[Senate Hearing 106-362]
[From the U.S. Government Publishing Office]
S. Hrg. 106-362
PROSTATE CANCER
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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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U.S. GOVERNMENT PRINTING OFFICE
59-317 CC WASHINGTON : 2000
_______________________________________________________________________
For sale by the U.S. Government Printing Office
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ISBN 0-16-060204-1
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
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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
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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
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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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