U.S. GOVERNMENT PRINTING OFFICE

72–932 DTP WASHINGTON : 2001

CANCER CARE FOR THE NEW MILLENNIUM—

INTEGRATIVE ONCOLOGY

HEARINGS

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED SIXTH CONGRESS

SECOND SESSION

JUNE 7 AND 8, 2000

Serial No. 106–235

Printed for the use of the Committee on Government Reform

(

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http://www.house.gov/reform

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Mail: Stop SSOP, Washington, DC 20402–0001

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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-HAGE, 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

JAMES C. WILSON, Cheif Counsel

LISA SMITH ARAFUNE, Chief Clerk

PHIL SCHILIRO, Minority Staff Director

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C O N T E N T S

Page

Hearing held on:

June 7, 2000 ............................................................................................................. 1

June 8, 2000 ............................................................................................................. 221

Statement of:

Navarro, James, Tucson, AZ; Michael Horwin, San Diego, CA; Raphaele

Horwin, San Diego, CA; Dr. Jeremy Geffen, Geffen Cancer Center

and Research Institute; Roger Cary, Cancer Treatment Centers of

America; and George Devries, American Specialty Health Plans ............ 164

Nixon, Dr. Daniel Walker, M.D., president, American Health Foundation;

Alice and Hayne Folk Professor of Experimental Oncology, Medical

University of South Carolina; Dr. Giancarlo Pizza, Italy; and Burton

Goldberg, Tiburon, CA .................................................................................. 309

Payton, Connie, Walter Payton Cancer Fund; Jeanne Achterberg, Santa

Fe, NM; Dr. George Pettit, M.D., director, Cancer Research Institute,

Arizona State University, Natural Product Drug Development; Dr.

Wolfgang Woeppel, Germany; and Dr. Harold Freeman, M.D., North

General Hospital, New York, Minorities Access to Oncology Care ........... 226

Pryce, Hon. Deborah, a Representative in Congress from the State of

Ohio ................................................................................................................ 5

Straus, Dr. Stephen E., National Center for Complementary and Alternative Medicine; Dr. Robert Wittes, National Cancer Institute; Dr.

Jeffery Kang, Health Care Financing Administration; and Dr. Richard

Pazdur, Food and Drug Administration ...................................................... 19

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

Achterberg, Jeanne, Santa Fe, NM, prepared statement of ......................... 248

Cary, Roger, Cancer Treatment Centers of America, prepared statement

of ..................................................................................................................... 186

Devries, George, American Specialty Health Plans, prepared statement

of ..................................................................................................................... 192

Geffen, Dr. Jeremy, Geffen Cancer Center and Research Institute, prepared statement of ........................................................................................ 179

Goldberg, Burton, Tiburon, CA, prepared statement of ................................ 331

Horwin, Michael, and Raphaele, San Diego, CA, prepared statement of .... 169

Kang, Dr. Jeffery, Health Care Financing Administration, prepared statement of ........................................................................................................... 50

Morella, Hon. Constance A., a Representative in Congress from the State

of Maryland, prepared statement of ............................................................ 211

Navarro, James, Tucson, AZ, prepared statement of .................................... 198

Nixon, Dr. Daniel Walker, M.D., president, American Health Foundation,

prepared statement of ................................................................................... 311

Payton, Connie, Walter Payton Cancer Fund, prepared statement of ......... 228

Pazdur, Dr. Richard, Food and Drug Administration, prepared statement

of ..................................................................................................................... 62

Pettit, Dr. George, M.D., director, Cancer Research Institute, Arizona

State University, Natural Product Drug Development, prepared statement of ........................................................................................................... 260

Pizza, Dr. Giancarlo, Italy, prepared statement of ........................................ 317

Pryce, Hon. Deborah, a Representative in Congress from the State of

Ohio, prepared statement of ........................................................................ 9

Schakowsky, Hon. Janice D., a Representative in Congress from the

State of Illinois, article dated June 6, 2000 ................................................ 299

Straus, Dr. Stephen E., National Center for Complementary and Alternative Medicine, prepared statement of ...................................................... 22

Wittes, Dr. Robert, National Cancer Institute, prepared statement of ....... 37

Page

IV

Letters, statements, etc., submitted for the record by—Continued

Woeppel, Dr. Wolfgang, Germany, prepared statement of ............................ 238

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CANCER CARE FOR THE NEW MILLENNIUM—

INTEGRATIVE ONCOLOGY

WEDNESDAY, JUNE 7, 2000

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

The committee met, pursuant to notice, at 1:10 p.m., in room

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

of the committee) presiding.

Present: Representatives Burton, Morella, Ros-Lehtinen, Horn,

LaTourette, Walden, Norton, Cummings, and Schakowsky.

Staff present: Kevin Binger, staff director; David A. Kass, deputy

counsel and parliamentarian; Mark Corallo, director of communications; S. Elizabeth Clay and Nicole Petrosino, professional staff

members; Lisa Smith Arafune, chief clerk; Robert A. Briggs, assistant clerk; Robin Butler, office manager; Michael Canty and Toni

Lightle, legislative assistants; Josie Duckett, deputy communications director; John Sare, staff assistant; Phil Schiliro, minority

staff director; Phil Barnett, minority chief counsel; Sarah Despres,

minority counsel; Ellen Rayner, minority chief clerk; and Jean

Gosa and Earley Green, minority assistant clerks.

Mr. BURTON. Good afternoon. A quorum being present, the Committee on Government Reform will come to order.

The ranking Democrat, Mr. Waxman, is on his way. He said he

would be a little bit late. We thought we would go ahead and get

started.

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 articles, exhibits and extraneous and tabular material referred to be included in the record.

Without objection, so ordered.

Today, the Committee on Government Reform begins the first of

2 days of cancer hearings. During the 2 days of our hearings, over

3,200 lives will be lost to cancer and 6,575 individuals will be told

that they have cancer. This hearing will address four issues.

Pediatric cancers and the challenges parents face in making

treatment decisions, racial disparity in cancer treatments, reimbursement issues related to complementary therapies in an oncology setting, and anti-tumor drug development from natural products.

Probably the only thing more difficult than personally being diagnosed with cancer is the diagnosis of cancer for your child. A recent

New England Journal of Medicine article stated that one out of

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four children diagnosed with cancer will die from the disease—one

out of four. Unfortunately, many of them will die without a referral

to a hospice and with poor pain management. The referral to a hospice can reduce the pain and fear of children who are terminally

ill.

In 1999, it was estimated that 7,800 children in the United

States would be diagnosed with cancer. Forty-two families in

United States will be told their child has cancer during the 2 days

of our hearings. They will have to make care and treatment decisions based on what their physicians and oncologists tell them and

what they can learn on their own from their family and friends and

on the Internet. Fortunately, the recent addition of the Clinical

Trials data base on the National Institutes of Health’s Web site

makes it easier for families to learn about clinical trials.

Today, my colleague and friend, Congresswoman Deborah Pryce,

will share with us her experience about losing a child to neuroblastoma this past fall. Neuroblastoma is a rare nerve cancer that

strikes 500 children in this country each year.

Michael and Raphaele Horwin lost their only child, 2-year-old Alexander—that is a picture of him up there—to medulloblastoma

last year. Medulloblastoma is a brain cancer. They have done an

excellent job of putting together a chronology of quotes drawn from

peer-reviewed medical journal articles on cancer research. The

statements show that, as parents, they were justified in their concern about the effects of the drugs offered as ‘‘state-of-the-art.’’ We will also hear from James Navarro, the father of Thomas.

Last summer, when Thomas was barely 4 years old, he was diagnosed with medulloblastoma. That is a picture of him. After researching their options, the family decided that the best course of

action for Thomas was a non-toxic treatment available through a

Food and Drug Administration-approved clinical trial. Unfortunately, the Food and Drug Administration denied Thomas access to

this clinical trial because he had not first gone through and failed

chemotherapy and radiation.

Many of you may recall a hearing 2 years ago when Dustin

Kunnari—that is a picture of Dustin—testified. Dustin, who was

the last child that the Food and Drug Administration allowed to receive this treatment as a first choice, is healthy and without having

suffered the life-altering side effects of chemotherapy and radiation. He is not alone in surviving cancer through the use of

antineoplastons and not suffering the irreversible side effects of

other more toxic treatments. You might take a look at him and his

family.

I think we have some other slides. These are children that survived.

Thomas’ story struck a chord with many Americans who feel

strongly that the decision to access another treatment protocol outside the ‘‘standard’’ cancer protocols of chemotherapy and radiation

should be the patient’s choice and not the decision of a government

agency. In fact, I have introduced, and many of my colleagues have

cosponsored, H.R. 3677, the Thomas Navarro Patient’s Rights Act

as a remedy for this situation.

This bill would assure that patients would have the option to

make an informed decision to participate in clinical trials after

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being fully informed of all of their options, rather than being forced

to accept a treatment with known toxic side effects.

Unfortunately, right now, the FDA can put a clinical trial on

hold for a treatment that is safe and has no serious side effects because the FDA is satisfied with existing treatments, even treatments that can cause serious adverse events including sterility,

stunted growth, hormone disorders, blindness, hearing loss, mental

retardation and secondary cancers.

H.R. 3677 is a first step in assuring medical freedom in the

United States.

There is something inherently wrong with a system when doctors

threaten to have a child with cancer taken away from parents and

put in State custody when they refuse to subject their child to

chemotherapy as a means of forcing treatment. How can it be that

in the United States of America a doctor can and will have the

State’s Child Protective Services take a child with cancer away

from his or her parents, with charges of child neglect and abuse,

when those parents love their child enough to question administering drugs that can do severe and irreparable harm? These children

are then placed in foster care so that the child can be subjected to

chemotherapy and radiation. This is exactly how the Navarros and

other families have been threatened by government agencies.

These threatening tactics by the medical profession on families

must stop, and they must stop now.

In his State of the Union address on January 22, 1971, President

Richard Nixon declared a war on cancer. The thought was that if

we took the same approach with curing cancer as we did with putting a man on the moon, pouring lots of funding into the issue,

then we could beat cancer. In 1984, the National Cancer Institute’s

director predicted that cancer deaths would be reduced 50 percent

by the year 2000. There is a slide showing what the actual situation is.

The American taxpayer has invested over $43 billion in the National Cancer Institute, the primary government cancer research

agency, during the past 29 years. What has that taxpayer investment accomplished? Dr. Robert Wittes will be updating the committee on the activities of the National Cancer Institute, focusing

on the areas of complementary and alternative medicine and natural product drug development.

Dr. Steven Straus, the new Director of the National Center for

Complementary and Alternative Medicine, is appearing before the

committee for the first time. Surveys indicate that the majority of

cancer patients will use some form of a complementary or alternative medicine treatment during the course of their disease, some

will integrate complementary therapies with conventional approaches, and others will choose a treatment as an alternative to

conventional medicine. What has the Center accomplished to date

and what are the Center’s research plans for the future?

Earlier this year, Dr. Straus announced his intentions to develop

a frontier sciences research program. Frontier sciences can be defined as areas of science and medicine outside the mainstream, including consciousness studies, subtle energies in biology, the scientific basis of alternative and complementary medicine, and the

interface of science and spirituality. Research in this area of

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science will offer significant advances in how we treat and prevent

cancer in this new millennium. At some point in the future, we will

have a hearing looking specifically at this field.

We have asked Dr. Jeffrey Kang of the Health Care Financing

Administration to outline the current and planned activities in reimbursement of complementary and alternative therapies for cancer patients under Medicare.

Dr. Robert Pazdur will present testimony about clinical trials in

alternative cancer treatments on behalf of the Food and Drug Administration. He has been asked to provide information about the

number and types of calls received regarding these types of clinical

trials. We have received complaints from families who, when calling the FDA to gain information about possible inclusion in the

antineoplaston clinical trials, were offered negative information

about Dr. Burzynski’s clinical trials. These individuals felt that the

FDA staff was attempting to dissuade patient participation.

We will also hear from Dr. Jeremy Geffen, who we asked to return and specifically address reimbursement challenges from the

perspective of an oncologist in private practice who integrates complementary therapies in his treatment.

Mr. Roger Cary, the chief operating officer of Cancer Treatment

Centers of America, has learned that patients fare better when allowed to select an integrated treatment approach, including therapeutic nutrition, spiritual care, exercise and massage therapy programs, and naturopathic medicine. Unfortunately, as long as most

complementary therapies are not reimbursed, the best approach to

treating cancer, an integrated approach, remains available only to

those who have the means to pay out of pocket. The poor people

just do not have a chance to be involved in that.

Dr. George Devries, president and chief executive officer of American Specialty Health Plans, will share with us how 25 million

Americans have been able to access companies’ complementary and

alternative therapies through complementary and alternative benefits programs, network programs and discount network programs,

have been beneficial.

The challenges of cancer are immense and complex and at times

very emotional. Anybody who has had anybody in their family that

has had cancer knows what I am talking about. Last year, within

a 2-year span, I lost both of my parents to lung cancer. My wife

is a 6-year survivor of breast cancer, in large part, I believe, due

to her participation in a clinical trial to test an alternative cancer

protocol. As a committee and a Congress, we must remain vigilant

in our oversight of the war on cancer and look for ways to improve

research, access and care.

The hearing record will remain open until June 21 for those who

would like to submit a statement for the hearing record.

Mr. Waxman is not year here. Ms. Schakowsky, would you like

to make an opening statement in place of Mr. Waxman?

Ms. SCHAKOWSKY. Not speaking on behalf of Mr. Waxman, but

if I could just say a few words, Mr. Chairman.

There was a fascinating story in yesterday’s Wall Street Journal

about a treatment for a kind of leukemia and clinical trials that

were being used in a limited way. This information got out over the

Internet where patients now are engaging much more in their own

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research and their own discovery of alternatives. Suddenly, there

was this vast number of people who wanted to participate in this

clinical trial which presents new opportunities but also a lot of new

challenges. The manufacturer, how are they going to produce in

quantity, what is the role of government in regulating that?

On the other hand, I completely understand why, as a cancer victim or a family member, I would certainly want this option available.

So I think your legislation and this discussion and this hearing

about what is the balance of protecting health and safety and making sure that life-saving options are available to people and that we

are not interfering with that in an unreasonable way is most important. So I want to thank you, Mr. Chairman, and the witnesses

today for this important hearing.

Mr. BURTON. Thank you.

Do any other Members have statements they would like to make

at the beginning here?

If not, I would like to welcome our dear friend and colleague,

Congresswoman Deborah Pryce, one of the leaders here in Congress, to come forth and testify. We welcome you. This is the second time I have seen you today, with our good friend Dave Thomas,

and I am glad to have you. You are recognized to make an opening

statement.

STATEMENT OF HON. DEBORAH PRYCE, A REPRESENTATIVE

IN CONGRESS FROM THE STATE OF OHIO

Ms. PRYCE. Thank you, Mr. Chairman. My statement is somewhat lengthy, and I will do my very best to cut it down and stay

within the committee’s timeframe.

Mr. Chairman, we have been together twice today, once to celebrate the unveiling of the adoption stamp, which we both worked

very hard on, and now to talk about cancer.

Adoption and cancer. Those are two issues that have profoundly

touched my life, one in a very happy and joyous way and the other

in the most heartbreaking. As many of you know, my family recently waged a battle against cancer that eventually claimed the

life of my adopted daughter Caroline. Today, I would like to share

with you my own experience navigating our health care system in

an effort to provide Caroline with the best care possible.

After three trips to the pediatrician’s office to determine the

cause of pain in her left leg, Caroline was finally diagnosed with

cancer in September 1998. I cannot begin to describe the horror

and confusion that a parent faces. Unfortunately, the initial diagnosis of the cancer was incorrect. But, based on this misdiagnosis,

we brought Caroline to the National Institutes of Health, where

there was a study under way focused on Ewing’s sarcoma, which

we were told was the disease with which she suffered.

After a couple of weeks of testing at NIH, the doctors began to

doubt Caroline’s diagnosis. We then learned an even worse fate

was in store for us. Caroline had neuroblastoma, a very rare nerve

cancer with a survival rate of less than 20 percent of children like

Caroline.

Once again we had to start over and make decisions about where

to seek treatment, what treatment, who to believe and who to

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trust. NIH provided a list of neuroblastoma programs across the

country, but the doctors were reluctant to make a decision, and everybody had their own way of treating it, and we had to decide

which was the best course.

After much research, phone calls and networking, we seized on

what we thought was our best opportunity at Memorial Sloan Kettering in New York City. Caroline bravely endured months of

chemotherapy, radiation, surgery, and even a brief clinical remission before the cancer claimed her life.

So, in my view, there are a number of improvements that need

to be made in the manner in which our current health care system

treats pediatric cancer.

First of all, I believe that pediatricians and parents need a wakeup call. Cancer strikes over 10,000 children in this country every

year. It is the leading cause of death by disease in children. It is

the leading cause of death by disease in children. Parents have to

be aware of this fact, and pediatricians should be trained to look

for even the most subtle signs of cancer and improve screening of

children for the disease.

Children are much more likely to have their symptoms dismissed. We were told at first it was shin splints, and then we were

told that it was growing pains. They are much more likely to have

their symptoms dismissed, and that delays treatment, and it certainly delays diagnosis. In children, this is especially detrimental,

because pediatric cancers spread rapidly. Pediatricians must resist

tendencies to offer a perfunctory examination of children with

seemingly innocuous symptoms and just dismiss them. A simple x

ray or blood test would only add a small cost to our health care system and could have the invaluable benefits of timely and successful

treatment.

Of course, once cancer is diagnosed, it is crucial that the type of

cancer be correctly identified so the appropriate course of treatment may be initiated as soon as possible. Through my interactions

with other parents, I have discovered we were not alone in our misdiagnosis. In fact, Memorial Sloan Kettering confirmed that

misdiagnoses of small round cell tumors at an atypical age is not

uncommon and perhaps is as high as 20 percent.

Now, I know that this committee is looking at alternative and

complementary therapies, so let me just address that very briefly.

In our own experience, these therapies were not overtly presented

at all. Chairman Burton, I think you were the only person in the

whole course of our treatment to even suggest we look into it, and

I appreciate that. But we did not seek them out. We had our hands

and heads full enough just wading through the many options that

traditional therapies offered. However, therapies such as exposure

to music and art and play, medical play especially, and other distractions to keep the patients focused on something other than

treatment and/or pain were available through the institutions

where Caroline was treated, and I view them as very positive influences in her care.

Beyond treatment decisions, knowledge is crucial to parents, because they are the ones who must be the advocates for their children in the cancer system.

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In the judicial system, which I am more familiar with, we are

making more and better use of court-appointed special advocates

[CASAs], to help coordinate and protect the interests of children.

There is no such animal in the health care system. If we had not

made it our business to know and understand every step of every

procedure, many irreversible mistakes would have been made, I believe, some of which were as serious as having the wrong kind of

catheter inserted into our daughter surgically, to as minor but

every bit as significant to a little child as having a nurse have to

stop placing an IV that wasn’t necessary, because she could have

drawn blood from the catheter. Every step of the way you have to

be vigilant.

Unfortunately, palliative care is also a very real part of cancer

treatment that has, to a certain extent, been neglected. As a parent

watching my child suffer, I could not understand why more relief

could not be provided in the hospital setting at the end of care

Caroline’s life compared to what was available in hospice care. In

my mind, there is absolutely no reason that there has to be such

a bright line between pain relief offered at the last stage of aggressive treatment in a hospital and that offered when alleviating pain

through the hospice system. Sadly, studies based on parental reports show that 89 percent of children experience substantial suffering in the last month of life.

This study also shows a discrepancy between what parents and

physicians perceive about children’s symptoms. There are a number of obstacles that stand in the way of effective pain management

for children, including perceptions about their threshold for pain,

the ability of children to effectively communicate their pain, and

concerns about addictions. That is just to name a few. There is

great need for more training and research in this area.

I myself believe there is a need for more home hospice care for

children. While we were fortunate enough to have this option, it is

not often available in many communities for many reasons. The demand is oftentimes low, thank God, but it is also difficult to staff

these organizations as people generally don’t want to even think

about hospice care for children. In the interest of these kids, we

have to improve education; and, through knowledge, we have to

change attitudes.

Thankfully, not all children suffer Caroline’s fate. Tremendous

progress has been made in its last 30 years, and today childhood

cancer is a very curable disease in three-quarters of the patients.

I have to qualify this by saying that it is largely due to great

strides in the cure for leukemia. Solid tumor cancers are still horrible killers and claim a great number of our children.

Continued research is the hope for cancer patients in the new

millennium. The triumphs over childhood cancer are to be celebrated, but there continue to be limitations on pediatric research.

Each child diagnosed with cancer is getting only one-sixth of the

Federal research support allocated to each patient afflicted with

AIDS; and for every dollar spent on a patient with breast cancer,

less than 30 cents is spent on a child with cancer. We need to invest more resources in pediatric cancer, with a focus on increasing

survival and accessibility to care.

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We need also to do more to provide incentives for new drug development, which is currently lacking due in part to a very small

market and to liability issues that we are all aware of. Cooperation

among medical institutions, philanthropic organizations and the

Federal Government can move us toward the day in the new millennium where there is hope for all children and no child need fall

victim to the scourge that is cancer.

I thank the committee for their indulgence. I appreciate the opportunity to be here.

[The prepared statement of Hon. Deborah Pryce follows:]

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Mr. BURTON. Let me just say on behalf of the committee that we

sympathize with you, and we pray for you and your family. I know

it has been a very difficult time. I watched you go through that and

all my colleagues did, and when you see a good friend go through

that or somebody in your family go through that, you feel it, too,

from afar. Not nearly like you did. But you are a heck of a woman.

We are very pleased you are with us today. Thank you.

Does anybody have any questions?

Ms. SCHAKOWSKY. I just wanted to say thank you for your testimony.

Ms. PRYCE. I appreciate the opportunity. I think it is important

that these personal experiences be related. Cancer has touched us

all; and, Mr. Chairman and committee members, it is wonderful

you are exploring this. I give you great credit. I appreciate the

work you are doing here.

Mr. BURTON. I have just a few questions real briefly, if you don’t

mind answering them.

You testified about the need to improve hospice care for children.

Can you tell us how existing hospices improve their services for

children—how they can improve their services for children?

Ms. PRYCE. Well, I think that the hospice care that we underwent was excellent. Unfortunately, the problem that we experienced is that we were not really released from traditional treatment until 3 days before her death, although I think it was obvious

to her physician that things were imminent and I wish we had

sought hospice earlier. I think hospice care is something that I

don’t have any problems with as we experienced it, but I do know

it is not available in some sectors of the country and in many communities, especially as it relates to kids.

People have a hard time seeing children be ill, and it is very difficult to watch a child die. That is what hospice nurses and hospice

personnel do. I think it is just a matter of changing attitudes and

better educating folks. It is such an important thing.

Mr. BURTON. I don’t want to cause you any additional pain by

asking these questions, but you talked about a difference between

how her pain was managed while she was in the hospital and in

the hospice care. Can you be a little more definitive on that?

Ms. PRYCE. Absolutely. We were giving Caroline a few last doses

of radiation treatment before we left because we thought that

would shrink the tumor in her brain and the spine and perhaps alleviate some of the pain. We were doing that to reduce pain. But

the physician in control of anesthesia at the cancer center where

she was getting the radiation would not even allow her to have a

Valium for fear that, for whatever reason, she would not say, Caroline perhaps would die. We all knew she was dying, and therefore

she couldn’t relax, and she moved around, and it was extra painful

for her. That was the afternoon that we checked out of the hospital

and went home, and at that point she had large doses of Valium

and other drugs to control her pain, which we were just asking for

one small dose and it was denied her. That is when we said this

is enough. This is definitely enough.

So there doesn’t have to be such a bright line between what they

can do in the hospital and what they can do at home. I don’t understand it at all.

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Mr. BURTON. Did anyone talk to you about alternative pain—possible remedies like acupuncture or anything?

Ms. PRYCE. No, that was never, ever broached.

Mr. BURTON. Never even talked to you about that.

You mentioned your daughter’s cancer was misdiagnosed repeatedly. Do you feel that doctors don’t think of serious illnesses such

as cancer when a child comes in with symptoms like pain?

Ms. PRYCE. I absolutely feel that way. Our pediatrician group

saw her at least twice, and I think three times, with this complaint

in her leg, and there was never so much as an x ray ordered or

anything. They did some manipulation and questioning of my

daughter. Other than that, they just dismissed it outright as just

the growing process or shin splints or whatever. She was even

dragging her leg behind her. She couldn’t put pressure on it at all.

Those symptoms were clearly stated, but dismissed.

Mr. BURTON. The gentlelady from Florida?

Ms. ROS-LEHTINEN. I just want to thank my good pal Deb for the

grace and dignity which she has bestowed upon this institution

with the way that she conducted herself through these difficult

times. Like you said, Mr. Chairman, our prayers are with her and

Randy. You know we love you, Deb.

Ms. PRYCE. Thank you. I felt that all along the way from my colleagues. It is so much appreciated.

Mr. BURTON. Any other questions or comments?

If not, thank you very much for being here and sharing that with

us.

We have some votes on the floor. We will stand in recess until

the votes are over, and we will come right back.

For those who are going to be testifying, I understand we will

have five or six votes on the floor. We will have 15 minutes on the

first vote, followed by five 5-minute votes. We will be gone for

about an hour.

I really apologize for the time problem. I can’t control the floor.

So we will be back as soon as possible. Thank you. You can rest

or take a little time off.

[Recess.]

Mr. BURTON. The committee will reconvene. Mr. Elijah

Cummings, one of our members, is not here today, but I wanted to

extend condolences on behalf of the committee because his father

passed away yesterday. I hope those in the minority will be sure

to extend our condolences to Representative Cummings. I know it

is a tough time for him.

Our second panel is Dr. Straus, Dr. Wittes, Dr. Kang and Dr.

Pazdur. Would you please come forward.

While they are coming forward, I would like to thank the ladies

and the families that gave me this pin who lost their children to

cancer. I will wear this with great pride, and I want to thank you

very much for thinking of me. I will try to make sure that your loss

was not in vain. Maybe we can get some things done that will

make sure this sort of thing doesn’t happen in the future, or at

least it is minimized.

Would you gentleman—do we have everybody? Dr. Kang, Dr.

Wittes we do not have yet, Dr. Pazdur. Are they still here? They

were downstairs having coffee? Is there anybody that can run and

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grab their coffee cup and lead them up here? Coffee drinkers will

follow their coffee cup.

We will have more Members come as time progresses. I ran back

here. That is why I am perspiring, because I didn’t want to hold

you folks up any longer.

So we have now Dr. Wittes with us, and we are waiting on Dr.

Pazdur. Is he down having coffee? Hello? Does anybody know?

Why don’t we go ahead and get started. I will swear him in when

he gets back.

Will you gentleman please rise? Are you Dr. Pazdur? Oh, he is

in the men’s room. Have a seat. We will wait just a minute.

Dr. WITTES. After all that coffee.

Dr. PAZDUR. Sorry, Mr. Chairman.

Mr. BURTON. Dr. Pazdur. Well, we understand you had coffee

and made a stop on the way. We are glad you are prepared for the

hearing. I apologize to you once again for the delay in our hearing.

Will you please rise, please.

[Witnesses sworn.]

Mr. BURTON. Thank you, and let the record reflect that the witnesses responded in the affirmative.

On behalf of the committee I want to welcome you all here today.

You are all recognized to make an opening statement, if you please.

We will start with Dr. Straus.

STATEMENTS OF DR. STEPHEN E. STRAUS, NATIONAL CENTER

FOR COMPLEMENTARY AND ALTERNATIVE MEDICINE; DR.

ROBERT WITTES, NATIONAL CANCER INSTITUTE; DR. JEFFERY KANG, HEALTH CARE FINANCING ADMINISTRATION;

AND DR. RICHARD PAZDUR, FOOD AND DRUG ADMINISTRATION

Dr. STRAUS. Thank you, Mr. Chairman. It is an honor to appear

before the committee for the first time and to address the opportunities that complementary and alternative medicine have to offer

in the management of cancer.

As you commented in your opening remarks, about two in five

Americans rely on some forms of complementary and alternative

medicine, and more than four in five cancer patients do so, by the

survey conducted by our new colleague in NCCAM, Dr. Mary Ann

Richardson, when she was our grantee at the University of Texas

in Houston.

The vast majority of this use is complementary in nature to alleviate the terrible symptoms and complications, and the minority of

use is as alternative therapy.

I can tell you, as one who has lost loved ones to cancer, that I

understand the desperation and the needs of patients, but I

wouldn’t attempt to be as eloquent as the honorable speaker was

prior to the break in commenting upon the needs of her child.

As a physician, however, I can say that I understand the frustration that we face on a daily basis, knowing that we cannot provide

our patients everything that they truly deserve.

My responsibility as a scientist and as the first director of

NCCAM, however, really requires me to take the long-term look to

invest in a rigorous fashion, in approaches that will provide the

American public the definitive answers they need for the future.

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There are very good reasons to think that some CAM modalities

would be beneficial. We know that to be the case with some

botanicals, such as St. John’s Wort for depression, but in studying

these modalities we become increasingly aware of unanticipated

adverse reactions. The imperative to study them carefully is even

greater.

For example in today’s New England Journal of Medicine, there

is a cautionary tale from Europe of a Chinese herb that not only

failed to alleviate suffering, but caused cancer in women.

So this is a complex and challenging enterprise, and NCCAM’s

approach is to harness the tools of rigorous science in a very openminded fashion. Our strategic plan for doing so is now posted on

our Web site for public comment, and it outlines the tiered approach we are going to use.

Cancer is one of our most important targets. We survey the entire field of medicine in our efforts, but by virtue of the needs of

cancer patients, this is a priority for us.

Shortly after assuming directorship I met with Dr. Richard

Klausner, the Director of NCI. We have met multiple times since

then. I have met with Dr. Wittes and Dr. Jeff White, his colleague,

on a monthly basis to discuss a joint portfolio to make sure we are

harnessing our collaborative resources as well as possible.

Our portfolio is still evolving. We have just completed our first

year in NCCAM having been established in February 1999, and our

budget for this year invests in cancer at three times what it did

last year, and our best judgment for our budget-expected potential

for 2010 would be an additional doubling.

We are already funding a collaborative project with the NCI the

first large definitive trial of shark cartilage as a therapy for nonsmall-cell lung carcinoma. We are investing in controversial therapies as well, such as the study at Colombia University of Dr. Gonzalez’s nutritional approach to the management of pancreatic cancer, for which the standard therapies are suboptimal.

With the NCI we have agreed to use a novel and expedited review process known as the quick trials mechanisms for funding

grants, and we jointly benefit from the availability and the advice

of the Cancer Advisory Panel on Complementary and Alternative

Medicine [CAPCAM], which has the responsibility, among other

things, to advise us about novel therapies through the best-case series mechanism. We are currently funding two such best-case studies, and we are looking forward in the September meeting to additional ones.

This very week we reviewed for the first time applications to

fund large centers dedicated exclusively to CAM approaches to cancer.

All of these efforts combined need to be communicated effectively

to the American public, and we do so with a very aggressive communications and outreach portfolio. In my first months in NCCAM

I realized that our fact sheets and our written material provided

by the NCCAM clearinghouse is inadequate. We are currently engaged in writing an additional 46 of them, including 10 on cancer

alone, together with the NCI.

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We are also funding, starting today, Dr. Jim Gordon’s Conference

on Comprehensive Cancer Care, which I have the pleasure of addressing Saturday.

So, in my first several months, I have joined an active and dynamic group. We have doubled its size already in the past 7

months. We look forward to building an aggressive and very excellent scientific portfolio addressing CAM and cancer.

Thank you, Mr. Chairman.

Mr. BURTON. Thank you, Dr. Straus.

[The prepared statement of Dr. Straus follows:]

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Mr. BURTON. Dr. Wittes, would you like to address the committee?

Dr. WITTES. My name is Robert Wittes. I am the Deputy Director

of Extramural Science at the National Cancer Institute. With me

is Dr. Jeff White, who is the Director of the Cancer Institute’s Office of Complementary and Alternative Medicine. It is a pleasure

for us to be here as well to tell you about some of the progress we

have made in the areas of interest to the committee.

The title of the hearings today, Integrative Oncology, is an interesting way of expressing the notion that our object really in medicine, in oncology specifically, is to put together everything that we

know for the benefit of the patient, whatever it is and wherever it

comes from.

Now, in order to do that in the best way, you have to have high

standards for evidence, because ultimately things hang on the answer to the question, does it work? It has seemed to us, and it

seems to many people, this is not a unique insight, that there can’t

be multiple different standards surrounding the issue of how rigorous evidence needs to be.

It is probably worth commenting that that is actually a rather

recent notion in medicine—if medicine is 4,000 or 5,000 years of

age—in the last half century or so, and it has pervaded the medical

community, actually, gradually over that period of time. I would

say also perhaps somewhat unevenly. Different people have for

themselves different standards of evidence for what—the judgment

of what works.

So when one is talking about the mainstream medical community and the complementary and alternative medicine community,

there is sometimes the assumption that there is a two-cultures

issue here. But I think times are changing, and my own observation is that there are enough like-minded people on both sides of

the mainstream in alternative communities to meet in the middle

and to interact productively in ways that will really move the evaluation of evidence in the direction that I think most of us think it

ought to be moving.

There is evidence that this is already happening, I think, and

one can see the establishment of complementary and alternative

medicine units in academic medical centers and in some medical

school curricula.

The meeting here in Washington that Dr. Straus just referred to

is, I think, an example of an organizational effort that has really

made an effort to bring all of the various people and constituencies

that are interested in the care of the patient together to see whether this kind of integration can occur at the care level and also at

the research level. There have been multiple actions by the NIH.

There are parts of the NIH to bridge the gap between mainstream

NCCAM communities, and Dr. Straus already mentioned several of

them, and I have summarized these, the NCI contribution to this,

in my written testimony which I am, of course, submitting in parallel with these oral comments.

The organization of the Office of Complementary and Alternative

Medicine in the Cancer Institute is actually sort of an organizational embodiment of our belief that it would be wrong for us to

isolate complementary and alternative medicine from the activities

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of the rest of the Institute. The reason we were interested in setting this up as a coordinating office within our Institute was so

that everywhere that it made sense within the Institute, the various programs that we have, could begin to address matters that

are currently called complementary and alternative. I think we

have started to do this. The organization of the CAPCAM, jointly

with the NCCAM, is an example of how we are attempting to integrate expertise from both communities.

We have a very aggressive best-case series program which we

started a number of years ago, actually, to try to elicit from the

community of complementary and alternative practitioners evidence, bodies of evidence, that they have obtained in the process

of their practices that should be considered by the medical community at large for action. We are trying to aggressively advertise the

existence of this process in the hope that people will come forward

and bring ideas that they have, evidence they have, about interventions to us.

Dr. White has done a terrific job of writing letters to about 150

different people about this. We have a leaflet that is going to be

distributed at the conference here. We have a Web site now that

advertises the details of this and will go into further detail as it

is developed.

This is actually a major focus of our impetus that we have to try

to bring these communities together and evaluate evidence that

looks promising.

We have started a clinical trials effort, and Dr. Straus has mentioned some of the examples of this. I also have to mention that

there is a new evaluation panel, a peer review evaluation panel for

clinical oncology proposals, that spans the spectrum of clinical oncology that I expect will be the perfect place for complementary and

alternative medicine investigators to come in with clinical proposals. My expectation is they will get a fair review in that setting,

and I have asked Dr. White to pay particular attention to the flow

of applications into the Institute and to make sure that CAM issues

are adequately represented on that committee.

In the matter of providing information, we are working closely

with the NCCAM about this. Our protocol data base CancerNet,

part of which, PDQ, has been in existence since the mid-1980’s or

so, has recently been totally revamped and updated; and as part

of this a couple of years ago we decided to take down a lot of the

information that we have on complementary and alternative approaches for the reason that Dr. Straus already mentioned, that we

just considered them inadequate, and we have been rebuilding this

and putting it back up and attempting to have fair-minded and

complete evidence-based reviews of what is going on in the CAM

area.

So let me just in the interest of time move on quickly to the natural products area, because I know that is of interest to you, Mr.

Chairman, in particular. This is an area, of course, that is very old

in medicine, it is about as mainstream as you can get, but with important conceptual links, interesting conceptual links to the world

of complementary and alternative medicine.

For natural products, one thinks of a whole variety of medicines

in medicine—morphine for pain, quinine derivatives for cardiac

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irregularities, digitalis for heart failure, any number of antibiotics

for bacterial infections, and the statins for cholesterol lowering;

and, of course, vincristine, vinblastine, doxorubicin, camptothecins,

taxol, taxotere and other anticancer drugs all come from one or another corner of the natural world.

Now, the notion of the natural world as a repository of medicinal

chemicals actually provides a pretty clear conceptual link between

the world of hard science on the one hand and the world of alternative practices on the other. There is nothing complementary or

alternative about natural products’ chemistry. What you have there

is a body of really rigorous science that can be used to explain, if

we are clever about it, real observations that are made with natural substances that may come out of the experience of practitioners

that are doing empirical kinds of therapies that they have a feeling

work and they have observed seem to work.

The issue for us is to really tack this down as much as possible

and make it as rigorous as possible. There are some interesting

complexities and differences in the approaches between these two

worlds. Natural products chemists tend to be really interested in

pure compounds. They are interested in fishing out pure compounds from impure extracts and trying to define what is active

and what is not within these extracts. Whereas traditional practitioners and traditional kinds of medical practice frequently emphasize the efficacy of complex mixtures.

So one of the things we are going to have to confront as an Institute in the not-too-distant future is this matter of how we can rigorously evaluate the kinds of complex mixtures that may come to

the best-case series and may possibly look good to the people doing

the evaluations in the best-case series.

So where do we want to go with all of this? We actually feel that

the natural products effort is so important even in the changing

scientific context that we are in now that we really want to

strengthen it.

The search for new drugs involves basically the answer to two

questions: Where do you look for the new drugs and how do you

look for them? The traditional answer to the where question is in

the natural world. That is why natural products are so important.

People look there.

The traditional answer to the how do you look question is you

set up screens, you set up assays of some sort based on some empirical effect, in the case of cancer, like cell killing, and then you

expose the assay to mixtures of natural products or synthetic

chemicals and you see what happens. That is how a lot of drugs

have been discovered. Both these things are changing now, actually. They are changing in remarkable ways.

The answer to the where question is now not only natural products and pure chemicals, it is complex libraries that clever chemists

can actually synthesize in their laboratories, generating huge

amounts of chemical diversity there. The answer to the how question is now no longer empirical but involves concentration on molecular targets.

In the Wall Street Journal article yesterday that was already

mentioned with the new compound for leukemia is an example actually of a synthetic search for a ligand to a molecular target. The

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key point about this and the reason I am bringing this up in this

kind of detail is that these changes, the increasing amount of

science in cancer drug discovery now, do not make natural products

less important. In fact, sometimes they probably make them more

important, because the natural world is probably the best single

place to find a diversity of structures that no chemist, no matter

how smart, would ever have had the insight to synthesize a ligand

to a particular target that might be as useful against cancer.

So we are currently thinking about ways to increase this resource and broaden it so it is not only an internal resource for the

Institute but it is made available on a competitive basis, to discovery laboratories across the country that wish to employ natural

products in their own discovery efforts.

I think in the interests of time I will stop here.

Mr. BURTON. Thank you, Dr. Wittes. We will get back to you

with some questions shortly.

[The prepared statement of Dr. Wittes follows:]

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Dr. KANG. I was going to say he could have my time if it means

I didn’t have to testify. I am kidding.

Mr. Chairman, distinguished committee members, thank you for

inviting us to discuss Medicare coverage for complementary and alternative therapies and experimental treatments, as well as our efforts to address racial disparities in health care.

We are well aware of the increasing integration of alternative

therapies into conventional therapy. I have referred my own patients for treatment such as acupuncture in my own private patience.

However, for Medicare coverage and payment to be made, there

must be reliable scientific evidence that a treatment is reasonable

and necessary. To date, there has been a paucity of such evidence

for complementary and alternative modalities, and we are actually

eager and anxious to work with our colleagues at NIH, FDA and

the National Center for Complementary and Alternative Medicine

to address the necessary evidence needed for Medicare coverage decisions.

Once that evidence is generated that Dr. Wittes and Dr. Straus

referred to and it is adequate, we will move quickly to provide coverage whenever and wherever that evidence is sufficient, within

the limits of our statutorily defined benefit categories.

For experimental therapies, Medicare has historically not covered

them because they do not meet the statutory requirement for reasonable and necessary. However, as the President announced this

morning, we will explicitly authorize payment for routine patient

care costs associated with clinical trials. Furthermore, the President asked us by Executive order this morning to report to him

within 90 days regarding the feasibility and advisability of providing additional financial support for the non-covered or non-routine

costs associated with clinical trials.

We want to do all we can to help generate the kinds of data we

need to make prompt coverage decisions on experimental and alternative treatments. Our new open and accountable coverage determination process will help that.

For example, we—following our testimony last fall, my agency’s

testimony last fall to this committee, we actually thoroughly reviewed all of the studies cited in the National Institutes of Health

Consensus Conference on Acupuncture in 1997. That conference

concluded that the scientific evidence suggests that acupuncture is

promising for the treatment of conditions such as chemotherapy-related nausea and vomiting and post-operative dental pain.

We will actually use that information as a starting point, and we

have just initiated a national coverage determination process to

look at those two cases for coverage in Medicare, and we are requesting any additional scientific information that has been generated since 1997.

We also have several initiatives under way to address racial disparities in care. We are particularly focusing on making health

care and health care information understandable and obtainable

for all populations, and we are stressing the importance of cultural

competency, which emphasizes the need to recognize and respect

the use of beneficiaries’ traditional treatments and beliefs from

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whatever cultures they may come from and then to integrate them

into the conventional medical care that we pay for.

We greatly appreciate the desire of this committee for wider coverage of alternative and experimental therapies and steps to address racial disparities in care. We will continue to work closely

with our colleagues on this panel today to develop the scientific

knowledge and evidence we need for coverage. We will also move

quickly to implement the revised coverage policy regarding routine

costs announced by the President today, and we are committed to

working to address reducing racial disparities.

I thank you, Mr. Chairman and committee members, for the opportunity to testify today and am looking forward to answering any

questions you may have.

Mr. BURTON. Thank you, Dr. Kang.

[The prepared statement of Dr. Kang follows:]

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Mr. BURTON. Dr. Pazdur.

Dr. PAZDUR. Mr. Chairman, members, I am Richard Pazdur, MD,

Director of the Division of Oncology Drug Products at the Center

for Drug Evaluation and Research at the Food and Drug Administration. Prior to coming to the FDA 9 months ago, I was at the

University of Texas M.D. Anderson Cancer Center in Houston for

11 years, where I was involved in patient care, research, medical

education and administration. To the extent that information is

publicly available, I would like to address the specific issues in

your letter.

We understand that cancer patients and their families are often

unfamiliar with the FDA’s statutory responsibilities. To more

thoughtfully work with the concerns of cancer patients and families, the FDA hired staff in 1994 who are available to answer questions and discuss concerns.

I would now like to address the issues in your letter.

Our primary obligations are those vested in us by Congress in

the Federal Food, Drug and Cosmetic Act to help ensure that marketed medical drugs are properly labeled, safe and effective and

that the procedures and studies conducted on unapproved drugs

are designed to protect the vulnerable, particularly patients with

life-threatening diseases such as cancer. The FDA is interested in

good clinical studies and data, independent of the type of therapy

used. It does not matter whether a drug is labeled alternative, complementary or conventional.

You asked us to address patient access to unapproved drugs. The

access process starts with a sponsor, usually a drug company, seeking to develop a new drug. Testing experimental drugs in patients

presents medical and ethical dilemmas. Medical and ethical standards prohibit substitution of an unproven drug where curative

treatments are available.

For example, in the initial treatment of Hodgkin’s disease, testicular cancer, child leukemia and medulloblastoma, there are curative therapies. Therefore, the use of an unproven drug before the

standard therapy has been used is medically imprudent and ethically unacceptable.

The ideal mechanism for a patient to receive a promising but

unproven drug is in a controlled clinical trial. Such trials provide

appropriate patient protections and potential benefits. It is not always possible, however, for each patient who might benefit from

the drug to enroll in clinical trips. Our regulations allow patients

to have access to unapproved drugs even though they cannot enter

clinical trials.

In the drug development process, the sponsor must decide whether it is willing to make the unapproved drug available for an individual patient. If the sponsor is not willing, even if the FDA has

no objections, the patient will not be able to obtain the unapproved

drug.

One may ask, why is the FDA involved in this process? Because

the FDA has access to confidential information about the safety of

the unapproved agent, our participation in the decisionmaking

process is critical. We work closely with the sponsor and the patient’s physician. For patients for whom no curative therapy exists,

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our practice has been to liberally allow patients access to unapproved drugs.

Mr. Chairman, you asked, can an unapproved therapy believed

to be less toxic be tried prior to a curative therapy that has known

serious adverse events? The answer is no. The most important aspect of any potential cancer therapy is the likelihood for prolonging

life or, hopefully, cure. Indirectly, drugs can be harmful if they lead

people to delay or reject proven therapies, possibly worsening their

condition.

The first chance for a cure is the best chance for a cure. This is

because progressive tumor growth and deterioration in a patient’s

health makes subsequent therapy much more difficult. Researchers

are always focusing on the goal of new and better treatments with

minimal side effects.

For example, in childhood leukemia, progress has been made in

improving the cure rate and decreasing the toxicity. With careful

observation and no compromise in cure rate, well-designed clinical

trials allow the development of less toxic therapies. Now the cure

rates for some kinds of childhood leukemias are greater than 90

percent.

Mr. Chairman, we are often asked the question, how should we

balance public health protection with personal autonomy? We think

the Congress has established the balancing correctly in the Food,

Drug and Cosmetic Act. As a practicing oncologist for over 20

years, I understand that some patients will never stop seeking

treatment that they think might help them. Our regulations protect the public from unsafe and ineffective drugs but also are flexible and allow desperately ill patients access to promising unapproved therapies.

Thank you very much for the opportunity to testify. I would appreciate if my full written statement would be entered into the

record. I will be happy to answer any questions the committee may

have.

Mr. BURTON. Thank you, Doctor.

[The prepared statement of Dr. Pazdur follows:]

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Mr. BURTON. Dr. Pazdur, let me start with you. As an expert in

colon and rectal cancer, can you please state your expertise in medulloblastoma?

Dr. PAZDUR. Medulloblastoma, I do not treat pediatric oncology

patients. The decision at the FDA regarding special exceptions to

NDAs for pediatric oncology drugs is handled by a board-certified

pediatric oncologist. This is reviewed by myself and is also reviewed by a team leader who is a board-certified medical oncologist

and also at the office level.

In cases—— Mr. BURTON. I guess the answer is you do not have any expertise

in medulloblastoma?

Dr. PAZDUR. I am not a pediatric medical oncologist.

Mr. BURTON. Well, I didn’t need to have the whole history there.

I just wanted to ask you that question, do you have any expertise

in that area, and you say no.

Dr. PAZDUR. No, I do not have personal expertise in that area.

Mr. BURTON. You are familiar with the legislation that I have

sponsored, I presume, aren’t you, the Thomas Navarro bill?

Dr. PAZDUR. I have read it, yes.

Mr. BURTON. You are familiar with the situation with the Thomas Navarro boy?

Dr. PAZDUR. I am intimately aware of the case. We have spent

many hours considering our decision in this case.

Mr. BURTON. Can you tell me what the side effects are for chemotherapy and radiation on a person who has that ailment?

Dr. PAZDUR. OK. The side effects for chemotherapy and radiation

and the discussion of toxicities need to be individualized for a given

patient.

Mr. BURTON. Well, let’s be a little bit more general than that. Do

you have a list of the side effects that we have—that we have

found out about with chemotherapy and radiation? The reason I

bring that up, Doctor, is because in the case of that boy and several

others that we have had contact with, the side effects—mental retardation, a whole host of which I will read to you in just a moment—cause a lot of the parents to be very concerned about Dr.

Burzynski’s treatment down there and how it might be as effective

or more effective without the potential side effects. The adverse

events we understand include sterility, stunted growth, hormone

disorders, blindness, hearing loss, mental retardation and secondary cancers.

Now, in the case of the boy we are talking about and others that

have had this kind of treatment that Dr. Burzynski has advocated

and performed down there—in a clinical trial, I might add—they

had some pretty good results. We have talked to some of the parents who have had some remarkable results with this kind of treatment.

Yet because the Navarro boy’s parents did not want him to go

through the potential side effects that might arise from chemotherapy and radiation, they decided they wanted to have the alternative therapy that is in a clinical trial that Dr. Burzynski proposed. The problem they ran into is they said he could not take the

alternative therapy, which is in a clinical trial, until he had taken

chemotherapy and radiation; and they went so far as to say that

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if he did not take the chemo and radiation first, which had these

potential side effects, that the State agencies might come in and

take the boy from the parents and force the foster parents or whoever took charge of the child to give the boy chemotherapy and radiation in spite of the possibilities of the side effects.

So I guess my question is this: Why should that family or any

family, when there is a clinical trial going on, have to go through

what they perceived to be a real danger to their child, chemotherapy and radiation, when there is another approach in clinical

trials that might provide better treatment and longer survivability

for the child?

Dr. PAZDUR. The answer to the question is a very complicated

answer. When we are dealing basically with a decision of therapy,

there is a question of efficacy and toxicity, how well does the therapy work, how well has it been established to work.

The conventional therapies for medulloblastoma is one of the few

success stories of pediatric oncology in that it allows a curative potential in over 75 percent of patient—— Mr. BURTON. May I interrupt you real briefly? Because I saw

some of the children cured by this treatment. I saw them. They

were mentally retarded, they couldn’t talk, they couldn’t speak.

The cancer supposedly was cured, but the child was a vegetable.

I am not sure that that is what those parents envisioned when they

went through the conventional treatment.

So why shouldn’t—and I see my time has run out and I will yield

to my colleagues, but why shouldn’t a parent have the right to

choose between a clinical trial that is ongoing and a treatment that

might endanger their child’s life or health dramatically?

Dr. PAZDUR. First of all, the patient did not qualify for the clinical trial in that the clinical trial is written that patients need to

have had progressive disease on standard therapy. This is getting

back to the major issue that formulated our decision, and that is

the curative potential standard therapy that has been well-tested

over decades, that has led to the cure in patients.

Now, granted, you have seen examples of children that have

probably suffered severe side effects. There has been tremendous

progress in reducing doses of radiation therapy using different

chemotherapy regimens in an attempt to reduce the toxicities experienced by patients in the treatment of this disease. No. 1, Thomas

Navarro did not qualify for the protocol because it was specifically

stated that patients must have had an attemptive curative therapy.

Mr. BURTON. Meaning chemotherapy and radiation first?

Dr. PAZDUR. And radiation, because of the cure.

Mr. BURTON. Let me interrupt here. I think I understand this.

So the child and the parent is taken out of the decisionmaking

process at that point. Either they go along with chemotherapy and

radiation and the potential side effects, or their child cannot get

the other treatment?

Dr. PAZDUR. Here again—— Mr. BURTON. That is true, though, isn’t it?

Dr. PAZDUR. Our decision is based on a balance between efficacy

and toxicity.

Mr. BURTON. I understand what you are saying. But what we are

saying is the parent is no longer able to participate in the decisionVerDate 11-MAY-2000 08:49 Jul 30, 2001 Jkt 000000 PO 00000 Frm 00155 Fmt 6633 Sfmt 6633 C:\DOCS\72932.TXT HGOVREF1 PsN: HGOVREF1
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making process unless they first use chemotherapy and radiation,

though knowing full well the side effects that might occur.

Dr. PAZDUR. Given the known efficacy data regarding

antineoplastins in this disease, we cannot substitute it for a known

curative regimen that carries with it a 70 percent survival.

Mr. BURTON. Why don’t you just give me a straight answer? The

straight answer is, yes, they cannot participate in the clinical trial

unless the child has first had chemotherapy or radiation.

Dr. PAZDUR. That is the eligibility criteria of the trial.

Mr. BURTON. What if you have a child, you, and the child has

this devastating cancer, and this child has to go through this treatment, and you have done all the reading and research, you have

gone to the Internet and talked to a lot of other parents that had

problems with this, and you came to the conclusion that the risk

of chemotherapy and radiation was greater than going the alternative route and trying to help your child with clinical trial, what

would you do? Would you say, OK, we are going to go ahead and

take the risk?

Dr. PAZDUR. No. Let me emphasize that I have been in practice

for 20 years in medical oncology, and the issue here is the Internet

and the information that patients get from the Internet. We applaud and we want patients to be active participants in their care,

but this does not substitute for the experience of physicians that

have treated patients with medulloblastoma. I am not saying this

in an autocratic, authoritative, authoritarian fashion. Nevertheless,

when we made our decision, we contacted leading experts that

treated medulloblastoma, and they believed the risk-toxicity benefit

versus the known survival advantage was far outweighed.

Mr. BURTON. I am going to yield to my colleague, but I want to

make one real brief comment.

I went to Africa, and I got a terrible stomach problem, and I

came back, and I had this bug for 2 years. I couldn’t eat properly,

I had to take everything, Zantac, everything for my stomach for a

long time.

I read about a doctor from Australia, and he had said for the

first time that he believed that the problem that people have with

stomach ailments was not caused by nerves, ulcers and all of that

sort of thing, but it was caused by a bacteria. And I went down to

see him, because I couldn’t live with what I was going through.

He treated me, and in 1 week I was cured. He is now recognized

all over the world as one of the leading doctors in his field, and

what he said was the H pylori bacteria does exist and probably 90

percent of the people in the world could be cured if they just took

a combination of medicines. FDA wouldn’t approve it, FDA didn’t

look at it, none of that was approved, and yet I was cured before

that happened.

Now, the thing that bothers me is I participated in the decisionmaking process myself, and I went down there, and I was cured.

A parent who has a child who is dying of cancer, who knows that

the chances of survival is not all that great, who knows the side

effects of chemotherapy and radiation and knows there is another

approach like Dr. Burzynski’s that is in clinical trials, it is my contention that they ought to have a voice in the decisionmaking process. And what we see is that—and you say you are not an autocrat,

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but what we see is we see the agency of government, the Food and

Drug Administration, saying to that parent, no. Your child is going

to go through chemotherapy and radiation, or else. And if the child

has the side effects that I have seen where a child is a mental basket case, a vegetable because of the side effects of the chemotherapy and radiation, then that is just tough.

I am one of those who believes that the parent, if it is a clinical

trial that has been approved by the Food and Drug Administration,

at least ought to have a voice in the decisionmaking process, and

you folks continue to say no, and that bothers me a great deal. But

we will talk about this further.

Mr. Horn, you are recognized for 5 minutes.

Mr. HORN. I would be glad to yield you 2 minutes more.

Mr. BURTON. That is all right.

Mr. HORN. No. 1, I would like to ask Dr. Wittes, you are at NIH,

is it true that there has been a loss of personnel in the portion of

NIH where drug development was being reviewed? Is that correct?

I am told almost 30 have been dismissed there or reassigned to

other parts of NIH.

Dr. WITTES. I don’t know what your point of reference is, your

time point of reference. But we—— Mr. HORN. The last 4 months.

Dr. WITTES. No. It is not true.

Mr. HORN. It is not true.

Dr. WITTES. Right.

Mr. HORN. So nobody is being—you know what I am talking

about, on drug development and marine plant life and plant life.

Dr. WITTES. Correct, there has than been no loss of personnel in

the last 4 months.

Mr. HORN. Then maybe some of the newspapers are a little in

error. But that bothered me, to say the least.

What type of a program do you have going on plant life and marine life?

Dr. WITTES. Well, we will have and have had for a long time a

pretty extensive program that actually goes out to far corners of

the world and searches ecosystems like tropical rainforests and marine ecological niches, soils and so on, to try to procure examples

of plant, animal or microorganism life for our natural products repository, which is a repository that is actually a natural treasure.

It contains about 140,000 extracts of one sort or another, and this

has actually been the basis for the natural products work that has

gone on at the Cancer Institute.

A little while ago, a year or two ago, we established a program

that makes the repository available to people outside the Institute

interested in screening for compounds in cancer and also outside

the area of cancer. So it would please us greatly, for example, if

people interested in drug discovery for other serious medical illnesses would regard this also as a repository for them.

That is one aspect of what we do.

Mr. HORN. What is the next one?

Dr. WITTES. Well, also, there has been in place for a number of

years now a screening system that depends on inhibition of growth

of a panel of various cell lines. This has been actually very useful

in discovering extracts and pure compounds that might have

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anticancer activity, although the proof of that is always in the pudding, but it is an initial screen.

We have come to question in the last few years whether that cell

line screen is the right way to be asking questions about what

might be useful in cancer. Based on new knowledge in cancer biology we have big plans, actually, to try to reorient our approach in

the direction of molecular targets but still use the same kinds of

chemical diversity that we have been talking about in the past

also. Enhanced, however, by some of these new synthetic methods

in the laboratory that I mentioned briefly in my comments before.

We also have a development program. Development is the process by which you take a chemical that looks like it might be interesting and you turn it into a substance that you can administer to

an animal or downstream to a human being. That involves lots of

tests that give you reason to think that, if you were to give it to

a person, it would be safe and it wouldn’t cause horrific side effects,

at least not initially, depending on how you ended up giving it, but

certainly it would be safe to introduce into clinical trials. It woudl

also have the potential to kill cancer or stop it from growing in a

whole animal or a person as opposed to just a petri dish. That is

a long, complicated process that involves many steps like toxicology, pharmacology and formulation and things like that.

Mr. HORN. Has there been substantial interest from the pharmaceutical firms?

Dr. WITTES. We collaborate with, I would guess, probably somewhere between 100 and 200 pharmaceutical companies and also

academic laboratories all over the world who submit compounds,

unknown compounds and known compounds, to our screening systems. We also commonly collaborate with companies in the clinical

development of agents that either we license to them or they want

to co-develop with us. This process has been a collaborative one for

decades now, and it is really only going to increase in intensity as

industry becomes more and more interested in cancer, which they

are in both the pharmaceutical and biotechnology sectors.

Mr. HORN. We hear every time we talk to the pharmacological industry that it costs them about $300 million in research on that.

You are doing a lot of the research at the NIH. Is there any recompense from the industry when they are successful or maybe

when they are not successful? And I would just be curious the

way—are you able to award a particular scientist on your payroll

at NIH and doing a lot of this or, through grants from NIH, is

there ever a chance for that individual who has taken and pursued

a particular line of endeavor where there is any monetary award?

Dr. WITTES. That is a complicated question.

Mr. HORN. I am thinking from the pharmaceutical group, in

terms of your contract.

Dr. WITTES. Right. So the reward system that is in place for scientists who discover things that end up being useful, if that happens within the intramural program of the NCI, that is on the

campus in Bethesda or in Frederick, there it is now possible for inventors to receive royalties up to a certain level once there is a revenue stream from the sale of something. Of course, for extramural

grantees, grantees of the NIH that discover something under

grants or contracts, the legislation allows licensing, patenting and

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licensing; and they, of course, can therefore also benefit from a revenue stream once there is one.

There is not, in general, direct financial feedback, however, from

drug companies to the NIH, except when there is a collaborative

research and development agreement in place, which is, I am sure

you know, a formalized process actually created by the Congress to

enable collaborations between outside organizations and the government.

Mr. HORN. And you feel that is helping maintain first-rate scholars in science to the NIH?

Dr. WITTES. I think it is a factor. I think most of the people who

work at the NIH work at the NIH because they love it. Nobody gets

rich by working at NIH.

Mr. HORN. It is hard to beat. You don’t have students and a university bothering you either.

Dr. WITTES. Some of us like students.

Mr. BURTON. Mr. Horn, we will come back to you in just a

minute.

Mr. Cummings.

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

Chairman, I want to thank you for taking a moment of silence on

behalf of my father who passed away on Sunday. I sincerely appreciate that, and I appreciate the thoughts and the prayers of the

committee.

I just have a few very brief questions.

Dr. Wittes, let me just ask you, does NCI evaluate all research

proposals by the same criteria?

Dr. WITTES. Well, can you say a little bit more about what you

mean by that?

Mr. CUMMINGS. Does the NCI hold unconventional and conventional research proposals to the same standards?

Dr. WITTES. That is certainly the intention, yes. You see, the reason I am not simply saying yes is a lot of the evaluation of the proposals is done by a peer review system, which involves committees

of experts drawn from the outside, and depending on who you get

together around the table to discuss things, you may get a greater

or lesser degree of enthusiasm for one type of thing or another. The

intention is certainly to mainstream the evaluation of complementary and alternative approaches, yes.

Mr. CUMMINGS. Many people now turn to the Internet for information about cancer and how to prevent, detect and treat it. What

steps has the NCI taken to make accurate information available on

the Internet?

Dr. WITTES. We have devoted an immense amount of time and

energy over the last few years to that issue.

I mentioned in my opening statement the revamping of our protocol and information data base relating to cancer and cancer research. This data base is called CancerNet, and it involves thousands and thousands of pages of Internet pages of text about stateof-the-art treatments for cancer and about available clinical studies. It has a new powerful search engine that allows people to put

in information that is more closely tailored to their own circumstance, including where they live, by the way, and come up

with not only protocols that are available for them for their stage

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and kind of disease but also in the geographic area in which they

live.

We also have a new Web site called CancerTrials which is full

of contextual information about the research setting. So it tells people, for example, about why they should care about clinical trials,

what clinical trials are, what the informed consent process is all

about, the kind of questions they should ask of people. We have

really I think done a much better job over the last few years in exactly that direction.

Mr. CUMMINGS. I understand in the State of Maryland it is estimated that 22,600 new cancer cases will be diagnosed this year.

Maryland is not a big State. A lot of those cases will take place in

my district which is Baltimore city, predominantly African American. The thing that concerns me is we have seen articles here recently that show that there are significant racial disparities in the

way people are treated for their cancers. Could you describe any efforts by the NCI to determine the reasons for these disparities?

Dr. WITTES. Yes. That is another area, actually, of intense interest to us, and we have actually a very ambitious plan relating to

cancer and the disparity of the burden of cancer in various segments of our population.

We are doing a lot with that now, including the creation of a series of ambitious community-based networks to try to create infrastructures in areas suffering a disproportionate burden of cancer.

These infrastructures will actually serve as research platforms to

ask exactly the kind of questions that your question focuses on,

which is why is there an excess burden of certain kinds of cancers.

We don’t have a very good idea right now, for example, of why African American men suffer disproportionately from prostate cancer.

It is known they do. We don’t know why. These kinds of issues are

the issues we need to get to the bottom of.

There are a number of other things we are doing also, including

trying to establish relationships between sites of research in minority-serving institutions and the cancer center networks that the

Cancer Institute already supports. We are doing this with the Office of Research on Minority Health and expect that that kind of

fusion between institutions that are oriented toward the care of minority groups on the one hand and then institutions that are

science-rich places that may not have been thinking about the particular problems in minorities, will be a very creative way of getting people to put this on their radar screens and make it a real

issue for them.

Mr. CUMMINGS. Dr. Pazdur, what is the cure rate of children

with pediatric brain cancer using the standard care treatment?

Dr. PAZDUR. The standard treatment, I assume we are talking

about medulloblastomas here——

Mr. CUMMINGS. I didn’t know whether I could pronounce that

word right.

Dr. PAZDUR. It is in excess of 70 percent. In some series, it is

even 80 percent or higher. It is a very curative disease.

Mr. CUMMINGS. Well, what is the cure rate for children when we

use Dr. Burzynski’s treatment?

Dr. PAZDUR. This is one of the problems in determining the adequacy of his treatment. We really do not have adequate survival

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data, because we are dealing with a very limited number of patients that have been entered on clinical trials. Basically we are

taking a look at—if we take a look at the number of patients entered on clinical trials, it is in the range of about 17 patients. The

survival data we do not have complete data on because many of

these patients are obviously being treated at this time. We do not

analyze a clinical trial until the trial is completed.

The activity that we have seen using this therapy have included

some responses. However, by responses I mean tumor reductions.

But in order to acquaint that therapy to the body of knowledge that

has been evolved really over the decades using radiation and chemotherapy is impossible to answer at this time.

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

Mr. BURTON. Following up on what Mr. Cummings just asked,

how many people would you say was in that clinical trial down

there? Seventeen, I think you said. I am pretty sure that is what

you said.

Dr. PAZDUR. The most recent update on the protocol, on the protocol in 1999, which is the most recent, we have eight patients on

the protocol, and nine patients that were exceptions that we entered on the protocol.

Mr. BURTON. One of the things you said when I was talking to

you a while ago, and I think you just said now, you have such limited knowledge from the clinical trial. That is true, isn’t it? We

have very limited knowledge.

Dr. PAZDUR. We have 17 patients treated.

Mr. BURTON. I understand. But you limit the number of people

on that clinical trial, and then after you limit the number of people

in the clinical trial, you say you don’t have enough evidence. You

know, I don’t understand that. Would you explain that to me? You

say we don’t have enough evidence because we don’t have enough

people on the clinical trial, and at the same time you are saying

we won’t let anybody beyond a certain number on the clinical trial.

What you are saying is you are going to make sure you know the

result ahead of time. The result is, we don’t have enough evidence

from the clinical trial. You won’t let them in, so you are never

going to get the kind of end result that might come out. Isn’t that

correct?

Dr. PAZDUR. No, it is not.

Mr. BURTON. How many people will you allow in the clinical

trial?

Dr. PAZDUR. We will allow the patients that meet the eligibilities

criteria.

Mr. BURTON. And that is? Chemotherapy and radiation first?

Dr. PAZDUR. Yes.

Mr. BURTON. The ones that don’t die or become vegetables, then

you will allow them in the clinical trial?

Dr. PAZDUR. I think that is a gross mischaracterization of a

standard therapy and the results that one gets from therapies that

are administered to patients with this disease.

I would like to bring up——

Mr. BURTON. Then you should have come to our press conference

and should have talked to the parents who had their kids there in

wheelchairs who were just degenerating into nothing because of the

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conventional treatment instead of the other treatment that they

could have taken.

Dr. PAZDUR. We have talked to pediatric oncologists who are experts in this disease, and they believe that the risk-toxicity benefit

is warranted in the relationship to the cure rate. We have allowed

over 300 patient exceptions, patients to be exempted and to be

treated on antineoplaston. So I don’t think we are limiting the access to this drug in appropriate situations.

Mr. BURTON. It was after, though, they had the chemotherapy

and radiation, correct?

Dr. PAZDUR. This is in a variety of diseases.

Mr. BURTON. Oh. But as far as the medulloblastoma, how many

have you had?

Dr. PAZDUR. As I stated before, the number of patients that are

on medulloblastoma trial, there were eight on the trial and nine exemptions that did not fit the criteria for the trial.

Mr. BURTON. Why didn’t they fit the criteria?

Dr. PAZDUR. They could have had minor laboratory abnormalities, etc.

Mr. BURTON. Minor laboratory abnormalities. Tell me what those

are?

Dr. PAZDUR. I don’t have that data in front of me.

Mr. BURTON. I mean, could it have been a mental problem or a

physical problem that resulted from the chemotherapy or radiation?

Dr. PAZDUR. I do not believe so.

Mr. BURTON. Well, do you know?

Dr. PAZDUR. I would have to look into that and get back to you.

Mr. BURTON. Would you look into it and get back to me? I would

like to know if the chemotherapy or radiation had side effects for

those nine patients that resulted in their non-acceptance into the

program down there. So would you let me know that?

Dr. PAZDUR. I would be happy to let you know that.

Mr. BURTON. Thank you.

Dr. Straus, I understand that one of your employees is a Reiki

master. Could you explain what that therapy is?

Dr. STRAUS. He is the expert. You are referring to Dr. Morgan

Jackson who we recently had the good fortune of having join us.

Hw was until now the Director of Minority Health Studies at the

Agency for Health Care Research and Quality. He is a licensed internist trained at Harvard and Harvard Medical School, and he is

also interested in a range of complementary therapy.

Reiki therapy, as I understand it, involves manipulation of particular points on the feet for therapeutic purposes. He is interested

in that therapy.

Mr. BURTON. And has he had some positive results from the therapy he is using?

Dr. STRAUS. I believe he has, but he has been with us now for

about 2 weeks, and his responsibility is to develop our entire portfolio of research addressing the issues of health disparities using

CAM approaches to traditional and indigenous health care systems.

Mr. BURTON. What is the role of spirituality in healing as a physician? Do you ever pray with your patients, and, if not, would you

be uncomfortable doing that? I am just curious.

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Dr. STRAUS. I am a religious person myself, Mr. Chairman, and

I have prayed when my children have been ill, as many parents do,

and I support and respect my patients’ wishes for that kind of therapy and offer them clerical support if they wish to pray.

I have not prayed in any religious context with my patients. My

own religious beliefs may be different. But, as I say, these spiritual

efforts are very supportive in comforting patients and families.

Mr. BURTON. Regarding acupuncture and other therapies, do you

think that they have been shown to be effective and should be reimbursed by Medicare?

Dr. STRAUS. I believe that acupuncture, despite its thousands of

years of use and its venerable traditions, is in the area of, still, controversy for some cases. It is touted for many, many illnesses. Most

of those cases have not been studied at all. There have been some

good studies, although not absolutely definitive, suggesting that

acupuncture is beneficial for certain types of pain disorders and not

others.

There was a consensus panel of outside experts convened at the

NIH in 1997 who, upon reviewing the literature to that time, concluded that the burden of evidence suggested acupuncture is beneficial for pain associated with dental extraction, as well as an adjunctive therapy for relief of nausea and vomiting following chemotherapy.

As to whether the level of evidence is adequate for reimbursement, reimbursement issues are not ones I am particularly knowledgeable about, but I would say the evidence for acupuncture for

all CAM modalities should be exactly the same as for all conventional therapies. When there has been adequate controlled trials of

a prospective nature that says it works and is safe, that should be

sufficient.

Mr. BURTON. Thank you, Doctor.

Mr. Horn.

Mr. HORN. Thank you very much, Mr. Chairman. Let me pursue

some of that drug laboratory situation.

Do you see—after several years, maybe decades, of this, do you

see any major stream that might be the most productive as a result

of that laboratory and the grants that are granted in a similar nature? Where are we, in other words, in it right now, in terms of

plant life, marine life, etc?

Dr. WITTES. Well, I think as far as sources of chemicals is concerned, it has to be said that the microbial world has probably been

more intensively investigated than either plants or the marine

world. Now I say that with some hesitance because the discovery

of a whole new genre of life, the so-called bacteria that live in very

hostile places like near deep sea vents and so on, plus the increasing knowledge there are actually very large numbers of organisms

that are not culturable by conventional technology, means that

there is a whole lot of microbiology we are just beginning to learn

about. It may very well be that there will be very interesting

chemicals coming out of that source.

The business about plant life in endangered ecosystems has gotten a lot of public attention, and we are doing what we can to collect specimens that are not already represented in our repositories.

160

Marine life is also another area of real attention. You will be

hearing from Dr. Petit tomorrow, who has actually made a lot of

contributions in this whole area.

Mr. HORN. Well, I thank you.

Dr. Kang, I would like to ask you, because of your affiliation with

Medicare, do you advise the health care financing system as to

what pharmaceuticals ought to be recognized by Medicare in relation to cancer? Is that one ever your roles?

Dr. KANG. You have to understand that Medicare actually currently does not have a drug benefit.

Mr. HORN. We are going to give it in the next 3 months, so you

will be doing that.

Dr. KANG. Yes. I am responsible for Medicare’s coverage decisions and to the extent that there is a limited drug benefit with

regard to some cancer drugs, and I do make those decisions. I certainly endorse the statements that Dr. Wittes and Dr. Straus have

made, that the evidentiary standards for whether certain drugs

should or should not be included for Medicare coverage should be

the same and the scientific method should be the same.

Mr. HORN. One much the drugs that women have to get, which

is tamoxifen—how do you pronounce it?

Dr. KANG. Tamoxifen.

Mr. HORN. Is that approved for Medicare?

Dr. KANG. Unfortunately, that is an oral drug, and it is not a

Medicare benefit. That is something that legislation needs to pass.

But I will tell you if you gave—— Mr. HORN. A number of health plans do have that, and so I am

thinking when we will get to this in the next few months that I

would hope that that would be recognized, because there are so

many people out there, particularly widows, with maybe only $500

a month in a Social Security pension, their husband is dead, and

then this gets to be very expensive.

Have you looked—even though you don’t have the authority now,

have you looked at the range of pharmaceuticals that might well

be utilized by health care, both physicians, hospitals and clinics

and all the rest, that are eligible?

Dr. KANG. In general, the administration has overall looked at

the drug benefit in its total package, but we have not gone drug

by drug. Obviously though, if we were to get a drug benefit, we are

in full support of this; and tamoxifen certainly for the treatment

of breast cancer I think would be on the list.

Mr. HORN. I appreciate that.

I guess I would ask Dr. Wittes, when we are talking about Medicare people, we are talking about some of us that are over 60 years

of age.

Dr. WITTES. Don’t look at me.

Mr. HORN. No, I am saying, to what degree have we included

them? And I might add the same for FDA, to what degree are people over 60 in some of these particular trials that we hear about

from FDA and we see in NIH and universities and elsewhere? Is

there a sensitivity to sort of making sure the elderly—— Dr. KANG. I think this is actually why the President’s announcement this morning—currently, roughly one-third of beneficiaries

over the age of 65 are participating in cancer and clinical trials,

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when we know that roughly they comprise roughly two-thirds of actually the people with cancer in this Nation. So there is somewhat

of a lag for the elderly.

One of the barriers to that is the payment for routine costs associated with those clinical trials, and the President announced this

morning that Medicare would do that, make it explicitly clear that

because people enter a clinical trial, they don’t lose their Medicare

benefit.

Obviously, there are other reasons why the elderly may not participate in trials, but certainly we are interested in removing the

financial barriers.

Mr. HORN. Is it tilted primarily for women because of the sort

of scourge of breast cancer we have in this society?

Dr. KANG. Not that I am aware of.

Dr. WITTES. No, we also have the scourge of prostate cancer.

Mr. HORN. Yes, I am one of those. I am zero on my PSA for the

last 5 years. I thank the people that did it.

By the way, one of my urology surgeons had just the situation

that the chairman mentioned on stomach upsets, ulcer, etc., and

the man from Australia certainly saved him after 20 years.

Mr. BURTON. Dr. Barry Marshall is his name.

Let me now yield to Mr. Cummings.

Mr. CUMMINGS. Thank you.

Mr. BURTON. Incidentally, Dr. Barry Marshall, I understand, has

received one of the highest awards of any physician here in the

United States for his medical research, and I understand he may

be nominated for a Nobel Prize for science in the future.

If I might just—one second, Mr. Cummings—tell you, I told my

stomach doctor in Indianapolis about my experience with Dr. Marshall, and he was visibly angry, and he turned around and walked

off. And that kind of surprised me, because I guess the treatment,

the conventional treatment that he had been using for years with

which he made his living was being jeopardized by Dr. Marshal,

and it made him very upset.

Mr. Cummings.

Mr. CUMMINGS. Thank you very much, Mr. Chairman. I didn’t

have a preliminary statement, but I do appreciate you holding this

hearing. I really do, because I think it is such an important subject.

I want to take a moment to thank our panelists for all that they

do every day to help people live the very best lives that they can

and help people live, period. I think sometimes we can get so

caught up in what we do that we forget how many lives we touch.

So I want to express my appreciation to all of you and to all of the

people who are associated with you who may be watching this right

now.

One of the things, Dr. Kang, that I am just serious about, if we

had a drug benefit like Mr. Horn just talked about, and I have just

as much optimism as he does with regards to this Congress doing

that, how do you determine what kinds of criteria is used to determine what drugs would go under that benefit with regard to cancer? I am not asking you for specific drugs, just what do you look

at? Do you look at price, do you look at effectiveness, things of that

nature?

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Dr. KANG. Under the President’s drug proposal, those drugs approved by FDA and their indications, because they have already

been labeled safe and effective, would be covered. So that would be

one criteria.

I think, in general, we would be very interested in looking at the

outcomes, the health outcomes and what contributes to the patients’ not only cure rates and quantity of life but quality of life.

Under the President’s proposal currently, I should say those decisions would be made by the pharmacy benefit managers. The point,

though, is that beneficiaries should get access to the FDA-approved

drugs that have been deemed safe and effective.

Mr. CUMMINGS. You know that there are people who are right

now glued to their televisions watching this, or maybe watching it

later, and they heard the President this morning, and there are

people sitting there watching us right now who are suffering from

cancer and suffering from other problems. I know you have talked

about it a little bit earlier, but, you know, I am sure they are sitting there saying, exactly what does this mean for me? If I have

got a problem, what does this mean for me and how do I now go

about making sure that—first of all, did I fall within the category

that the President was talking about? Second, how do I make this

work for me?

I think the chairman would agree that if there is something

available to the public, we want to make sure they understand it

and not have any misconceptions and that kind of thing. Can you

just kind of tell us real quick, as if there were somebody looking

at this right now wondering?

Dr. KANG. I think the most important message is that, because

of participation, if someone participates in a clinical trial, he or she

would not lose their Medicare benefits. I think that is the most important message. We will pay for the routine costs associated with

the trials.

I think that the other important message is we will—the President did say that the agency and the administration will work on

efforts to actually educate the community. But I think there is

some misunderstanding about what is covered and what is not covered, and the last thing we want to do is to make sure beneficiaries

who go into trials know what the Medicare program will be paying

for and what the trial sponsors will be paying for and really understand their liabilities.

Mr. CUMMINGS. Thank you very much.

Thank you, Mr. Chairman.

Mr. BURTON. We are about to go to our next panel. I just had

one more question for Dr. Straus.

Dr. Straus, you talked about the foot therapy that Dr.—is it

Reiki? I think you are talking about a different subject. Because

Dr. White—where is Dr. Jeffrey White? He indicated that the Reiki

treatment is energy therapy and not foot therapy. So I thought you

may have been thinking about something else. I just thought I

would mention that.

Dr. STRAUS. Let me stay, Mr. Chairman. I thank you for the opportunity to reflect my ignorance.

Mr. BURTON. No, we are not——

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Dr. STRAUS. The fact is, I have been hired to be director of the

Center because of my expertise as a clinical scientist, but my background is in infectious disease and immunology. If you would be

like to discuss that, I would like to entertain you with that sometime. But I am not knowledgeable of the many hundreds of CAM

therapies. That is why I recruit the best and the brightest to help

us develop the programs to do so.

Mr. BURTON. Very good.

One last question. I would like to say to all of you, though—I

would like to submit to you a whole host of questions we haven’t

had time to get to you today, and I would like you to submit them

for the record. In particular, I would like to have the backgrounds

on those nine people we were talking about earlier.

Finally, Dr. Straus, is there a role for complementary and alternative therapies in the hospice environment?

Dr. STRAUS. One of the largest uses of complementary therapy is

to alleviate suffering from chronic illness, be it pain, be it nausea,

and that is, in fact, some of the most successful uses.

My own background involves a lot of studies of chronic pain associated with shingles infection. Those are the kinds of areas in

which one can explore acupuncture, patients who are chronically ill

or often depressed understandably from that illness; and the use of

botanical products that may raise their mood could be beneficial.

I would say that palliative care is a huge place for CAM studies.

The NIH has just announced that it has hired a director of palliative care to join us this summer in the clinical center. She comes

from the Foxchase Cancer Center where she has had extended experience in this area.

Mr. BURTON. Very good.

Well, as I thank you for your help, let me just say one of the

things that bothers me continually and bothers a lot of other people

in the country is that people like Mr. Navarro have had to take

their loved ones or themselves or their children out of the country

to get treatment that they think is going to be beneficial for their

families, and many of the treatments that are being used in other

countries and Europe have been beneficial that are not yet recognized or accepted in the United States because of FDA and HTS

regulations. That is unfortunate, because it costs so much money

to take somebody to Europe or someplace else or Germany for a

treatment that might save their lives when, if it is effective, it

should be utilized here as well.

One of the things that I have never understood is why countries

that have an effective treatment for a disease, such as cancer, why

there is not some kind of cross-pollination between that country

and the United States and vice versa so that those treatments and

those scientists’ minds and proposals can’t be utilized across intercontinental borders.

So I just leave that thought with you. I want to thank you all

very much for being here today.

We will now bring our next panel forward. I hope, if you have

a moment, you can stay and hear some the stories these people are

going to tell. We are going to have patients here.

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Mr. Navarro, Mr. and Mrs. Horwin, Dr. Geffen, Mr. Cary and

Mr. Devries, would you please come forward? Would you please

rise? This is a standard procedure.

[Witnesses sworn.]

Mr. BURTON. Let the record reflect the witnesses have responded

in the affirmative, and we will now recognize each one of you for

an opening statement.

STATEMENT OF JAMES NAVARRO, TUCSON, AZ; MICHAEL

HORWIN, SAN DIEGO, CA; RAPHAELE HORWIN, SAN DIEGO,

CA; DR. JEREMY GEFFEN, GEFFEN CANCER CENTER AND RESEARCH INSTITUTE; ROGER CARY, CANCER TREATMENT

CENTERS OF AMERICA; AND GEORGE DEVRIES, AMERICAN

SPECIALTY HEALTH PLANS

Mr. BURTON. Mr. Navarro, it is nice having you back with us.

Why don’t you tell us how your son is doing and what has transpired since we last met.

Mr. NAVARRO. Well, thank you.

Mr. BURTON. I hate to say this, but because of the lateness of the

day, if you could confine your remarks to 5 minutes, if it is possible, we would really appreciate it.

Mr. NAVARRO. Thank you, Mr. Chairman. As we speak, Thomas

is in therapy outside the United States; and in spite of the events

of the last almost 9 months, he is doing quite well in defeating his

illness.

Mr. BURTON. Very good. Do you have a statement?

Mr. NAVARRO. No, I wanted to share something with you before

my testimony. You happen to be in luck today because I happen

to have a copy of protocol BT–29 for your review, which was a new

protocol submitted to the FDA on Thomas’ behalf that mirrors the

FDA-approved trial, with the exception that Thomas would be allowed treatment without prior radiation and chemo damaging his

body.

Mr. BURTON. Is that right? Well, would somebody go down there

and pick that up from him? We will take a look at that. Thank you

very much. We will look at that.

Do you have a statement you would like to make other than your

son is doing well?

Mr. NAVARRO. Well, that is everything to me.

Mr. BURTON. OK.

Mr. NAVARRO. But in following with your opening speech, I am

here to tell you that I am a living testament to your opening speech

and to the current cancer statistics. We are both fighting it now.

Mr. BURTON. Yes, I understand. For those in the audience, Mr.

Navarro has just discovered recently that he has fourth stage prostate cancer and so you are in the fourth stage, so you are in a battle as well as your son.

Mr. NAVARRO. Yes, and having three sons, we are two out of four

males, which is the one in two statistic.

Mr. BURTON. Let me just say we will all say a prayer for you and

hope that the treatment you get will be beneficial.

Mr. NAVARRO. Thank you, sir. I am glad to be here and hope that

we can break some barriers today.

Mr. BURTON. We are going to continue to work on that.

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Mr. Horwin.

Mr. HORWIN. Good afternoon. My name is Michael Horwin. My

wife Raphaele and I, would like to thank Congressman Burton for

the opportunity to speak about the experience our 2-year-old son

Alexander had with chemotherapy that resulted in his death.

Can I have the first slide, please?

Today is Alexander’s birthday. He was supposed to be 4 years old

today. Alexander was a strong, happy, very intelligent little boy

who loved life, but when he was 2 years old everything changed.

On August 10, 1998, Alexander was diagnosed with medulloblastoma, a highly malignant brain tumor that represents a quarter of all brain tumors in children. After two brain surgeries, Alexander was tumor free, but we were warned that without further

treatment his tumor would return.

We met with the oncologist at Children’s Hospital Los Angeles,

and he told us that radiation was out of the question because it

would destroy Alexander’s developing brain, but he told us his ‘‘state-of-the-art’’ chemotherapy would provide a good chance of survival.

This protocol was called CCG–9921, and was comprised of four

chemo drugs—cyclophasphamide, cisplatin, etoposide, and

vincristine. He warned us that, although the side effects were not

as bad as radiation, they could be severe.

Can I have the second slide, please?

Heart damage, lung damage, liver damage, kidney damage, loss

of hearing, secondary cancer, intellectual decline, ineffectiveness

and death. After hearing this, we continued researching other cancer treatments and focused on the Burzynski Clinic in Houston,

TX. We spoke to parents of children who were doing well on

Burzynski’s nontoxic therapy and decided that this was the very

best treatment for Alexander.

On September 21, 1998, Burzynski met with us, looked at our

son’s latest MRI and said that because there was no tumor he

could not treat Alexander. He explained that the FDA controlled

his protocols and required that Alexander have tumor in his brain.

We explained that our son had suffered through 16 hours of brain

surgery to be tumor free.

Burzynski said he was sorry, there was nothing he could do.

In Los Angeles, we scrambled for other options, but we were unable to find any other viable, nontoxic therapy. Reluctantly, we returned to Children’S Hospital for chemotherapy on October 7th.

Later, we would find out that the oncologist had contemplated taking Alexander from us with a court order if we resisted.

Slide three, please.

After the first round of chemo, Alexander began to change—constant vomiting, hair gone, dark skin turned pale as a ghost. He got

sick with fevers and spent weeks in the hospital. There were blood

transfusions and hearing and kidney and liver tests; antibiotics

squirted up his nose; injections in his legs; all standard fare with

chemotherapy.

Three months after starting chemotherapy and one-fourth the

way into a 12-month protocol, Alexander was diagnosed with 30 tumors throughout his brain and spine. We were told that he had

about 3 days to live. We were given decadron and morphine and

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sent home. But now, with 3 days to live, Alexander met the FDA

criteria for Dr. Burzynski’s therapy. He had measurable tumors, 30

of them, and he had already had the benefit, so-called benefit, of

chemotherapy.

We chartered an air ambulance. The first time Alexander had

been to Burzynski’s on September 21st, he had joked with the

nurses, watched TV and played. Now he was brought in on a

stretcher with an escort of emergency personnel.

After fighting like hell to live, Alexander died on January 31,

1999, in my wife’s arms. Our son was only 21⁄2 years old.

After Alexander was buried, we wanted to know what happened.

Why did he die while receiving ‘‘state-of-the-art’’ chemotherapy?

We started researching the medical literature. What we found

stunned us. In 1994, St. Jude’s Hospital had given the exact same

four chemotherapy drugs to children the same age as Alexander,

with exactly the same tumor as Alexander. The protocol had to be

terminated because 11 of the 13 children had their brain cancers

return and spread in an average of 5 months, just like Alexander’s

did.

This was hard for us to understand. This so-called state-of-theart chemotherapy had already been used before and had failed.

Why were they giving this to our son now?

We continued our research and found that the chemo drugs that

they had given Alexander had been used for over 20 years, and the

oncologists were admitting in their journals, in their medical journals, that they were incredibly toxic and ineffective alone or in

combination.

Here is a sample of what we had written about chemotherapy—

a sample of what they had written about chemotherapy.

If I could have the next slide, please.

This is just a sample. We have over 40 citations in our written

testimony.

1985, written by an oncologist, in respect to medulloblastoma

and chemotherapy: Responses are generally transient and virtually

no cures are reported.

1988: Aggressive treatment of medulloblastoma has not improved

survival.

1993: The absolute benefit of chemotherapy for the treatment of

medulloblastoma in childhood is, as yet, not proven.

1994: The median time to progression, return of the tumor, was

6 months.

1996: The outcome for the majority of children with malignant

brain tumors remains poor, despite surgery, radiation and conventional chemotherapy.

1998: For many years, chemotherapy has been utilized for the

treatment of malignant brain tumors with minimal success.

This is what oncologists are writing in their journals.

We wondered what else oncologists were writing in their medical

journals and not telling parents or the public. We discovered that

chemotherapy wasn’t only toxic but it was also highly carcinogenic,

according to the NIH and the FDA. This explained why some children treated with chemo actually died from a different cancer.

Can I have the next slide, please?

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We wanted to know how the FDA and others could spout encouraging statistics like what we heard earlier when the children were

relapsing and dying. We found journal articles that discussed how

response rates to chemotherapy could be found where it did not

exist.

Others illustrated that a response rate has nothing to do with

survival, and others explained that dead children are not counted

in the statistics, the theory being that if a child dies while on the

chemo protocol, he or she did not have the benefit of the entire

therapy and therefore should not be counted.

The medical literature is clear. There is no standard of care for

this disease in young children. The FDA policy of not allowing terminally ill children access to other therapies is outrageous. It must

be stopped immediately.

My wife now has some final testimony.

Mr. BURTON. I would like to have your entire testimony and all

the slides that you have. I want to send all that information over

to the FDA for a response from them about that.

The doctor that made the comments about the conventional

treatment, we asked him to stay. He left. So we are going to make

sure that he has a chance to review this and respond to us.

Mr. HORWIN. Thank you, Mr. Chairman.

Mr. BURTON. Mrs. Horwin.

Mrs. HORWIN. Because the FDA did not allow us to use a therapy

that could save Alexander’s life, we never gave our son a fighting

chance to survive his disease. When conventional therapy has nothing to offer, the FDA should not sentence children to death by taking away an option that could save their life. A parent should have

the right to work with their doctor and choose the best nontoxic

therapy available when their child has a terminal disease.

Why does the FDA not allow this?

Five days of chemotherapy cost our insurance company between

$23,000 and $31,000. Alexander’s body was a profit center to the

drug companies and oncologists. But chemo is an ineffective treatment in pediatric brain tumors.

Faced with a choice, no parent would use it, and that is why the

drug companies, through the FDA, make sure there is no choice.

We urge the committee to take a hard look at the conflict of interest that exists between the FDA decisionmakers and the drug companies that profit from these decisions. Children should not be used

as guinea pigs for profit.

Two hours before Alexander died, he looked at me, and he gave

me a little smile. He said, ‘‘I love you, mommy.’’

Our son was our life. We thank you for listening.

Mr. BURTON. Thank you, Mrs. Horwin.

I know that this is a very difficult time for you, but I can tell

you that we are checking into the issue you are talking about. We

have sent subpoenas to the FDA and HHS and CDC for all the people who are in the decisionmaking process. Our staff has spent

many, many, many hours going through to find out if there are

conflicts of interest. We believe we have found a number of those

in the advisory panels, and we will be holding a hearing on those

in the future and releasing that information to the public once we

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get through it all, because there is so much of it. But we are looking into it and you can be assured that we will get to the bottom

of it.

[The prepared statement of Raphaele and Michael Horwin follows:]

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Mr. BURTON. Dr. Geffen.

Dr. GEFFEN. Good afternoon. My name is Dr. Jeremy Geffen. I

am honored to be here today to speak with you about a subject that

I care very deeply about, and to which I have devoted my entire

professional career.

I am a practicing medical oncologist and have spent the last 10

years exploring meaningful and responsible ways of integrating the

very best available conventional cancer treatments with a wide variety of alternative and complementary therapies. In 1994, I opened

the Geffen Cancer Center and Research Institute in Vero Beach,

FL, with the vision of providing leadership in this field by creating

a model of what truly integrative cancer care would look like, how

it would feel, how it would run, what it would offer, and how it

would differ from mainstream centers in the way it cared for people

with cancer and their loved ones.

My compelling motivation to create such a cancer center appeared in my life 14 years ago, while I was a senior in medical

school. In that year, my father was diagnosed with metastatic gastric cancer, and he died less than 4 months later. In a heartbeat,

as almost always happens with this disease, my own life—as well

as that of my father and everyone in our family—was turned upside down and changed forever.

A somewhat unusual aspect of our situation was that, prior to

medical school, I had had years of experience exploring and studying a variety of alternative and complementary approaches to healing. Like so many other cancer patients and family members, I

longed for a place to bring my father where he could receive the

very best of both worlds; that is, state-of-the-art conventional medicine, along with alternative and complementary therapies, administered in a genuinely open-minded and open-hearted manner.

I firmly believed that this kind of integrative care could help

save his life, or at the very least, help improve the quality of his

life in the time that remained.

Although I searched everywhere, I could find no such place because it didn’t exist. I vowed that 1 day I would build the cancer

center that I had been looking for.

A summary of our approach at the Center, including examples

from real patients who have gone through our program, is described in my book, ‘‘The Journey Through Cancer: An Oncologist’s

Seven-Level Program for Healing and Transforming the Whole Person,’’ recently published by Crown.

In the remainder of my time today I would like to emphasize two

lessons which I have learned in building an integrative oncology

program and guiding patients and loved ones on their journey

through cancer.

The first lesson is very simple, yet profound, and it is this: Cancer almost always 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, and as we have heard over and

over and over again today, this simple lesson is overlooked by

mainstream medicine, and most especially by Medicare and HMOs,

as well as the major government and university research institutions and regulatory agencies.

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In the urgent, compelling search for newer and better ways to diagnosis and treat cancer—with scientifically based methods, and

now with alternative and complementary therapies as well—the

person who has the disease, and those who love them, are often left

behind.

From my years of experience as an oncologist, and as a friend or

loved one of cancer patients, I can tell you with absolute certainty

that focusing only on the physical dimensions of this—or any

other—disease will never, ever be enough.

Thus, as we begin to embrace a more integrative approach to

cancer care, I believe it is time that medicine learns to honor and

care for every dimension of who we all are as human beings—physically, mentally, emotionally and spiritually—and that we do so

with equal skill and integrity. Nothing less will ever provide the

healing and fulfillment that all people seek in life—especially, especially when facing an ordeal as challenging as the journey through

cancer.

How we can achieve this is the other lesson I would like to very

briefly address this afternoon. First and foremost, we need to clearly acknowledge that this is an area that is worthy of our time and

attention, in equal measure to the resources that we give to the biological aspects of disease. We need vastly more significant funding

and reimbursement for all kinds of modalities of healing that honor

and address the needs of the whole person.

In my opinion, Mr. Chairman and committee members, there is

something very deeply flawed about a health care system in which

I, as an oncologist, can readily spend tens of thousands of dollars

of Medicare funds, with the full blessings of Medicare, to extend

the life of an elderly man with advanced lung cancer for perhaps

3 or 4 months, utilizing second, third, fourth, or even fifth-line expensive chemotherapy regimens, growth factors, blood transitions,

CT scans, MRI scans and other costly diagnostic procedures, but I

cannot find $100, or even $50, for an acupuncture treatment, a

therapeutic massage, or a private counseling session for a frightened, terrified, single mother of three children who is battling

metastatic breast cancer—and who happens to be sitting in the

very next room.

I have faced this circumstance, sad to say, countless times in my

career, and I think it is wrong. It is also heartbreaking, frustrating,

and, I believe, very short-sighted on our part as a Nation.

Make no mistake, the advances and developments in biomolecular medicine that we enjoy in this country are nothing short of

stunning and profound; and we must continue to pursue them with

great vigor, focus and attention. In the same way, we must continue and even further expand our explorations of the value and

benefits of alternative and complementary therapies.

However, at the same time, we must finally begin to address a

deep and fundamental issue. In America, doctors are paid to treat

diseases, not to genuinely care in a comprehensive way for the people who have the disease.

Honestly facing this hard truth is, I believe, one of the most fundamental challenges that lies before us today, especially as we

begin to explore how we might create a cancer care for the new

millennium.

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In this process, we must not forget that the system of cancer care

that we choose to create will be called upon to meet the needs of

real people everywhere, not only people just like you and me but

perhaps literally you and me, and people who we know and love

who might need that care today, tomorrow and beyond.

In closing, I would like to thank you, Chairman Burton, for your

courage in sponsoring these hearings, for your leadership in helping to create an integrative form of cancer care, for opening the

minds and the hearts of this government and this country, and for

the opportunity and privilege to appear before you today. Thank

you.

Mr. BURTON. Thank you, Dr. Geffen.

Just one real brief comment, and that is that there was a movie

called The Doctor—I think it was called The Doctor, wasn’t it— about a doctor who was very direct and callous with his patients

until he became a cancer victim and went through the whole process, and his whole attitude changed. It is a shame that he had to

go through that, and I think your message I hope is heard by physicians all across the country.

[The prepared statement of Dr. Geffen follows:]

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Mr. BURTON. Mr. Cary.

Mr. CARY. Yes. Chairman Burton and Representative Horn,

thank you for the opportunity to be able to address you today. As

the chief operating officer of Cancer Treatment Centers of America,

I am ecstatic about being able to talk with you today.

Cancer Treatment Centers of America has been providing comprehensive, integrative care for patients for over 20 years, and the

reason we do this is because patients demand it. This innovative

approach derives from our corporate mission and vision, and what

we look for is figuring out ways to deliver care in such a manner

that we can make a difference in the lives of patients, similar to

what Dr. Geffen talked about.

Our patient-centered and interdisciplinary approach stands in

stark contrast to the traditional allopathic gatekeeper model. Although in our treatment setting the allopathic attending physician

retains overall patient responsibility, the integration of complementary oncology services assures better patient outcomes.

What we find by complementary medicine and the integration of

complementary medicine is we have fewer side effects. The

toxicities of chemotherapy, radiation and surgery are much diminished by finding ways to buildup the immune system.

We also find—it is anecdotal, I would admit, but we also find

that we have improved tumor response, and we have fired up immune system, and we believe that that also contributes strongly to

patient outcomes and the responses our patients get. This is in

sharp contrast to what happens today in our conventional systems.

As the doctor is the gatekeeper, he is making the decisions. In our

centers, the approach is that the patient is in the middle of the decision, and they choose which services they want and don’t want.

However, the doctor does—the allopathic doctor does continue to

remain in control of their care.

Our unique and comprehensive integrated oncology approach

does begin with the best of conventional treatments. We do everything from bone marrow transplant to high-dose rate

brachytherapy for prostate cancers, to photodynamic therapy for

lung cancers. We are into biological and gene therapies as well as

surgery, but we believe that the complementary therapies that we

integrate into patient treatment plans by a multidisciplinary team

adds so much to the value and the outcome and the quality of life

of our patients.

The National Center for Complementary and Alternative Medicine describes complementary medicine as those medical practices

not currently integral—an integral part of the conventional medicine. While this is true, that so-called conventional medicine overlooks many of the great traditions in nature and holistic medicine.

The integration of these practices is the foundation of our treatment.

So, again, what we want to be able to do is to take the best of

conventional medicine and integrate that with more natural medicines.

You know, many patients around the country who are treated

only with conventional therapies suffer greatly. They tend to sometimes even discontinue their treatment because of the side effects

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of treatment. Sometimes it is so toxic and so bad they can’t continue.

With the use of many of the naturopathic or complementary

medicine therapies, we find that patients can tolerate therapy

much better. Recent studies, and you have heard as well today, indicate that 40 to 72 percent of all cancer patients utilize complementary medicine or alternative medicine. The sad news is that

less than 50 percent of these patients disclose this to their

oncologist, and there can be contraindications, as you heard today,

and it turns into disjointed or unproductive care.

Cancer patients have traveled hundreds of miles and, in many

cases, thousands of miles to come to our hospitals. We have had patients from all 50 States and 45 foreign countries. So if the question is do patients want alternatives to just conventional, we would

have to say emphatically yes.

What we do is we integrate five therapies, complementary therapies, into our conventional program. Without going into great detail

with them, they include: Therapeutic nutrition. These are therapies

that work to enhance the body’s immune system and get the body’s

immune system to be on the attack instead of being one of the

problems to their potential outcome.

Spirituality is another important part of our treatment process.

Meeting the spiritual needs of patients with cancer is critical. I can

give many examples of that.

Psychoneuroimmunology, or what is also called mind-body medicine, allows us to be able to destress the patient and allow the patient to focus their energies toward healing and getting better.

And then we have exercise and massage therapies. We work to

restore the highest level of immune function by making the body

more physically fit.

Cancer Treatment Centers of America is the only hospital system

in the United States that has naturopathic physicians—practitioners working alongside medical oncologists, and the intent of the naturopathic practitioner is to find natural nontoxic therapies to be

able to work along with the allopathic oncologist.

The benefits that we have seen from this is increase in efficiencies of the traditional medicines, the body to heal itself and reduce side effects.

A brief point on reimbursement. In November 1998, the Journal

of the American Medical Association stated that the majority of patients receiving complementary care paid for it out of their own

pocket. What we have created in our society is a two-tiered system.

Those who can pay for the treatments or can buy a premium health

insurance seek out alternative care, seek out locations where they

can get that; those who don’t sometimes are relegated to having to

go a conventional route and try to pay for it out-of-pocket. Because

of the lack of reimbursement for complementary therapies from

Medicare and other insurers, the majority of hospitals have been

reluctant to finance these therapies.

In brevity, I come from Chicago. One of our hospitals is in Chicago. Recently, the Metropolitan Chicago Health Council stated

that 50 percent of the 130 hospitals they represent are losing

money.

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With the Balanced Budget Act, which is going to be instituted in

August of this year, they are projecting 70 percent. With hospitals

struggling to survive, it becomes more difficult for them to be able

to fund complementary care for their patient and to address that

issue.

As far as the choice issue, at Cancer Treatment Centers of America we never make a choice whether a patient should get complementary care, whether an insurance company is going to pay for

it or not. We do not believe that the care provider should be put

in that position. We believe that it is important to stand up now.

It is important that we start here with Medicare and then work

with other insurances to get these complementary therapies approved.

We take too long taking some of these therapies from the lab

bench to the patient’s bedside, and if I could implore anything upon

you today it would be to move with a lot more speed.

The time for action is now. We need to stand tall, make it happen. We need to do something which we coined as the ‘‘mother

standard’’. We need to do whatever it takes to make a difference

in the life of patients. My own mother had a bout with breast cancer, as well as the chairman of our company. If we can treat each

patient with the same care that we would want one of our loved

ones, we will do whatever it takes to make a difference in the lives

of patients, and I believe we, starting today, can do that.

I thank you for the time.

Mr. BURTON. Thank you, Mr. Cary. I have had a chance to meet

some of the people with your company, and I was very impressed

with them and the work they do.

[The prepared statement of Mr. Cary follows:]

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Mr. BURTON. Mr. Devries.

Mr. DEVRIES. Good afternoon, Mr. Chairman and Congressman

Horn. I am pleased to be before you to discuss insurance coverage

issues on complementary and alternative medicine.

I am the chairman, president and CEO of American Specialty

Health. My company is a specialty health services organization for

complementary and alternative health care. We provide specialty

health plans, networks, managed care programs and discount provider networks for chiropractic, acupuncture, massage therapy, dietetics and naturopathy. American Specialty Health assists health

plans and insurance carriers in providing CAM programs for their

covered members. When health plans and insurance carriers offer

CAM programs, they currently often outsource the provision and

administration to companies like ours.

American Specialty Health currently covers 25 million Americans

through 68 health plans under CAM discount network programs,

benefit programs and network programs.

There has been, over the last 10 years, we all know, a surge in

interest in complementary and alternative health care. Dr. David

Eisenberg’s two studies at Harvard University have shown the dramatic increase of interest by consumers in the use of various complementary and alternative health care therapies over the last 10

years.

Basically, in another study conducted by the International Society of Employee Benefit Specialists, they surveyed employee benefit

specialists, those people with employer groups and union trust

funds who help their organizations make decisions on which employee benefits to cover. Basically, two-thirds of those employee

benefit specialists expect to see an increased coverage of CAM in

the future, and that’s basically certainly driven by the consumer interest in complementary and alternative health care in the direction we see consumer interest driving employers to go ahead and

offer coverage in these areas.

I personally speak with three to five health plans that offer or

are considering offering complementary and alternative health care

services for their enrollees and generally find significant interest.

The question that really comes up is what approach will the health

plan take?

Most health plans have a lack of understanding and experience

in working with complementary and alternative health care and

many are choosing to start with a simpler approach through a network discount program.

Under a network discount program, the health plan does not actually provide a covered benefit program but offers their members

access to a credentialed network of complementary and alternative

health care providers such as chiropractors, acupuncturists, massage therapists, naturopaths and dietitians. The members still pay,

they still self-pay for services. However, they are able to obtain

these services at a discount from a credentialed prescreened provider.

The CAM provider who participates in these programs, we believe, benefits since major health plans are promoting and encouraging the use of complementary and alternative health care to

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their enrollees and giving significant public visibility of these programs.

Invariably we see, as employers have exposure to the discount

network programs and they see the interest in complementary and

alternative health care on the part of their employees, that those

employers invariably come back and are asking health plans, well,

the discount network was a nice start but how do we go to the next

level and actually obtain coverage for our employees for complementary and alternative health care?

We really see that it is coming along three different levels where

the benefits are being—and it is really just in the beginning stages,

but where they are beginning to be incorporated.

The first is really through employer-sponsored health plan programs where the health plans create supplemental benefit programs for services like chiropractic or acupuncture, massage therapy or naturopathy, and where employers are able to purchase a

supplemental benefit program for complementary and alternative

health care, much like they would purchase a dental or a vision

program.

The second area we see of great interest is MedicarePlus Choice

plans. As Dr. Kang had mentioned in his written comments earlier,

written testimony earlier, that as HCFA provides prospective payment to certain MedicarePlus Choice plans, they certainly have the

ability to enhance benefits that they provide for their members,

and we have certainly seen MedicarePlus choice plans who, for example, provide coverage for acupuncture, even though they are

under no mandate to provide such.

The third area in terms of benefit coverage is coming through

State mandates, where certain States legislatively are requiring

health plans and insurance carriers in their States to provide coverage for complementary and alternative health care. The State of

Washington probably has the broadest mandate for alternative

health care, but there are many other States, also.

From our perspective, we believe that CAM has become an important part of the average American’s personal health care system, that when you talk to most Americans now they will not only

talk about their primary care physician, perhaps a specialist like

an OB/GYN, but they will also talk about their chiropractor; they

will talk about the acupuncturist who is treating their mother; they

will talk about their vitamins or herbal supplements; they will talk

about other types of complementary and alternative health care.

We still have a long way to go before our complementary and alternative health care is fully integrated into our health care system, but I believe that there are a variety of steps the Federal Government can take to support the development of complementary

and alternative health care in our country and specifically within

third-party reimbursement systems.

Quickly, those are, No. 1, the Federal Government can encourage

States to enact licensure statutes and procedures for providers. For

example, naturopathic physicians are only licensed in 11 States.

Acupuncturist licensure or certification varies significantly among

the approximately 30 to 40 States where they are licensed or certified, and these disparities create unequal access to complementary and alternative health care for Americans in these various

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States. This certainly could be corrected by providing CAM benefits

for Medicare beneficiaries which would stimulate licensure in those

States or the consistency of licensure.

No. 2, the Federal Government can support and encourage the

accreditation of schools and universities that train providers in

complementary and alternative health care. The U.S. Department

of Education and the Department of Health and Human Services

ought to explore ways to achieve this objective the way it has for

chiropractic.

No. 3, the Federal Government should promote and fully fund research on the clinical efficacy of complementary and alternative

health care, and this would mean the continued funding expansion

of the National Center for Complementary and Alternative Medicine at the NIH.

No. 4, the Federal Government should promote tax equality employee benefit plans allowing coverage of CAM benefits like dietary

supplements. Legislation such as H.R. 3306, which has been introduced by you, Mr. Chairman, would create tax incentives and a

quality necessary to create benefits in health plans for nutritional

supplements. I personally know of Fortune 500 companies who

have expressed interest in obtaining such coverage but will not because of the tax issue.

No. 5, the Federal Government should promote and encourage

complementary and alternative health care education at U.S. medical schools.

Really, those are the five areas which I believe would significantly and positively impact the introduction of complementary and

alternative health care into third-party reimbursement systems.

Thank you for your time. I will be pleased to answer any questions.

Mr. BURTON. Thank you for being with us. We appreciate your

statement and your recommendations.

[The prepared statement of Mr. Devries follows:]

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Mr. BURTON. Mr. Navarro, I understand you had a brief statement you wanted to make. Do you feel a little bit more secure now

and relaxed?

Mr. NAVARRO. Thank you, Mr. Chairman. I apologize for not following your instructions a little more clearly.

Mr. BURTON. No, that’s all right.

Mr. NAVARRO. As you know, my name is Jim Navarro; and I am

the father of Thomas Navarro, who is a 4-year-old victim of cancer.

My son Thomas has medulloblastoma, which is a brain tumor located on the cerebellum. He was diagnosed with his illness September 17, 1999.

I cannot begin to tell you the impact the news had on his mother

and me, and his brothers and sister. To say that it was overwhelming is an understatement compared to what we dealt with afterwards. It was the lesser of two evils, for the evil that was perpetrated against our family was the reality that we, as parents,

had been stripped of our rights to make life-and-death decisions for

our son. You see, we had discovered, much to our horror, that as

parents of a terminally ill child we were no longer deemed intelligent enough or responsible enough to make decisions regarding

our son’s care. We had been stripped of our freedom, the freedom

of choice.

So I am here today in an effort to answer the question that has

haunted his mother and me since that dark day in September. The

question is: Who decides? Who decides which doctors will treat my

son? Who decides which medicines will be introduced into his body

to fight this disease? Who decides whether he lives with dignity

and quality of life or dies as some doctor’s clinical experiment?

If any of you here today can answer this question, please tell me,

who decides?

Since those early days in September when Thomas was first diagnosed, we have been challenged as to our capability. We have

been challenged as to the type of parents we are. Our integrity has

been brought into question. Our name has been attacked. We have

been threatened with the loss of our child, not by the disease that

he fights but by the Child Protective Services acting as the strongarm enforcers of the medical community.

To me, it is a grievous injustice in this country we call America

that we as parents do not have the right to do that which we feel

is best for our son. Our decisions regarding Thomas’ health have

not been made out of emotion but by the sheer will and determination to see our son survive when all others have said he will not

live.

I do not want my son kept alive using radiation and chemotherapy so that some doctor can see he reached a 5-year survival

rate, so that some doctor can say he is a smashing success, when

in reality history of this disease tells us that he will be left severely

damaged as a result of the devastating side effects of the chemo

and radiation.

In the process of doing what we felt would be best for our son,

we have paid a very heavy price. It has cost us our home, our business and our friends. But it is a price that we would gladly pay

again for the results that we have achieved to date. Those results

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cause of radiation and chemotherapy but because we found an alternative therapy that has not only shown to be winning against

his cancer but it has allowed him to maintain his dignity and quality of life.

Mr. Chairman, I ask that this hearing not be a time of petty

jealousies being brought to light in the medical community but that

it be a time the world be made aware that if we dare call ourselves

Americans that we be allowed to live as a free people, free to make

our own choices, free to pick our own doctors, free to pick our own

treatments, free indeed to decide our own destinies.

It is time to say good-bye to the old way of thinking. It is time

to say good-bye and time to embrace the future, a future of new

ideas, a future of alternatives.

Radiation and chemo have left in their path a grim testimony,

a lineage that my wife and I have seen over the past months of

death and despair; a path of children left blind, sterile, retarded,

mentally and physically damaged by the excellent results of conventional medicine.

Mr. Chairman, every child that was diagnosed with my son from

the day he first became ill we have buried, and what discourages

me about today is that the very doctor who has sat in judgment

over my son and denied him access to medical attention that we

choose best and denied him freedom didn’t even extend to me the

courtesy to stay here and hear me speak, and I have traveled thousands of miles from a foreign country to spend 5 minutes with you.

I understand he has an important job as a Director at the FDA,

but I, too, like many other parents, have a very important job, and

that is that I am the father of a terminally ill child and it is my

solemn duty to keep him alive and healthy and happy.

Thank you, sir, for your time.

Mr. BURTON. Well, I can assure you he will get a copy of your

statement.

Mr. NAVARRO. Thank you.

[The prepared statement of Mr. Navarro follows:]

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Mr. NAVARRO. Mr. Chairman, can I just show you something

really quick?

Mr. BURTON. What is that?

Mr. NAVARRO. As a man of common sense, I am sure you will

agree. You have seen my son Thomas. This is his new best friend,

Linn, after 2 months of chemotherapy. It triggered in him a reaction of tumors throughout his head and broke his jaw.

May I show the audience?

Mr. BURTON. Sure.

Mr. NAVARRO. This is Thomas using alternative therapy and this

is Linn, conventional therapy, 2 months’ worth.

Which would you chose? Who decides?

Mr. BURTON. Thank you, Mr. Navarro. If you have an extra copy

of those pictures, we would like to have those submitted for the

record as well.

Mr. NAVARRO. Yes, sir.

Mr. BURTON. Let us get on with the questions here.

Mr. Navarro, let’s start with you. How much research did you do

before you determined that your son’s treatment should be in the

area that you talked about?

Mr. NAVARRO. Mr. Chairman, I have to date read approximately

100 books on neurology, pediatric cancers, brain tumors, medulloblastoma. I have gone through literally every medical abstract that

I could get my hands on, and that is from all the major cancer clinics throughout North America and Europe, and I am ready to challenge the test to become a doctor, I think, at this point.

Mr. BURTON. OK. Since the Food and Drug Administration has

denied Thomas access to antineoplastons, what did you do? You

took him out of the country, is that what you had to do?

Mr. NAVARRO. Yes, sir, we did.

Mr. BURTON. Because of the threat that the different agencies

might take custody of your son?

Mr. NAVARRO. It was actually twofold. It was not only to keep

him safe from the harm of conventional medicine but also because

we realized, because of the nature of his cancer, that he needed

treatment soon before we lost him to recurrence.

And, sir, if I might add to that, one of the things that perhaps

wasn’t clarified earlier is the fact that, although they may say they

do have a 70 percent success rate, I think the part that got left out

was the fact that they may stop or even destroy the medulloblastoma but what you are not told is it is the new cancer that the

chemo creates that kills the child. Many times they may start with

medulloblastoma but they die of a secondary type of cancer, and I

am sure Mr. Horwin can substantiate that through his research.

Mr. BURTON. What do you say to the statements made by physicians and those at the FDA that the success rates are so profound

for chemotherapy and radiation with medulloblastoma that it is

standard treatment that should be followed? The same thing I

guess you just said.

Mr. NAVARRO. I would——

Mr. BURTON. You challenge it?

Mr. NAVARRO. I would not only challenge that, I would remind

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ment for their social ills in World War II Germany, and it didn’t

make that right.

We are experiencing a new genocide today.

Mr. BURTON. Mr. and Mrs. Horwin, if you had read the papers

you put together for this hearing prior to choosing treatment for

Alexander, I presume you would have done it differently?

Mrs. HORWIN. Absolutely.

Mr. HORWIN. Yes. What we did at that point is listen to our

oncologist. He said that there was a very good likelihood that he

would be able to help our son, but at the same time he reminded

us of the severe neurotoxic effects of his therapy, and when he outlined those to us we said, gee, the treatment sounds worse than the

disease in some respects, and we began to look for other things.

We found Burzynski’s therapy. We did the responsible thing that

parents would do in a case like this, which means do your research,

do your homework, speak to other parents, go down to the clinic,

which I did. I met with the patients. I spoke with them. I met the

children. I realized that this was exactly what Alexander needed.

We went down there with our son ready to start treatment; and,

as I mentioned, we were turned away. At that point, we didn’t

know what to do. We had no other options left. We went back, enrolled him in the chemotherapy protocol.

Again, we were reminded many, many times that this was stateof-the-art. It was going to be successful. If it didn’t save his life,

it was going to extend his life. So that’s why 3 months into this

protocol, when he had—again, this is a point that Mr. Navarro just

made. My son was diagnosed with medulloblastoma. According to

the neurosurgeons, he died of leptomeningeal carcoma. It is another cancer. He had this other cancer come back. It was 30 tumors

throughout his brain and spine, and they sent us home. They said,

he is going to die.

Mr. BURTON. I presume that the information that you are giving

us, all that research that you have done, there is no question you

would have handled it differently.

Mr. HORWIN. Yes.

Mr. BURTON. We will make sure all of your information is forwarded to the FDA and ask for a response to that.

Mr. HORWIN. May I add one other thing, Chairman?

Mr. BURTON. Sure.

Mr. HORWIN. Thank you. When they talk about standard of care,

I get extremely frustrated with that because, frankly, it is a very

irresponsible comment to make that there is a standard of care for

this disease. All you have to do is to be able to read English to

know there is no standard of care.

The other thing you might want to remind some of these folks

at the FDA is there are some very prominent cancer hospitals out

there. I will name two of them. One is St. Jude’s. The other is Memorial Sloan Kettering. You would imagine if there is a standard

of care that it would be practiced at both of those hospitals.

We were at St. Jude’s at one point to see if there was something

there for Alexander. This is the standard of care right now at St.

Jude’s—this is a very experienced pediatric oncologist who has

been practicing for 20 years, realizes that these children are dying,

and he is doing what he can to try to save their lives. This is his

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therapy right now: He drills holes in children’s brains. He puts in

an ommaya reservoir. This allows him to inject chemotherapy directly into the brain. He also does, every other day, spinal taps for

the very same purpose. This is a very desperate measure, injecting

chemotherapy directly into the brain and spine.

When we asked him about the track record for this, he was a

very honest physician, he said there is none. I asked him about the

long-term side effects, the short-term side effects, the efficacy. He

had no information for us. My wife turned to him and said, are you

going to use our son as a guinea pig? And he looked at her and

he said, yes, Mrs. Horwin.

So this is the kind of desperate measures this one very experienced pediatric oncologist is using. If there was an effective standard of care, do you think he would use something as desperate as

this? I don’t think so.

Memorial Sloan Kettering, same thing. There is a doctor there

using what is called ABMT, autologais bone marrow transplant.

The idea behind that is you give a child such high dose chemotherapy that his bone marrow can no longer produce blood cells,

and he will die. So what they do in preparation for this is actually

take bone marrow, they store it in a freezer and they take it out

forcibly, store it in a freezer, give the child very high dose chemotherapy, bring him to the brink of death and then, quote, and this

is in their language, they try to rescue him, they try to rescue him

by giving back his bone marrow.

The only problem with this one is, if you read his articles, anybody can do it who can read English, the death rate from the treatment itself is 8 to 10 percent. That means almost 10 percent of the

children die from the therapy. They give this kid—these kids such

high dose chemo and they die within a couple of days. That’s a

pretty desperate measure.

Again, if there was an effective standard of care for this disease

you wouldn’t have experienced pediatric oncologists in leading cancer hospitals using such ridiculous methods.

Mr. BURTON. Well, thank you, Mr. and Mrs. Horwin.

Dr. Geffen, do you think we can move to an integrated approach

to treating cancer and not be required to use chemotherapy and radiation? Do you think that can happen, and do you think it should

happen?

You are an oncologist, and you have used chemotherapy and radiation, I presume—— Dr. GEFFEN. That’s correct.

Mr. BURTON [continuing]. In conjunction with others. Do you

think there is alternative therapies that could be used that would

not necessitate the use of those?

Dr. GEFFEN. From my experience over about 10 years practicing

oncology, what has become very clear to me is that chemotherapy

and radiation are not the problem. If you were to ask Lance Armstrong, for example, his opinion of chemotherapy, he would have a

completely different view. It saved his life. He had metastatic testicular cancer. Chemotherapy and radiation cures many, many,

many people, but it is very clear, from what we have heard today

and from what we know, that there are perhaps equally as many

people, if not more, who it doesn’t cure.

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I think what is needed is the honesty, the humility, to admit that

we are very handicapped in our ability to treat many cancers. But

let’s not discount the areas where we have phenomenal success.

I don’t think the problem is chemotherapy. I think the problem

is when it is used indiscriminately, when it is used in a rigid, formalized protocol. As I said earlier, the problem is that mainstream

medicine focuses on the disease. The goal is to get rid of the disease and, along the way, the person with the disease and their

loved ones, as we have heard, are left behind. We have heard some

very moving examples of just exactly that problem.

I believe it stems from the basic orientation of our health care

system, which is one which reimburses doctors to diagnose and

treat diseases, rather than to ask deep and meaningful questions

about how can we really help this human being—besides focusing

on what is their tissue diagnosis and what are the current standard protocols calling for.

I think that the problem won’t be solved until we decide as a culture that our goal really is to love and care for people, not at the

expense of scientifically based medicine but in a context of love and

care that says—in which we are honest and say—you know, we

can’t solve this problem, but we can explore any modality that can

help, and we will.

Mr. BURTON. Mrs. Morella, do you have any questions?

Mrs. MORELLA. First of all, I want to thank you, Mr. Chairman,

for your efforts to hold this important hearing on integrative oncology.

This last panel is exceedingly moving. Certainly, I am someone

who represents the National Institutes of Health in my district and

the Food and Drug Administration in my district, and I know that

we do have that office and I recognized and appreciated, Mr.

Devries, the suggestions that you gave and I marked up—and the

others perhaps all agree with it—where he mentioned the need for

further research that should be done, research on clinical efficacy

of the complementary and alternative therapies.

It seems to me also full information is necessary, too. We need

to do more with educating the public, educating our medical community, to be open about it. And I think with the full information

I think we need to look at the credentials, history, official information. There is just so much more we need to do, and I think this

is what you have pointed out with this very moving hearing.

I continue to have some questions, but I will be following those

in terms of what is being done at our medical facilities and what

is being done in States in terms of various kinds of licensing. So

I thank you for being here and sharing with us your very moving

stories.

I thank you, Mr. Chairman, for your leadership throughout on

this on this issue.

Mr. BURTON. Thank you, Mrs. Morella.

[The prepared statement of Hon. Constance A. Morella follows:]

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Mr. BURTON. Let me go to Mr. Cary.

What things can Medicare do to improve the reimbursement

structure of the integrated oncology?

Mr. CARY. Basically to include things that Mr. Devries said that

many other insurers are waking up to, and that is the fact that

many of the naturopathic and complementary things that we are

talking about are not that much—they are not that expensive compared to conventional medicine, and the patient outcome is better.

So I would say the licensing of naturopaths as in 11 States, to

keep pushing that forward; and then to cover some of the complementary things like psychoneuroimmunology, nutrition counseling, vitamins, botanicals, etc., need to be included.

Speaking from a hospital operation’s perspective, many hospitals

are having a hard time doing that. We at the present time include

it in our therapies, regardless if it is a Medicare patient or anyone

else, even though they don’t pay, but that’s becoming more and

more difficult. In talking to my colleagues and in telling some of

the other hospital administrators that I relate to, they are telling

me they would like to provide more therapy, but they are not able

to for financial reasons.

Mr. BURTON. I think it was Mr. Devries that a while ago was

talking about some senior patients—I think it was you, or Mr.

Cary, I am not sure which—and they were going through chemotherapy and radiation at an advanced stage and maybe some other

treatments as well—or maybe it was Dr. Geffen, I can’t recall who

it was—and had they maybe had some complementary therapy

along with it the problem—their life quality of life would have been

better and they might have lived longer. And I presume you were

talking about massage therapy and the other therapies, maybe acupuncture and other things that went along with that.

I don’t know if there are any clinical studies or anything that

would bear on this, but when all these things are done together,

do people live longer? I mean, do we have any statistics or any empirical evidence that would say that somebody who gets a combination of these treatments instead of just a standard treatment would

survive and live a longer and better quality of life? Whichever one

of you wants to answer.

Mr. CARY. My answer would be it is still anecdotal. We don’t

have a large enough sample size, but every patient that goes

through it, the quality of life has improved.

On things that we have sample sizes, it indicates that patients

are doing better by having those treatments.

As Dr. Geffen was saying, chemotherapy, radiation and surgery

benefit many patients. The problem is, those things are toxic on the

body. They pull the body down. And by building up the body’s immune system, by making it stronger, it is able to tolerate those

treatments better, and we also believe there is an immune response.

Mr. BURTON. So you believe—although you don’t have statistical

evidence but you believe they do live longer afterwards?

Mr. CARY. Yes. I would like to see more funding come into locations like Dr. Geffen and to Cancer Treatment Centers of America

where we can prove our point. If we get stuck in phase one and

phase two trials forever, we are never going to get it to the

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bedsides, and there is going to be more cases like the Navarros and

the Horwins in the future.

The longer we wait, time is an issue.

Mr. BURTON. Well, you are not saying this but I am, one of the

things that concerns me is that the conventional wisdom and the

pharmaceutical companies and the other people who are involved

in helping in the quality of medicine have a vested interest in

maybe keeping some of these practices going on, and the new alternative therapies that could be combined with conventional therapy

are being left out like an orphan child because of the almighty dollar.

I know you guys can’t say, especially Dr. Geffen, because he is

a physician who might be in jeopardy down the road from some

medical entity. I don’t know who it might be, but it does concern

me. It concerns me a great deal.

We ought to be concerned about the pharmaceutical companies

creating new and better drugs that can help improve and extend

the quality of life, but we should not keep ourselves in the mold

that we are in right now when there is new therapies coming along

that, when added to the conventional therapies, can do a better job.

I sometimes think that maybe the FDA and other health agencies in this country maybe are inadvertently controlled in part by

the pharmaceutical companies, so we don’t get these new therapies

and these new things added to the mix. I think that is unfortunate.

But we are looking into that, and I can promise you we are going

to continue to look into it, look into conflicts of interests and all

that sort of thing, to get it as cleaned up as possible.

Does anybody have any final comments? I think we are getting

ready to wrap this up.

Mr. NAVARRO. Mr. Chairman, I promise to be brief.

I just discovered Thomas’s consent form for radiation and what

the doctor said he would face: hair loss, skin redness, fatigue, nausea, vomiting, loose BMs, fluid in the middle ear, hearing loss,

hypothyroidism, spinal growth deficit, loss of IQ, memory loss, secondary tumors, hypopituitarism, low level hormones, and radiation

necrosis, which is a disintegration of his brain matter. This helped

make the decision that we made.

Mr. BURTON. The doctor gave you that and said that was the side

effects one could expect.

Mr. NAVARRO. Yes.

Mr. BURTON. Anyone else have any final comments?

Dr. GEFFEN. I just wanted to say, you know, not only am I not

afraid to speak the truth, but in fact in my testimony today I said

that I really believe one of the most fundamental core issues that

sooner or later we are going to have to confront in this country, as

we are involved in this discussion of how do we proceed in a way

that makes sense, is the fact that, in America, doctors are paid to

treat diseases. We are not paid, we are not honored, we are not

trained and certainly not reimbursed, to care for people in a comprehensive way. So it is impossible to overestimate the overbearing

influence of that on every decision that is made in the medical environment.

I am not condemning physicians, because I believe most physicians are genuinely motivated by a desire to help. But we are operVerDate 11-MAY-2000 08:49 Jul 30, 2001 Jkt 000000 PO 00000 Frm 00222 Fmt 6633 Sfmt 6633 C:\DOCS\72932.TXT HGOVREF1 PsN: HGOVREF1
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ating as physicians in a health care system that is fundamentally

crazy in many, many respects. Because our interest of caring for

a person is in opposition to Medicare regulations, insurance regulations, reimbursement structures, that do not allow us to really care

for the human being. We have to make a diagnosis and prescribe

a drug and move on. And that is a fundamental issue that sooner

or later will have to be looked at.

Mr. BURTON. Very good.

Anyone else?

Mr. CARY. The last comment that I would like to make is the proton—the photon and the neutron that hit the tumor do kill the

tumor. The problem is, as he said, the side effects are what are so

draconian. But through naturopathic and CAM therapies, we can

alleviate that. You don’t have to have as high doses, or you can pinpoint it more closely, or you can take other therapies and

botanicals that have an offsetting effect. Similar to what you said

related to your stomach, we have similar things with cancer patients.

In our Seattle practice, we have patients that went through very

extensive bone marrow transplants, and the quality of life was so

poor, treated somewhere else, but so poor, they did not—they were

thinking of—they had suicidal ideations. They had all kinds of

problems. But we were able to alleviate the side effects and the results of their conventional therapy through naturopathic medicine,

through CAM therapies.

It would be so much better if our integrated health care system

could be providing that at the same time, so you get the therapeutic effects of CAM therapies at the same time you can tie in

conventional and alleviate the radiation therapy, the surgery, the

chemotherapy, by using more CAM therapies.

Mr. BURTON. You know, I will be contacting people at the Food

and Drug Administration, the doctors and others, and some of

them are still here. And I have talked to some of the people in your

facility, and they have told me that where chemotherapy is concerned and radiation, that sometimes they will give smaller doses

over a longer period of time, spread out, and, in the interim, they

will give vitamins and minerals and other supplements that stimulate the immune system so while the chemotherapy is killing the

tumor or cancer, the body’s immune system has been boosted. It

seems to me that is something that our health agencies ought to

take a look at, whether or not just a bombardment by conventional

medicine is going to solve the problem, or whether or not it should

be maybe extended over a longer period of time, along with the

supplements that you are talking about.

Mr. CARY. We find that patients can tolerate treatment much

better. Patients that could not take the high doses of chemotherapy

can take it over time much better, tolerate it, and the tumor response is very high. And, as you said, the immune system is fired

up, and it gives you a better result.

Mr. BURTON. I want to thank all of you for being here. It has

been a long day. I apologize for the time we were on the floor and

had those votes. But you have all had so much to contribute.

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I know that some of you have suffered a great deal, and our

heart goes out to you, and we will try to continue to be vigilant in

trying to bring about some positive change.

Thank you very much. We stand adjourned.

[Whereupon, at 5:15 p.m., the committee was adjourned.]

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CANCER CARE FOR THE NEW MILLENNIUM—

INTEGRATIVE ONCOLOGY

THURSDAY, JUNE 8, 2000

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

The committee met, pursuant to notice, at 1 p.m., in room 2154,

Rayburn House Office Building, Hon. Stephen Horn (acting chairman of the committee) presiding.

Present: Representatives Horn, Burton, Morella, Sanford, Hutchinson, Waxman, Norton, Cummings, and Schakowsky.

Staff present: Kevin Binger, staff director; David A. Kass, deputy

counsel and parliamentarian; Mark Corallo, director of communications; S. Elizabeth Clay and Nicole Petrosino, professional staff

members; Lisa Smith Arafune, chief clerk; Robert A. Briggs, assistant clerk; Robin Butler, office manager; Michael Canty and Toni

Lightle, legislative assistants; Beth Craine and Robin Daugherty,

interns; Josie Duckett, deputy communications director; John Sare,

staff assistant; Phil Schiliro, minority staff director; Phil Barnett,

minority chief counsel; Sarah Despres, minority counsel; Ellen

Rayner, minority chief clerk; and Jean Gosa and Earley Green, minority assistant clerks.

Mr. HORN. Good afternoon. The Committee on Government Reform will come to order.

And I ask unanimous consent all Members’ and witnesses’ written and opening statements will be automatically included in the

record. And without objection, that’s so ordered.

I ask unanimous consent that all articles, exhibits, extraneous or

tabular material referred to in the hearing will be included in the

record. Without objection, so ordered.

Today the Committee on Government Reform begins the second

of our 2 days of cancer hearings. This has been a busy week for

cancer awareness. It’s also been very moving when you see the witnesses that have come before us with their stories and their losses

and their benefits.

June 3rd was the Coleman National Race for the Cure event in

Washington. 69,000 participated in this Washington event, which

is one of the 109 events sponsored across the country to raise

awareness and research dollars to work toward a cure for breast

cancer. June 4th was National Cancer Survivors Day. Tomorrow

and through the weekend, the Third Annual Comprehensive Cancer Care Conference on Complementary and Alternative Medicine,

sponsored by the Center for Mind/Body Medicine, the National

Cancer Institute, the National Center for Complementary and AlVerDate 11-MAY-2000 08:49 Jul 30, 2001 Jkt 000000 PO 00000 Frm 00225 Fmt 6601 Sfmt 6601 C:\DOCS\72932.TXT HGOVREF1 PsN: HGOVREF1
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ternative Medicine, and the University of Texas at Houston Medical Center.

Yesterday we were pleased to hear from Congresswoman Deborah Pryce, the Horwin family, James Navarro, about the challenges

parents face when their child is diagnosed with cancer. We also

heard from Dr. Jeremy Giffin and Mr. Roger Kerry about integrating complementary therapies into a conventional oncology environment. They explained the benefits, including better quality of life

and at times extension of life, and also the challenges which include the lack of reimbursement for treatments such as acupuncture, guided imagery, massage therapy and naturopathic medicine.

Mr. George DeVries outlined advances in the private sector insurance programs regarding the addition of complementary and alternative therapy benefits packages.

We also received updates from the National Center for Complementary and Alternative Medicine, the National Cancer Institute, the Health Care Financing Administration and the Food and

Drug Administration. Today I’m pleased that we will be hearing

from Mrs. Connie Payton. Mrs. Payton established the Walter

Payton Cancer Fund as a living legacy of her husband, the Hall of

Fame running back from the Chicago Bears who died last year

from cancer.

She will be joined by Dr. Jeanne Achterberg, a psychologist and

expert in mind/body medicine. In addition to being the senior editor

of Alternative Therapies in Health and Medicine, a peer reviewed

medical journal, Dr. Achterberg is also a cancer patient. Dr. Harold

Freeman, Director of Surgery at North General Hospital in New

York City, will address racial disparities in care.

Last year, the New England Journal of Medicine published research that highlighted one area of racial disparity. The observational study assessed the rates of resection and survival among elderly patients with early stage, non small cell lung cancer. There

is agreement that surgical resection saves lives in patients with

early stage non small cell lung cancer.

After accounting for the confounding effects of sex, coexisting illness, socioeconomic status, insurance coverage and availability of

care, the study showed that Black patients, once lung cancer had

been diagnosed and staged, were 12.7 percent less likely than

White patients to undergo surgical resection. Blacks also had a

lower 5 year survival rate than Whites. The authors concluded that

if Blacks were to undergo surgery at the same rate as Whites, the

survival rate among Blacks would be substantially improved and

almost equal to that among Whites.

Dr. George Pettit is the director of the Cancer Research Institute

at Arizona State University. Dr. Pettit will address the discovery

and development of new anti-cancer drugs from plants, marine organisms and microorganisms. If we’re going to find a cure for cancer, it most certainly is going to be from nature. It is very important that the National Cancer Institute strike an appropriate balance with genetics research, natural product drug development,

complementary and alternative therapies for cancer, prevention research and other research portfolios.

Dr. Daniel Nixon, the president of the American Health Foundation in New York, and a professor of experimental oncology at the

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Medical University of South Carolina in Charleston will present

testimony on integrative approaches in lung cancer. Dr. Giancarlo

Pizza of Italy and Dr. Wolfgang Woeppel of Germany will present

testimony regarding developments in integrative oncology in Europe. Burton Goldberg has led the field in providing the informative publications in alternative medicine. These publications include Alternative Medicine, the Definitive Guide to Cancer. The

hearing record will remain open until June 21st for those who

would like to submit a statement into the hearing record.

I now will yield to the chairman of the full committee, the gentleman from Indiana, if he’d like to comment at this point.

Mr. BURTON. Thank you, Mr. Chairman. I want to say I really

appreciate you handling the hearing today and being chairman of

this very important meeting.

I had an opportunity last night to be with Connie Payton, who’s

with us today. I was a great admirer, Mr. Chairman, of her husband, who was not only an outstanding football player, but a very

fine human being as well. He was a real credit to the athletic community as well as to the human race.

And I got to know Connie yesterday, and she’s now heading up

the Walter Payton Cancer Fund, to also work on cancer research.

I wanted to say hello to her and tell her I would be here for her

testimony, for the early part of the hearing, but then I have to

leave. But I really do appreciate all you’re doing and what you’ve

gone through.

I also want to thank the other members of the panels that are

going to be here today. I really appreciate them being here, because

it’s such a very, very important topic. And I want to apologize for

my having to leave. It’s one of those situations where I’ve just got

double duty. Thank you very much.

Thank you, Mr. Chairman.

Mr. HORN. Thank you, Mr. Chairman.

We have the presence of the Delegate from the District of Columbia. I’m delighted to recognize Ms. Norton for an opening statement.

Ms. NORTON. Thank you very much, Mr. Chairman.

I very much appreciate that the chairman, himself, has called

this very important hearing. I had intended to be here for the entire hearing. My staff tells me that a colloquy between myself and

Chairman Porter must take place almost immediately during this

period, while they’re in general debate. So I am literally running

to the House floor, because it involves one of my own bills.

Then there is a press conference with our Mayor on school board

elections. I will endeavor to get back. I did want to say to Mrs.

Payton, who came to speak and spoke eloquently to the Congressional Black Caucus yesterday, how much I appreciate the leadership she is taking on cancer, a disease in outsize proportion in our

community.

More than anything that any elected official can do, even the

kindness of our chairman in holding this hearing, a role model like

you who has suffered a loss which the entire country has felt can

help us reach people who we might otherwise have not been able

to reach, and to obtain treatments of the kind that have not been

popularized because they are so little known. You struck a real

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chord when you spoke so beautifully and eloquently yesterday

about what the non-traditional treatment had done for your husband, a great athlete and a great man.

So I come on my way to the House, both to thank the chairman,

and of course, above all, to thank you for what you’re doing and

what it means to our country. Thank you very much, Mr. Chairman.

Mr. HORN. We thank you for that presentation.

I now yield to the ranking member of the full committee, the

gentleman from California, Mr. Waxman, for an opening statement.

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

We continue this hearing today, after the hearing yesterday on

the same subject, and we face many challenges relating to cancer.

There are many questions about the causes and biology of many

cancers and there are ongoing debates about the best treatments.

Because so much remains unknown, and because cancer continues

to affect so many lives, it is imperative that we continue to concentrate our efforts on developing the most effective prevention, detection and treatment approaches.

We must also work to ensure that all patients 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 cancer treatment and prevention. But our first priority

must be ensuring patients have access to treatments which are

proven to offer the best chances of curing them.

Our second priority should be the rigorous testing of new therapies, including complementary and alternative therapies, to determine their safety and efficacy. We cannot rely on anecdotal evidence which sometimes proves to be misleading. Instead, we need

to rely on the scientific method, which can give us objective answers about whether a product works and is safe. This standard

must be applied to all therapies in order to ensure that patients

can rely on the claims made by providers or manufacturers.

Some of the witnesses at our hearings on this subject will share

their personal experiences with cancer. Others will highlight ongoing efforts to advance cancer prevention, detection and treatment.

There’s also been testimony regarding payment for these treatments. This discussion will increase our understanding of the options currently available to people who have been diagnosed with

cancer, and of the research efforts we should continue to explore.

I join my colleagues in welcoming them and look forward to their

testimony.

This hearing marks a truly landmark event. A couple of days

ago, President Clinton announced that Medicare will cover the cost

of participating in clinical trials. This is a dramatic and enormously important step forward for the health of older Americans.

It will speed the development of new therapies and it should lead

Congress to ensure that routine patient costs are covered for all

who received their health care from Government programs like

Medicaid, veterans, community health centers and the Indian

Health Service.

Older Americans will now be more willing and able to enter

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thritis and other common diseases affecting the elderly. So I applaud the President and Secretary Shalala for this decision.

But we should also recognize that Health Care Financing Administration’s new policy is based on legislation sponsored by our colleagues Nancy Johnson, Ben Cardin and Ken Bentsen, as well as

Senators Rockefeller and Mack. They should be very pleased that

their proposal will benefit the health and welfare of older Americans.

I want to welcome the hearings that will be here today, and Mrs.

Payton particularly. I’m delighted you’re here to share your concerns with us and we’re looking forward to hearing from you and

from all the witnesses. I have to say in advance that unfortunately

on the House floor is the appropriations bill for Health and Human

Services, so I’m going to have to be on the House floor and won’t

be here to personally hear all the testimony.

But I will get a chance to review all the testimony, and I may

even ask, if the Chair would permit, to send questions and to receive responses in writing, so those can also be in the record,

should these written testimonies reported at today’s hearing provoke additional questions that I might have and want to have for

the record.

I thank you, Mr. Chairman, for recognizing me and yield back

my time.

Mr. HORN. Without objection, both majority and minority staff

will have a series of questions. And once we swear the witnesses,

we will try to get many of these questions in today. But we know

you have travel schedules and so do some of the Members. So we

will, if you don’t mind, try to respond to these questions. We’ll

make it part of the hearing record, to round out all the different

questions.

So we will now swear in the witnesses, and we would like for

panel four, since we had three yesterday, Mrs. Payton, Dr.

Achterberg, Dr. Freeman, Dr. Woeppel, Dr. Pizza, and Dr. George

Pettit, if you will all come up. There are signs here for you, starting

with Dr. Freeman, Dr. Achterberg and Dr. Woeppel and Mrs.

Payton. If you’ll raise your right hands.

[Witnesses sworn.]

Mr. HORN. Thank you. If there are any staff behind you, let us

know.

So we’re just going to go down the list. Mrs. Payton is going to

have staff behind. So in remarks you will be giving here, please,

you will have the truth, the whole truth and nothing but the truth.

OK, the clerk will get the names, put them in the record at that

point. I do want to recognize former Congressman Berkeley Bedell,

Democrat from Iowa, who’s done a lot to help alternative cancer

and his great interest. So I wonder, Congressman, if we can—— Mr. BEDELL. Right here.

Mr. HORN. Oh, OK. We don’t have a sign for you somehow, but

welcome. We’re delighted to have you here. Because you’ve made

some of the witnesses possible to be here, and that’s appreciated.

Mr. BEDELL. You know, Mr. Chairman, Congressmen do not like

to be identified as such, so that’s why I don’t have a sign.

Mr. HORN. OK. Now, we’ll start then with Mrs. Connie Payton,

of the Walter Payton Cancer Fund. Mrs. Payton, please proceed.

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STATEMENTS OF CONNIE PAYTON, WALTER PAYTON CANCER

FUND; JEANNE ACHTERBERG, SANTA FE, NM; DR. GEORGE

PETTIT, M.D., DIRECTOR, CANCER RESEARCH INSTITUTE,

ARIZONA STATE UNIVERSITY, NATURAL PRODUCT DRUG DEVELOPMENT; DR. WOLFGANG WOEPPEL, GERMANY; AND DR.

HAROLD FREEMAN, M.D., NORTH GENERAL HOSPITAL, NEW

YORK, MINORITIES ACCESS TO ONCOLOGY CARE

Mrs. PAYTON. Distinguished members of the House Committee

on Government Reform, I am honored to be invited here by Chairman Burton to testify at your extremely timely and important

hearings.

Our common concern for developing a cure for cancer and promoting creative new methods for treatment for those who are currently suffering from cancer unites us all regardless of our race,

creed or political persuasion. I would also like to thank the committee staff, including Beth Clay, T.J. Lightle and Mark Corallo, for

their assistance this week on Capitol Hill of the kickoff of the Walter Payton Cancer Fund.

As most of you know, my late husband Walter died November 1st

at the age of 45. I would like to share with you today my personal

story of how Walter and my family struggled with cancer and why

I firmly believe in integrative oncology. And my story is this. Walter was fortunate that he had great insurance coverage. And I’m

thankful for that today, because today we’re still receiving invoices

from bills from insurance companies. So I’m thankful that we

weren’t burdened with that.

But he also got real good treatment from other major hospitals,

but it was in August of last year, after finding out that Walter had

aggressive tumors in his bile duct area, that he had started having

severe pain and by this time, we were told that there was nothing

much the doctors could do for him but just keep him comfortable,

and under their assumption, they pretty much just put him on extremely harsh drugs that kept him so out of it that he had no communication at all with family members. He was pretty much laying

there and dying.

And through a friend of mine who was a cancer survivor, who

had been a patient at the Cancer Treatment Centers of America,

she invited me to an outing they were having on nutrition that

made me realize that my husband was laying there dying mainly

from, he had cancer, but it was malnutrition and dehydration that

was going to kill him before the cancer. And thank goodness, we

found out about the Cancer Treatment Centers of America, who are

real into real innovative treatments. And also, they have a human

side. You felt comfortable sharing with them.

And if you’re spiritual people, like my husband and I are, they

had wonderful pastoral counselors and within a week, they made

a difference in my husband’s life. The first week there, he had no

knowledge of what was going on, because that’s how drugged up he

was. And within a week, through nutrition and vitamins and relaxation techniques and pastoral counseling to nourish his spiritual

side and to continue to give him hope to fight with this dreaded

disease, they made a big difference in my husband’s life.

So I’m proud to be involved, and I’m proud to be here today because I know it makes a difference in a person’s life. And I would

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hope that insurance companies and the medical field would be open

to these services and use them as a complement to other medicines

that are out there. My husband was treated with high doses of radiation. It’s not something he wanted, but he was told that was his

only help. So what do you do, when you’re told that’s the only way

you can live.

And he did, he went through 4 to 5 weeks of intense radiation

that he felt damaged his kidneys, took away his taste, took away

his smell. And he couldn’t enjoy foods and foods that he normally

would enjoy. And my husband was a man who loved smelling wonderful things, but all of that became a burden to him after he had

gone through the radiation.

So I’m here to say that integrative oncology and innovative medicines do work, and they gave my husband back to my kids and I

for 21⁄2 months, to a way where we were able to interact with him.

And he was able to live his last couple of months on this Earth

with some dignity. I’m happy to be here, and if launching this Walter Payton Fund will make a difference in our researching new integrative medicines, to make a difference in cancer patients’ lives,

then I’m happy and I feel like I’ve done my job and I’ve done his

name justice and for what he stood for. Because he was a good

human being, and he was into helping people. And I know he

would want us to do something to fight this dreaded disease.

[The prepared statement of Mrs. Payton follows:]

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Mr. HORN. A very moving statement, just as the ones about children were yesterday. So I think we get a feeling, although we can

never be in your shoes, we get a feeling of how moving that is. And

I know your husband would really appreciate what you’ve done.

Our next witness has a travel problem, Dr. Wolfgang Woeppel,

so we’re going to ask you to speak next, sir.

Dr. WOEPPEL. I am Dr. Wolfgang Woeppel. I operate a medical

hospital in Bad Merghentheim, Germany, specializing in the treatment of cancer.

We operate from a different basic belief in regard to cancer as

compared to conventional cancer treatments. Conventional treatments focus exclusively on the destruction of the cancer tumor, primarily with surgery, chemotherapy and radiation. We believe that

cancer is a disease of the whole body, and our cancer treatments

focus on the patient’s entire body, enabling the body to overcome

the disease.

We believe that it is insufficient to destroy the tumor if one does

not also focus on restoring the patient to sufficient health so that

the body will prevent the reoccurrence of cancer. Our treatments

consists of several individual methods, directed at detoxifying the

body, strengthening the immune system and restoring the patient’s

total health.

Statistics show that for 30 or 40 years, there has been a certain

stagnation in the healing rate of cancer with conventional treatment. We need, therefore, a change in the thinking.

I am able to use some medical treatments, for example, that are

legal in my country but not in yours. All of these medications are

essentially non-toxic and I believe highly beneficial.

A study done by the University of Wuerzburg of our treatments

stated, ‘‘We found that the survival time from the beginning of general metastases here was much longer than those mentioned in

conventionally treated groups. The earlier such a treatment began,

the longer was the survival time.’’ The cost of treatment at my clinic is about $240 per day, including room, board, medication and doctor’s consultations. The treatment usually lasts from 4 to 6 weeks. In Germany, this is covered

by government health insurance.

To summarize, first, I believe that the lack of progress in the

treatment of cancer in spite of the billions of dollars spent for cancer research means that we need to take a new look at cancer

treatment. Second, I am administering essentially non-toxic cancer

treatments focused on the patient’s entire body as compared to

treatments focusing exclusively on destruction of the tumor. These

conventional treatments frequently not only destroy the tumor but

also damage the patient’s health as well.

Third, studies have confirmed the effectiveness of my treatment.

Fourth, I am advised that these non-toxic treatments are substantially less expensive than conventional cancer treatments in the

United States.

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Fifth, some of the parts of my non-toxic treatment are prohibited

in the United States. And I am absolutely convinced that your cancer patients might benefit greatly if such treatments could be made

available in your country.

I thank you.

[The prepared statement of Dr. Woeppel follows:]

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Mr. HORN. Thank you very much. We appreciate that statement.

I know you have to leave, so bon voyage. If you can stay for some

questions, we’d appreciate it.

Our third witness now on this panel is Dr. Jeanne Achterberg.

Please proceed.

Ms. ACHTERBERG. My name is Jeanne Achterberg, and I’m a psychologist and a physiologist by training, and a human being by

birth, which is one thing that we need to keep in mind as we begin

to talk about cancer.

The crisis of cancer is one of immense proportions and it calls

forth all the resources and makes glaringly clear the deficiencies in

the culture of modern medicine. It is, in fact, ladies and gentlemen,

a crisis of the soul, and for the first time in our lives we may be

asking questions about our immortality or mortality. And when

cancer is diagnosed in oneself or a loved one, that which is cream

rises to the top and trivialities float down.

To think that cancer can be treated with only pills and potions

and surgery and radiation, no matter how advanced they are,

misses the whole point of this journey through cancer, which is

awesome and terrible. The field of mind/body medicine, which is

now being called mind/body medicine, includes many therapeutic

techniques, including counseling, biofeedback, hypnosis, imagery,

meditation, and is now being expanded to include prayer and community support.

I, along with my co-chairs, Dr. Larry Dossey and Dr. James Gordon, published the state-of-the-art of this field in Alternative Medicine: Expanding Medical Horizons, which was a report to NIH

which I have included with my materials for this presentation. We

concluded that the evidence was strong that the interactions between mind and body and spirit were primary to the practice of

medicine and not secondary.

Furthermore, in comparison to other so-called alternative or integrative or complementary treatments, the mind/body field is soundly researched and provides a very, very good data base as well as

a standard for other types of alternative therapies to follow. The

mind/body work is not just something you do while you’re waiting

for the undertaker to come, I have to tell you that.

There is good evidence now that well crafted support groups may

increase your life span by two times over. We know that certain activities, such as spending 20 minutes a day relaxing or meditating,

increase the power of the immune system. We also know that joy,

love and expressing your emotions from a deep level stimulate your

immunology. And that having company, community, support group

or the lack thereof is the single greatest risk factor in death from

all disease, including cancer. So again, they’re not nice little activities to do to keep you from thinking so much about the diagnosis

you’ve received.

Over the past year, however, I learned about cancer in a far

more profound way than I did over 25 years of being a research scientist. On July 23rd, I was diagnosed with an ocular melanoma in

my left eye and I was going blind. The ironies were too great. I had

written a book which is regarded as a classic text on imagery and

the use of inner vision. My work for the past 25 years has been

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about and with cancer and its psychological and spiritual dimensions.

St. Lucy, the patron saint of vision, was on my book, Woman as

Healer, 10 years ago. And over the past few years, I’ve been senior

editor of Alternative Therapies, which is a peer reviewed medical

journal. I know virtually everyone in the alternative and complementary community, and I taught at a medical school, got tenure, was there for 12 years. So I’m fully aware of the politics of

cancer and medicine.

And as I say this, I do it with some humility. For now I have

a disease so rare that there are no records in the world of a single

case of primary ocular melanoma being treated by so-called alternative methods. In the United States, the treatment of choice is

high-tech radiation, or for me, because of the size of the tumor, removal of the eye. And ladies and gentlemen, I could not do it. I

simply could not have my eye removed.

Although I fully anticipated using western medicine, when it

came right down to it, I said, there must be a better way. Removal

of my eye would not save my life. In fact, there is some evidence

that eye removal is followed by an increased instance of metastasis.

But I knew that my tumor was very immunoreactive.

So I gathered from all around the world everything that I knew

about stimulating the immune system. And I became a walking

chemical stew. Happiness stimulates the immune system. So I

worked consistently, since the diagnosis, to bring more happiness

into my life. The evidence that prayer heals is overwhelming, and

I became the subject of hundreds of prayers, thousands of prayers,

from all around the world. And the healing power of community

was given to me and touched my heart on a daily basis. Love, gifts,

cards, poetry, songs, from so many people who said, we have no

medicine, but we have these. And on November 17th in Washington, DC, I held on to the sides of a bed in a hotel room for 5 days

while whatever it was in the back of my eye exploded. I knew that

I could not present myself to modern medicine because the treatment would be cortisone, and that would stop the inflammatory

process. And at some level, instinctual level, I knew that my eye

needed to inflame.

So molecule by molecule, photon by photon, I’m getting well. I’m

still alive, I don’t have a safety net of conventional medicine. I am

the most privileged of all people with this grim diagnosis, and yet

still in the middle of the night, I wake in sheer terror.

My conclusions about the practice of medical care in this country

for cancer are that it must be imbued with trust, caring, effective

communication and a remembrance that all medicine practiced in

all places in the world is connected to the divine. And that medicine for cancer, as practiced in this country, is brutal. That’s a fact.

With all the critical flaws in the institute of medicine, though,

I’ve found that there are mystics and sages and healers in the

health care professions, and they too seek to resolve this crisis of

human values. Research into the causes and cure of cancer will not

provide effective treatment unless the broad spectrum of mind/body

and even spirit issues is addressed. And in years to come, finally,

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any medicine that does not honor the deepest core of humanity

with love, caring and recognition of the interaction of mind, body

and spirit, will be declared both inhumane and unethical.

Thank you.

[The prepared statement of Ms. Achterberg follows:]

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Mr. HORN. Thank you very much. That is a very sensible presentation for us.

The next witness I would like consent of my colleagues to have

Representative Salmon of Arizona introduce Dr. Pettit. So if you

want to come down this way, you’ve got any choice of seats.

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

I’m pleased to introduce to the committee Dr. George Robert

Pettit, the director of the Arizona State University Cancer Research Institute, which is based in my district. Dr. Pettit has devoted 43 tireless years to cancer research. In that time, he’s discovered numerous anti-cancer drugs in nature, marine life, plants and

microorganisms. Six of the drugs discovered by the ASU Cancer

Research Institute are in clinical trials, and dozens more are in

pre-clinical development or heading toward pre-clinical development.

Dr. Pettit’s anti-cancer drugs have been acknowledged by CNN,

Fortune Magazine, Time Magazine and U.S. News and World Report, just to name a few. The ASU Cancer Research Institute,

under Dr. Pettit’s brilliant leadership, is the National Cancer Institute’s most prolific source of drugs derived from natural products

and is regarded as one of the most productive anti-cancer drug discovery research groups in the world.

I’m also pleased to be here as the chairman of the Honorary Advisory Council of the International Foundation for Anti-Cancer

Drug Discovery, a charitable organization founded and chaired by

my friend Sid Rosen of Phoenix, which works hard to accelerate the

Nation’s drug discovery pipeline. They also have a wonderful executive director, and her name is Marcia Horn. I think you might

know her.

Mr. HORN. I think I do. [Laughter.]

Mr. SALMON. Finally, I’d like to wish a very happy birthday to

Dr. Pettit today. Happy birthday. I’d sing to you but I’m a little off

key. Thank you.

Mr. HORN. Well, since he only looks in his forties, I’d hate to

admit what his age is. Welcome. We’re delighted to have you here.

Dr. PETTIT. Distinguished chairman, distinguished members of

the committee, the Honorable Matt Salmon from Arizona, who I

thank very much for that most kind introduction.

Mr. Chairman, I’m here as a friend of the Congress, your committee, cancer patients and their families and the U.S. National

Cancer Institute. What I’d like to relate is an ongoing problem that

we have suffered over the last 25 years in our Government’s cancer

conquest program.

To begin with, thanks to the Congress, we are now saving, in the

United States, several hundreds of thousands of cancer patients a

year, and over the world’s population, that amounts to millions of

cancer patients. That had its start in congressional action in 1937,

with the establishment of the U.S. National Cancer Institute.

The next really crucial step was followed about 1955 with an appropriation of $5 million for starting an anti-cancer drug discovery

program in the U.S. National Cancer Institute that actually became viable by about 1957. In fact, it was September 1957, and

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tional Cancer Institute when I was a 2-week old assistant professor

at the University of Maine.

As a result, I either have the fortune or misfortune of being the

only chemist that has the institutional memory of our Government’s anti-cancer drug discovery program over the past 43 years.

The next really major event which was again the result of the

wonderful actions of Congress, namely the passage of the Cancer

Conquest Act of 1971, that allowed the National Cancer Institute’s

anti-cancer drug discovery program to be greatly accelerated and

by 1974, the stage was set to actually double the discovery of anticancer drugs. However, due to the retirement of the brilliant director of the Division of Cancer Treatment at that time, the window

was opened for massive attacks on the NCI anti-cancer drug discovery programs. And as a result, within the next year or so, we

lost all the research in the NCI for the structural modification synthesis of new anti-cancer drugs.

And the next event was in 1981 when we lost all the natural

products based anti-cancer drug discovery research. And that was

an especially disastrous event, because most of the drugs that are

now in use in the United States and worldwide were discovered in

the period up to 1974. And had our Government’s program been allowed to continue after that period, we would not be losing 600,000

patients this year, and in the next year getting to the point where

cancer will actually exceed and become the No. 1 killer of people

in the United States, in a year from now, after heart disease.

So we have allowed a devastating series of events to take place.

And if one realizes that in nature, we have some probably 800,000

plant species, of which only about 5 percent have ever been investigated for anti-cancer constituents, we have some 30 million microorganisms, again which a very small percentage have ever been

looked at. We have 2 million marine animals, for example, of which

only 20,000 have even had a cursory examination so far.

If you assume that you can extract 3,000 or 4,000 compounds

from each specimen, that would lead to some 100 billion to 140 billion compounds that would be available, not only for cancer, but for

the various medical problems right across the spectrum. To give

you an idea of some of the successes up to 1974, and those subsequently from the NCI’s anti-cancer drug discovery programs, you

need only look at the drugs such as Taxol, camptothecin and its derivatives, such as 9AC, CPT–11, topotecan and so on. And I see my

time is getting very short.

Mr. HORN. Go ahead.

Dr. PETTIT. Thank you, Mr. Chairman.

So I would like to point out that in 1984, thanks to a new director of the Division of Cancer Treatment in the early 1980’s, it was

possible to restart some of the natural products based anti-cancer

drug discovery. One of the deputy directors, Dr. Michael Boyd, who

is the second really brilliant leader in the National Cancer Institute over this timeframe, demoted himself and became the head of

the new laboratory for discovery of new anti-cancer drugs and their

development.

However, over the past 4 years, that remaining anti-cancer drug

discovery program in the National Cancer Institute has been undergoing successive destruction. And the situation now is that we

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have roughly a half a dozen chemists left in the National Cancer

Institute. That’s out of a staff of nearly 3,000. Whereas we really

need not 5 but 5,000, and at least 500 chemists working on this

problem. Otherwise, it’s going to continue and will haunt all of us

for the rest of our days.

What I’d like to do is make a plea to save what is left of our National Cancer Institute discovery programs, and also to make a series of three recommendations that could turn the situation around

rather abruptly, not only for cancer, but for the remaining lethal

and debilitating diseases that our population suffers from, and

again, across the world.

And this could be achieved by first of all the establishment of a

new Division in the National Cancer Institute designated the Division of anti-cancer drug discovery and development. Then as efficiently as resources permit, that Division could be developed into

an institute for cancer treatment drug discovery, not only for the

drugs that you need directly to treat metastatic cancer patients,

but also the drugs you need for AIDS and related viral diseases involved in the cancer problem, and of course in general. Also the

antibiotics, the antifungal agents that you need to help cancer patients and a variety of other drugs that are very necessary to improve cancer treatment in the United States and elsewhere.

Furthermore, to ensure that this new Division is properly directed, it should be written into statute that the new Division director be an internationally respected organic chemist, natural

products chemist and/or medicinal chemist. And the reason for this

is that this type of chemist is the one who discovers new drugs.

And that is what’s been missing for 25 years now in our National

Cancer Institutes, in our Government’s programs.

And this person should have a tremendous motivation and

knowledge of pharmacology and cancer medicine. That organizational structure would make maximum use of our country’s best

chemists, pharmacologists and cancer biologists in a new and

greatly accelerated war on cancer that would soon be extraordinarily successful.

It will also have a multitude of critics, just as your congressional

action in 1971 did, where you’re going to have many private sector

critics. However, the result today is that what you did in 1971 and

prior to that is now saving hundreds of thousands of people in the

United States every year.

Second, I would like to urge and recommend that you consider

the addition of a new drug discovery and development Division in

each of the NIH institutes. Again to ensure that the new Division

be properly directed, it should be written into statute that the new

Division director be an internationally respected organic chemist,

natural products chemist and/or medicinal chemist with tremendous motivation and a knowledge of medicine important to that institute.

This is what we’ve been missing in our NIHs through my whole

knowledge over the past 50 years. We have not undertaken the discovery of the drugs in our NIH that will really cure these diseases

that the NIH is directed at.

Third and finally, I also strongly urge and recommend the creation of a completely new institute in the NIH called the institute

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for drug discovery and development for all other diseases that are

not covered by our present NIH system. As with the new NCI Division director, the new NIH institute director must be highly respected and motivated and either an organic chemist, natural products chemist or a medicinal chemist with a knowledge of pharmacology, and in this case, general medicine. These qualifications

too should be memorialized in statute.

Mr. Chairman, members of the House Committee on Government

Reform, thank you for inviting me to participate in this important

congressional hearing on cancer care for the new millennium. I

have high hopes that your work will result in the proper redirection of the NCI to its core mission, namely the discovery and development of the new anti-cancer drugs and a renewed war against

cancer. That would be a fitting tribute to all who fought in the cancer crusade and hammered out the National Cancer Act of 1971 30

years ago next year.

Mr. Chairman, members of the committee, thank you very much.

[The prepared statement of Dr. Pettit follows:]

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Mr. HORN. Well, thank you. That’s very positive and it’s something that I’m sure the full committee and the relevant subcommittees will do the work and see what can be done to get just that line

that you’ve suggested.

So the next witness on panel four is Dr. Harold Freeman, the

North General Hospital in New York. And he’s a specialist in minority access to oncology care.

Dr. FREEMAN. Thank you, Mr. Chairman. Thank you for inviting

me.

Dr. Pettit mentioned the declaration of the war against cancer in

1971 by President Nixon, something about which we can all be

proud. That stimulated the research that has been translated into

much improvement for the American people. I don’t think the research effort is perfect, but I think we’ve had a lot of success in

the treatment of cancer when you compare the point that in 1900,

only 20 percent of cancer victims survived, and in the year 2000,

two-thirds survive, so progress has been made.

But despite that, what I am aware of through my personal experience as a surgeon in Harlem for three decades is that there’s an

unequal burden of cancer in our country. And I’ve struggled over

these 30 some years to try to understand why some people don’t

do as well as others when they develop cancer. One of the issues

that we looked at closely was race. And we know, for example, that

Black Americans have the highest death rate from cancer compared to all racial groups.

But when we looked at poverty, as part of the research that I’ve

done, we found that most of the disparity, but not all, in Black

Americans, disparity was corrected when it corrected for economic

status. But something was left over that we couldn’t explain.

Recently, in the last 7 or 8 years, there have been at least a

dozen major published papers in the peer reviewed literature that

have showed that the problem is beyond poverty. The problem also

includes the point that Black Americans, and sometimes Hispanic

Americans, don’t get treated the same way at the same stage of

disease at the same economic status. And this is very troubling to

me.

An editorial that I was invited to write in the New England Journal of Medicine goes into this, and to cite some instances of this

failure to treat people the same according to race, include the point

that in a large veterans study, national study, Black men were not

worked up as vigorously when they had chest pain that might

mean that they had coronary heart disease. In another study from

Harvard, they found that Black people, male and female, were not

as likely to be referred for renal transplantation at the same economic status.

Other studies have shown differences in the treatment of pain

according to race, and in a study just published in New York City,

for Mount Sinai, it was found that the pharmacies in Black and

Hispanic neighborhoods tend not to carry the morphine-like medicines, so it’s harder for people who are Black and Hispanic to obtain medicines for chronic pain related to race.

The study that you mentioned in your introduction, Mr. Chairman, was a study by Bach at Memorial Sloane Kettering which

showed at the same stage of early lung cancer, stage one lung canVerDate 11-MAY-2000 08:49 Jul 30, 2001 Jkt 000000 PO 00000 Frm 00294 Fmt 6601 Sfmt 6601 C:\DOCS\72932.TXT HGOVREF1 PsN: HGOVREF1
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cer, Blacks and Whites are not treated the same although the economic status is the same. So this is a troubling set of issues which

is superimposed on the point that Blacks don’t do as well related

to disproportionate poverty and lack of education.

And I would like to indicate the way that I see this issue. I was

asked to give my opinion in the New England Journal of Medicine.

I believe that doctors don’t intentionally hurt anybody. I have no

evidence that doctors don’t treat people fairly, in their own thinking. But I believe that even within the medical profession, there

are reflections of society itself, doctors and others are socialized before they become educated. So it is very possible that certain biases

are carried with the person into his higher level of education or her

higher level of education that influence the assumptions that are

made when they look at different groups of people, without intending to do harm.

So I believe that leads us to the question of what could be done,

if this is correct. Certainly the findings are correct. The question

is, is this a bias situation, do the patients themselves have a role

in not accepting treatment. That has to be studied. Are there problems on the side of patients who don’t accept treatments because

they don’t believe in treatment. That’s another issue that has to be

looked at.

But yet it is such an important issue, Mr. Chairman, that I believe that it requires further studies. And the studies should look

at, for example, not only are we doing the right research, which

has been brought up here, but have we paid attention to the point

that there is a disconnection, Mr. Chairman, between discovery and

delivery. The discovery system is working rather well. But I believe

that we don’t always apply across the entire population what we

discover. And this is a problem.

I believe we need to consider the training of a more diverse research and care giving force in our Nation. That would create more

sensitivity, because if the people who we train mirror the population, in whatever that may mean racially and ethnically, and in

every other way, there would be more of a chance that these kinds

of insensitivities, if they do occur, would not occur.

Also I think we have to tear down the economic and cultural barriers to early diagnosis and treatment. I also recognize the point

that there are geographic areas in America that can be defined economically and culturally which need very special attention. An example of that is described in a paper which I authored in 1990

which showed that males in Harlem have less of a chance of reaching age 65 than males in Bangladesh, which is a Third World country by that definition.

Let me end by saying that I think there’s a lot we can say positive. We have conducted a war against cancer that we’ve fought

rather well. But we have trouble now in translating the findings

to all people in a fair way, including racial differences. Cancer is

a broad societal problem as well as a scientific problem and that

must be considered.

Finally I think we must see cancer disparities not only as a scientific problem, but also a moral and ethical challenge to our Nation. Thank you very much.

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Mr. HORN. We thank you. You’ve made some useful suggestions.

As I listen to them, having spent about 40 years of my life in civil

rights matters, I find that a lot of those studies are very clear, and

we know what the problem is. Now we have to figure out a way

to get people into the hospital, into preventive care, all of that at

the same time. So I don’t know if we need too many studies, we

just need to do it, as Churchill’s greatest commence address was,

when he got up and looked at the students and he said, ‘‘Do it,’’ and he sat down.

And I think we all know what the do its are. You’ve made a very

good rounding out of that total situation, and you’re living it every

day. So we appreciate your presentation.

We will now go to questions. And we’ll go with majority, minority, 5 minutes to a side and the first will be the senior member

here of the Government Reform, the gentlewoman from Maryland,

Mrs. Morella.

Mrs. MORELLA. Thank you. Thank you, Mr. Chairman.

I want to thank you all for testifying. As I listened and tried to

digest the elements from your very moving testimony, I was reminded of a definition that Robert Frost once gave to a poem. He

said it begins in delight and it ends in wisdom. And at the end,

it tells me something I didn’t know I knew, because there were elements of what each of you have stated that should be common

sense, that some time we tend to not think about in the total context. And that’s of course what integrative technology and oncology

is really all about.

Your story was very moving, Mrs. Payton, and I guess one of the

elements I got from it was the fact that nobody ever told you about

integrative technology, and that we are not unilateral elements,

that we are a combination of elements. And in listening to your

wonderful comments, Dr. Achterberg, I realized even music, as well

as faith, and I’ve often thought that what every hospital, every

health care provider institution should have should be a humor

ward, I mean, truly where there is humor, where people can laugh.

Because I think if they can laugh, this is another element of a totality.

And Dr. Pettit, you had some very interesting comments with regard to every institute of NIH, which is in the district I represent,

should have some drug discovery facet of it with chemists. I would

be interested in at some point pursuing how you do that and what

does it mean, are you adding a whole extra element, could it not

be done right now with what they have and why aren’t they doing

something like that in some way. And Dr. Freeman, your concept

of the disconnect between discovery and delivery and the need for

studies.

So I think you’re all saying we need more research, we need

more studies, and we shouldn’t have blinders on in terms of what

the elements are beyond just trying to give somebody chemotherapy or whatever traditional mode of curative or medicine might

be, to not be so traditional, but remember those things we take for

granted.

OK. Out of each of your statements, if you could give me maybe

one sentence that you think is most important that you want to

make sure that this subcommittee, those of us who are here, of

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those who aren’t here who will be able to read the testimony, remember, what would it be? I could start with any one of you. Dr.

Pettit.

Dr. PETTIT. Representative Morella, I’ll try to be very brief in response to your question about chemists in the National Institutes

of Health and the National Cancer Institute. The National Cancer

Institute’s program, when it was set up for discovery and development of new anti-cancer drugs, and that was primarily in 1957,

that was the best program in the world. It was a model program,

it was serving as a model program for the rest of our country’s endeavors. That was because there were chemists there that were actually discovering the drugs. They were doing it both in the National Cancer Institute and in research contract type endeavors

that were supervised by chemists from the National Cancer Institute.

Unfortunately, it was that absolutely marvelous initiative that

began to undergo dismantling in 1975 to 1977 and again in 1981.

However, had it been preserved, again, we would not be losing

600,000 cancer patients this year.

Also in the other NIHs, they could use that model very effectively

for the other diseases that they are involved with, everything from

coronary diseases to mental illness. And the fact that we have in

our country, with our resources, not made better progress toward

the solution to these medical problems, I think you can point to

very accurately is a result of this lack of focused effort in the discovery of new drugs in the various institutes. Because when you

look at the personnel in the various institutes, you’ll find very few

chemists, I mean really few, you can count them on one hand, and

they are primarily involved in various administrative duties rather

than directing substantial and very productive programs to discover the new drugs necessary to patients with those particular afflictions.

So we know how to do it. But the focus and motivation has been

lacking and that has been primarily due to attacks from some segments in the private communities. Sorry about that long answer.

Mrs. MORELLA. If I could just ask the rest of you if there’s any

brief comment you’d like to make. And I appreciated that, Dr.

Pettit.

Ms. ACHTERBERG. Just a brief one. I would also like to reiterate

that it’s time to do it, that the research base for the mind/body

therapies, mind/body techniques is sound, it’s old, it’s phenomenal

and it’s really time for implementation.

Dr. FREEMAN. Congresswoman, I would like to say that since I

believe that the critical problem that produces the unequal burden

in cancer is the disconnect between what we know we should do

and what we actually do, the disconnect between discovery and delivery, I believe that we need to find ways to eliminate the barriers

that prevent the benefits of research from reaching all American

people, irrespective of who they are, economically and racially.

Mrs. MORELLA. Mrs. Payton.

Mrs. PAYTON. And my statement would be to ensure adequate research in the areas of complementary medicines and to provide coverage and assets to complementary therapies for all people. And

hopefully that will allow, no, I should say I know it would allow

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a family to function better, to work, to go to school, because I know

in my case, when my husband was lying there in the state that he

was in, it affected all of us. He might have been physically ill, but

it affects the whole family, it affects friends, it affects everybody

that is involved.

Mrs. MORELLA. I want to thank you all very much. I yield back,

Mr. Chairman.

Mr. HORN. I now yield 5 minutes to the gentleman from Maryland, Mr. Cummings, for questioning.

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

I too want to thank all of you for being here. As I’m sitting up

here, listening to you, and I think about all the people that suffer

from cancer.

It sounds like you’re saying that there are much better ways to

address this dreadful disease. But in this country, which can send

a man to the moon, and a country that is basically the world leader

in so many areas, is it that we just don’t get it? Or is it that there

are such forces going against traditional methods that we just don’t

do it? We don’t do the things that make sense?

As I’m listening to you, you sound like you’re making sense. But

I’m trying to figure out, when you think about something like cancer, and you think about something like death, it just seems as if

in this country, we would connect them. You talked about discovery

to delivery, Dr. Freeman. Dr. Pettit, you talked about having, you

use the word attack, and I couldn’t remember what you were saying, you said, Mrs. Morella asked you a question, and you said because of attacks from folks in the private sector, I think you said,

can you elaborate on that for us a little bit?

Dr. PETTIT. Thank you, Congressman Cummings. I certainly

would.

The problem in our system, in the NIHs and the National Cancer

Institute, is that primarily there are some forces coming from the

pharmaceutical companies and elsewhere and also in some scientific quarters, too, that are avidly against having new drugs discovered in our Government laboratories and in our university laboratories. And this of course is abominable, because we are all in

the same jeopardy from cancer and all of the other diseases. And

everybody in this country should be pulling on the same oar and

trying to get these problems solved, instead of some political agendas that prevent this from being done.

And as our great chairman has just indicated, with a statement

from Mr. Churchill, we need to do it. We need to be disciplined and

get it done. Because we have the resources, both financially and intellectually, to solve these problems. And at the state-of-the-art in

various scientific disciplines, now in the year 2000, there is no reason why we can’t solve these problems relatively rapidly, if we marshall the forces.

But again, having the correct leadership. We have lacked the correct leadership terribly in these various medical areas.

Mr. CUMMINGS. When you heard the story of Mrs. Payton, when

you heard her story, about how her husband was in this vegetative

state and then basically came back to life for 21⁄2 months, have you

heard those kinds of stories before? Have you seen examples of

that?

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Dr. PETTIT. Representative Cummings, I have. In fact, I’m in the

difficult position of being a director of a cancer research institute

where we do not treat patients, because we’re focused entirely on

the discovery of new anti-cancer drugs. However, daily I have discussions with cancer patients who wish to talk about the possibility

of new drugs coming, and of course their own personal involvement, or with family members. And it’s enough to tear your heart

out every day.

But you do see that with the anti-cancer drugs that are available

and the treatments that are available today, that depending on the

type of cancer, you can get curative results, at least a certain percentage with certain types of human cancer. But there is nothing

that will do it 100 percent. And this is why we desperately need

the new drugs, to save patients.

Also, you will find too that 1 cancer patient in 1,400 will have

a spontaneous remission. No matter what you do, that patient will

get well by his or her own. And of course, that confuses many

issues, too.

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

Mr. HORN. Thank you. I’m going to ask a few questions on my

5 minutes, and then will yield to Ms. Schakowsky.

Dr. Pettit, I’m curious. What drugs have been developed from

your various discoveries? What drugs, just to get it in the record

here, have been developed from your discoveries?

Dr. PETTIT. Thank you, Chairman Horn.

For example, bryostatin 1, was a lead that we started on 32

years ago, in 1968, from a marine bryozoan. And fortunately, in

1993, the National Cancer Institute decided to proceed ahead with

it in its clinical trials programs. Incidentally, the U.S. National

Cancer Institute’s clinical trials programs are second to none in the

world. They are absolutely excellent. The oncologists that work in

the CTEP division are routinely excellent.

That drug is either in trials accruing patients, or with trials that

are already closed, there have been some 90 human cancer trials

either initiated or completed. And the current trials that are involving combination drug therapy are giving excellent results. And

that’s just one example.

Another example might be our combretastatin A4 pro-drug. That

was a drug that we discovered in a tree, used primarily by the

Zulus in southern Africa, with a long history of primitive medical

use. And we found that drug is one that turns out to be a powerful

cancer anti-angiogenesis drug. It will actually go right to the metastatic tumor, and cutoff the blood supply, so within a few hours, I

might add too, this is just finishing the first four human cancer

clinical trials, and what the oncologists are finding is that this drug

will generally cause pain in the tumor about 2 hours after the injection of the drug. And that’s because the blood is being cutoff to

that metastatic tumor.

And within 24 hours, there’s a 100 percent cutoff of the blood to

the tumor. There have been several patients, just among the first

few, that have now been saved with that drug. And we’re hoping

as the clinical trials expand, and that’s certainly in combination

with other drugs that might remove the last of the viable cancer

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cells around the peripheral aspects of the tumor, that it’s going to

be a very successful treatment.

But these are only two examples, one from a plant, one from a

marine animal. That gives you some good feeling, not only good

feeling, but every expectation that if we could concentrate in this

area and certainly have our national effort focused far more strongly than the half dozen chemists in the National Cancer Institute

directed by, superbly, the NCI superstar, Dr. Michael Boyd, and

that if that program could be expanded, we would have all sorts

of drugs of this sort being discovered and developed.

And of course, it’s a tragedy, a travesty for our country that we

are in that position.

And also, some of these new drugs are exactly what we need, for

example, for bettering the treatment in our Afro-American population, which has, for example, a higher incidence of prostate cancer. And we need drugs like the one I was just talking about that

will go to those tumors, cutoff the blood supply and put that patient on the road to complete recovery.

Mr. HORN. Let me ask all of you, and particularly Dr. Freeman,

this next question. We’ve been looking at the role of complementary

and alternative medicine now for several months in our health care

system, and in particular in relation to cancer. Are there differences in access to these treatments for these types of therapies?

Dr. FREEMAN. In my own experience, I don’t have much experience with alternative treatments. Complementary treatments I

know more about.

I think that there’s a need to open up our ability to test these

drugs that are brought up as complementary and alternative, and

bring the same scientific analysis to those drugs that we bring to

drugs coming up in the routine way. I believe that there’s little debate now in the medical world about a complementary treatment,

in other words, going along with the so-called traditional treatment, and adding a complementary treatment that doesn’t have an

untoward effect.

The question is, how much more resources we should put toward

providing complementary treatments. And I believe we should put

resources toward proving the so-called alternative treatments

which displace the traditional treatment. That needs a lot more effort.

Mr. HORN. Any other thoughts on that by any of you? Yes, Dr.

Pettit.

Dr. PETTIT. Mr. Chairman, in 1973, I had the experience of being

sent to the People’s Republic of China by the U.S. National Academy of Sciences and the National Cancer Institute. That was the

first scientific medical delegation, and the intention was to explore

medicine in the People’s Republic of China. I had a very interesting

experience in about 60 different hospitals and research institutes

and what was left of the universities at that time, and found that

the Chinese were doing exactly as some of my colleagues here have

suggested. They were combining, in fact, Dr. Freeman just made

this suggestion, the combination of alternative treatments, of

course, with the sharply focused, for example, anti-cancer drug

treatments.

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That was exactly what was going on in China. The mission there

was to use the traditional medical treatments of China, where they

have roughly 5,000 plant materials that have been found to have

use against various types of medical problems in China. And in the

case of cancer, to use some of those therapies in connection with

the drugs that at that time had been discovered in our U.S. National Cancer Institute’s programs, to improve the patient’s immune system, to reduce toxicity, and in fact, in general, to reduce

nausea, and in general make the life of the patient far more manageable.

And I’m convinced, as I was then and today, that there is an excellent place for alternative therapies in the treatment of cancer

patients. But fundamentally, you must have the drugs that we

know will give curative results.

Mr. HORN. Any other comments? Dr. Achterberg.

Ms. ACHTERBERG. I just would like to make three observations,

brief observations, based on the history of cancer and medicine as

I know it. And that’s that nothing cures everybody. Nothing. And

that everything cures somebody. And that’s a fact. Everything

cures somebody, and that nothing works forever. That’s another

fact. I think if we take that kind of a dogma, which I believe it is,

into consideration, we have to acknowledge the versatility of the

human condition and the need to be versatile in our

conceptualization of what medicine might be for the treatment of

cancer.

Mr. HORN. That’s well put. Mrs. Payton.

Mrs. PAYTON. Well, I would just like to say that it saddens me

to know that today that still we have to worry about things like

all Americans, regardless of race, not being treated equally, with

any types of medical care. And hopefully through this fund, we will

use it as a platform to address those issues. And I just think everybody should be treated the same.

And it happens, because my husband, like I said, was fortunate

to have good insurance. But there are times, too, that we walked

into hospitals, and if he was not recognizable right away, he was

treated differently. And things like that really bothered him, too.

And that even today, we are still being faced with those types of

issues. So I’m glad those issues are being brought up today and

hopefully will be taken care of in the future.

Mr. HORN. Well, you’re right. I think almost every family in the

Nation sometimes, when you look at the bill, they always have that

old gag that they put you in a wheel chair to wheel you out, and

that’s because you see the bill on the way out. [Laughter.]

I will now yield 5 minutes to the gentlewoman from Illinois, Ms.

Schakowsky.

Ms. SCHAKOWSKY. Thank you, Mr. Chairman.

First, I want to say to Mrs. Payton that, and to all of you, that

I apologize for not being here for your testimony. I have read some

of it. But Mrs. Payton, I’m from Chicago and represent a district

in Chicago where your husband, for so many wonderful years, was

our hero in the way that he played, but also in the way that he

lived, and finally in the way that he died as well.

And I know that while your pain is incomparable to anyone

else’s, that Chicagoans are also grieving for him. And I want to

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thank you for taking your pain and your grief and your knowledge

now and using it as an opportunity to save lives. So thank you very

much for all that you do, being here today, but everything else as

well. We really appreciate it.

I wanted to tell you a personal experience of mine. My father

lived with me for the last 6 years of his life. He had prostate cancer, and was pretty healthy until about the last few months. And

then at the end had hospice care. It wasn’t until he had hospice

care that there was a whole new attitude. Now that all hope was

gone, there was this emphasis on comfort, on his emotional as well

as his physical well-being.

Suddenly, quite frankly, there were all kinds of different options

available to him, and a new level of caring and concern. And it

seemed to me, in retrospect, at the time we were just grateful for

that, that why is that? It’s not until hope is gone, there is no longer

a chance of life being greatly extended. And I read in your testimony, Mrs. Payton, that it seems in a way that that was true and

you had to fight for it, to make sure that pain was really well controlled and appropriate.

I just wondered if any one of you had thoughts on that, and

maybe all of your testimony already referred to that. I apologize if

it has already. It seems like there’s a disconnect here that we’re

not treating the whole person until that person is about to die.

Dr. FREEMAN. In my experience as a teacher in a hospital and

residency program, I’m always concerned about this point. I think

in general in America, my opinion is that our technology has outstripped our humanity. You get into a technical setting, and the CT

scans and MRIs. Sometimes my residents are paying more attention to the tests than they are to the patient.

I think somehow we have to reinject the humanitarian part into

the people, the doctors and others who are treating people for cure,

or at the point even where treatment fails. And to get a balance

between the wonderful technological advances that we all are

proud of, but at the same time, I think there’s been a diminishment

about the human concerns. And that needs to be fixed.

Mrs. PAYTON. I just feel this is probably where educating people

as to other alternatives. Because if you don’t know any better, then

you won’t do better. And I think in our case that was it. You sort

of do what your doctors tell you, and you followed their lead. And

like I said, thank goodness for some lady who was an angel in my

life, and saw fit to come to me and give me another alternative. I

think educating people that they do have other choices and that

they can feel comfortable with these other choices is what we need

to do.

Ms. SCHAKOWSKY. And that’s a good segue. I wonder, Mr. Chairman, if I could have included in the record an article that was in

the Wall Street Journal on June 6th, ‘‘Cyberspace is Spurring Demand for a New Leukemia Treatment.’’

Mr. HORN. Without objection, it will be put in the record at this

point.

[The information referred to follows:]

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Ms. SCHAKOWSKY. Thank you.

I wanted to direct a comment about that, in the brief time I

have, to Dr. Freeman. It talks about how a clinical trial with a new

drug for a certain kind of leukemia became communicated over the

internet and suddenly there was this great demand by the growing

number of patients who are trying to take care into their own

hands. But I wanted to raise this issue, does this not make the digital divide, that is the problem that you’ve raised in your work of

the disparity between perhaps low income people, so if they don’t

have access to the internet, they may not even know about this, or

other treatments that may be available.

Dr. FREEMAN. Congresswoman, you’ve touched on a very critical

issue. The problem is that the more advances we make, technological and computer and things like the example you mentioned,

the wider the disparity becomes between those who don’t have resources and those who do. And so there’s a catch–22. We clearly

want to advance, and we will advance, and we’re going to keep putting money into research. We need to do that.

But we have to be aware of the point that when we do that, we

widen the gap between the people who are poor and uneducated

and not include into the mainstream of the American society. So

it’s an issue that becomes a deep moral and ethical issue for U.S.

policymakers and for the Nation as a whole.

Ms. SCHAKOWSKY. Thank you, Mr. Chairman.

Mr. HORN. Quite welcome. Good line of questioning.

I’m going to ask a few more on the subject of the alternatives.

And Dr. Achterberg, I’d like to know, how important is music and

visualization to healing in your judgment?

Ms. ACHTERBERG. I think what they represent is essential to

healing. Not everyone will like music and not everyone wants to do

visualization. But it’s the idea that they tap deeper into our humanity than the pills and potions that are being administered.

So rather than focus on those two things, I’d like to broaden it

to the whole base that they represent, which is the creative, expressive arts, for example, ways of self-care. It is absolutely true

that what we believe and our thoughts affect our bodies. And anything that influences a sense of hope, a sense of peace, a sense of

well-being, a sense of trust, is bound to be healing. Not just in the

sense of healing your mind or healing your psyche, but healing

your body.

Mr. HORN. I happen to agree with you, having once wanted to

be a music major. And Louise Slaughter from New York and I are

the co-chairs of the Arts Caucus. We’ve been trying to educate

them on just what you’re trying to talk about.

Ms. ACHTERBERG. Arts are healing.

Mr. HORN. You’re right.

Where can individuals find good information on the mind/body

techniques to use when facing cancer?

Ms. ACHTERBERG. I think a place to start is the report that I

mentioned that was created for the National Institute of Health.

Mr. HORN. Is that still in print?

Ms. ACHTERBERG. I assume it’s still in print—is it, Beth? It is

truly the state-of-the-art as of 1994, anyway, and there haven’t

been that many developments since that period of time. So I would

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recommend that they start there. It was written with great integrity for this purpose.

Mr. HORN. I’ve found Norman Cousins books are also very helpful.

Could you explain some of the alternative approaches to pain

management?

Ms. ACHTERBERG. Pain is a confusing phenomena, because we’re

not ever sure how much pain is really depression, and for cancer,

especially, how much pain is really, stems from anxiety. So many

of the alternative techniques which are attempting or based to

stem factors of anxiety would be recommended for cancer pain.

Interestingly enough, cancer pain has not been given the attention that it should have been over the years. When I first started

this work in 1973, there wasn’t a single pain protocol for a child

with cancer. I think we made the assumptions, or the assumptions

were made that children with cancer don’t feel pain. That’s improved somewhat but not a lot in recent years.

Mr. HORN. Yesterday we had a doctor from the Health Care Financing Administration on one of our panels. And he testified

about Medicare’s coverage of complementary and alternative therapies for cancer patients. Do you think that treatments such as acupuncture, massage therapy, music therapy, we could add art therapy, a whole series of them, should be reimbursed by Medicare?

Ms. ACHTERBERG. To some extent. But we need to go back and

take a look at the data base for all of those therapies. For example,

acupuncture has been shown effective for pain. But not for a lot of

other conditions associated with cancer. Yes, they should be reimbursed provided they can come forth with research, a data base.

Mr. HORN. Anybody else want to get in on that? Dr. Freeman?

Dr. FREEMAN. I agree that you need a scientific base of proof before Medicare will pay for something.

Mr. HORN. Dr. Pettit, any thoughts on that?

Dr. PETTIT. I’d like to add that as part of the experience in 1973,

I had tremendous exposure to acupuncture in some of the large

hospitals in China. And it was pretty clear that for pain management, it can be very, very effective. In fact, I watched numbers of

different types of pretty severe surgeries being conducted under

acupuncture anaesthesia.

I’d also like to add that, as a general thought, that three quarters of the world’s population now are treated with traditional medical materials, materials from plants and animals. That’s only

about, again, a quarter of our world’s population, normally here in

the western world, that are treated with the drugs that we normally know.

And it tells us that there’s a vast treasure house of substances

that we could find in these various natural materials on our planet

that could very well solve essentially all of the medical problems

that we’re confronted with.

Mr. Chairman, I’m sorry, I need to add one other thought. In the

United States today, probably 30 percent or more of all prescriptions written are for plant and animal products. And the other

drugs that we use, if you trace back, when you’re thinking as an

organic chemist, you’ll find that all of those leads pretty much all

go back to naturally occurring substances.

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And also these substances that you find in nature have chemical

structures that we organic chemists would have never thought of.

And as a result, they’re just absolutely superb for the ever-increasingly more effective design of new drugs.

Mr. HORN. I remember when I was a little boy of 7 or so, and

I’d put my hands and pulled up some poison ivy in the east, poison

oak in the west. And my father, being a chemist, said, well, go look

and see what plants are around that. And sure enough, there was

a plant you could put in, boil, take all the itching out of it. So a

few things are in nature.

Now, is there anything any of you would like to say before we

ask the next panel to come up? Mrs. Payton. Anything you want

to add that we haven’t asked?

Mrs. PAYTON. No, when you were talking about alternative medicines and being picked up, I was just going to say, from a personal

side, the treatments that Walter had, he didn’t have acupuncture,

but he did have a naturopath who did real deep tissue massage

therapies on him. And the nutrition and the relaxation techniques

and some of those therapies he used, and they did make significant

difference.

I think if it’s proven that these things work, then I would hope

that they would be looked at and covered by some insurance.

Mr. HORN. Well, I think you’re right about that. And we started

prodding the gentleman yesterday.

Dr. FREEMAN. Mr. Chairman, I think that I’d like to end with

one thought. I think we know how to fight a war in this country.

We have a military that understands how to fight war. And what

I’ve noticed that they do is they create these weapons of destruction, and then when a war occurs, they use them against where the

enemy is invading the most.

I think there’s something to be learned from that philosophy. We

develop weapons in research, in cancer, but we don’t use them

where the enemy is invading the most. And there’s something to

be learned by that.

Mr. HORN. Well, I think you’re right. Some of this is a management situation where there has to be a goal set, whether it be

President Kennedy saying we go to the moon, or all sorts of things,

we’ve had a makeover with the nuclear navy, they achieved great

things. And we need to do the same in this field, obviously.

Yes, Dr. Pettit.

Dr. PETTIT. Mr. Chairman, I’d like to followup on those thoughts.

It’s exactly what the cancer problem needs, and it’s sort of all the

other terrible problems that we have that kill people. And we’ve

had good experience in our Nation, for example, with the Manhattan Project that helped to end the second World War. As you just

indicated, we had another strike force approach with NASA to put

a person on the moon.

And this is what we’ve been missing in the cancer problem. And

that’s what we need, to have a strike force. And the only way

you’re going to do this is to have several hundreds or several thousands of chemists, organic chemists, discovering the drugs, to solve

the cancer problem. And that can best be done through our U.S.

National Cancer Institute. But it would have to be reorganized

along the lines that I’ve been urging.

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And the same applies to our NIHs.

Mr. HORN. Well, I want to definitely pursue some of that, since

we are a subcommittee dealing with that organization. But obviously, we’ve got to get them to come along and not just fight everything, or maybe set up two NIHs or something.

Does the gentleman from Maryland have any more questions

he’d like to ask?

Mr. CUMMINGS. Just very briefly, Mr. Chairman.

Mr. Chairman, and to our panel, I want to thank you for being

here. We’ve heard from Dr. Harold Freeman of North General Hospital, and I thank you, Dr. Freeman, for being here. And I think

I had something to do with having you here. And the reason why

I wanted you to be here was because according to the American

Cancer Society’s publication, and I’ll be brief, Mr. Chairman, cancer

facts and figures for African Americans, African Americans are

more likely to develop cancer than persons of any other racial and

ethnic group. For a number of years, it has been assumed that

health disparities were due to social and economic differences.

But as reported in the Journal of the National Cancer Institute,

a study conducted at the University of Pittsburgh suggested that

differences in diagnosis and treatment accounted for a higher number of some cancer cases. I certainly appreciate the invitation extended to Dr. Freeman to speak about racial disparities in cancer

treatments. But I feel the issue merits a separate hearing.

As such, the minority members of the committee have joined in

a letter to request such a hearing, Mr. Chairman. I’ll submit that

to you at this time. Thank you very much.

Mr. HORN. Well, thank you. Does the gentlewoman from Illinois

have anything else?

Is that for the record?

Mr. CUMMINGS. It’s for the record, Mr. Chairman.

Mr. HORN. OK. We thank you very much. We know we’ve taken

a lot of your time, but I think a lot of good ideas came out of this,

and that’s why we have the hearing process. We learn a lot. Hopefully some of you might have learned from the iteration of your colleagues.

We’re now going to move to the last panel, panel five. Mr. Dan

Nixon of the American Health Foundation, Mr. Giancarlo Pizza

from Italy, Mr. Burton Goldberg from Tiburon, CA.

Gentlemen, the tradition of the Government Reform is we have

the oath administered to all of the witnesses and any of their life

supports, as we say nowadays, I guess.

[Witnesses sworn.]

Mr. HORN. The clerk will note the witnesses have affirmed the

oath. And we will go in the order on the panel five, on the agenda.

So Dr. Dan Nixon of the American Health Foundation will be first.

Please proceed. And automatically, your written statements are in

the record. We’d like a summary, really.

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STATEMENTS OF DR. DANIEL WALKER NIXON, M.D., PRESIDENT, AMERICAN HEALTH FOUNDATION; ALICE AND HAYNE

FOLK PROFESSOR OF EXPERIMENTAL ONCOLOGY, MEDICAL

UNIVERSITY OF SOUTH CAROLINA; DR. GIANCARLO PIZZA,

ITALY; AND BURTON GOLDBERG, TIBURON, CA

Dr. NIXON. Well, I am Dr. Dan Nixon, president of the American

Health Foundation, which is a National Cancer Institute funded

cancer prevention center. It’s in Valhalla, NY and in Manhattan,

with affiliates throughout the United States.

I’m honored to accept this invitation, and I want to first explain

what the American Health Foundation is all about and hopefully

to broaden the focus of the discussion today into a consideration of

the 70 percent of cancers that are preventable in this country

today. That means about 300,000 lives that we lose that we don’t

have to lose.

American Health Foundation is a translational research organization, taking prevention research from the lab to the clinic to the

community. We have about 60 senior scientists and 130,000 square

feet of labs. We are vigorously pursuing the ways to prevent malignant disease. This includes integrative medicine. We’re looking at

nutrition, phytochemicals, nutrients, tobacco carcinogenesis prevention, and how to put all that into the clinic.

Specifically, we’re looking at, and I appeal to the committee to

support this kind of research, the effects of phytochemicals in lung

cancer prevention, and colon cancer and breast cancer. We have a

number of preventive chemicals, several thousand actually exist in

fruits and grains. We are focusing specifically on phytochemicals in

teas, anti-neoplastic effects of certain chemicals in berries, such as

raspberries, strawberries, blackberries and mulberries. And certain

synthetic chemicals, along with some organic materials like selenium. We have very good data that these chemicals will kill cancer

cells in the lab.

We’re now moving these into clinical trials. And we also have evidence that a high fat diet is very effective as a cancer promoter,

even in lung cancer. My predecessor, Dr. Ernst Wynder, was very

perceptive in figuring out that a high fat diet might promote the

development of cancer of the lungs, so we have clinical trials in this

area as well.

So how do we really put this together so that it’s a translational,

real prevention process? And you have to think about this not so

much as prevention in the traditional sense, it’s really almost

treatment before the tumor develops. We know that for example

prostate cancer takes about 30 years to develop, so that before the

tumor is there, you’ve still got a malignant process going on. And

this is what we’re targeting, those cells that have gone down the

road toward malignancy, but haven’t actually started to invade and

spread.

I’ll give you three examples of what we’re doing. We have a grant

from the National Cancer Institute that’s looking at molecular epidemiology. Why do some patients get cancer and why do some patients not get cancer, even though they’re exposed to the same carcinogens? Very interesting question. One out of eight women get

breast cancer. Seven women don’t get breast cancer. Why is that?

Could we identify that one and focus on that one and leave the

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other seven alone throughout their lives, for example, no mammograms or anything would be necessary.

The second item I want to mention to you is the WINS project,

the Women’s Intervention and Nutrition Study. We have the largest breast cancer recurrence prevention trial currently in the world.

We’ve got over 40 hospitals around the country entering patients

into this trial. It’s a trial to determine if decreasing fat in the diet

will prevent recurrence of breast cancer. We now have almost 2,300

patients in this trial, and should finish accrual at the end of this

year.

To put all this together and to try to address some of the disparities that Dr. Freeman and others have mentioned, we are now establishing an informatics system so that we can link our laboratories with clinics in the low country of South Carolina, the Beaufort Jasper Comprehensive Health Care Agency, and clinics in the

inner city of Harlem and other inner city areas, so that we can

reach those who are at disproportionate risk of cancer with our

chemo preventive clinical trials.

And the final item I want to mention to you is our new clinical

trial that we are about to start with certain chemicals from berries

in lung cancer. We know that some of the anticyanidins from berries, this is a natural product area, do affect malignant cells in the

clinics. So now we’re going to look at the people who have stopped

smoking, who are still at cancer risk, or who have continued to

smoke, give them a various variety of berry extracts, which will be

produced by a group of botanists in Canada, and use certain intermediate markers of oxidative damage and stress to see if we can

stop the malignant process before it becomes a tumor.

So in summary, we’ve got to concentrate on cancer prevention research as well as cancer treatment research. I’m a cancer treater

by trade, so I’m now convinced that we must do this cancer prevention research as well. Cancer prevention and intervention, chemo

prevention, nutritional strategies, when proven, are especially appropriate for integrative medicine approaches and cancer control.

To give the one sentence summary that Mrs. Morella asked for earlier, we can save 300,000 lives in this country every year by prevention, so let’s do it.

Thank you very much, Mr. Chairman.

[The prepared statement of Dr. Nixon follows:]

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Mr. HORN. Thank you very much.

Dr. Pizza.

Dr. PIZZA. Mr. Chairman, I am very pleased to be before you to

report on my experiences as medical doctor in Italy, particularly as

it relates to the treatment of cancer. I operate in a 2,000 bed hospital in Bologna, Italy. My treatments for cancer are paid for by

our national government health insurance and are very different

from those generally administered in the United States. They are

essentially non-toxic and include treatment with transfer factor,

interleukin 2, human monoclonal antibodies and other medications.

Specific transfer factor is the treatment which Congressman Bedell

believes cured his Lyme disease.

I believe I can document for several kinds of cancer that this

non-toxic treatment is significantly more effective than current

treatments being administered in your country. For example, I

have done a study of 122 metastatic renal cell cancer patients

treated with my non-toxic protocol in which I have documented a

survival of over 11 years by 25 percent of the patients. I am informed that an 11 year survival from such cancers with conventional treatment is less than 10 percent.

I believe that the patients with other types of cancer also treated

with my non-toxic treatments could show significant longer survival than patients only conventionally treated.

Except for renal cell cancer, metastatic, my treatment consists of

one injection per month. For an American coming to Italy to be

treated by me for such cancers, our charges would be about $20 per

month. This is partly subsidized by our government. Without such

subsidy, I estimate the cost would still be less than $200 per month

for treatment.

In summary, I believe that I am an example of an Italian medical doctor where I am administering treatments that are, first, generally more effective for the cancers I treat than are conventional

treatments for such cancers, with documented increased survival in

studies I have done. Second, these treatments are essentially nontoxic. Third, the treatment costs significantly less than conventional cancer treatment. Fourth, these treatments are not administered in the United States because of your laws and regulations,

and I believe it would be to the benefit of American cancer patients

if such treatments could be permitted in your country.

Thank you.

[The prepared statement of Dr. Pizza follows:]

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Mr. HORN. Thank you very much.

Dr. Goldberg, Tiburon, CA. Beautiful part of the world, I know.

What are you doing here this afternoon?

Dr. GOLDBERG. I came here to make a difference.

Mr. HORN. Great.

Mr. GOLDBERG. Cancer is epidemic. The American Cancer Society

now says every other man in America will have cancer in his life.

Breast cancer is one in eight. In Marin County, where I live, in

Paradise, it’s one in six. In Long Island, it’s one in seven, breast

cancer of the female.

In 1960, that number was 1 in 14. In 1950, that number was 1

in 20. And in 1900, 1 in 33 Americans, men, women or children,

had cancer of any kind, shape or form. So you see the escalation,

and we know the escalation, we know what’s causing cancer.

When I was born in 1926, and through the 1930’s, cancer was

the 10th cause of death in children. Today it’s the second, behind

accidents, both. The holistic, alternative, complementary, there’s all

kinds of names out there, but they all mean the same thing, getting out of the paradigm of conventional treatment, which is surgery, radiation, and chemotherapy, the object and the paradigm is

to treat the person rather than the disease.

You and I could be diagnosed with the identical cancer, yet the

causes are totally different. The mind/body plays a role. You have

a bad marriage, it could be 90 percent of it, the emotions which affect the immune system. But the main cause, and when you ask

conventional oncologists what caused cancer, they say, well, sun

and smoking and we don’t know. And yet their medical journals

are full of the research.

And let me give you an example. Israel, 1973, they discover the

relationship between female breast cancer and pesticides and herbicides. They then do a 10-year study, and the citizens are

outcrying and the government forbids the use of pesticides and herbicides in only two things, the feed of milk cows and cattle. And

there was a 10-year study, 1976 to 1986. And here are the results.

Women under 40, the female breast cancer rate plummeted 34 percent. Now, this is in medical journals that is accessed to everyone

else. I’m a medical journalist and I know it. For all women for

those 10 years, it dropped 8 percent, while we in the United States

went up 4 percent for those 10 years.

The causes are pesticides and herbicides. They did the same

thing in the Connecticut General Hospital where they took two tumors and they did what the call a split biopsy. Half went to pathology, it was cancerous, the other half went to toxicology. Inside the

tumor in the one that was benign and one was cancerous, they

found through toxicology, DDT, DDE and PCBs. The same thing is

in prostate cancer, because the breast and the prostate are both

fatty tissue and they suck up like a blotter, these toxins.

And in the prostate, they find when they do digital examination

that the hard part, the BPH, is next to the colon. So it seems to

transfer the poisons. Because when they split biopsies, they find arsenic, chlordane and DDT. Why aren’t conventional doctors talking

about it? We must go to the causes. We must get the poisons out

of our food supply, whether it’s the Agriculture Department.

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But this is not being talked about. You’ve got to first go to the

cause to stop this holocaust.

Alternative medicine paradigm and treatment is 180 degrees different than conventional medicine. You first have to find out what

the insults to your immune system are. You can transfer all kinds

of organs, but you can’t transfer the immune system. And the immune system is how the holistic physicians treat it. First, you have

to get food that has nutrition and lots of our food is produced by

factory techniques, where they throw chemicals at the crops. So the

corn looks beautiful, but what’s missing is one part per million the

selenium, molybdenum, chromium, the zinc, the nutrition that we

need to flourish on.

So it’s important to stop and put nutrition back in food. Organic

food is different.

Quite often you hear that fat causes cancer, high fat diets. And

it’s true, because it’s what’s inside the fat. When they produce beef

in this country, they feed them corn to fatten them up with pesticides and herbicides laden. They then put hormones into the animal so that the animal gets big and fat, so that they get more

weight. What happens to us when we consume that fat?

They use antibiotics to keep them alive in filthy conditions. That

goes for chickens as well. And these antibiotics come into our body

and they kill the flora, the good enzymes within our body. Antibiotics are a double edged sword. They’re marvelous. They saved

my life. But if you don’t take probiotic, acidopholus and

lactobacillus and a whole bunch of other things to reforestate, you

end up with acid alkaline imbalance and you end up with the parasites living within you and candida and yeast infections and the

breeding grounds for disease.

The early detection, now I’m going to say something that is absolutely going to blow you out, and that is, mammograms cause cancer. People can’t buy that. But we’ve studied it. We’ve looked at the

research of Dr. Goffman at Berkeley University who finds that 90

percent of all breast cancer is in part due to medical x-rays. Now,

let me give you an example. You go to the dentist to have your

teeth x-rayed. They put a lead sheet over your sexual organs and

then they run. Why are they running? Because it kills the DNA in

the cells.

Now there’s a reason for x-rays, you have to do surgery, you have

to do an x-ray. But there’s a safer way, and that’s thermography.

Thermal imaging where you can see cancer coming much earlier.

In the case of breast cancer, you can’t see it through a mammogram before it’s multiplied 25 to 30 times. By the time it’s multiplied 40 times, it’s lethal. And yet the simple, using thermal imaging, which is less expensive and can see disease coming 3 to 5

years earlier, with no radiation, far less false positives. And in

mammography, they squeeze the breast. And if there is a pustule

or something, it can go into the blood stream. Because cancer is

systemic, it travels through the blood. So if the knife comes in and

inadvertently hits some of the cancer, it travels through the blood

and metastasizes.

In early detection, we have the Darkfield microscope, which conventional medicine won’t take a look at. It reminds me of Galileo,

he said, gentlemen, look at the moon and the stars, look at my teleVerDate 11-MAY-2000 08:49 Jul 30, 2001 Jkt 000000 PO 00000 Frm 00332 Fmt 6601 Sfmt 6601 C:\DOCS\72932.TXT HGOVREF1 PsN: HGOVREF1
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scope. And they refused. It’s the same thing going on today with

the Darkfield microscope. With the prick of a finger on the slide,

you can see the aberrant blood. You can see disease coming as

much as with a competent physician, 5 to 10 years in advance.

Those are only a few of the techniques. We have electric dermal

screening, which uses a meridian system of the Chinese, which is

ignored by mainstream medicine. The basis of acupuncture, the

river of energy, charted by the French and Koreans, totally ignored

and not taught in medical schools unless they’re teaching acupuncture. And it affects the mouth. The nervous system and the meridian system and the teeth, teeth. One of my mentors, a Catholic

priest from Germany, finds that the dental implication can be as

much as 50 percent in the removal of cancer and the reversal of

cancer. And I’m here to tell you that if you don’t have chemotherapy and radiation, sometimes surgery is necessary and if it is,

the holistic physician encapsulizes the tumor by using enzymes and

nutritional substances that Dr. Pettit talked about.

I know of a cancer clinic in Tijuana that’s using his drug right

now. This is an over the counter anti-angiogenesis, and using it on

the young boy who testified yesterday, lovely Thomas Navarro, who

I visited down there, and he’s doing extremely well using the system. Whereas conventional medicine has really truly no cure.

But it’s a system. You go to the causes, you remove every single

insult to the immune system. Then you feed the body absorbable

nutrients, usually intravenously, orally. The diet is essential, because cancer loves sugar. No sugar.

Which brings up the subject of the National Cancer Institute. I’m

here to tell you that the General Accounting Office caught them,

and caught the smoking gun, where it proves that the National

Cancer Institute doesn’t want anything other than chemotherapy,

radiation and surgery. There is a drug called hydrazine sulfate that

could have helped Mrs. Payton’s husband. I don’t say it’s going to

cure, because it does have a small aspect of curing. But it helps

cachexia, the wasting away process.

This drug was said by Dean Burk, the head of cellular biology

of the National Cancer Institute many years ago, he said in his 35

years of experience, there’s not another drug like it. And yet

DeVita, who came much after him, said, we throw away better

drugs than this. And the study was scuttled, even after the General

Accounting Office did a study of 14 months. It was brought about

by Representatives Towns and Shays of Connecticut. They muddied

the report.

And let me give you an example of how this is done. The original

report that Barry Tice, a 28 year veteran of the General Accounting

Office, which is usually impeccable, the title that he put in here

was, the National Institute’s actions spur continued controversy

over hydrazine sulfate therapy. After politics, after this report was

sent to the National Cancer Institute, they came back and argued

with the political powers that be at the time, and then it was

changed. And here’s what the change was. Contrary to allegations,

the National Institute of Health studies on hydrazine sulfate were

not flawed.

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cent of the population got results, in some cases even remissions,

provided the proper dose was given. And when they did it at Sloan

Kettering and other areas in this country, there were higher doses.

And Dr. Gold, who developed this, said, I’m telling you, if you go

on the higher doses, it’s not going to work. As a matter of fact,

you’re going to get death.

And another proviso, no barbiturates, alcohol, sleeping pills,

tranquilizers and things along that line. If you do, it will negate

it. Every single person by the independent investigator used that

kind of product and negated the results. That’s a smoking gun you

can easily verify. It will show you why Dr. Pettit’s work is being

diminished, why you don’t have the chemists that he called for.

They don’t want to cure cancer. And this is the proof.

I believe in order to have the Office of Alternative Medicine function as it should, thanks to the great work of Berkeley Bedell, you

are spending now $2 billion, it’s now up to $3 billion a year on cancer. And where is it going? Nowhere. And the reason? They don’t

want to cure cancer.

The Office of Alternative Medicine must be managed by people

who understand alternative medicine. The whole system, there are

no magic bullets, there’s no essiac tea, there’s no one drug or one

vitamin. It’s a system that has to be understood.

And there are 50, in the books I gave you, the book on cancer

that I did, Alternative Medicine, Definitive Guide to Cancer, we

have 50 different therapies, many of which are used to help the patient.

I believe that the Office of Alternative Medicine must be pulled

from the National Institute of Health. Because I’ve been tracking

it since its inception. The attitude at the NIH is, how dare you tell

us that we’ve been hurting people all these years.

Billions of dollars, and we’re going nowhere. I think that’s it. God

bless.

[The prepared statement of Mr. Goldberg follows:]

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Mr. HORN. You stated it very eloquently.

The gentlelady from Illinois, for questioning.

Ms. SCHAKOWSKY. I wanted to ask Dr. Nixon a question.

In your written testimony, actually you referred a little bit more

even to the issue of smoking as a way of preventing many, many

thousands of death, and smoking in children. And you probably are

aware of the recent Supreme Court decision that struck down FDA

regulations that would have prevented tobacco companies from

marketing products to children. And it was not because they think

that they should be marketed to children, but basically turned,

passed the ball back to the Congress and said that the Congress

should act on this. And so far, Congress has failed to do so.

I wondered if you had any suggestions for us on what we might

do to make sure that we have done everything possible to prevent

children from beginning to smoke and thus creating the most preventable cause of disease that we have in this country.

Dr. NIXON. Yes, you are correct, the cause of cancer, the percentage of cancer attributed to cigarettes and tobacco use is about 35

percent of the total, and about 30 percent from nutrition. How do

you convince children not to do hazardous things? We have a pediatric task force, headed by one of the leaders in the Nation’s pediatric development research community addressing these issues

now. We have an affiliation with a group in New Orleans to look

at our Know Your Body program and to move that into a younger

age group, rather than the grades one through six, but at the preK and the K.

What we’re trying to address is the situation that we all see as

parents, that if you tell an adolescent not to do something, they’re

going to do it. Don’t drive fast, they go drive fast, don’t smoke, they

tend to smoke. So what we want to do is through the pediatric task

force and another task force on spirituality and health is try to

teach a philosophy of health to very young children, which would

include smoking cessation, proper dietary habits, drug avoidance,

all the good things of life and health promotion.

We haven’t been able to do it in the current KYB milieu of teaching, the age group that we’re looking at. So I again would call for

congressional attention toward teaching, learning how to teach

very young children, perhaps as young as the age of 2, not facts,

but philosophy, and how to maintain their health.

Ms. SCHAKOWSKY. Are you concerned at all that the financial interests of the tobacco companies may have some undue influence

in policymaking? In your view, is this an issue?

Dr. NIXON. I think it’s clear that the tobacco companies would

like to sell more cigarettes to whoever they can, overseas, young

people, any age group. Whether that influences congressional

thought, I would hesitate to say that.

Ms. SCHAKOWSKY. I don’t mean congressional, necessarily. We

find all kinds of races being sponsored by tobacco companies and

all kinds of institutions, private as well as public, where there’s a

close relationship between tobacco companies and there seems to be

a contradiction there.

Dr. NIXON. There’s clearly a contradiction there. The American

Health Foundation’s founders first linked tobacco and lung cancer,

so we go back at least 50 years in this area. And it’s focusing speVerDate 11-MAY-2000 08:49 Jul 30, 2001 Jkt 000000 PO 00000 Frm 00356 Fmt 6601 Sfmt 6601 C:\DOCS\72932.TXT HGOVREF1 PsN: HGOVREF1
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cifically on youth education as one of the things that Dr. Wynder

did for decades. And the KYB program is designed as a smoking

cessation program, and now we’re just trying to move it backward

into earlier ages.

The problem of what to do with tobacco companies’ influence is

immense. I don’t have any bright ideas there, I’m sorry.

Mr. HORN. The gentleman from South Carolina, Mr. Sanford, 5

minutes for questioning.

Mr. SANFORD. Yes, sir.

I would first of all say to Dr. Nixon, thank you very much for

coming up this way, or down this way, I’m not sure which direction

we’re coming from today. But as one who lives down in the low

country of South Carolina, I appreciate all that you’ve done to

make a difference in people’s lives back home.

I went to the University of Virginia for graduate school. And

there they believed in the Socratic method. So it struck me as Mr.

Goldberg was speaking that some of what he was saying was contrary to some of what you had said. It would help me if you all

would just bicker a little bit back and forth. In other words, would

you pick out three things that he said that didn’t make any sense,

and then if you would say why he’s wrong in suggesting that what

he’s suggesting you said didn’t make sense, and really does make

sense, just a little bit of back and forth would help me a whole lot

in trying to get to the bottom of the cancer thing.

And at the end, if you would just tack on as a personal supplement to me one, I notice that you’re not pasty white. And I thought

that, I grew up on a farm down in South Carolina, I love being outside. We’ve got four young boys, I’m constantly outside. But I never

grew up putting on sunscreen. My mother-in-law says, whatever

you do, don’t put on sunscreen, it actually causes cancer. So which

is the truth there?

And too, if you would give me sort of three personal pointers, Mr.

Goldberg, aside from hell no, I won’t go to the dentist, what would

be two other pointers in terms of things you’d suggest in terms of

personally avoiding cancer. But Dr. Nixon, if you’d lead off.

Dr. NIXON. Thank you very much. I do disagree with a number

of things that were said, and I think that would be pretty apparent.

Let’s talk first about pesticides. There is no doubt that pesticides

occur in human tissue. There is no doubt that pesticides, that exposure to pesticides 20 years ago can still lead to pesticide residues

in the breast.

The problem with the argument, and I’m not saying it’s a good

thing to have pesticides in your breast, maybe it’s related to the

asthma epidemic or something like that, but as far as cancer is

concerned, breast cancer rates increased in this country extraordinarily rapidly around the turn of the century and before, about

1870 and 1900. And in fact, the American Cancer Society was

founded on the recognition of a group of surgeons in New York that

there was an epidemic of breast cancer.

The pesticide argument fails here because there were not any

pesticides at that point in widespread use, and breast cancer rates

went like that. The last 50 years or so, they’ve been sort of wavering up and down a little bit at a very high level.

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So in the pesticide era, breast cancer has not changed a great

deal. So that would be my first point. Do you want to respond to

that, or do you want me to go with the other three?

Mr. SANFORD. Let me just throw one more zinger at them, because I m going to be tight on time with 5 minutes.

Mr. HORN. Don’t worry about the 5-minutes. I have a special rule

for South Carolinians. [Laughter.]

Dr. NIXON. We’re neighbors on Sullivans Island.

The other big thing I take strong exception to is the contention

that the National Cancer Institute does not want to cure cancer.

I take absolute violent almost exception to that. I’ve worked at the

NCI, I’ve been in the cancer field for now 30 years. Never seen anybody in cancer research or cancer treatment that didn’t hate the

disease and want to get rid of it in any way that they can. There

is not a conspiracy against, to promote cancer. It’s just not there.

I’m sorry, but it’s not.

Mr. BURTON. Well, I don’t believe you have read the report of the

General Accounting Office and the article, and I’d like you to have

a copy of my testimony where I lay it forth. The report absolutely

shows this. As a matter of fact, Barry Tice, the man who did the

report, this 28 year old veteran, Barry Tice strongly objected to

having his 14 months of work distorted.

This is a quote from Barry Tice. He’s now retired, living in Maryland, and I spoke to him the other day. You can imagine how upset

I was, and still am, about the title, he told Mr. Kamen in a subsequent interview. The impact of the changes and a few key deletions

was tremendous. Those changes took NCI almost completely off the

hook. This is Mr. Tice of the General Accounting Office, and you

know what kind of a reputation they have. There’s politics.

As far as pesticides are concerned, I give you numbers that I get

from medical journals. The New England Journal of Medicine had

an article on, one of the gentlemen said, we’ve lost this war on cancer. We’ve got to do so many other things. But the numbers are

this. Breast cancer in 1950 was 1 in 20 women. Pesticides started

coming in 1950, big time. In 1960, it was 1 in 14 would have breast

cancer. In other words, it was 1 in 20, and today, in other words,

it comes down, the lower the number, the more women have it

today. One in eight American women have breast cancer. This is

in the world of pesticides, the wonderful world of chemistry.

Now, how do I know this? Because when you look at the research

at Connecticut General Hospital on split biopsies and toxicology,

you don’t hear this. They don’t talk about this, because this flies

in the face of the food industry, the chemical industry, the pharmaceutical industry, the medical industry and everybody else whose

economic, petroleum industry where a lot of these things come

from, it’s in their interest. And you don’t hear it in the media, because they’re the recipients of the ads. How many ads have you

seen for drugs now, going directly to the patient? And then with

the side effects of the drug, your left ear will turn yellow and fall

off, your nose will this, you’ll have a headache, you’ll vomit and so

forth and so on.

Drugs today are the third cause of death in our society. First is

heart disease, cancer and then drugs. Used to be fourth behind

strokes.

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The sun, melanoma usually occurs where the sun doesn’t shine.

It is important, most of our doctors will agree that the sunshine,

getting vitamin D3 on the pineal gland and on the face, not too

much sun, certainly you don’t want to injure the skin, so that’s why

you put the stuff on. But the sun God provided to nourish us. Our

eyes get the light of the sun and it affects us. So many people living in Wisconsin, so far away from South Carolina, have the SADD

disease, because there’s not enough sun and they go into depression and so forth.

The dentist, silver fillings are 50 percent mercury. If your kid

broke a thermometer in the mouth, you’d go crazy. You would put

him in a hospital. The American Dental Association says it doesn’t

leach. But if you put a device in that measures the vapors, you will

see that it’s wrong. It does leach. And it goes into the ganglia and

all through the bodies.

And one of the techniques of detoxification, which is the word

you will hear for this century, your liver is the filter of the body.

And if it gets clogged and dirty, it can no longer filter, it’s like a

barrel you put the poisons in, one thing on top of the other. When

it overflows, that’s when we end up with degenerative disease, including cancer.

And mercury goes into the ganglia. In the case of breast cancer,

the blood supply and the lymph system, which is not paid attention

to at all by conventional medicine, which is the seat of your immune system, lymphocytes in the small intestine, control and help

your immune system. And if you don’t open up that lymph system

and allow the garbage to come out of the body, as a matter of fact,

in chemotherapy—— Mr. SANFORD. Could I interrupt on that point? Dr. Nixon, I’d be

curious to hear your thoughts on that. I had a friend that actually

went to Switzerland and had the traditional fillings taken out of

his teeth to put in some kind of plastic or whatever. But then I

talked to another friend who’s a doctor who actually said the data

is bad on that, taking out the fillings really doesn’t make any difference. Do you agree or disagree?

Dr. NIXON. I disagree that the tooth filling has anything to do

with malignant disease, the tooth filling composition, the amalgams that dentists use. There is certainly mercury toxicity, there’s

a Japanese disease that is a central nervous system disorder from

excessive mercury. There’s no doubt that mercury is toxic. But the

link between teeth, fillings of teeth and cancer is in my opinion

very, very weak and tenuous.

Mr. GOLDBERG. I would like to balance that out with, the Coors

Beer people had a daughter-in-law and she was not doing well, out

in Colorado. So they sent her to Hal Huggins, a dentist in Colorado

Springs. And they paid, after she got well by having in part her

dental work done and other things, they paid for a study. And

here’s how the study went.

There were 33 patients with silver fillings, I think there were an

average of 18, 20 fillings in the mouth. They gave a quarter of a

million dollar amount for this study. They took the immune system

competence by blood test before they removed the fillings. Then

when you remove these fillings, you have to properly do it, otherwise the patient can get very bad, you have to use oxygen in the

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nose, they use a dam in the mouth and they have the suction, and

most of the doctors wear gas masks in the chamber in the office.

They remove the fillings and then they put in plastic fillings.

They then took the competence of the immune system and it went

from the basement to the ceiling. They then removed the plastic,

put back the mercury and the immune system went back into the

basement.

I’m going to tell you a story of a little boy by the name of Smith

in Denver, CO. He couldn’t swallow when he was born. And the

mother took him to all the hospitals, Denver Children’s, he even

went to Boston, and nothing they could do. They were about to put

a tube in his belly to feed him, for his life. I directed the family

to Dr. Lee Cowden in Dallas, TX, who’s a holistic physician and

who is my co-author of my cancer book. He discovered that the boy

was laden with mercury, and the mercury was in the ganglia of the

throat.

He used the DMPS, which is a drug out of Russia, and there are

studies done in this country, to pull out mercury. The child got

back his swallowing ability and no longer needed the tube and is

living a happy, normal life. That speaks to dentistry.

How to avoid cancer. No. 1, organic food, chicken, beef, vegetables, range-grown beef and chicken, vegetables that are organically

grown. If you can’t afford to have organic, use grapefruit seed extract from a health food store or Blue Label Clorox, wash your

vegetables there, a tablespoon per gallon. It will take care of pesticides, herbicides and parasites. And parasites play an enormous

role.

No. 2, filter all your drinking water. And your shower water, you

have eight times more poison from the skin, the largest organ in

your body then from the shower. Avoid fluoride. They tell you that

it stops children’s cavities. Not true. There is no difference between

those areas that fluoridate and those that don’t. It’s a rat poison.

And the union for the Environmental Protection Agency is totally

against fluoridation of the water, and another thing, one of the reasons we have so much Alzheimer’s in this country, they use aluminum sulfate by the truckload to take the cloudiness out of water

in communities. And then they put it back into the rivers after

they complete it and it goes into the next village. And it builds up,

and that’s one of the reasons you find aluminum in Alzheimer’s.

We can go on and on and on, because in my book, which you will

receive a copy of, we give you the 33 categories of the causes of cancer. Now, we have a holocaust. What’s causing it? Come up with

another solution, Mr. Nixon. How do you explain this holocaust,

this increase? One in two men in America, by the American Cancer

Society, will have cancer in his lifetime? This is outrageous.

Mr. SANFORD. Any last refutation point?

Dr. NIXON. Well, the example of the kid with the swallowing difficulty may have been mercury toxicity. I’ll give you that. But

that’s not a cancer case, that’s something else.

Mr. GOLDBERG. Well, you say there’s no relationship.

Dr. NIXON. No, I said mercury is toxic.

Mr. GOLDBERG. Well, we know mercury is toxic.

Mr. SANFORD. Could we say this? In other words, if you listen to

his suggestions in terms of organic food, filtering water, because

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my mother-in-law, in fact, she must have read your book, she says

the same stuff, which is you need to filter your shower, filter the

water, eat organic food, whatnot. If you were to do those things, do

you think that would reduce one’s chances of cancer, or it would

be a placebo?

Dr. NIXON. Well, he asked what I think the cause of cancer is.

I think it’s nutritionally based and too much exposure to toxins

from tobacco. Those are the two big things. So if you eat a vegetarian diet with lots of fruits and vegetables and grains, we are in

agreement there. I wouldn’t fuss on whether it’s organic or not. But

fruits and vegetables and grains are preventive and cancer protective.

Mr. SANFORD. How about filtering your water in your shower and

whatnot?

Dr. NIXON. I don’t do it at home. Although the Sullivans Island

water may need it some. But it’s a different problem. But no, I

think that that is not very high on my worry list for cancer, the

water.

Mr. GOLDBERG. Mr. Sanford, I’d like to know who is financing

your studies and whether we have chemical companies, agricultural companies and pharmaceutical companies that are funding

your research.

Dr. NIXON. No, actually, 99 percent of our funding comes from

the Federal Government, the National Cancer Institute. We are a

cancer center funded by the NCI.

Mr. GOLDBERG. And we’re back into old things, the how dare you

prove us wrong. They’re not going to find the cause of cancer. They

haven’t been able to do this—with $3 billion a year, to be able to

go on satellites, as Mr. Cummings said, and we can’t knock out

cancer? I have many clinics that can knock out cancer, even end

stage cancers, using the system known as alternative medicine.

Mr. SANFORD. I thank you all for your time. Mr. Goldberg, my

mother-in-law is going to be calling you. Mr. Nixon, I look forward

to seeing you back on Sullivan’s Island.

Mr. Chairman, I yield back to you.

Mr. HORN. Thank you very much. We really appreciated that

line, and I’ve learned a lot from you today, as I’ve learned throughout the campaigns in the last year. There’s where we ought to get

something changed, is with all you experts on how you change

things. And campaigns can do it.

A number of us tried to talk to previous Presidential nominees

about a decent war on cancer. And we never got much attention

from them back in the, like 4 years ago and 8 years ago and so

forth. So there’s a lot of things that we have learned today, and I

think we’ve got to followup on them. And we will, because Mr. Burton is pretty well focused, our committee chairman. And I’m partially focused, so anyhow, we really thank you for coming and we’ve

learned a lot.

Mr. SANFORD. Mr. Chairman, if you’re closing out the time, could

I ask one last question?

Mr. HORN. Please.

Mr. SANFORD. And this would be of Dr. Pizza. Sir, if you were

to suggest from the European or from the Italian perspective, two

things that we’re doing wrong in terms of either addressing the

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cancer issue from the standpoint of surgery, or from the standpoint

of research, what would they be?

Dr. PIZZA. I think surgery and chemotherapy and radiotherapy

are the most important approach in treatment. But it is not enough

to cure cancer. We do immunotherapy, we did immunotherapy the

last 27 years. And we cured a lot of patients, using very simple

products that are used from the immune cells of our body to communicate each other to do something.

One of these molecules is called the transfer factor, it is extracted from the lymphoid cells of the spleen or blood, and it can

be produced also in vitro. This small molecule is completely nontoxic. It is today wasted in your country, because you could take

for example, the buffy-coat of blood bank and extract it from the

buffy-coat and inject to cancer patient, mainly two types, in which

we showed, demonstrated the effectiveness.

Prostate metastatic cancer in stage D3, when the tumor is not

more responsive to the hormones, we showed that the median survival for these patients treated also with the transfer factor is

about 110 weeks, with respect to 55, 40 weeks of untreated patients. And in lung cancer, we treat the patients with lung cancer

and we have a long experience with that. We have 14 years of experience of treatments for lung cancer. And we have a long series

of patients treated and control series also, evaluated longitudinally.

And we observe that the transfer factor improved significantly the

survival of patients in stage III of the disease and in stage II.

So my suggestion is not to say, to do more research in your country. I believe that your country is more advanced, I think it is the

most advanced. I have been visiting scientists at NIH, National

Cancer Institute, in 1980. I have collaboration with the epidemiology branch of National Cancer Institute. I collaborate also with

George Washington University. So I cannot suggest to do more research. It would be not right.

What I am suggesting is to do today what can be done, and what

can be done is to use the new products that we are already sure

that are working. You can take transfer factors simply from the

buffy-coats that you put into garbage. A very simple way to take

this is one source. If you want to go to the specific transfer factor,

you can produce in vitro.

So I would not suggest to make different research. But being a

practitioner, being a medical doctor treating patients, I would suggest to do that, because this can be done today.

Mr. HORN. We thank you, gentlemen. And one of the traditions

we have here is to thank the staff that worked on this hearing.

And we had T.J. Lightle as legislative assistant, Beth Crane, intern, Robin Daugherty, intern, to my left here and your right is

Beth Clay, the professional staff member in charge of this area.

And Lisa Arafune is the clerk and Bob Biggs is the assistant clerk.

So with that, we thank all of you for coming and spending your

time with us. We are adjourned.

[Whereupon, at 3:29 p.m., the committee was adjourned.]

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