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[House Hearing, 106 Congress]
[From the U.S. Government Publishing Office]

        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

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

                               -----------

                   U.S. GOVERNMENT PRINTING OFFICE
72-932                     WASHINGTON : 2001

_______________________________________________________________________
 For sale by the Superintendent of Documents, U.S. Government Printing 
                                 Office
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                     COMMITTEE ON GOVERNMENT REFORM

                     DAN BURTON, Indiana, Chairman
BENJAMIN A. GILMAN, New York         HENRY A. WAXMAN, California
CONSTANCE A. MORELLA, Maryland       TOM LANTOS, California
CHRISTOPHER SHAYS, Connecticut       ROBERT E. WISE, Jr., West Virginia
ILEANA ROS-LEHTINEN, Florida         MAJOR R. OWENS, New York
JOHN M. McHUGH, New York             EDOLPHUS TOWNS, New York
STEPHEN HORN, California             PAUL E. KANJORSKI, Pennsylvania
JOHN L. MICA, Florida                PATSY T. MINK, Hawaii
THOMAS M. DAVIS, Virginia            CAROLYN B. MALONEY, New York
DAVID M. McINTOSH, Indiana           ELEANOR HOLMES NORTON, Washington, 
MARK E. SOUDER, Indiana                  DC
JOE SCARBOROUGH, Florida             CHAKA FATTAH, Pennsylvania
STEVEN C. LaTOURETTE, Ohio           ELIJAH E. CUMMINGS, Maryland
MARSHALL ``MARK'' SANFORD, South     DENNIS J. KUCINICH, Ohio
    Carolina                         ROD R. BLAGOJEVICH, Illinois
BOB BARR, Georgia                    DANNY K. DAVIS, Illinois
DAN MILLER, Florida                  JOHN F. TIERNEY, Massachusetts
ASA HUTCHINSON, Arkansas             JIM TURNER, Texas
LEE TERRY, Nebraska                  THOMAS H. ALLEN, Maine
JUDY BIGGERT, Illinois               HAROLD E. FORD, Jr., Tennessee
GREG WALDEN, Oregon                  JANICE D. SCHAKOWSKY, Illinois
DOUG OSE, California                             ------
PAUL RYAN, Wisconsin                 BERNARD SANDERS, Vermont 
HELEN CHENOWETH-HAGE, Idaho              (Independent)
DAVID VITTER, Louisiana

                      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

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

 
        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 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 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 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 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 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 wake-up 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.
    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.
    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.
    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 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.
    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 open-minded 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 non-small-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.
    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 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 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 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 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, 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 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 decisionmaking 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, 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 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 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 state-of-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 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 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 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.
    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.
    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, 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?
    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----
    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.
    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.
    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 
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 2\1/2\ 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-the-art 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?
    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
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.
    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.
    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 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.
    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 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 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 strong-arm 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 are that our son is winning his fight against his 
illness, not because 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 you, Mr. Chairman, that genocide was Hitler's standard 
of treatment 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 
state-of-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 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.
    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 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 operating 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.
    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.]

        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 Alternative 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 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 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 
trials for new cancer treatments, as well as for heart disease, 
arthritis 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.

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 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 2\1/2\ 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.
    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 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,
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 that's when I had the honor of starting to work with 
the U.S. National 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 anti-cancer 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 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 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 cancer, 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.
    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 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 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 2\1/
2\ months, have you heard those kinds of stories before? Have 
you seen examples of that?
    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 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.
    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 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 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.
    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.
    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.

    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 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 non-toxic. 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.
    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 telescope. 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.
    And yet in studies in UCLA, Harbor Hospital, and in Petrov 
Institute in Russia, which came up with the identical results, 
51 percent 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 pre-K 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 specifically 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.
    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.
    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 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 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 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 non-toxic. 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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