<DOC>
[106th Congress House Hearings]
[From the U.S. Government Printing Office via GPO Access]
[DOCID: f:64044.wais]
FIGHTING PROSTATE CANCER: ARE WE DOING ENOUGH?
=======================================================================
HEARING
before the
COMMITTEE ON
GOVERNMENT REFORM
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTH CONGRESS
FIRST SESSION
__________
SEPTEMBER 23, 1999
__________
Serial No. 106-112
__________
Printed for the use of the Committee on Government Reform
Available via the World Wide Web: http://www.gpo.gov/congress/house
http://www.house.gov/reform
________
U.S. GOVERNMENT PRINTING OFFICE
64-044 CC WASHINGTON : 2000
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, Idaho (Independent)
DAVID VITTER, Louisiana
Kevin Binger, Staff Director
Daniel R. Moll, Deputy Staff Director
David A. Kass, Deputy Counsel and Parliamentarian
Carla J. Martin, Chief Clerk
Phil Schiliro, Minority Staff Director
C O N T E N T S
----------
Page
Hearing held on September 23, 1999............................... 1
Statement of:
Dole, Hon. Bob, former Senator of the U.S. Congress; Hon.
Randy ``Duke'' Cunningham, a Representative in Congress
from the State of California; and Mrs. Betty Gallo, vice
president, Dean and Betty Gallo Cancer Research Foundation. 43
Geffen, Jeremy, M.D., Geffen Cancer Center and Research
Institute; Konrad Kail, M.D., Phoenix, AZ; Sophie Chen,
Ph.D., Brander Cancer Research Institute, New York Medical
College; Allan Thornton, M.D., Indiana University; Richard
Kaplan, M.D., National Cancer Institute, accompanied by
Jeffrey White, M.D., Director, NCI's Office of Cancer
Complementary and Alternative Medicine; Andrew C. von
Eschenbach, M.D., American Cancer Society; and Dr. Ian
Thompson, COL.M.C., University of Texas Health Science
Center at San Antonio...................................... 73
Letters, statements, et cetera, submitted for the record by:
Biggert, Hon. Judy, a Representative in Congress from the
State of Illinois, prepared statement of................... 40
Burton, Hon. Dan, a Representative in Congress from the State
of Indiana, prepared statement of.......................... 5
Chen, Sophie, Ph.D., Brander Cancer Research Institute, New
York Medical College, prepared statement of................ 112
Cunningham, Hon. Randy ``Duke'', a Representative in Congress
from the State of California, prepared statement of........ 56
Dole, Hon. Bob, former Senator of the U.S. Congress, prepared
statement of............................................... 49
Gallo, Mrs. Betty, vice president, Dean and Betty Gallo
Cancer Research Foundation, prepared statement of.......... 67
Geffen, Jeremy, M.D., Geffen Cancer Center and Research
Institute, prepared statement of........................... 76
Kail, Konrad, M.D., Phoenix, AZ, prepared statement of....... 85
Kaplan, Richard, M.D., National Cancer Institute, prepared
statement of............................................... 135
Thompson, Dr. Ian, COL.M.C., University of Texas Health
Science Center at San Antonio, prepared statement of....... 155
Thornton, Allan, M.D., Indiana University, prepared statement
of......................................................... 126
von Eschenbach, Andrew C., M.D., American Cancer Society,
prepared statement of...................................... 146
Waxman, Hon. Henry A., a Representative in Congress from the
State of California, prepared statement of................. 13
FIGHTING PROSTATE CANCER: ARE WE DOING ENOUGH?
----------
THURSDAY, SEPTEMBER 23, 1999
House of Representatives,
Committee on Government Reform,
Washington, DC.
The committee met, pursuant to notice, at 10:05 a.m., in
room 2154, Rayburn House Office Building, Hon. Dan Burton
(chairman of the committee) presiding.
Present: Representatives Burton, Morella, Shays, McHugh,
Horn, Mica, Barr, Terry, Biggert, Vitter, Waxman, Owens,
Maloney, Norton, Cummings, Kucinich, Turner, and Schakowsky.
Staff present: Kevin Binger, staff director; Daniel R.
Moll, deputy staff director; James Wilson, chief counsel; David
Kass, deputy counsel and parliamentarian; Carla J. Martin,
chief clerk; Lisa Smith Arafune, deputy chief clerk; Heather
Bailey, legislative assistant; Robert Briggs and Michael Canty,
staff assistants; Robin Butler, office manager; S. Elizabeth
Clay, professional staff member; Mark Corallo, director of
communications; Corinne Zaccagnini, systems administrator; Phil
Schiliro, minority staff director; Phil Barnett, minority chief
counsel; Kristin Amerling and Sarah Despres, minority counsels;
Ellen Rayner, minority chief clerk; and Jean Gosa, minority
staff assistant.
Mr. Burton. The committee will come to order, and a quorum
being present, the Committee on Government Reform will start
its business.
I ask unanimous consent that all Members' and witnesses'
written opening statements be included in the record. Without
objection, so ordered.
I ask unanimous consent that all exhibits and materials
referenced to be included in the record. Without objection, so
ordered.
And if our first panel, Senator Dole, if you would like to
come forward, sir, and our good friend, the great Congressman
from California and, Mrs. Gallo, would you come forward. Duke,
I am surprised you are not out flying a plane this morning.
Mr. Cunningham. Tomorrow.
Mr. Burton. You are going to fly tomorrow? For those of you
who don't know, Duke was an Ace in Vietnam. And of course we
know that Senator Dole was not only a great Senator but a war
hero as well.
We are here this morning to talk about a disease that will
affect over 175,000 men this year, prostate cancer. In fact,
unless we change course, one in five men will develop prostate
cancer during their lifetime. Today, 101 Americans will die
each day from prostate cancer. That is 37,000 men this year
that will be killed by this dreaded disease.
Prostate cancer affects more men than any other cancer
except skin cancer, and it is the second leading cause of
cancer-related deaths in men. We have a slide that shows this.
The National Institutes of Health reports to Congress, and
they state that despite advances over the past decade our
treatments for prostate cancer are inadequate, the side effects
of treatment are unacceptable, and troubling questions remain
about the relative benefit of early detection for the disease.
We are here today to talk about what the current level of
knowledge is in preventing prostate cancer. We will also talk
about current treatment options and research that will develop
better and more compassionate treatments for men to choose. It
is a travesty for a man to be forced to choose to save his life
by choosing a treatment that has a good chance of leaving him
impotent or incontinent for the rest of his life.
I am pleased to have three colleagues and friends joining
us for the first panel today. Senator Dole is a true American
hero. He was elected by the people of Kansas to the House of
Representatives in 1960. He retired in 1996 after serving four
terms in the House and five terms in the Senate and being
elected Senate Majority Leader in 1984. He has continued as one
of the Nation's leaders now as an advocate saving the lives of
men with early detection testing for prostate cancer and access
to better care.
After testifying, Senator Dole will be visiting the
confidential prostate specific antigen screening that is taking
place here in the Rayburn Building this morning and on the
Senate side this afternoon. I hope all of my colleagues and the
staff will take the time for screening today.
Most of us keep a close eye on our cholesterol levels and
on our blood pressure, but are we watchful about our PSAs? This
is a simple blood test which has been shown to be a valuable
indicator to the possibility of prostate cancer and we should
all pay attention to this.
Congressman Randy ``Duke'' Cunningham was re-elected to the
House of Representatives in 1998 for his fifth term. Gosh, has
it been that long? Five terms? I understand that Duke may have
to leave early since he is a member of the Appropriations
Subcommittee on Labor, Health and Human Services and Education,
one of the cardinal committees. We do not want him to miss the
markup that is happening concurrent with our hearing. We will
benefit greatly by Duke sharing his personal story of dealing
with prostate cancer, and we look forward to working with Duke
on prostate legislation.
Additionally, we are delighted that Mrs. Betty Gallo, whose
husband Dean was a friend of mine, is joining us to share her
perspectives as the wife of a prostate cancer victim,
Congressman Dean Gallo. She will share their story and discuss
the work of the Dean and Betty Gallo Prostate Cancer Institute
of New Jersey, including the role of nutrition in preventing
prostate cancer.
Dr. Jeremy Geffen, board certified in medical oncology and
internal medicine and executive director of the Geffen Cancer
Center and Research Institute, will lead the second panel. In
addition to his extensive training in oncology and hematology,
Dr. Geffen is also trained in the medical and spiritual
traditions of the East. He will share with us his perspectives
in the reality of treating prostate cancer in a compassionate
manner. In politics there is more than one philosophy or school
of thought. This freedom to be diverse is one of the greatest
benefits of democracy and the same is true in medicine.
Dr. Konrad Kail is a naturopathic physician from Phoenix,
AZ and a member of the new Advisory Council on Complemental and
Alternative Medicine. He will discuss natural approaches to
treating cancer and interactions between the naturopathic
medical community and conventional oncologists.
Dr. Sophie Chen is an associate professor at the New York
Medical College and will discuss Chinese botanicals and their
use in the treatment of prostate cancer. Dr. Chen patented PC
SPEC, a Chinese botanical that research indicates may slow the
growth of cancer cells.
Dr. Alan Thornton is the chief advisor to the Midwest
Proton Radiation Institute at Indiana University in the great
State of Indiana, and he will provide testimony on the benefits
offered prostate cancer patients by proton therapy. Dr. Richard
Kaplan, a leading expert on prostate cancer, will present
testimony on behalf of the National Cancer Institute. Dr.
Andrew von Eschenbach of the Anderson Cancer Treatment Center
will present testimony on behalf of the American Cancer
Society. And Dr. Ian Thompson from the University of Texas
Health Science Center at San Antonio will testify about
research in preventing prostate cancer.
There has been a lot of progress in prostate cancer. Today
we will hear about that progress. But are we doing enough and
are we spending enough?
Is the funding of research at the National Institutes of
Health adequate and properly focussed to get viable, effective,
and compassionate treatments for prostate cancer? Are we
looking enough into the natural approaches to healing? Are we
looking closely enough at the emotional and psychological-
physiological issues that arise as men and their families face
prostate cancer? Are we moving forward in getting real answers
about the nutritional aspects of cancer prevention, including
organic and plant based diets and the role of dietary
supplements? Are we looking at the role of pain management
issues, including complementary approaches like meditation,
guided imagery, acupuncture, aroma therapy, and music therapy?
Is the spending on prostate cancer in line with the spending
for other diseases that affect the comparable number of
individuals?
This is very interesting, and I want to put this slide up
there right now. I hope everybody can see this. When we
calculated this, the disparity was shocking. I was not aware of
this and I don't think any Member of Congress is. In fiscal
year 1999 for HIV/AIDS, the National Institutes of Health is
spending on average $44,960 for each new case of AIDS in the
United States this year just for research alone. That is almost
$45,000 for research on AIDS for each case. And that is not
talking about all the treatments, just for research alone.
In cardiovascular disease the National Institutes of Health
is spending $2,019.69 per new case, and in the case of prostate
cancer, that is going to affect 175,000 men this year, they are
devoting $941. Now, I want you to know that I think AIDS is a
tragic thing for anyone to have to deal with, and we should pay
attention to that and we should appropriate money for research,
but the disparity is unconscionable. We have a lot of other
diseases that are extremely important to the American people
and to spend $45,000 for each new case of AIDS on research and
less than $1,000 on research for prostate cancer just does not
make any sense.
In our June hearing we asked the National Cancer Institute
to provide us a list of all the new drugs, devices, and
treatments available in Canada and Europe that are not
currently available here. Just yesterday, we received a letter
that lists six chemotherapy drugs available and an explanation
that so far they haven't been able to compile the rest of the
requested information. We were told at the June hearing that
the National Cancer Institute staff stays in communication with
international experts. If they cannot even provide a list of
the existing international alternative advances in cancer
detection and treatment, how can they be taking advantage of
these advances in research and moving to increase America's
access to them? The Congress and the American taxpayer have
entrusted the National Cancer Institute with over $3 billion to
fight cancer this year alone. I said in the past that the less
than 1 percent of the NCI budget that is being spent on
complementary and alternative medicine is not enough
considering that over 50 percent of cancer patients use these
therapies. I will reiterate my request again to the National
Cancer Institute to step up to the research plate and set aside
a larger percentage of research funds for this necessary
research.
The time for watchful waiting in prostate cancer research
is over. We as a government have to join organizations like
CapCURE, the National Prostate Cancer Coalition, Men's Health
Network, U.S. 2, and the American Foundation for Urologic
Disease to get answers to the questions of how to prevent
cancer, how to detect cancer as early as possible, and how to
treat prostate cancer with effective compassionate treatments.
Then we must empower men with this knowledge so that 101 men do
not die each day from prostate cancer.
The hearing record will remain open until October 7th for
those who would like to make some statements in addition to
what they are going to say today. Let me end up by saying that
I hope those who are here from the National Cancer Institute
and the National Institutes of Health will address this
disparity in funding for HIV and prostate cancer. And we are
talking not about overall; we are talking about $45,000 per HIV
patient, new HIV patient for research alone, not for the cure
or helping those people. And less than $1,000 for prostate
cancer. That just doesn't make any sense. I now recognize my
colleague from California.
[The prepared statement of Hon. Dan Burton follows:]
[GRAPHIC] [TIFF OMITTED] T4044.001
[GRAPHIC] [TIFF OMITTED] T4044.002
[GRAPHIC] [TIFF OMITTED] T4044.003
[GRAPHIC] [TIFF OMITTED] T4044.004
[GRAPHIC] [TIFF OMITTED] T4044.005
[GRAPHIC] [TIFF OMITTED] T4044.006
[GRAPHIC] [TIFF OMITTED] T4044.007
Mr. Waxman. Thank you, Mr. Chairman. I am pleased that we
are having a hearing on the important issue of prostate cancer.
Except for skin cancer, prostate cancer is the most commonly
diagnosed cancer in American men, and this year alone an
estimated 37,000 American men will die of the disease.
We face many challenges relating to prostate cancer.
Questions remain unresolved about the causes and biology of
prostate cancer and about why there are racial differences in
the incident rates. We must concentrate our efforts on
developing the most effective prevention, detection, and
treatment approaches. We must also work to ensure that all men
have access to appropriate treatment and to accurate
information about their treatment options.
As we face these challenges, it is important that we keep
an open mind about innovative and unconventional approaches to
prostate cancer treatment and prevention. At the same time, we
must promote thorough testing and review of these approaches to
avoid unnecessary harm and expense to consumers.
Some of today's witnesses will share their personal
experiences with prostate cancer. Others will highlight ongoing
efforts to advance prostate cancer prevention, detection, and
treatment. This discussion will increase our understanding of
the options currently available to men who are diagnosed with
prostate cancer and of the research efforts we should continue
to explore.
I look forward to their testimony. I want to explain to
witnesses that many of us have conflicts in our schedule, and I
know I won't be able to be here for the full hearing but I will
have an opportunity to review the record and the statements
that will be submitted. So, while many of our colleagues are
not present, we are making an important record today that will
be shared with all of our colleagues and others interested in
this field.
I particularly want to recognize and welcome Senator Dole.
He and I have had an opportunity to work together over the
years, and he has been a tremendous champion for research and
trying to fight this and other diseases, and for making sure
that people have access to care. He has my undying admiration
and respect for the work he has done in this and many other
areas.
I am pleased we have our other colleague and spouse of our
former colleague with us as well.
Mr. Chairman, I appreciate the fact that we are holding
this hearing. It is important that we pursue this issue and I
look forward to the testimony.
[The prepared statement of Hon. Henry A. Waxman follows:]
[GRAPHIC] [TIFF OMITTED] T4044.008
[GRAPHIC] [TIFF OMITTED] T4044.009
[GRAPHIC] [TIFF OMITTED] T4044.010
[GRAPHIC] [TIFF OMITTED] T4044.011
[GRAPHIC] [TIFF OMITTED] T4044.012
[GRAPHIC] [TIFF OMITTED] T4044.013
[GRAPHIC] [TIFF OMITTED] T4044.014
[GRAPHIC] [TIFF OMITTED] T4044.015
[GRAPHIC] [TIFF OMITTED] T4044.016
[GRAPHIC] [TIFF OMITTED] T4044.017
[GRAPHIC] [TIFF OMITTED] T4044.018
[GRAPHIC] [TIFF OMITTED] T4044.019
[GRAPHIC] [TIFF OMITTED] T4044.020
[GRAPHIC] [TIFF OMITTED] T4044.021
[GRAPHIC] [TIFF OMITTED] T4044.022
[GRAPHIC] [TIFF OMITTED] T4044.023
[GRAPHIC] [TIFF OMITTED] T4044.024
[GRAPHIC] [TIFF OMITTED] T4044.025
[GRAPHIC] [TIFF OMITTED] T4044.026
[GRAPHIC] [TIFF OMITTED] T4044.027
[GRAPHIC] [TIFF OMITTED] T4044.028
[GRAPHIC] [TIFF OMITTED] T4044.029
[GRAPHIC] [TIFF OMITTED] T4044.030
[GRAPHIC] [TIFF OMITTED] T4044.031
Mr. Burton. Thank you, Mr. Waxman. Do any other Members
have a comment they would like to make an opening statement?
Mrs. Morella?
Mrs. Morella. Thanks, Mr. Chairman. I want to thank you for
holding this hearing today to examine the current status of
prostate cancer issues, including prevention, early detection,
treatment, and research.
As you listen to the compelling statements of our panels,
particularly Senator Dole, our colleague Duke Cunningham, and
Mrs. Gallo. I served with your late husband and have great,
great respect and love for him, I appreciate the three of you
coming to discuss this with us. Indeed we must keep in mind
that prostate cancer is the most frequently diagnosed nonskin
cancer, the second leading cause of cancer deaths among men,
second only to lung cancer. In fact, prostate cancer is the
most common type of cancer in men in the United States.
The statistics are one out of every six men will develop
prostate cancer at some point during his life. African-American
men have the highest incidence of prostate cancer in the world.
There are many parallels I find between prostate cancer in men
and breast cancer in women. Like breast cancer in women, the
risk of having prostate cancer increases with age. The American
Cancer Society estimates that 180,000 new cases of prostate
cancer will be diagnosed in 1999. It kills 37,000 men each
year. Breast cancer kills over 46,000 women. Prostate cancer is
the second leading cause of cancer death in men. Breast cancer
is the second leading cause of death in women after lung
cancer.
Although testing for early detection for prostate cancer
has become more common, too many lives are still lost to this
disease, and I think it is critical that American men use every
means available to fight prostate cancer, including regular
testing and medical examinations.
I know Senator Dole is going to be chairing a luncheon
panel in the Senate at noon as part of Prostate Cancer
Awareness Week to further educate men about this disease. Free,
confidential prostate cancer screenings will be offered
immediately after the luncheon until 3:30 this afternoon. I
encourage the men in this room and others to take advantage of
this opportunity because it was through a similar Capitol Hill
screening that I eventually discovered that I have
osteoporosis. So one never knows.
In conclusion, Mr. Chairman, I have been a strong supporter
of increasing the Federal Government's commitment to biomedical
research. In particular, I was leading an effort to double the
funding for the National Institutes of Health over the next 5
years and we are working toward that goal. Funding biomedical
research through the NIH is today's investment in America's
future. We must continue our commitment now if we are to find
better ways to fight prostate cancer and to ensure the future
health of our Nation.
Recently, I attended the opening of an expanded Department
of Defense Prostate Cancer Research Center in Rockville, MD.
This is a wonderful partnership with NIH in Bethesda, and will
also work with other departments and even the private sector in
prevention, early detection, and a cure for prostate cancer.
I just want to mention one comment, Mr. Chairman, and that
is I would be very much against pitting one disease against
another. I mean, I think you have to be very careful when you
look at the kind of money that goes into AIDS and you don't
want it to be in combat with breast cancer, prostate cancer,
whatever it may be.
But I really look forward to the discussion today and the
testimony of our witnesses. Thank you very much.
Mr. Burton. Before I yield to my next colleague, let me
just say that they are spending $2,700 for every new case of
breast cancer research, and I have had that happen in my
family. And while you cannot make everything equal and you
should not, I think that we ought to seriously look at why some
are getting a great deal more attention, huge quantities more
of money per case for research than others. I think it is a
question that at least needs to be answered.
Mr. Horn.
Mr. Horn. Thank you, Mr. Chairman. I appreciate you setting
up this hearing. My wife has had breast cancer and I have had
prostate cancer, and I have a daughter who heads an anticancer
foundation. So the family is deeply involved.
And I think Senator, you and I had the same doctor, Dr.
McLeod, who is an outstanding surgeon. We are very lucky that
we had his talents work on both of us and a lot of other
Members of the House. We have an alumni group, a McLeod alumni
group. They ought to make him a General with all the lives he
has saved.
I thank you for being here, you and Mr. Cunningham, and,
Mrs. Gallo, I had great affection for your husband. He was a
wonderful Member. Thank you very much and we will maybe get
results as a result of this hearing.
Mr. Burton. Thank you, Mr. Horn. I neglected to alternate
back to our colleagues on the other side of the aisle, so I
will yield to two of them in a row. First, Mr. Kucinich.
Mr. Kucinich. Thank you very much, Mr. Chairman. I want to
begin by stating my appreciation to the Chair and to our
ranking member, Mr. Waxman, for their ongoing commitment on
matters of health, and over the years I think we have seen
great leadership from many members of this committee on health
issues and our American community, and we see our congressional
community represented here by Senator Dole, Congressman
Cunningham, and Mrs. Gallo.
It takes great courage to share your experience with us and
to share with the people of the United States the things that
can be done to protect their families through early protection
through perhaps raising health issues to a higher priority on
this Nation's agenda through addressing it with funding and new
strategies.
So thanks to all of you, to my good friend Senator Dole for
his willingness to come forward and to Mr. Cunningham for his
never-ending insight into matters, which makes all in Congress
very grateful, and to Mrs. Gallo for sharing your husband's
career with this Congress and for your willingness to come back
here and talk about what can be done to help other Americans
who have struggled with this. Thanks to all of you and again
thanks to the Chair.
Mr. Burton. Thank you. Mrs. Maloney.
Mrs. Maloney. Thank you, Mr. Chairman. And thank you very,
very much for having this hearing and for our distinguished
guests, distinguished panel. And until we come up with a cure,
the only thing that we really have is preventive screening and
early detection. And all of your speaking out on this disease,
particularly Mr. Dole, have hopefully brought more people to
doctors for screening.
As we sit here today, Supreme Court justice Ruth Bader
Ginsberg, who is just 66 years old, is undergoing colon cancer
treatment and, like many other women and men, she was
misdiagnosed for several months. Very often, women and men over
age 50 are not advised to get tested for cancer despite their
risk. Routine screening really should be taking place between
ages 50 and 65.
I am glad that we are focusing on prostate cancer, but
really it should be interrelated with all cancers, many cancers
are interrelated. And I want to mention a bill, along with the
cochair of the Women's Caucus Sue Kelly, we have put forward,
and it is a cancer screening bill.
One of the bills that I authored with Mrs. Morella and
others that was part of the balanced budget amendment was the
Breast Cancer Early Detection Act, which allowed for annual
mammograms for women on Medicare, and we are pleased that this
became part of the law of this country. But what about men and
women who are at threat for prostate cancer--prostate cancer
for Medicare was also covered but what about below the age of
65, at the age of 50, when most cancers could begin and when
screenings should likewise be taking place?
Our bipartisan bill, the Cancer Screening Coverage Act,
would help ensure preventive care--that it becomes, you know,
part of our routine health care and it would have insurance
coverage for prostate cancer, breast cancer, cervical cancer,
and colorectal cancer. And we do not need to or we shouldn't be
looking at cancer with a body part by body part perspective.
I am glad that we are focussing on prostate cancer here
today, but how many of you are aware that colon cancer is the
second leading cancer killer just behind lung cancer. And so I
just want to say that the American Cancer Society and many
others have endorsed this bill and they say that people who do
not receive screening tests because their doctors do not
encourage it, and if you ask doctors why is it not encouraged
it is because it is not covered. So it is important that
screening, when it is advisable or necessary, is covered.
I thank the chairman for organizing this and our
distinguished panel for being here.
Mr. Burton. Thank you, Mrs. Maloney. Mrs. Biggert.
Mrs. Biggert. Thank you. I am particularly eager to hear
from our distinguished witnesses, particularly Senator Dole and
our colleague Congressman Cunningham, so I would ask unanimous
consent to submit my opening statement for the record.
[The prepared statement of Hon. Judy Biggert follows:]
[GRAPHIC] [TIFF OMITTED] T4044.032
[GRAPHIC] [TIFF OMITTED] T4044.033
Mr. Burton. Without objection, so ordered. Mr. Turner.
Mr. Turner. Thank you, Mr. Chairman. I want to commend you
on organizing this hearing. It is a very important subject. And
I want to thank Senator Dole for his leadership. It took a lot
of gutsiness to make those commercials, Senator. It meant a
whole lot to the cause that you spoke out on behalf of.
Our second panel has two distinguished professionals from
Texas today, so I think we have a good second panel, Dr. von
Eschenbach and Dr. Thompson.
Mr. Burton. There is one from Indiana as well.
Mr. Turner. So we are in for a good hearing today. Thank
you, Mr. Chairman.
Mr. Burton. Thank you. Mr. Terry, do you have any comments?
Mr. Cummings.
Mr. Cummings. Thank you very much, Mr. Chairman. I want to
just take this moment to thank our panel for being here. In my
district, we have one of the greatest hospitals in the world,
Johns Hopkins, and some of probably the greatest experts in
this area in prostate cancer, whom I have gotten to know very
well. But at the same time, we have one of the highest death
rates from prostate cancer.
I have said it often, when I go to the bank on Saturdays it
is not unusual for me to run into someone, Mr. Chairman, who is
about to undergo some type of prostate surgery or has just come
through it or is recovering from it.
And so I want to thank our panel for what you are doing. So
often, I think what happens is that we in government and those
not in government who speak out on these issues wonder what
effect what we do has. I mean we always wonder. But I can tell
you that it has had a profound impact to raise this issue to a
level where people can talk about it. I think it was
Congresswoman Maxine Waters who said: ``Secrets kill. Keeping
things hidden and not dealing with them and not bringing them
out kill.''
And so, I too join the voices of my colleagues to say thank
you, simply thank you, for those you will never meet. For those
who have been touched by seeing you on C-SPAN or hearing you
all testify at a hearing like this. But touching their lives
because when you open the door and break down the walls of
discussion, then you also break down the walls so that people
can get the kind of diagnosis and treatment that they need.
And so I thank you. Thank you, Mr. Chairman.
Mr. Burton. Mr. Vitter, no comment? Ms. Norton.
Ms. Norton. Thank you, Mr. Chairman. May I thank you for
organizing this hearing about a form of cancer that I think
needs very special awareness.
If I may, I would like to thank Senator Dole first for his
work on behalf of the District as head of the Federal City
Council. The Senator was most gracious as the District was
coming out of crisis to offer his extraordinary and unique
leadership. That leadership has been felt and the District, its
residents, and its elected officials are most grateful to you
for your work.
I share with the Senator what has been his lifelong habit
of not speaking much about his own personal life and struggles.
I am sometimes squeamish when I hear people talk much about
themselves and what they have gone through physically or
mentally, but I must say that I have come to believe that there
are some conditions where to hear from a person who is very
distinguished and very admired is to render a unique service.
To talk about a disease like prostate cancer to people, I have
in mind men who are reluctant even to go to the doctor, is to
do something that doctors cannot do, that Members of Congress
cannot do, that only someone whom they respect, whom they know
would not be inclined to simply speak about himself for the
sake of hearing--telling about himself, that person gets the
attention in a way nobody else does, and that person can save
lives.
And I submit to you without being able to document it that
I believe that Senator Bob Dole has saved lives by having the
guts to go on television and talk personally about prostate
cancer.
And I must thank you, Senator, as well because not only is
that the case for men in general who go only at the last minute
and perhaps because they think it is a sign of weakness even to
go to the doctor when they have a cold, but for many men,
especially African-American men where prostate cancer is out of
control, the whole notion of going about this disease simply
was off the radar and off the table. To hear a man whom they
regard as manly speak about this disease has had an effect
which I think we will never know, but I think all of us should
be grateful for, and I want to express my gratitude personally
to the Senator here this morning.
Thank you, Mr. Chairman.
Mr. Burton. Thank you, Ms. Norton. Well, without further
ado we will start with Senator Dole. We really do appreciate
you being here. We appreciate all of you being here. I would
just like to say that I have known a lot of people who had some
kind of prostate problems that led to prostate cancer and they
were very reluctant to even talk about it to anybody. And I
think because of you and others like you, Mr. Cunningham, Mrs.
Gallo, and others, I think that people are now willing to talk
about it and look into it. And thanks to you very much, Mr.
Dole.
STATEMENTS OF HON. BOB DOLE, FORMER SENATOR OF THE U.S.
CONGRESS; HON. RANDY ``DUKE'' CUNNINGHAM, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA; AND MRS. BETTY GALLO,
VICE PRESIDENT, DEAN AND BETTY GALLO CANCER RESEARCH FOUNDATION
Senator Dole. Well, thank you, Mr. Chairman and members of
the committee. I really appreciate this opportunity. It is good
to be back on the Hill. And I know the experts are lined up
behind us. We are here to sort of set the stage and then they
can make very appropriate statements.
But I think it is true that not many people like to talk
about their own problems, whether it is an illness or anything
else. We go through life and some people have some problems,
some people have other problems, and that is all a part of
life. But this is Prostate Cancer Awareness Week, and for the
past 8 years, I have been speaking out on prostate cancer.
When it was diagnosed, I recall some difference in my
staff. Maybe I should just have it done quietly and nobody
would know about it because it might make people think that I
wasn't going to be able to carry out my job and all these
things. But it occurs to me that maybe just sending a signal
might encourage others to do the same. And since that time, I
have literally talked to hundreds of men--in fact I was coming
out of the hotel this morning, we are living there temporarily
while they are fixing up our apartment, the doorman stopped me
and said, ``You know, I have prostate cancer.'' This was less
than an hour ago. And can we talk about it? And I said, yes, I
am going to be here for a couple of months. And so he has some
good new theory that he doesn't have to have an operation.
Maybe there is an option that I am not aware of.
The point is that it is out there. It is every day. It
affects Republicans and Democrats, liberals, conservatives,
black, white, yellow, brown, whatever. It doesn't spare
anybody. And the case that I remember is Senator Sparky
Matsunaga, who was one of my colleagues. We served together in
the House and then in the Senate, and then of course he died of
prostate cancer, which spread throughout his body.
I remember talking to Dean shortly before his death, and I
must say he was a man of great courage. His spirits were good.
He understood what was about to happen. And it is great that
Betty is carrying on with the foundation to help others.
One thing that we have done, and I found it to be very good
policy and might also be good politics, but at the Kansas State
Fair, we have a screening booth, the Bob Dole screening booth.
We have mammograms and PSA tests and we got the cooperation of
the State Urological Society and generally some of the drug
companies to help underwrite part of it. That ended as soon as
I left the Senate, I might add. But we are still doing that. We
are still finding the funds. It is a good way because some
people will not go to the doctor, particularly men. It takes
about two laps around the midway to get them in that little
booth there for that blood test, which is painless, and we
discovered even in our small state we do about 3,000 PSAs
during that week and maybe 100 cases of cancer, prostate cancer
that could be treated because there is early detection.
We hope to do this at both national conventions next year
in Philadelphia. We are working with some doctors to see if we
can, because we will have a lot of opinion makers there, there
will be a lot of people at the Democratic Convention and
Republican Convention that people will listen to and we think
it is a great opportunity just to spread the word. We did it at
the Republican Convention in 1996. There wasn't much else going
on. About the most exciting thing that happened were the PSA
tests. But in any event, we think it is an opportunity and I
know there is certainly enough support for it there.
I think it is fair to say that almost every family in
America has been touched by cancer. And when you hear the word
``cancer,'' it scares a lot of people, and men are not any
different than women. As I said, I think I have talked to, I
don't know, hundreds of men because their son asked me to call
or the wife asked me to call or the mother, whoever, and just
say that there is life after prostate cancer, as Cliff knows
and others in the Congress. Suddenly your whole perspective
changes when you hear the word, and again when it is determined
by biopsy after the PSA test, what the cancer may be. I share
the view that it is not just prostate cancer, it is cancer
across the board. Great progress is being made and I commend
those who are making that progress. But it seems to me that
early detection is, of course, the key.
As I said, it was about 8 years ago and I have been in
great health since that time. I have made a commercial or two
and I must say I got a lot of ridicule for one. But I think
when you look at the 30 million men that may be benefited, you
have to take a little heat sometime. Most of it came from the
misinformed media. They are generally misinformed when it comes
to some of these issues, and it seemed to me a little unfair,
because there are 30 million men and their wives who would be
affected by the message I was trying to send without endorsing
any products. I don't endorse any products and don't intend to
endorse any products and I didn't keep any money. There was no
monetary motivation. But I must say some of the reaction, not
from the people but from the media, was a little distressing.
But so what I think some of us can do is encourage others,
as Eleanor said, and others have said, encourage others to see
their doctor. For some reason men just don't want to see their
doctor. If you look at percentages of men versus women, and you
are the experts, doctor visits are much higher among women, and
they do it on an annual basis. For some reason, men, they don't
want to go to the doctor, they don't think they are ever going
to be sick and so they put it off and put it off and put it
off. My father was a good example of that. He would go to our
little hospital and maybe spend all night with a patient, but
he would never want to go to the hospital himself. And I am
sure there are others like that and some women like that too,
but primarily men.
I think the early detection message is the important one.
It is like anything else. If you find what the problem is
early, you can deal with it. And I think the options are
changing. You are going to hear some of the new options
available. Eight years ago, when I went out to see Dr. McLeod,
a fantastic and a very good person, a good surgeon, I was told
there were two options: Surgery and radiation. And I explored
both, because I didn't know much about what was happening. And
none of this sounded very appealing to me, but I finally
decided and I was 68 years old at the time--so to get to the
point where maybe watchful waiting, maybe you don't do
anything--but I was in good health physically and I finally
decided to do the radical prostatectomy. But other men, 68, 70,
and older, may have other health problems and doctors don't
want to chance surgery. If you have got other health problems
you may not want surgery. My point is that the more effective
treatment options available, the more men will be cured of
prostate cancer, and that is where the role of Congress and the
administration come in.
And I might say just looking at the figures that are over
there, I think about 9 years ago, maybe 7 years ago, Mr.
Chairman, the amount spent for prostate cancer on a Federal
level was hardly anything. And I must say that Senator Stevens,
who has gone through the same procedure at Walter Reed
Hospital, is on the Appropriations Committee, sort of made it a
crusade to see that we couldn't spend a little more for
prostate cancer research. And that is why we have, even though
it is not as high as some of the others, certainly much higher
than it was just a few years ago.
Now the way our system works, at least the way it worked
when I left here 3 years ago, is that if Medicare adequately
reimburses a treatment, it is widely available. If you are
going to get treatment, going to get paid for it, it is going
to be there. And every day there is a scientist looking for the
cure for cancer or looking for a new treatment option.
Companies invest large sums of capital in this endeavor, and we
all hope that there will be a cure. We all hope the government
will have the wisdom to recognize it when they see it. Is our
government prepared to take the necessary steps so that when a
new technology for treatment becomes available, patients with
the disease can have access to it?
I mean, if you have a new treatment option that has been
demonstrated effective and safe and you can't get access to it
because you don't have the money and Medicare doesn't cover it,
of course that is a problem. Brachytherapy is an example where
the role of Medicare reimbursement is critical. It is an
innovative treatment option for prostate cancer where
radioactive seeds are implanted in the prostate to destroy the
cancer. For some patients it is a minimally invasive procedure
done on an outpatient basis. You are in and out of the
hospital. You don't stay as you do with the surgery and all the
other things. It has shown to treat some forms of prostate
cancer. Now, I am not here advocating. I am just saying this is
one new option.
This procedure is reimbursed by Medicare currently, but a
proposed change in the regulation will reduce the rates of
reimbursement dramatically, in effect making this treatment
unavailable. And I agree with everybody here, you have to find
a way to stop some of the increased costs and you have to make
certain changes. But I think this is one area that at least
ought to be addressed. You have to determine how it is going to
affect patients who could benefit from this procedure. Is this
really the type of decisionmaking which the government needs to
involve itself? Maybe it ought to be left to physicians and
others to make that choice.
There is another new treatment--there are probably others
we are going to hear about, ones that I haven't heard about,
later from the other panel. Cryosurgery is another treatment
option where the prostate is frozen to prevent the growth of
cancer. And again this is a sort of noninvasive procedure. I
think you maybe stay overnight in the hospital. There is no
blood shed. It is just frozen and it took over 3 years to
receive Medicare reimbursement for that procedure. And again
you kind of wonder, well, maybe if you are too old or your
health is not good enough for surgery, you reject radiation,
are these other options available? And if so, are they covered
and should they be covered? That is a decision that doctors and
patients and the marketplace have to make. As I said, I am an
advocate for solvency of Medicare, but I think our health care
system continues to change with all this new technology. We
have to keep up with it. Medicare was passed originally in
1964, so maybe we haven't kept abreast of all the technology
and I think we do need to take a look at these options.
The private sector is always looking for new therapies and
new options because they are more cost effective in many cases
and you could go back and look at some of the options here that
are probably more cost-effective and less demanding on the
patient.
I know that Congress is considering a number of Medicare
reforms. I am not here lobbying for anything except we have got
to keep in mind in 11 years we are going to have 77 million
baby boomers descend on us and there is going to be a big, big
demand out there and the money has to come from somewhere and
we have got to have priorities. I am certain there are people
in this committee on a bipartisan basis who are going to be
looking at that very carefully.
I think a successful Medicare program will mean that when
an individual receives a diagnosis of cancer or any other
serious disease, his life doesn't have to flash in front of
him. He or she will understand that there is going to be some
protection, some way they can receive treatment. I am just here
to underscore the importance of communication. The thing that I
have learned over the years as sort of a spokesperson for
prostate cancer, and there are a number of them, but is that
most people do not understand, they do not know what to do.
It is pretty hard for somebody to do the right thing if
they do not know what the right thing is. The right thing
obviously is to see your doctor, and even some doctors there is
not enough communication between the doctor and the patient. I
have been speaking to medical groups urging doctors to be more
forthcoming. If you don't ask the patient the right questions
you are not going to find out what the problem is because
sometimes patients, we all tend to be very shy. We don't go in
there and lay out our soul because we are in a doctor's office.
The doctor has to sort of draw it out of some of us, and I
think that is very important.
Last week or in fact this past Sunday, my wife was off
somewhere doing what she's doing, and so I was reading the
Washingtonian, and I just happened to read a story, which
probably should be made part of the record--that costs money,
but it is called ``Under the Knife.'' You may know David
Dorsen. I don't know David Dorsen, but I called him on the
telephone after I read the story. It is the story of a 62-year-
old man--I think that is the right age--who discovers he has
prostate cancer and he doesn't know how to deal with it. He is
in a state of denial. He doesn't think it is real. He doesn't
understand the different options and they go through the
options. He keeps it from his wife. He does not discuss it with
his wife. And of course that leads to a rather tense situation,
until he finally faces up to reality that this has to be dealt
with.
And then the story sort of goes on in how he dealt with it
and how successful it was, and so he feels very good about it.
But I think it is the kind of story that if all men could read
it, they would be a little more apt to go visit their doctors.
So I would at least call it to the attention of the committee
and I told Mr. Dorsen it is the kind of thing that ought to be
circulated at State fairs, anywhere people have a chance to
pick up information.
Again, I want to thank all the committee and the chairman
for holding this hearing. I hope in 10, 20 years, we may not
have prostate cancer, many of these diseases will be gone. And
those of us who have had the successful operation, radiation,
cryosurgery, or Brachytherapy, whatever, I think have some
responsibility to encourage our friends and encourage our
neighbors.
I think that is just the way it is, and I think most of us
will do that and by spreading the word and getting good
information, not trying to prescribe anything, I think we will
be able to reach out to more and more men. So thank you very
much and I appreciate this opportunity.
[The prepared statement of Hon. Bob Dole follows:]
[GRAPHIC] [TIFF OMITTED] T4044.034
[GRAPHIC] [TIFF OMITTED] T4044.035
[GRAPHIC] [TIFF OMITTED] T4044.036
Mr. Burton. Well, thank you very much, Senator Dole. I know
there are great demands on your time and we appreciate it.
Senator Dole. I am unemployed.
Mr. Burton. Give our regards to your wife. I understand she
is doing some important things right now.
Senator Dole. Send money. Thank you.
Mr. Burton. One of my heroes is Duke Cunningham. He was an
Ace in Vietnam and has been a hero here in the Congress as
well. Duke would you like to go next?
Mr. Cunningham. Thank you, Mr. Chairman and Mr. Waxman and
panel.
Mrs. Gallo, unlike Strom Thurmond, I didn't know Abraham
Lincoln, but I did know your husband and he reminded me a lot
of my dad. He was a big, assuming guy and I can still remember
his smile. We all miss him. And I would say to my former
colleague, Senator Dole, the day after I found out I had
prostate cancer, I called Bob Dole. I think that the amount of
information that we put out and the knowledge and that call was
probably the most helpful that I had, because today there is
not a day goes by that I don't have somebody call me and say
Duke, can I talk to you about prostate cancer because they
don't know. You become an automatic expert on the issue because
you read, you study, you do everything that you possibly can.
We are having a markup in Labor-HHS and I am proud to say
that last year we increased medical research by 15 percent.
This year, medical research is going to exceed 8.5 percent. I
believe in it. I would invite each of you to sit in on a panel.
Actually it is very difficult. John Porter, the chairman, asked
me to chair a couple of the hearings and I told him I would
never do it again because we had about 16 children that had
exotic diseases and one of them looked up and said, ``Mr.
Congressman, you are the only person that can save my life.'' I
had to shut down the hearing. It is just too hard. So medical
research is very, very important.
While we talk here today, four men will die, just in the
time that we talk, an equal number of breast cancer surgeries.
I don't know why I am teary. I am happy. I am the luckiest guy
in the whole world. But it is very--something that happens and
it is difficult.
On May 10, 1972, I was coming down in a parachute over
North Vietnam and it is something that always happens to the
other guy that gets shot down. It is not Duke Cunningham. I am
invincible. And the realization that you are coming down over
North Vietnam and going to die or be a prisoner, there was no
white scarf and no Bentsen and Hedges coming out. But the most
scared individual you would ever imagine, that is not second to
a doctor looking you in the face and saying, Duke, you have got
cancer.
The first is denial, no, it can't be me. You have the wrong
test. I am invincible. It happens to the other person. I can't
have cancer. I am Duke Cunningham; I just can't have it. And
the next thing is to find out everything you can and say, OK,
Doc, what do I have to do?
I called two people. I called Father George from Georgetown
University, a good hunting buddy of mine, and I called my
friend, Senator Dole. And I want to tell you some of the things
that you go through in this.
First of all, early detection, as Senator Dole has talked
about, is the most important thing. Dr. Christiansen, my
surgeon, told me about a lady that had four lumps in her
breast. All were benign. She was a soccer mom and she got a
fifth lump. She, like most moms, are busier than we are, they
are taking their children to school, they are taking them for
soccer, the piano lessons, cooking dinner, and all the other
things. She let it go for over a year.
This lady is now going through chemo, she had a mastectomy,
and they don't know if she is going to exist anymore. She is
fighting for life itself. Not just life, but the quality of
life and what those people can be giving back to their
children.
In my case, I had an annual physical. Dr. Christiansen,
who--I am very fortunate, Bob, the Navy, and we are going to
beat Army this year in football, but the Navy doctors have been
in the Capitol for the history of Congress, and Dr. Eisold is
no exception.
I had my annual physical. I had a prostate check. They
found no cancer. But because of a blood test called a PSA,
there had been, and it really wasn't that high, but there was a
delta between what it was last year and it had gone up
slightly, Dr. Eisold said, ``Let's do a sonogram.'' They found
no cancer on the prostate.
They then said, ``Let's do an MRI.'' They found no cancer.
Dr. Eisold said, ``Duke, we want you to go out to Bethesda and
have a biopsy.'' I would tell the panel, I would rather fly
over Hanoi again and get shot down again than get a shot. You
can imagine when the doctor said he was going to use a needle
that big in my prostate, I said ``Doc, I ain't going. You told
me I don't have cancer.'' Probably, like Steve went through,
the night before, I am a coward when it comes to shots, and I
sweated bullets thinking, man, this thing is going to hurt so
bad.
I want to tell the panel, first of all, it doesn't hurt.
You sit there and you wait, and it sounds like a cap gun goes
off, and you say, is that all there is to it? You say, I know
the next one is going to hurt. But it doesn't. You go through.
But unfortunately when Dr. Eisold called me and said, Duke, I
have some bad news for you, he said, in two of the eight
biopsies you have a low-grade cancer.
The next that I had never heard, he said Gleason. I said
who is that? Jackie Gleason? He said no, Gleason is the
aggressiveness of a cancer, a 10 being the highest and the
lower numbers the least aggressive. I had a 4. He said, well,
Duke, you can go for years by just observing this and watching
it, and you don't have to have surgery or the other things for
a while.
I said wait a minute, Doc, you told me I have an enemy
inside of me, an enemy more deadly than any MIG that I ever
shot down, that this guy is going to try to sneak up on you. I
said, is it in the lining of the prostate? Is it in the center?
He said, statistically you can go for a long time.
The next thing is to find out the information and the
different options that you have. Is it cryogenics? There had
not been enough information at that time, so I chose not to.
What about radiation? And then the doctor goes through the
different side effects--incontinence, where you can't control
your bladder because when they remove the prostate, they have
to detach the urethra and reattach it to the bladder. Sometimes
you end up incontinent. The next thing is impotence, a pretty
serious thing for a man and for his family.
You go through the different choices of what you have, and
I chose, like Senator Dole, to go through the surgery. I said,
I want it out. I told Dr. Christiansen, I don't care if it
takes you 40 hours, you protect those nerves.
And I am happy to say I don't need Viagra. I appreciate
your calling. This was one Member of Congress that saluted,
what you did on TV, and didn't criticize Senator Dole because--
for us that are trying to get the information out and know that
it is important to do that.
The second thing that Senator Dole mentioned that I think
is very, very important, it is very, very difficult to go to
your wife and say, sweetheart, I may be impotent after the
surgery. I may be incontinent, and we may have to live with
that.
My wife looked at me and said, sweetheart, I will support
you all the way. She supported me 100 percent whatever those
decisions were, and you need to bring in the family as well.
Those things are very, very important.
But something else that I found in my studies, Mike Milton,
who was famous for another reason, has invested millions of
dollars into prostate cancer. I met with Mike and he has put
out a diet book. And I spoke--I see Mrs. Holmes Norton--I spoke
the day before yesterday at a hospital in D.C. right down by
the air force base there, Bolling Air Force Base. D.C. has the
highest prostate cancer rate in the United States, and among
African Americans, it is even higher, prostate cancer. And they
have done studies, and the reason I bring it up, on diet, that
people that are African Americans that come directly from the
continent have a less incidence of prostate cancer. But once
they come to the United States, and the same is true with
Asians, once they come to the United States, their incidence
goes up.
There are a lot of studies that say it is diet, the fatty
foods and so on. So my mom was right, you need to eat your
veggies and those things. But that kind of information, is
very, very important.
I would like to address another subject real quickly. I
think it is a good question to ask as far as the disparity
between the amount spent on prostate cancer versus other
diseases, but I want to tell you something. Many of us went out
with Dr. Varmus and Dr. Klausner--Dr. Varmus, head of NIH, and
Dr. Klausner in cancer research. I saw an African American lady
that had Parkinson's, that they implanted an electrode into her
brain. She had been in a wheelchair, couldn't eat and walk, had
been taken away from her family. We asked what happened to her,
because the film ended.
She ran down the center of the aisle, jumped in front of us
and started talking to us. That kind of medical research in
those things.
I met an AIDS patient that contacted AIDS in 1989. He said,
Duke, the only thing I thought about was death. Every morning I
woke up, I only thought about dying.
You know that since they have had some of these new
research techniques, that he has bought stocks and bonds, he
has bought a new home, that he has hope?
Ovarian cancer, I know Mrs. Ginsburg, you talked about,
with colon cancer, for the first time NIH is identifying PSA-
type markers for ovarian cancer, and they have never had that
before.
So support the medical research that comes in. I would say
that Senator Stevens and Jerry Lewis on the House side, we have
put more money into breast and prostate cancer in the military.
We have a captured force there, and we can look and make those
kinds of studies. It is important.
I would say, also, I think it is time that many of us do
believe that we need HMO reform, because some HMOs don't do
PSA's and the other things. Some of the veterans hospitals
don't have those, Mr. Waxman. I would tell you there are two
bills out there--Norwood is one bill, and the other one is, I
think, Dr. Coburn--but take a look at them. It is time to put
doctors in charge of our health care again. But it is not time
to put trial lawyers into the driver's seat, in the Democrat
bill, which is why we oppose that kind of HMO reform. Unlimited
lawsuits is just not going to work, and it will drive more
people out of the issue.
But I want to thank the panel for having this hearing, and
Senator Dole, and also Mrs. Gallo. Thank you.
Mr. Burton. Thank you, Duke.
[The prepared statement of Hon. Randy ``Duke'' Cunningham
follows:]
[GRAPHIC] [TIFF OMITTED] T4044.037
[GRAPHIC] [TIFF OMITTED] T4044.039
[GRAPHIC] [TIFF OMITTED] T4044.040
Mr. Cunningham. Can I mention one other thing real quick?
This stamp on cancer awareness, breast cancer, this stamp
right here, does not add to medical research for cancer. We
have a bill that does. Like in breast cancer, we would like to
propose, this is a 4-year committee, and you can act on it, Mr.
Chairman--that we would like to bring forward a stamp that
actually--I think we have to get every Member of Congress in
their campaigns to use that stamp, the breast cancer stamp,
that goes for medical research. I know I would.
Mr. Burton. We will see if we can't talk to the Postmaster
General about that.
Mrs. Gallo, we have about 12 minutes, I think, before the
vote. Would you like for us to come back after the vote to hear
your testimony, or you would like to do it now?
Mrs. Gallo. Whatever is easiest for the committee.
Mr. Burton. Why don't we recess for the vote and come back,
and then--we appreciate it.
Senator Dole, will you be able to stick with us for a while
or do you have to leave?
Senator Dole. I will be here for a while.
Mr. Burton. We will be back as soon as the vote is over
because we have some questions for you. Thank you.
[Recess.]
Mr. Burton. If we could get the witnesses to once again
take their seats, we will have witnesses coming back. We just
finished our second vote. Because we have that good-looking
Senator Robert Dole with us--I know he has some time
constraints, as well as the other panelists--I thought we would
go ahead and get started.
While we are waiting on Mrs. Gallo, let me just ask Senator
Dole a question or two, if it is all right, Senator.
You spoke about the emotional side of facing cancer, the
disbelief, fear, hope and so forth. How did you and your wife
cope with this when you first found out about it?
Senator Dole. Well, I think a little like Duke Cunningham
said.
First of all, you think it must be a mistake. It can't be
my biopsy, because I don't have prostate cancer. But then there
is the realization that it is there and then you have to decide
how to deal with it. So we went to--I learned a lot more about
it since the operation than I knew before the operation. I am
not saying I might have picked a different route, but I don't
know. We were a little panicky, and we went out to Walter Reed
Hospital, and they talked to both of us about side effects and
all the other things.
But once you make a decision, that is it. Then you just do
the best you can.
Mr. Burton. It sounds like you handled it pretty well. Was
it kind of like when you realized all the severity of your
wounds when you were in World War II?
Senator Dole. I guess I had great faith in medicine and
doctors, and I think they certainly played a major role in my
life from way back when I was 19 years of age.
But I think the important thing is--we were just visiting
here while you were voting--how do we get the information out
there? How do we get the average guy on the street, who may be
walking around with a PSA of 10, 12--and that is not foolproof,
it may not make any difference, but how do we get him to
understand that it is important to go to the doctor?
We have all the experts here today, and they can tell us
about all the options, but there has to be some way for that
information to leave this room and get out to the average guy
on the street in Indiana or Kansas or California or wherever.
Mr. Burton. I wish we had a lot more coverage today than we
have. We have print media here that will probably be talking
about it. We need to really work on getting the message out.
You have been very helpful in that regard. We will see if
we can't be of assistance too.
Senator Dole. I need to speak at noon.
Mr. Waxman. I thought the Senator had mentioned he had to
be at this luncheon at noon. Would you allow me to ask a
question or two?
Mr. Burton. If Mrs. Gallo doesn't mind, would you mind if
we ask a few questions of the Senator?
OK.
Mr. Waxman. Senator Dole, you have been a very important
force in raising awareness, public awareness, about prostate
cancer and all the related problems; and I want to congratulate
you and express my appreciation to you in that regard.
You are also spokesman for the product Viagra. That product
was approved by the Food and Drug Administration where they
evaluated numerous randomized placebo controlled trials
involving more than 3,000 men; and then FDA published
information on potential side effects of this product and other
interactions Viagra might have with other substances.
But there are some herbal products being advertised on the
Internet, and they are being called alternatives to Viagra. One
product, for example, says they are 100 percent herbal
sensation, touted as the herbal Viagra, and they make a number
of claims that the product will relieve lack of desire,
impotency, orgasm dysfunction. Additionally, they state it will
help relieve prostate problems, lower cholesterol, help urinary
function. They say you don't need a prescription. There are no
side effects; there are only positive things from using this
drug.
If Pfizer were to make some of these claims, they would
have to extensively prove them to protect the public health,
but for some of these herbal products, there are no FDA
approvals, because it is not a drug, they say, and they cite no
clinical studies to support their claims. There is only
testimony, always of users.
I would like to know how you feel about that and whether it
is a concern and whether we ought to have more scrutiny over
these kinds of products?
Senator Dole. I must say I think the first part of this, I
almost got into this by accident. I was talking to Larry King
one time in the Green Room, I learned not to do that since,
just visiting before the show, and I was telling him about this
trial I was in, this protocol, and it turned out to be Viagra.
Of course, Larry made a mental note of that and raised it
publicly on the show about 2 minutes later.
So, with you, I have had people send me these things. They
have heard about what I have been doing; this is better, do
this, do this, do this. It seems to me there ought to be some
basis for all the claims that are made. At least it ought to
say at the bottom it may not help, but it won't do you any
harm. There ought to be something there.
Mr. Waxman. What assurances would you want to have before
you would feel comfortable in promoting any kind of product
like that?
Senator Dole. I don't promote that product. I have some
stuff called Macho Man, somebody sent me a case of it in the
mail. I would be happy to bring it up here and distribute it.
Mr. Burton. You think we need that, do you?
Senator Dole. They make a lot of claims, but I don't have
any information at all, whether it is, because they don't have
to comply with any regulation. They don't have to satisfy that
it is safe and effective.
Mr. Waxman. Do you think the Congress and the regulators
should require some substantiation before claims to consumers
are made about the effect of these products?
Senator Dole. I think it would be helpful. I know it is a
very tough issue when you get into vitamins and everything else
and herbal remedies. At least there ought to be some
determination that it is not going to hurt someone. I don't
know how you do that. Aside from whether it is doing all the
things you read off, I think that is probably mostly hype,
would be my guess.
They also had different herbal remedies for brain power. I
got a case of that the other day. Just take a couple of drops a
day and your brain functions, which is different than it has
been.
Mr. Waxman. The way the Congress decided to deal with the
issue is, we said if it is a claim about just your general good
health, you can go ahead and make it. But if it is a claim you
are going to cure a disease, there automatically should be more
substantiation because then it gets to be close to a drug.
Senator Dole. I agree.
Mr. Waxman. You agree with that kind of distinction?
Senator Dole. We are talking about health and new
technology, new options for all these different things, not
just cancer, but everything else. We have to be very careful.
We are dealing with consumers, a lot of people that don't have
information, are not sophisticated; and they pick up some
magazine, they will read all these things and they are going to
head for the store.
In fact, there was one last night on TV that I am going to
check out myself, not about any of this, but about your general
energy. We will see what happens.
Thank you.
Mr. Waxman. Thank you very much.
Mr. Burton. Mr. Horn, do you have any questions briefly for
the Senator?
Mr. Horn. Well, let me make one point. We named some
colleagues that really have helped in getting the money for
cancer research--you, Senator Stevens and so forth on your
side. I want to say Jack Murtha, when he was the chairman of
the Defense Appropriations Committee pumped millions of dollars
into the Defense Department to face up finally to both breast
cancer and prostate cancer, and he felt with the military
having women in the services and breast cancer being the plague
that it is, that that ought to be done. I think he can take
great pride in what has happened in the grants over there.
One of them I am aware of, at UCLA, the person had been
denied a grant by NIH, and why? Because they had never had a
grant from NIH. Now, if that wasn't a catch-22, I don't know
what is. But the military has made some real progress in
research with the grants given to the Department of Defense.
Senator Dole. Steve, I appreciate that. I think it is fair
to say the record is pretty clear, this is a nonpartisan-
bipartisan area, where you have got, in this case, men on both
sides of the aisle who have had the problem.
I remember getting a very irate letter from a lady in
Kansas after we appropriated money for prostate cancer
research. This is after my operation, but she concluded this
was to help me, and I advised her that it was too late to help
me, but it might help her grandson. So there is misinformation
or noninformation or whatever. But certainly in the Congress,
it has had across-the-board support.
Mr. Burton. Mr. Turner.
Mr. Turner. No questions.
Mr. Burton. Mr. Ose.
Mr. Ose. I do want to say hello to the Senator.
Senator Dole. Good to see you again. Good to see you here.
Mr. Burton. Mr. Owens, do you have a comment?
Mr. Owens. No.
Senator Dole. I watch him on the Late Show. I watch C-SPAN
at night.
Mr. Burton. You do? I may have to get on there more often.
Mr. Barr.
Mr. Barr. No questions. No, thank you, Mr. Chairman.
Mr. Burton. I had a lot of questions for you, Senator, but
I think you covered just about everything. We really appreciate
you and your wife and how you represent all these issues to the
country. You are a real credit to America.
Senator Dole. On Sunday, for example, I will be in Des
Moines, IA. I am not a candidate----
Mr. Burton. Are you sure?
Senator Dole. But there is going to be a Walk for Prostate
Cancer to raise money for prostate cancer.
So it is happening. All these things are happening, so
there is more awareness. A lot of it is being done by men who
have been through the process, radiation, whatever treatment
they might have had. So I think the word is getting out.
But certainly this hearing will be helpful and what you do
individually will be helpful as you go back to your districts,
town meetings, whatever. Thank you.
Mr. Burton. Thank you, Senator.
Mrs. Gallo, thank you for your patience. Once again we
really appreciated your husband, serving with him and traveling
with him. He was a fine fellow. We appreciate what you are
doing by carrying on his memory with this Institute.
Mrs. Gallo.
Mrs. Gallo. Thank you very much, Mr. Chairman. I want to
thank the committee for allowing me to testify today,
especially before the people who knew and worked with Dean in
Congress. That is why it is nice to be here, because I am
talking to people who really knew him. So if I can use him as
``a poster child''--for prostate cancer, I think that is very
important. You put a face with the disease, and this is exactly
what I am trying to do.
I want to give you a little background on what happened to
Dean with regard to prostate cancer. Back in March 1991, he had
his normal physical in Congress, and about August 1991, he
started with a backache. Of course, as is typical of men, they
don't go to the doctor, and I kept bugging him. Finally, in
February 1992 he went to an orthopedist, who gave him cortisone
shots. Didn't work. They gave him a bone scan, and he called me
up and said, ``Honey, I have got prostate cancer.'' I
responded, ``What? What is prostate cancer?'' Not knowing what
I was getting myself into and how my life was going to change
at that point. He said his bone scan lit up like a Christmas
tree.
I am not sure if everyone is aware of the PSA test. A
normal PSA, the prostate specific antigen, is usually 1 to 4.
Dean's PSA was 883. He was already in the advanced stages of
prostate cancer; it had already metastasized to his bones.
His prognosis was only 3 to 6 months. This was back in
1992, and, as you all know, he was in Congress until 1994.
Dean went to his urologist where we lived in Morris County.
He said, what can you do for me? The doctor said they could
remove his testicles, because the testosterone is what causes
the cancer cells to grow. I said to him, I think before we go
to that extreme, I would like to look at other options.
Because he was down here in Washington most of the time and
we did not have a cancer institute in New Jersey, he decided to
go to the National Institutes of Health. Dean was treated by
Dr. Charles Myers and was actually one of the first two people
on a protocol called suramin, which--I don't know if you
remember Bill Bixby, they tried it on him when he had prostate
cancer, but unfortunately, it had already advanced to his
organs.
With that, Dean's PSA did come down between 1992 and 1993.
In January, it was 3.5. People in Congress at the time did not
realize Dean was sick with prostate cancer. In fact, Senator
Dole made a comment: Do you say anything? Will people look at
you differently? And that is what Dean's concern was. He loved
his constituents and didn't want them to feel sorry for him
because he was going through this process of dealing with
cancer.
So for the following couple of years he seemed to be doing
OK. He was on different protocols. One of the things you live
by is the PSA. He would get it checked every month, and
sometimes it would be up, sometimes it would go down; and then
you have to decide, if it went up, what were you going to do
next.
I am sorry, I am just trying to gather myself here.
Finally, what happened was, toward the fall of 1994, as you
all recall, Dean had decided to retire from Congress. He had
very bad bone pain, and it couldn't be controlled at that
point. So he decided not to run for re-election in November.
When Dean left Congress, he decided to try to work harder
on the cancer, which he did, but unfortunately, the pain was so
much out of control that there wasn't too much more they could
do for him. Unfortunately, in October 1994, he fell and broke
his shoulder, which put him in the hospital.
The bone pain was so excruciating, it was very difficult to
treat it. Most of the time, they treat bone pain with morphine,
and from what I understand, that doesn't always take the pain
away like it should.
Unfortunately, the cancer was so well advanced that he died
on November 6, 1994. All I can say is that Dean and I had the
best 2\1/2\ years of our 8-year relationship when he had the
cancer. It brought us much closer together and created a love
that I may never know again. I saw a very warm and loving side
of Dean that I may have never known had he not had cancer.
When Dean was diagnosed, we started going to church and we
believed that the Lord would get us through the tough times.
Dean was a wonderful, strong individual, and he put up an
incredible fight. I truly believe the support system was part
of what helped him through that tough time.
If the PSA had been available when Dean had his yearly
physical, maybe Dean would have been diagnosed in the early
stages rather than the advanced stages in 1992. If we had had
more funding for prostate cancer at that point, and research,
perhaps Dean would have survived.
We do need more money for prostate cancer research. If we
don't have the funding, we can't attract the scientists to come
and do research in this field. Prostate cancer, as Chairman
Burton had remarked, has the highest incidence rate in the
Nation.
We need the funding, to be able to prevent or possibly cure
this disease. We need the FDA to find a better approach to move
the approval process which affects the public. We also need to
focus on research for pain management. As I said before, the
bone pain is horrible. We need to look at how to improve the
quality of life, not always the quantity of life.
We need more studies and funding for complementary and
alternative medicines. I have seen that people that have been
on some kind of complementary or alternative medicines, along
with standard chemotherapy, seem to do a little better.
I feel nutrition is a very important part, of prevention
and the treatment of prostate cancer. I feel it helps to build
the immune system and keep it healthy when the body is being
fed the toxins to destroy the cancer cells.
Dean had a nutritionist come in before he passed away, and
unfortunately, I wish I had done it sooner. I think it would
have helped him to survive or possibly do better with his
chemotherapy treatments.
Unfortunately, the other point with nutrition is, our foods
do not have the nutrients like they used to because we process
the foods for shelf life. We lose a lot of our nutrients, so
that is why the supplements are so important.
Today, prostate cancer is no longer an older man's disease;
30 to 40 percent of men over 50 will be diagnosed with prostate
cancer. A prime example is my husband's doctor, Dr. Charles
Myers, who treated my husband. To me he was my hero because he
kept Dean alive for 2\1/2\ years and Dr. Myers was just
diagnosed a couple of months ago with prostate cancer.
Since Dean's death, I have become a prostate cancer
advocate. I have worked with the American Cancer Society and
developed a prostate task force to educate the community. I
have worked with the American Foundation of Urologic Disease. I
am also a founding and present board member of the National
Prostate Cancer Coalition, and I also work with the Men's
Health Network.
I have also testified at the State level for two bills. One
was to name June as Prostate Cancer Awareness Month in memory
of Dean, and the other was for insurance coverage for the PSA
and the digital rectal exam.
One concern which is important that Senator Dole mentioned
before, is the funding for medication for the patients. I think
Congressman Cunningham referred to that also--that the
medications are so expensive and even some of the treatments
they have to go through, the patients can't always afford them.
I think that is one area we need to have more money available
to them, whether it be through Medicare or their own insurance
companies.
I know the patients that come to the Cancer Institute where
I work, there are certain parts that are not always paid for,
like some of their visits and whatnot. It becomes very costly
when you are treating any kind of cancer or any kind of
disease.
I am currently working at the Cancer Institute of New
Jersey, which is the State's only NCI-designated center. I am
director of advocacy and fund-raising for the Dean and Betty
Gallo Prostate Cancer Center, which was just recently created
in memory of Dean. Dean was very helpful in getting the initial
funding to build the Cancer Institute of New Jersey. I am also
on the scientific review board at the Cancer Institute.
With regard to the Prostate Cancer Center, our intention is
to create more programs, bring in more research funding, and do
education and awareness. We want to make this a premier center
in memory of Dean.
One of the programs I am involved with that I am bringing
on board to the Prostate Cancer Center which, I am vice chair
of, is the 100 Black Men Prostate Cancer Initiative. We are
planning to screen the underserved population in the 21
counties of the State of New Jersey by the year 2001. We are
doing an educational part to educate the underserved on
prostate cancer, and are doing screenings.
Advocacy is really important. Part of what when Senator
Dole mentioned is getting out there to get out the word. It is
groups like the National Prostate Cancer Coalition, the ``us
too'' groups, and the grassroots that gets out there and tells
people how important it is to have early detection and
education on prostate cancer. That is the only way you are
going to stop it from going into the advanced stages like Dean.
It has been almost 5 years since Dean's death. My mind
knows time, but my heart doesn't. My goal is to prevent others
from suffering from prostate cancer the way Dean and his family
did. This is a family disease.
I want to advocate the importance of early detection,
awareness, and education. In doing so, I know when I leave this
Earth, I will have made a difference, as Dean had, and I know
we will be together again.
Thank you.
[The prepared statement of Mrs. Gallo follows:]
[GRAPHIC] [TIFF OMITTED] T4044.041
[GRAPHIC] [TIFF OMITTED] T4044.042
[GRAPHIC] [TIFF OMITTED] T4044.043
[GRAPHIC] [TIFF OMITTED] T4044.044
Mr. Burton. Thank you for that very moving testimony. We
really appreciate it. I know it was difficult for you.
You mentioned the incredible pain that Dean was suffering,
and it was treated, I guess, by morphine primarily?
Mrs. Gallo. Primarily. They also put him on this protocol
called strontium, which unfortunately I have a very tough time
with, because most of the men on it die from it. I think that
is what happened with Dean, it hits the immune system.
Mr. Burton. Were you offered anything as an alternative,
like acupuncture, or any other complementary treatments that
might have helped?
Mrs. Gallo. Not at that time. Unfortunately, I wasn't that
well educated to realize that may have been very helpful. I
think now--as time has gone on, I realize patients are
beginning to use that. I think it is helping a lot of patients.
Mr. Burton. I see. I don't know, do you know if any of that
is paid for by any of the insurance plans?
Mrs. Gallo. Probably not. I think most of them are not. A
lot of patients try to do something to help their chemotherapy.
I think some of the complementary medicines out there you have
to be concerned about, such as the herbal medicines. One of our
scientists, doctors, had done research on the PC SPES, which is
used to bring the PSA down. It does work, but the only problem
is you have to monitor it.
I do believe you need some kind of regulations when it
comes to any kind of herbal medications. You don't want the
person to get really ill if it is not monitored. I think it is
important to have alternative medicines cancer patients,
because they feel it does help to heal the good cells and keep
them going. I have seen people who have done that and they have
done very well with their chemotherapy.
Mr. Burton. Let me just ask you one or two more questions.
Did the spirituality that you were active in with Dean, did
that really help?
Mrs. Gallo. The spirituality with Dean and me was
incredible. I didn't really touch on that as much. I put it in
my testimony. But Dean and I did start going to church, every
Sunday, I had never given up hope that Dean was going to
survive. Up until the week before he died, I was not going to
let this man die. I was going to do everything humanly
possible.
On that Sunday I had said to my pastor that I had spoken to
the Lord 2 years ago and he promised he was going to heal Dean.
He said to me, the Lord doesn't always heal physically, he
heals spiritually. That is exactly what he had done with Dean.
I will give you a for-instance. We had been engaged a year.
I wanted to give Dean something for our anniversary of being
engaged, and I bought him this cross. He had been in the
hospital at this time because he had a hip replacement. I went
in and gave him the present, and he opened it. I didn't buy him
a chain because I didn't know if he would wear it. He was not a
real big jewelry person. Dean started to cry. He put the cross
around his neck, and he wore it until the day he died.
Another thing, along that note was, he died on Sunday, but
on the previous Thursday he was in excruciating pain. I went
in, and he said, honey, I can't do this anymore. I want to die
and be with the Lord. I just looked at him. I had no clue what
was happening at that point. I am sure, knowing Dean you knew
he wanted to know what was going on next. So finally he looked
at me 2 hours later and he said, honey, how long is this going
to take? I am looking at him, I don't know. Do I have a
heavenly contact somewhere? I had no clue what was happening at
this point.
On that Friday, one of the last things he said before they
put him into a comatose like state, which is when they brought
up his morphine count and also gave him Ativan to relax him, he
said, Jesus, please take me now.
So my pastor was right in the fact God had healed him
spiritually, and I guess that is what I felt my mission to him
was, to bring him to the peace he had when he passed away.
Mr. Burton. Did you get any nutritional advice from the
oncologist that was working with Dean?
Mrs. Gallo. I actually got a nutritionist to come in to
evaluate Dean. She gave a regimen of different vitamins he
should be taking and some changes in his diet. This was toward
the end. Again, I was learning so much in the process of
dealing with this disease. I really wish I had done it sooner,
because I think it really had some good merit to it.
I think one of the interesting parts is green tea which
seems to be helpful in even preventing cancer, and when you
have cancer, it supposedly helps to maybe not let it spread
further. There are still some studies being done with that.
Green tea seems to be one of the areas that they are saying has
some credence to it.
Mr. Burton. But the oncologist wasn't one of those who
recommended any kind of nutrition?
Mrs. Gallo. No.
Mr. Burton. I see my colleague is on the phone here. Let me
ask him one more question and then yield to him and then go to
the next panel.
Did anybody ever talk to you about why African American men
get--you said you worked with them a little bit--get and die
more from prostate cancer?
Mrs. Gallo. Part of it is, I think, the culture. Part of it
is the fact a lot of them don't have insurance and their fear
of medical community. These are the three areas. One of the
reasons I have gotten involved with the ``100 Black Men,'' is
because they do have the ability to bring us into the community
to educate them so they are not as afraid of the medical
community and are willing to get tested for prostate cancer.
Mr. Burton. Mr. Barr, do you have any questions?
Mr. Barr. No, Mr. Chairman. I appreciate the testimony.
Mr. Burton. I want to thank you very much, Mrs. Gallo, for
being with us. Continue your good work. If we can be of any
help, let us know.
Mrs. Gallo. If I can be of any help, I am here to help.
Mr. Burton. And we all miss Dean.
Mrs. Gallo. I do too. Thank you.
Mr. Burton. Would the next panel come up, the experts. We
appreciate your being so patient. We will try not to keep you
too long.
I can't recall when we have had so much knowledge and
talent at that table at one time. I only regret that more of my
colleagues are not here. I am sure there will be more coming
back and forth, running from different meetings. So I apologize
for that.
Dr. Geffen, I have been instructed to ask you if you have
an opening statement and let you start off, if you would like.
STATEMENTS OF JEREMY GEFFEN, M.D., GEFFEN CANCER CENTER AND
RESEARCH INSTITUTE; KONRAD KAIL, M.D., PHOENIX, AZ; SOPHIE
CHEN, Ph.D., BRANDER CANCER RESEARCH INSTITUTE, NEW YORK
MEDICAL COLLEGE; ALLAN THORNTON, M.D., INDIANA UNIVERSITY;
RICHARD KAPLAN, M.D., NATIONAL CANCER INSTITUTE, ACCOMPANIED BY
JEFFREY WHITE, M.D., DIRECTOR, NCI'S OFFICE OF CANCER
COMPLEMENTARY AND ALTERNATIVE MEDICINE; ANDREW C. VON
ESCHENBACH, M.D., AMERICAN CANCER SOCIETY; AND DR. IAN
THOMPSON, COL.M.C., UNIVERSITY OF TEXAS HEALTH SCIENCE CENTER
AT SAN ANTONIO
Dr. Geffen. Good afternoon. I am honored and privileged to
be here today and to have the opportunity to speak with you
about a subject that I care very deeply about, namely the
journey through cancer in general, and prostate cancer
specifically.
Like so many others, I have been touched by this disease in
many ways, including through members of my own family. I spent
14 years studying and training to become a medical oncologist
at some of the finest universities and medical centers in the
United States, and have also been fortunate to have studied
medical and spiritual traditions in other parts of the world.
For the past 10 years, I have also had the privilege of serving
as physician, guide, mentor, coach, and friend to thousands of
cancer patients and their family members, many of whom were
dealing with the often formidable challenges associated with
prostate cancer.
Along the way, I have learned one lesson over and over and
over again that I believe lies at the heart of what patients
and families experience on their journey through cancer. That
lesson is very simple, yet profound, and it is this: Cancer
often challenges the mind, heart, and spirit of patients and
their family members, as deeply, if not more deeply, than it
challenges the physical body.
Unfortunately, even tragically, this simple lesson is often
overlooked in the compelling search for newer and better ways
to diagnose and treat cancer.
The urgent drive to eradicate illness has caused Western
medicine, which we are so richly blessed to have, to focus
almost exclusively on the physical dimensions of disease,
rather than on caring for the whole person who has the disease.
This is especially true in the field of oncology.
With respect to prostate cancer, for example, as we have
heard today, we typically speak of incidence and mortality
rates, PSA screening programs and Gleason scores. We talk of
radical versus nerve-sparing prostatectomies, external beam
versus seed implant radiation therapy, and things like simple
versus total androgen deprivation therapy. In recent years, we
have also started to talk about the role of diet, nutrition,
and alternative and complementary therapies in cancer
prevention and treatment.
This is the language of prostate cancer, and it is also the
language that physicians, researchers, and legislators tend to
use when we talk about where the field is today and where it
should be going in the future. If we listen carefully to all of
this language, however, and if we have the courage to really
hear, we will notice something that is almost always glaring in
its omission: namely, the mind, heart, and spirit of the men
who are going through the nightmare of prostate cancer, and the
spouses and family members who are going through it with them.
Make no mistake, aggressively pursuing all avenues of
research in early diagnosis, prevention, and treatment of
cancer is a vitally, critically important task. However,
technological breakthroughs in science and medicine, no matter
how breathtaking or spectacular, will never fully resolve the
enormous spectrum of challenges encountered by people with
cancer.
And in a similar vein, as valuable as they are--undoubtedly
valuable--neither will diets, herbs, vitamins, antioxidants,
exercise programs or other similar regimens. Focusing primarily
on treating the physical body ignores the profoundly important
mental, emotional, and spiritual dimensions of this disease,
and it also ignores the important inner healing potential that
lies within all of us.
Thus, as radical as it may seem, I have one simple message
that I would like to bring to this committee. I believe it is
time for our medical and health care system to make a firm,
uncompromising, and unwavering commitment to honor and embrace
every single dimension of who we all are as human beings,
particularly in the care of people with cancer. At our cancer
center in Florida, we have implemented a unique program which,
along with high-tech conventional medical cancer treatments, is
designed explicitly to accomplish this very goal. The program,
which has seven levels, addresses each and every aspect of the
healing process that patients encounter on the journey through
cancer.
Very briefly, the seven levels are as follows: First is
education and information, which is designed to give patients
answers to the urgent, pressing questions which they have about
their disease and treatment options.
Next is psychosocial support, which focuses on the need and
benefits of having a strong support network on the journey
through cancer as well as the journey through life.
Third is what we call the body as garden, which encourages
patients to think of their body as a garden that can be
cultivated and nurtured rather than as a machine that is simply
to be fixed by the doctor. This level of the program is where
we also explore the vast array of alternative and complementary
therapies which can definitely help facilitate this process.
The fourth level of the program is called emotional
healing, and here we help patients and family members deal with
the difficult and at times overwhelming emotional challenges
encountered on the journey through cancer.
Fifth is the nature of mind, which helps patients gain an
understanding of how their own thoughts and beliefs, and the
meaning they give to events, including cancer, profoundly
influences their day-to-day experience of life and their
treatment process.
Sixth is life assessment, which helps patients understand
and connect more deeply to their life's deepest meaning and
purpose and to their most important goals and priorities for
the coming year.
And last, No. 7, is the nature of spirit, which teaches
patients to connect with the nonphysical, timeless,
dimensionless, and profoundly healing spiritual aspect of life
that we all share.
Years and years of experience have proven to me that these
are the seven areas of care that all patients need, in addition
to the very best that high-tech conventional medicine has to
offer. I believe that our challenge and our opportunity is to
find a way to make them available to every man, woman, and
child in America who has cancer. Thank you.
[The prepared statement of Dr. Geffen follows:]
[GRAPHIC] [TIFF OMITTED] T4044.045
[GRAPHIC] [TIFF OMITTED] T4044.046
[GRAPHIC] [TIFF OMITTED] T4044.047
[GRAPHIC] [TIFF OMITTED] T4044.048
Mr. Burton. Thank you, Doctor. We will take a look at your
book. I presume what you just talked about is in your book.
Dr. Geffen. That is right.
Mr. Burton. Hopefully it will help give us a more in-depth
understanding of how to deal with it. My mom and dad died of
cancer last October and November, and my wife has had breast
cancer for 5 years, so this is the kind of literature that we
have in the house all the time.
Dr. Kail, would you like to go next, sir?
Dr. Kail. I want to thank Chairman Burton and the members
of the committee for holding this hearing on one of the leading
forms of cancer affecting U.S. males. I am a licensed
naturopathic physician and a physician's assistant.
Mr. Burton. Doctor, this is going to be for the record and
it will be disseminated to the Congress. So we need you to talk
straight into the microphone.
Dr. Kail. I have a private practice in Phoenix, AZ, and
serve as the chairman of the board of the Southwest College of
Naturopathic Medicine and Health Sciences. I am here as a
representative of the American Association of Naturopathic
Physicians. I formerly was on their board of directors and I
participate in several other alternative medicine
organizations. I am currently a naturopathic physician
representative to the advisory council of the newly created NIH
Center for Complementary and Alternative Medicine, and I am
serving as the first NCCAM advisory council liaison to the
National Institutes of Health advisory panel as well.
I attended the last NCAP meeting and was pleasantly
surprised at the high level of interest among conventional
cancer specialists with alternative medical therapies.
Admittedly, they had little knowledge about how they worked,
but they were interested in the outcomes that they were
observing.
I hope that this will eventually become part of the day-to-
day course of medical events, but as of this reading, most
alternative treatments are not even considered as an option in
looking at the list of medical events that can happen in regard
to this.
My written statement refers to several things: The
similarities and differences in the training of naturopathic
and allopathic physicians, the medical philosophy that is
different and why that creates barriers to integrating this
into care, and we are also going to talk about some of the
things you can do to deal with prostate cancers and what we can
do to get by the barriers to care.
I had some slides prepared. This first slide looks at some
of the differences in training as far as specifics and some of
the softer areas of clinical science that we have specific
education in.
Next slide.
The next slide shows more equivalence of our education. If
you look at the top three schools, they are all naturopathic
colleges and the bottom three schools are well-known medical
universities. The main information here is that our total
number of hours is basically the same in basic sciences and
clinical sciences. You can see that in allopathic medical
sciences we are just a little bit short and of course the
naturopathic medical sciences, if you will, don't show any
representation at all in the allopathic venues.
Next slide.
This is even a bigger discrepancy when you look at some of
the things that were allowed to counseling and therapeutic
nutrition. The other differences that come other than our
education involve philosophy and the types of therapeutics.
Natural therapeutic modalities include five basic types:
Nutrition, botanical medicine, energy medicine, physical
medicine, psychological medicine, and minor surgeries, which
sometimes includes home birthing. And in some jurisdictions,
naturopathic physicians can write prescriptions and dispense
medications as well.
As to our philosophy, the next slide please, one of the
concepts that we hold as naturopathic physicians is the concept
of the vital force, that each person has in them a force that
innately tries to optimize conditioning and functioning. We
view health as more than the absence of disease but a balance
of a variety of forces moving toward the optimal condition.
Next slide.
Toxification is one factor that opposes this natural
inclination toward optimal. Toxification is the concept that
dysfunction of metabolic processes to detoxify internally
generated or ingested xenobiotics is a progenitor and
aggravator of disease and this is an event that can be
measured. Internal cleansing via detoxification protocols to
simulate liver and other organ functions result in a lower
level of internal toxic burning and hence facilitate healing.
Next slide, please.
There are basic tenets of care that are shared by most
healing traditions. The healthy lifestyle and treating the
whole person in the context of their environment are the things
that might be unique to us.
Next slide.
Naturopathic health care services are focused in a
different area. Our fortes are treatment of preclinical disease
and chronic disease management.
Next slide, please.
Diagnosis is around health risks, tissue function, and
finally gets to pathology. But we think it is very important if
you want to look at prevention that you look at the things that
precede disease. Your risk goes up; your function goes down.
Next slide.
Outcomes are based--hopefully, therapeutics are based on
outcomes. We review the medical literature. We develop the
protocol. We track our outcomes. We refine the protocol.
Next slide.
Studies have shown potential savings could be great. And
this is looking at naturopathic patients who were 50 percent
lower or discontinue conventional medication; 16 percent forgo
a surgery procedure, 96 percent get educated well at home, and
92 percent as a result of that change their lifestyle.
Next slide, please.
If you look at likelihood of use of therapies when
conventional therapies fail, of course supplements and diet
lead the pack, but increase likelihood when other things fail.
Epidemiology, there are a couple of points on here that are
important. First, that 80 percent of cancers are slow growing
and 20 percent of prostate enlargement is cancer. The rest of
the demographics you are familiar with.
Next slide.
If you look between 1983 and 1991, new cases increased
dramatically. But if you look at deaths due to cancer and
percentage of deaths, they are actually modest increases and
actually decrease in percentage of deaths. This reflects
earlier intervention due to better diagnosis. This is the
result of people getting those PSA tests out there.
Next slide.
This is probably the most dramatic slide I can show you,
and that is that this cries for conservative treatment. In one
study that is treated here only 8.5 percent of the people
followed for over 10 years died from their cancer, 47 percent
of those people died from other causes. The survival rate was
86.8 percent with no treatment at all compared to survival
rates of 65 and 83 percent with irradiation and prostatectomy.
The mean survival time of 10 years was found in 85 to 90
percent of the patients involved. This cries for conservative
treatment.
Next slide.
Some basic approaches that are different between allopathic
and alternative medicine. Allopathic medicine with regards to
cancer focuses on decreasing the cancer mass while alternative
methods focuses on increasing host survival. Allopathic usually
are single modality. There are some multimodality uses, but by
and large all alternatives are multimodality. The agents are
noninvasive and conventional agents reduce host defenses where
CAM agents build them. The best I can say is that the best
outcomes are an integration of both.
If we can go through the next slide quickly. If you look at
utilization of therapies, chronic conditions basically are
treated better by alternative medicine than possibly
conventional medicine. If you go to the next slide you will see
efficacy. With cancer in particular, you find that alternative
methods are on a par with conventional methods. In other words,
alternative treatment alone doesn't do any better than
conventional treatment alone. It is when you do both together
that you get a synergistic effect and actually do better.
Next slide.
Primary cancer therapy for alternatives is avoidance xeno
biotics, lifestyle modification, detoxification, energy
balancing, optimizing function, relaxation, and visualization.
Secondary therapies include antioxidants, immune
modulation, endocrine modulation, and specific therapy as to
tissue types.
Next slide.
Nutrition is a big part of that. This is also part of
prevention as well as treatment. There are several things
listed there that are very useful. The big ones of course are
modified citrus pectin seems to prevent metastases, and IV
vitamin C seems to be very promising.
Botanical medicines have specific indications for treating
prostate cancer. They either block estrogen or follow
stimulating hormone or somehow have a direct effect.
Next slide.
There are a whole bunch of other agents that have indirect
effects, or are more suited for specific treatment of symptoms.
Next slide, please.
There are also other therapies that are less formal and
secondary that are also very usual. As you can see there is a
wide variety. Homeopathic medicine is very noninvasive and we
have reviewed some cases at the NIH which are very dramatic in
homeopathic response to cancers. Dendritic cell therapy and
some others are very important.
Next slide.
Basically our modalities are inexpensive, they are easily
managed at home, they have less side effects, and do result in
better outcome than conventional medicine, and they do result
in better quality of life for patients that have them.
Next slide.
Barriers to integration. There are two big barriers. One is
46 percent of HMOs actively discourage patients from using
alternatives. This makes it real hard for people to go see a
doctor of their own. Another big barrier that is not stated
here is Federal policy and this has to do with entitlements. If
you are not entitled--if you look at the language of
entitlement of virtually every Federal program, there is no
language that enables alternative participation.
Other barriers to integration--next slide. This has to do
with the practitioners in the allopathic community. There is
lack of information about training of the providers in the
alternative community. There is lack of information about
alternative therapeutic modalities. There is lack of
information about interaction with allopathic therapeutics. And
in general there is a fear of liability with conventional
physicians comanaging patients with alternative physicians.
Part of this is due to the training that they receive. The
next slide please. You will see that a survey that I did of
conventional medical colleges that were training in alternative
methods we found that out of 26 schools we surveyed, 9
responded. But as you can see the quality of the courses here
were less than desirable. They are basically survey courses.
There is no place where conventional physicians can get formal
information that is quality information about alternative
modalities without going to school.
Some things to facilitate integration. I will be brief.
This is my last slide. Public demand for CAM health care
services is forcing these things. The public is driving this
boat. I think that is why we are all sitting here. Inclusion of
CAM providers into third-party reimbursed multispecialty care
networks forces communication. I am in many of these. I have to
communicate with the primary care doctors as part of my
consultation, and as a result of that, we are getting to know
each other and we trust each other's therapeutics more and we
interact more for the benefit of the patient.
Integration training. There is a leg that can be done on
both sides of the fence to help people understand each other
better. The NIH, of course, National Center for Complementary
and Alternative Medicine is a big step forward; however I want
to put this in context. Even though their funding went from
approximately $19 million to $50 million last year it still
represents only one-third of 1 percent of the total NIH budget.
I think that is a very dramatic place to state where
alternative medicine is in the conventional community,
certainly within the research community. It is the smallest,
tiniest little consideration out there. I think if you look at
the Federal Government in general that reflect business, the
same attitude.
Potential cost savings is so great, and the plan for
integration is so necessary, that there are several alternative
medicine organizations that have been working on a national
plan to address the Federal public policy issues in regards to
this. I have a copy of the plan that has been put together by
these organizations here with me. I would like to see it
entered into the record. I would also ask that you and other
members of the committee or committee staff review the document
and submit comments, criticisms, and suggestions for
improvement to the organizations who are leading this effort.
I think if you read this, the magnitude of this document
will suggest there are some very solid and good ways without a
lot of funding, with just entitlement and other things, that we
can do to greatly accelerate this process of integration which
I believe again shows the best outcomes for all those
concerned. I thank the committee for your time.
[The prepared statement of Dr. Kail follows:]
[GRAPHIC] [TIFF OMITTED] T4044.049
[GRAPHIC] [TIFF OMITTED] T4044.050
[GRAPHIC] [TIFF OMITTED] T4044.051
[GRAPHIC] [TIFF OMITTED] T4044.052
[GRAPHIC] [TIFF OMITTED] T4044.053
[GRAPHIC] [TIFF OMITTED] T4044.054
[GRAPHIC] [TIFF OMITTED] T4044.055
[GRAPHIC] [TIFF OMITTED] T4044.056
[GRAPHIC] [TIFF OMITTED] T4044.057
[GRAPHIC] [TIFF OMITTED] T4044.058
[GRAPHIC] [TIFF OMITTED] T4044.059
[GRAPHIC] [TIFF OMITTED] T4044.060
[GRAPHIC] [TIFF OMITTED] T4044.061
[GRAPHIC] [TIFF OMITTED] T4044.062
[GRAPHIC] [TIFF OMITTED] T4044.063
[GRAPHIC] [TIFF OMITTED] T4044.064
[GRAPHIC] [TIFF OMITTED] T4044.065
[GRAPHIC] [TIFF OMITTED] T4044.066
[GRAPHIC] [TIFF OMITTED] T4044.067
[GRAPHIC] [TIFF OMITTED] T4044.068
[GRAPHIC] [TIFF OMITTED] T4044.069
[GRAPHIC] [TIFF OMITTED] T4044.070
[GRAPHIC] [TIFF OMITTED] T4044.071
[GRAPHIC] [TIFF OMITTED] T4044.072
[GRAPHIC] [TIFF OMITTED] T4044.073
Mr. Burton. Thank you. We will review that followup on that
and I have some questions for you too on the record when we get
to that.
Dr. Chen.
Dr. Chen. Mr. Chairman, and members of the committee, thank
you for your invitation to testify today. It is my honor to
present to you information on scientific research on botanicals
for treatment of prostate cancer.
I appear before you today as a medical researcher. I got
into this field because of personal experience with family
members who had prostate cancer. In the past 10 years, we have
learned that the fight against cancer requires multiple
interventions and efforts. The good news I can say today is
there are botanicals that can be beneficial for cancer
treatment and for prevention. The bad news is we do not have
enough clinical studies and there is still a long way to go.
One role for botanicals is that they can serve as
complementary medicine to enhance the conventional therapies.
They will not be a replacement for cancer therapy at this
point. There are large numbers of botanical components that
have been identified as antioxidants, immune stimulants, and
others and are shown to be preventive for prostate cancer.
These include selenium, vitamin E, green tea extract, lycopene
from tomatoes, soy products, and PC SPES.
It is postulated that the reason Asian men and women have a
lower incident rate of prostate and breast cancer is because
their diet is rich in botanicals.
I feel the more we study these compounds, the better we can
utilize them to help patients. Here I would like to discuss PC
SPES, which has been studied at many different prestigious
laboratories and hospitals across the United States. To my
knowledge, more than 1,000 men are taking PC SPES at the
recommendation and suggestion of their physicians. PC SPES is a
standardized botanical formulation composed of seven purified
Chinese herbs and one American herbal extract. The preparation
is based on a patented formulation which I developed. The
laboratory data so far has shown that it can inhibit prostate
cancer cell growth in a test tube. It can also induce them to
go suicidal.
Two different animal studies confirm the laboratory finding
and show a 50 percent reduction in prostate tumor incident
rate, in tumor volume and in metastasis.
At the present time there are several clinical trials in
phase two. Two of them have been reported recently. Dr. Eric
Small from the University of California San Francisco found
that 61 advanced stage prostate cancer patients responded to PC
SPES; 27 of them belong to the group of hormone sensitive and
they responded 100 percent. The other 34 hormone failure
patients responded with 57 percent. He also found some
reduction in the pain of those patients.
A separate study by German physician Dr. Ben Pfeifer with a
team studied 16 hormone refracture patients. They also had
failed the conventional therapy and were at the end of their
life. The response rate among this group was about 70 percent
and the quality of life was found to be profoundly improved.
Those data were preliminary. There are some side effects that
need to be investigated. We need more funding and more studies
to conclude these exciting results and hope we can help more
prostate cancer patients using this new approach with multiple
components based on scientific studies.
In conclusion, I would like to suggest that Congress
consider fully refunding and expanding the budget for the
National Center for Complementary and Alternative Medicine and
the Office of Dietary Supplement at the NIH to undertake
clinical studies on botanicals which show promise for prostate
cancer treatment. I also would like to suggest that the
Congress can promote and encourage more clinical research on
botanicals by the NCI. Thank you for your time.
[The prepared statement of Dr. Chen follows:]
[GRAPHIC] [TIFF OMITTED] T4044.074
[GRAPHIC] [TIFF OMITTED] T4044.075
[GRAPHIC] [TIFF OMITTED] T4044.076
[GRAPHIC] [TIFF OMITTED] T4044.077
[GRAPHIC] [TIFF OMITTED] T4044.078
[GRAPHIC] [TIFF OMITTED] T4044.079
[GRAPHIC] [TIFF OMITTED] T4044.080
[GRAPHIC] [TIFF OMITTED] T4044.081
[GRAPHIC] [TIFF OMITTED] T4044.082
[GRAPHIC] [TIFF OMITTED] T4044.083
[GRAPHIC] [TIFF OMITTED] T4044.084
Mr. Burton. Thank you, Dr. Chen. We will have some
questions for you and NIH about your findings in just a little
bit.
Dr. Kaplan, would you rather someone else go first?
Dr. Kaplan. I thought that Dr. Thornton was going ahead of
me.
Mr. Burton. Dr. Thornton.
Dr. Thornton. Thank you, Congressman Burton, for the
opportunity to speak before you and your committee this
morning. I serve as the chief advisor for the Midwest Proton
Radiation Institute, and my current faculty position is as a
member of the Department of Radiation Oncology at Massachusetts
General Hospital and a member of the Harvard Medical School. I
have prepared a brief summary of prostate cancer and then I
will focus on proton therapy.
In general, cancer of the prostate is common in men of
developed countries second only to lung cancer in incidence.
The current incidence is greater than 75 per 100,000 with an
annual incidence of new cases of 120,000 in this country. The
tumor is more common in men of African-American ancestry and
increases in incidence with age.
Most cases of prostate cancer are composed of what is known
as adenocarcinoma cells, a pattern that is seen on pathologic
specimens under the microscope. A small percentage of these
cells are transitional tumors, which are much more aggressive.
Importantly, the degree of differentiation of the tumor as
seen under the microscope when the tumor is first diagnosed is
the single most important factor to determining survival and
how aggressive the tumor will be.
The cancer of the prostate usually spreads, that is
metastasizes, by passage through the lymph system to lymph
nodes, that is one mechanism; second, by direct extension to
tissues around the prostate gland; and also by direct invasion
into the blood vessels and thereafter into other organs
throughout the body. The tumor may spread to bones, which we
have heard about today, where severe pain and fracture may
occur, as well as to the liver, to the lungs, but rarely the
brain. Patients often live for significant periods of time
after the tumor has spread subject to prolonged pain and
compromise of quality of life due to these bone and organ
metastases.
Fortunately, many prostate tumors are now detected at an
early age due to the development of PSA antigen test which we
have been hearing about today, which was developed in the
1980's. Formerly, patients were not diagnosed until changes in
either the urine stream or frequency prompted a rectal exam.
With sensitive PSA screening, a significant number of patients,
now thought more than 50 percent, present with early stage
disease, which represents a clear pattern shift, disease
diagnosed prior to the likely spread of the tumor. This offers
potential for long-term control and cure to increasing numbers
of American people if the control of the tumor in the prostate
gland can be realized.
The current therapeutic options as standardly recognized
include surgery, radiation, and we have heard cryotherapy for
very early stage disease. Hormonal therapy alone is effective
therapy only for very early cases in elderly men who are
thought too senior for either radiation or surgery.
Chemotherapy has thus far been relatively unsuccessful in
affecting this tumor. Surgery is reserved for men with tumor
confined to the prostate gland and it is usually designed for
men with lower grade--that is less likely to spread--types of
tumors. Men must be healthy in order to tolerate the surgery
and they must recognize that over 50 percent of the time they
will lose sexual function and may lose control of their bladder
function.
Radiation is an effective alternative to surgery for
prostate cancer supported by the consensus development
conference of the NIH in 1988. Radiation has the advantage of
less toxicity with greater likelihood of preservation of sexual
function and bladder function. It is also used widely for men
with more advanced tumors, those who have a higher likelihood
of spread of their tumors, or those who are thought not
suitable for surgical rejection.
However, conventional radiation, which is known as photon
or x-ray radiation, that is available in most community
hospitals and most university hospitals, cannot be aimed to
selectively treat only the prostate gland and not the adjacent
rectum and bladder. Therefore, the doses that can be safely
delivered with conventional photon radiation are limited.
Proton therapy involves the precise delivery of high doses
of radiation with particle beams from hydrogen atoms, the
hydrogen atom nuclei, designed to treat only the prostate gland
and involved tissues around the gland. This therapy for
prostate patients is predicated on the knowledge that prostate
cancer remains localized for a significant length of time in
the earlier stages of the disease. However, we know from very
elegant Canadian studies by Juanita Crook in 1987 that over 38
percent of men will still harbor tumor cells within their
prostate glands after conventional radiation.
Of great significance is the knowledge that patients whose
biopsies are positive after this treatment will have over a 70
percent likelihood of going on to develop metastatic disease.
However this represents an incurable situation for these
patients. However, if the biopsy is negative after radiation,
then only 25 percent of the patient will develop metastatic
disease and will likely be cured. Therefore, effective control
of the tumor within the prostate is the key to long-term
control and the cure of this otherwise relentless disease.
Proton therapy has been used for many years, since 1962,
for the treatment of tumors at the base of skull, inaccessible
to neurosurgeons. Cure rates with tumors at the base of brain
have been increased by 35 percent at the Massachusetts General
Hospital in Boston, working in conjunction with the Harvard
Cyclotron Laboratory. The physics and computer dosimetry of
proton therapy has been developed to a very sophisticated
degree, spurring increasing elegance of conventional therapies
as well.
Figure 1--and I have but one slide here--graphically
demonstrates the high degree of concentration of protons in the
prostate gland as viewed horizontally on a CT scan, which is
known as computerized tomography scan. The concentric colored
lines represent the areas treated by the protons with very high
degrees of concentration. Volumes outside these lines receive
only 20 percent of the prescribed dose. If you look carefully,
you will see a crescent-shaped white line which represents the
anterior wall of the rectum, which is a very sensitive
structure and this is largely untreated and spared with
protons.
Currently only two centers exist in the United States to
treat patients with proton therapy: Massachusetts General
Hospital in Boston and Loma Linda Medical Center in Los
Angeles. No center exists to treat patients in the Midwest, who
must travel great distances and stay for an average of 2 months
of proton treatment in either Boston or L.A.
The Midwest Proton Radiation Institute, a consortium of
Midwest universities led by Indiana University, is seeking to
convert an existing accelerator at the Indiana University
Bloomington campus into a facility for the treatment of
prostate cancers using proton therapy. Recognizing the need to
provide access to this type of cancer treatment to patients in
the Midwest, the House Labor, Health and Human Services,
Education Appropriations Subcommittee in the 1999 committee
report accompanying the appropriations bill, encouraged the NCI
to assist with the conversion of an accelerator for proton
therapy treatments in a location not currently served by two
existing facilities. The MPRI clearly fits this outline and
MPRI sponsors, led by Indiana University, submitted an
application to the NCI earlier this year to seek assistance
with the conversion of this accelerator at the cyclotron
facility for proton therapy treatments. To date, NCI has not
reviewed the application.
I ask your committee to inquire of the agency its plans for
responding to the language in the House report supporting the
establishment of a proton therapy facility in the Midwest and
how that agency plans to specifically address the proposal put
forth by Indiana University. It is our hope that congressional
support for prostate cancer will include assistance to the
Midwest Proton Therapy Institute so that the proven benefits of
proton therapy may be available to patients throughout the
United States with more equitable regional access.
We appreciate the opportunity to review the effectiveness
of proton therapy for prostate cancer with this committee.
Thank you.
[The prepared statement of Dr. Thornton follows:]
[GRAPHIC] [TIFF OMITTED] T4044.085
[GRAPHIC] [TIFF OMITTED] T4044.086
[GRAPHIC] [TIFF OMITTED] T4044.087
[GRAPHIC] [TIFF OMITTED] T4044.088
[GRAPHIC] [TIFF OMITTED] T4044.089
[GRAPHIC] [TIFF OMITTED] T4044.090
Mr. Burton. That was one of the slickist bits of lobbying I
have ever seen, it was well done.
Dr. Kaplan, are you next?
Dr. Kaplan. Congressman Burton and members of the
committee, I coordinate NCI's extramural clinical research on
prostate cancer treatment. I am accompanied by Dr. Jeffrey
White, who is directly behind me, the Director of the NCI's
Office of Cancer Complementary and Alternative Medicine. I am
pleased to appear before you to describe NCI's prostate cancer
research program and our interest in complementary and
alternative approaches to prostate and other cancers.
The Congress has asked NIH to make prostate cancer a top
priority in allocating funding increases to accelerate spending
on prostate cancer and to consult closely with the research
community. We have undertaken a vigorous effort to respond in
all of these areas.
Prostate cancer has risen in clinical and research
importance in the last decade faster than any other neoplasm.
Some of the many factors responsible for this are greatly
improved methods to identify the disease before it causes
symptoms; major public awareness campaigns, including the sorts
of things that Senator Dole has had such an impact on; some
modest improvements in surgery, radiation, and hormonal therapy
that have rendered management options more acceptable; and
important new research opportunities.
When Dr. Klausner assumed leadership of the NCI he
envisioned a new strategy of evaluating the entire research
portfolio for a particular disease from the ground up and
structuring future efforts according to the insight and advice
of the entire extramural research community and of
stakeholders, including patients, advocacy and patient support
organizations, and professional societies.
This new process called a Progress Review Group [PRG], was
initiated in prostate cancer and breast cancer and it was
extremely productive. The Prostate Cancer PRG laid out a
framework for planning and identified a number of particularly
important problems and potentially productive areas of
research. There are about 20 new NCI initiatives outlined in
the reports that we have provided, but I would like to go
through some examples.
The following sequence of three initiatives taken together
should speed the development of new interventions, that is to
say treatments, of any type from initial work in the
laboratory, or animal, all the way into definitive testing in
men with cancer. The RAID and RAPID programs, as they are
called, are intended to expedite new agent development by
moving novel molecules toward clinical trials. Often there is a
catch-22. Many scientists don't have the resources to do all
the required animal testing or drug formulation before tests in
humans can begin. At the same time it is not easy to get a
pharmaceutical or biotech industry partner to commit such
resources until an agent is further along.
This is where RAID and RAPID can step in. Independent
investigators are given access on a competitive basis to NCI's
own preclinical drug development resources and expertise. They
are assisted with necessary development steps to enable
investigational new drug application filing with FDA and
initiate proof-of-principle trials. Then NCI steps back out and
the investigators are free to develop industry collaborations.
The next step is to actually carry out preliminary patient
clinical trials to find out how best to apply the new
intervention and whether it actually does appear to do
something useful in patients. These studies are time consuming
and personnel intensive and may require sophisticated tests.
And it is increasingly difficult in today's medical care system
to do such trials without grant funding. But it is challenging
to get a conventional grant with little preliminary data and
there can be frustrating and unsatisfactory delays.
For this reason, we developed the Prostate Cancer Quick
Trials program, a process for rapid approval and funding of
early trials of new agents. We feel we can increase the number
of early clinical trials and the number of patients
participating by two to threefold. If the Quick Trials approach
works the way we anticipate it will, we want to make a similar
mechanism available to researchers working in other cancers as
well.
Then how do we speed up definitive testing of agents that
do appear promising in these early trials? And how do we assure
that patients all over the country have access to these?
NCI has begun a complete restructuring of the national
system in which the best new approaches are compared with
established treatments. These studies will be available not
just for particular teams of doctors but to patients anywhere
through any qualified oncologist. This new system is a complex
one to set up and so it will be tried out in a limited number
of diseases at first. Prostate cancer was selected as one of
the two types of cancers in which to start.
It should be noted that all of these new initiatives are
inherently open, competitive ones. They do not specify that the
interventions be drugs. They could be dietary supplements or
surgical procedures or new radiation techniques or gene
therapies, whatever, and they may be intended for either
treatment of established prostate cancers or for prevention.
And they may arise within the conventional medical research
community or from the alternative medical community, academia
or industry.
In addition, the NCI is moving very quickly in important
directions to develop CAM information and expand research
opportunities for CAM investigators. These activities are broad
in scope and include strengthening our relationship with the
National Center for Complementary and Alternative Medicine
[NCCAM], the careful evaluation of alternative therapies and
the development of accurate CAM information for the public.
One collaborative goal is to develop centers for CAM
research as well as specialized research centers to investigate
the biological effects of botanicals, including those that are
available as dietary supplements. Several studies of
alternative approaches are already under way. NCI-sponsored
projects recently have suggested that both vitamin E and
selenium supplements may be capable of preventing prostate and
other cancers. More investigation is needed, and NCI continues
to support several studies addressing the effectiveness and the
prevention of prostate cancer by lycopine and dietary soy as
well as by vitamin E and selenium.
Now, everything I have described thus far has to do with
applying interventions that build on what we have already
discovered, but the greatest potential for actually eliminating
prostate cancer depends on dissecting and understanding biology
of the disease, how it does its damage, what genetic and
molecular abnormalities allow it to grow, spread, and for it to
resist therapy. In fact, the real answer to many of the
dilemmas in management of patients may be found only when we
know enough about individual tumors to predict their behavior
and access their vulnerabilities.
For example, we currently estimate which prostate cancers
are most likely to recur by their appearance under a
microscope, their stage, and the PSA level. But there is so
much overlap that the decisionmaking for most patients is still
terribly difficult. If we had better ways to classify whether
an individual patient's tumor is one with a high malignant
potential or one of the larger number that poses considerably
less risk, then we could much more easily test early detection
and screening technologies and we could provide the confidence
to spare many men the long-term side effects of prostate
surgery or radiation.
Mr. Chairman, if you would allow me to have 1 or 2 more
minutes I would like to cover one other initiative. For these
all important reasons, I would highlight these two other
programs. The Cancer Gene Anatomy Project, which is CGAP, which
has thus far discovered 146 genes that appear to be prostate
specific and 400 genes that appear to be expressed differently
between normal prostate tissue and prostate cancer.
This information and subsequent discoveries of CGAP will
provide the raw material for undertaking the next initiative,
the NCI Director's Challenge for Molecular Diagnostics. Its
goal is to develop a tumor classification system that is firmly
based on cell biology of cancers rather than on microscopic
appearance. Prostate cancer is a particularly important area of
application for this effort because its behavior is so variable
from patient to patient.
Mr. Chairman, I appreciate the level of interest this
committee has shown in prostate cancer. I hope my testimony
demonstrates NCI's commitment to advancing our knowledge about
prostate cancer as rapidly as possible. Our activities, and
specifically Dr. Klausner's leadership efforts over the past
year, have invigorated the prostate cancer research community.
It is this essential partnership between NIH, other funders and
that research community that will successfully accomplish the
ambitious goals of this plan.
Dr. White and I will be pleased of course to answer any
questions you may have.
[The prepared statement of Dr. Kaplan follows:]
[GRAPHIC] [TIFF OMITTED] T4044.091
[GRAPHIC] [TIFF OMITTED] T4044.092
[GRAPHIC] [TIFF OMITTED] T4044.093
[GRAPHIC] [TIFF OMITTED] T4044.094
[GRAPHIC] [TIFF OMITTED] T4044.095
[GRAPHIC] [TIFF OMITTED] T4044.096
[GRAPHIC] [TIFF OMITTED] T4044.097
[GRAPHIC] [TIFF OMITTED] T4044.098
[GRAPHIC] [TIFF OMITTED] T4044.099
Mr. Burton. Thank you, Dr. Kaplan. Dr. von Eschenbach.
Dr. von Eschenbach. Good afternoon Mr. Chairman, members of
the committee. I am honored to be here today representing the
American Cancer Society as a national board member and would
like to thank you and the committee for the opportunity to
appear to testify on issues concerning our Nation's fight
against prostate cancer.
In addition to my involvement in the American Cancer
Society, I have been privileged to participate in this fight in
a variety of other ways, serving as the chairman of the
Prostate Cancer Multidisciplinary Research Program at the
University of Texas M.D. Anderson Cancer Center. As well as
being the chairman of the Integration Panel for Prostate Cancer
in the congressionally directed research program at the
Department of Defense, I am a medical and scientific advisory
cochair of the National Prostate Cancer Coalition and a member
of the Scientific Advisory Board of CAP-Cure. This involvement
in prostate cancer has impressed upon me that this disease is a
national tragedy.
Mr. Chairman, this morning you so eloquently described the
burden of this disease by demonstrating those statistics. And
we heard earlier today from Senator Dole and Congressman
Cunningham and Mrs. Gallo the enormous pain and suffering that
this disease inflicts on both patients and their families.
The Cancer Society recognizes that prostate cancer is a
medical and scientific problem as well as a cultural and social
problem and economic problem. And so we have chosen to really
advocate a comprehensive three-pronged approach that recognizes
the importance of contributing to and enhancing the funding of
research so we can develop more effective strategies of
prevention and therapy, to advocate for equal access to quality
care throughout this entire country and to improve our
education and promotion of early detection and treatment
options.
Today I can only focus on one of those many important
issues and I would like to then comment specifically upon the
importance of enhancing our commitment to the research
endeavor.
The American Cancer Society supports the strategic plan of
the National Cancer Institute and the Department of Defense to
promote and enhance our research effort in prostate cancer.
This disease is an incredibly complex problem. There are
important fundamental issues that need to be addressed if we
are truly going to face and change those statistics that you
pointed out to us this morning.
Why in one patient is this a latent disease while in
another like Congressman Gallo it can be incredibly virulent
and lethal in a short period of time? Why does it take such an
enormous toll on African-Americans in this country? And why
does the lethal form of prostate cancer that kills us
preferentially metastasize to bone where it then becomes
refractory to our standard treatments?
If we are going to make a difference, the only way to make
that difference is by understanding these processes so we can
then rationally develop appropriate, effective strategies to
interrupt them.
It is true that you should take great pride in what you
have already accomplished in supporting research throughout
this country through your efforts, and that research is bearing
fruit. The PSA that you have heard about today from so many
people that has altered and changed our ability to find this
disease early in its course when it is potentially curable is a
direct result of research. There are now new therapies that are
being introduced in the clinic today, including at M.D.
Anderson trials where we are now taking some of the genes that
are defective in the more virulent forms of prostate cancer
and, using an adeno virus as a carrier, we are able to reinfect
those prostate cancer cells with the normal gene in an effort
to prevent their lethal progression.
You have heard about a variety of new compounds and
substances that are coming to us, such as the antiangiogenesis
factors that stop the blood supply to these tumors and keep
them from being able to spread and progress.
And so much is being accomplished but so much yet needs to
be done, and frankly the funding to do it is inadequate. As I
mentioned, I chair the Integration Panel at the Department of
Defense. You have been generous in this Congress in fiscal year
1999 to allocate $50 million to that program for research, of
which we had about $41 million to spend across a wide variety
of needs, including the training of new investigators in the
field, the development of programs in minority universities and
colleges, and then we had about $20 million left over to fund
novel new ideas in prostate cancer research as well as the
development of young investigators.
We received in that program over 560 applications of which
we had only sufficient money to fund 46, an 8 percent funding
level. If we just look at those ideas that the peer review
panels believed to be outstanding and excellent and scored
about 2.0 in their priority scores, we were only able to fund
one of three; two out of every three ideas had to be rejected,
not because they were not excellent but because we did not have
sufficient funds.
It is essential for us to change the face of this disease
to understand it better, and then to translate that
understanding into clinical trials, evaluating new and
effective methods so that we can make them available to men and
their families to achieve the scientific breakthroughs that you
expect of us.
I have been privileged for over 25 years to walk this
journey with prostate cancer patients and their families, and
my own father died of this disease. I thank you and your
committee for the concern and dedication that you are
demonstrating in having these hearings. And this week, National
Prostate Cancer Awareness Week, is a special time to remember
the fathers and husbands and brothers who have been lost to
this disease. The American Cancer Society and I, along with all
the organizations I am privileged to be a part of, look forward
to working with you in a partnership to change this journey of
fear and suffering into a journey of hope. Thank you.
[The prepared statement of Dr. von Eschenbach follows:]
[GRAPHIC] [TIFF OMITTED] T4044.100
[GRAPHIC] [TIFF OMITTED] T4044.101
[GRAPHIC] [TIFF OMITTED] T4044.102
[GRAPHIC] [TIFF OMITTED] T4044.103
[GRAPHIC] [TIFF OMITTED] T4044.104
[GRAPHIC] [TIFF OMITTED] T4044.105
[GRAPHIC] [TIFF OMITTED] T4044.106
Mr. Burton. Thank you, Doctor. Dr. Thompson.
Dr. Thompson. Good afternoon, Mr. Chairman, members of the
committee. My name is Ian Thompson. I am a urologic oncologist
from San Antonio. I am a professor of urology at the University
of Texas Health Science Center, director of the Prostate Cancer
Program at the San Antonio Cancer Institute, and consultant in
urology to the Surgeon General of the United States Army. I
would like to express my sincere appreciation for the
opportunity to participate in this important hearing.
With the successful aging of the U.S. population, prostate
cancer has become an increasingly important public health
threat. This disease will assume increasing importance as its
frequency is directly related to a man's age. With the
continued improvement in life expectancy in the United States,
prostate cancer will become an even more significant disease.
Traditionally, we have focused on two methods of addressing
the disease. The first was an effort to improve our treatment
of prostate cancer which as of this morning you heard it can
spread to the bone and can be associated with significant pain,
decreased appetite, and a major reduction in the quality of
life. While much knowledge has been attained through cancer
clinical trials, rarely can this stage of the disease be cured.
With the advent of prostate specific antigen [PSA], testing
in the 1980's, the focus moved to early detection and
treatment. Over the subsequent decade we have witnessed a fall
in prostate cancer deaths. The degree to which this fall is due
to PSA testing is yet undetermined, but it is an extremely
important and promising development. Nevertheless, the cost and
side effects of such treatment can be significant.
The science of cancer prevention is one of the youngest
fields of oncology. Nevertheless, important advances have been
witnessed in the past 10 to 15 years with many of these
advances heralding a new age in our approach to prostate
cancer. I often tell my colleagues and my residents and my
peers that I personally believe the next decade will be the
decade of prevention in oncology, and I am very optimistic that
much will be accomplished in the very near future.
We are currently witnessing a confluence of many
discoveries that when paired with the considerable interest by
your committee and by the National Cancer Institute and other
funding agencies, can be expected to provide patients and
clinicians with practical, proven methods to reduce a man's
risk of developing prostate cancer.
On the basic science front we are understanding much better
those individual steps that cause a normal prostate cell to
divide, invade the prostate, and then spread. Each of these
steps involves many processes and each offers a target of
opportunity to prevent development or spread of the disease.
Through observational studies we have also identified a
number of new agents and approaches that deserve investigation,
many of which offer tremendous promise to reduce the risk that
a man will develop prostate cancer.
We know, for example, that male hormones play a major role
in the development of the prostate and ultimately of
enlargement of the prostate and prostate cancer. With the
development of the first five-alpha reductase inhibitor
medication called finasteride that reduces the hormonal
stimulation of the prostate, the National Cancer Institute in
collaboration with the Southwest Oncology Group developed the
Intergroup Prostate Cancer Prevention Trial to determine if
this agent can prevent the development of prostate cancer.
The response of men in this country to this trial was
overwhelming and indeed 18,881 men ultimately enrolled in this
study and this study reached its enrollment goals exactly 3
years to the date of its inception directly on schedule. We
were actually overwhelmed with the response. My understanding
is that the Cancer Information Center of the National Cancer
Institute received its largest volume of phone calls the day
after we had a press conference here in Washington to announce
this trial. I oftentimes say that men voted with their feet.
They thought that they would never participate in a prevention
trial. These were healthy men without evidence of prostate
cancer and we were overwhelmed by the interest.
We expect the results of this study to be available in the
next several years. Efforts at prostate cancer prevention,
however, have not stopped there. I am aware of many trials
assessing the effects of multiple novel agents on prostate
cancer development. We in San Antonio are currently conducting
a study of alpha tocopherol, which is vitamin E, a very
promising chemo-preventive agent in men at high risk of
developing prostate cancer.
A second micronutrient, selenium, an agent which may, like
vitamin E, function as an antioxidant is also being studied in
a number of trials. In response to the evidence of the
potential effectiveness of these agents the Southwest Oncology
Group and the Department of Veterans Affairs have collaborated
to develop the neat intergroup prevention trial called SELECT,
the Selenium and Vitamin E Chemoprevention Trial, a study
proposed to study 32,400 men and we hope if it is funded it
will begin next summer. I am very optimistic that for many of
my generation and certainly for those of my son's generation--
and I have to reflect back, my grandfather passed away from
prostate cancer as well, and so I have a personal interest in
this as well--that we will have clear evidence that the risk of
prostate cancer can be reduced.
We are currently approaching this challenge on many fronts:
In the molecular biology laboratories of the United States,
through epidemiologic studies, using cancer models and most
importantly through well-designed prospective clinical trials.
It is only through these trials that we will be able to assure
men with confidence that our recommendations are scientifically
valid. The contributions of the Cooperative Clinical Trials
Groups and the National Cancer Institute have been enormous, as
has this interest by this committee, and your collaboration
sets the stage for the discoveries over the next decade.
Again, Mr. Chairman, members of the committee, it has been
a distinct honor to have been here, and I thank you for your
interest.
Mr. Burton. Thank you very much, Dr. Thompson.
[The prepared statement of Dr. Thompson follows:]
[GRAPHIC] [TIFF OMITTED] T4044.107
Mr. Burton. Dr. Kail, you indicated that one-third of 1
percent of the total NIH budget is used for alternative
therapies; is that correct?
Dr. Kail. That was the figure that was passed out at the
NCCAM meeting that recently was held when they looked at just
what funding characteristics they had had. Other interesting
things there was about this much basic science funding and this
much clinical outcome funding, which I thought was quite
appropriate.
The thing I found most interesting about the funding
pattern was that many of the institutions that put forth
proposals at least, at the NCCAM meeting, were conventional
institutions. I mean Harvard for instance had 10 or 12
proposals put forth. Many of these institutions have no CAM
providers in their proposals and they were not being done at
CAM institutions. With the paucity of knowledge in the
conventional community about alternative therapies, I find that
we are having the same research organizations as apply for
conventional grants turn right around and go for funding under
alternative medicine.
It is very clear that the alternative medicine research
community is not equipped to compete for funds even under NCCAM
guidelines. We have to go out and recruit these individuals,
mostly because the best research--the best treatment of cancer
patients does not occur in the research institution itself,
does not even occur in medical schools. It occurs by
alternative medicine doctors practicing on their own in the
field and most of these people are getting good outcomes but
not even tracking them.
They have an inherent fear of dealing with research
organizations, especially allopathic ones, because they are
concerned that they may not have control of the research and
the outcomes may not be the same as they could achieve. This is
a real problem about getting alternatives really looked at
under this microscope. We have to get them access to it.
Mr. Burton. Dr. Chen, you were talking about this new
combination of vitamins and other things that was put into what
did you call it, PC SPES?
Dr. Chen. Yes, a combination of plant extracts.
Mr. Burton. And you said that there were some side effects.
What kind of side effects were you talking about?
Dr. Chen. The side effect has not been officially
established but based on the observation include the decrease
in libido.
Mr. Burton. Decreasing libido?
Dr. Chen. Yes, and some breast tenderness.
Mr. Burton. Some breast tenderness? And that is a
combination of how many different kinds of vitamins? Selenium,
vitamin E. What else? Green tea.
Dr. Chen. Well, there are eight different herbs. Seven of
them are Chinese herbs and one American herb. The herbs belong
to the common use.
Mr. Burton. I think I take all of those things and I
haven't had any of those side effects yet, but I don't take
them in one pill.
Let me just ask those of you who are from the National
Institutes of Health and National Cancer Institute, why is it
that we don't put more money into alternative research? One-
third of 1 percent seems like such an insignificant amount,
especially when there is a growing percentage of Americans and
if you don't believe it, all you have to do is go to the health
food stores. They are voting with their feet and their dollars.
They believe that there are some preventive qualities in some
of these things that they are buying at health food stores and
from going to these alternative physicians.
Why is it that the NIH and National Cancer Institute are
not allocating more money for research in those areas? Can
somebody answer that for me? One-third of 1 percent of the
total budget doesn't seem like very much to me.
I think the answer is not so much why they are not putting
so much money in as much as why are investigators not applying
more effectively to get that money. Most of the money that is
spent is spent in response to applications that come in from
independent investigators who say, here is an experiment that I
want to do, and it gets peer reviewed; and as we all know, we
don't get to fund as many as review well, but we fund as many
as we can. But a lot of the money goes to whatever research
applications come in that are very well done.
If they don't come in, the money doesn't go in that
direction so much.
Mr. Burton. You heard Dr. Kail talk about one of the
problems that he had with it.
Dr. Kaplan. I did. Can I respond to that? Because I think
he was describing a glass that was half empty, but I would say,
in a sense, that is a glass that is half full. I actually find
it encouraging that conventional practitioners and institutions
are, in fact, willing to take up this level of research, that
there is not some wall between the types of agents involved or
the types of research.
There has been an unfamiliarity, but it looks like there
are efforts afoot to break down that unfamiliarity, and those
researchers do have the track records of knowing how to get
patients to respond and participate. I think that is going to
be a tremendous asset to evaluation of these techniques.
Mr. Burton. Do you have a comment?
Dr. von Eschenbach. Thank you, Mr. Chairman.
I cannot speak for the National Cancer Institute, actually,
but with regard to the Department of Defense program in
prostate cancer, I will be happy to provide specific detail
later. I don't have it, but I do know that in that research
effort, we did fund and have received important applications in
looking at the role of diet and dietary supplements, such as
the ones that were mentioned today.
So much interest is being developed in the scientific
community in looking at these opportunities. Even at an
institution such as M.D. Anderson, which is a very large,
complex academic cancer center, we have a substantial
investment in what would be described as complementary and
alternative medicine, including research that is being
developed in the role of spirituality, stress reduction. We
have the availability of tai chi and yoga, the availability of
acupuncture.
So I think the point to be made is that there is an
explosive interest in what we would consider to be first-line
academic, scientific institutions, to look into this area, but
to look into it in a critically important way so we can then
apply it to patients in a rational fashion.
Mr. Burton. Mr. Turner, do you have some questions?
Mr. Turner. You know, it is always, I think, confusing for
most men when they hear all these stories and come across
articles about dietary supplements and vitamins and herbs that
were perhaps helpful in preventing prostate cancer, and it
would be interesting--in fact, I guess I might ask Dr. Thompson
or Dr. von Eschenbach. If we were to do a survey of the
established medical community at the Health Science Center in
San Antonio or down at M.D. Anderson, what would we find the
urologists and oncologists taking, more likely than not, as a
dietary supplement? Because that would probably indicate where
at least the medical community thinks there might be the most
hope for some effective prevention by way of dietary
supplement. What would we find?
This is kind of a talk you might have over coffee with your
colleagues, but what would you find them doing?
Dr. Thompson. I will answer perhaps for San Antonio, and
perhaps Andy can answer for Houston.
We have actually looked at not just members of the medical
community, but our patients as well, and we find as many as 45
percent to 50 percent in an average urologic practice are
taking some form of dietary supplements, micronutrients and so
forth.
I recently addressed about 400 men who are participants in
the prevention trial in San Antonio, and when I asked how many
were taking vitamin E, which I suspect is second maybe only to
a baby aspirin that frequently they are taking at that age,
probably one-third to one-half of those men raised their hands.
I suspect that our medical colleagues are probably doing that
as well.
The difficulty with it, though, is that we suspect that it
may have that effect. Heretofore we know that populations who
take betacarotene have a lower cancer risk, but then when the
National Cancer Institute collaborated with the Finnish and did
the study where you take the supplement itself to try to reduce
lung cancer risk, it actually increased it. So we have that
suspicion that it may work, but actually it takes the clinical
trial to move that forward.
I suspect vitamin E and perhaps aspirin is the answer to
your question. But, unfortunately, we are kind of--we have no
autopilot, we are not sure exactly where we are going until we
actually do that clinical trial.
Dr. Kaplan. Congressman, I would echo those comments. It is
extremely important for us to engage our patients in this
regard, so that we know what they are doing and how that might
or might not interact or complement what we are doing with
regard to therapy and treatment, because sometimes they may be
taking things that could actually be harmful with regard to the
kind of treatments that we are applying.
We provide to patients dietary survey. We provide to them
dietary consultation and recommendations regarding low fat and
the use of supplemental vitamins. For me, personally, just on a
personal note, when I remember, I take my vitamin E and
selenium every morning.
Mr. Turner. Dr. Thompson, you mentioned the study that is
involving 18,000 men and then you mentioned one that will
involve 30,000 or something. I am not sure I understand exactly
what those two studies are designed to do.
Dr. Thompson. It is an excellent question, Congressman.
The prostate cancer prevention trial is the first large-
scale, randomized trial to address whether an agent can
actually reduce prostate cancer. It began in 1993, and it was
designed to enroll 18,000 men, actually we overaccrued because
of the interest, we had almost 19,000 men who participated.
Each one of these men, if you look at a map of the United
States, there are dots for each individual's home of record.
The map of the United States is covered with those dots.
There are 220 centers around the United States, ranging from
cancer centers to a community oncologist's private practice.
Those men are taking either the drug itself, which reduces the
hormonal stimulation of the prostate, or a placebo tablet, to
see whether it will actually reduce their risk of prostate
cancer.
The study will begin its end-of-study biopsies of the
prostate, as you heard earlier today, in January 2001. It takes
a long time to complete those studies because prostate cancer
grows and develops so slowly. But we hope by 2004, maybe a
little earlier, maybe a little later, we will have the results
of the first trial. It is, if you will, the male analog to the
tamoxifen trial for breast cancer, one of the first study
results.
We feel the data for selenium and vitamin E are so
compelling, we are not stopping there. We are planning to begin
the next trial to look at vitamin E and selenium to see whether
they can reduce the risk in a larger group of men, again men
without prostate cancer, absolutely healthy men. We hope to
begin that trial next summer. Because we are going to be
looking at two agents, it requires even more men and it will be
somewhere around 32,000 to address the question.
In 1993--it seems like ages ago that we began--but we are
just on the doorstep of our first results of that trial. We
feel very, very encouraged by the interest coming from
Washington and from the National Cancer Institute in supporting
these prevention trials.
Mr. Turner. Thank you, Mr. Chairman.
Mr. Burton. Dr. Kail.
Dr. Kail. I would like to respond to that a little bit.
Here again, is a single or double agent trial that has gone
on for years and years and years in a large population until
you look at again, alternative medicine uses multiagents. I
realize it is difficult to study that, but we cannot use the
same old tired methodologies to look at the same stuff. Single-
agent, double-blind, crossover trial methodology does not work
for alternative medicine, period, end of discussion.
I would like to ask these gentleman if any alternative
medical providers are on their staffs or were consulted in
protocol or consulted to look at how the care is delivered. I
think these are key, key questions that have to be answered by
the research community, and we have to get to some new
methodology.
This level of trial and taking this long to get to answers
is not serving anyone. Too many people are dying. What is wrong
with instituting a whole protocol of alternative medicine
during this watchful-waiting period and look at outcomes in a
group that get a whole protocol designed in alternative
medicine doctors' institutions and see what is the outcome
there?
If we go agent by agent in this design, we are going to
take a long time to get to answers and it will cost us a lot in
morbidity and mortality.
Mr. Burton. Do any of these organizations within NIH or the
National Institute have anybody on their boards that practice
alternative medicine?
Dr. Kaplan. Oh, yes. Certainly the NCI Office of
Complementary Alternative Medicine does have people on its
board. But I think that is not exactly the answer to the
question of the studies that Dr. Thompson was describing. Those
are, as Dr. Kail points out, not packages of a series of
complementary treatments all together; they are in fact----
Mr. Burton. Very specific.
Dr. Kaplan [continuing]. Concentrating on specific agents.
They don't perhaps require for that kind of study exactly what
you are describing, perhaps. But I absolutely agree, for what
you are describing, we need to develop the correct methodology
and probably need the advice of your entire community to
develop it, because I don't know how we would come up with it
otherwise.
Mr. Burton. Let me tell you a problem. This is on a
different subject, but I think it bears on the point that is
being made here. Do you know what chelation therapy is?
Dr. Kaplan. Yes.
Mr. Burton. Some people think it is bogus, others think it
really does help with coronary problems and heart disease and
so forth.
We sent 564 case histories from various chelation
physicians around the country, these are doctors who use
chelation as an adjunct to their practices, international
heart-lung, and we found that they said there was not
sufficient information in these reports that we sent in, and
they wrote back and asked for more information. They couldn't
make an evaluation based upon what was sent in. So we are
writing a letter back to all those physicians asking for at
least 100 of these cases to go into great detail. It is going
to take them a lot of time and effort to give us these details.
But it seems as though there was a doctor over there, one
of the people that makes the decisions, that said they were not
going to move on--they said they wouldn't do a clinical trial
because they just didn't think they had enough information.
Now, we have people all across this country, myself
included, that are using chelation therapy, and it seems to me,
like I said a while ago, with people voting with their feet and
their pocketbooks, and more and more people are trying this all
the time, some with some extraordinary results--I have talked
with a number of people who have had extraordinary results--
people told they should have open heart surgery or heart
transplant, they didn't do that, they went to chelation
instead, and they had some tests done that showed their
arteries were actually opening up to a degree and the chest
pain, the angina they had, was going away.
Why is it that the alternative therapy money, one-third of
1 percent, why is it they are not using more money in that area
to look at these alternative therapies and maybe use different
approaches to finding out whether or not they are effective,
instead of the same approaches they have always used, with the
double-blind studies?
I think that Dr. Kail makes a good point, that while we are
going through these studies that take 3, 4, 5, 6, 7 years,
people are dying, and if there are alternative therapies that
physicians--and the one that is giving me chelation therapy has
an advanced education in medicine, so he didn't come off the
assembly line of doctors, he is a pretty sharp fellow--it just
seems to me we ought to let the alternative therapy have a
little bit more money for research and let them see what they
can come up with, as well as the conventional approach which is
these double-blind studies that take 3, 4, 5, 6 years. I just
don't understand it.
We had a boy here who was dying of, I think it was
leukemia, and his parents wanted to have him go to a doctor
that tried an unconventional approach dealing with that. He had
been judged terminally ill; there was nothing more that could
be done for him. He was being prevented to get treatment even
though the parents wanted that, and there appeared to be some
hope from previous patients that had been down there, because
they said there hadn't been enough research.
Well, this kid is going to die. Why should we prevent that
parent from looking at that, especially when there is some
record that there has been some success, although not a huge
amount?
I just don't understand the rationale, because people are
dying from these various problems, prostate cancer and others;
and it looks like, to me, that there ought to be some more
attention paid to alternative therapies as adjunct to
conventional therapies that could be researched thoroughly
through the alternative therapy budget. And there is not enough
money there to do it, and one-third of 1 percent just does not
cut it.
I am for getting more money for conventional research, and
I believe my colleagues on both sides are, as well. But while
we are willing to get more money for conventional treatment and
studies for cancer, why not let the other people who are
generally looked upon with disdain and disfavor by a lot of
people in the medical community, why not let them have their
shot at the egg, too, because there are some positive results.
Does anybody have an answer to that? You are with NIH.
Dr. Kaplan. I do actually have some thoughts about that.
Could I have Dr. White also address some of your points?
Mr. Burton. Sure.
Dr. White. Thank you. I am Dr. Jeffrey White from the
National Cancer Institute.
Mr. Burton. You have been before us before.
Dr. White. Yes, once before.
I can address the issue about case reports as sources of
evidence. We do actually have at the National Cancer Institute
a best-case program, best-case series program, that does allow
actually for the review of case report information and internal
review within the NCI.
What I am talking about then is the alternative medicine
practitioner who is treating cancer patients with an
alternative approach, who has records of improvements of those
patients and can send those records to my office and have--what
I do is review them for completeness, in much the same way
apparently NIH did with your records. If it is not complete, we
go back and forth with correspondence about what does need to
be added to it to make it complete.
Then we present them actually to the panel of experts of
both cancer and alternative medical backgrounds. Actually, Dr.
Kail is on that panel. This is done in collaboration with the
National Center for Complementary and Alternative Medicine. So
we have recognized that case report information is the type of
information that comes out of complementary and alternative
medicine practices generally, rather than clinical trials, and
we are trying to make use of that information to make research
decisions.
Mr. Burton. That is commendable.
I want to yield again to my colleague in a second.
That is commendable, but why is it that there isn't a
bigger percentage appropriated or allocated by NIH for these
alternative studies and therapies? I just don't understand it.
One-third of 1 percent is such a small amount, especially when
the American people are clamoring for it. You know that. I know
you know that, because if you don't believe it, look at the
tremendous amount of money that is being spent for alternative
therapies and vitamins and minerals and all kinds of things--
shark cartilage. You know what I am talking about.
It seems to me that, as a defense mechanism if nothing
else, NIH would say, hey, we need to get these Congressmen and
these Senators off our back. Let's put a little bit more money
into alternative therapies so we can shut them up and find out
if this stuff really works.
I mean, that is such a small percentage. Can you give me an
answer on that?
Dr. White. Part of it is, I don't know what the actual
percentage is, because the definition of complementary and
alternative medicine is actually a very difficult one to make;
and a lot of things we have talked about today, certain
specific vitamins or minerals as single compounds, some people
would not consider them to be alternative.
Really, you can debate it. But certainly support group
research is an important element that I think might have been
touched upon a little bit, but some people may not consider
that to be complementary and alternative medicine.
I think there are issues so that if you wanted to look at
all the nutritional-type work that is done as cancer prevention
and as adjunctive therapy, or all of the behavioral research
done, I think those numbers would be much larger. So a lot of
it does break down to what the real definition is.
But I do think we are growing our research portfolio, and I
think we have established linkages with the National Center to
address some the specific things, like the concerns of Dr. Kail
about naturopathic schools or other alternative practitioner
schools not vying well in the funding. There are programs that
are in development to get them in collaboration with
experienced research programs to help buildup their research
departments. So I think we are making inroads there.
Mr. Burton. Did you have some more questions?
Mr. Turner. I don't, Mr. Chairman.
Mr. Burton. Dr. Kail, did you have something else to say
too? Let me go to Dr. Geffen first and then we will come back
to you real quick.
Dr. Geffen. I just wanted to make one point that--actually
two points, very briefly.
First of all, I want to speak again from the perspective of
a treating oncologist in the community, but also as somebody
who spent many years in academic medicine, has been very
involved in scientific research, has had NCI grants. I am very
familiar with the process. There is no question that I am a
firm believer and advocate for research of anything that has
potential.
I also want to once again remind my colleagues and all of
us that we are talking about--our language again is about
treating prostate cancer. But we are not really treating
prostate cancer. We are treating men, human beings, who happen
to have prostate cancer.
I honestly feel that this is as fundamental a paradigm
shift that we need to make as the paradigm shift of embracing
alternative and complementary therapies might appear.
Do you understand what I am saying?
This is the problem. We can spend years and years studying
this chemotherapy drug or this herb or that herb, and I can
tell you as a physician, it is absurd. I have patients coming
with bushel baskets full, shopping bags full of vitamins and
herbs and supplements, or men with prostate cancer who were
given all of the standard treatments; they are neurotic,
frightened, they are afraid, they are not sleeping.
I am spending thousands of dollars a year performing
studies that are being demanded. Their marriages are in
shambles, and I think that it is time that we make an equal
commitment to addressing this component of cancer, which is
really, I tell you, this is where the rubber hits the road in
the community. This is really where the real action is, taking
care of real people. It is not in how many micrograms of
selenium to take. It is absurd.
I feel strongly about it because I spent years answering
the phone calls in the middle of the night from these people,
and I say--I want to be clear; I love science, and I love
alternative and complementary therapies, and I will always
advocate for doing everything that we can think of to pursue
this area of research. But really it is time to say, wait a
minute, we are not treating cancer, we are treating human
beings, and explore how we need to reorganize ourselves in this
entirely new framework. That is really the challenge before us.
One last thing I want to say also. You know, it is amazing
to me, and this is part of this discussion in terms of where do
we really want to put our resources. As strong an advocate for
scientific research as I am, I think we need funding to learn
how to take care of people. I think it is unconscionable that
as a physician, I could spend easily $20,000, $30,000, $40,000
with the full blessing of Medicare to prolong the life of a 89-
year-old man with prostate cancer by 6 or 9 months with every
therapy and MRI scans and bone scans and strontium and growth
factors and Neupogen shots at $125 a pop for weeks or months at
a time.
But there is no funding for therapists for these people,
for massage therapy, there is no funding for end-of-life
discussions. I mean, it is crazy. But this is the reality of
taking care of people in the community, and I think I can't sit
here and not say that.
Don't you think it is kind of crazy?
I can get the full blessing of Medicare to do this, as long
as I follow the documentation guidelines. It is painful.
Mr. Burton. I am sure it does make sense to everybody here,
and perhaps Congressman Turner and I and others can talk to our
colleagues on the appropriate Appropriations Committees--I
think Congressman Porter is one of them--to take a look at
maybe revising how we approach something like that. It is going
to take a real education process I think, because I had never
really thought about it before until you mentioned it.
You just don't think about those things. You think about,
how do you take care of the guy that is sick. You don't think
about quality of life and how close they are to the end of the
road, which we are all going to be facing.
Dr. Kail.
Dr. Kail. Well, just, first of all, I wanted to acknowledge
the National Cancer Institute at the NIH and the CAPCAM
advisory panel. I think they are taking the lead within NIH in
bringing the alternative medicine into the NIH. I think the
best-case series is the best mechanism I have seen so far to go
identify the alternative practitioner in the field and get him
started.
But CAPCAM is not a funding agency. It does not grant
funds. All it does is recommend strategies so that they can do
better competition in the research pool.
What I am saying is, that is not quite good enough. We are
going to have to go out and do something else that is not going
to take multiyears get these people involved. Why can't you put
an advisor in every part of the NIH and have them put an
alternative spin, if you will, on every study that comes
through, or some direction toward the director of the panels?
I don't know what the answer is. I think the National
Cancer Institute is taking a big step forward and doing the
best-case series. I applaud them for doing that. I am out
personally recruiting people in my field to apply for that
best-case series, but that does not imply funding. All the
funding that has come through for alternative medicine research
has been mandated by this body, by the Congress, and I think
that is where the answer is. The Congress has to mandate the
funds. Then the NIH will spend the funds.
Thank you.
Mr. Burton. Well, as a first step, maybe we can talk to
some of the heads of the various agencies at NIH and see about
trying to get some input from the alternative therapy
physicians in some way, because I think that is probably a good
idea, to at least have that input.
Did you have a comment, Dr. Geffen? I have a series of
questions, and I will let you guys get out of here, for the
record.
Dr. Kaplan. I just wanted to follow up on points that both
Dr. Kail and yourself have made regarding the design of studies
and whether it is necessary to do randomized control trials and
so forth.
Randomized control trials are not something that just the
alternative community objects to; every scientist wants to see
things move faster than randomized trials can allow. I should
say, by the way, that most of them are not placebo controlled.
But, anyway--if we didn't have those, however, there is no
question that we would think, for instance, as I would have
said a few years ago, that betacarotene is probably a good
thing and everybody should take more of it. It turns out to be
a bad thing. If we didn't have a randomized controlled trial,
we would still be doing radical mastectomies, which we did for
100 years, when everybody thought it was better than limited
mastectomies. The randomized clinical trials answered that.
We have got to constantly question our own assessments. I
have been wrong, like everybody else, many, many more times
than I have been right about what seemed to be working with the
drugs I have worked on myself. We always have to look at that
carefully.
Now, I can easily imagine a situation, however, in which a
number of alternative approaches could be piggybacked onto lots
of studies. There could be trials of conventional therapy with
or without another alternative approach added to it. It doesn't
mean you would have to have twice as many patients or separate
studies. You can actually use a sort of piggybacking technique
and still get that high-quality scientific evidence without
having to say we are going to go one way or another.
Mr. Burton. That may be one approach to doing it.
It just seems to me that, and I am not a physician, I have
a son who is a physician, who believes everything that the FDA
says, so he and I have arguments from time to time, not that I
don't think the FDA does a good job, you understand, but we do
have differences. But it seems to me, and I think to a lot of
my colleagues, because we have talked about this numerous times
at the committee hearing and on the floor, that while the
conventional approach to checking everything out, the double-
blind studies and all that, is very important, and that is
probably where the vast majority of the funding ought to go, it
seems to me the alternative therapy approach ought to have at
least an adequate amount of funds so they can try it from their
viewpoint as well. There is more than one way to skin a cat.
You have heard that before. It seems to me whether it is
piggybacking on or letting them have funds to try another way,
and then looking at the results over a 10 or 5-year period, it
seems it makes sense, especially when we are talking about the
huge quantities of money which the Congress is putting out,
which still isn't adequate, but nevertheless we are spending a
lot of money, $3 billion at NCI.
Let me go through a series of questions, and if Mr. Turner
has any, interrupt at any time.
Dr. Geffen, Senator Dole talked about Medicare coverage
being important for access to adequate care. Do you offer
treatments at your center, conventional and complementary, that
would help a patient but that you cannot get reimbursement for
through Medicare?
Dr. Geffen. Yes, many. It is a big problem. As I was saying
earlier, I think that this is something that we are going to
really have to grapple with, because until we have--and I will
just say my own personal belief is the most effective answers
are probably going to come from molecular biology. They are
probably not going to come from randomized trials of compounds,
no matter how toxic or natural they may be. I think the real
advances are going to come from molecular biology, but that is
going to take time. In the meantime, we have to take care of
people, human beings, who are suffering. We have to use
everything that is available.
Mr. Burton. Let me interrupt. Could you do me a favor?
Could you in a one page send us a list of things that you think
ought to be looked at seriously in Medicare adjustments,
adjustments to Medicare that would help people? If you could
get us that, we can sit down and talk to the relevant leaders
in the Congress and see if that can't be incorporated into the
long-range planning for Medicare.
Dr. Geffen. Terrific.
Mr. Burton. Just get that to us. Rather than telling me,
let me have it in writing so Beth and I can get it to the
proper people. What do you say to a patient who wants to try an
alternative therapy?
Dr. Geffen. What do I say personally?
Mr. Burton. Yes.
Dr. Geffen. Well, I try, first of all, to do a
comprehensive medical evaluation and try to make an assessment
as to whether or not there is a conventional therapy that we
can reliably predict what it is likely to do. My own personal
bias is I don't really embrace alternative therapies as cancer
treatment. I can be, as open-minded as I have been and as far
as I have traveled in this world to study and learn and try to
see what is effective, I have not been convinced that there is
any alternative therapy for cancer that is as or any more
effective than conventional therapies are on a reliable,
consistent basis. So I typically don't offer alternative
therapies, unless I have a patient who really has a cancer for
which there is no meaningful conventional therapy.
Mr. Burton. So if they have been judged by conventional
medicine to be in a hopeless situation, you would talk about
something?
Dr. Geffen. Exactly. But there is some gray zone between
what is alternative and what is complementary, and
complementary medicine includes things that I consider to be
therapies that can be used very elegantly in conjunction with
conventional therapy. That is really where our primary focus
is, is trying to explore a whole universe of phenomenally
wonderful things that are not in conflict with conventional
therapies.
Mr. Burton. Dr. Kail, how do you co-manage patients with
allopathic physicians?
Dr. Kail. That is a great question. This speaks to where
everybody has spoken here. Again, allopathic physicians, as Dr.
Geffen said, they will try any allopathic or conventional agent
that will work and, at the exhaustion of those, will send a
patient or allow their patient or recommend their patient seek
alternatives. Unfortunately, that is the worst case scenario
for the success of the alternative therapy.
Mr. Burton. Too late in most cases.
Dr. Kail. Well, the person's recuperative abilities have
already been spent by the rather extreme measures they have.
Most alternative practitioners would suggest you need to
start the alternative therapies early on, as early as you can
find. They are not bailout therapies. They will not succeed if
someone is totally compromised. I don't care how good they are.
Although there are some case reports of that happening, the
chance is very little.
The best case scenario, it is best to start with a person
who has an inkling that they might have some increased risk and
aggressively attack that risk, and then alternatives become
very viable in actually reducing or stopping the cancer
process. But they haven't been studied.
There are plenty of docs that I could tell you about that
have clinical results but haven't been studied. So my approach
is usually I start treating a patient and then they go see an
oncologist. I always recommend that they do. As a matter of
fact, I hesitate to treat patients if they don't see an
oncologist.
Usually in that scenario, when they are already doing what
they are, and then going for conventional care, they get better
results, meaning I report from the oncologist, which usually
doesn't matter, they don't care if I am using alternatives, as
long as I can assure them that it is not going to adversely
affect their therapy, which I usually can.
Mr. Burton. You are talking about using it in conjunction
with?
Dr. Kail. Absolutely. In that scenario, I think we do very
well. My feedback from the oncologists has been that my
patients tolerate conventional treatments better, they get
better outcomes, and have a better quality of life. That is the
feedback I get from my patients.
Mr. Burton. Does the general public have access to
naturopathic physicians?
Dr. Kail. The other States----
Mr. Burton. But they are not reimbursed under Medicare or
other insurance programs regularly?
Dr. Kail. There are none, in no cases. There are two States
that enjoy mandates, Connecticut and Alaska. Other States, in
Arizona we do get insurance reimbursement by choice. There is
no mandate, but we have three or four, Cigna, Intergroup and
some other health plans, because their consumers wanted them,
have put us on as providers.
That is a very good situation, because now I have to
communicate with their primaries, we have to write consultation
reports, we have an exchange of ideas. Sometimes that person
says I don't understand this, I don't want to know about it, go
get another primary. Sometimes they start to interact with me
and then they get to understand what I do and I get to
understand what they do a little bit better and the benefit is
to the patient. The patient ends up doing better and having two
doctors that are very happy to talk with each other.
Mr. Burton. Dr. Chen, is the NIH funding any studies on
your invention, your scientific research?
Dr. Chen. No, Mr. Chairman. As a matter of fact, I wrote an
application for NIH funding and it was rejected. Some of my
funding comes from private research foundations such as
CapCURE.
Mr. Burton. That is Milken's foundation?
Dr. Chen. Yes.
Mr. Burton. But you were turned down?
Dr. Chen. I was rejected several times.
Mr. Burton. Are you aware of any government funding on
Chinese botanicals and prostate cancer prevention?
Dr. Chen. Not that I know of.
Mr. Burton. Do any of you know if there is any funding by
NIH for any of that research? Nobody knows?
Dr. Chen. There is only a so-called alternative medicine
category, and just like Dr. Kail said, any application in
alternative medicine usually goes to famous hospitals, Harvard,
Stanford, M.D. Anderson, their research groups get it.
Dr. Thompson. Mr. Chairman, from the physician's data
query, which is NCI sponsored, there is a phase three
randomized study of the effect of a diet low in fat, high in
soy, fruits, vegetables, green tea, vitamin E and fiber on PSA
levels in patients with prostate cancer. It is NCI sponsored
and it looks like it is being conducted at Memorial Sloan
Kettering Cancer Center.
Mr. Burton. But that sounds like that may be the exception,
rather than the rule. Well, anyhow----
Dr. Chen. The problem is, each time you talk about a
mixture, it is also a question. According to conventional
strategy, anything has to be single agents. If you talk about
more than two, it is a no-no.
Mr. Burton. That is what I was talking about. I think Dr.
Kaplan touched on it when we were talking about piggybacking on
a study. Maybe you could in some way put something like that in
the study, in a small percentage of it, and it might give you
some very telling results. Does NIH ever do that or have they
ever done that? You suggested it. Maybe it is a great
suggestion. But have they done that?
Dr. Kaplan. Normally the kinds of studies in these large
studies that are done----
Mr. Burton. Straight double blind.
Dr. Kaplan. No, it is normally from investigators proposing
that these are the arms that should be in the study, this
versus that. If we can in our advising them, if we can come up
with some other suggestions and say there is something else
viable and we think at the time are strong enough, would you
consider that, then they may in fact be willing to add those
substances to those studies. But it is not normally something
where we will direct them what they should specifically study.
The investigators themselves have to become convinced that the
data warrant that.
Mr. Burton. I understand. But, you know, the one who gives
the money plays the tune to which people dance. I think you get
the message there. It seems to me that if there is a suggested
study and there is something that is very close to or uses some
of the same substances that you are doing the study, it seems
they could be piggy-backed on by suggestion of the people at
NIH.
Dr. Kaplan. They could. The difficulty I have with
suggesting it outright is making the case for it, is the fact
we have heard just in this room today of many, many approaches
that could be useful, and I think we all hope that they are all
going to be useful, but we also all know that not every one of
them is. Somehow we have to decide if we are going to say here
is a study of 5,000 men, let's add such-and-such to 2,500 and
not to the other 2,500, which is that going to be right now.
Mr. Burton. I understand. And that being the case, it seems
to me there ought to be more funds allocated for alternative
therapy research so that they can at least follow the line of
thinking that they are talking about. One-third of 1 percent
sounds like a very small amount.
Anyhow, I think you understand what we are talking about
and I hope you will carry this message back. We will have more
hearings on this in the future and discuss it further.
Dr. Kaplan, what specific complementary and alternative
treatments are under consideration for research on prostate
cancer right now?
Dr. Kaplan. I don't think I can answer that
comprehensively, aside from, for instance, the study that was
just read to you.
Mr. Burton. That wasn't for prostate cancer.
Dr. Kaplan. Yes, that was for prostate cancer.
Mr. Burton. The one you were talking about a minute ago,
that was for prostate cancer?
Dr. Kaplan. Yes. There are a handful of others on a scale
that have already come in and are being funded, but there are
certainly, I think, many investigators out there in both the
alternative community and the conventional community who are
looking at a lot of possibilities and thinking about this. I
think particularly the prostate cancer quick trials program may
bring several more really promising applications to us, because
I think there are fewer hurdles for people to overcome to get
funding that way.
Mr. Burton. Dr. von Eschenbach, in your experience, what
complementary therapies may be helpful for prostate cancer
patients?
Dr. von Eschenbach. Well, as I mentioned earlier, one of
the things we do promote is a diet low in fat and an exercise
program. We have also been beginning to investigate in a
complementary fashion the role of stress reduction.
Mr. Burton. But that is something we need here in Congress,
I will tell you. If you have any ideas, aside from some of
these pills they give us, I would appreciate knowing about it.
Dr. Thompson, you are also a colonel in the Medical Corps.
Does the prostate cancer care differ at all for active duty
military than those who are not on active duty?
Dr. Thompson. I don't believe so, Mr. Chairman. We have
actually looked at prostate cancer outcomes in DOD health care
beneficiaries, and there have been about three or four studies
in the United States that have looked at outcomes. Some have
suggested that ethnicity plays a role in survival. For example,
if you are African American, you have lower survivals. We found
in health care beneficiaries at the Department of Defense
ethnicity did not affect survival, such that if you look at the
same stage of the disease African Americans and Caucasians have
the same survival.
Some of that may have to do with health seeking behavior
and the fact that if you are in the military after the age of
40 you have a regular physical examination, and we think that
plays a little bit to the differences we see in the Department
of Defense beneficiary population.
Mr. Burton. I just have a couple more questions. Are there
new screening devices and tests in development over there?
Dr. Thompson. In the Department of Defense?
Mr. Burton. Yes.
Dr. Thompson. Actually there are any number of new
opportunities. In fact, there are a number of imaging studies
that are being looked at, the ability of PET scans and some new
methods of using MRI. There are new bio markers being looked
at.
At this time, truly the most reassuring thing is that
although it has been around for 15 to 20 years, prostate-
specific antigen remains a superb screening tool, perhaps
better than virtually any other type of screening tool. You are
able to tweak it a little bit by looking at fractions of the
PSA, the PSA that is bound to plasma proteins, and to perhaps
improve your detection abilities in younger men and perhaps to
reduce the number of biopsies that are required in older men.
Mr. Burton. Dr. White, you get the last question from me.
Can you tell me about the homeopathy cancer projects?
Dr. White. Yes. This is one project, actually there were
two projects that were reported, both from the same group. One
of them was withdrawn and the other one is going forward.
This is a best case series of homeopathic preparations for
the treatment of cancer that was presented by a group from
Calcutta, India, and they presented 12 cases of cancer that
they felt had been benefited by their approach. It was
presented to the CAPCAM, the Cancer Advisory Panel for
Complimentary and Alternative Medicine in July, and on the
basis of review by the panel, they recommended we do some
prospective observational research in the clinic in Calcutta,
which basically would be to track new patients that come
through the clinic, specifically lung cancer patients, be sure
that they have good pathology that could be confirmed, and good
radiologic followup, and just look at outcomes.
So we are in the process of trying to put together
basically a research contract mechanism that will allow us to
get a clinical researcher to go to the clinic there in Calcutta
and actually start taking statistics about patients that come
in following these patients getting the CAT scans reviewed.
So I hope to give a summary of where we are in the December
13th meeting of the CAPCAM.
Mr. Burton. If you could let us know about it, we would
appreciate that.
I want to thank all of you for your patience. It has been a
very interesting hearing. I think we have learned a lot, and
hopefully we will be able to get some results down the road
from what we have learned.
Mr. Turner, do you have any other questions?
Mr. Turner. No, thank you, Mr. Chairman.
Mr. Burton. Thank you very much. We stand adjourned.
[Whereupon, at 2 p.m., the committee was adjourned.]
[Additional information submitted for the hearing record
follows:]
[GRAPHIC] [TIFF OMITTED] T4044.108
[GRAPHIC] [TIFF OMITTED] T4044.109
[GRAPHIC] [TIFF OMITTED] T4044.110
[GRAPHIC] [TIFF OMITTED] T4044.111
[GRAPHIC] [TIFF OMITTED] T4044.112
[GRAPHIC] [TIFF OMITTED] T4044.113
[GRAPHIC] [TIFF OMITTED] T4044.114
[GRAPHIC] [TIFF OMITTED] T4044.115
[GRAPHIC] [TIFF OMITTED] T4044.116
-