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