in other cancers as well.

Then how do we speed up definitive testing of agents that do appear promising in these early trials? And how do we assure that

patients all over the country have access to these?

NCI has begun a complete restructuring of the national system

in which the best new approaches are compared with established

treatments. These studies will be available not just for particular

teams of doctors but to patients anywhere through any qualified

oncologist. This new system is a complex one to set up and so it

will be tried out in a limited number of diseases at first. Prostate

cancer was selected as one of the two types of cancers in which to

start.

It should be noted that all of these new initiatives are inherently

open, competitive ones. They do not specify that the interventions

be drugs. They could be dietary supplements or surgical procedures

or new radiation techniques or gene therapies, whatever, and they

may be intended for either treatment of established prostate cancers or for prevention. And they may arise within the conventional

medical research community or from the alternative medical community, academia or industry.

In addition, the NCI is moving very quickly in important directions to develop CAM information and expand research opportunities for CAM investigators. These activities are broad in scope and

include strengthening our relationship with the National Center for

Complementary and Alternative Medicine [NCCAM], the careful

evaluation of alternative therapies and the development of accurate

CAM information for the public.

One collaborative goal is to develop centers for CAM research as

well as specialized research centers to investigate the biological effects of botanicals, including those that are available as dietary

supplements. Several studies of alternative approaches are already

under way. NCI-sponsored projects recently have suggested that

both vitamin E and selenium supplements may be capable of preventing prostate and other cancers. More investigation is needed,

and NCI continues to support several studies addressing the effectiveness and the prevention of prostate cancer by lycopine and dietary soy as well as by vitamin E and selenium.

Now, everything I have described thus far has to do with applying interventions that build on what we have already discovered,

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but the greatest potential for actually eliminating prostate cancer

depends on dissecting and understanding biology of the disease,

how it does its damage, what genetic and molecular abnormalities

allow it to grow, spread, and for it to resist therapy. In fact, the

real answer to many of the dilemmas in management of patients

may be found only when we know enough about individual tumors

to predict their behavior and access their vulnerabilities.

For example, we currently estimate which prostate cancers are

most likely to recur by their appearance under a microscope, their

stage, and the PSA level. But there is so much overlap that the decisionmaking for most patients is still terribly difficult. If we had

better ways to classify whether an individual patient’s tumor is one

with a high malignant potential or one of the larger number that

poses considerably less risk, then we could much more easily test

early detection and screening technologies and we could provide the

confidence to spare many men the long-term side effects of prostate

surgery or radiation.

Mr. Chairman, if you would allow me to have 1 or 2 more minutes I would like to cover one other initiative. For these all important reasons, I would highlight these two other programs. The Cancer Gene Anatomy Project, which is CGAP, which has thus far discovered 146 genes that appear to be prostate specific and 400 genes

that appear to be expressed differently between normal prostate

tissue and prostate cancer.

This information and subsequent discoveries of CGAP will provide the raw material for undertaking the next initiative, the NCI

Director’s Challenge for Molecular Diagnostics. Its goal is to develop a tumor classification system that is firmly based on cell biology of cancers rather than on microscopic appearance. Prostate

cancer is a particularly important area of application for this effort

because its behavior is so variable from patient to patient.

Mr. Chairman, I appreciate the level of interest this committee

has shown in prostate cancer. I hope my testimony demonstrates

NCI’s commitment to advancing our knowledge about prostate cancer as rapidly as possible. Our activities, and specifically Dr.

Klausner’s leadership efforts over the past year, have invigorated

the prostate cancer research community. It is this essential partnership between NIH, other funders and that research community

that will successfully accomplish the ambitious goals of this plan.

Dr. White and I will be pleased of course to answer any questions you may have.

[The prepared statement of Dr. Kaplan follows:]

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Mr. BURTON. Thank you, Dr. Kaplan. Dr. von Eschenbach.

Dr. VON ESCHENBACH. Good afternoon Mr. Chairman, members

of the committee. I am honored to be here today representing the

American Cancer Society as a national board member and would

like to thank you and the committee for the opportunity to appear

to testify on issues concerning our Nation’s fight against prostate

cancer.

In addition to my involvement in the American Cancer Society,

I have been privileged to participate in this fight in a variety of

other ways, serving as the chairman of the Prostate Cancer Multidisciplinary Research Program at the University of Texas M.D. Anderson Cancer Center. As well as being the chairman of the Integration Panel for Prostate Cancer in the congressionally directed

research program at the Department of Defense, I am a medical

and scientific advisory cochair of the National Prostate Cancer Coalition and a member of the Scientific Advisory Board of CAP-Cure.

This involvement in prostate cancer has impressed upon me that

this disease is a national tragedy.

Mr. Chairman, this morning you so eloquently described the burden of this disease by demonstrating those statistics. And we heard

earlier today from Senator Dole and Congressman Cunningham

and Mrs. Gallo the enormous pain and suffering that this disease

inflicts on both patients and their families.

The Cancer Society recognizes that prostate cancer is a medical

and scientific problem as well as a cultural and social problem and

economic problem. And so we have chosen to really advocate a comprehensive three-pronged approach that recognizes the importance

of contributing to and enhancing the funding of research so we can

develop more effective strategies of prevention and therapy, to advocate for equal access to quality care throughout this entire country and to improve our education and promotion of early detection

and treatment options.

Today I can only focus on one of those many important issues

and I would like to then comment specifically upon the importance

of enhancing our commitment to the research endeavor.

The American Cancer Society supports the strategic plan of the

National Cancer Institute and the Department of Defense to promote and enhance our research effort in prostate cancer. This disease is an incredibly complex problem. There are important fundamental issues that need to be addressed if we are truly going to

face and change those statistics that you pointed out to us this

morning.

Why in one patient is this a latent disease while in another like

Congressman Gallo it can be incredibly virulent and lethal in a

short period of time? Why does it take such an enormous toll on

African-Americans in this country? And why does the lethal form

of prostate cancer that kills us preferentially metastasize to bone

where it then becomes refractory to our standard treatments?

If we are going to make a difference, the only way to make that

difference is by understanding these processes so we can then rationally develop appropriate, effective strategies to interrupt them.

It is true that you should take great pride in what you have already accomplished in supporting research throughout this country

through your efforts, and that research is bearing fruit. The PSA

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that you have heard about today from so many people that has altered and changed our ability to find this disease early in its course

when it is potentially curable is a direct result of research. There

are now new therapies that are being introduced in the clinic

today, including at M.D. Anderson trials where we are now taking

some of the genes that are defective in the more virulent forms of

prostate cancer and, using an adeno virus as a carrier, we are able

to reinfect those prostate cancer cells with the normal gene in an

effort to prevent their lethal progression.

You have heard about a variety of new compounds and substances that are coming to us, such as the antiangiogenesis factors

that stop the blood supply to these tumors and keep them from

being able to spread and progress.

And so much is being accomplished but so much yet needs to be

done, and frankly the funding to do it is inadequate. As I mentioned, I chair the Integration Panel at the Department of Defense.

You have been generous in this Congress in fiscal year 1999 to allocate $50 million to that program for research, of which we had

about $41 million to spend across a wide variety of needs, including

the training of new investigators in the field, the development of

programs in minority universities and colleges, and then we had

about $20 million left over to fund novel new ideas in prostate cancer research as well as the development of young investigators.

We received in that program over 560 applications of which we

had only sufficient money to fund 46, an 8 percent funding level.

If we just look at those ideas that the peer review panels believed

to be outstanding and excellent and scored about 2.0 in their priority scores, we were only able to fund one of three; two out of every

three ideas had to be rejected, not because they were not excellent

but because we did not have sufficient funds.

It is essential for us to change the face of this disease to understand it better, and then to translate that understanding into clinical trials, evaluating new and effective methods so that we can

make them available to men and their families to achieve the scientific breakthroughs that you expect of us.

I have been privileged for over 25 years to walk this journey with

prostate cancer patients and their families, and my own father died

of this disease. I thank you and your committee for the concern and

dedication that you are demonstrating in having these hearings.

And this week, National Prostate Cancer Awareness Week, is a

special time to remember the fathers and husbands and brothers

who have been lost to this disease. The American Cancer Society

and I, along with all the organizations I am privileged to be a part

of, look forward to working with you in a partnership to change

this journey of fear and suffering into a journey of hope. Thank

you.

[The prepared statement of Dr. von Eschenbach follows:]

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Mr. BURTON. Thank you, Doctor. Dr. Thompson.

Dr. THOMPSON. Good afternoon, Mr. Chairman, members of the

committee. My name is Ian Thompson. I am a urologic oncologist

from San Antonio. I am a professor of urology at the University of

Texas Health Science Center, director of the Prostate Cancer Program at the San Antonio Cancer Institute, and consultant in urology to the Surgeon General of the United States Army. I would like

to express my sincere appreciation for the opportunity to participate in this important hearing.

With the successful aging of the U.S. population, prostate cancer

has become an increasingly important public health threat. This

disease will assume increasing importance as its frequency is directly related to a man’s age. With the continued improvement in

life expectancy in the United States, prostate cancer will become an

even more significant disease.

Traditionally, we have focused on two methods of addressing the

disease. The first was an effort to improve our treatment of prostate cancer which as of this morning you heard it can spread to the

bone and can be associated with significant pain, decreased appetite, and a major reduction in the quality of life. While much

knowledge has been attained through cancer clinical trials, rarely

can this stage of the disease be cured.

With the advent of prostate specific antigen [PSA], testing in the

1980’s, the focus moved to early detection and treatment. Over the

subsequent decade we have witnessed a fall in prostate cancer

deaths. The degree to which this fall is due to PSA testing is yet

undetermined, but it is an extremely important and promising development. Nevertheless, the cost and side effects of such treatment can be significant.

The science of cancer prevention is one of the youngest fields of

oncology. Nevertheless, important advances have been witnessed in

the past 10 to 15 years with many of these advances heralding a

new age in our approach to prostate cancer. I often tell my colleagues and my residents and my peers that I personally believe

the next decade will be the decade of prevention in oncology, and

I am very optimistic that much will be accomplished in the very

near future.

We are currently witnessing a confluence of many discoveries

that when paired with the considerable interest by your committee

and by the National Cancer Institute and other funding agencies,

can be expected to provide patients and clinicians with practical,

proven methods to reduce a man’s risk of developing prostate cancer.

On the basic science front we are understanding much better

those individual steps that cause a normal prostate cell to divide,

invade the prostate, and then spread. Each of these steps involves

many processes and each offers a target of opportunity to prevent

development or spread of the disease.

Through observational studies we have also identified a number

of new agents and approaches that deserve investigation, many of

which offer tremendous promise to reduce the risk that a man will

develop prostate cancer.

We know, for example, that male hormones play a major role in

the development of the prostate and ultimately of enlargement of

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the prostate and prostate cancer. With the development of the first

five-alpha reductase inhibitor medication called finasteride that reduces the hormonal stimulation of the prostate, the National Cancer Institute in collaboration with the Southwest Oncology Group

developed the Intergroup Prostate Cancer Prevention Trial to determine if this agent can prevent the development of prostate cancer.

The response of men in this country to this trial was overwhelming and indeed 18,881 men ultimately enrolled in this study and

this study reached its enrollment goals exactly 3 years to the date

of its inception directly on schedule. We were actually overwhelmed

with the response. My understanding is that the Cancer Information Center of the National Cancer Institute received its largest

volume of phone calls the day after we had a press conference here

in Washington to announce this trial. I oftentimes say that men

voted with their feet. They thought that they would never participate in a prevention trial. These were healthy men without evidence of prostate cancer and we were overwhelmed by the interest.

We expect the results of this study to be available in the next

several years. Efforts at prostate cancer prevention, however, have

not stopped there. I am aware of many trials assessing the effects

of multiple novel agents on prostate cancer development. We in

San Antonio are currently conducting a study of alpha tocopherol,

which is vitamin E, a very promising chemo-preventive agent in

men at high risk of developing prostate cancer.

A second micronutrient, selenium, an agent which may, like vitamin E, function as an antioxidant is also being studied in a number

of trials. In response to the evidence of the potential effectiveness

of these agents the Southwest Oncology Group and the Department

of Veterans Affairs have collaborated to develop the neat

intergroup prevention trial called SELECT, the Selenium and Vitamin E Chemoprevention Trial, a study proposed to study 32,400

men and we hope if it is funded it will begin next summer. I am

very optimistic that for many of my generation and certainly for

those of my son’s generation—and I have to reflect back, my grandfather passed away from prostate cancer as well, and so I have a

personal interest in this as well—that we will have clear evidence

that the risk of prostate cancer can be reduced.

We are currently approaching this challenge on many fronts: In

the molecular biology laboratories of the United States, through

epidemiologic studies, using cancer models and most importantly

through well-designed prospective clinical trials. It is only through

these trials that we will be able to assure men with confidence that

our recommendations are scientifically valid. The contributions of

the Cooperative Clinical Trials Groups and the National Cancer Institute have been enormous, as has this interest by this committee,

and your collaboration sets the stage for the discoveries over the

next decade.

Again, Mr. Chairman, members of the committee, it has been a

distinct honor to have been here, and I thank you for your interest.

Mr. BURTON. Thank you very much, Dr. Thompson.

[The prepared statement of Dr. Thompson follows:]

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Mr. BURTON. Dr. Kail, you indicated that one-third of 1 percent

of the total NIH budget is used for alternative therapies; is that

correct?

Dr. KAIL. That was the figure that was passed out at the

NCCAM meeting that recently was held when they looked at just

what funding characteristics they had had. Other interesting

things there was about this much basic science funding and this

much clinical outcome funding, which I thought was quite appropriate.

The thing I found most interesting about the funding pattern

was that many of the institutions that put forth proposals at least,

at the NCCAM meeting, were conventional institutions. I mean

Harvard for instance had 10 or 12 proposals put forth. Many of

these institutions have no CAM providers in their proposals and

they were not being done at CAM institutions. With the paucity of

knowledge in the conventional community about alternative therapies, I find that we are having the same research organizations as

apply for conventional grants turn right around and go for funding

under alternative medicine.

It is very clear that the alternative medicine research community

is not equipped to compete for funds even under NCCAM guidelines. We have to go out and recruit these individuals, mostly because the best research—the best treatment of cancer patients does

not occur in the research institution itself, does not even occur in

medical schools. It occurs by alternative medicine doctors practicing on their own in the field and most of these people are getting

good outcomes but not even tracking them.

They have an inherent fear of dealing with research organizations, especially allopathic ones, because they are concerned that

they may not have control of the research and the outcomes may

not be the same as they could achieve. This is a real problem about

getting alternatives really looked at under this microscope. We

have to get them access to it.

Mr. BURTON. Dr. Chen, you were talking about this new combination of vitamins and other things that was put into what did

you call it, PC SPES?

Dr. CHEN. Yes, a combination of plant extracts.

Mr. BURTON. And you said that there were some side effects.

What kind of side effects were you talking about?

Dr. CHEN. The side effect has not been officially established but

based on the observation include the decrease in libido.

Mr. BURTON. Decreasing libido?

Dr. CHEN. Yes, and some breast tenderness.

Mr. BURTON. Some breast tenderness? And that is a combination

of how many different kinds of vitamins? Selenium, vitamin E.

What else? Green tea.

Dr. CHEN. Well, there are eight different herbs. Seven of them

are Chinese herbs and one American herb. The herbs belong to the

common use.

Mr. BURTON. I think I take all of those things and I haven’t had

any of those side effects yet, but I don’t take them in one pill.

Let me just ask those of you who are from the National Institutes of Health and National Cancer Institute, why is it that we

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cent seems like such an insignificant amount, especially when

there is a growing percentage of Americans and if you don’t believe

it, all you have to do is go to the health food stores. They are voting

with their feet and their dollars. They believe that there are some

preventive qualities in some of these things that they are buying

at health food stores and from going to these alternative physicians.

Why is it that the NIH and National Cancer Institute are not allocating more money for research in those areas? Can somebody

answer that for me? One-third of 1 percent of the total budget

doesn’t seem like very much to me.

I think the answer is not so much why they are not putting so

much money in as much as why are investigators not applying

more effectively to get that money. Most of the money that is spent

is spent in response to applications that come in from independent

investigators who say, here is an experiment that I want to do, and

it gets peer reviewed; and as we all know, we don’t get to fund as

many as review well, but we fund as many as we can. But a lot

of the money goes to whatever research applications come in that

are very well done.

If they don’t come in, the money doesn’t go in that direction so

much.

Mr. BURTON. You heard Dr. Kail talk about one of the problems

that he had with it.

Dr. KAPLAN. I did. Can I respond to that? Because I think he was

describing a glass that was half empty, but I would say, in a sense,

that is a glass that is half full. I actually find it encouraging that

conventional practitioners and institutions are, in fact, willing to

take up this level of research, that there is not some wall between

the types of agents involved or the types of research.

There has been an unfamiliarity, but it looks like there are efforts afoot to break down that unfamiliarity, and those researchers

do have the track records of knowing how to get patients to respond and participate. I think that is going to be a tremendous

asset to evaluation of these techniques.

Mr. BURTON. Do you have a comment?

Dr. VON ESCHENBACH. Thank you, Mr. Chairman.

I cannot speak for the National Cancer Institute, actually, but

with regard to the Department of Defense program in prostate cancer, I will be happy to provide specific detail later. I don’t have it,

but I do know that in that research effort, we did fund and have

received important applications in looking at the role of diet and

dietary supplements, such as the ones that were mentioned today.

So much interest is being developed in the scientific community

in looking at these opportunities. Even at an institution such as

M.D. Anderson, which is a very large, complex academic cancer

center, we have a substantial investment in what would be described as complementary and alternative medicine, including research that is being developed in the role of spirituality, stress reduction. We have the availability of tai chi and yoga, the availability of acupuncture.

So I think the point to be made is that there is an explosive interest in what we would consider to be first-line academic, scientific

institutions, to look into this area, but to look into it in a critically

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important way so we can then apply it to patients in a rational

fashion.

Mr. BURTON. Mr. Turner, do you have some questions?

Mr. TURNER. You know, it is always, I think, confusing for most

men when they hear all these stories and come across articles

about dietary supplements and vitamins and herbs that were perhaps helpful in preventing prostate cancer, and it would be interesting—in fact, I guess I might ask Dr. Thompson or Dr. von

Eschenbach. If we were to do a survey of the established medical

community at the Health Science Center in San Antonio or down

at M.D. Anderson, what would we find the urologists and

oncologists taking, more likely than not, as a dietary supplement?

Because that would probably indicate where at least the medical

community thinks there might be the most hope for some effective

prevention by way of dietary supplement. What would we find?

This is kind of a talk you might have over coffee with your colleagues, but what would you find them doing?

Dr. THOMPSON. I will answer perhaps for San Antonio, and perhaps Andy can answer for Houston.

We have actually looked at not just members of the medical community, but our patients as well, and we find as many as 45 percent to 50 percent in an average urologic practice are taking some

form of dietary supplements, micronutrients and so forth.

I recently addressed about 400 men who are participants in the

prevention trial in San Antonio, and when I asked how many were

taking vitamin E, which I suspect is second maybe only to a baby

aspirin that frequently they are taking at that age, probably onethird to one-half of those men raised their hands. I suspect that our

medical colleagues are probably doing that as well.

The difficulty with it, though, is that we suspect that it may have

that effect. Heretofore we know that populations who take

betacarotene have a lower cancer risk, but then when the National

Cancer Institute collaborated with the Finnish and did the study

where you take the supplement itself to try to reduce lung cancer

risk, it actually increased it. So we have that suspicion that it may

work, but actually it takes the clinical trial to move that forward.

I suspect vitamin E and perhaps aspirin is the answer to your

question. But, unfortunately, we are kind of—we have no autopilot,

we are not sure exactly where we are going until we actually do

that clinical trial.

Dr. KAPLAN. Congressman, I would echo those comments. It is

extremely important for us to engage our patients in this regard,

so that we know what they are doing and how that might or might

not interact or complement what we are doing with regard to therapy and treatment, because sometimes they may be taking things

that could actually be harmful with regard to the kind of treatments that we are applying.

We provide to patients dietary survey. We provide to them dietary consultation and recommendations regarding low fat and the

use of supplemental vitamins. For me, personally, just on a personal note, when I remember, I take my vitamin E and selenium

every morning.

Mr. TURNER. Dr. Thompson, you mentioned the study that is involving 18,000 men and then you mentioned one that will involve

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30,000 or something. I am not sure I understand exactly what

those two studies are designed to do.

Dr. THOMPSON. It is an excellent question, Congressman.

The prostate cancer prevention trial is the first large-scale, randomized trial to address whether an agent can actually reduce

prostate cancer. It began in 1993, and it was designed to enroll

18,000 men, actually we overaccrued because of the interest, we

had almost 19,000 men who participated. Each one of these men,

if you look at a map of the United States, there are dots for each

individual’s home of record.

The map of the United States is covered with those dots. There

are 220 centers around the United States, ranging from cancer centers to a community oncologist’s private practice. Those men are

taking either the drug itself, which reduces the hormonal stimulation of the prostate, or a placebo tablet, to see whether it will actually reduce their risk of prostate cancer.

The study will begin its end-of-study biopsies of the prostate, as

you heard earlier today, in January 2001. It takes a long time to

complete those studies because prostate cancer grows and develops

so slowly. But we hope by 2004, maybe a little earlier, maybe a little later, we will have the results of the first trial. It is, if you will,

the male analog to the tamoxifen trial for breast cancer, one of the

first study results.

We feel the data for selenium and vitamin E are so compelling,

we are not stopping there. We are planning to begin the next trial

to look at vitamin E and selenium to see whether they can reduce

the risk in a larger group of men, again men without prostate cancer, absolutely healthy men. We hope to begin that trial next summer. Because we are going to be looking at two agents, it requires

even more men and it will be somewhere around 32,000 to address

the question.

In 1993—it seems like ages ago that we began—but we are just

on the doorstep of our first results of that trial. We feel very, very

encouraged by the interest coming from Washington and from the

National Cancer Institute in supporting these prevention trials.

Mr. TURNER. Thank you, Mr. Chairman.

Mr. BURTON. Dr. Kail.

Dr. KAIL. I would like to respond to that a little bit.

Here again, is a single or double agent trial that has gone on for

years and years and years in a large population until you look at

again, alternative medicine uses multiagents. I realize it is difficult

to study that, but we cannot use the same old tired methodologies

to look at the same stuff. Single-agent, double-blind, crossover trial

methodology does not work for alternative medicine, period, end of

discussion.

I would like to ask these gentleman if any alternative medical

providers are on their staffs or were consulted in protocol or consulted to look at how the care is delivered. I think these are key,

key questions that have to be answered by the research community, and we have to get to some new methodology.

This level of trial and taking this long to get to answers is not

serving anyone. Too many people are dying. What is wrong with instituting a whole protocol of alternative medicine during this

watchful-waiting period and look at outcomes in a group that get

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a whole protocol designed in alternative medicine doctors’ institutions and see what is the outcome there?

If we go agent by agent in this design, we are going to take a

long time to get to answers and it will cost us a lot in morbidity

and mortality.

Mr. BURTON. Do any of these organizations within NIH or the

National Institute have anybody on their boards that practice alternative medicine?

Dr. KAPLAN. Oh, yes. Certainly the NCI Office of Complementary

Alternative Medicine does have people on its board. But I think

that is not exactly the answer to the question of the studies that

Dr. Thompson was describing. Those are, as Dr. Kail points out,

not packages of a series of complementary treatments all together;

they are in fact——

Mr. BURTON. Very specific.

Dr. KAPLAN [continuing]. Concentrating on specific agents. They

don’t perhaps require for that kind of study exactly what you are

describing, perhaps. But I absolutely agree, for what you are describing, we need to develop the correct methodology and probably

need the advice of your entire community to develop it, because I

don’t know how we would come up with it otherwise.

Mr. BURTON. Let me tell you a problem. This is on a different

subject, but I think it bears on the point that is being made here.

Do you know what chelation therapy is?

Dr. KAPLAN. Yes.

Mr. BURTON. Some people think it is bogus, others think it really

does help with coronary problems and heart disease and so forth.

We sent 564 case histories from various chelation physicians

around the country, these are doctors who use chelation as an adjunct to their practices, international heart-lung, and we found that

they said there was not sufficient information in these reports that

we sent in, and they wrote back and asked for more information.

They couldn’t make an evaluation based upon what was sent in. So

we are writing a letter back to all those physicians asking for at

least 100 of these cases to go into great detail. It is going to take

them a lot of time and effort to give us these details.

But it seems as though there was a doctor over there, one of the

people that makes the decisions, that said they were not going to

move on—they said they wouldn’t do a clinical trial because they

just didn’t think they had enough information.

Now, we have people all across this country, myself included,

that are using chelation therapy, and it seems to me, like I said

a while ago, with people voting with their feet and their pocketbooks, and more and more people are trying this all the time, some

with some extraordinary results—I have talked with a number of

people who have had extraordinary results—people told they

should have open heart surgery or heart transplant, they didn’t do

that, they went to chelation instead, and they had some tests done

that showed their arteries were actually opening up to a degree

and the chest pain, the angina they had, was going away.

Why is it that the alternative therapy money, one-third of 1 percent, why is it they are not using more money in that area to look

at these alternative therapies and maybe use different approaches

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to finding out whether or not they are effective, instead of the same

approaches they have always used, with the double-blind studies?

I think that Dr. Kail makes a good point, that while we are going

through these studies that take 3, 4, 5, 6, 7 years, people are dying,

and if there are alternative therapies that physicians—and the one

that is giving me chelation therapy has an advanced education in

medicine, so he didn’t come off the assembly line of doctors, he is

a pretty sharp fellow—it just seems to me we ought to let the alternative therapy have a little bit more money for research and let

them see what they can come up with, as well as the conventional

approach which is these double-blind studies that take 3, 4, 5, 6

years. I just don’t understand it.

We had a boy here who was dying of, I think it was leukemia,

and his parents wanted to have him go to a doctor that tried an

unconventional approach dealing with that. He had been judged

terminally ill; there was nothing more that could be done for him.

He was being prevented to get treatment even though the parents

wanted that, and there appeared to be some hope from previous patients that had been down there, because they said there hadn’t

been enough research.

Well, this kid is going to die. Why should we prevent that parent

from looking at that, especially when there is some record that

there has been some success, although not a huge amount?

I just don’t understand the rationale, because people are dying

from these various problems, prostate cancer and others; and it

looks like, to me, that there ought to be some more attention paid

to alternative therapies as adjunct to conventional therapies that

could be researched thoroughly through the alternative therapy

budget. And there is not enough money there to do it, and onethird of 1 percent just does not cut it.

I am for getting more money for conventional research, and I believe my colleagues on both sides are, as well. But while we are

willing to get more money for conventional treatment and studies

for cancer, why not let the other people who are generally looked

upon with disdain and disfavor by a lot of people in the medical

community, why not let them have their shot at the egg, too, because there are some positive results.

Does anybody have an answer to that? You are with NIH.

Dr. KAPLAN. I do actually have some thoughts about that. Could

I have Dr. White also address some of your points?

Mr. BURTON. Sure.

Dr. WHITE. Thank you. I am Dr. Jeffrey White from the National

Cancer Institute.

Mr. BURTON. You have been before us before.

Dr. WHITE. Yes, once before.

I can address the issue about case reports as sources of evidence.

We do actually have at the National Cancer Institute a best-case

program, best-case series program, that does allow actually for the

review of case report information and internal review within the

NCI.

What I am talking about then is the alternative medicine practitioner who is treating cancer patients with an alternative approach, who has records of improvements of those patients and can

send those records to my office and have—what I do is review them

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for completeness, in much the same way apparently NIH did with

your records. If it is not complete, we go back and forth with correspondence about what does need to be added to it to make it complete.

Then we present them actually to the panel of experts of both

cancer and alternative medical backgrounds. Actually, Dr. Kail is

on that panel. This is done in collaboration with the National Center for Complementary and Alternative Medicine. So we have recognized that case report information is the type of information that

comes out of complementary and alternative medicine practices

generally, rather than clinical trials, and we are trying to make use

of that information to make research decisions.

Mr. BURTON. That is commendable.

I want to yield again to my colleague in a second.

That is commendable, but why is it that there isn’t a bigger percentage appropriated or allocated by NIH for these alternative

studies and therapies? I just don’t understand it. One-third of 1

percent is such a small amount, especially when the American people are clamoring for it. You know that. I know you know that, because if you don’t believe it, look at the tremendous amount of

money that is being spent for alternative therapies and vitamins

and minerals and all kinds of things—shark cartilage. You know

what I am talking about.

It seems to me that, as a defense mechanism if nothing else, NIH

would say, hey, we need to get these Congressmen and these Senators off our back. Let’s put a little bit more money into alternative

therapies so we can shut them up and find out if this stuff really

works.

I mean, that is such a small percentage. Can you give me an answer on that?

Dr. WHITE. Part of it is, I don’t know what the actual percentage

is, because the definition of complementary and alternative medicine is actually a very difficult one to make; and a lot of things we

have talked about today, certain specific vitamins or minerals as

single compounds, some people would not consider them to be alternative.

Really, you can debate it. But certainly support group research

is an important element that I think might have been touched

upon a little bit, but some people may not consider that to be complementary and alternative medicine.

I think there are issues so that if you wanted to look at all the

nutritional-type work that is done as cancer prevention and as adjunctive therapy, or all of the behavioral research done, I think

those numbers would be much larger. So a lot of it does break

down to what the real definition is.

But I do think we are growing our research portfolio, and I think

we have established linkages with the National Center to address

some the specific things, like the concerns of Dr. Kail about naturopathic schools or other alternative practitioner schools not vying

well in the funding. There are programs that are in development

to get them in collaboration with experienced research programs to

help buildup their research departments. So I think we are making

inroads there.

Mr. BURTON. Did you have some more questions?

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Mr. TURNER. I don’t, Mr. Chairman.

Mr. BURTON. Dr. Kail, did you have something else to say too?

Let me go to Dr. Geffen first and then we will come back to you

real quick.

Dr. GEFFEN. I just wanted to make one point that—actually two

points, very briefly.

First of all, I want to speak again from the perspective of a treating oncologist in the community, but also as somebody who spent

many years in academic medicine, has been very involved in scientific research, has had NCI grants. I am very familiar with the

process. There is no question that I am a firm believer and advocate for research of anything that has potential.

I also want to once again remind my colleagues and all of us that

we are talking about—our language again is about treating prostate cancer. But we are not really treating prostate cancer. We are

treating men, human beings, who happen to have prostate cancer.

I honestly feel that this is as fundamental a paradigm shift that

we need to make as the paradigm shift of embracing alternative

and complementary therapies might appear.

Do you understand what I am saying?

This is the problem. We can spend years and years studying this

chemotherapy drug or this herb or that herb, and I can tell you as

a physician, it is absurd. I have patients coming with bushel baskets full, shopping bags full of vitamins and herbs and supplements, or men with prostate cancer who were given all of the

standard treatments; they are neurotic, frightened, they are afraid,

they are not sleeping.

I am spending thousands of dollars a year performing studies

that are being demanded. Their marriages are in shambles, and I

think that it is time that we make an equal commitment to addressing this component of cancer, which is really, I tell you, this

is where the rubber hits the road in the community. This is really

where the real action is, taking care of real people. It is not in how

many micrograms of selenium to take. It is absurd.

I feel strongly about it because I spent years answering the

phone calls in the middle of the night from these people, and I

say—I want to be clear; I love science, and I love alternative and

complementary therapies, and I will always advocate for doing everything that we can think of to pursue this area of research. But

really it is time to say, wait a minute, we are not treating cancer,

we are treating human beings, and explore how we need to reorganize ourselves in this entirely new framework. That is really the

challenge before us.

One last thing I want to say also. You know, it is amazing to me,

and this is part of this discussion in terms of where do we really

want to put our resources. As strong an advocate for scientific research as I am, I think we need funding to learn how to take care

of people. I think it is unconscionable that as a physician, I could

spend easily $20,000, $30,000, $40,000 with the full blessing of

Medicare to prolong the life of a 89-year-old man with prostate cancer by 6 or 9 months with every therapy and MRI scans and bone

scans and strontium and growth factors and Neupogen shots at

$125 a pop for weeks or months at a time.

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But there is no funding for therapists for these people, for massage therapy, there is no funding for end-of-life discussions. I

mean, it is crazy. But this is the reality of taking care of people

in the community, and I think I can’t sit here and not say that.

Don’t you think it is kind of crazy?

I can get the full blessing of Medicare to do this, as long as I follow the documentation guidelines. It is painful.

Mr. BURTON. I am sure it does make sense to everybody here,

and perhaps Congressman Turner and I and others can talk to our

colleagues on the appropriate Appropriations Committees—I think

Congressman Porter is one of them—to take a look at maybe revising how we approach something like that. It is going to take a real

education process I think, because I had never really thought about

it before until you mentioned it.

You just don’t think about those things. You think about, how do

you take care of the guy that is sick. You don’t think about quality

of life and how close they are to the end of the road, which we are

all going to be facing.

Dr. Kail.

Dr. KAIL. Well, just, first of all, I wanted to acknowledge the National Cancer Institute at the NIH and the CAPCAM advisory

panel. I think they are taking the lead within NIH in bringing the

alternative medicine into the NIH. I think the best-case series is

the best mechanism I have seen so far to go identify the alternative

practitioner in the field and get him started.

But CAPCAM is not a funding agency. It does not grant funds.

All it does is recommend strategies so that they can do better competition in the research pool.

What I am saying is, that is not quite good enough. We are going

to have to go out and do something else that is not going to take

multiyears get these people involved. Why can’t you put an advisor

in every part of the NIH and have them put an alternative spin,

if you will, on every study that comes through, or some direction

toward the director of the panels?

I don’t know what the answer is. I think the National Cancer Institute is taking a big step forward and doing the best-case series.

I applaud them for doing that. I am out personally recruiting people in my field to apply for that best-case series, but that does not

imply funding. All the funding that has come through for alternative medicine research has been mandated by this body, by the

Congress, and I think that is where the answer is. The Congress

has to mandate the funds. Then the NIH will spend the funds.

Thank you.

Mr. BURTON. Well, as a first step, maybe we can talk to some of

the heads of the various agencies at NIH and see about trying to

get some input from the alternative therapy physicians in some

way, because I think that is probably a good idea, to at least have

that input.

Did you have a comment, Dr. Geffen? I have a series of questions, and I will let you guys get out of here, for the record.

Dr. KAPLAN. I just wanted to follow up on points that both Dr.

Kail and yourself have made regarding the design of studies and

whether it is necessary to do randomized control trials and so

forth.

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Randomized control trials are not something that just the alternative community objects to; every scientist wants to see things

move faster than randomized trials can allow. I should say, by the

way, that most of them are not placebo controlled. But, anyway—

if we didn’t have those, however, there is no question that we

would think, for instance, as I would have said a few years ago,

that betacarotene is probably a good thing and everybody should

take more of it. It turns out to be a bad thing. If we didn’t have

a randomized controlled trial, we would still be doing radical

mastectomies, which we did for 100 years, when everybody thought

it was better than limited mastectomies. The randomized clinical

trials answered that.

We have got to constantly question our own assessments. I have

been wrong, like everybody else, many, many more times than I

have been right about what seemed to be working with the drugs

I have worked on myself. We always have to look at that carefully.

Now, I can easily imagine a situation, however, in which a number of alternative approaches could be piggybacked onto lots of

studies. There could be trials of conventional therapy with or without another alternative approach added to it. It doesn’t mean you

would have to have twice as many patients or separate studies.

You can actually use a sort of piggybacking technique and still get

that high-quality scientific evidence without having to say we are

going to go one way or another.

Mr. BURTON. That may be one approach to doing it.

It just seems to me that, and I am not a physician, I have a son

who is a physician, who believes everything that the FDA says, so

he and I have arguments from time to time, not that I don’t think

the FDA does a good job, you understand, but we do have differences. But it seems to me, and I think to a lot of my colleagues,

because we have talked about this numerous times at the committee hearing and on the floor, that while the conventional approach

to checking everything out, the double-blind studies and all that,

is very important, and that is probably where the vast majority of

the funding ought to go, it seems to me the alternative therapy approach ought to have at least an adequate amount of funds so they

can try it from their viewpoint as well. There is more than one way

to skin a cat. You have heard that before. It seems to me whether

it is piggybacking on or letting them have funds to try another

way, and then looking at the results over a 10 or 5-year period, it

seems it makes sense, especially when we are talking about the

huge quantities of money which the Congress is putting out, which

still isn’t adequate, but nevertheless we are spending a lot of

money, $3 billion at NCI.

Let me go through a series of questions, and if Mr. Turner has

any, interrupt at any time.

Dr. Geffen, Senator Dole talked about Medicare coverage being

important for access to adequate care. Do you offer treatments at

your center, conventional and complementary, that would help a

patient but that you cannot get reimbursement for through Medicare?

Dr. GEFFEN. Yes, many. It is a big problem. As I was saying earlier, I think that this is something that we are going to really have

to grapple with, because until we have—and I will just say my own

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personal belief is the most effective answers are probably going to

come from molecular biology. They are probably not going to come

from randomized trials of compounds, no matter how toxic or natural they may be. I think the real advances are going to come from

molecular biology, but that is going to take time. In the meantime,

we have to take care of people, human beings, who are suffering.

We have to use everything that is available.

Mr. BURTON. Let me interrupt. Could you do me a favor? Could

you in a one page send us a list of things that you think ought to

be looked at seriously in Medicare adjustments, adjustments to

Medicare that would help people? If you could get us that, we can

sit down and talk to the relevant leaders in the Congress and see

if that can’t be incorporated into the long-range planning for Medicare.

Dr. GEFFEN. Terrific.

Mr. BURTON. Just get that to us. Rather than telling me, let me

have it in writing so Beth and I can get it to the proper people.

What do you say to a patient who wants to try an alternative therapy?

Dr. GEFFEN. What do I say personally?

Mr. BURTON. Yes.

Dr. GEFFEN. Well, I try, first of all, to do a comprehensive medical evaluation and try to make an assessment as to whether or not

there is a conventional therapy that we can reliably predict what

it is likely to do. My own personal bias is I don’t really embrace

alternative therapies as cancer treatment. I can be, as open-minded

as I have been and as far as I have traveled in this world to study

and learn and try to see what is effective, I have not been convinced that there is any alternative therapy for cancer that is as

or any more effective than conventional therapies are on a reliable,

consistent basis. So I typically don’t offer alternative therapies, unless I have a patient who really has a cancer for which there is no

meaningful conventional therapy.

Mr. BURTON. So if they have been judged by conventional medicine to be in a hopeless situation, you would talk about something?

Dr. GEFFEN. Exactly. But there is some gray zone between what

is alternative and what is complementary, and complementary

medicine includes things that I consider to be therapies that can

be used very elegantly in conjunction with conventional therapy.

That is really where our primary focus is, is trying to explore a

whole universe of phenomenally wonderful things that are not in

conflict with conventional therapies.

Mr. BURTON. Dr. Kail, how do you co-manage patients with

allopathic physicians?

Dr. KAIL. That is a great question. This speaks to where everybody has spoken here. Again, allopathic physicians, as Dr. Geffen

said, they will try any allopathic or conventional agent that will

work and, at the exhaustion of those, will send a patient or allow

their patient or recommend their patient seek alternatives. Unfortunately, that is the worst case scenario for the success of the alternative therapy.

Mr. BURTON. Too late in most cases.

Dr. KAIL. Well, the person’s recuperative abilities have already

been spent by the rather extreme measures they have.

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Most alternative practitioners would suggest you need to start

the alternative therapies early on, as early as you can find. They

are not bailout therapies. They will not succeed if someone is totally compromised. I don’t care how good they are. Although there

are some case reports of that happening, the chance is very little.

The best case scenario, it is best to start with a person who has

an inkling that they might have some increased risk and aggressively attack that risk, and then alternatives become very viable in

actually reducing or stopping the cancer process. But they haven’t

been studied.

There are plenty of docs that I could tell you about that have

clinical results but haven’t been studied. So my approach is usually

I start treating a patient and then they go see an oncologist. I always recommend that they do. As a matter of fact, I hesitate to

treat patients if they don’t see an oncologist.

Usually in that scenario, when they are already doing what they

are, and then going for conventional care, they get better results,

meaning I report from the oncologist, which usually doesn’t matter,

they don’t care if I am using alternatives, as long as I can assure

them that it is not going to adversely affect their therapy, which

I usually can.

Mr. BURTON. You are talking about using it in conjunction with?

Dr. KAIL. Absolutely. In that scenario, I think we do very well.

My feedback from the oncologists has been that my patients tolerate conventional treatments better, they get better outcomes, and

have a better quality of life. That is the feedback I get from my patients.

Mr. BURTON. Does the general public have access to naturopathic

physicians?

Dr. KAIL. The other States——

Mr. BURTON. But they are not reimbursed under Medicare or

other insurance programs regularly?

Dr. KAIL. There are none, in no cases. There are two States that

enjoy mandates, Connecticut and Alaska. Other States, in Arizona

we do get insurance reimbursement by choice. There is no mandate, but we have three or four, Cigna, Intergroup and some other

health plans, because their consumers wanted them, have put us

on as providers.

That is a very good situation, because now I have to communicate with their primaries, we have to write consultation reports,

we have an exchange of ideas. Sometimes that person says I don’t

understand this, I don’t want to know about it, go get another primary. Sometimes they start to interact with me and then they get

to understand what I do and I get to understand what they do a

little bit better and the benefit is to the patient. The patient ends

up doing better and having two doctors that are very happy to talk

with each other.

Mr. BURTON. Dr. Chen, is the NIH funding any studies on your

invention, your scientific research?

Dr. CHEN. No, Mr. Chairman. As a matter of fact, I wrote an application for NIH funding and it was rejected. Some of my funding

comes from private research foundations such as CapCURE.

Mr. BURTON. That is Milken’s foundation?

Dr. CHEN. Yes.

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Mr. BURTON. But you were turned down?

Dr. CHEN. I was rejected several times.

Mr. BURTON. Are you aware of any government funding on Chinese botanicals and prostate cancer prevention?

Dr. CHEN. Not that I know of.

Mr. BURTON. Do any of you know if there is any funding by NIH

for any of that research? Nobody knows?

Dr. CHEN. There is only a so-called alternative medicine category, and just like Dr. Kail said, any application in alternative

medicine usually goes to famous hospitals, Harvard, Stanford, M.D.

Anderson, their research groups get it.

Dr. THOMPSON. Mr. Chairman, from the physician’s data query,

which is NCI sponsored, there is a phase three randomized study

of the effect of a diet low in fat, high in soy, fruits, vegetables,

green tea, vitamin E and fiber on PSA levels in patients with prostate cancer. It is NCI sponsored and it looks like it is being conducted at Memorial Sloan Kettering Cancer Center.

Mr. BURTON. But that sounds like that may be the exception,

rather than the rule. Well, anyhow——

Dr. CHEN. The problem is, each time you talk about a mixture,

it is also a question. According to conventional strategy, anything

has to be single agents. If you talk about more than two, it is a

no-no.

Mr. BURTON. That is what I was talking about. I think Dr.

Kaplan touched on it when we were talking about piggybacking on

a study. Maybe you could in some way put something like that in

the study, in a small percentage of it, and it might give you some

very telling results. Does NIH ever do that or have they ever done

that? You suggested it. Maybe it is a great suggestion. But have

they done that?

Dr. KAPLAN. Normally the kinds of studies in these large studies

that are done——

Mr. BURTON. Straight double blind.

Dr. KAPLAN. No, it is normally from investigators proposing that

these are the arms that should be in the study, this versus that.

If we can in our advising them, if we can come up with some other

suggestions and say there is something else viable and we think at

the time are strong enough, would you consider that, then they

may in fact be willing to add those substances to those studies. But

it is not normally something where we will direct them what they

should specifically study. The investigators themselves have to become convinced that the data warrant that.

Mr. BURTON. I understand. But, you know, the one who gives the

money plays the tune to which people dance. I think you get the

message there. It seems to me that if there is a suggested study

and there is something that is very close to or uses some of the

same substances that you are doing the study, it seems they could

be piggy-backed on by suggestion of the people at NIH.

Dr. KAPLAN. They could. The difficulty I have with suggesting it

outright is making the case for it, is the fact we have heard just

in this room today of many, many approaches that could be useful,

and I think we all hope that they are all going to be useful, but

we also all know that not every one of them is. Somehow we have

to decide if we are going to say here is a study of 5,000 men, let’s

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add such-and-such to 2,500 and not to the other 2,500, which is

that going to be right now.

Mr. BURTON. I understand. And that being the case, it seems to

me there ought to be more funds allocated for alternative therapy

research so that they can at least follow the line of thinking that

they are talking about. One-third of 1 percent sounds like a very

small amount.

Anyhow, I think you understand what we are talking about and

I hope you will carry this message back. We will have more hearings on this in the future and discuss it further.

Dr. Kaplan, what specific complementary and alternative treatments are under consideration for research on prostate cancer right

now?

Dr. KAPLAN. I don’t think I can answer that comprehensively,

aside from, for instance, the study that was just read to you.

Mr. BURTON. That wasn’t for prostate cancer.

Dr. KAPLAN. Yes, that was for prostate cancer.

Mr. BURTON. The one you were talking about a minute ago, that

was for prostate cancer?

Dr. KAPLAN. Yes. There are a handful of others on a scale that

have already come in and are being funded, but there are certainly,

I think, many investigators out there in both the alternative community and the conventional community who are looking at a lot

of possibilities and thinking about this. I think particularly the

prostate cancer quick trials program may bring several more really

promising applications to us, because I think there are fewer hurdles for people to overcome to get funding that way.

Mr. BURTON. Dr. von Eschenbach, in your experience, what complementary therapies may be helpful for prostate cancer patients?

Dr. VON ESCHENBACH. Well, as I mentioned earlier, one of the

things we do promote is a diet low in fat and an exercise program.

We have also been beginning to investigate in a complementary

fashion the role of stress reduction.

Mr. BURTON. But that is something we need here in Congress,

I will tell you. If you have any ideas, aside from some of these pills

they give us, I would appreciate knowing about it.

Dr. Thompson, you are also a colonel in the Medical Corps. Does

the prostate cancer care differ at all for active duty military than

those who are not on active duty?

Dr. THOMPSON. I don’t believe so, Mr. Chairman. We have actually looked at prostate cancer outcomes in DOD health care beneficiaries, and there have been about three or four studies in the

United States that have looked at outcomes. Some have suggested

that ethnicity plays a role in survival. For example, if you are African American, you have lower survivals. We found in health care

beneficiaries at the Department of Defense ethnicity did not affect

survival, such that if you look at the same stage of the disease African Americans and Caucasians have the same survival.

Some of that may have to do with health seeking behavior and

the fact that if you are in the military after the age of 40 you have

a regular physical examination, and we think that plays a little bit

to the differences we see in the Department of Defense beneficiary

population.

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Mr. BURTON. I just have a couple more questions. Are there new

screening devices and tests in development over there?

Dr. THOMPSON. In the Department of Defense?

Mr. BURTON. Yes.

Dr. THOMPSON. Actually there are any number of new opportunities. In fact, there are a number of imaging studies that are being

looked at, the ability of PET scans and some new methods of using

MRI. There are new bio markers being looked at.

At this time, truly the most reassuring thing is that although it

has been around for 15 to 20 years, prostate-specific antigen remains a superb screening tool, perhaps better than virtually any

other type of screening tool. You are able to tweak it a little bit by

looking at fractions of the PSA, the PSA that is bound to plasma

proteins, and to perhaps improve your detection abilities in younger men and perhaps to reduce the number of biopsies that are required in older men.

Mr. BURTON. Dr. White, you get the last question from me. Can

you tell me about the homeopathy cancer projects?

Dr. WHITE. Yes. This is one project, actually there were two

projects that were reported, both from the same group. One of them

was withdrawn and the other one is going forward.

This is a best case series of homeopathic preparations for the

treatment of cancer that was presented by a group from Calcutta,

India, and they presented 12 cases of cancer that they felt had

been benefited by their approach. It was presented to the

CAPCAM, the Cancer Advisory Panel for Complimentary and Alternative Medicine in July, and on the basis of review by the panel,

they recommended we do some prospective observational research

in the clinic in Calcutta, which basically would be to track new patients that come through the clinic, specifically lung cancer patients, be sure that they have good pathology that could be confirmed, and good radiologic followup, and just look at outcomes.

So we are in the process of trying to put together basically a research contract mechanism that will allow us to get a clinical researcher to go to the clinic there in Calcutta and actually start taking statistics about patients that come in following these patients

getting the CAT scans reviewed.

So I hope to give a summary of where we are in the December

13th meeting of the CAPCAM.

Mr. BURTON. If you could let us know about it, we would appreciate that.

I want to thank all of you for your patience. It has been a very

interesting hearing. I think we have learned a lot, and hopefully

we will be able to get some results down the road from what we

have learned.

Mr. Turner, do you have any other questions?

Mr. TURNER. No, thank you, Mr. Chairman.

Mr. BURTON. Thank you very much. We stand adjourned.

[Whereupon, at 2 p.m., the committee was adjourned.]

[Additional information submitted for the hearing record follows:]

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