[Senate Hearing 106-362]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 106-362
 
                            PROSTATE CANCER

=======================================================================

                                HEARING

                                before a

                          SUBCOMMITTEE OF THE

            COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE

                       ONE HUNDRED SIXTH CONGRESS

                             FIRST SESSION

                               __________

                            SPECIAL HEARING

                               __________

         Printed for the use of the Committee on Appropriations




 Available via the World Wide Web: http://www.access.gpo.gov/congress/
                                 senate

                                 ______

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                      COMMITTEE ON APPROPRIATIONS

                     TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi            ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania          DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico         ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri        PATRICK J. LEAHY, Vermont
SLADE GORTON, Washington             FRANK R. LAUTENBERG, New Jersey
MITCH McCONNELL, Kentucky            TOM HARKIN, Iowa
CONRAD BURNS, Montana                BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama           HARRY REID, Nevada
JUDD GREGG, New Hampshire            HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah              PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado    BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho                   DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas          RICHARD J. DURBIN, Illinois
JON KYL, Arizona
                   Steven J. Cortese, Staff Director
                 Lisa Sutherland, Deputy Staff Director
               James H. English, Minority Staff Director
                                 ------                                

 Subcommittee on Labor, Health and Human Services, and Education, and 
                            Related Agencies

                 ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi            TOM HARKIN, Iowa
SLADE GORTON, Washington             ERNEST F. HOLLINGS, South Carolina
JUDD GREGG, New Hampshire            DANIEL K. INOUYE, Hawaii
LARRY CRAIG, Idaho                   HARRY REID, Nevada
KAY BAILEY HUTCHISON, Texas          HERB KOHL, Wisconsin
TED STEVENS, Alaska                  PATTY MURRAY, Washington
JON KYL, Arizona                     DIANNE FEINSTEIN, California
                                     ROBERT C. BYRD, West Virginia
                                       (Ex officio)

                           Professional Staff

                            Bettilou Taylor
                             Mary Dietrich
                              Jim Sourwine
                               Aura Dunn
                        Ellen Murray (Minority)

                         Administrative Support

                             Kevin Johnson
                       Carole Geagley (Minority)




                            C O N T E N T S

                              ----------                              
                                                                   Page

Statement of Harold Varmus, M.D., Director, National Institutes 
  of Health, Department of Health and Human Services.............     1
Statement of Richard Klausner, M.D., Director, National Cancer 
  Institute, National Institutes of Health, Department of Health 
  and Human Services.............................................     1
Statement of Christopher Logothetis, M.D., Chairman and professor 
  of clinical cancer, Department of Medical Oncology, University 
  of Texas.......................................................     1
Statement of Robert Dole, former U.S. Senator....................     1
Statement of Michael Milken, founder and Chairman, CapCURE, 
  Association for the Cure of Cancer of the Prostate.............     1
Statement of Joe Torre, Manager, New York Yankees................     1
Opening statement of Senator Arlen Specter.......................     1
Summary statement of Dr. Harold Varmus...........................     3
Summary statement of Dr. Richard Klausner........................     4
    Prostate cancer research plan................................     5
    Prostate cancer clinical trials..............................     6
    Rapid access to intervention development program.............     7
    High priority questions related to Prostate cancer...........     7
    Prepared statement...........................................     8
        NCI Highlights...........................................     9
        Other Institutes.........................................    12
        NIDDK....................................................    12
        NHGRI....................................................    13
        NIEHS....................................................    13
        Public Understanding.....................................    13
        National Cancer Institute web sites......................    14
Opening statement of Senator Dianne Feinstein....................    14
    Prepared statement...........................................    15
        Research is key..........................................    15
        Cancer coalition: some challenges........................    15
        We need a battle plan....................................    16
Opening statement of Senator Thad Cochran........................    16
Summary statement of Christopher Logothetis......................    17
    Prepared statement...........................................    18
Opening statement of Senator Ted Stevens.........................    20
    Prepared statement...........................................    20
PSA testing......................................................    21
Prostate cancer in minority populations..........................    27
Administrative costs related to research.........................    27
Summary statement of Hon. Bob Dole...............................    29
    Prepared statement...........................................    31
Summary statement of Michael Milken..............................    32
    Prepared statement...........................................    35
Summary statement of Joe Torre...................................    38
    Prepared statement...........................................    41


                            PROSTATE CANCER

                              ----------                              


                        WEDNESDAY, JUNE 16, 1999

                           U.S. Senate,    
    Subcommittee on Labor, Health and Human
     Services, and Education, and Related Agencies,
                               Committee on Appropriations,
                                                    Washington, DC.
    The subcommittee met at 9:34 a.m., in room SD-192, Dirksen 
Senate Office Building, Hon. Arlen Specter (chairman) 
presiding.
    Present: Senators Specter, Cochran, Stevens, and Feinstein.

                DEPARTMENT OF HEALTH AND HUMAN SERVICES

                     National Institutes of Health

STATEMENTS OF:
        HAROLD VARMUS, M.D., DIRECTOR
        RICHARD KLAUSNER, M.D., DIRECTOR, NATIONAL CANCER INSTITUTE

                       NONDEPARTMENTAL WITNESSES

STATEMENTS OF:
        CHRISTOPHER LOGOTHETIS, M.D., CHAIRMAN AND PROFESSOR OF 
            CLINICAL CANCER, DEPARTMENT OF MEDICAL ONCOLOGY, UNIVERSITY 
            OF TEXAS
        ROBERT DOLE, FORMER U.S. SENATOR
        MICHAEL MILKEN, FOUNDER AND CHAIRMAN, CapCURE, ASSOCIATION FOR 
            THE CURE OF CANCER OF THE PROSTATE
        JOE TORRE, MANAGER, NEW YORK YANKEES


               opening statement of senator arlen specter


    Senator Specter. The hearing of the Appropriations 
Subcommittee on Labor, Health and Human Services, and Education 
will now proceed. Our subject today is on prostate cancer. We 
will be reviewing the funding and the work of the National 
Institutes of Health and the National Cancer Institute.
    We have a very distinguished array of visitors today: Dr. 
Harold Varmus, Director of NIH; Dr. Richard Klausner, Director 
of the National Cancer Institute; Dr. Christopher Logothetis, 
chairman and professor of Clinical Cancer Research at the 
University of Texas; Senator Robert Dole, former Senate 
majority leader; Mr. Michael Milken, founder and chairman of 
the Association for the Cure of Cancer of the Prostate; and Mr. 
Joe Torre, manager of the New York Yankees.
    The issue of research on funding is one of enormous 
importance and it is front and center in the Congress of the 
United States today. There is a consensus that research is 
necessary and that the funding ought to be provided, and when 
the sense of the Senate resolution was voted on not too long 
ago, it passed 98 to nothing to double research for NIH over 5 
years.
    Those were the druthers, the preferences. But when the time 
came to put up the dollars, the votes were not there. Three 
years ago, Senator Harkin and I authored an initiative to add a 
billion dollars which was defeated 63 to 37. We sharpened our 
pencils and found the money by establishing priorities in our 
existing funds.
    Two years ago a similar effort was made and again we were 
defeated, 57 to 42, but we were moving up. Last year again, we 
lost 52 to 48, but we were able to add some $2 billion to the 
total of NIH, and that has been reflected in the funding which 
has been provided for the Cancer Institute, which for fiscal 
year 1999 was $2.93 billion, a $375.9 million increase over 
fiscal year 1998.
    But our work is cut out for us this year if we are to be 
able to find the funding. We have not been able to move ahead 
with the processing, so-called ``markup,'' of the subcommittee 
bill here because of the caps and limitations, and we are 
struggling now to find the funds.
    This subcommittee is committed and determined to do its 
utmost to find increased funding for NIH, and we have again 
targeted an increase of $2 billion. Whether that will occur 
remains to be seen. But this is a dedicated crowd today, a 
dedicated audience, which can play a significant role in 
helping put the political pressure on Congress to get this kind 
of funding, and these kinds of high visibility hearings have a 
very significant effect.
    My own personal view is that it is unthinkable in a country 
as wealthy as ours not to fund all the meritorious applications 
for research, that is not to fund them all if they are 
meritorious, and the decision ought to be made on really if 
they are worthwhile, not whether we have the money to do it. 
This is a rich and powerful country and we have a Federal 
budget of $1.7 trillion and there is no higher priority than 
health.
    Just this week it was brought home to me. My former 
executive director in Philadelphia has a daughter who is 13. I 
was there at her birth. She has lymphoma, and fortunately she 
has a good prognosis. My chief of staff yesterday told me that 
his 14-year-old nephew has such a serious case of cancer that 
they are going to be excising his shoulder blade.
    I look at my three grandchildren and I look at my own PSA 
score and I see the people who are here today, prostate cancer 
survivors, and say that we ought to be funding every last 
research grant which is meritorious. We can afford to do it and 
we cannot afford not to do it.
    Senator Dole has been a leader in this field for a very 
long time. In 1991, he had a prostate cancer operation and he 
came back to the Republican Caucus. We were assembled for our 
Tuesday lunch and he said: ``I just had a successful prostate 
operation; it strikes one man out of nine; you eight fellows 
are safe.'' Then he pointed to Ted Stevens and he said: ``Ted 
just had a prostate operation, successful, and you eight 
fellows are safe.''
    Then he turned and looked at Strom and he said: ``Strom, 
you are too old to get prostate cancer.'' [Laughter.]
    Bob and I are from the same little town in Kansas, so I am 
permitted to steal one joke a month, to replay one of his 
stories.
    But he has been a tremendous leader in the field. He has 
made a suggestion which I think is an excellent one, that 
everybody in the room who is a prostate cancer survivor should 
stand, if you would, please. [Men stand.]
    Thank you all very much. Congratulations to you.
    You can be a model for others.
    I want to turn now to our two very distinguished research 
scientists: Dr. Harold Varmus, Director of the National 
Institutes of Health; and Dr. Richard Klausner, Director of the 
National Cancer Institute. In the appropriations, where we have 
very materially increased NIH funding, I must candidly say that 
there are questions raised by my colleagues as to whether the 
NIH can really use these funds effectively and whether they are 
using them efficiently. The subcommittee sent Dr. Varmus a 
letter recently asking for details on their expenditures, what 
they are doing with the funds.
    In looking to next year, we have examined, and we will be 
looking at it further, a spreadsheet as to where these funds 
are going to go. Those are very important questions to be 
answered because too often major Federal agencies turn up with 
big deficiencies, and all you need is one big deficiency and 
then forget about the funding. There are so many places to 
fund. It has to be done and it has to be done right.
    We have had a fairly sharp response. Again, candidly and 
openly, I want to put all the cards up on the table on the 
problems as well as the successes. But when we had to cancel an 
earlier scheduled hearing on prostate cancer because the report 
which was originally scheduled to be released on April 22 was 
not released--and it is going to be released today--we got two 
letters from prostate cancer community leaders expressing 
concern to Dr. Varmus that the missed deadlines exemplified the 
NIH's ``neglect and indifference'' to cancer sufferers and 
``abruptly terminated its commitment'' to prostate cancer 
sufferers.
    So the kind of a sense of urgency which we have has to be 
recognized at all times. We are constantly beset with a variety 
of people, well intentioned sufferers from one malady or 
another, what want to know why their particular ailment is not 
getting more funding, and they can always find one to point to, 
which on a per capita basis, is getting more.
    The subcommittee and the full committee and the Congress 
have stayed away from our judgment. We want to leave it to your 
judgments, the medical judgments and the peer judgments, as to 
what ought to be funded.


                 summary statement of dr. harold varmus


    We turn now to Dr. Harold Varmus, who has been Director of 
the NIH since November of 1993. At the University of California 
at San Francisco he won the Nobel Prize for his work on the 
causative link between certain genes and cancer. A graduate of 
Amherst College, Harvard University, and the Columbia Medical 
School.
    Thank you for your contribution, Dr. Varmus. Thank you for 
joining us today. The floor is yours.
    Dr. Varmus. Thank you, Senator Specter.
    Senator Specter. Our rules provide for a 5-minute green 
light, 1-minute yellow light, and a red light. So to the extent 
we can stay within those time limits it would be appreciated.
    Dr. Varmus. Senator, thank you. I will be very brief. I am 
going to turn over most of my time to Dr. Klausner, who, as the 
Director of NCI, coordinates the trans-NIH efforts on this 
particular problem, prostate cancer. But I did want to make a 
few comments before yielding the microphone to him.
    First, I want to thank you for holding this hearing on this 
very important scientific and medical topic. It allows us to 
show a specific example of how the NIH can respond with 
increased research activity against a major public health 
threat, especially when we are equipped with the increased 
funds which your Committee has provided for us and when we are 
supported by the remarkable progress that has been made in our 
understanding of cancer at the genetic, cell biological and 
physiological level over the last several years.
    It also allows us to illustrate how research activities can 
be coordinated within a major institute like the NCI and across 
the several NIH institutes that are active in research against 
prostate cancer. As you will see in your reading of the report, 
there are nine institutes and centers that have some 
involvement in prostate cancer research; but for the most part 
their involvement is relatively minor compared to the activity 
of the NCI, which funds over 85 percent of prostate cancer-
specific research at the NIH.
    I want to commend the NCI in particular for a thorough 
planning process that has been ongoing now for at least 2 to 3 
years, bringing in a large array of activists, scientists, 
patients, and others.
    I also want to apologize for any delay in the issuance of 
the report. This was not a delay that had any impact on our 
execution of the scientific programs, but represented a 
misapprehension by us about how much time it would take to get 
the report through the various clearing processes at the 
Department and OMB and elsewhere in order to deliver the report 
in a finished, cleared manner to you at the hearing.
    But let me restate that we are sorry that any of the 
prostate cancer patients felt that this represented any lack of 
commitment on our part or any delay in the scientific agenda. 
Neither was true, although that impression is clearly 
understandable. I hope that with the issuance of the report 
today and our report on what has been achieved in prostate 
cancer in the last couple of years those who are most concerned 
about this disease will be at least partially reassured.
    I again thank you for holding the hearing, and, would like 
to turn the proceedings over to Dr. Klausner.


               summary statement of dr. richard klausner


    Senator Specter. We turn now to Dr. Richard Klausner. 
Appointed Director of the National Cancer Institute in August 
of 1995, he has served as Chief of Cell Biology and Metabolism 
Branch of the National Institute of Child Health and Human 
Development. Undergraduate degree from Yale, a medical degree 
from Duke, and postgraduate work at Harvard.
    Thank you for all you have done, Dr. Klausner. We look 
forward to your testimony.
    Dr. Klausner. Thank you, Senator Specter, for both having 
this hearing and providing the leadership and support that has 
allowed us to, as I think I will show you, act with the sense 
of urgency that we all feel is needed to make progress against 
prostate cancer. I am particularly pleased to appear before you 
today to describe our response to the congressional request to 
develop a plan and a professional judgment estimate of the 
scientific opportunities in prostate cancer.
    Prostate cancer is the single most common form of cancer of 
men in the United States. This year alone, NCI predicts there 
will be 179,000 new diagnoses of prostate cancer and about 
37,000 men will die of the disease. It exacts a particularly 
devastating toll in the African American community, with 50 
percent increased incidence and a twofold increase in mortality 
compared to white Americans.
    But this catalogue of prostate cancer statistics does 
little to convey the real fear and pain and uncertainty 
experienced by men when they are diagnosed with prostate 
cancer. Despite advances over the past decades, currently our 
treatments for prostate cancer are inadequate. The side effects 
of treatment are unacceptable and troubling questions remain 
about the efficacy of early detection for this disease. Every 
day too many men in the United States hear the life-changing 
words, ``You have prostate cancer.'' Too many men are faced 
with the agonizing decision of how to treat their prostate 
cancer, and too many men are dying too young of this disease.


                     prostate cancer research plan


    Dr. Varmus said nine NIH Institutes are involved in this 
prostate cancer research plan. The NCI is the lead Institute, 
responsible for the majority of the research, and we 
participate in and help coordinate all of these activities. 
This morning I am going to focus on the NCI activities.
    The request for this report in last year's appropriations 
bill came at a propitious time in NCI's internal planning and 
implementation process. Over 2 years ago, we initiated a 
prostate cancer review process, bringing together scientists, 
clinicians and advocates, challenging all of us together to 
review our current prostate cancer research portfolio, to 
develop a prioritized set of questions that needed to be 
answered, to identify resources that needed to be developed, 
and to provide a vision to chart a course for prostate cancer 
research.
    This is the report and we are happy to make it available to 
the Committee. It has been very helpful to have this report so 
that we have a set of priorities as we move forward with 
increased investments.
    The report being presented today is a two-part plan for 
research in prostate cancer. First, the current fiscal year 
1999 budget commits a 63-percent increase over fiscal year 
1998, for a projected total of $141.5 million this year for NCI 
and $180 million for NIH for prostate cancer. Second, we have 
developed a professional judgment estimate covering the 
following four fiscal years.
    But we have already this year embarked on an aggressive 
prostate cancer research agenda based upon this several years 
of planning, and it is this aggressive agenda that will lay the 
groundwork for future efforts as described in the report. The 
report lays out clear priorities.


                    prostate cancer clinical trials


    Seventy percent of the targeted dollars would be directed 
to clinical and translational research, with the opportunity to 
rapidly, with near-term outcomes, affect the experience of men 
with prostate cancer. Let me illustrate this with a few 
examples. In the areas of clinical trials for patients with 
prostate cancer, we have set out explicit goals to test new 
approaches and new agents aimed at a variety of clinical 
situations that men face. We have established a novel program 
we call Quick Trials to provide a rapid and efficient way to 
move new ideas for therapeutic interventions out of the 
laboratory into phase one and phase two clinical trials for 
prostate cancer.
    This program will greatly increase the critical early phase 
clinical trials carried out at cancer centers around the 
country. The NCI's goals this year are to increase the number 
of patients participating in early clinical trials in prostate 
cancer by two to threefold and to initiate 10 to 15 new trials 
in the first year of this Quick Trials program.
    In addition, the NCI's Cancer Therapy Evaluation Program 
will initiate approximately 35 new phase one and two trials in 
prostate cancer, with over 25 novel drugs, agents, or 
combinations, many of which have not been used before but show 
promise in the laboratory, directed against a number of 
particularly promising molecular targets and mechanisms, which 
is what we have to move toward.
    The targets include: angiogenesis and metastasis, the 
process by which cancer induces new blood vessels, invades 
those blood vessels, and is spread through the body; targets 
against growth factors and their receptors, which mediate the 
growth and the survival of prostate cancer cells; and targets 
against genes whose products are specifically expressed in 
normal prostate and prostate cancer cells, thus allowing us to 
specifically target a variety of killing modalities.
    In these trials we will test novel small molecule drugs, 
specific antibodies, vaccines, targeted gene therapy, targeted 
radiation sensitizers, and others.
    Now, compared to the level of effort in 1998, this plan 
already more than doubles the number of early clinical trials 
initiated in prostate cancer in 1999. This year, we will 
additionally activate up to ten new multi-center phase three 
clinical trials in prostate cancer that will attempt to 
optimize hormonal approaches and move forward with important 
new chemotherapeutic approaches for the most common clinical 
presentations of the disease, including adjuvant therapy in the 
setting of primary surgical or radiation treatment. In fact, in 
recent clinical trials we have been able to see the first 
reduction in mortality from more aggressive regional prostate 
cancer with this combination of adjuvant therapy with 
radiation.
    We will look at neo-adjuvant therapy, treatment after 
hormone therapy, treatment in the setting of rising PSA levels 
after definitive local therapy, and, importantly, new 
treatments for advanced and metastatic disease.
    With this initial ramp up in clinical trials, and 
contingent upon overall funding levels, we estimate the ability 
to double again the number of new phase three trials initiated 
over the following 4 years. The agents entering these trials 
are new and have shown significant promise in early phase 
trials against prostate cancer, and these early results bolster 
our hope that we can rapidly expand the currently very limited 
selection of therapies that are available for men with prostate 
cancer with advanced or recurrent disease.
    The NCI is also engaged in a major restructuring of its 
clinical trials system to expand, speed and improve clinical 
trials. We have been working this past year very productively 
with CapCURE to develop and deploy a common data element system 
for protocol authoring, trial simplification, monitoring, 
reporting, and analysis.


            rapid access to intervention development program


    We have initiated a new program which we call the RAID 
program, creating a virtual drug development system for the 
Nation that enables investigators in laboratories, academia, or 
small business to access resources, to move molecules out of 
the laboratory and into new clinical trials within 12 to 24 
months. This year we have already approved 25 new agents that 
have not been used before in patients through the RAID program, 
at least 5 of which are directly related to prostate cancer and 
the majority of which appear relevant to prostate cancer.
    Over the next 5 years our goal is that 25 or more novel 
therapeutics relevant to prostate cancer will be brought out of 
the laboratory into patients through this mechanism.


           high priority questions related to prostate cancer


    As laid out in the report, we are addressing a number of 
additional high priority questions about prostate cancer, and I 
will quickly review that list:
    First, we will be testing promising preventive agents, 
particularly in high risk individuals.
    Second, and this is very important, we have laid out a goal 
to switch prostate cancer diagnosis from the way it has been 
done for years, looking under the microscope, to molecular 
diagnostics. So we will learn which prostate cancers are going 
to spread, which are not going to grow, which may need therapy, 
and how to tailor therapy to the molecular machines in each 
prostate cancer.
    Third, we will validate current and develop new early 
detection markers through the newly established early detection 
research network. This year we will expand the critical PLCO 
early detection trial involving 75,000 men followed for the 
development of prostate cancer. We have in the last few months 
established an international consortium to monitor and rapidly 
share data on screening of prostate cancer results throughout 
the world.
    Fourth, we will develop a National Cooperative Prostate 
Cancer Tissue Resource beginning this year.
    Fifth, we will expand studies linking imaging, especially 
functional imaging, to therapy.
    Sixth, we will enhance the Specialized Programs of Research 
Excellence in prostate cancer by expanding the numbers of 
programs and by linking the current three programs around the 
country into a national consortium.
    Seventh, we will accelerate epidemiologic studies that are 
ongoing to attempt to systematically identify correlates of the 
profound geographic and population differences in prostate 
cancer rates.


                           prepared statement


    Finally, we have laid out a program to develop new animal 
models, the lack of which has limited research progress in the 
past, that will attempt to faithfully reproduce human prostate 
cancer in order to better understand tumor development and 
spread and as a way to more rapidly test preventive and 
therapeutic interventions.
    Senator Specter. Dr. Klausner, we are having two votes 
scheduled at 10:45. Those votes were put in the schedule long 
after we had scheduled this. So to the extent you could 
summarize, we would appreciate it.
    Dr. Klausner. That was the end of my statement. I 
appreciate the level of interest the committee has shown in 
prostate cancer and I am pleased to present this report, which 
gives a vision of our commitment and our sense of urgency that 
we have had for prostate cancer.
    I know Dr. Varmus and I are pleased to answer any questions 
you or your colleagues will have.
    Senator Specter. Well, thank you very much, Dr. Klausner.
    [The statement follows:]

                 Prepared Statement of Richard Klausner

                              introduction
    Good morning, Senator Specter and Members of the Subcommittee. I am 
Richard Klausner, M.D., Director of the National Cancer Institute 
(NCI). I am accompanied today by Harold Varmus, M.D., Director of the 
National Institutes of Health (NIH).
    We are pleased to appear before you today to describe our response 
to the Congressional request to submit (1) a report outlining 
activities NIH is undertaking to enhance prostate cancer research 
programs and (2) a report outlining NIH's professional judgment for 
prostate cancer research for the next five years. The Congress has also 
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.
    The nature and magnitude of the burden of prostate cancer has been 
tracked by NCI's surveillance program, and we estimate that about 
180,000 men will be newly diagnosed with prostate cancer this year and 
about 37,000 will die. Prostate cancer exacts a particularly 
devastating toll on African American men; incidence rates are 
substantially higher among African Americans, and mortality rates in 
African American men remain more than twice as high as rates in white 
men.
    This catalogue of statistics, while accurate, does little to convey 
the very real pain, fear, and uncertainty experienced by every man who 
is diagnosed with prostate cancer. 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 efficacy of early detection for the disease. Every day, too 
many men in the United States hear the life-changing words ``You have 
prostate cancer.'' Every day, too many men are faced with the agonizing 
decision of how to treat their prostate cancer. And every day, too many 
men are dying too young of this disease. The limited knowledge about 
the causes of prostate cancer, how to prevent it and how to 
successfully treat it demand a clearly articulated and adequate 
approach to research.
                                overview
    The NIH, with leadership from NCI, has aggressively sought 
participation from researchers, advocates, and patients in reviewing 
the prostate cancer research portfolio and charting a plan for a 
vigorous expansion of the prostate cancer research program. The initial 
evaluation of the research program and a broad outline of future 
directions were completed in August 1998 and are described in part I of 
the report being presented today, ``Planning for Prostate Cancer 
Research: Expanding the Scientific Framework.'' The NIH efforts in 
coordinating a research plan for prostate cancer have focused on 
continuing development of a widely disseminated research program 
coordinated and supported by the NIH and accompanied by continuing 
involvement of researchers, professional societies, advocacy groups and 
patients. The report of the NCI-convened Prostate Cancer Progress 
Review Group described a nationwide program involving a significant 
investment in infrastructure across the nation. It is recognized that 
each of the 35 NCI Comprehensive Cancer Centers, geographically 
dispersed throughout the nation, devote significant effort to 
education, training, treatment and research on prostate cancer and 
cover the full spectrum of prevention, early diagnosis and treatment.
    Part II of the report, ``Planning for Prostate Cancer Research: 
Five Year Professional Judgment Estimates,'' describes prostate cancer 
research opportunities from 1999 through 2003. NIH has increased 
prostate cancer research funding significantly from a 1998 level of 
$114 million to a current projection of $180 million in 1999. This plan 
estimates that $420 million of potential research opportunities could 
be supported in 2003. It must be noted that this estimate is based on 
our assessment of scientific opportunities over the next five years, 
without consideration of economic constraints or other competing 
priorities of the NIH or the Federal government. This plan includes 
many efforts already initiated in 1999. Two institutes, the National 
Institute of Mental Health and the National Institute of Deafness and 
Other Communication Disorders were not previously focused on prostate 
research, but are now newly included in the NIH prostate efforts. 
Furthermore, this level of support must be integrated with other 
research efforts of the NIH. A total of nine institutes have important 
intersecting interests that contribute to the NIH prostate cancer 
research effort and have been consulted in the development of this 
plan.
                             nci highlights
    The NCI is the lead NIH institute for prostate cancer research. The 
report describes a number of new NCI initiatives, projects, and 
mechanisms that have the potential to directly improve the quality of 
life of prostate cancer patients and survivors, as well as those at 
risk for the disease. Indeed, fully 70 percent of the research 
opportunities presented here are targeted at clinical or translational 
research that would have a direct impact on patients, survivors, and 
at-risk men.
    The request in last year's appropriation bill for such a report 
came at a propitious time in NCI's internal planning and implementation 
processes. Before describing this plan, following are several relevant 
features of the NCI planning processes.
    For the past 3\1/2\ years, the NCI has taken an intense three-part 
approach to planning. First, we established a series of blue-ribbon 
committees to review and propose reforms to our major venues for cancer 
research including clinical trials, cancer prevention, cancer control 
and the drug discovery and development processes. Scores of 
recommendations to create more effective and efficient means of making 
progress have or are being implemented.
    Second, we established a process to evaluate areas of extraordinary 
opportunity with new investments and new programs that promised to 
capitalize on untapped, near term opportunities to make progress 
against cancer. These opportunities and the plans and progress made are 
outlined in the NCI By-Pass Budget.
    Neither of these first two planning approaches are specific to 
cancer sites. Rather, the planning and implementation processes are 
specifically charged with establishing the commonality of needs across 
all cancer sites and to assure that the opportunities for progress are 
likewise implemented for all cancer sites.
    Third, over two years ago, we initiated a disease-specific planning 
process called a progress review group or PRG. The Prostate Cancer PRG 
involved scores of individuals--scientists, clinicians, and advocates--
and challenged the prostate cancer research community and the NCI to 
review our current prostate cancer research portfolio, to develop a 
prioritized set of questions that needed to be answered and resources 
that needed to be developed or applied, and provide a vision to chart a 
course for research and progress in prostate cancer. The PRG report was 
presented to the NCI last September and since then we have acted to 
implement a plan that we believe will fulfill the vision of progress 
articulated by the PRG. The PRG report, which I am pleased to provide 
to this committee, represents an important component of the scientific 
opportunities and professional judgment report which we are presenting 
today.
    The PRG not only gave us a consensus vision of what the needs are 
but, importantly, greatly reinforced the premise of our other planning 
processes in that the vast majority of identified research needs in 
prostate cancer (and for breast cancer from the parallel breast cancer 
PRG) could be directly accommodated and accomplished through the 
several dozen programs already initiated as a result of our more global 
planning.
    In all three of our planning phases we have involved a variety of 
members of the prostate cancer communities including researchers, 
clinicians and advocates. To ensure that the professional and advocacy 
groups were fully represented, the PRG invited the input of 32 
``stakeholder'' groups that represented both professional societies and 
advocacy groups.
    The report being presented today highlights that NCI plans to spend 
$114.5 million on prostate cancer research in fiscal year 1999, a 63 
percent increase over fiscal year 1998. NIH in total expects to spend 
$180 million on prostate cancer research in fiscal year 1999. At the 
Congress' request, we have also developed a five-year professional 
judgment estimate in collaboration with eight other Institutes and 
Centers that includes what we foresee as prostate cancer research 
opportunities over the following four fiscal years. If we could not be 
concerned with any economic constraints or other competing priorities 
of the NIH or the Federal government, we estimate NCI could support 
$340 million, and NIH in total could support $420 million worth of 
targeted prostate cancer research by fiscal year 2003.
    We have begun, in an aggressive way, to accelerate funding for 
prostate cancer as reflected in the report being presented here today.
  --A special section of the NCI Web site calls attention to more than 
        20 initiatives through which high priority areas can be 
        addressed.
  --I have met with the representatives of the prostate cancer research 
        community, the PRG, and the leadership of professional 
        societies, such as the American Urological Association, in 
        order to communicate these initiatives and to enlist the 
        research community's support in responding to these 
        opportunities.
  --Extensive outreach and advertising will alert the larger research 
        community to these opportunities to energize their 
        participation in this prostate cancer research program.
    The scientific opportunities we project are presented in four major 
areas:
    (1) Clinical Science--the near term direct testing of new 
interventions in patients or in those at risk for prostate cancer.
    (2) Translational Science--moving ideas from the laboratory to the 
point of clinical testing.
    (3) Risk, Burdens & Outcomes Science--attempting to ask critical 
questions about cause, the unequal levels of cancer in different 
populations, outcomes and survivorship.
    (4) Basic research and discovery--longer term investments in 
gaining insight into the development and biology of prostate cancer and 
the development of models for study.
    Priorities are identified in the report. Seventy percent of the 
targeted research opportunities are directed to clinical and 
translational research. Let me illustrate with a few examples. In the 
area of clinical trials for patients with prostate cancer, we need to 
test new approaches and new agents aimed at a variety of clinical 
situations. We have established ``Quick Trials,'' a new program to 
provide a rapid and efficient way to move new ideas for therapeutic 
interventions into Phase I and II clinical trials for prostate cancer. 
This program has been set up in recognition of the urgent need for new 
types of interventions that are effective at different stages of 
prostate cancer, as well as the growing number of therapeutic ideas 
that are ready to be tested in patients.
    In this type of project, where it is necessary to evaluate untested 
leads in the absence of preliminary data, conventional application and 
review procedures are not well suited. Quick Trials utilizes a process 
for rapid approval of early clinical trials. The NCI's goals are to 
increase the number of patients participating in early clinical trials 
by two to three-fold and to initiate 10-15 new trials through this 
accelerated mechanism. In addition, this year through NCI's Cancer 
Therapy Evaluation Program, we will initiate approximately 35 new Phase 
I/II trials in Prostate Cancer with agents directed against a number of 
particularly promising molecular targets and mechanisms. The targets 
include:
  --angiogenesis and metastasis, the processes by which cancers induce 
        new blood-vessel formation, invade these blood vessels, and 
        spread throughout the body;
  --growth factors and their receptors, which mediate growth signals to 
        cancer cells; and
  --tissue-specific genes expressed selectively in prostate or prostate 
        cancer cells, thus allowing for the targeting of tumor-killing 
        modalities to these cells.
    We will test:
  --Novel small molecule drugs
  --Specific antibodies
  --Vaccines
  --Virus-based gene therapy
  --Targeted radiation sensitizers
    Compared to the current level of effort, this plan could more than 
double the number of early clinical trials in prostate cancer in the 
first year, with another doubling projected at the full professional 
judgment in the next four years.
    This year, we will activate 5 new multi-center phase III clinical 
trials in prostate cancer that will attempt to optimize and test new 
hormonal and chemotherapeutic approaches for the most common clinical 
presentations of the disease, including:
  --adjuvant therapy in the setting of primary surgical or radiation 
        treatment;
  --neo-adjuvant therapy, which has shown promising results in reducing 
        the mortality from locally advanced prostate cancer;
  --treatment after hormone therapy;
  --treatment in the setting of rising PSA levels after definitive 
        local therapy; and
  --advanced disease, particularly directed at bony metastases.
    With this initial ramp up in clinical trials, we project the 
ability to double the number again over the following four years.
    We have initiated a new program creating a drug development process 
that enables investigators to begin clinical trials with novel 
molecules discovered in academic laboratories. We do this by giving 
academic investigators access, on a competitive basis, to NCI's 
preclinical drug development resources and expertise. Investigators who 
have molecules that hold promise for cancer treatment but without 
access to the development resources required for initiation of clinical 
studies are invited to submit applications twice a year. Those selected 
for support are assisted with necessary development steps to enable IND 
filing with the Food and Drug Administration and to begin initiation of 
proof-of-principle clinical trials. For fiscal year 1999, our goal is 
the development of three to five new therapeutic agents, each relevant 
to prostate cancer. Projects already approved include development of a 
bioreductive compound with potential as a radio and chemosensitizer, 
and a gene-therapy approach that will convert inactive pro-drugs into 
toxic agents within prostate cancer cells. Over five years, 15 new 
therapeutic agents for prostate cancer could potentially be developed.
    The plan covers a number of additional central questions about 
prostate cancer and describes potential strategies to address them. 
These include:
    (1) Testing promising preventive agents, particularly in high risk 
individuals;
    (2) Developing new, predictive molecular diagnostics;
    (3) Validating current and new early detection markers;
    (4) The linkage of imaging to therapy;
    (5) Epidemiologic studies to attempt to systematically identify 
correlates of the profound geographic and population differences in 
prostate cancer rates; and
    (6) Developing new animal models that faithfully reproduce human 
prostate cancer in order to better understand tumor development and 
spread, and to better test preventive and therapeutic interventions.
    This plan also envisions opportunities for a four-year increment of 
215 investigator-initiated research grants that target 18 areas of 
clinical, translational, epidemiologic and fundamental research.
    The five year professional judgment report I am presenting today 
builds on a strong base of existing prostate cancer research including:
    1. The Cancer Genome Anatomy Project (CGAP), the goals of which are 
to build an index of all genes that are expressed in tumors and support 
development of new technologies that will allow high throughput 
analysis of gene and protein expression as well as mutation detection. 
The tumor type with the highest representation in the early stages of 
the CGAP effort is prostate cancer. NCI has facilitated investigator 
collaborations of interdisciplinary studies following the recent 
discovery of a susceptibility gene on chromosome 1. Leads from this 
effort may help to clarify genetic and gene-environment interactions 
responsible for black-white differences in risk.
    2. NCI funded (in total or in part) 246 clinical trials in prostate 
cancer, including 80 Phase III studies and 37 Phase II studies. NCI 
clinical studies in prostate cancer have significant African-American 
participation. One NCI study shows that 14.7 percent of men enrolled 
onto NCI sponsored prostate cancer treatment trials are African 
American while 10.3 percent of Americans diagnosed with prostate cancer 
are African American.
    3. NCI's ongoing Prostate Cancer Prevention Trial (PCPT) involves 
18,000 healthy men over the age of 55 to determine if the drug 
finasteride can prevent prostate cancer.
    4. NCI's ongoing Prostate, Lung, Colorectal, and Ovarian Cancer 
Screening Trial (PLCO) is assessing the efficacy of prostate cancer 
screening. New PLCO sites are being added to enhance minority patient 
accrual. NCI is sponsoring two trials in which ``watchful waiting'' is 
being compared in terms of outcome with surgical removal of the 
prostate and with radiation therapy. These trials are intended to 
determine if treatment of localized disease is effective.
    5. NCI staff and the Department of Defense have collaborated in a 
study of treatment data and shown that equal treatment yields equal 
outcome within stage. This finding suggests that all NCI efforts to 
improve prevention, diagnosis and treatment of this disease benefit all 
patients equally. However, NCI staff analyzing SEER Program data have 
shown that there are tremendously differing patterns of care among 
black and white men with prostate cancer.
    6. NCI, along with the American Cancer Society and the Centers for 
Disease Control and Prevention sponsored a Leadership Conference on 
Prostate Cancer in the African-American Community in November of 1997. 
Developed in cooperation with the 100 Black Men of America, the 
Intercultural Cancer Council, the National Black Leadership on Cancer, 
and the National Prostate Cancer Coalition, the conference represented 
a significant step toward developing a strategy for the full 
participation of African Americans in prostate cancer research and 
control.
    7. In addition, NCI recently conducted a large interview-based 
study of prostate cancer in African Americans and whites. Analysis of 
the results have not thus far revealed any specific factor that could 
explain the racial differences in risk. However, further studies are 
underway, including an extensive evaluation of the role of different 
components of the diet.
                            other institutes
    Several NIH Institutes conduct and support research on prostate 
cancer and related diseases that will advance our knowledge of prostate 
cancer [National Institute of Diabetes and Digestive & Kidney Diseases 
(NIDDK); National Human Genome Research Institute (NHGRI); National 
Center for Research Resources; National Institute of Environmental 
Health Sciences (NIEHS); National Institute on Aging; National 
Institute of Nursing Research; National Institute of Mental Health; 
National Institute of Deafness and Other Communication Disorders]. 
These research activities are coordinated through formal and informal 
collaborations, interest groups, and other interactions. Following are 
highlights from some of these Institutes' professional judgment of 
potential research opportunities. A complete description of the 
research activities of other NIH Institutes may be found in the report, 
``Planning for Prostate Cancer Research.''
                                 niddk
    The discoveries that will lead to improved therapy and ultimately 
prevention and cure need to be sought through a number of avenues:
  --The outcome of cancer depends not just on the behavior of the tumor 
        cell--but also on the normal surrounding cells that are not 
        themselves cancerous. We need to know more about the normal 
        prostate cells -B and the genes they express--in order to 
        identify new targets for disease intervention. We also need to 
        know more about the interactions between prostate cancer cells 
        and bone, to understand the determinants of metastasis.
  --Developmental biology is proving to be an important source of clues 
        about disease. We need to understand the developmental program 
        for formation of the prostate and the lineage of the cells that 
        make up the gland.
  --What is the action of androgen, the genes it controls and the 
        mechanisms by which the hormone turns genes on and off? These 
        are critical basic questions broadly anticipated to yield the 
        basis for new therapeutic approaches.
  --We know too little about the variation in susceptibility of 
        different populations to the disease of the prostate. Careful 
        monitoring of epidemiological trends in the burden of benign 
        and malignant prostate disease is an important priority. 
        Particularly, the enhanced susceptibility of certain racial 
        groups to prostate cancer--and the relative protection of other 
        groups--are phenomena that we need to understand.
  --Better strategies to prevent the two feared complications of 
        surgery on the prostate--urinary incontinence and impotence--
        are needed urgently. Although new surgical approaches for both 
        benign prostatic hypertrophy and prostate cancer have reduced 
        the rate of these complications, further progress is needed.
  --Prostate cancer is a hormone responsive tumor and the major forms 
        of treatment of advanced prostate cancer involve pharmacologic 
        blockade of the gonadatrophin release or antagonism of the 
        androgen receptor. There are new and emerging opportunities to 
        improve these approaches.
                                 nhgri
    Over the next five years, NHGRI investigators aim to identify all 
of the common contributing genes to hereditary susceptibility--besides 
HPC1 and HPCX, there is strong evidence pointing to another region of 
another chromosome, and other regions also contain hints of hereditary 
factors. As the precise genes are identified, clinical studies would be 
undertaken to offer genetic testing to men from high risk families, to 
identify those at greatest risk for life-threatening disease and design 
a program of surveillance to identify their cancers early enough to 
achieve cure. In addition, using the chip technology, the common 
changes in gene expression that contribute to various steps in 
malignant transformation would be cataloged, and used to derive new 
hypotheses about the molecular steps involved in prostate cancer. These 
would in turn suggest new and more powerful ways to treat or prevent 
the disease.
                                 niehs
    Human diseases, such as prostate cancer, are generally the 
consequence of both genetic susceptibility and environmental exposure. 
The tools of molecular genetics provide new opportunities to understand 
the genetic basis for individual differences in susceptibility to 
environmental exposure. The NIEHS is expanding its research program on 
genetic susceptibility to environmentally-associated diseases through a 
new Environmental Genome Project. Over the next five years, the 
Environmental Genome Project would systematically identify the allelic 
variants of disease susceptibility genes in the U.S. population, 
develop a central database of known polymorphisms for these genes, and 
foster population-based studies of gene- environment interaction in 
disease etiology. By identifying those genes and allelic variants that 
affect individual response to environmental toxins, we can better 
predict health risks and develop environmental policies to protect the 
most vulnerable subgroups of the population from such diseases such as 
prostate cancer.
    The NIEHS Environmental Genome Project would be a broad, multi-
center effort to identify systematically in the U.S. population the 
alleles of environmental disease susceptibility genes. Susceptibility 
genes will be chosen through a peer-reviewed process and are expected 
to include five broad gene classes: genes controlling the distribution 
and metabolism of toxicants; genes for the DNA repair pathways; genes 
for the cell cycle control system; cell death/differentiation genes; 
and, genes for signal transduction systems controlling expression of 
the genes in the other classes. This effort would result in the 
systematic identification of the polymorphisms of these genes found in 
the U.S. population. A central database of the polymorphisms would be 
made available. This database will support both functional studies of 
alleles and population-based studies of disease risk.
                          public understanding
    Communicating with cancer patients, individuals at high risk for 
cancer, the general public, and the health care community is a central 
component of NCI's mission and mandate. For prostate cancer, the 
institute communicates information to all of those groups, as well as 
to the cancer research community.
    Materials available from NCI, including print, video, and web 
products, range from basic information about the disease, information 
about research now ongoing to improve understanding and management of 
the disease, and information for men about early detection and 
treatment options.
    One of the most recent communications initiatives is a partnership 
with the prostate cancer advocacy organization, US TOO, to develop a 
national communications initiative, called Know Your Options, to better 
inform men and their families about the disease. The initiative is 
based on an information package or kit that provides a solid base of 
information about prostate cancer to help US TOO chapters work with 
their hometown media. The media, in turn, use the information provided 
by US TOO with the NCI imprimatur, to keep their readers, listeners, 
and viewers informed about the disease. The kit includes the latest 
medical and scientific information available, as well as information 
about where US TOO chapter leaders can go for more information, advice, 
and help.
    In addition, information specialists from the NCI-sponsored Cancer 
Information Service provide more than 60,000 people annually with 
information about prostate cancer, information about research on the 
disease, information about screening and treatment options, and 
information about coping with physical and psychological side effects 
of the disease and its treatment. The NCI web site provides information 
about prostate cancer clinical trials as well as information about 
treatment options for every stage of the disease.
    During this summer and next fall, NCI is working with the Centers 
for Disease Control and Prevention and with the Health Care Financing 
Administration to develop an educational video for men on issues they 
could face about prostate cancer screening, diagnosis, and treatment. 
The video, intended to be relevant to a general male audience, will be 
developed to have special relevance to African-American men. The video 
will provide educational material on what men need to know about 
prostate cancer screening options, what they need to know about 
diagnostic follow if a screening test is positive, and what they need 
to know about treatment options if the diagnosis is positive.
    NCI's basic print product about the disease, ``What You Need to 
Know about Prostate Cancer,'' is now available on the web as well. It 
provides information about prostate cancer; its symptoms, diagnosis, 
staging and treatment; clinical trials; side effects of treatment; 
nutrition and other support for prostate cancer patients; and what 
prostate cancer research holds for the future.
    A new publication from NCI, ``Understanding Prostate Changes: A 
Health Guide for All Men,'' will soon be available on the web too. It 
covers all aspects of prostate cancer in more depth than the basic 
booklet, but also describes non-cancerous prostate conditions. Another 
product in development, called ``Prostate Cancer Treatment: Know Your 
Options,'' will be published in print format soon and will also be 
available on the NCI web site.
    NCI is communicating vigorously with the cancer research community. 
Earlier this year, NCI staff described all of the prostate cancer 
research initiatives that exist at the institute, and placed that 
information on its web site. The institute then promoted the 
availability of that information and issued an invitation for grant 
applications from the scientific community. The promotion of the 
information on the web site including the placement of advertisements 
in major scientific journals, the distribution of packets of 
information to the nation's cancer centers, and the distribution of 
information through direct mail to cancer investigators. Since the 
promotion began in late February, the web page listing prostate cancer 
grant opportunities has had thousands of hits from those seeking 
information about the grant opportunities.
    Mr. Chairman, I appreciate the level of interest this Committee has 
shown in prostate cancer. I hope this plan demonstrates NIH and NCI's 
commitment to advancing our knowledge about prostate cancer as rapidly 
as possible. Our activities 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. Varmus 
and I would be pleased to answer any questions you may have.
                  national cancer institute web sites
    To access electronic information about prostate cancer from NCI 
visit our web site at: http://www.nci.nih.gov
    The National Institutes of Health Report, Planning for Prostate 
Cancer Research will be posted: http://www.nci.nih.gov/
prostateplan.html
    Prostate Cancer Initiatives is available at:
    http://www.nci.nih.gov/prostate.html
    The Prostate Cancer Progress Review Group Report is available at: 
http://wwwosp.nci.nih.gov/planning/prg/default.htm

             opening statement of senator dianne feinstein

    Senator Specter. We have four additional witnesses. We are 
going to call at this time Dr. Christopher Logothetis to join 
us and to present his opening round of testimony. Then we will 
have questions all around.
    But before we do that, we have been joined by Senator 
Dianne Feinstein. Would you care to make an opening statement, 
Senator Feinstein?
    Senator Feinstein. Thank you very much, Mr. Chairman. I 
would like to put my opening statement in the record if I 
might.
    Senator Specter. Without objection.
    Senator Feinstein. I might just say that Senator Mack and I 
co-chair the Senate Cancer Coalition and we have held to date 
six hearings on the subject of cancer. Certainly prostate 
cancer emerges as a major category. We found a number of 
problem areas that need further development. Dr. Klausner and I 
have been working with the American Cancer Society to try to 
generate a cancer dialogue, a national cancer dialogue. As a 
matter of fact, President Bush and Mrs. Bush are the co-chairs 
of that effort.

                           prepared statement

    So it has been I think a very rewarding experience, and I 
just want to have the opportunity to welcome Dr. Klausner here, 
Dr. Varmus as well. I think his remarks had some good news with 
respect to that 63-percent increase, and I look forward to 
having an opportunity to ask them some questions.
    So thank you, Mr. Chairman, for your leadership and for 
holding this hearing.
    Senator Specter. Thank you very much, Senator Feinstein.
    [The statement follows:]
             Prepared Statement of Senator Dianne Feinstein
    Thank you, Chairman Specter for holding this hearing today on 
prostate cancer. The incidence of prostate cancer for all men steadily 
rose starting in the 1970s and then began to decline in the mid-1990s. 
Even with the decline, there still there will be 179,300 new cases of 
prostate cancer this year, including 16,300 new cases in California. 
There will be 37,000 deaths from prostate cancer, the second leading 
cause of cancer death in men.
    Prostate cancer rates are highest among African American men. 
Mortality rates in African-American men remain more than twice as high 
as rates in white men.
    I have heard men say, ``My doctor told me if I live long enough, I 
will get prostate cancer.'' That is frightening.
                            research is key
    As early as 2010, as our population ages, cancer incidence will 
increase by 29 percent. The battle against all cancers must be fought 
on many fronts. Congress created the National Cancer Institute in 1937. 
We declared the War on Cancer in 1971 and enacted a National Cancer 
Program. Congress has appropriated over $42 billion for cancer research 
since 1937. Last year, we increased the appropriation for the NCI by 13 
percent, putting it now at $2.9 billion for fiscal year 1999. We 
increased NIH's funding by 14.6 percent. Yet sadly, we all know that we 
still have not done enough, when in fiscal year 1999, NCI could only 
fund around 30 percent of approved grants. And so, we must devote 
adequate funding to cancer research.
                   cancer coalition: some challenges
    The Senate Cancer Coalition, which I co-chair with Senator Mack, 
has had six hearings on cancer. We have examined cancer and genetics; 
the promises and perils of the drug, tamoxifen; unmet challenges of 
breast cancer research; the implications of environmental risk factors 
for cancer; and new breakthroughs in cancer treatments.
    In the Senate Cancer Coalition, we have been presented a number of 
challenges:
  --Research Funding.--The September Cancer March's Research Task Force 
        presented recommendations from a group of 164 leading 
        scientists and cancer advocates, some of whom are here today, 
        in which they called for a ``national strategy to incrementally 
        increase our investment in all areas of cancer research . . . 
        an increase to $10 billion over the next 5 years.''
  --Uneven Care.--Experts have pointed to the April study of the 
        Institute of Medicine which concluded that many patients do not 
        receive care known to be effective. Describing the problem as 
        ``substantial,'' they say there is a big gap between what 
        doctors would call ``optimal'' care and what people actually 
        receive.
  --Clinical Trials Participation.--Cancer March leaders stressed the 
        need to improve clinical trials participation, testifying that 
        only 2 (two) percent of cancer patients are enrolled in 
        clinical trials. Of those participating, only 25 percent are 
        elderly, even though cancer is disproportionately a disease of 
        aging and the median age of cancer diagnosis is 68. Of people 
        participating in clinical cancer trials, only 2-3 percent are 
        minorities. One way of encouraging more participation, they 
        said, is to require public and private insurers to cover 
        routine medical costs. I am supporting a bill to do just that 
        and will continue that push in the new Congress.
  --Expand Screening.--We must develop effective screening methods, 
        make sure that insurance plans cover screening for prostate and 
        other cancers and encourage people to be screened. Congress 
        passed prostate screening for Medicare which can save 12,000 
        lives a year, according to the American Foundation for 
        Urological Disease.
  --Quality Care.--Cancer patients have told us that they are too often 
        disadvantaged by an uncaring--even hostile--health care 
        climate, largely influenced by managed care plans that place 
        arbitrary limitations on and roadblocks to care. Insurers, for 
        example, they refuse to cover certain treatments and block 
        access to specialists.
  --Environmental Risk Factors.--Some experts say that insufficient 
        attention is given to environmental risk factors that 
        contribute to cancer's genesis and development.
  --Unexplained Patterns.--Similarly, experts at our June 13, 1996 
        hearing told us that rates of many types of cancer vary between 
        and within countries, that, for example, women in Japan have 5 
        times less breast cancer than women in the U.S., that rates in 
        the northeastern U.S. are substantially higher than in the 
        south. They said that when people migrate they tend to acquire 
        cancer at rates closer to those of the newly adopted countries 
        within a generation. What does this tell us? They called more 
        research on environmental risk factors.
  --New Treatments.--At our July 16, 1998 hearing, we heard experts 
        outline work on several potential breakthroughs such as anti-
        angiogenesis, cancer vaccines, and monoclonal antibodies that 
        hone in on specific proteins on the surface of cancer cells. 
        They, like the September March leaders and many others, made a 
        vigorous plea for accelerating and expanding the nation's 
        clinical research effort, again pointing out that people over 
        age 65 account for only 25 percent of clinical trials 
        participants, even though the elderly are 63 percent of the 
        National Cancer Registry.
                         we need a battle plan
    Our nation needs a battle plan for conquering cancer. This 
subcommittee, by increasing funding for the National Institutes of 
Health has been a leading force for advancing research and today our 
scientists and doctors understand cancer better than efforts.
    But as our witnesses will tell us today, we need to do more.
    I look forward to hearing from these experts today and receiving 
their guidance.

               opening statement of senator thad cochran

    Senator Specter. Senator Cochran.
    Senator Cochran. Thank you, Mr. Chairman. Let me just join 
you in welcoming these witnesses and the panel to follow. We 
appreciate your coming today to talk about this very important 
area of research. We hope that what we do in this committee 
assists you, helps you, supports what you are doing, and does 
not end up being more of a hindrance than a help.
    I do mention that because I worry sometimes that we write 
into our legislation here and our appropriations bills some 
restraints or restrictions or directions that end up causing 
difficulties in some of the research regimes. I hope that 
during the course of this morning's hearing you might touch on 
that and give us some suggestions for restraint or in other 
ways guard against being an impediment to the good work that 
you are doing.
    Senator Specter. Thank you, Senator Cochran.

              summary statement of christopher logothetis

    Senator Specter. Our next witness, Dr. Christopher 
Logothetis, is chairman of the Department of Medical Oncology 
at the University of Texas, the Anderson Cancer Center, also a 
professor; received his medical degree at the Athens School of 
Medicine, interned at Cook County Hospital, and is a fellow at 
the Anderson Cancer Senator--Center; a Freudian slip.
    Dr. Logothetis, the floor is yours. Thank you.
    Dr. Logothetis. Mr. Chairman and members of the 
subcommittee: It is a pleasure to have an opportunity to 
present before you. My name is Christopher Logothetis. As you 
mentioned, I am a professor of medicine and chairman of the 
Department of GU Oncology at the M.D. Anderson Cancer Center. I 
have had 20 years of experience treating, trying to develop 
therapy, and witnessing the suffering from prostate cancer. So 
I think I bring a unique perspective that permits me to see the 
changes that have occurred over time, the opportunities for the 
future, and to address the problems as close as one can from 
the eyes of the suffering.
    First I would like to point out that the problem of 
prostate cancer is not going to go away, and it is not going to 
go away because our population is aging and this is an age-
dependent disease. So it is going to confront us, it is going 
to be with us as a social, economic, and human problem.
    The second thing is the baby boomers are coming into the 
time when they are at risk.
    Third, we are the country which has the dubious 
distinction, as Dr. Klausner mentioned, of having the single 
population with the highest, most aggressive form of prostate 
cancer in the world. That is the African American citizens of 
this country. This is the worst subset of prostate cancer that 
exists worldwide. So it is a social, moral imperative that we 
simply cannot escape from.
    The second dilemma that we have is who are the 
constituencies and how are we going to make advances? It is my 
belief that there are three groups that participate and will 
hopefully contribute to the conquest of this disease. The first 
groups are the patients and their families, and I think they 
have demonstrated in many ways, by participation in 
investigational trials with significant inconvenience and risk 
to them in trying to develop therapy--it is not uncommon in the 
clinic for me to hear: Even if it does not help me, I hope it 
will help somebody else. It is a routine statement. You would 
be surprised at the heroism.
    The second group I think is the medical and scientific 
communities represented by the NCI and the NIH, the cancer 
centers and the universities.
    The third group I think is represented by you, that is the 
Federal Government, to which we seek support to expand our 
research efforts.
    What is the basis for the optimism that I think, and the 
opportunities for future development? I will speak from the 
perspective of the Cancer Center, the M.D. Anderson Cancer 
Center. Over the last years I have seen the disease change. 
When I first started treating prostate cancer I only saw 
patients who had widespread metastatic disease, that were 
immediately threatened, and that were only candidates for 
novel, experimental therapies. Now it is routine for me to see 
patients with localized disease, with many therapy options, 
none of which are adequate, but each of them promising and have 
a significant chance of altering the course.
    The second thing that I have seen is I have seen the time 
between a laboratory or an experimental observation to the time 
it is confirmed as valid in the clinic and a therapy target 
identified be shortened dramatically. The time course for 
development of some new drugs that we are particularly involved 
with and I briefly mentioned to Dr. Klausner before, a gene 
therapy where we actually have identified the target gene, 
produced the virus, replaced the virus in humans, and seen that 
that virus has resulted in the production of a protein which 
has suppressed cancer growth in humans, has taken about 3 
years. That is slow in the perspective of patients and 
lightning speed in the perspective of scientists and 
physicians.
    While that is not therapy, it certainly is the basis on 
which we will develop therapy and represents a new foundation 
for treatment. Other similar examples at our institution and 
elsewhere exist throughout.
    So how are we going to do this? Well, I think that some of 
the initiatives that were described by Dr. Klausner are 
central. NCI needs to and has demonstrated a willingness to 
embrace the community centers, the outreach centers, the major 
universities, and that is reflected in their proposal.
    If you look closely at many of the studies that are being 
embraced by the National Cancer Institute and expanded on, they 
were actually developed in the cancer centers. That is not to 
mean that they were developed in a vacuum. They were developed 
with specific support from the NCI and in many ways this 
complements the NCI.

                           prepared statement

    Finally, we need additional fundings, because if we are 
going to accelerate the development of therapy, if we are going 
to apply these quickly, if we are going to impact the illness 
in real time, there is nothing that replaces the resources that 
are required to this, and this is what we are going to have to 
turn to you for.
    So I am optimistic and I am grateful for the opportunity, 
and I detect a change both in the science and clinical medicine 
that I believe to be very real.
    Thank you.
    Senator Specter. Thank you very much, Dr. Logothetis.
    [The statement follows:]
            Prepared Statement of Christopher J. Logothetis
    Mr. Chairman and members of the Senate Subcommittee on Labor, HHS & 
Education Appropriations, my name is Christopher J. Logothetis. I am 
Professor and Chairman of the Department of Genitourinary Medical 
Oncology at the University of Texas--M.D. Anderson Cancer Center. I am 
delighted to be testifying before Senator Kay Bailey Hutchison, who 
represents both my cancer center and me.
    I am here today on behalf of the millions of men and families whose 
lives have been devastated by prostate cancer. We need a national 
strategy to end the toll that prostate cancer takes on our nation. 
Simply put, Mr. Chairman, with adequate resources, prostate cancer can 
be prevented, controlled and cured. The NIH five-year strategy for 
prostate cancer research provides part of the mechanism. But it can 
only operate with an fiscal stream, and that means that Congress must 
make an appropriation of not less than $260 million for prostate cancer 
research at NIH in fiscal year 2000.
    By most standards, prostate cancer research is underfunded. It is 
certainly underfunded in this country on the basis of disease burden. 
You already know that prostate cancer is the most commonly diagnosed 
nonskin cancer in America today, affecting nearly 200,000 men in 1999. 
You know that nearly 40,000 men will lose their lives to the disease 
this year. The thousands of patient visits logged each year in my 
clinic give testimony to the impact of prostate cancer on health care 
in our community, visits which are multiplied over and over at 
hospitals, clinics and physicians' private offices in every 
neighborhood and in every state. The burden of disease is particularly 
acute among African American men, who bear a disproportionate share of 
both incidence and mortality of prostate cancer.
    Our population is aging, and, with the ``greying'' of the baby boom 
generation, prostate cancer will become an ever-more-important health 
and medical economic problem--unless changes occur now. Health 
economists claim that an investment in an aging population may not 
result in returns proportional to an investment in youth. In my 
opinion, prostate cancer presents a social and moral imperative that 
cannot be ignored. The youth of America--whose physical and emotional 
well being have lately been the focus of considerable national 
concern--need the guidance of fathers and grandfathers. Without it, 
they can't contribute to the welfare of this nation as they become 
fathers and grandfathers themselves.
    Then, too, prostate cancer is not a disease that only affects older 
men. Fully 25 percent of cases occur in men under the age of 65, during 
the years that their contribution to the country is most important, 
economically and socially.
    Prostate cancer research is also underfunded on the basis of 
scientific opportunity. In the past five years alone, our advancing 
knowledge about the biology of malignancies has shortened the time for 
research to get from the laboratory to the clinic. The NIH proposal 
makes a significant commitment to invest in this important area called 
``translational research.''
    At the same time, NIH must make a large, parallel investment in 
clinical research, so that new treatments can be tested thoroughly and 
quickly. For example, chemotherapy now works for prostate cancer, 
although it is not yet curative. We need to accelerate both the search 
for and testing of new agents to propel a cure forward.
    We have also recently established that a gene can be replaced in 
prostate cancer cells so that proteins are produced that suppress the 
tumor's growth. With the appropriate investment, we can test this--and 
other promising therapies, like angiogenesis inhibitors, which destroy 
a tumor's nutrient blood supply; inhibitors of growth factors; and 
agents that inhibit the survival of cancer cells.
    To maximize scientific opportunity, we need to assure that 
complementary research activities are maximized, those at NIH, at 
cancer centers and at university medical centers. Research successes at 
cancer centers and university medical centers have occurred largely 
because of a growing investment by NCI. We need to expand this 
complementary in order to rapidly test both existing therapies and 
novel treatments that will rapidly come ``on-line.''
    The NIH proposal increases the number of prostate cancer SPORES, or 
specialized programs of research excellence. NCI has, to date, funded 
three prostate cancer SPORES; we need to see that network grow 
nationwide. SPORES--and the growth of informatics--are two crucial 
components of a research system that will help achieve ``integration of 
outcomes,'' so that research results, particularly from clinical 
trials, are rapidly shared both within centers and among centers. 
Success will not happen in a vacuum of solitary investigation; it will 
happen because scientists talk to each other and aggressively share 
what they are learning about prostate cancer research.
    The proposed additions to the QuickTrials and RAID programs will 
accelerate new treatments, because investigators will be able to 
acquire the reagents necessary for novel therapeutics and get 
treatments from the laboratory into the clinic. Both of these 
initiatives are important for the recruitment of new talent into the 
pool of physicians and scientists working to solve the problem of 
prostate cancer.
    Through your leadership, Mr. Chairman, and the leadership of your 
colleagues, the NIH investments in prostate cancer research have jumped 
60 percent from fiscal year 1998 to fiscal year 1999. We are grateful 
for the new talent and new opportunities that this investment--and five 
additional years of continued acceleration--will bring to our field. We 
are excited that, in addition to the potential achievements in clinical 
and translational research, these funding increases will see a greater 
number of investigator initiated research projects come to fruition. 
The low payline for these projects currently means that about three-
quarters of worthy approved research projects--including too many in 
prostate cancer--go unfunded because resources aren't available.
    You are now changing that. Your increasing commitment has helped 
prostate cancer research ``get up to speed.'' It is now time to give 
research the resources to win the race. Cure is possible. You can help 
make it happen. The men and families whose lives have been touched by 
this horrible disease know that you must make it happen.
    Thank you, Mr. Chairman.

                opening statement of senator ted stevens

    Senator Specter. I am told that we have an extraordinarily 
long line outside and I am wondering if we might not be able to 
bring some more people in in the corners, and we could even 
have some people sitting in the Senators' chairs until the 
Senators arrive, so that we can try to admit as many people as 
we can to the hearing room.
    We have been joined by our distinguished chairman of the 
full committee, who has some special insights on this subject. 
Senator Stevens, would you care to make an opening statement?
    Senator Stevens. Well, I would ask you to put my statement 
in the record in view of the fact that I am late.
    Senator Specter. Without objection.
    Senator Stevens. My insight is that I am a fellow survivor 
along with Senator Dole and Mr. Milken, Mike, and others, and I 
am very interested to see that you are pursuing this to the 
depth you are, Mr. Chairman. So I congratulate you and look 
forward to the statements.
    Doctor, nice to see you.
    [The statement follows:]
               Prepared Statement of Senator Ted Stevens
    Mr. Chairman, I'm pleased that you are holding this hearing today 
to hear from NIH about the report which our Committee requested them to 
develop to highlight the steps that NIH is taking to enhance its 
prostate cancer research program. I am looking forward to hearing from 
Dr. Varmus and Dr. Klausner.
    I also welcome my friends former Senate Majority Leader Bob Dole 
and Mike Milken--and Mr. Joe Torre of the New York Yankees. We are all 
part of the fraternity of prostate cancer survivors--and we are all 
exerting our best efforts to help find a cure and more effective 
treatments for this disease which continues to be the most frequently 
occurring cancer (aside from skin cancer), representing 29 percent of 
all new cancer cases in American men, and costing as much as $15 
billion per year, including medical care and lost wages and 
productivity.
    Just last week, the Senate passed the Department of Defense 
Appropriations bill for fiscal year 2000, which contains $100 million 
in funding for research on prostate cancer. But, as I continue to 
remind my friends in the prostate cancer advocacy groups, I believe 
that our main focus for medical research, including funds for prostate 
cancer, must continue to be in the National Institutes of Health. I 
believe strongly that we must continue to fund medical research at a 
level which will allow us to take advantage of rapidly developing 
biotechnology breakthroughs in finding causes, cures and treatments for 
diseases like prostate cancer. I look forward to hearing NIH's 
blueprint for prostate cancer research that will lead us forward toward 
a cure and better treatment.

                              psa testing

    Senator Specter. We will begin now the 5-minute round of 
questions by Senators, and I shall begin.
    Dr. Klausner, I think it will be useful if you would 
describe what the PSA test is, what men need to know about it, 
and to comment about its accuracy in detecting prostate cancer.
    Dr. Klausner. Yes. The PSA test is a blood test that 
detects a protein that is pretty uniquely produced by prostate 
cells, not prostate cancer cells, but either prostate cancer 
cells or normal prostate cells, that leaks into the blood with 
the structural changes in the prostate of often relatively 
early prostate cancer.
    It is absolutely clear that PSA is capable of detecting 
prostate cancer, and in fact the dramatic change in the 
profile, the distribution of newly diagnosed prostate cancer 
from late disease to early disease, is overwhelmingly due to 
the introduction and the widespread use of this test.
    Senator Specter. How reliable is it?
    Dr. Klausner. Well, PSA itself does not mean prostate 
cancer is present. If the PSA is elevated beyond a certain 
level, and especially if its rate of rise is followed, it is an 
alarm that says there may be prostate cancer there. There are 
other things that may cause a rise in PSA.
    Senator Specter. If PSA does not sound the alarm, does that 
still mean the individual might have prostate cancer?
    Dr. Klausner. Individuals may have very microscopic 
prostate cancer or very well differentiated and localized 
prostate cancer that has not led to the structural changes in 
the prostate and still have normal PSA. But PSA is a very good 
test for detecting prostate cancer.
    Senator Specter. Dr. Varmus, what would the funding have to 
be for the National Cancer Institute, NIH, so that you granted 
research funds for all the meritorious applications?
    Dr. Varmus. It is a difficult question, Senator, because we 
cannot anticipate exactly how many applications we will have in 
the future. As you know, we currently award funds to roughly 30 
to 35 percent of our applicants. We view the vast majority of 
the applications we receive as meritorious at some level--that 
is, worthy of support if resources were totally unlimited.
    We recognize that the Federal Government does not have 
totally unlimited resources; therefore, we use peer review to 
stratify those applications.
    Senator Specter. The allocation of the resources is up to 
the Congress, and I believe we have very extensive resources. 
As I said earlier, $1.7 trillion. We are a very rich country 
and I believe Americans would be prepared to pay whatever it 
took. So we need to know from you what the NIH budget should 
be, what the National Cancer Institute budget should be, so 
that all the meritorious applications may be granted.
    I know your figures went up from the high twenties into the 
low to mid thirties when we increased your funding.
    Dr. Varmus. That is correct.
    Senator Specter. But the next line of questioning is, what 
would it take to fund all of the meritorious application? Would 
you give that some thought and report back to the committee?
    Dr. Varmus. We can also tell you that in the report we have 
submitted there is a professional judgment budget that gives 
some notion of what we think we would need to pursue most or 
all of the goals that we think are meritorious. This is not to 
fund all the applications, but to pursue those meritorious 
goals. The numbers are provided in the report.
    Senator Specter. OK, we will review that and see if we have 
a follow-up question.
    Dr. Varmus. Thank you.
    Senator Specter. Dr. Logothetis, you comment, and 
understandably so, about prostate cancer being a part of the 
aging process. In these hearings we are always asking perhaps 
the impossible question about a cure for cancer. We have had 
some hearings on stem cells recently and on Parkinson's 
disease. We have heard estimates that perhaps 5 years, 10 years 
at the outside, Parkinson's disease may be cured.
    I would like your evaluation as to the possibility of 
curing--I know when you talk about cancer there are many 
different forms. But what is the possibility, theoretical, of 
curing cancer? What is the possibility of curing prostate 
cancer?
    Dr. Logothetis. I guess the best statement is it is hard 
until it is easy. I think that there is a view on how we can 
get there that has a reasonable chance of significantly 
altering the course of this illness and can lead to cure. Let 
me describe how I think that that will happen.
    First of all, I do not think that there is a single drug 
that will develop that will cure this disease. It has not 
happened in the other curable diseases. There will have to be a 
convergence of events that will cure the disease. One is we 
will have to detect the disease earlier. My optimism comes from 
the fact that that has already happened. As mentioned, I rarely 
see advanced disease.
    Second is we will have to make technological advances in 
the imaging of the prostate so we can actually deliver drugs to 
the prostate very easy and monitor its effectiveness in a 
functional way.
    Third, we are going to have to change our views of how we 
intervene and how we sort of view this disease. Let me 
describe. The traditional approach to prostate cancer is that 
it is not a disease until it is cancer. If a general internist 
who is taking care of heart disease waited until you had a 
heart attack to intervene, that would be considered irrational.
    What we view this as is a chronic degenerative disease that 
has a process that precedes its malignant manifestation--high 
blood pressure followed by a heart attack--and we are waiting 
until the late event, and we are actually only treating the 
late event and then not intervening with the processes that are 
contributing.
    I think that once that cultural change has occurred, which 
I already see has changed, early intervention happens. We will 
have a strategy including new drugs, new technology, and a 
willingness of the population to be treated that has a chance 
of curing this disease, between 5 and 10 years would be my 
guess if you were to ask. Now, I am cured an incurable 
optimist, so I have a form of cancer, too. But I think it is 
real, and you can see it when you look at patients and see the 
changes over time.
    Senator Specter. Thank you very much.
    My time has expired. Under our early bird rule, we turn now 
to Senator Feinstein.
    Senator Feinstein. Thank you very much, Mr. Chairman.
    Perhaps, Dr. Logothetis, I should ask you this question. 
Dr. Peter Rosen, a UCLA professor and co-director of UCLA's 
Advanced Prostate Cancer Clinic, is quoted in UCLA Medicine by 
saying this: ``The last important discovery that impacted the 
treatment of prostate cancer was made in the 1940's.'' Do you 
agree with that?
    Dr. Logothetis. No. The last important one that has been 
applied, it is correct. We have spent from the forties until 
very recently, a long period of time, suppressing the growth of 
prostate cancer by suppressing male hormone production. It is 
true that there has not been a wide application of the new 
moves and I think that there is ample evidence that PSA has 
changed the disease in how it presents to us and has changed 
the clinical problem.
    So while I agree that there has not been a fundamental 
applied change in the disease that has spread, I disagree that 
there have not been significant advances in the disease.
    Senator Feinstein. Now, on page two of your remarks you say 
that chemotherapy now works for prostate cancer, although it is 
not yet curative.
    Dr. Logothetis. Yes.
    Senator Feinstein. And just a few moments ago you mentioned 
that there probably has to be, at least I thought you said, 
some interrelationship between drugs that we do not yet know 
about. Is that interrelationship between drugs or other 
techniques, like radioactivity or radiation?
    Dr. Logothetis. Let me maybe place the question in a 
perspective. In order to prove cure in prostate cancer, it 
would take 10 years for us to detect a difference. But the 
degree of effectiveness of the combination chemotherapies which 
are currently being used and are now widely applied has reached 
a level where it is equal to that seen in other common solid 
tumors, such as breast cancer, such as some forms of lung 
cancer, where it impacts survival.
    What is missing is the piece of giving chemotherapy early 
to see if it affects survival.
    Senator Feinstein. That is where screening comes in.
    Dr. Logothetis. It is screening to detect it early and 
apply therapy, which clearly helps patients with advanced 
disease, clearly helps them, in a setting, as Dr. Klausner 
said, where we can now exploit the advantage that we have been 
furnished with by PSA detection by treating patients earlier 
and then applying the biological techniques to select the 
proper patient for such therapy.
    I think that those events are converging.
    Senator Feinstein. Interesting.
    Now, I did not know that the United States has the most 
virulent form of prostate cancer in the world. Why would that 
be and what would the genesis of that be?
    Dr. Logothetis. Again, we have the most virulent form in 
our African American citizens, and that is important because 
obviously they suffer and die more from the disease. But it is 
also very important because it provides a tremendous amount of 
insight into the events that may lead to this disease that may 
have wider application.
    We do not know the specific mechanisms. It is reasonable to 
implicate diet. It is reasonable to implicate all sorts of 
environmental factors. It is probably genetically not so 
uniform. It is a heterogeneous population, more heterogeneous, 
more different than one would think. But if you were to ask me 
to guess, it is going to be social and dietary factors that are 
more likely to be implicated in this.
    Senator Feinstein. Dr. Klausner, Dr. Varmus, can you add to 
that?
    Dr. Klausner. Well, I think Dr. Logothetis is right, it is 
most likely to be exogenous factors, although again across the 
populations there are some different distributions of inherited 
common variations, for example in the androgen receptor gene, 
in the vitamin D receptor gene. So there may be some biologic 
differences. It is true African Americans are a diverse 
population. But there are differences generally in the 
population between Asians, Caucasians, and African Americans, 
in the distribution of certain biological characteristics that 
may also have an effect.
    But I suspect, as most of us do, that it is probably due to 
dietary or environmental factors. But we do not know, though we 
have been looking, what those dietary factors are.
    Dr. Varmus. It is perhaps useful to distinguish between the 
incidence and the mortality of the disease. There is about 30 
percent higher incidence of prostate cancer among African 
Americans than among Caucasians in our country, and about a 
twofold increase in the death rate.
    We think that most of that disparity in death rate is due 
to the speed with which people seek care and perhaps the level 
of care. In studies that the National Cancer Institute has 
carried out using a control between African American and white 
patients, African Americans seem to respond equally well to the 
therapies that have been tested. So it is not clear that the 
response is different to the therapies that are being 
developed.
    The issue with respect to genetics is an important one. 
Investigators at the National Human Genome Research Institute 
have identified at least two chromosomal sites at which there 
is a gene predisposing individuals to prostate cancer. However, 
we have no evidence as yet that those genes are more likely to 
be mutated in African American populations.
    Senator Feinstein. I see the red light. Thank you, Mr. 
Chairman. Thank you very much.
    Senator Specter. Thank you very much, Senator Feinstein.
    Senator Cochran.
    Senator Cochran. Mr. Chairman, thank you.
    In Dr. Logothetis' testimony you mentioned the fact that 
prostate cancer research is underfunded on the basis of 
scientific opportunity. This goes to the question I think the 
chairman asked Dr. Varmus earlier. You then say: ``The NIH 
proposal makes a significant commitment to invest in an 
important area called translational research.'' What is that 
and how does that offer promise for dealing with this disease?
    Dr. Logothetis. One of the challenges in medical research 
and in cancer research specifically is to bridge the gap 
between exciting observations in the laboratory and their 
application in the clinic. The whole processes that make up 
that difference, that big canyon, is translational research. It 
requires the sort of methodical, plodding type of research that 
frequently is not exciting, to get all the information from 
large populations, target the subset with your appropriate 
therapy.
    So I would call translational research the process by which 
one prioritizes, learns, and finally applies successfully 
therapy based on exciting ideas that have been developed in the 
clinic. That is a big, big chasm.
    Senator Cochran. Would it be helpful--and I am directing 
this at Dr. Varmus and Dr. Klausner--to earmark funds for this 
purpose or are you more comfortable with a more general 
provision of just money and letting you decide based on the 
applications you get for the research? Do we make a mistake by 
earmarking for something specific like this?
    Dr. Varmus. We favor some position in between, Senator. As 
you know, there are many problems that we believe could be 
pursued more vigorously with more funds, prostate cancer and 
many others. We are a public institution. We are responsive to 
the concerns of the public, manifested in the Congress, and we 
do want to know what concerns you and the public most.
    It obviously makes life more difficult for us to have to 
shape the research agenda to fit a specific dollar assignation. 
We hope that we can illustrate this principle today in the 
conduct of prostate cancer research, as well as in the context 
of other diseases, by showing you how effectively and speedily 
we can respond to that clear public concern, and indeed the 
increased incidence and severity of the disease, by shaping a 
research program that does reflect a deeper commitment than is 
evident from the overall increase in funding of the NIH.
    Senator Cochran. Another specific undertaking--and I think 
this is in the statement of Dr. Klausner--the Environmental 
Genome Project. Tell us about that? Should we try to target 
funds for that as well?
    Dr. Klausner. The Environmental Genome Project is a project 
of the National Institute of Environmental Health Sciences. It 
is an attempt to identify common variations in genes across the 
human population. We recognize that the future of medicine in 
many ways will be driven by understanding why one person is 
different from another. There are dramatic examples of that. If 
you have two people who smoke, one person gets cancer, the 
other does not, why? And on and on. How they respond to 
therapy, etcetera.
    We all believe that this in part relates to the millions of 
variations between any two individuals that are not identical 
twins. So that project actually dovetails with many projects 
across the NIH, including one NCI released just last week, 
where we are annotating genes in a database for all researchers 
to use that lay out the common variations. These variations 
will be essential in interpreting research, clinical trials, 
and environmental studies.
    In fact, we think one of the reasons it has been so 
difficult to pinpoint environmental causes is because it is not 
the environment per se, but it is the interaction of the 
environment, the complexity of the environment, with individual 
variations, how they metabolize things, how they respond.
    So this is going to be the new world of applying this 
approach of variation genetics to all aspects of our research, 
and the project that you are talking about is one of the 
integrated set of projects that all of the Institutes are 
involved in to get that information and to make it available to 
the research community.
    Senator Cochran. Thank you, Mr. Chairman.
    Senator Specter. Thank you very much, Senator Cochran.
    Senator Stevens.
    Senator Stevens. I have got real trouble with the way the 
NIH has been handling prostate cancer. It has led to an 
increased demand on our defense appropriations bill and a 
different approach in the Department of Defense to the 
allocation of the money that we provide from that bill for 
prostate cancer research.
    Despite the fact that there has been a substantial increase 
in the last 20 years in prostate cancer incidence, or 
detection, whichever you want to say, you have had practically 
a flat line in terms of prostate cancer research coming out of 
NIH.
    Can you tell me, why is that?
    Dr. Klausner. Well, I think it has not been a flat line. I 
can describe what we have done for the last 4 years since I 
have been there. In each year we have increased the amount of 
prostate cancer research spending, actually for each of the 4 
years, out of proportion to the growth of the budget, with this 
year's 63 percent increase compared to the 15 percent increase 
that we have had.
    But more important than the numbers--the numbers are 
important, and we have talked about this with this committee 
before--there are in prostate cancer and in fact as far as I 
can see in all of our cancer research more possibilities, more 
needs than we have resources for. So our approach has been both 
to increase the funding, which we have done and we think quite 
significantly, as well as to make sure that that is coupled 
with the most effective and efficient way to spend, which 
involves setting priorities, bringing the broad communities 
together to tell us, not for us to tell them, what those 
priorities ought to be, by developing a real, for us for the 
first time, prostate cancer research plan, which we initiated 
almost as soon as I began, and to coordinate the activities 
between NCI and other funders of prostate cancer research, 
whether it is the Department of Defense or private funders, 
which we have moved to do, so that whatever dollars are there, 
inadequate to the task for this cancer and others, we make the 
best use of them.
    Senator Stevens. As a matter of fact, I am more and more of 
the opinion that we should follow the matching fund concept and 
put all Federal dollars into a pot and say we will match, we 
will provide 25 percent or whatever it might be of the funding 
necessary for the projects that the private sector will put its 
money into, and stop some of the costs that are associated with 
the way you handle money.
    You have built two brand new buildings out there in the 
time that we have been trying to increase prostate cancer 
research. As a matter of fact, the last time I went out to that 
campus I did not even recognize it. I hope you will do me the 
honor not to name a building after me, because my predecessors 
all have buildings out there now, and I really do not think 
that is what you should be into.
    You should be finding a way to handle this money so the 
public gets the best return for the dollars we are spending 
from the taxpayers' money.

                Prostate cancer In minority populations

    Incidentally, the statistics--and no offense to the black 
people who are here--the highest incidence of cancer in the 
United States is in the indigenous people. You somehow or other 
separate the Alaska Native people from the American Indian 
people and as a consequence got two categories. If you add them 
up, the indigenous people of the United States have the highest 
cancer incidence. I do not think we have ever explored that, 
have we? Why is it that we sort of overlook that? But American 
Indians and Alaska Natives, add them together, they have the 
highest cancer incidence and they have the highest number of 
deaths.
    Have you ever explored that? Why?
    Dr. Klausner. Yes. In fact, the reason we know that number 
is because NCI has a surveillance system, called SEER, to 
monitor the rates in Alaska among a variety of Native American 
populations, and then whenever we see changes in patterns, we 
provide funding to do special studies, which we are doing in 
Alaska and elsewhere, to try to understand why patterns are 
different.
    Prostate cancer rates are relatively low in both of those 
populations, although the survival rates are very poor compared 
to virtually all other groups with cancer. But the incidence 
rates in fact are, for prostate cancer, much lower in Native 
Americans and Alaska Natives than in the white, Hispanic, or 
African American community.

                administrative costs related to research

    Senator Stevens. I have got one last question. What is your 
overhead cost? When we put up $10 million for cancer research, 
how much actually goes out the door to someone doing the 
research?
    Dr. Klausner. Yes. Our administrative cost for running the 
Institute is approximately 4 percent of the total budget.
    Senator Stevens. That is not what I asked. What are you 
holding back from when I put up $10 million? How much goes out 
the door to contracts?
    Dr. Klausner. Well, about 15 percent of our budget is spent 
on research at the campus. We have a big intramural research 
program, and that is research. I assume you are talking about 
what gets spent in research. Essentially, everything but the 
administrative cost, which is about 4 percent, gets spent on 
research. Eighty-five percent leaves Bethesda, goes throughout 
the country to support cancer centers and projects everywhere, 
and about 15 percent is for intramural. Then we divide the 
administrative cost, which is about 4 percent, across those.
    Senator Stevens. Where does that tremendous construction 
cost fit into that, doctor?
    Dr. Varmus. The construction costs, Senator, are in our B 
and F budget for the intramural program. I should emphasize the 
nature of the buildings that you are seeing. First of all, one 
building is being constructed to replace laboratory buildings 
that were constructed in the 1940's, which are unsafe by the 
criteria of many evaluations for current laboratory work. 
Another building is to replace the clinical research building, 
in which all our clinical research activity is carried out, 
which was constructed in 1953, and which was again recommended 
for replacement or demolition by the Army Corps of Engineers 
and many others. And the third is a small building that is 
being constructed to support our important new vaccine research 
initiative directed against HIV and other novel infectious 
agents.
    Overall, the NIH spends, as Dr. Klausner indicated, between 
3 and 4 percent of its budget on administrative costs. When our 
money is sent to extramural institutions, on the average about 
one-third of the dollars are spent at those institutions for 
facilities and administrative costs and the rest for direct 
application to research.
    Senator Stevens. I am going to pursue that later.
    Thank you very much.
    Senator Specter. Thank you, Senator Stevens.
    Thank you very much, Dr. Logothetis, Dr. Klausner, and Dr. 
Varmus. We very much appreciate your testimony.
    I would like to turn now to Senator Dole, Mr. Milken, and 
Mr. Torre. Our first witness is the distinguished former 
majority leader of the United States Senate, Senator Bob Dole. 
Senator Dole began his public career by playing end on the 
Russell High School football team in 1941, was a basketball 
star, and as late as 1996 Dr. Erwin Luthey, the coach of the 
debate team, noted his absence from the State championship 
debate team in 1941 in Russell, Kansas.
    Senator Dole served in----
    Senator Stevens. Pardon me. Is there not sort of an 
emphasis on Russell, Kansas? What is that for?
    Senator Specter. To draw your attention, Senator Stevens.
    Senator Dole. Appropriations, you know, money.
    Senator Stevens. That the two of you are each from Russell, 
Kansas, yes, OK.
    Senator Specter. This is all in the staff's introductory 
comments, Senator Stevens. I always read it verbatim.
    He served in the Kansas legislature, was county attorney in 
Russell. Interesting story: was drafted by both political 
parties, checked the registration, and accepted the Republican 
nomination, was county attorney.
    Served four terms in the House of Representatives from 
1960, to election to the Senate in 1968; the chairman of the 
National Republican Party, vice presidential Republican nominee 
in 1976, presidential nominee in 1996, and star witness today, 
and who knows for the future.
    Senator Dole, the floor is yours.

                   summary statement of hon. bob dole

    Senator Dole. Thank you very much for that very kind 
introduction, which I sent up to you, and I appreciate your 
repeating it. [Laughter.]
    I saw Stevens rolling in this morning in a convertible. You 
looked good in there, Ted, so that is great.
    But I am very honored to be here with two very 
distinguished gentlemen in this case: Michael Milken, who we 
all know has been sort of pioneering efforts with real money 
and all the things that it takes, and traveling all over the 
country and all over the world, and I applaud his efforts; and 
then Joe Torre. I have always been a Yankee fan, Joe.
    Mr. Torre. I was not always a Yankee fan.
    Senator Dole. I go back to DiMaggio and Gehrig and those 
days, when I knew all the earned run averages and how many two-
base hits, triples. I had them all memorized. It has been some 
time ago. Joe is a recent, well, survivor.
    I want to thank all the men and their wives, spouses, who 
may be here also. I would just summarize my statement, because 
I think we are here to underscore the importance of research 
and also the importance of reaching out for new technologies.
    I had this all happen to me 8 years ago and it happened to 
Ted just a little before then. I would say there is no doubt 
about it, the reason we have had an increase in research funds 
has been largely due to Senator Stevens' efforts. I remember 
getting a very--when I said we are going to increase prostate 
cancer research, I got a very nasty letter from a constituent. 
It said: There you go helping yourself again.
    Well, it was too late for me. I mean, it was already gone. 
I was thinking more about her son or her grandson, and I think 
many of these survivors who are here today have that same 
feeling.
    One thing that we do that maybe others do on the committee, 
we have a Bob Dole Screening Booth at the Kansas State Fair and 
we do mammograms and PSA's. We have been doing it for, I do not 
know, 8, 10 years. One thing I discovered, I finally figured it 
out. When I was no longer the Majority Leader, the funding 
dropped a little from the drug companies, so it is a little 
harder to raise the money now for the PSA tests and the 
mammograms. But I think it is an excellent idea, and we 
probably find we do about 3 or 4,000 and probably, I do not 
know how many, a hundred or so men discover they have a 
prostate problem they did not know about.
    So I will use this opportunity today to say again, if you 
are a male over age 40, particularly if you have a family 
history, ask your doctor about getting a prostate checkup.
    People ask me how I can be so open about my own experience 
with prostate cancer, and I must admit that I decided to go 
public before the operation because I think silence can be 
deadly. Almost by default, I have become some sort of a 
spokesperson for prostate cancer. I have talked to hundreds of 
men across the country and their wives. In fact, yesterday I 
talked to the Mayor of Wichita, Kansas, who is having surgery 
tomorrow morning, to reassure him that it was going to be fine.
    But I must say I think the media needs to be educated on 
not only what happens, but side effects and all the other 
things, because I can tell you some are very, very insensitive 
to a real, real problem that affects the man and the spouse, 
and hopefully that is a matter of education.
    There are all kinds of treatments out there. Senator Helms 
had radiation. We had surgery. I think my first awareness of 
prostate cancer and how serious it was was on the death of my 
good friend Spark Matsunaga, who suffered and suffered and 
suffered with prostate cancer and it spread and it spread. I do 
not know which--you can have radiation, you can have surgery. I 
do not know which is the best. I had surgery and 8 years later 
my PSA is negligible, so I assume I made the right decision.
    But it has been indicated here this morning by the three 
experts there are all these other things happening out there 
looking for new treatment options. I think one of these days it 
will be a thing of the past. He said 5 to 10 years, and I think 
maybe Michael may comment on that, too.
    But I think it is an important thing for us to think about, 
whether we are prepared to take the steps that are necessary so 
when we have this new technology for treatment becomes 
available we are going to have access to it. You have got to 
have access or it is not going to be much good.
    Let me just quickly; I see the red light snapping there. 
One example is the proposed change in the reimbursement rate 
for an innovative prostate cancer treatment known as 
brachytherapy. This therapy involves the implantation of 
radioactive seeds in the prostate directly. You go in and do it 
in the afternoon, you are in the swimming pool the next day. I 
do not know how--they still do not have enough experience how 
effective it is, but these seeds emit radiation that destroys 
cancer cells while minimizing exposure for surrounding tissues. 
For some patients this very minimal procedure, done on an 
outpatient basis, can treat some forms of cancer.
    Now, currently Medicare reimburses for this procedure, but 
if the reimbursement is reduced as proposed right now this type 
of technology is going to be gone.
    I would say in the interest of full disclosure I also serve 
on an advisory board of a California company called Endocare, 
and they do this cryosurgery. They freeze the prostate. Again, 
that is making about a half-inch incision. They freeze the 
prostate and you go home. It is all in an afternoon.
    Now, as Senator Stevens and others know who have had 
prostate surgery, that takes a while. In addition to the 
hospitalization, it takes 6 to 8 weeks or more to regain your 
strength.
    So I say there are new technologies there. There are things 
happening. And one of these days it is going to be at least, if 
not cured, at least other options for patients. So I just 
commend this committee. We are talking about the baby boomers 
and 77 million of these in the year 2011. The demand is going 
to be high. There is going to be more pressure for funds from 
this committee and other committees. Of course, by the year--I 
would ask that my statement be made part of the record----
    Senator Specter. Without objection.

                           prepared statement

    Senator Dole [continuing]. And just close by saying in the 
year 2011 Michael Milken and CapCURE will have found a cure for 
prostate cancer, Joe Torre will own the Yankees----
    Mr. Torre. No, thanks.
    Senator Dole [continuing]. And I will be writing my memoirs 
on being the country's First Gentleman.
    Thank you very much.
    Senator Specter. Thank you very much, Senator Dole. As 
usual, thank you.
    [The statement follows:]
                 Prepared Statement of Senator Bob Dole
    Mr. Chairman, Senator Harkin: Thank you for inviting me here this 
morning to discuss prostate cancer. It seems that just about every 
family in America has been touched in some way by cancer. My family 
has. And, I have.
    Over eight years ago I was diagnosed with prostate cancer. I was 
lucky to have had the disease diagnosed early and treated promptly 
through surgery.
    Eight years later, I am happy to say I am cancer free. Since the 
time of my diagnosis I have tried to speak out as much as possible 
about the value and importance of early detection. I truly believed 
then, and continue to believe today, that early detection saved my 
life. The cancer was found when it was still contained within the 
prostate gland and when I had a variety of treatment options from which 
to choose.
    I will use this opportunity today to say it again: If you're a male 
over age 40, particularly if you have a family history, ask your doctor 
about getting a prostate check up. People ask me how I can be so open 
about my own experience with prostate cancer. I must admit, when I 
first started speaking out about this disease there were plenty of 
awkward moments. But, then I decided that the alternative--silence--can 
be deadly.
    So, when I am fortunate enough to be asked to testify before 
Congress on this issue, I do it.
    While my message of the importance of early detection is one that I 
will continue to deliver, I would like to take a moment to talk about 
treatment options.
    When I was diagnosed, I was basically given two options: Surgery or 
radiation. That was it. I was told of the side effects of both, the 
risks of the procedures, and the probability for cure. I have to admit, 
it was almost a toss up. Both had side effects that sounded unpleasant, 
to say the least, but both also had high rates of success. I chose 
surgery. And, since I am cancer free today, I of course believe I made 
the right decision.
    But, every day there is a scientist looking for the cure for 
cancer, or looking for a new treatment option. And, one of these days--
I think in the not so distant future--there will be a cure. But, the 
question is will we recognize it when we see it? And, I think that is 
an important question for Members of Congress and the administration to 
think about. Is our Government prepared to take the steps that are 
necessary so that when a new technology for treatment becomes 
available, patients with the disease can access it?
    One example is a proposed change in the reimbursement rate for an 
innovative prostate treatment known as brachytherapy. This therapy 
involves the implantation of radioactive seeds into the prostate 
directly. The seeds emit radiation that destroy cancer cells while 
minimizing exposure to surrounding tissues. For some patients, this 
minimally invasive procedure, done on an outpatient basis, has been 
shown to treat some forms of prostate cancer.
    Currently, Medicare reimburses for this procedure. But, if the 
reimbursement is reduced, as is currently proposed, this type of 
technology will become less available to patients.
    I am on the advisory board of a company that makes a cryosurgical 
device that freezes the prostate so that the cancer can no longer grow. 
When I had my surgery, I was in the hospital for a week and recovering 
for months. With cryosurgery, a patient can leave the hospital the same 
day and return to work the next.
    It's not for every patient, of course, but neither is surgery. Yet, 
despite it's success, Medicare took three years to cover this 
procedure, and it actually will not begin coverage until next month. I 
wonder how many patients could have benefited from cryosurgery, but 
couldn't because of the Government's reimbursement policies.
    Please do not misunderstand me. I have been and will continue to be 
an advocate for Medicare's solvency. But, as our health care system 
continues to evolve and change, policy makers must encourage the 
adoption of innovative therapies. What's the point of science making 
advances everyday if there is no way to deliver the technologies to 
patients who need them?
    The private sector readily accepts new therapies partly because 
they are often cost effective, but mostly because the consumers in the 
market demand them. As the baby boomers age, I believe Medicare will 
feel the same pressure from its consumers.
    When the country's 77 million baby boomers start becoming Medicare 
eligible in 2011, the Government is going to have to deliver--the 
demand will be so high. In order to satisfy that demand, the Medicare 
Program will have to be modernized. That means looking at new therapies 
and keeping pace with scientific advances.
    Of course, in 2011, Michael Milken and CapCURE will have found a 
cure for prostate cancer, Joe Torre will own the Yankees, and I will be 
writing my memoirs on being the country's ``first gentleman''.
    Thank you very much.

                  summary statement of michael milken

    Senator Specter. We turn now to our next witness. This 
panel happens to be in alphabetical order. Michael Milken, 
founder and Chairman of CapCURE, the Association for the Cure 
of Cancer of the Prostate. Mr. Milken is a cancer survivor, 
having been diagnosed with prostate cancer in February of 1993, 
a graduate of the University of California at Berkeley, a 
Master's from the Wharton School at the University of 
Pennsylvania.
    Thank you for all you are doing, Mr. Milken. We look 
forward to your testimony.
    Mr. Milken. Thank you, Mr. Chairman and members of the 
subcommittee. It is a pleasure to be here today.
    Not only am a 6-year survivor of prostate cancer, I have 
lost 10 of my closest relatives to various forms of cancer in 
the last few years.
    I think I would like to just touch on today three or four 
items. One of them particularly is investment. I do not believe 
the American public is fully aware of the amount of money that 
our country has invested in cancer research since the war was 
declared in 1971. This year we will spend less than four 
thousandths of one percent of the GDP on cancer research and we 
will spend less than 20 cents on a dollar--out of $100 that we 
have in the Federal budget, less than 20 cents goes to cancer 
research. In spite of the fact that one in two men and one in 
three women will get cancer, we are investing less than 20 
cents out of $100.
    This is one of the few areas in the world where you spend 
30 to 40 times as much money on care as on research in trying 
to solve the problem. There is no private industry, there is no 
private company, that could afford to continue in business 
spending 30 to 40 times as much money on servicing the problem 
and care as to do on correcting the problem. It makes no sense 
for private industry and it makes no sense for government.
    The Federal Government has made extraordinary investments 
long term in our country's infrastructure. The interstate 
highway system is a case in point. We believe it is now time to 
make a similar investment in our country's human capital, which 
holds the great values for the next century. The suffering of 
cancer patients and the grief of families and friends are 
beyond calculation.
    But some distinguished economists, including Kevin Murphy, 
who recently won the award as the world's greatest economist 
under 40, have attempted to calculate the economic value to our 
country of cancer. Based on his calculations, the 560,000 
Americans who will die this year alone from cancer will result 
in a loss of value to the United States measured in trillions, 
not billions, of dollars.
    The 560,000 fathers, mothers, brothers, sisters, neighbors, 
and friends, that is approximately the same number of men and 
women who served in Desert Storm. Imagine the reaction of the 
country if General Schwartzkopf had announced that no Americans 
sent to the Gulf were coming home, not one had survived. 
Imagine that impact. That happens every year in America.
    Opportunity costs. The approximately $2.9 billion that the 
Federal Government will invest in cancer research allows the 
NCI to fund, as we have heard, approximately 30 percent of 
approved grants. But this is just the tip of the iceberg. As 
many of our country's leading young scientists have told us, 
many of them have been told if they go into cancer research, 
particularly prostate cancer research, it is professional 
suicide. There is not enough money available. If they choose 
that for their career, they will be little known in the future.
    In addition to that, when they see Nobel Prize winners' and 
others programs not funded that have been approved, they see 
little hope and opportunity for themselves in this career. We 
discourage our best and brightest to go into the field of 
prostate cancer research and cancer research, rather than 
encourage them.
    When the war was declared on cancer in 1971 and promise of 
a solution in a decade, the same as President Kennedy's earlier 
goal of putting a man on the moon, which was achieved in less 
than 10 years, many thought it would work, and many of the news 
services recently have pointed out that people expected us to 
have a cure for cancer, not put a man on the moon by the end of 
this century.
    We thought this because when President Roosevelt declared a 
war on polio it produced a Salk vaccine. My family knows 
something about polio because my father contracted it as a 
child, and I was among the first of the baby boomers to receive 
that vaccine. A very simple concept: Get a shot, wipe out a 
disease. Surely we should be able to do the same for cancer.
    At The National Cancer Summit in 1995, General Schwartzkopf 
pointed out for military lessons--we can apply this to the war 
on cancer--there comes a time when, he said, we must get on 
with the battle. You never have perfect intelligence on the 
enemy. The fact is we have plenty of information for the 
offensive. We lack sufficient firepower.
    How much firepower do we need? On September 25, 1998, when 
600 organizations came here to testify and participate in the 
march in front of Senators Mack and Feinstein, I suggested we 
needed at least $10 billion a year for cancer research, at 
least $10 billion. That is $40 per American. It is a fraction 
of the cost of failure, of treating more than 100 million 
Americans who are currently living who are expected to get 
cancer in their lifetime. A $100 investment for each American 
who is expected to get cancer today might save us $100,000 in 
expenditures per American later.
    It is embarrassing when we see single companies invest more 
money in their own R&D and capital expenditures than our entire 
Federal Government spends on cancer research. One, and not the 
largest investor, Intel Corporation, spends more than twice as 
much money on their R&D and capital expenditures as the Federal 
Government spends on cancer research.
    Senator Specter. Mr. Milken, I am sorry to interrupt you. 
They have just called a vote and we can come back later. Are 
you available to wait a few minutes? There are two votes. If we 
go at the very end of the first vote and pick up the second 
vote, we will not be gone too long. But I know you are all busy 
men.
    Senator Dole. The Yankees won last night, so he feels----
    Mr. Torre. I am safe for a couple hours, anyway.
    Mr. Milken. I do not think we can think of anything that is 
more important, Senator.
    Senator Specter. If you can return, I would like to explore 
when we finish the rounds of questioning how we can stimulate 
more public concern and more funding, which is really what we 
need to do. So if you can wait, we will not rush Mr. Milken.
    Proceed.
    Mr. Milken. I will just make a couple brief points here. 
Education has been the subject of many of our leaders, and one 
of our great education leaders said: ``If you think education 
is expensive, try ignorance.'' I think if you think of 
investment in cancer research as expensive, try paying for the 
treatment of 100 million Americans who are going to get cancer.
    I would like to make two more points, and some of them are 
beyond the scope of this committee. I believe that Congress and 
the Senate should consider a tax incentive for research such as 
enhanced investment tax credits. If we could do it for 
automobiles, maybe we could also do it for cancer. The ability 
to sell tax loss carryforward for the biotech companies of our 
country, who lost $2.5 billion last year, investing $7.5 
billion in R&D--if we have a real war on cancer, why do we not 
issue cancer war bonds? I would be happy to buy $50 million of 
them myself.
    Why not extend patent lives, accelerate FDA approvals, and 
authorize direct contracting of corporations for R&D? It is the 
kind of public-private partnership that helped us win World War 
Two and could help us win the war on cancer.
    I believe in all these proposals that we can accelerate 
science. If we give cancer researchers the same kind of tools 
that the cancer companies see out there in technology companies 
and employ them for scientific development, we can move things 
along faster.

                           prepared statement

    It is up to you, Mr. Chairman, and your colleagues to 
provide and direct the necessary resources to pave the way. We 
owe this not to ourselves, but to our families and future 
generations. You have strived to leave our children and Nation 
free of debt and a world free from war, a world that cherishes 
the sanctity of a single human life. Yet we have lost 11 
million Americans to the war on cancer since it was declared 
and we have not been willing to make the investment to find a 
solution to this problem. This is a sad legacy for those of us 
in the baby boomer generation to leave to our children.
    We need your help. We welcome your support. Thank you very 
much.
    Senator Specter. Thank you very much, Mr. Milken.
    [The statement follows:]

                  Prepared Statement of Michael Milken

    Mr. Chairman and members of the Subcommittee on Labor, Health & 
Human Services and Education Appropriations, my name is Michael Milken. 
I am Founder, President and Chairman of CaP CURE, the Association for 
the Cure of Cancer of the Prostate--the world's largest private funder 
of prostate cancer research. I am a six-year survivor of prostate 
cancer, and I have lost 10 close relatives to cancer.
    The federal investment in finding cures for cancer--$3 billion 
annually--is less than zero point zero zero zero four percent of our 
gross domestic product, or about one-seventh of what Americans spend on 
beauty products. At the same time, we often hear that our nation is 
spending more than $100 billion annually--much of it by the federal 
government--for cancer care. With the graying of the baby- boom 
generation and its greater risk of cancer as members pass the age of 
50, cancer- care dollars are likely to double within a decade. Is there 
any organization that would spend more than 35 times as much money to 
deal with the effects of a problem as it would to solve the problem? It 
makes no sense in the private sector, and, with current concerns about 
spending rates and budget caps, it should make no sense in government.
    The federal government has, for example, made extraordinary 
investments--long-term--in components of the country's infrastructure; 
the interstate highway system is a case in point. It is now time to 
make a similar commitment in human capital. The suffering of cancer 
patients and the grief of their families and friends are beyond 
calculation. But some distinguished economists--such as Kevin Murphy at 
the University of Chicago--have calculated the economic value of the 
lives lost. These figures amplify cancer's already staggering annual 
morbidity and mortality costs. At Murphy's average valuation of $4 
million per life, the 560,000 individuals who will die from cancer this 
year result in losses in trillions, not billions, of dollars.
    Five hundred sixty thousand of our fathers, mothers, brothers, 
sisters, neighbors and friends--that's approximately the same number of 
men and women who served in Operation Desert Storm. Imagine the 
reaction if General Norman Schwarzkopf had announced that no Americans 
sent to the Gulf had survived. Then imagine that that happened every 
year! That's the impact that cancer should have on all of us.
    The approximately $3 billion that we will invest in cancer research 
in 1999 only allows the NCI to fund about 28 percent of approved 
research grants; 72 percent go unfunded because of a lack of resources. 
In the 1970s, the National Cancer Institute could fund 60 percent of 
these grants. Mr. Chairman, it is clear that we are not advancing as 
quickly as we should toward victory in this nation's war on cancer.
    When President Nixon announced that war in 1971, his intention then 
was to produce a cure within a decade--just as President Kennedy's 
earlier goal of putting a man on the Moon had been achieved in less 
than ten years. We all thought it would work. After all, President 
Roosevelt had declared war on polio in 1938, and 17 years later, we 
produced the Salk vaccine. My family knows something about polio 
because my father had contracted it as a child and I was among the 
first of the baby boomers to receive the new vaccine. What a simple 
concept: get a shot and wipe out a disease. Surely we should do the 
same with cancer.
    Then, two years after President Nixon's declaration, my mother-in-
law was diagnosed with breast cancer. Four years after that, my father 
found out he had malignant melanoma. In the late 1970s, following my 
father's diagnosis, my family began a program of funding cancer 
research, later expanded and formalized by the Milken Family 
Foundation. In 1993, I founded CaP CURE to help fight the most commonly 
diagnosed non-skin cancer in America.
    In 1995, I told the National Cancer Summit that General 
Schwarzkopf, a fellow prostate-cancer patient, believed military 
lessons should be applied to the war on cancer. ``There comes a time,'' 
he said, ``when you must get on with the battle. You'll never have 
perfect intelligence on the enemy.'' The fact is that we have plenty of 
information for the offensive--we just lack sufficient firepower.
    How much firepower do we need? Last fall, as part of THE MARCH . . 
. COMING TOGETHER TO CONQUER CANCER, I suggested to Senators Connie 
Mack and Dianne Feinstein, at a hearing of the Senate Cancer Caucus, 
that the annual federal investment in cancer research be increased to 
$10 billion. While such a sweeping plan is beyond the immediate purview 
of this committee, I'd just like to say that a $10 billion investment 
is less than $40 per American. It is a fraction of the cost of 
failure--the cost of treating the more than 100 million Americans 
currently living who are expected to get cancer.
    Consider what part of our national income we have spent on the 
military in wartime, and then consider the fact that an American 
soldier is more likely to die from cancer than from enemy action. Just 
as we don't fight guns-and-bullets wars with a 40-hour week, we must 
recognize that the war against the foreign invader we call cancer is a 
24-hour-a-day, seven-day-a-week effort.
    A single U.S. company, the Intel Corporation, spends more than 
twice the government's annual cancer research budget on R&D and capital 
expenditures: investing in laboratories and research procedures and 
then investing over and over again as new opportunities for discovery 
present themselves in subsequent years. Marketplace competition means 
that the investment is required--not just considered; it is an 
essential part of the company's success. We should learn from our 
country's technology leaders and make the same kind of investment in 
cancer research.
    Perhaps it is cooperation and competition from the newly created 
Department of Defense cancer research projects that has propelled NIH's 
investments forward in this area. Perhaps it is cooperation and 
competition from the private sector that has generated rapid results in 
the National Human Genome Project. With competing companies claiming 
that they will unravel the human genome quickly, the government project 
may complete its work a half decade sooner than expected.
    Technological advances could propel us further and faster on the 
road toward a series of cures. Improvements in imaging technology, for 
example, can help us visualize cancer cells. Adaptations of military 
technologies can be used to target radiation more effectively. These 
and thousands of investigations we haven't yet considered--including 
some that should be declassified from the military--will cost much less 
than the cost of failure.
    An education leader once said, ``If you think education is 
expensive, try ignorance.'' I would paraphrase that as, ``If you think 
cancer research is expensive, try paying for continued treatment of 100 
million Americans.''
    The 76 million members of the baby-boom generation--31 percent of 
our population--are turning fifty at the rate of one every seven 
seconds. As they pass that threshold, their risk of cancer--including 
prostate cancer--increases. Prostate cancer will affect about one man 
in six in this country, which means that more than six million boomers 
could become its victims during the next decades resulting in more than 
$600 billion in expenditures.
    Consider the further economic and social impact of prostate cancer. 
Take, as an example, the potential impact of the disease on the eight 
million individuals--including men in uniform and retirees--who receive 
health care in the Defense Department's worldwide network. It's easy to 
see, but painful to recognize, that there are--and will continue to 
be--extraordinary losses in human capital to prostate cancer. It's easy 
to see, but painful to recognize, that the future liability of prostate 
cancer is, in fact, in the trillions of dollars. These losses are part 
of the cumulative skills and experience of men in the workforce--and 
they are great because prostate cancer most often strikes employees and 
managers with the longest tenure, men who are in the midst of making 
their most significant contributions to this country. And the pain will 
continue--for individuals, families and society--unless we decide to do 
something about the problem now.
    In the six years since my diagnosis, the federal government has 
invested about $800 million dollars to find a cure for prostate cancer, 
only about $3,000 for each life lost to the disease. Compare that to 
the nearly $3 billion our government has wisely appropriated during 
that six-year period for breast cancer research--a disease that 
annually claims approximately the same number of lives. Or compare it 
to the more than $10 billion that the federal government has spent 
trying to find a cure for AIDS. It's not that breast cancer research or 
AIDS research gets too much research funding. As long as lives are lost 
to those diseases, or pain and suffering endured, no amount is ``too 
much.'' It's just that prostate-cancer research has gotten too little.
    Then, Mr. Chairman, in the fiscal year 1999 appropriation, you and 
your colleagues required a sea change in the prostate cancer research 
strategy that will, this year, lead to NIH's investment of 
approximately $175 million. It is an important beginning. On behalf of 
the more than one-quarter of the families in this country who find or 
will find a member diagnosed with prostate cancer, we thank you, Mr. 
Chairman. We also thank the chairman of the full committee, Senator Ted 
Stevens, and your colleagues on the committee for your leadership.
    Still, in the short time I'm speaking today, another American will 
have died from prostate cancer. That's five men every hour, more than a 
hundred men every day--almost 40,000 men this year alone. While 
prostate cancer kills men, its victims are also women--the wives, 
mothers, daughters, sisters, aunts and friends of those whose lives are 
cut short--part of the human tragedy of this devastating disease.
    That's why it's so encouraging to see that NIH is both increasing 
and diversifying its investments in prostate cancer research. But, 
given the aggressive impact of this disease, even this novel, assertive 
NIH investment strategy may not go far enough--in dollars or research 
development.
    We believe that, as NIH and NCI ``ramp up'' their efforts to find a 
cure for prostate cancer, there will be a compelling need to visit with 
your committee, in the next four years, to ask for more funds for 
clinical prostate-cancer research. We think important clinical 
developments are taking place now and, with more funding, will only 
accelerate. For example, CaP CURE-supported research has already led to 
more than 70 new treatments that are currently in clinical trials. 
Among the most promising medical advances are:
  --treatments using viruses programmed to replicate in prostate cancer 
        cells and kill them;
  --new chemotherapies that are successful in stopping the growth of 
        previously untreatable tumors; and
  --novel vaccines that cause patients to mount significant immune 
        responses to their own tumors.
    We know that an investment in clinical and translational research 
makes good business sense. As an example, in the 1980s, experts were 
predicting that, at the end of this century, American deaths from AIDS 
would exceed 500,000 annually. While AIDS is still a great human 
tragedy, this year, about 15,000 people--not half a million people--
will die from the disease. We cannot yet celebrate a cure for AIDS and 
it is wrong to become complacent, but the impact of research 
breakthroughs through the creation of new treatments has been 
astounding.
    Similarly, we need to accelerate research efforts for prostate 
cancer. We applaud NCI's creation of QuickTrials and RAID, new programs 
to hasten new treatments. And we applaud the creation of prevention 
trials, which could save lives in future generations.
    We support NCI's Herculean commitment to collect more than one 
million men for prevention trials. But we would like to see their 
similar commitment directed to the collection of one million men--or 
more--for clinical trials. That fewer than five percent of eligible 
adults participate in cancer clinical trials--even less in prostate-
cancer clinical trials--is staggering, and we'd like to encourage 
dedicating federal resources and ingenuity to solve that problem.
    We would like to see more than five cents of every cancer research 
dollar dedicated to prostate-cancer research, because we think the 
value of the investment is already assured. According to the National 
Prostate Cancer Coalition, which CaP CURE is proud to support and 
sponsor, at least $500 million could be invested in new and underfunded 
research areas in 1999. These include:
  --chemotherapies that destroy cancer cells and halt the progression 
        of disease;
  --vaccines and other stimulators of the immune system;
  --anti-angiogenesis therapies that destroy a tumor's nutrient blood 
        supply;
  --differentiation agents that normalize prostate cancer cells;
  --treatments affecting the prostate cancer cell's androgen receptor;
  --promoting apoptosis, or programmed cell death;
  --radiobiology and radiology treatments;
  --tumor molecular biology including the molecular ``fingerprinting'' 
        of disease;
  --genetics that may help stop the disease at its earliest stages; and
  --nutritional and other alternative therapies that may impede or 
        reverse the progression of disease.
    We would like to encourage NIH to reduce barriers related to its 
grants procedures and encourage a streamlining of the process that 
would get funds into researchers' laboratories and clinics more 
rapidly. At CaP CURE, we know it can be done without sacrificing the 
integrity of peer review.
    But there's even more that America can do. While it's beyond the 
scope of this Committee's work, I believe the Congress should consider 
tax incentives for research, such as enhanced investment tax credits, 
R&D credits, and sales of tax-loss carry- forwards. If we have a real 
war on cancer, then why not issue ``cancer war bonds''? Why not extend 
patent lives, accelerate FDA approvals and authorize direct contracting 
with corporations for research and development? That kind of public-
private partnership helped win World War II and it can win World War 
Cancer.
    I believe in all of these proposals because it's clear to me that 
we can accelerate science. If we give cancer researchers the same kinds 
of tools that technology companies employ in accelerating scientific 
development, we can find a cure faster. That will relieve the suffering 
of more than 100 million Americans.
    We have talented people working on this inside and outside the 
government. Let's give them the tools and the incentives to finish this 
job. Let's send a message to our best and brightest young scientists 
that cancer research is an exciting profession and not--as one CaP 
CURE-supported scientist was told by his medical-school mentor--
``career suicide.'' Finally, let's show all these dedicated people that 
we share their sense of urgency.
    It is up to you, Mr. Chairman, and your colleagues, to provide and 
direct the necessary resources to pave the way. We owe this not to 
ourselves, but to our families and to future generations. We strive to 
leave our children a nation free from debt and a world free from war--a 
world that cherishes the sanctity of a single human life. That world 
must not allow the scourge of cancer to continue. Let us find a cure 
for cancer now. Let us choose life.
    Thank you.

                     summary statement of joe torre

    Senator Specter. We turn now to the Manager of the New York 
Yankees, Mr. Joe Torre. During his 17-year playing career Mr. 
Torre was named to the All-Star Team 9 times. In 1977 he began 
his managerial career with the New York Mets. He has managed in 
Atlanta, St. Louis, and returned to New York to manage the 
Yankees. Within the past month, after having been diagnosed 
with prostate cancer earlier this year on March 10 during a 
routine exam and having undergone surgery, he looks good. The 
team is winning.
    Mr. Torre. That makes me healthy and look good.
    Senator Specter. Thank you very much for joining us, Mr. 
Torre, and the floor is yours.
    Mr. Torre. Mr. Chairman and members of the subcommittee: 
Again, thank you for having us here.
    I am Manager of the Yankees, as of last night anyway. I am 
also a prostate cancer survivor, also a 4-year survivor of 
George Steinbrenner, which is not easy. I began managing the 
Yankees prior to the 1996 season, which was a tough job. After 
managing several ball clubs coming to the highest profile team 
in baseball and the toughest media mecca in the world, that was 
quite a challenge.
    In our first 3 years, fortunate and talented, went to the 
post-season 3 times, won the World Series twice, the first time 
in 1996, beating the Braves when we were down two games to 
zero, and then of course last year, winning 114 games and 
having to validate that by winning the World Series. These were 
two of the most challenging experiences of my life.
    However, none of these challenges have come close to what I 
dealt with in my battle against prostate cancer. I was 
diagnosed with prostate cancer this past March. It was 
discovered during a routine physical in spring training, when 
my PSA was elevated. A follow-up biopsy confirmed that I did in 
fact have prostate cancer.
    I came out, as did Senator Dole, before I had the surgery. 
I sort of had no choice. My wife said: See, if you had retired 
when I asked you to nobody would know about this. But maybe it 
was the best thing.
    After consulting with my doctors, I decided to have surgery 
to remove the prostate. Dr. Bill Catalona performed the surgery 
in St. Louis on March 18 and so far everything checks out and I 
feel wonderful.
    A lot of men are diagnosed so late and with the disease so 
bad that their treatment options are severely limited or 
nonexistent, and too often the disease comes back.
    Mr. Chairman and members of the committee, I thank you for 
your work you have done to protect men and their families from 
prostate cancer. But more must be done. When I was initially 
diagnosed, my first thoughts centered on my family. I have four 
children, including a 3-year-old daughter named Andrea Rae. 
This was one of those moments that clarifies personal 
priorities. The needs and concerns of my family were front and 
center. Baseball is definitely my life, but being diagnosed 
with a serious disease makes you realize what is really 
important.
    Fortunately, my family gave me the encouragement that was 
so crucial to my coping and the initial shock of the diagnosis, 
as well as the surgery and my ongoing recovery. My wife Ali has 
given me the unconditional support that I needed and that at 
the end of the day has made all the difference in my fight 
against this disease.
    During my recovery I also received many letters and phone 
calls from men who had faced the same challenge. You do not 
realize how many people are affected until you are on that ball 
club, I guess.
    Also important, members of the Yankee family, led by George 
Steinbrenner, came to my side during the difficult time. The 
Yankees, unfortunately, are all too familiar with cancer. This 
disease in different forms has touched the organization in its 
history. Babe Ruth lost his life to cancer, last year Darryl 
Strawberry learned he had colon cancer, and this year Joe 
DiMaggio died after facing lung cancer and pneumonia.
    My close friend Bob Watson, former Yankee general manager, 
had been battling prostate cancer for several years. He and his 
wife Carol were outspoken about the need for more research 
funding when they testified before a Senate committee last 
year. I look to these people and to my close friends for 
inspiration and support.
    I feel lucky to say that my fight against prostate cancer 
was a team effort, one that involved many caring family 
members, friends, fans, and members of the Yankee organization. 
I know and continue to know that I am not alone in this fight.
    Unfortunately, a man dies from this disease every 13 
minutes. That is simply too many men and too many wives, 
daughters, and sons who are devastated by prostate cancer. The 
toll that this disease takes each day and each year is nothing 
less than epidemic. While prostate cancer accounts for 15 
percent of all cancer diagnosis, only 5 percent of Federal 
cancer dollars are directed toward prostate cancer research.
    A man has a one in six chance of getting prostate cancer in 
his lifetime if he has a close friend with prostate--if he has 
a close relative with prostate cancer, his risk doubles. With 
two close relatives, his risk increases fivefold. Three close 
relatives, it is nearly 97 percent. Make no mistake, this is a 
family disease.
    As pointed out earlier, the African American community is 
even more at risk. African American men have the highest 
prostate rate in the world, 35 to 50 percent greater than the 
rate of white males, and African American men endure twice the 
mortality rate.
    I am here to tell you that prostate cancer does not 
discriminate based on age. This is not an old man's disease. 
About one in four prostate cancer cases strikes a man during 
his prime working years. I am 58 and the number of men in their 
forties and fifties who are battling prostate cancer is 
increasing. Doctors around the country report seeing more 
aggressive forms of disease in younger men.
    These statistics are even more troubling when as we look 
forward the incidence of prostate cancer is expected to keep 
rising. Do not forget, as the baby boomer generation ages its 
risk of prostate cancer, if unchecked, will continue to 
increase. That is why this hearing is so crucial and why 
Congress' role in protecting men and their families from 
prostate cancer will make such a tremendous difference in the 
lives of millions of Americans.
    Congressional action is needed on two key fronts: the first 
is oversight; the second is providing much needed funding for 
prostate cancer research. With the ability to hold NIH 
accountable, Congress can ensure that research dollars and 
strategies will be effectively directed to break through--to 
treatment breakthroughs and a cure. Combined with increased 
research funding, this oversight role brings unprecedented hope 
to the men and their families who are affected by this disease.
    The bottom line is that if we are to mount a serious attack 
on prostate cancer researchers must have the tools and 
resources that they need. The NIH plan holds promise for rapid 
progress toward better treatments and ultimately a cure. But 
unless this program is adequately funded, it is just a plan on 
a piece of paper and its promise will remain unrealized.
    I commend you, Mr. Chairman, and the other members of this 
committee, and indeed the entire Senate, for all you have done 
to accomplish our shared goal of successfully fighting prostate 
cancer. But I also ask that you do all you can in the coming 
months and years to provide adequate funding for prostate 
cancer research. Given that so many lives are at stake, finding 
a cure for prostate cancer must be a national priority.
    With Father's Day just days away, I am happy to be able to 
spend this holiday with my loved ones. I am also happy to be 
able to be a spokesman for the CapCURE's Home Run Challenge, 
its annual week-long effort with major league baseball centered 
on Father's Day to raise awareness and private sector funding 
for prostate cancer research.

                           prepared statement

    For too many families, this holiday is a time to remember 
the fathers, husbands, and brothers who have been lost to this 
disease. By providing increased research funding, you can stem 
rising rates of prostate cancer and protect future generations 
of men and their families from its devastation.
    Thank you.
    Senator Specter. Thank you very much, Mr. Torre.
    [The statement follows:]
                    Prepared Statement of Joe Torre
    Mr. Chairman and members of the Subcommittee on Labor, Health & 
Human Services and Education Appropriations, my name is Joe Torre. I am 
the manager of the New York Yankees. I am also a prostate cancer 
survivor.
    I began managing the Yankees prior to the 1996 season and 
immediately faced the significant challenges that come with guiding a 
high-profile team in a competitive league and the biggest media market 
in the nation.
    In my first three years with the Yankees, we've been fortunate--and 
talented--enough to appear in post-season play three times, winning the 
World Championship twice. In 1996, the Yankees overcame a two-games-to-
none deficit against the powerful Atlanta Braves in the World Series. 
And, in 1998, we faced the considerable challenge of validating our 
American League record of 114 wins in the regular season. These were 
two of the most-challenging experiences of my life.
    None of these challenges, however, has come close to what I dealt 
with in my battle against prostate cancer. I was diagnosed with 
prostate cancer this March. After a routine team physical during spring 
training, I found out that my PSA--Prostate Specific Antigen--level was 
elevated. A follow-up biopsy confirmed that I did, in fact, have 
prostate cancer.
    After consulting with my doctors, I decided to have surgery to 
remove my cancerous prostate gland. Dr. William Catalona performed the 
surgery in St. Louis on March 18th and, so far, everything checks out, 
and I'm fine. I was lucky, though. A lot of men are diagnosed so late 
or with disease so bad that their treatment options are severely 
limited or nonexistent. And, too often, the disease comes back. Mr. 
Chairman and members of the committee, I thank you for the work you've 
done to protect men and their families from prostate cancer, but much 
more must be done.
    When I was initially diagnosed, my first thoughts centered on my 
family. I have four kids, including a 3-year old daughter named Andrea 
Rae. This was one of those moments that clarifies personal priorities; 
the needs and concerns of my family were front and center. Certainly, 
baseball is my life, but being diagnosed with a serious disease like 
prostate cancer makes you realize what's really important!
    Fortunately, my family gave me the encouragement that was so 
crucial to my coping with the initial shock of the diagnosis--as well 
as the surgery and my ongoing recovery. My wife, Ali, has given me the 
unconditional support that I needed and that, at the end of the day, 
has made all the difference in my fight against this disease. During my 
recovery, I also received many letters and calls from men who were 
faced with the same challenge.
    Also important, members of the Yankee family--led by George 
Steinbrenner--came to my side during this difficult time. The Yankees, 
unfortunately, are all too familiar with cancer. This disease--in 
different forms--has touched the organization in its history. Babe Ruth 
lost his life to cancer. Last year, Darryl Strawberry learned he had 
colon cancer. And this year, Joe DiMaggio died after facing lung cancer 
and pneumonia.
    My close friend Bob Watson, former General Manager of the Yankees, 
has been battling prostate cancer for several years. He and his wife, 
Carol, were outspoken about the need for more research funding when 
they testified before a Senate committee last year. I looked to these 
people, and to my other close friends, for inspiration and support.
    I feel lucky to say that my fight against prostate cancer was a 
team effort, one that involved many caring family members, friends, 
fans and members of the Yankees. I knew--and continue to know--that I'm 
not alone in this fight. I know that, throughout it all, my friends and 
loved ones were 100 percent behind me.
    Unfortunately, a man dies from this disease every 13 minutes. That 
is simply too many men, and too many wives, daughters and sons, who are 
devastated by prostate cancer. The toll that this disease takes each 
day and each year is nothing less than epidemic. While prostate cancer 
accounts for 15 percent of all cancer diagnoses, only 5 percent of 
federal cancer dollars are directed toward prostate cancer research.
    A man has a one in six chance of getting prostate cancer in his 
lifetime. If he has a close relative with prostate cancer, his risk 
doubles. With two close relatives, his risk increases five-fold. With 
three close relatives, his risk is nearly 97 percent. Make no mistake, 
this can be a family disease.
    The African American community is even more at risk. African-
American men have the highest prostate cancer rate in the world, 35 
percent-50 percent greater than the rate for white males, and African-
American men endure twice the mortality rate.
    I'm here to tell you that prostate cancer doesn't discriminate 
based on age. This is not ``an old man's disease.'' About one in four 
prostate cancer cases strikes a man during his prime working years, 
under the age of 65. I am 58 years old and the number of men in their 
40s and 50s who are battling prostate cancer is increasing. Doctors 
around the country report seeing more aggressive forms of the disease 
in younger men.
    These statistics are even more troubling when, as we look forward, 
the incidence of prostate cancer is expected to keep rising. Don't 
forget, as the baby boom generation ages, its risk of prostate cancer, 
if unchecked, will continue to increase. That's why this hearing is so 
crucial and why Congress's role in protecting men and their families 
from prostate cancer will make such a tremendous difference in the 
lives of millions of Americans.
    Congressional action is needed on two key fronts: the first is 
oversight; the second is providing much-needed funding for prostate 
cancer research. With the ability to hold NIH accountable, Congress can 
assure that research dollars and strategies will be effectively 
directed to treatment breakthroughs and a cure. Combined with increased 
research funding, this oversight role brings unprecedented hope to the 
men and their families who are affected by prostate cancer.
    The bottom line is that if we are to mount a serious attack on 
prostate cancer, researchers must have the tools and resources that 
they need. The NIH plan holds promise for rapid progress toward better 
treatments and ultimately a cure. But unless this program is adequately 
funded, it's just a plan on a piece of paper and its promise will 
remain unrealized.
    I commend you, Mr. Chairman, the other members of this committee 
and, indeed, the entire Senate for all you have done to accomplish our 
shared goal of successfully fighting prostate cancer. But I also ask 
that you do all you can in the coming months and years to provide 
adequate funding for prostate-cancer research. Given that so many lives 
are at stake, finding a cure for prostate cancer must be a national 
priority.
    With Father's Day just days away, I'm happy to be able to spend 
this holiday with my loved ones. I am also happy to be able to be a 
spokesman for CaP CURE's ``Home Run Challenge,'' its annual week-long 
effort with Major League Baseball, centered on Father's Day, to raise 
awareness and private-sector funding for prostate cancer research. For 
too many families, this holiday is a time to remember the fathers, 
husbands and brothers who have been lost to this disease. By providing 
increased research funding, you can stem rising rates of prostate 
cancer and protect future generations of men and their families from 
its devastation.
    Thank you.

    Senator Specter. The situation is this. We will arrive 
right at the conclusion of the first vote and they should start 
the second vote unless there are stragglers. Senator Dole knows 
that better than anyone. But we should be able to return here 
within 10, 12 minutes, and I think it would be useful if we 
pursued the subject of how we stimulate public awareness and 
funding.
    So we will recess for just a few minutes.
    [A brief recess was taken.]
    Senator Dole. You did a good job.
    Senator Specter. We will resume the hearing. Thank you, 
Senator Dole. That was a pretty good job, was it not, taking 
two votes and back in about 15 minutes. While we were gone, 
Senator Stevens and I held an informal conference en route. We 
talked to Senator Roth on the floor. Senator Stevens wants to 
go easy on that.
    Let me yield to Senator Stevens for whatever he thinks 
ought to be said.
    Senator Dole. Roth has been there, too, yes.
    Senator Stevens. Mr. Milken, we have conferred with the 
chairman of the Finance Committee about the concept of cancer 
bonds and we will pursue that. It is a good suggestion. It 
needs to be defined, but if there is a jurisdictional problem 
there with regard to Appropriations and Finance we will try and 
work that out.
    Senator Specter. Well, let us start there, Mr. Milken. You 
mentioned the idea of bonds, but I would like to for a few 
minutes to try to explore ways we can get extra funding and how 
we can stimulate the interest of the American people in the 
subject. When Joe Torre and Bob Dole and Mike Milken talk about 
it, people focus on it. It is a step in the right direction.
    We have talked about a number of proposals. Senator 
Hatfield and Senator Harkin and I were co-sponsors on 
legislation which had proposed a 1 percent fee on all medical 
insurance that was written, on the theory that if that was 
dedicated to research, biotechnical research, that it would cut 
down the cost of payments that insurance companies would have 
to make for health delivery. That legislation had never gotten 
too far.
    As I had said earlier, there has been a sense in the 
Congress to double NIH funding and increase cancer research 
funding, but when it comes to voting for it the votes have not 
been there. So what Senator Harkin and I have had to do--and he 
could not be with us today--is to take our overall budget, 
which impacts on education programs and drug programs and other 
health programs and worker safety--we have three Departments, 
the Department of Labor, the Department of Education, and the 
Department of Health and Human Services. But we have 
established the priorities to carve out $2 billion more last 
year.
    That is a very difficult thing to do. We really would like 
to do it again this year, but I do not know that that is going 
to be possible, depending on where we come out on the caps.
    But Mr. Milken, go into a little bit more detail about how 
you would suggest structuring the bond program. We are off to a 
good start with your, was it, a $50 million pledge or $50 
billion to get it started?
    Senator Dole. Billion.
    Mr. Milken. I would like to be able to pledge $50 billion, 
but I will have to start with $50 million.
    Senator Specter. That is a pretty good start, Mr. Milken.
    Mr. Milken. I think the issue there of how do you raise 
capital to invest in this effort on cancer--one of the real 
forefronts of our effort for solution, not just of cancer 
problems but all medical problems, are biotech companies. As I 
stated earlier, they invested last year in R&D $7.5 billion to 
try to find cures for medical problems and they collectively 
lost $2.5 billion. They cannot use the losses that they are 
achieving.
    I know the Governor of New Jersey and others have thought 
about it from the States' standpoint of allowing them to sell 
their tax loss carryforwards, something we have allowed other 
companies to do in the past 30 years, if they redeployed that 
back into medical research or cancer research. That would 
enable them to reinvest more, and they are on the forefront of 
the work that is going on, and this would be a private sector 
initiative where they would invest their own capital.
    Investment tax credits, which have gone into effect many 
times in the past 30 years in our country when we wanted to 
encourage people to buy computers or automobiles; we obviously 
have that opportunity if people do cancer research, saying this 
is a priority of the government from that standpoint also.
    Cancer bonds, I think many of us would be very happy to buy 
low interest rate government bonds that can be deployed into 
cancer research in some joint efforts, as Senator Stevens has 
suggested, to get more capital flowing where it would be 
matched by both the private industry and the public sector. I 
think the public-private partnerships in our country's 
history--the recent landing on Mars last year, a partnership 
between NASA and other government agencies and Lockheed Martin 
Marietta and others, was at a cost of less than 10 percent of 
what the cost was of the first landing we had on Mars and was 
managed by the private sector.
    So I think the ability to interact with one another--there 
is, and I am sure Dr. Varmus and Dr. Klausner know far better 
than I, there are significant restrictions on the NIH and the 
NCI's ability to interact with private industry, and I think 
one should take a look at those restrictions in interaction.
    I think we only have to look today to particularly Silicon 
Valley to see the benefits to our country through developments 
where Stanford University and the University of California-
Berkeley particularly encouraged interaction between university 
science centers and private industry, and the benefits that 
have flowed to our entire country.
    Senator Dole. Mr. Chairman, if I could add a note there, I 
think in addition to how we raise the capital, we need to raise 
the awareness of the problem, particularly with men. I mean, 
men do not see their doctors on a regular basis as most women 
do. Men do not get annual checkups, and you can have all this 
research and all these new things happening, but you still have 
to educate the men to see a doctor.
    That is one thing we have been trying to do in a narrower 
sense, but I think there needs to be a focus on men's health 
issues and to find people like Joe and Michael and others 
willing to work together to get the word out, because each of 
us touch a different group.
    I know I talked to the American Foundation for Urological 
Disease. They have a representative here this morning. They 
have had thousands of phone calls based on an advertisement 
that I have done, and taken a little heat on it from the media 
that is not too bright. They are not here today, but in any 
event.
    Senator Specter. They just turned off the cameras.
    Senator Dole. That is all right. [Laughter.]
    But it is a serious problem and there are serious 
consequences. It affects millions and millions of people, 
whether it is prostate cancer or heart disease or diabetes or 
whatever it is. Men do not go to the doctor. I do not know--
this would all be helpful, of course, if they understand there 
is a better way to treat things. Maybe they would be more apt 
to go.
    But I think that is an underlying problem that we need to 
address. A lot of that can be done in the private sector. It is 
being done by General Schwartzkopf. But Michael Milken started, 
really, and Joe Torre and others, Senator Stevens, people who 
have gone public, once they have had the radiation, surgery, 
whatever, in this area--and I am certain there are others out 
there who would be willing to help in a broader sense when it 
comes to men's health.
    Mr. Milken. Men are very shy, as Senator Dole said, and we 
have a lot to learn from women. Obviously, Mother's Day comes 
first in the year, and Mother's Day did come first. Actually, 
prostate cancer has benefited tremendously from the activism of 
women, who have dragged their husbands, their fathers, their 
brothers, their friends, their neighbors. I think the breast 
cancer movement has served as a great role model for many of 
the people working in prostate cancer today.
    Senator Specter. Senator Stevens.
    Senator Stevens. Well, I am interested in pursuing the 
funding problem. My basic problem as chairman of the 
Appropriations Committee is we live under caps, absolute limits 
of expenditures, and there just is no additional money to 
allocate to this subcommittee. It is going to be one of great 
challenges of the Congress to be able to fund the whole Labor, 
Health and Human Services Subcommittee without getting into 
what we call a train wreck as far as the whole process is 
concerned with the administration.
    My mind goes off on another rabbit trail, and that is if 
you look at this all cancers combined chart that we have 
obtained and see that Alaska Native and American Indians, with 
an incidence of cancer in excess of those of black people, 
enter in with the black Americans and the Alaskan Natives and 
put those together, then add in the white Americans, you find 
that the total of those, of the people who originate in the 
North American continent, is about ten times that of those who 
have come to this country from other nations.
    There has got to be some environmental research here beyond 
just medical research to locate that. Up my way, when the 
mining community wants to find a mineral they start taking 
people to analyze the water, to see where those trace elements 
come from, and you just keep going back the tributaries into 
little streams and, guess what, pretty soon you have got a good 
indication of where the central lode is. But I do not think we 
are doing that on this. We are concentrating right now on 
medical research, and I would like to see more money put into 
the environmental research on this continent to find out why 
this is.
    But I do believe that we have got--Mike, you have got some 
great ideas. And Bob, you have been prostate cancer pin-up boy. 
Without you, we probably would not have had a lot of this 
recognition we have got right now.
    Senator Dole. I have had a lot of pins stuck in me.
    Senator Stevens. Well, I remember a friend of mine, a good 
friend of mine, when I held a little meeting at home on the 
pro-cure concept, talking to people, men who might be 
interested in this, after I had my surgery, a great friend of 
mine took me aside and said: Ted, you are wrong; you should not 
talk--men do not talk about these things; do not talk about 
this.
    I said: You have got to be wrong. The problem is the 
complications from not knowing are worse than knowing.
    Senator Dole. I think Joe discovered that, too.
    Mr. Torre. There is no question, and the PSA has been our 
best friend. I will tell you, when Dr. Catalona took out my 
prostate, he said he held it in his hand and he said he did not 
see anything wrong with it. So if it was not for the blood test 
it would have been years down the road before it was discovered 
with the digital exam and other means. And by that time who 
knows where it would have gone, because I had an aggressive 
form of cancer.
    Senator Stevens. I am like you. After it was taken out, I 
demanded a slice of it and I turned it over to one of my great 
friends who is a pathologist and said: Was that really 
cancerous? He came back and said it was really cancerous; you 
got it just in time. A lot--maybe other people are not that 
skeptical, but the problem of having that type of operation is 
an enormous one. But the results I think warrant it. The three 
of us know that. Mike has got another course.
    Mr. Milken. I think there is two elements you have raised 
here, Senator: one, environment and nutrition. The NCI is 
focused, I believe, on trying to collect up to a million men 
for prevention trials to measure that. We would also like to 
see if we could get a million men who have been diagnosed in 
just the last 6 years with prostate cancer into clinical 
trials, not just prevention trials.
    But as you know, during the cancer march last September we 
did attempt, and successfully with support, and both of you 
joined us for lunch, to have a non-fat vegetarian lunch, and we 
were able to get it on the menu in the Senate Dining Room as a 
starter.
    We have been a little remiss, but Doctors Varmus and 
Klausner have embraced the concept of maybe reducing the level 
of fat in the NCI's own dining room if you go down there in the 
cafeteria. So I think there is a lot of opportunities to focus 
on what we have learned today and bring that as a potential, 
using nutrition.
    But I think the overriding element in terms of your 
allocation of funds and the difficulty I think is just bridging 
the gap of a couple years here. It is only a matter of time 
before the American people realize how little money has been 
spent on cancer research. It is only a little time before they 
realize that we have spent twice as much on the Gulf War as we 
have on all cancer research in this country in the last 28 
years. In an 8-month Gulf War, we decided we could get the 
resources and allocated it, the world could.
    In our efforts that we decided we needed to have a 
commitment to Yugoslavia and the former parts, that will 
eventually exceed by a far amount. And the efforts in Somalia 
exceeded the amount we have spent on cancer research.
    So anything in life is a question of allocation of 
resources. But with 100 million Americans projected to be 
diagnosed with cancer who are currently living, at some point 
they will ask themselves for a reallocation. I doubt if the 48 
Senators who voted against it will be able to vote that way. 
Whether that is 2 years away or 1 year away, I do not know, but 
it is not that far away. And I think the cancer march, the 600 
cancer organizations that were here last September, were a 
clear message that there is an interest here.
    When you realize we spend 1 percent of the Federal budget 
on the NIH to provide health and a healthy future for the 
people of this country, we might decide we need to spend more 
than 1 percent of our budget on that area.
    Senator Stevens. Mike you have got a point. I do not 
dispute that. But of the 13 subcommittees we have got, only one 
of them will--only one of them will be the same as the funding 
for 1999 in the year 2000, and that will be Defense, but just 
barely. In this year, with an agricultural problem, a real 
disaster in some places, and now with the Kosovo incident 
taking on a longer proportion, with Bosnia still being there, 
and Iraq, the problem in Iraq, and with higher alerts in South 
Korea, we cannot take any more money from defense.
    I really do not know where we can get it. I think I am the 
strongest supporter of what you want to do, but we are doing 
some other things. For instance, do not forget what we are 
doing at Walter Reed. We are building a baseline now, whether 
you know it or not. Military people, men and women, get their 
annual physical. We are starting to track that over a period of 
years. We will track that, and we will try to get some more 
information as detectives look at it, where those people were 
from, what their backgrounds were. And we are getting more and 
more incidence of both breast cancer and prostate cancer in the 
military as a result of the tests that they are taking. We will 
keep that record going for a series of years and perhaps it 
will help solve some of these problems we are worried about.
    But I tell you, I do not know where the money is going to 
come from in terms of meeting the necessity to have increased 
money. And I believe it. That is why I want to explore that 
cancer bond issue concept. And I do believe the public wants to 
do that.
    If we could put up the money, if we could put up the cancer 
bonds and get the money in for the next two or three fiscal 
years, it is my opinion that by the time the baby boomers have 
retired we will have had such progress that we would reduce the 
cost of Medicare and Medicaid in that generation, the largest 
generation in the history of the United States.
    So if anyone else has any ideas--it is a grand idea. We 
have talked about it before, but I think it is time we really 
pushed it now, because there is no question we have reached the 
limit of our current budget in terms of this war on cancer. We 
have got to find some additional money and dedicate it to 
research, and I would welcome your suggestions.
    But I do thank all of you--I have got to go--for what you 
have done. And Joe, maybe we ought to make you--you have done 
such a good job winning the World Series, maybe you ought to 
take on the task of being the chairman of that bond drive.
    Thank you very much.
    Senator Specter. Thank you, Senator Stevens.
    Well, thank you very much, Senator Dole, Mr. Torre, Mr. 
Milken. I think this was very useful, a lot of focus of 
attention. I know the media will be glad to pick up all of 
Senator Dole's comments, especially his complimentary comments.
    But we will continue to work on it. This subcommittee has 
not given up on the effort to increase the funding very 
substantially to NIH. If we can sharpen our pencils to a fine 
enough point, we are going to try to find $2 billion. And we 
will pursue these tax ideas.
    We get more work done in the well of the Senate, as Senator 
Dole can comment, with bringing the issue up to Senator Roth, 
chairman of Finance. He is receptive. We cannot pass any bills 
on taxes out of this committee, but we are going to pursue it.
    There is a lot of determination in what you men have said 
here today and what the doctors have said that will aid us in 
that effort. Thank you all very much.
    Senator Dole. You know, they did unveil a stamp in 
Philadelphia--I was up there a couple weeks ago--a prostate 
cancer stamp, so it gets back to the awareness. There are a lot 
of things happening out there that make men aware of it. I 
think Joe--probably all the baseball players will know about 
it. That will help, too, because they have got a lot of 
friends, celebrity status, and men will listen.
    Mr. Torre. But I think Senator Dole's point, one more 
second about getting examinations, letting men know that it is 
not a death sentence if you get this thing early and they 
should not be afraid of taking a physical and taking a blood 
test, because the blood test does not hurt at all, as long as 
you turn the other way, and it is very treatable if it is 
gotten in the early stages. That is what the PSA has done for 
you.

                         conclusion of hearing

    Senator Specter. Thank you all very much for being here, 
that concludes our hearing. The subcommittee will stand in 
recess subject to the call of the Chair.
    [Whereupon, at 11:37 a.m., Wednesday, June 16, the hearing 
was concluded, and the subcommittee was recessed, to reconvene 
subject to the call of the Chair.]

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