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



 
             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:]
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    Mr. Waxman. Thank you, Mr. Chairman. I am pleased that we 
are having a hearing on the important issue of prostate cancer. 
Except for skin cancer, prostate cancer is the most commonly 
diagnosed cancer in American men, and this year alone an 
estimated 37,000 American men will die of the disease.
    We face many challenges relating to prostate cancer. 
Questions remain unresolved about the causes and biology of 
prostate cancer and about why there are racial differences in 
the incident rates. We must concentrate our efforts on 
developing the most effective prevention, detection, and 
treatment approaches. We must also work to ensure that all men 
have access to appropriate treatment and to accurate 
information about their treatment options.
    As we face these challenges, it is important that we keep 
an open mind about innovative and unconventional approaches to 
prostate cancer treatment and prevention. At the same time, we 
must promote thorough testing and review of these approaches to 
avoid unnecessary harm and expense to consumers.
    Some of today's witnesses will share their personal 
experiences with prostate cancer. Others will highlight ongoing 
efforts to advance prostate cancer prevention, detection, and 
treatment. This discussion will increase our understanding of 
the options currently available to men who are diagnosed with 
prostate cancer and of the research efforts we should continue 
to explore.
    I look forward to their testimony. I want to explain to 
witnesses that many of us have conflicts in our schedule, and I 
know I won't be able to be here for the full hearing but I will 
have an opportunity to review the record and the statements 
that will be submitted. So, while many of our colleagues are 
not present, we are making an important record today that will 
be shared with all of our colleagues and others interested in 
this field.
    I particularly want to recognize and welcome Senator Dole. 
He and I have had an opportunity to work together over the 
years, and he has been a tremendous champion for research and 
trying to fight this and other diseases, and for making sure 
that people have access to care. He has my undying admiration 
and respect for the work he has done in this and many other 
areas.
    I am pleased we have our other colleague and spouse of our 
former colleague with us as well.
    Mr. Chairman, I appreciate the fact that we are holding 
this hearing. It is important that we pursue this issue and I 
look forward to the testimony.
    [The prepared statement of Hon. Henry A. Waxman follows:]
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    Mr. Burton. Thank you, Mr. Waxman. Do any other Members 
have a comment they would like to make an opening statement? 
Mrs. Morella?
    Mrs. Morella. Thanks, Mr. Chairman. I want to thank you for 
holding this hearing today to examine the current status of 
prostate cancer issues, including prevention, early detection, 
treatment, and research.
    As you listen to the compelling statements of our panels, 
particularly Senator Dole, our colleague Duke Cunningham, and 
Mrs. Gallo. I served with your late husband and have great, 
great respect and love for him, I appreciate the three of you 
coming to discuss this with us. Indeed we must keep in mind 
that prostate cancer is the most frequently diagnosed nonskin 
cancer, the second leading cause of cancer deaths among men, 
second only to lung cancer. In fact, prostate cancer is the 
most common type of cancer in men in the United States.
    The statistics are one out of every six men will develop 
prostate cancer at some point during his life. African-American 
men have the highest incidence of prostate cancer in the world. 
There are many parallels I find between prostate cancer in men 
and breast cancer in women. Like breast cancer in women, the 
risk of having prostate cancer increases with age. The American 
Cancer Society estimates that 180,000 new cases of prostate 
cancer will be diagnosed in 1999. It kills 37,000 men each 
year. Breast cancer kills over 46,000 women. Prostate cancer is 
the second leading cause of cancer death in men. Breast cancer 
is the second leading cause of death in women after lung 
cancer.
    Although testing for early detection for prostate cancer 
has become more common, too many lives are still lost to this 
disease, and I think it is critical that American men use every 
means available to fight prostate cancer, including regular 
testing and medical examinations.
    I know Senator Dole is going to be chairing a luncheon 
panel in the Senate at noon as part of Prostate Cancer 
Awareness Week to further educate men about this disease. Free, 
confidential prostate cancer screenings will be offered 
immediately after the luncheon until 3:30 this afternoon. I 
encourage the men in this room and others to take advantage of 
this opportunity because it was through a similar Capitol Hill 
screening that I eventually discovered that I have 
osteoporosis. So one never knows.
    In conclusion, Mr. Chairman, I have been a strong supporter 
of increasing the Federal Government's commitment to biomedical 
research. In particular, I was leading an effort to double the 
funding for the National Institutes of Health over the next 5 
years and we are working toward that goal. Funding biomedical 
research through the NIH is today's investment in America's 
future. We must continue our commitment now if we are to find 
better ways to fight prostate cancer and to ensure the future 
health of our Nation.
    Recently, I attended the opening of an expanded Department 
of Defense Prostate Cancer Research Center in Rockville, MD. 
This is a wonderful partnership with NIH in Bethesda, and will 
also work with other departments and even the private sector in 
prevention, early detection, and a cure for prostate cancer.
    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:]
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    Mr. Burton. Without objection, so ordered. Mr. Turner.
    Mr. Turner. Thank you, Mr. Chairman. I want to commend you 
on organizing this hearing. It is a very important subject. And 
I want to thank Senator Dole for his leadership. It took a lot 
of gutsiness to make those commercials, Senator. It meant a 
whole lot to the cause that you spoke out on behalf of.
    Our second panel has two distinguished professionals from 
Texas today, so I think we have a good second panel, Dr. von 
Eschenbach and Dr. Thompson.
    Mr. Burton. There is one from Indiana as well.
    Mr. Turner. So we are in for a good hearing today. Thank 
you, Mr. Chairman.
    Mr. Burton. Thank you. Mr. Terry, do you have any comments? 
Mr. Cummings.
    Mr. Cummings. Thank you very much, Mr. Chairman. I want to 
just take this moment to thank our panel for being here. In my 
district, we have one of the greatest hospitals in the world, 
Johns Hopkins, and some of probably the greatest experts in 
this area in prostate cancer, whom I have gotten to know very 
well. But at the same time, we have one of the highest death 
rates from prostate cancer.
    I have said it often, when I go to the bank on Saturdays it 
is not unusual for me to run into someone, Mr. Chairman, who is 
about to undergo some type of prostate surgery or has just come 
through it or is recovering from it.
    And so I want to thank our panel for what you are doing. So 
often, I think what happens is that we in government and those 
not in government who speak out on these issues wonder what 
effect what we do has. I mean we always wonder. But I can tell 
you that it has had a profound impact to raise this issue to a 
level where people can talk about it. I think it was 
Congresswoman Maxine Waters who said: ``Secrets kill. Keeping 
things hidden and not dealing with them and not bringing them 
out kill.''
    And so, I too join the voices of my colleagues to say thank 
you, simply thank you, for those you will never meet. For those 
who have been touched by seeing you on C-SPAN or hearing you 
all testify at a hearing like this. But touching their lives 
because when you open the door and break down the walls of 
discussion, then you also break down the walls so that people 
can get the kind of diagnosis and treatment that they need.
    And so I thank you. Thank you, Mr. Chairman.
    Mr. Burton. Mr. Vitter, no comment? Ms. Norton.
    Ms. Norton. Thank you, Mr. Chairman. May I thank you for 
organizing this hearing about a form of cancer that I think 
needs very special awareness.
    If I may, I would like to thank Senator Dole first for his 
work on behalf of the District as head of the Federal City 
Council. The Senator was most gracious as the District was 
coming out of crisis to offer his extraordinary and unique 
leadership. That leadership has been felt and the District, its 
residents, and its elected officials are most grateful to you 
for your work.
    I share with the Senator what has been his lifelong habit 
of not speaking much about his own personal life and struggles. 
I am 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:]
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    [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:]
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    Mr. Burton. Thank you, Doctor. We will take a look at your 
book. I presume what you just talked about is in your book.
    Dr. Geffen. That is right.
    Mr. Burton. Hopefully it will help give us a more in-depth 
understanding of how to deal with it. My mom and dad died of 
cancer last October and November, and my wife has had breast 
cancer for 5 years, so this is the kind of literature that we 
have in the house all the time.
    Dr. Kail, would you like to go next, sir?
    Dr. Kail. I want to thank Chairman Burton and the members 
of the committee for holding this hearing on one of the leading 
forms of cancer affecting U.S. males. I am a licensed 
naturopathic physician and a physician's assistant.
    Mr. Burton. Doctor, this is going to be for the record and 
it will be disseminated to the Congress. So we need you to talk 
straight into the microphone.
    Dr. Kail. I have a private practice in Phoenix, AZ, and 
serve as the chairman of the board of the Southwest College of 
Naturopathic Medicine and Health Sciences. I am here as a 
representative of the American Association of Naturopathic 
Physicians. I formerly was on their board of directors and I 
participate in several other alternative medicine 
organizations. I am currently a naturopathic physician 
representative to the advisory council of the newly created NIH 
Center for Complementary and Alternative Medicine, and I am 
serving as the first NCCAM advisory council liaison to the 
National Institutes of Health advisory panel as well.
    I attended the last NCAP meeting and was pleasantly 
surprised at the high level of interest among conventional 
cancer specialists with alternative medical therapies. 
Admittedly, they had little knowledge about how they worked, 
but they were interested in the outcomes that they were 
observing.
    I hope that this will eventually become part of the day-to-
day course of medical events, but as of this reading, most 
alternative treatments are not even considered as an option in 
looking at the list of medical events that can happen in regard 
to this.
    My written statement refers to several things: The 
similarities and differences in the training of naturopathic 
and allopathic physicians, the medical philosophy that is 
different and why that creates barriers to integrating this 
into care, and we are also going to talk about some of the 
things you can do to deal with prostate cancers and what we can 
do to get by the barriers to care.
    I had some slides prepared. This first slide looks at some 
of the differences in training as far as specifics and some of 
the softer areas of clinical science that we have specific 
education in.
    Next slide.
    The next slide shows more equivalence of our education. If 
you look at the top three schools, they are all naturopathic 
colleges and the bottom three schools are well-known medical 
universities. The main information here is that our total 
number of hours is basically the same in basic sciences and 
clinical sciences. You can see that in allopathic medical 
sciences we are just a little bit short and of course the 
naturopathic medical sciences, if you will, don't show any 
representation at all in the allopathic venues.
    Next slide.
    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:]
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    Mr. Burton. Thank you. We will review that followup on that 
and I have some questions for you too on the record when we get 
to that.
    Dr. Chen.
    Dr. Chen. Mr. Chairman, and members of the committee, thank 
you for your invitation to testify today. It is my honor to 
present to you information on scientific research on botanicals 
for treatment of prostate cancer.
    I appear before you today as a medical researcher. I got 
into this field because of personal experience with family 
members who had prostate cancer. In the past 10 years, we have 
learned that the fight against cancer requires multiple 
interventions and efforts. The good news I can say today is 
there are botanicals that can be beneficial for cancer 
treatment and for prevention. The bad news is we do not have 
enough clinical studies and there is still a long way to go.
    One role for botanicals is that they can serve as 
complementary medicine to enhance the conventional therapies. 
They will not be a replacement for cancer therapy at this 
point. There are large numbers of botanical components that 
have been identified as antioxidants, immune stimulants, and 
others and are shown to be preventive for prostate cancer. 
These include selenium, vitamin E, green tea extract, lycopene 
from tomatoes, soy products, and PC SPES.
    It is postulated that the reason Asian men and women have a 
lower incident rate of prostate and breast cancer is because 
their diet is rich in botanicals.
    I feel the more we study these compounds, the better we can 
utilize them to help patients. Here I would like to discuss PC 
SPES, which has been studied at many different prestigious 
laboratories and hospitals across the United States. To my 
knowledge, more than 1,000 men are taking PC SPES at the 
recommendation and suggestion of their physicians. PC SPES is a 
standardized botanical formulation composed of seven purified 
Chinese herbs and one American herbal extract. The preparation 
is based on a patented formulation which I developed. The 
laboratory data so far has shown that it can inhibit prostate 
cancer cell growth in a test tube. It can also induce them to 
go suicidal.
    Two different animal studies confirm the laboratory finding 
and show a 50 percent reduction in prostate tumor incident 
rate, in tumor volume and in metastasis.
    At the present time there are several clinical trials in 
phase two. Two of them have been reported recently. Dr. Eric 
Small from the University of California San Francisco found 
that 61 advanced stage prostate cancer patients responded to PC 
SPES; 27 of them belong to the group of hormone sensitive and 
they responded 100 percent. The other 34 hormone failure 
patients responded with 57 percent. He also found some 
reduction in the pain of those patients.
    A separate study by German physician Dr. Ben Pfeifer with a 
team studied 16 hormone refracture patients. They also had 
failed the conventional therapy and were at the end of their 
life. The response rate among this group was about 70 percent 
and the quality of life was found to be profoundly improved. 
Those data were preliminary. There are some side effects that 
need to be investigated. We need more funding and more studies 
to conclude these exciting results and hope we can help more 
prostate cancer patients using this new approach with multiple 
components based on scientific studies.
    In conclusion, I would like to suggest that Congress 
consider fully refunding and expanding the budget for the 
National Center for Complementary and Alternative Medicine and 
the Office of Dietary Supplement at the NIH to undertake 
clinical studies on botanicals which show promise for prostate 
cancer treatment. I also would like to suggest that the 
Congress can promote and encourage more clinical research on 
botanicals by the NCI. Thank you for your time.
    [The prepared statement of Dr. Chen follows:]
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    Mr. Burton. Thank you, Dr. Chen. We will have some 
questions for you and NIH about your findings in just a little 
bit.
    Dr. Kaplan, would you rather someone else go first?
    Dr. Kaplan. I thought that Dr. Thornton was going ahead of 
me.
    Mr. Burton. Dr. Thornton.
    Dr. Thornton. Thank you, Congressman Burton, for the 
opportunity to speak before you and your committee this 
morning. I serve as the chief advisor for the Midwest Proton 
Radiation Institute, and my current faculty position is as a 
member of the Department of Radiation Oncology at Massachusetts 
General Hospital and a member of the Harvard Medical School. I 
have prepared a brief summary of prostate cancer and then I 
will focus on proton therapy.
    In general, cancer of the prostate is common in men of 
developed countries second only to lung cancer in incidence. 
The current incidence is greater than 75 per 100,000 with an 
annual incidence of new cases of 120,000 in this country. The 
tumor is more common in men of African-American ancestry and 
increases in incidence with age.
    Most cases of prostate cancer are composed of what is known 
as adenocarcinoma cells, a pattern that is seen on pathologic 
specimens under the microscope. A small percentage of these 
cells are transitional tumors, which are much more aggressive.
    Importantly, the degree of differentiation of the tumor as 
seen under the microscope when the tumor is first diagnosed is 
the single most important factor to determining survival and 
how aggressive the tumor will be.
    The cancer of the prostate usually spreads, that is 
metastasizes, by passage through the lymph system to lymph 
nodes, that is one mechanism; second, by direct extension to 
tissues around the prostate gland; and also by direct invasion 
into the blood vessels and thereafter into other organs 
throughout the body. The tumor may spread to bones, which we 
have heard about today, where severe pain and fracture may 
occur, as well as to the liver, to the lungs, but rarely the 
brain. Patients often live for significant periods of time 
after the tumor has spread subject to prolonged pain and 
compromise of quality of life due to these bone and organ 
metastases.
    Fortunately, many prostate tumors are now detected at an 
early age due to the development of PSA antigen test which we 
have been hearing about today, which was developed in the 
1980's. Formerly, patients were not diagnosed until changes in 
either the urine stream or frequency prompted a rectal exam. 
With sensitive PSA screening, a significant number of patients, 
now thought more than 50 percent, present with early stage 
disease, which represents a clear pattern shift, disease 
diagnosed prior to the likely spread of the tumor. This offers 
potential for long-term control and cure to increasing numbers 
of American people if the control of the tumor in the prostate 
gland can be realized.
    The current therapeutic options as standardly recognized 
include surgery, radiation, and we have heard cryotherapy for 
very early stage disease. Hormonal therapy alone is effective 
therapy only for very early cases in elderly men who are 
thought too senior for either radiation or surgery. 
Chemotherapy has thus far been relatively unsuccessful in 
affecting this tumor. Surgery is reserved for 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:]
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    Mr. Burton. That was one of the slickist bits of lobbying I 
have ever seen, it was well done.
    Dr. Kaplan, are you next?
    Dr. Kaplan. Congressman Burton and members of the 
committee, I coordinate NCI's extramural clinical research on 
prostate cancer treatment. I am accompanied by Dr. Jeffrey 
White, who is directly behind me, the Director of the NCI's 
Office of Cancer Complementary and Alternative Medicine. I am 
pleased to appear before you to describe NCI's prostate cancer 
research program and our interest in complementary and 
alternative approaches to prostate and other cancers.
    The Congress has asked NIH to make prostate cancer a top 
priority in allocating funding increases to accelerate spending 
on prostate cancer and to consult closely with the research 
community. We have undertaken a vigorous effort to respond in 
all of these areas.
    Prostate cancer has risen in clinical and research 
importance in the last decade faster than any other neoplasm. 
Some of the many factors responsible for this are greatly 
improved methods to identify the disease before it causes 
symptoms; major public awareness campaigns, including the sorts 
of things that Senator Dole has had such an impact on; some 
modest improvements in surgery, radiation, and hormonal therapy 
that have rendered management options more acceptable; and 
important new research opportunities.
    When Dr. Klausner assumed leadership of the NCI he 
envisioned a new strategy of evaluating the entire research 
portfolio for a particular disease from the ground up and 
structuring future efforts according to the insight and advice 
of the entire extramural research community and of 
stakeholders, including patients, advocacy and patient support 
organizations, and professional societies.
    This new process called a Progress Review Group [PRG], was 
initiated in prostate cancer and breast cancer and it was 
extremely productive. The Prostate Cancer PRG laid out a 
framework for planning and identified a number of particularly 
important problems and potentially productive areas of 
research. There are about 20 new NCI initiatives outlined in 
the reports that we have provided, but I would like to go 
through some examples.
    The following sequence of three initiatives taken together 
should speed the development of new interventions, that is to 
say treatments, of any type from initial work in the 
laboratory, or animal, all the way into definitive testing in 
men with cancer. The RAID and RAPID programs, as they are 
called, are intended to expedite new agent development by 
moving novel molecules toward clinical trials. Often there is a 
catch-22. Many scientists don't have the resources to do all 
the required animal testing or drug formulation before tests in 
humans can begin. At the same time it is not easy to get a 
pharmaceutical or biotech industry partner to commit such 
resources until an agent is further along.
    This is where RAID and RAPID can step in. Independent 
investigators are given access on a competitive basis to NCI's 
own preclinical drug development resources and expertise. They 
are assisted with necessary development steps to enable 
investigational new drug application filing with FDA and 
initiate proof-of-principle trials. Then NCI steps back out and 
the investigators are free to develop industry collaborations.
    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:]
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    Mr. Burton. Thank you, Dr. Kaplan. Dr. von Eschenbach.
    Dr. von Eschenbach. Good afternoon Mr. Chairman, members of 
the committee. I am honored to be here today representing the 
American Cancer Society as a national board member and would 
like to thank you and the committee for the opportunity to 
appear to testify on issues concerning our Nation's fight 
against prostate cancer.
    In addition to my involvement in the American Cancer 
Society, I have been privileged to participate in this fight in 
a variety of other ways, serving as the chairman of the 
Prostate Cancer Multidisciplinary Research Program at the 
University of Texas M.D. Anderson Cancer Center. As well as 
being the chairman of the Integration Panel for Prostate Cancer 
in the congressionally directed research program at the 
Department of Defense, I am a medical and scientific advisory 
cochair of the National Prostate Cancer Coalition and a member 
of the Scientific Advisory Board of CAP-Cure. This involvement 
in prostate cancer has impressed upon me that this disease is a 
national tragedy.
    Mr. Chairman, this morning you so eloquently described the 
burden of this disease by demonstrating those statistics. And 
we heard earlier today from Senator Dole and Congressman 
Cunningham and Mrs. Gallo the enormous pain and suffering that 
this disease inflicts on both patients and their families.
    The Cancer Society recognizes that prostate cancer is a 
medical and scientific problem as well as a cultural and social 
problem and economic problem. And so we have chosen to really 
advocate a comprehensive three-pronged approach that recognizes 
the importance of contributing to and enhancing the funding of 
research so we can develop more effective strategies of 
prevention and therapy, to advocate for equal access to quality 
care throughout this entire country and to improve our 
education and promotion of early detection and treatment 
options.
    Today I can only focus on one of those many important 
issues and I would like to then comment specifically upon the 
importance of enhancing our commitment to the research 
endeavor.
    The American Cancer Society supports the strategic plan of 
the National Cancer Institute and the Department of Defense to 
promote and enhance our research effort in prostate cancer. 
This disease is an incredibly complex problem. There are 
important fundamental issues that need to be addressed if we 
are truly going to face and change those statistics that you 
pointed out to us this morning.
    Why in one patient is this a latent disease while in 
another like Congressman Gallo it can be incredibly virulent 
and lethal in a short period of time? Why does it take such an 
enormous toll on African-Americans in this country? And why 
does the lethal form of prostate cancer that kills us 
preferentially metastasize to bone where it then becomes 
refractory to our standard treatments?
    If we are going to make a difference, the only way to make 
that difference is by understanding these processes so we can 
then rationally develop appropriate, effective strategies to 
interrupt them.
    It is true that you should take great pride in what you 
have already accomplished in supporting research throughout 
this country through your efforts, and that research is bearing 
fruit. The PSA that you have heard about today from so many 
people that has altered and changed our ability to find this 
disease early in its course when it is potentially curable is a 
direct result of research. There are now new therapies that are 
being introduced in the clinic today, including at M.D. 
Anderson trials where we are now taking some of the genes that 
are defective in the more virulent forms of prostate cancer 
and, using an adeno virus as a carrier, we are able to reinfect 
those prostate cancer cells with the normal gene in an effort 
to prevent their lethal progression.
    You have heard about a variety of new compounds and 
substances that are coming to us, such as the antiangiogenesis 
factors that stop the blood supply to these tumors and keep 
them from being able to spread and progress.
    And so much is being accomplished but so much yet needs to 
be done, and frankly the funding to do it is inadequate. As I 
mentioned, I chair the Integration Panel at the Department of 
Defense. You have been generous in this Congress in fiscal year 
1999 to allocate $50 million to that program for research, of 
which we had about $41 million to spend across a wide variety 
of needs, including the training of new investigators in the 
field, the development of programs in minority universities and 
colleges, and then we had about $20 million left over to fund 
novel new ideas in prostate cancer research as well as the 
development of young investigators.
    We received in that program over 560 applications of which 
we had only sufficient money to fund 46, an 8 percent funding 
level. If we just look at those ideas that the peer review 
panels believed to be outstanding and excellent and scored 
about 2.0 in their priority scores, we were only able to fund 
one of three; two out of every three ideas had to be rejected, 
not because they were not excellent but because we did not have 
sufficient funds.
    It is essential for us to change the face of this disease 
to understand it better, and then to translate that 
understanding into clinical trials, evaluating new and 
effective methods so that we can make them available to men and 
their families to achieve the scientific breakthroughs that you 
expect of us.
    I have been privileged for over 25 years to walk this 
journey with prostate cancer patients and their families, and 
my own father died of this disease. I thank you and your 
committee for the concern and dedication that you are 
demonstrating in having these hearings. And this week, National 
Prostate Cancer Awareness Week, is a special time to remember 
the fathers and husbands and brothers who have been lost to 
this disease. The American Cancer Society and I, along with all 
the organizations I am privileged to be a part of, look forward 
to working with you in a partnership to change this journey of 
fear and suffering into a journey of hope. Thank you.
    [The prepared statement of Dr. von Eschenbach follows:]
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    Mr. Burton. Thank you, Doctor. Dr. Thompson.
    Dr. Thompson. Good afternoon, Mr. Chairman, members of the 
committee. My name is Ian Thompson. I am a urologic oncologist 
from San Antonio. I am a professor of urology at the University 
of Texas Health Science Center, director of the Prostate Cancer 
Program at the San Antonio Cancer Institute, and consultant in 
urology to the Surgeon General of the United States Army. I 
would like to express my sincere appreciation for the 
opportunity to participate in this important hearing.
    With the successful aging of the U.S. population, prostate 
cancer has become an increasingly important public health 
threat. This disease will assume increasing importance as its 
frequency is directly related to a man's age. With the 
continued improvement in life expectancy in the United States, 
prostate cancer will become an even more significant disease.
    Traditionally, we have focused on two methods of addressing 
the disease. The first was an effort to improve our treatment 
of prostate cancer which as of this morning you heard it can 
spread to the bone and can be associated with significant pain, 
decreased appetite, and a major reduction in the quality of 
life. While much knowledge has been attained through cancer 
clinical trials, rarely can this stage of the disease be cured.
    With the advent of prostate specific antigen [PSA], testing 
in the 1980's, the focus moved to early detection and 
treatment. Over the subsequent decade we have witnessed a fall 
in prostate cancer deaths. The degree to which this fall is due 
to PSA testing is yet undetermined, but it is an extremely 
important and promising development. Nevertheless, the cost and 
side effects of such treatment can be significant.
    The science of cancer prevention is one of the youngest 
fields of oncology. Nevertheless, important advances have been 
witnessed in the past 10 to 15 years with many of these 
advances heralding a new age in our approach to prostate 
cancer. I often tell my colleagues and my residents and my 
peers that I personally believe the next decade will be the 
decade of prevention in oncology, and I am very optimistic that 
much will be accomplished in the very near future.
    We are currently witnessing a confluence of many 
discoveries that when paired with the considerable interest by 
your committee and by the National Cancer Institute and other 
funding agencies, can be expected to provide patients and 
clinicians with practical, proven methods to reduce a man's 
risk of developing prostate cancer.
    On the basic science front we are understanding much better 
those individual steps that cause a normal prostate cell to 
divide, invade the prostate, and then spread. Each of these 
steps involves many processes and each offers a target of 
opportunity to prevent development or spread of the disease.
    Through observational studies we have also identified a 
number of new agents and approaches that deserve investigation, 
many of which offer tremendous promise to reduce the risk that 
a man will develop prostate cancer.
    We know, for example, that male hormones play a major role 
in the development of the prostate and ultimately of 
enlargement of the prostate and prostate cancer. With the 
development of the first five-alpha reductase inhibitor 
medication called finasteride that reduces the hormonal 
stimulation of the prostate, the National Cancer Institute in 
collaboration with the Southwest Oncology Group developed the 
Intergroup Prostate Cancer Prevention Trial to determine if 
this agent can prevent the development of prostate cancer.
    The response of men in this country to this trial was 
overwhelming and indeed 18,881 men ultimately enrolled in this 
study and this study reached its enrollment goals exactly 3 
years to the date of its inception directly on schedule. We 
were actually overwhelmed with the response. My understanding 
is that the Cancer Information Center of the National Cancer 
Institute received its largest volume of phone calls the day 
after we had a press conference here in Washington to announce 
this trial. I oftentimes say that men voted with their feet. 
They thought that they would never participate in a prevention 
trial. These were healthy men without evidence of prostate 
cancer and we were overwhelmed by the interest.
    We expect the results of this study to be available in the 
next several years. Efforts at prostate cancer prevention, 
however, have not stopped there. I am aware of many trials 
assessing the effects of multiple novel agents on prostate 
cancer development. We in San Antonio are currently conducting 
a study of alpha tocopherol, which is vitamin E, a very 
promising chemo-preventive agent in men at high risk of 
developing prostate cancer.
    A second micronutrient, selenium, an agent which may, like 
vitamin E, function as an antioxidant is also being studied in 
a number of trials. In response to the evidence of the 
potential effectiveness of these agents the Southwest Oncology 
Group and the Department of Veterans Affairs have collaborated 
to develop the neat intergroup prevention trial called SELECT, 
the Selenium and Vitamin E Chemoprevention Trial, a study 
proposed to study 32,400 men and we hope if it is funded it 
will begin next summer. I am very optimistic that for many of 
my generation and certainly for those of my son's generation--
and I have to reflect back, my grandfather passed away from 
prostate cancer as well, and so I have a personal interest in 
this as well--that we will have clear evidence that the risk of 
prostate cancer can be reduced.
    We are currently approaching this challenge on many fronts: 
In the molecular biology laboratories of the United States, 
through epidemiologic studies, using cancer models and most 
importantly through well-designed prospective clinical trials. 
It is only through these trials that we will be able to assure 
men with confidence that our recommendations are scientifically 
valid. The contributions of the Cooperative Clinical Trials 
Groups and the National Cancer Institute have been enormous, as 
has this interest by this committee, and your collaboration 
sets the stage for the discoveries over the next decade.
    Again, Mr. Chairman, members of the committee, it has been 
a distinct honor to have been here, and I thank you for your 
interest.
    Mr. Burton. Thank you very much, Dr. Thompson.
    [The prepared statement of Dr. Thompson follows:]
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    Mr. Burton. Dr. Kail, you indicated that one-third of 1 
percent of the total NIH budget is used for alternative 
therapies; is that correct?
    Dr. Kail. That was the figure that was passed out at the 
NCCAM meeting that recently was held when they looked at just 
what funding characteristics they had had. Other interesting 
things there was about this much basic science funding and this 
much clinical outcome funding, which I thought was quite 
appropriate.
    The thing I found most interesting about the funding 
pattern was that many of the institutions that put forth 
proposals at least, at the NCCAM meeting, were conventional 
institutions. I mean Harvard for instance had 10 or 12 
proposals put forth. Many of these institutions have no CAM 
providers in their proposals and they were not being done at 
CAM institutions. With the paucity of knowledge in the 
conventional community about alternative therapies, I find that 
we are having the same research organizations as apply for 
conventional grants turn right around and go for funding under 
alternative medicine.
    It is very clear that the alternative medicine research 
community is not equipped to compete for funds even under NCCAM 
guidelines. We have to go out and recruit these individuals, 
mostly because the best research--the best treatment of cancer 
patients does not occur in the research institution itself, 
does not even occur in medical schools. It occurs by 
alternative medicine doctors practicing on their own in the 
field and most of these people are getting good outcomes but 
not even tracking them.
    They have an inherent fear of dealing with research 
organizations, especially allopathic ones, because they are 
concerned that they may not have control of the research and 
the outcomes may not be the same as they could achieve. This is 
a real problem about getting alternatives really looked at 
under this microscope. We have to get them access to it.
    Mr. Burton. Dr. Chen, you were talking about this new 
combination of vitamins and other things that was put into what 
did you call it, PC SPES?
    Dr. Chen. Yes, a combination of plant extracts.
    Mr. Burton. And you said that there were some side effects. 
What kind of side effects were you talking about?
    Dr. Chen. The side effect has not been officially 
established but based on the observation include the decrease 
in libido.
    Mr. Burton. Decreasing libido?
    Dr. Chen. Yes, and some breast tenderness.
    Mr. Burton. Some breast tenderness? And that is a 
combination of how many different kinds of vitamins? Selenium, 
vitamin E. What else? Green tea.
    Dr. Chen. Well, there are eight different herbs. Seven of 
them are Chinese herbs and one American herb. The herbs belong 
to the common use.
    Mr. Burton. I think I take all of those things and I 
haven't had any of those side effects yet, but I don't take 
them in one pill.
    Let me just ask those of you who are from the National 
Institutes of Health and National Cancer Institute, why is it 
that we 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:]


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