[Senate Hearing 107-906]
[From the U.S. Government Publishing Office]
S. Hrg. 107-906
CANCER RESEARCH AND PREVENTION
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HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
SECOND SESSION
__________
SPECIAL HEARING
JUNE 4, 2002--WASHINGTON, DC
__________
Printed for the use of the Committee on Appropriations
Available via the World Wide Web: http://www.access.gpo.gov/congress/
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COMMITTEE ON APPROPRIATIONS
ROBERT C. BYRD, West Virginia, Chairman
DANIEL K. INOUYE, Hawaii TED STEVENS, Alaska
ERNEST F. HOLLINGS, South Carolina THAD COCHRAN, Mississippi
PATRICK J. LEAHY, Vermont ARLEN SPECTER, Pennsylvania
TOM HARKIN, Iowa PETE V. DOMENICI, New Mexico
BARBARA A. MIKULSKI, Maryland CHRISTOPHER S. BOND, Missouri
HARRY REID, Nevada MITCH McCONNELL, Kentucky
HERB KOHL, Wisconsin CONRAD BURNS, Montana
PATTY MURRAY, Washington RICHARD C. SHELBY, Alabama
BYRON L. DORGAN, North Dakota JUDD GREGG, New Hampshire
DIANNE FEINSTEIN, California ROBERT F. BENNETT, Utah
RICHARD J. DURBIN, Illinois BEN NIGHTHORSE CAMPBELL, Colorado
TIM JOHNSON, South Dakota LARRY CRAIG, Idaho
MARY L. LANDRIEU, Louisiana KAY BAILEY HUTCHISON, Texas
JACK REED, Rhode Island MIKE DeWINE, Ohio
Terrence E. Sauvain, Staff Director
Charles Kieffer, Deputy Staff Director
Steven J. Cortese, Minority Staff Director
Lisa Sutherland, Minority Deputy Staff Director
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Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
TOM HARKIN, Iowa, Chairman
ERNEST F. HOLLINGS, South Carolina ARLEN SPECTER, Pennsylvania
DANIEL K. INOUYE, Hawaii THAD COCHRAN, Mississippi
HARRY REID, Nevada JUDD GREGG, New Hampshire
HERB KOHL, Wisconsin LARRY CRAIG, Idaho
PATTY MURRAY, Washington KAY BAILEY HUTCHISON, Texas
MARY L. LANDRIEU, Louisiana TED STEVENS, Alaska
ROBERT C. BYRD, West Virginia MIKE DeWINE, Ohio
Professional Staff
Ellen Murray
Jim Sourwine
Mark Laisch
Adrienne Hallett
Erik Fatemi
Bettilou Taylor (Minority)
Mary Dietrich (Minority)
Sudip Shrikant Parikh (Minority)
Candice Rogers (Minority)
Administrative Support
Carole Geagley
C O N T E N T S
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Page
Opening statement of Senator Tom Harkin.......................... 1
Statement of Hon. Tommy Thompson, Secretary, Department of Health
and Human Services............................................. 2
Prepared statement........................................... 5
Opening statement of Senator Arlen Specter....................... 9
Opening statement of Senator Thad Cochran........................ 10
Opening statement of Senator Patty Murray........................ 11
Prepared statement........................................... 11
Statement of Elmer E. Huerta, M.D., M.P.H., director, Cancer
Preventorium, Washington Hospital Center....................... 18
Prepared statement........................................... 20
Statement of Ronald B. Herberman, M.D., director, University of
Pittsburgh Cancer Institute.................................... 22
Prepared statement........................................... 24
Statement of Susie Novis, president, International Myeloma
Foundation..................................................... 25
Prepared statement........................................... 27
Statement of Michael Bruene, cancer survivor..................... 31
Prepared statement........................................... 33
Statement of Steve Case, chairman, AOL Time Warner............... 35
Prepared statement........................................... 38
Prepared statement of Senator Mary L. Landrieu................... 46
Prepared statement of Senator Ernest F. Hollings................. 47
CANCER RESEARCH AND PREVENTION
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TUESDAY, JUNE 4, 2002
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:35 a.m., in room SH-216, Hart
Senate Office Building, Hon. Tom Harkin (chairman) presiding.
Present: Senators Harkin, Murray, Specter, and Cochran.
opening statement of senator tom harkin
Senator Harkin. Good morning everyone. The Subcommittee of
Labor, Health and Human Services, and Education of the
Appropriations Committee will come to order.
Thirty years ago, in 1971 President Nixon declared war on
cancer. Today we are going to take a progress report on our
Nation's battle against this killer disease.
We have good news. We have made great strides since then.
Childhood leukemia is no longer the dreadful killer it once
was, and many of the side effects of chemotherapy are less
devastating than they used to be.
In 1998, we had a march on cancer here in Washington. I
assume many of you in this room were at that march. It was a
very inspiring event. I said then that we were not putting
anywhere near the funds needed into cancer research. That day
we set out to correct a problem. Today, 5 years later, I am
proud to report that with this year's appropriation and with
the support of Secretary Thompson and the administration, we
will have doubled funding for cancer research in 5 years. That
is an accomplishment you can all be proud of.
But now is not the time to take a victory lap. So far, we
have taken the beach, we have gathered troops, and set the
stage for the next part of this battle, for it is only through
a three-pronged offensive--research, treatment, and
prevention--that we will win this.
Cancer claims the lives of over 500,000 Americans each
year, and another 1.2 million are diagnosed annually. That is
1.2 million of our brothers and sisters, our mothers, fathers,
sons, and daughters, 1.2 million who this year will hear the
three scariest words in the English language: ``You have
cancer.''
All of us in this room today have had our lives touched by
this killer. I lost my only two sisters and two of my three
brothers to cancer. So, it has hit the Harkin family pretty
darned hard.
Today, as I said, we will take a progress report on how we
are doing in preventing other families from being hit so hard.
We are fortunate to have a truly distinguished panel of
witnesses to help us do that. We will hear from a panel of
people on the front lines of science, prevention, and patient
experience. I look forward to each of their statements.
I want to particularly welcome Michael Bruene from West Des
Moines. Mr. Bruene, I have heard a lot about the work you are
doing to raise awareness about cancer and I certainly thank you
for making the trip with your wife here this morning.
I also want to thank you in the audience. We have a great
crowd here this morning who have come from great distances to
be here. You are the ones who have put a human face to this
effort. You are the ones who deal with cancer every day and you
are the ones who will march to victory against cancer. It is
your hard work on the front lines and your dedication to
stopping this epidemic that will lead us to victory.
And we will win. We will come back next year and the next
year and the next year until cancer is a disease of only
historical relevance.
I also want to thank a long-time friend and trusted advisor
and fellow Iowan Dan Smith. As the founder and Chair of the One
Voice Against Cancer Coalition, he is making a tremendous
contribution to this great cause.
Senator Specter is unavoidably detained at the White House
for a meeting, and he will be here shortly.
STATEMENT OF HON. TOMMY THOMPSON, SECRETARY, DEPARTMENT
OF HEALTH AND HUMAN SERVICES
Senator Harkin. It is my great honor and distinct pleasure
to welcome once again to this subcommittee a great friend, a
good neighbor.
Secretary Thompson is the 19th Secretary of Health and
Human Services. He has had a long and distinguished career as a
public servant, starting first in 1966 as a representative in
Wisconsin's State Assembly. Of course, from 1987 to 2000, he
was the Governor of the State of Wisconsin and is now our great
Secretary of Health and Human Services.
Secretary Thompson, again, I thank you for your leadership,
especially in this effort on cancer. And I know how deeply you
feel about it, and I know that you have been working very
closely with those at NIH to again make sure that we stayed
focused and do everything that we possibly can. So, I welcome
you again to the subcommittee. Your statement will be made a
part of the record in its entirety. I know you have to leave
right after you make your statement, so please proceed as you
so desire.
Secretary Thompson. Thank you very much, Chairman Harkin. I
just would like to say thank you. Thank you, Senator, for what
you are doing, your leadership, your passion on this subject.
It comes through loud and clear, and I just want to say
publicly thank you for your leadership and that of Senator
Arlen Specter. The two of you make a dynamic duo in this fight
that we are waging, and I am confident with your leadership, we
are going to win and we are going to overcome this insidious
disease.
I want to thank you first for inviting me to come before
you today to discuss the progress that we are making in our
fight against cancer, as well as President Bush's bold
proposals to make sure that we win this battle so essential to
the health of our country.
I also want to thank Steve Case of AOL Time Warner. I
understand Steve's brother is waging his own battle against
brain cancer, and I want to thank them for their courage, as
well as their leadership in forming with Dan the Accelerate
Brain Cancer Cure Foundation. It is a wonderful effort, like
many other efforts of many wonderful people in this room who
are making the tremendous effort to fight this wonderful fight
against this insidious disease.
Mr. Chairman, in recent years, we have made stunning
progress in the war against cancer, some of which I will detail
in a moment. But the challenges remain real, as well as very
painful. Today I am here to report that the President and I
join with you and Senator Specter and all the members of this
committee in rededicating ourselves to meeting those challenges
head on. This year, as you have said, 1.2 million new cases of
cancer are expected in the United States, and about 550,000
Americans are expected to die of cancer. That means more than
1,500 individuals a day and a quarter of all deaths in our
country annually are caused by cancer.
The National Institutes of Health estimates the overall
monetary cost for cancer was $156 billion in the year 2001.
That is an astonishing figure, larger than the gross domestic
products of all but a few nations on earth.
But the greater cost, Mr. Chairman, is in the immeasurable
suffering, as you said, of cancer patients, their families and
friends as they struggle to survive and cope, and in the lost
contributions of those who are taken from us so soon.
I am personally passionate about this issue because of the
high toll it takes on our Nation, but like you, Senator Harkin,
because of cancer's effect on my own family. My grandfather
died of brain cancer. My mother died of melanoma. My mother-in-
law died of breast cancer and my wife, Sue Ann, is a breast
cancer survivor. Our family knows firsthand, like you do,
Senator Harkin, the stress of cancer treatments, the worrying
and the wondering that turns your world upside down. And now I
have two daughters and a granddaughter, and as Secretary of
Health and Human Services, I am absolutely passionate,
committing myself to doing everything, like you, I can to spare
them the pain and the anguish of this devastating, insidious
disease.
That is one reason we have already approved in less than a
year 41 State plan amendments that permit States to provide
treatment to women with breast and cervical cancer under
Medicaid. These are women who are screened through programs
funded by the Centers for Disease Control and Prevention and
who are not otherwise eligible for Medicaid. This optional
benefit was authorized in the Breast and Cervical Cancer
Prevention and Treatment Act of 2000. We had our first
application less than a year ago. 41 States have already been
approved, and I will be approving two more within the week. So,
we are moving forward to arrest cancer at every level.
The President's budget is a major step in achieving that
goal for my family, for your family, Mr. Chairman, as well as
for every American family in America. Within the fiscal year
2003 budget, we are requesting approximately $5.6 billion for
research on cancer throughout the National Institutes of
Health. This is an increase of almost $630 million, or nearly
13 percent over the current year.
We want to and must continue ample funding of the war on
cancer because we have begun to make some significant
breakthroughs. It is not an exaggeration to say that the tide
in the battle might well be turning.
In recent years, we have begun to think about cancer in a
different way. Now we know that cancer is really a collection
of up to 200 related but distinct diseases with different
properties. And we are no longer resigned to thinking of cancer
as a death sentence today. We can successfully treat or
increase life expectancy for more than half of all cancer
patients. That is a sign of the dramatic progress we have made
and will continue to make.
We are, Mr. Chairman, at the threshold of a new
understanding of cancer at the genetic and the molecular level.
Now more than ever before, we are bringing together researchers
with seemingly disparate scientific expertise into
interdisciplinary ventures. For example, last spring we
announced a new drug called Gleevec. It has been approved for
use in the cases of people with chronic myeloid leukemia, and
from the time it came out of NIH, we worked with FDA and got it
approved within 2 months, the fastest ever for a cancer drug in
the history of this country.
Gleevec marks the wave of the future because it is the
first cancer drug that is the product of molecular targeting,
the groundbreaking ability to deliver a drug directly to the
diseased cells, leaving the healthy cells alone. Gleevec
targets a single cancer-causing protein, and like a light
switch is able to turn off its signal to produce leukemia
cells.
Earlier this year, scientists from the FDA and the National
Cancer Institute reported a new way to find ovarian cancer
through a simple blood screening. The test can be completed in
as little as 30 minutes from blood obtained from a stick in
your finger. Using a sophisticated artificial intelligent
computer program, scientists were able to train the computer to
tell the difference between patterns of small proteins found in
the blood of cancer patients versus the control samples.
We made a similar breakthrough last year when artificial
intelligence combined with gene-expressed microarrays to
develop a method of genetic fingerprinting that can tell the
difference between several closely related types of childhood
cancer.
Gene-related research offers great promise. In February,
researchers at the National Genome Research Institute, in
tandem with scientists at Johns Hopkins and the Cleveland
Clinic said they found a gene associated with an inherited form
of prostate cancer.
As a final example, recently the FDA approved a capsule
that you can swallow that contains a tiny camera. This camera
snaps pictures twice a second as it moves through the small
intestine. The device enables the physicians to see areas that
are not reachable by endoscope, potentially facilitating early
detection of cancer of the small intestine.
We are working hard to get new interventions out to the
people who need them as quickly as possible. There are two new
NCI programs that are especially relevant to this effort. The
Rapid Access to Intervention Development and the Rapid Access
to Preventive Intervention Development expedite new agent
development by making NCI's preclinical drug development
resources and expertise available for clinical trials. That is
what we used, Mr. Chairman and Senator, in regards to Gleevec,
and that is why we were able to get it to market within 2
months.
In addition, since 1996, the FDA has approved about 80
cancer-related medications or new uses of already available
drugs. 35 of these products have been reviewed and marketed
within 6 months of their submission to the agency.
HRSA supports also a network of more than 3,300 community
health centers that now serve 11 million people annually, and
nearly 90 percent of these low-income uninsured, under-insured
women seen at our health centers are current with their PAP
smears and more than 60 percent are up to date with mammograms,
a higher percentage than the overall national average.
I would be remiss, however, not to note that tobacco use
remains the single most preventable cause of death in the
United States, with cigarette smoking accounting for nearly
one-third of all cancer deaths each year. So, we are actively
engaged in public education campaigns to help decrease
incidence of smoking among young people especially.
President Bush and all of us in the Department of Health
and Human Services are unrelenting in our dedication to win the
battle against cancer. We look forward to continuing to work
with this committee to that end.
prepared statement
I thank you very much, Mr. Chairman, Senator Specter,
Senator Cochran, for giving me this opportunity to speak with
you today about our efforts in this fight against cancer.
I now would be pleased to answer any questions that you may
have.
[The statement follows:]
Prepared Statement of Hon. Tommy G. Thompson
Thank you for your invitation to appear before the Subcommittee
today to talk about cancer, a disease that affects every one of us. The
President has said that while we are engaged today in a war against
terrorism to defend our way of life, we've been engaged in a war
against cancer for decades to defend our quality of life. In recent
years, we have begun to think about cancer in a different way. We are
no longer limited to thinking of cancer as one disease that may attack
any part of the body and spread. Now we know that cancer is really a
collection of related, but different diseases with different
properties. We are no longer resigned to thinking of cancer as a death
sentence. Today, we can successfully treat or increase life expectancy
for more than half of all cancer patients. There is real hope for a
future where all cancers are uncommon and easily treated, and where
everyone can benefit from the breathtaking progress that grows from
each new discovery.
The National Cancer Institute continues to press forward with an
ambitious agenda, featuring a large number of new and expanded
initiatives across a wide range of research areas identified by members
of the cancer research and advocacy community. The President''s Budget
for fiscal year 2003 requests $4.7 billion for NCI, an increase of $515
million over the fiscal year 2002 level. Across all of the Institutes,
we estimate total spending on cancer to be about $5.6 billion in fiscal
year 2003.
We are at the threshold of a new understanding of cancer at the
fundamental genetic and molecular level, and now more than ever before,
we are bringing together researchers from a broad array of scientific
disciplines. We are leveraging this new interdisciplinary approach to
find cancer sooner and treat it more effectively and with less ill
effect than ever before. Let me relate to you some examples of the
impact this is having for each one of us.
Ovarian cancer is one of the deadliest cancers for women, due in
part to lack of effective screening methods. There is new hope that
comes to us from a multidisciplinary team of investigators who recently
demonstrated that a sophisticated new computer-based screening tool can
recognize protein profiles. The tool was used successfully to
distinguish between blood samples of women who had ovarian cancer and
women who did not. This tool could potentially use the same technique
to detect new cancer cases in women who have no symptoms at an early
stage of disease. This new approach, which takes advantage of the
molecular signatures of cancer cells, may deliver powerful new tools
for detecting many types of cancer and its recurrence.
In the last decade, there has been an enormous investment in
developing molecularly targeted agents in cancer chemotherapy. As a
direct result, we have seen recently some inspiring success stories. A
few years ago, one of the first oncogene-targeted drugs, STI571 or
Gleevec, was developed based upon the identification of a defective
protein that is expressed in about 95 percent of chronic myeloid
leukemia (CML) patients, and in some patients with other types of
cancers. Gleevec, which was recently approved by the Food and Drug
Administration (FDA) in a record time of 2.4 months, has shown
remarkable promise in the treatment of chronic-phase CML--it was
recently demonstrated that Gleevec is superior to standard therapy in
the treatment of this disease--and the National Cancer Institute (NCI)
is partnering with Novartis, the drug manufacturer, to expand clinical
trials evaluating Gleevec for other cancers. Researchers have
identified over one hundred potential targets in the cancer process
that may present similar drug development opportunities.
Recently, FDA approved a swallowable capsule containing a tiny
camera that snaps pictures twice a second as it is moved by natural
muscular waves of the digestive track trough the small intestine. The
device enables the physician to see areas that are not reachable by
endoscope, potentially facilitating early detection of cancer of the
small intestine.
These developments are only the most recent in a long string of
successes in cancer research that are changing the way cancer affects
us. Five years ago, we began publishing an annual report about the
burden of cancer in our Nation. The report is a collaboration among HHS
agencies including NCI, the Centers for Disease Control and Prevention
(CDC) and its National Center for Health Statistics, along with our
partners at the American Cancer Society (ACS), and the North American
Association of Central Cancer Registries. It draws upon statistical
information from all of these sources to present a numerical picture of
how cancer affects our communities. This year, we are continuing to see
encouraging overall trends, including continued decline in the rate of
new cancer cases and cancer deaths. Adult smoking is down dramatically
from the 1960s for men and the increase in smoking among women has
finally reached a plateau. However, youth smoking continues to rise
except in states with vigorous tobacco control programs. While breast
cancer incidence continues to rise (due to increase in early stage
disease), overall breast cancer deaths continue to decline. And for the
first time ever, we are seeing a small, but significant decline in
breast cancer mortality among African-American women.
In spite of the stunning advances we have made against cancer in
recent years, we look around us and still see the persistent burden
cancer places on our communities. Cancer is still a common and ruthless
disease. This year over 1.2 million new cases are expected in the
United States, and about 550,000 Americans are expected to die of
cancer--more than 1,500 people a day. The number of new cancer cases is
still rising for some cancers such as esophageal, liver, melanoma, and
non-Hodgkin's lymphoma. And there remains a disparate burden of cancer
experienced by America's underserved populations.
The National Institutes of Health (NIH) estimates the overall
monetary cost for cancer was $156.7 billion in the year 2001. And while
the significance of that figure is not lost on any of us here today, I
think we can agree that the real cost is even more dear. The
immeasurable elements of the real cost can be seen in the suffering of
cancer patients and their families and friends as they struggle to
survive and cope, and in the lost contributions of those who are taken
from us too soon.
We have an obligation to continue to pursue promising research
leads, and HHS is committed to doing that. At the same time, we must
focus on increasing our ability to translate new advances in cancer
research into clinical practice at the community level. We are
employing a cross-institutional effort that mobilizes resources and
takes advantage of the expertise throughout HHS, as well as outside
HHS, to make progress in the fight against cancer.
The overall cancer research effort in the United States is
collectively referred to as the National Cancer Program, and is led by
NCI. When Congress formalized the National Cancer Program as part of
the National Cancer Act of 1971, the NCI Director was charged to ``plan
and develop an expanded, intensified, and coordinated cancer research
program encompassing the programs of NCI, related programs of the other
research institutes and other Federal and non-Federal programs.''
Today, we have a unique partnership, the National Dialogue on Cancer,
that is giving new life to the National Cancer Program that was
envisioned over 30 years ago. In December of last year, Dr. Andy von
Eschenbach was named by the President to be the Director of the NCI. At
that time, the President highlighted how we as a Nation stand on the
brink of an era of amazing research breakthroughs and new opportunities
in cancer therapies and cures. He set out the goals to move the fight
against cancer forward and I would now like to describe how the NCI and
other HHS agencies are actively pursuing these goals.
We will expand our nationwide infrastructure of cancer centers,
centers of research excellence, networks, and consortia in ways that
promote and facilitate complex scientific interactions and the sharing
of information and resources. Our Specialized Programs of Research
Excellence (SPOREs) exemplify our commitment to translational
research--that is, research that focuses on cancer biology specifically
as a driver for the development of new treatments. NCI will expand the
use of SPOREs in the coming year.
We will continue our efforts to ensure that the clinical trials
program addresses the most important medical and scientific questions
in cancer treatment and prevention quickly and effectively through
state-of-the-art clinical trials that are broadly accessible to cancer
patients, populations at risk for cancer, and the physicians who care
for them. Despite major advances in our understanding of tumor biology
and potential molecular targets for cancer prevention and treatment,
our capacity to apply and test these findings in clinical settings has
not kept pace. The NCI will invest more resources in developing and
testing new therapies and increasing access to and participation in
clinical trials.
To sustain the generation of new ideas, we will continue to nurture
and develop new scientists. To deliver new biology-based interventions,
we must educate and train capable physicians. That's why NCI will
continue to expand its efforts to design and implement opportunities
for scientists at all career levels to meet the challenge of building a
stable, diverse cadre of basic, clinical, behavioral, and population
scientists trained to work together effectively and use the most
advanced technologies.
An important collaborative activity is the mapping and tracking of
cancer patterns in populations. To accomplish this, a national cancer
surveillance system is in place that includes the National Program of
Cancer Registries at the CDC and the Surveillance, Epidemiology and End
Results (SEER) program at the NCI. CDC's NPCR complements the SEER
registry program, with SEER gathering in-depth data on cancer cases
diagnosed in five states and six metropolitan areas and submitting
their data to the NPCR state registries. Data collection efforts are
coordinated with other federal agencies, such as the Department of
Veterans Affairs, the Department of Defense, and American Indian/Alaska
Native organizations. The overall surveillance system enables public
health professionals to monitor cancer statistics to assess progress,
identify population subgroups and geographic areas where cancer control
efforts need to be concentrated, and to identify when and where cancer
screening efforts should be enhanced.
The components of HHS are working collectively and collaboratively
to expand access to quality systems of care developed around evidence-
based medical practices. We are building programs and creating outreach
efforts to reduce cancer as a public health problem.
We are working hard to get new interventions out to the people who
need them as quickly as possible. The NCI has two important programs,
Rapid Access to Intervention Development (RAID) and Rapid Access to
Preventive Intervention Development (RAPID) to address this concern.
These programs expedite new agent development on the part of
independent investigators in universities or biotechnology companies by
making NCI's preclinical drug development resources and expertise
available for moving novel molecules toward clinical trials.
The FDA has made great strides in making effective new drugs
speedily available to patients. Since 1996, the FDA has approved
approximately 80 new cancer-related medications or new uses of already-
available drugs. Some of these products treat the disease, some
alleviate its pain and other symptoms, some help to diagnose it, and
one reduces the risk of cancer in people who are considered at high
risk. Thirty-five of these products have been reviewed and marketed
within six months of their submission to the agency.
Within the DHHS, the Agency for Healthcare Research and Quality
(AHRQ) is the lead agency on the quality of health care. Once
biomedical research identifies new options for improving the
prevention, diagnosis, and treatment of cancer, health services
research done by AHRQ provides information so that Americans can make
wise cancer care decisions. AHRQ research helps to identify which
groups of patients are most likely to benefit from specific
interventions, ways to improve the accuracy and quality of specific
services, and ways to overcome the barriers physicians face in
providing quality cancer care. NCI and AHRQ are working together to
develop a core set of quality cancer care measures. This work is
critical for informed decision-making both by physicians in making
recommendations to patients and by the patients who must decide on
treatment options.
The Quality of Cancer Care Initiative is a collaborative activity
involving organizations across DHHS, as well as private entities. The
goal of the initiative is to enhance the state of the science for
defining, monitoring, and improving the quality of cancer care and
inform Federal-level decision making on cancer care delivery, coverage,
and regulation. NCI, Health Resources Services Administration (HRSA),
Center for Medicare and Medicaid Services (CMS) and the Department of
Veterans Affairs (VA) will be considering demonstration projects on
quality measurement and assessment, and will share new knowledge on
ways to translate research into practice at the Federal level with
private partners through the National Dialogue on Cancer, the National
Cancer Policy Board, private associations, and health care systems.
The Centers for Disease Control and Prevention (CDC) serves as a
leader for translation of knowledge gained through research into public
health practices. CDC conducts and funds studies to identify problems,
needs, and opportunities related to modifiable behavioral and other
risk factors for cancer and to identify the feasibility and
effectiveness of cancer prevention and control strategies. Results are
used to plan or improve cancer prevention and control activities, such
as the National Comprehensive Cancer Control Program and the National
Breast and Cervical Cancer Early Detection Program in the communities
where they are needed.
Health Resources and Services Administration (HRSA) programs reach
into every corner of America, providing a solid safety net of health
care services relied upon by millions of our fellow citizens. HRSA
supports a network of more than 3,300 community health center sites
that provide free and low-cost preventive and primary health care
services to 11 million people each year now. A Presidential initiative
will increase and expand this network in 1,200 communities over five
years, eventually doubling the number of patients served. HRSA-funded
community health centers provide a broad spectrum of cancer care for
patients, including prevention, screening, diagnosis, referral, and
follow-up. More than 88 percent of adult women seen at these centers
are up-to-date with their Pap smears and more than 63 percent are up-
to-date with mammograms, outpacing the national average for these
services. In 2000, 1 million women received Pap smears and 170,000
received mammograms through our efforts.
I support the President's commitment to expand beneficiary access
to preventive health services, and we are working on ways to improve
health quality for America's most vulnerable citizens. As you may know,
simply offering coverage for preventive health care services, like
cancer screening, is not always enough to guarantee that Medicare
beneficiaries take advantage of the benefits. We have to actually get
beneficiaries to come into the physician's office and be screened. That
is why we strive to use efficient and cost effective approaches by
partnering with other agencies and organizations, utilizing Medicare
contractors to educate people with Medicare about covered preventive
services and encouraging beneficiaries to use these services. To this
end, we include health promotion information as a part of many
education campaigns that address different aspects of the Medicare
program or Medicare+Choice options. We have partnerships among many HHS
agencies, including CMS, NCI, and CDC, to carry out health promotion
initiatives, distribute outreach kits, and produce multi-media, multi-
year campaigns involving numerous partners at the local and national
level.
Tobacco use remains the single most preventable cause of death in
the United States, with cigarette smoking accounting for nearly one-
third of all cancer deaths each year. CDC provides national leadership
working with federal, state, and local government agencies,
professional and voluntary organizations, and academic institutions to
develop and implement a comprehensive, broad-based approach to reducing
tobacco use. Activities in surveillance, prevention, treatment, and
research conducted across HHS contribute to this effort. CDC works to
build the capacity of states to prevent and control tobacco use,
providing technical assistance to help states plan, establish, and
evaluate tobacco control programs. AHRQ issues smoking cessation
guidelines and other materials for physicians, health care
professionals, and the general public. At the National Institutes of
Health, NCI conducts research on smoking cessation and promotes
programs to reduce the rate of illness and death associated with
smoking, and the National Institute on Drug Abuse supports research on
addiction, including the effects of cigarettes and other nicotine
products. The Substance Abuse and Mental Health Services Administration
(SAMHSA) conducts the National Household Survey that provides annual
estimates of the prevalence of tobacco use and monitors the trends in
use over time. CMS is testing ways to help older Americans stop
smoking. The demonstration cessation project will test specific
strategies for helping older people quit smoking, using counseling by
health care providers or counselors, and FDA-approved dugs such as
nicotine replacement therapy or prescription drugs in a variety of
combinations.
In the Department of Health and Human Services, we see our
responsibility to chart a course and develop a plan that will allow us
to maintain the high quality of our research and service delivery
programs while facing the challenges that come with new approaches,
technologies and knowledge. If the 20th century will be remembered for
its breakthroughs in basic cancer science and improved treatments, the
next century should be remembered for its progress in translating
discoveries and applying them to all populations.
Thank you very much for giving me the opportunity to speak with you
today about HHS efforts in the fight against cancer. I would be pleased
to answer any questions you may have.
Senator Harkin. Mr. Secretary, thank you.
I am going to tell you all here there is no stronger voice
in this administration against smoking than Secretary Thompson,
and you deserve our thanks and our applause for your
leadership.
I mean that, Mr. Secretary. You have just been great. And
you all know that. He has just been wonderful on this.
Before if I get to question you, I would recognize Senator
Specter for an opening statement.
OPENING STATEMENT OF SENATOR ARLEN SPECTER
Senator Specter. Thank you very much, Mr. Chairman. Welcome
again, Mr. Secretary. I regret being a little late here, but
the First Lady, Laura Bush, was having a special program on
libraries and I had wanted to be there for at least part of it.
I thank you, Mr. Chairman, for convening this hearing and I
thank you, Mr. Secretary, for your leadership on cancer.
When I take a look at the funding that has been provided by
the Federal Government for cancer, it is really very gratifying
to see that last year we had in excess of $5 billion, and this
year we will be approaching $6 billion. That has resulted, I
think fairly stated, from the advocacy of this subcommittee.
Senator Harkin and I took on the funding challenge a few years
back when it was $12 billion, and it is now $23 billion. And
the President, with the Secretary's advice, is asking for
$3,400,000,000 more this year. So, we will have more than
doubled the funding.
Now the question arises as to what happens next, and I am
frequently asked by scientist doctors around the country, what
are you going to do next? I have a very short answer. It is
triple it.
I did not get quite as much applause as you did, Mr.
Secretary, but pretty close.
We are a very wealthy country. We have a gross national
product of $10 trillion and a Federal budget of $2.1 trillion.
To be spending $26 billion for the National Institutes of
Health is not too much, and it is a matter of priorities. And
nothing is more important than health.
I do want to make one brief comment, controversial as it
may be. This subcommittee has never shied away from
controversy. We are facing a very difficult vote in the next
several weeks on the issue of nuclear transplantation which is
an aspect of using stem cells. And stem cells are controversial
because they come from embryos, and embryos can produce life.
And if all of the embryos created for in vitro fertilization
could produce life, I would be for it. That would be the
highest calling, but when you have 100,000 frozen not to be
used, I think that the wise course is to use them to save
lives.
Then we have the issue of reproductive cloning, which we
all disagree with. Then there is nuclear transplantation.
Without going in any detail, it is a procedure so that if
someone, for example, has cancer and you want to get a stem
cell, you have it with the DNA of the patient so the stem cell
is not rejected.
I know there are differences of opinion in this room and on
this dais on that subject, but we are going to be coming to a
vote, and every opportunity I have, especially when I am
talking to an assembly like this, to urge those of you who
agree that we ought to leave medical science able to do the
research they need to do to contact your Senators because it is
going to be a big, big vote. My own instinct is that when so
many people in America are touched by cancer or heart disease
or Parkinson's or Alzheimer's or other maladies, that if it is
really understood, America would insist on having science able
to move ahead with nuclear transplantation.
Thank you very much, Mr. Chairman, for letting me speak on
my somewhat tardy arrival.
Senator Harkin. Thank you very much, Senator Specter, and
thank you for your leadership on all issues of health care and
biomedical research. I appreciate that.
I would recognize Senator Cochran.
OPENING STATEMENT OF SENATOR THAD COCHRAN
Senator Cochran. Mr. Chairman, I am glad to have an
opportunity to welcome the Secretary to our hearing and to
thank him for his cooperation and his leadership which is now
well known.
I am hopeful that these hearings can lead us into a better
understanding of how we can allocate our research funds. We
need to increase funding, of course, through our Federal
agencies and through research centers that are doing
outstanding work trying to identify the causes that we can find
out about and reducing and eliminating those causes of cancer,
detecting better methods of screening so that we can detect
cancer at an earlier date. It was very encouraging to hear the
Secretary talk about some of these advances that are being
made. Treatments and therapies are very important too, but if
we can get into the process of discovering ways to detect and
to prevent cancer to start with, that would really be a
wonderful thing for our society. So, I hope our research
dollars can be allocated in that way, as well as the other ways
that we already know about and talk about.
Education and outreach is so important, developing ways to
communicate effectively with the general public about what can
be done by each individual to lessen the likelihood of cancer
in their lives or in their families is of enormous importance
and cannot be overstated.
Access to care and treatment. Those are challenges. I just
made notes of things that to me are important in my State.
We appreciate, incidentally, your coming to the University
of Mississippi Medical Center and delivering the commencement
address there. You were a big hit. We appreciate that so much.
You have gone all over the country talking to people about what
the Department is trying to do to be helpful in this area, and
we appreciate your attention to our concerns and interests in
my State as well.
Thank you very much, Mr. Chairman.
Senator Harkin. Thank you, Senator Cochran.
Welcome, Senator Murray. We have already heard from
Secretary Thompson. Do you have an opening statement?
OPENING STATEMENT OF SENATOR PATTY MURRAY
Senator Murray. Thank you, Mr. Chairman. I will submit my
opening statement for the record. I just want to thank you for
having this very important hearing on cancer today. I think we
have made a lot of strides. I think we have a lot work left to
go, particularly in prevention and access to treatment. So, I
want to go ahead and let us move to questions at this time, but
again I really appreciate your focusing on this today.
[The statement follows:]
Prepared Statement of Senator Patty Murray
Mr. Chairman, I want to thank you for scheduling this hearing and
for all your work on cancer research and prevention.
I know you've lived through the personal nightmare of cancer, and
you've used your experience to increase our commitment to cancer
research and prevention.
I look forward to hearing from today's witnesses on some of the
latest developments.
One of the most promising avenues in our war on cancer has been the
rapid development of biomedical technology.
In just five short years, I think we have all seen the rewards of
investing in NIH research and reforming the FDA to expedite the review
of life saving drugs and therapies.
Survival rates are increasing, and people are living longer with
cancer.
Today's treatments--including alternative and complimentary
medicine--have brought us to this point.
Unfortunately, I'm not sure our health care system has adapted to
this remarkable change.
While we have come so far, we still have a long way to go to
reaching the ultimate goal of curing cancer.
As we pursue that goal, we must continue to focus on prevention and
access to screening and treatment.
Senator Harkin. Thank you very much, Senator Murray.
Secretary Thompson, I do not really have so much of a
question as just an observation to discuss with you a little
bit about what we might be doing in the next few months in your
Department and with this committee.
One of the real concerns I hear from this community of
people who are involved with supporting more money for cancer
research and who are involved in a lot of clinical trials, and
the American Cancer Society is that we are doing more and more
basic research, but what is happening with translational? How
are we getting this to the bedside? How are we getting more
people in clinical trials? I just heard the figure from a group
that I was with before I came in here that only 3 percent of
adults with cancer are in clinical trials. And that does seem
to me to be low. I am not an expert in this area, but it does
seem to be low. Over the last few years, I keep hearing more
and more about this, that we are just not getting enough
translational research, clinical research, clinical trials out
there.
I do not know the answer, but what I would like to propose
is that perhaps sometime during the summer or sometime this
committee might want to get Dr. von Eschenbach down here
because he is the head of the NCI, CDC, HRSA, the Agency for
Healthcare Research and Quality, AHRQ, and get them together at
the table at one time to discuss about this aspect of more
clinical trials. I have not set a date for that, but it just
seems to me that we need to get everyone together and enlighten
us perhaps, enlighten me a little bit more as to what they are
doing to increase the number of clinical trials. Again, it is
not a question. It is just discussion. If you have any
observation on that, I would be glad to hear it.
Secretary Thompson. I certainly do. And I thank you. I
think we should be looking at all of these particular matters,
Senator, to find out how we can improve. I am one of those
people that abhor the status quo. I always believe there are
ways to improve it. If there are some complaints from the
cancer community, we should be looking at that.
We have set up a website for all questions and information.
Anybody can dovetail into website and get up-to-date
information.
In regards to clinical trials, it takes money away from
basic research. That is basically the decision that has to be
made by NCI and NIH. But I think it should be something that
should be reviewed, and I think your hearing would be very
apropos and would be very informative, not only for you but for
the cancer community.
In regards to a couple of things we have already done in
translating research into practice, the best one is Gleevec.
Gleevec, of course, is where the 9th and 22nd chromosome
collapses emitting a protein. It is called the Philadelphia
chromosome, Senator Specter. It emits a protein causing a
cancer, and Gleevec targets that and is able to turn off the
protein emissions, therefore starving the cancer. And Gleevec
went through the basic research at NIH and they collaborated
with FDA and were able to bring it to market within 2 months.
Herceptin is another one of those gene-targeting drugs. We
think we are on the cusp of having a lot of breakthroughs that
are going to be able to look at genes that cause cancer and
different forms of cancer, and that is the basic research that
is going on.
Then the question is, how do you get that to the market as
fast as possible like we did in Gleevec. But one-half of the
cancer drugs in the last 3 years were able to get to market
within 6 months. So, that is a positive thing of translating
from basic research into the cancer community, into those
individuals that are hurting. We can continue to work on that.
We can continue to improve and I am confident that we can,
Senator.
Senator Harkin. Thank you very much, Mr. Secretary.
I forgot to mention CDC is a part of that component also in
terms of prevention.
Secretary Thompson. CDC is putting out the information to
all the States for this cervical and breast cancer new
procedure, and we have 41 States now that have signed up that
have been approved. We have two more that are pending that I
will be granting their approval sometime this week. So, we will
have 43 out of the 50 States that now grant a Medicaid review
and Medicaid treatment for women who come in who are under-
insured or uninsured and are able to get treatment. It is a
wonderful program and I compliment the Congress and I
compliment the States for doing it.
Senator Harkin. Thank you, Mr. Secretary.
Do you have any questions, Senator Specter?
Senator Specter. Yes, thank you, Mr. Chairman.
Mr. Secretary, from time to time, this subcommittee has
explored the issue of success on curing a variety of maladies.
We had testimony not too long ago that the experts thought we
were within 5 years of curing Parkinson's. That is just a
speculative estimate. But it is very helpful when we seek
funding, as we move to the full committee and then to the full
Senate and in conference, as we have advocated these increases
for NIH, to the extent possible, to get judgments as to what
the progress has been, what the funding has accomplished, what
an additional number of dollars would do so that we can tell
our colleagues, in as practical of terms as possible, what the
money is used to accomplish. Obviously, you cannot be precise
on it.
I noted in a publication that success stories included a
majority of patients with Hodgkin's lymphoma and nearly all
patients with testicular cancer could be saved. I think it
would be very useful if you, Mr. Secretary, NIH, CDC, et
cetera--you have all the experts at your disposal--could give
us a breakdown of the various kinds of cancers, because there
are so many different categories, and a specification as to
where the funding is going for the various kinds and what the
progress has been.
Of course, a big part of it turns on early detection. We
would like to see on this subcommittee, as a matter of our
oversight, how much of the funding goes to early detection and
prevention and the relationship between early detection and
cure.
But when we talk to our colleagues about all this money,
the more specific we can be, the better off we are.
Secretary Thompson. Fine. Thank you very much, Senator. Why
do I not just make a compilation of all of the preventive
programs that we are doing, make it very short, concise, but
very complete, and also what we are doing as far as diagnosis,
as far as coming up with therapies and treatment and get that
to the members of the committee. I will send it to your
attention, Senator Specter. Hopefully we can get it done within
a week.
We have also got tobacco programs set up in every State now
through CDC. We are trying to integrate the departments so we
are all working as one body trying to make sure we get the
information out.
I also would quickly like to add that I know your passion
for embryonic stem cells. There has just been a breakthrough,
Senator Specter, at the Weisman Center where they have been
able to put an embryonic stem cell in a mouse's brain. It has
been able to emit dopamine, and it is just real exciting. I
went out to look at it. It is just fascinating and exciting.
So, there are a lot breakthroughs there. I think we are on the
cusp of really some wonderful new innovations and some new
therapies that are going to be very helpful in this particular
area.
Senator Specter. Well, Mr. Secretary, when you talk about
my passion, you are right. It reminds me of the title of my
book, Passion for Truth. It is in paperback.
On stem cells, I have been talking to some of my colleagues
who disagree with me about the issue of nuclear
transplantation, erroneously referred to as therapeutic
cloning. We are searching for a way where we might have some
sort of an accommodation. It is possible that neither side will
have 60 votes to cut off debate on Senator Brownback's bill,
the Brownback-Landrieu bill, or the legislation with Senator
Harkin and Senator Kennedy, Senator Feinstein, Senator Hatch,
and I have sponsored.
What my colleague and I were talking about was perhaps
moving ahead on reproductive cloning, to ban it. The thought
was on his idea of a regulatory group of some sort which could
oversee what is being done by research scientists on the
ethical side which would perhaps assuage some people as to what
is going on if the 60 votes are not there for either of the
bills to pass.
I would appreciate it if you and your experts at HHS, NIH,
and CDC would give some thought to that as well because when
the debate is over, we are still going to have the
responsibility for coming up with something constructive which
works. It is highly likely that the vote will not be
definitive. So, we really need to address the issue as to how
we look out for all the competing interests and, in the spirit
of accommodation, try to work something out which suits as many
people as possible. You will never satisfy everybody.
Secretary Thompson. No, that is true.
Senator Specter. Thank you, Mr. Secretary. Thank you, Mr.
Chairman.
Senator Harkin. Thank you, Senator Specter.
Senator Cochran.
Senator Cochran. Thank you, Mr. Chairman.
I notice in the statement that you had prepared and we were
furnished before the hearing, you mention the presidential
initiative through the Health Resources and Services
Administration. That caught my attention because I think in my
State we are qualified for some of the benefits of this program
particularly in research and how to translate the findings of
causes and treatments into information and outreach and
education so that people who are in areas that are under-
served, in terms of medical treatment centers and the like,
will have an opportunity to share in the benefits of the
research investments that are being made through our committee
and through NIH's activities.
I ask you what, if anything, we should be aware of in terms
of emphasis on that part of our funding. This is an
appropriations committee and we are trying to identify cost
effective ways to use Federal dollars, leverage against
networks like the community health center sites around the
country and other facilities. I just wanted to emphasize my
interest in that and encourage you to continue to explore ways
to make sure that every area of the country and every
population benefits from what we are trying to do in cancer
research and therapies and treatment.
Secretary Thompson. Senator, you are absolutely correct,
and that is what we are trying to do. We are trying to really
have a tremendous outreach program. NIH has got a great
website, NCI does, HRSA does, and CDC does. So, we have plenty
of information out.
We are also going beyond that. We are trying to go through
the State health departments to get information out through
CDC, through HRSA, and so on. Today we are announcing in all
the States that we are giving out $30 million worth of grant
dollars to improve nursing in America, another shortage. In
cancer, we are trying to get the information out about
herceptin and also Gleevec and the other gene-targeting drugs
that are coming through. FDA has got a great website to do
that.
We are trying to make sure that States like Mississippi and
other rural States and southern States that have not maybe had
the same access as before get as much access as they possibly
can have. And we are going to do that and we are going to reach
to every State we possibly can. If you have any ideas or any
suggestions how we can do a better job, please tell me. I will
be more than happy to implement them, Senator.
Senator Cochran. Thank you, Mr. Secretary.
Thank you, Mr. Chairman.
Senator Harkin. Thank you, Senator Cochran.
Senator Murray. Well, thank you very much, Mr. Chairman,
and thank you, Mr. Secretary, for clearly a passion for
improving cancer research, prevention, early diagnosis. We all
appreciate your focus on this.
I want to follow up on some of the questions regarding
access to early screening and prevention and care. One of my
concerns is that in reaching out to people, we often miss the
minority communities. Native Americans and Asian Pacific
Islanders, in particular, I note have less access. Their
survival rates are increasing, not decreasing. I was just
curious what this administration was doing to improve survival
rates for all populations, including minorities.
Secretary Thompson. Thank you very much, Senator Murray. I
mentioned in my opening testimony that 90 percent of the women
that are coming into our community health clinics across
America, which were 11 million last year, are receiving their
PAP screens. 60 percent are receiving cervical and breast
cancer examinations and mammograms. That is a much higher
percentage than the population at large.
We also, through NCI's Center to Reduce Cancer Health
Disparities, are doing research on how social, economic, and
cultural health care providers and factors contribute to health
disparities. We have got an ongoing program on that.
We have got special population networks identifying
barriers to screening, follow-up and treatment and developing
sensitive health curriculum and education curriculum. We have
got a breast and ovarian cancer family registry which
identifies genetic factors that contribute to breast cancer
risks and interactions with environmental factors. And by 2005,
the registry will have enrolled over 700 African American women
with breast cancer and their families.
We also have got a program called SEER which expands
coverage to include 24 percent of the U.S. African Americans to
enhance their capability to track cancer trends. That is up and
running. We are expanding that.
I also would like to point out that because of a program
that was passed by you and other members of the Congress called
the Cervical and Breast Cancer Law, we now have had an outreach
program, and we now have 41 States that have enrolled and I
have granted waivers to them, so that this program not only can
give under-insured and uninsured women all over America to come
in and get their breast and cervical examinations and their
mammograms, but if they detect cancer, Medicaid in those 41
States will treat them. It is a carve-out from the Medicaid,
and it is a wonderful program. There are two more States that
have just applied within the last week. I will be approving
them. That will get us up to 43. I have got an outreach going
out to the other 7 States encouraging them as well so that we
can get all the States into this wonderful program. It will be
tremendously helpful not only to African Americans and
Hispanics, but to all low income, uninsured and under-insured
women in America.
Senator Murray. Are you coordinating efforts with IHS too?
I have a real concern about Native Americans who are not
getting access.
Secretary Thompson. We are doing that through our Indian
Health Service, Senator, and we have got a wonderful outreach
program.
Senator Murray. So, you coordinate with IHS on that.
Secretary Thompson. Yes, we do.
Senator Murray. Okay, good. I would just note that the
Hutch in my State in Seattle is just hiring a new person to do
external affairs in minority communities to do outreach, to
determine what some of the barriers are to early access and
prevention. I would encourage this administration to look at
something similar. I think it is really important. Sometimes we
do not understand the cultural differences.
I also wanted to talk about children and childhood cancer.
I think we have made some really great strides there. We have
got a lot of really great, committed pediatric oncologists and
some wonderful children's hospitals who have contributed a lot
to that. It is wonderful that leukemia--there are a lot of kids
who are celebrating birthdays today that would not have even a
decade ago.
But I am really concerned that we keep our commitment to
GME for children's hospitals to ensure that pediatric cancer
specialists receive the support and the training that is so
important to their work. I really wanted to urge you today to
encourage the administration to do full funding for GME
children's hospitals and work with us to restore the proposed
30 percent reduction in the administration's budget.
Secretary Thompson. Thank you.
Senator Murray. I also, in working with children, just want
to mention pediatric testing and labeling for drugs was an
issue I know the administration was looking at, rolling back
some of the FDA requirements on pediatric testing. I am glad
that that did not occur.
Secretary Thompson. Could I just explain?
Senator Murray. Sure.
Secretary Thompson. That was a mistake. There was a
lawsuit. Some lawyer in FDA made a decision that did not go up
to the acting FDA Director, never got to my office. They made a
decision that was a wrong decision. We corrected it. I was out
of the District and I was out of the country. When I got back,
we corrected it immediately. I said this is not true.
The acting Director of FDA was absolutely appalled when he
read about it in the paper. Some things happen. I have got a
huge Department. Sometimes some people make decisions. We
rolled it back, and that I can assure you is not the policy of
the FDA, of me or the President.
Senator Murray. Well, I really appreciate that, and I am
glad to hear your strong convictions on that. Can you just tell
me what the administration is going to do in order to deal with
the court challenge on this?
Secretary Thompson. We are fighting it.
Senator Murray. Would you support, I think it is, 2394,
Senator Clinton and others working on codifying the FDA
regulation?
Secretary Thompson. We do not think it is necessary because
of our strong position, but that is a decision that you will
have to make, Senator.
Senator Murray. My time is out. I just want to mention
really quickly, Mr. Chairman, that I am very concerned about
asbestos, work place safety. I held a hearing on what happened
in Libby, Montana where thousands of innocent people
unknowingly have been exposed to asbestos from the vermiculite
mine there, and we have thousands of homes around the Nation
that have asbestos contaminated vermiculite in their homes.
I am going to be introducing legislation shortly to finally
ban asbestos, which we should have done many years ago and did
not. I really want to work with you as we try and move that
legislation forward. I think it is extremely important.
Secretary Thompson. I want to work with you. I want to work
with all of you. In fact, I have got to get out to Libby,
Montana. My Deputy Secretary took 1 day out of his vacation
last summer and spent it at Libby, Montana. So, it is high on
our agenda.
Senator Murray. Well, thank you. I appreciate that. I think
Senator Baucus from Montana and I would be happy to work with
you to facilitate any kind of visit out there.
Secretary Thompson. Thank you very much.
Senator Harkin. Well, thank you very much, Mr. Secretary. I
look forward to working with you.
Secretary Thompson. It is always a privilege.
Senator Harkin. Thank you, Mr. Secretary.
Next we will call our panel to the table. Dr. Elmer Huerta,
of Cancer Preventorium at the Washington Hospital Center; Dr.
Ronald Herberman, director of the University of Pittsburgh
Cancer Institute; Susie Novis, president of the International
Myeloma Foundation; Michael Bruene, Iowa cancer patient; Mr.
Steve Case, chairman of AOL Time Warner.
STATEMENT OF ELMER E. HUERTA, M.D., M.P.H., DIRECTOR,
CANCER PREVENTORIUM, WASHINGTON HOSPITAL
CENTER
Senator Harkin. We will proceed in the order in which the
witnesses were called. I would start first with Dr. Huerta. Dr.
Huerta is the Founder and Director of the Cancer Preventorium
of the Cancer Institute at the Washington Hospital Center. He
is internationally known through his radio and TV shows and for
his health promotion and disease prevention efforts in the
Hispanic community.
I would say to you, Dr. Huerta, and to all of you that your
statements will be made a part of the record in their entirety.
If you could just sum them up briefly for us, we would be very
appreciative so we could get into more of a discussion perhaps.
Dr. Huerta.
Dr. Huerta. Thank you, Mr. Chairman. Good morning. My name
is Elmer Huerta. I am the founder and director of the Cancer
Preventorium at the Cancer Institute of the Washington Hospital
Center in Washington, D.C. I am pleased to appear before you
today on behalf of One Voice Against Cancer.
Most of my work as a physician has focused on providing
care to those in greatest need. Early in my medical career, I
was a practicing medical oncologist where I have spent
significant time, medical resources, and money on people
diagnosed in the late stages of cancer who had very poor
prognosis. My observation, however, was that almost all of
those patients had tumors that could have been prevented or
detected earlier had people known how to do it. People know
more about soap operas, the life of their entertainment than
about health. That was very sad. And that was especially sad
because we know that 75 percent of cancers that kill people in
this country are either preventable or detectable. So, for me
as a medical oncologist, it did not make any more sense to give
chemotherapy to patients with advanced cancers that could have
been prevented or detected earlier had people known how to do
it.
That is why we started a center here in Washington, D.C. at
the Washington Hospital Center that has a sign that says, if
you think that you're healthy and you want to learn how to
prevent cancer and you want to have a complete cancer
screening, please come in. If you have a symptom, please visit
your primary care physician.
We started that center in 1994 here in Washington, D.C.,
and we have been very successful. We have attracted over 10,000
people to the center, 85 percent of them without any symptoms.
The reason why these people have shown up to my center is
because I use media, but the media used with four basic
principles.
First is that the media needs to be used every single day
like weather and like sports.
Second, media health education programs need to be
comprehensive. There is no point in talking only about cancer
when there are other needs in the community. What about
diabetes, hypertension? What about maternal and child health
problems? What about many other needs that the community has?
The third principle in using media is that we need to be
full-time media. Mr. Case here on the panel knows that very
well. We need to have programs, radio 1 hour, television,
Internet. We need to write articles for newspapers. In other
words, Mr. Chairman, we need to involve the community with
health education programs.
Fourth is creating trust in the community, and creating
trust in the community means you have to kind pull apart your
business from your educational messages.
Well, the center has been very successful. We have
attracted 10,500 people to the center, 85 percent of them
without any health problem just for cancer screening and cancer
prevention.
So, the point maybe this morning is that we can double the
NIH budget, and I think we should. Science needs to work. We
are on the verge of discovering but also we need to communicate
to the public all the discoveries.
We know that only 3 to 5 percent of adults in this country
get into clinical trials. We know that. But we do not know how
much those people know about clinical trials. Do they think
they are guinea pigs? Do they have many misconceptions about
clinical trials? I think we are doing more efforts in selling
cars, sodas, beer, things like that, than educating our public
in health issues.
Ninty percent of my clinic patients here at the Cancer
Preventorium are listeners of my radio program. Ninty-six
percent are Latinos. Eighty percent have no health insurance,
and as I said, 80 percent of them have no symptoms.
Mr. Chairman, my time is up. I just want to say that in the
1940's, there were 754 sanitoriums in the United States. A
sanitorium is defined as a place where sick people used to go,
tuberculosis, mental health--754 sanitoriums. It was the
industry of illness in the United States in 1940's.
My dream would be to have 754 preventoriums, places where
people are attracted healthy to have education, to have
screening, and to involve them in community activism. So, if we
were able to have 754 sanitoriums once, I think we should have
preventoriums in such a way that we can change the paradigm in
which we take care of people in the United States. My 10,000
patients that have found early hypertension, early diabetes,
early cancer--primary care doctors would be extremely happy to
have them because they can manage a less burdened population
with disease.
So, the CDC plays an extremely important role. The NIH is
the machine of creating knowledge. I think the CDC should be
the machine of delivering this knowledge to the public.
But again, in this time, 2002, yesterday or last week the
World Cup started in Korea and Japan, 1.3 billion people
watched that inauguration. 1.3 billion people. So, we are
living in a world where media is extremely important. I think
we have failed as a country to take advantage of using media in
public education, in health education for our communities.
So, I am here to really support the efforts of the One
Voice Against Cancer Coalition to increase funding not only for
cancer research but also prevention and education programs at
the CDC.
If some of the members of the committee want to visit here
right here at the Washington Hospital Center, you are welcome.
You can see how prevention and health promotion really work.
Thank you, Mr. Chairman.
[The statement follows:]
Prepared Statement of Elmer E. Huerta
Good morning. My name is Elmer Huerta, M.D. I am the founder and
director of the Cancer Preventorium of the Cancer Institute at the
Washington Hospital Center in Washington, D.C. I am pleased to appear
before you today on behalf of One Voice Against Cancer.
Most of my work as a physician has focused on providing care to
those in greatest need. Early in my medical career, I was a practicing
medical oncologist where I spent significant time, medical resources,
and money on people diagnosed in late stages of cancer who had very
poor prognosis. My observation, however, was that almost all of those
patients had tumors that could have been prevented or detected early,
had people known how to do it. Knowing that 75 percent of cancers that
kill people in the United States can be either prevented or detected
early. Because of this, I decided to pioneer a new concept in fighting
cancer starting before patients are sick, before they are even
diagnosed with cancer. My Preventorium has the goal of keeping healthy
people healthy through a multi-pronged approach to prevention and early
detection.
I am here to tell you more about this new theory of prevention and
treatment of cancer and how the federal government can put this new
concept to work in order to reduce the mortality of cancer. As a
nation, we have made tremendous scientific progress in the battle
against cancer. The federal government has made funding for cancer
research a top priority. I am here as a clinician who has experience on
the other end of the spectrum--the application of that science. The
knowledge gleaned from research concerning the nature of cancer is
providing us critical insights into how we can prevent, detect and
treat cancer more effectively. What better way to treat cancer than by
preventing it--or at least detecting it in healthy individuals rather
than in the late stages when most people with cancer enter care.
My center does just that. We educate the public--in this case a
minority population who would most likely be considered one of the
hardest to reach--through the use of radio, television and other media
outlets. Then we work with them to keep them healthy. In fact, we only
accept patients who are healthy (that is to say symptom-free) and
willing to invest in their health. Many of the patients at my Center
have origins outside of our borders. Many face linguistic barriers,
lack of health insurance, lack of access to culturally appropriate
medical facilities; lack of understanding of the medical system. In
real terms, what this means is that these individuals, in general, are
less likely to have a regular source of medical care, less likely to
have had a recent physician visit, more likely to delay seeking medical
care, more likely to report they have not received needed care, and
less likely to use preventive or early detection services.
Many of my patients did not have primary health physicians before
coming to my clinic. Many did not understand what preventive or early-
detection measures were. In my clinic, these individuals learn about
cancer risks and prevention/early-detection. They receive comprehensive
screenings for colorectal, prostate, cervical, breast cancers. They
learn about nutrition and eliminating behaviors that increase their
risk of cancer. And, if needed, they are referred to a specialist for
the early treatment of cancer. Otherwise, they agree to return each
year for an exam. My clinic sees approximately 1,500 individuals each
year and approximately 50 percent are returning patients.
What I have shown in my work, is that prevention and health
promotion does work. Given the knowledge and opportunity, even the most
disadvantaged populations will respond to this concept. My clinic
population has been at near capacity for 7 years.
What we have shown, is that if our investments in research and
prevention are increased and efforts are targeted to make the biggest
impact at the community level--particularly in medically underserved
communities--we can reduce death and suffering by preventing cancer
from occurring in the first place or, if cancer occurs, detecting it at
its earliest, most treatable stage.
We can double the NIH budget--and I think we should. But we must
also translate those research advances into meaningful prevention and
early detection practices to succeed in achieving our goal of
eradicating cancer at the earliest possible time.
Opportunities to reach all American citizens, in my opinion, lies
with linking sustained media-based educational campaigns to affordable
and accessible cancer prevention/detection/treatment programs. This
link is vital if we want to reverse the bleak panorama of underserved
communities. I tested this theory by creating a health education radio
program in the Washington, D.C. metropolitan area. The program has been
on the air daily, uninterrupted, since its inception in 1989. Different
surveys have shown that this program is listened to or watched by
approximately 60 percent of Latinos living in the Washington, D.C.
metro area. This interest demonstrates that, when offered quality
programs, the community is responsive to learning about health issues
through the media. A great percentage of these individuals are
encouraged to enter primary medical care to receive early detection for
cancer.
Ninety percent of my patients at the clinic are listeners of this
radio program. Ninety six percent of the patients at the Center are
Latinos, 80 percent have no health insurance and 85 percent have no
symptoms. Access to education led them to preventive care.
The Centers for Disease Control and Prevention (CDC) is critical in
the promoting and funding programs for the education and early-
detection of cancer. For example, the CDC's National Breast and
Cervical Cancer Early Detection Program is making an enormous
difference in the lives of poor, underserved women who are at greater
risk of breast and cervical cancer. This proven CDC program provides
important breast and cervical cancer screenings, outreach, and post
screening diagnostic and treatment services in all 50 states to women
who do not have health insurance coverage and who do not qualify for
either Medicaid or Medicare. Now in its eleventh year, the program
builds on the existing public health infrastructure and involves all
sectors of the community in outreach and delivery of services.
Through this program, more than 2.7 million screening examinations
have been performed. Over 8,600 breast cancers and 39,400 pre-malignant
cervical lesions have been diagnosed; and nearly half of all screenings
have been for minority women. Like many other CDC cancer programs, this
program suffers from inadequate funding. And while increased funding is
not the solution to every problem, we know that not much will happen in
its absence.
Another example is the National Hispanic Colorectal Cancer Outreach
and Education Project developed by the National Alliance for Hispanic
Health as a direct response to observed colorectal cancer morbidity and
mortality trends within the Hispanic community. The CDC identified
colorectal cancer as a priority area for prevention and early detection
activities, particularly in the Hispanic community where it is the
third most common cancer in Hispanic men and women. The Project's
primary purpose is to increase awareness about colorectal cancer
prevention and early detection in the Hispanic community through
education and outreach.
Similarly, the CDC leads programs focused on prevention and early
detection of skin and prostate cancers. The Comprehensive Cancer
Control Program provides an integrated approach to reducing cancer's
impact through prevention, early-detection, rehabilitation and end-of-
life care. This initiative provides support and technical assistance to
states and tribal entities so they can develop and implement a
comprehensive cancer control plan targeted towards the needs of their
state. Finally, complementing and partnering with the National Cancer
Institute's Surveillance, Epidemiology, and End Results (SEER) program,
CDC's National Registries Program supports cancer monitoring in 45
states, the District of Columbia and three territories.
By extending the reach of public education/awareness efforts geared
to prevention and early detection, including the few examples I have
provided today, we will sooner achieve our goal of reducing incidence
and mortality from all types of cancer, and improving the quality of
life for people living with cancer. In other words, Mr. Chairman, we
should not focus only in studying Mrs. Smith's tumor, as we have been
so far, but in Mrs. Smith herself.
The CDC plays an absolutely vital role in meeting these goals.
CDC's programs apply the advances gained as a result of our past and
continued federal investments in cancer research. We must not lose
sight of the fact that we invest dollars in cancer research ultimately
to save lives through better treatment, earlier diagnoses and more
targeted preventive strategies. From my experience at my clinic, I know
firsthand the value of cancer prevention and early detection and I
strongly support the efforts of the One Voice Against Cancer Coalition
to increase funding not only for cancer research but also prevention
and education programs at the Centers for Disease Control. Thank you.
STATEMENT OF RONALD B. HERBERMAN, M.D., DIRECTOR,
UNIVERSITY OF PITTSBURGH CANCER INSTITUTE
Senator Specter. Mr. Chairman, thank you for according me
the opportunity to introduce Dr. Ronald Herberman, a
distinguished science administrator from the University of
Pittsburgh, Associate Vice Chancellor for Research and Health
Studies. Dr. Herberman has had an extraordinary record starting
in 1968 with the National Institutes of Health, moving into a
specialized position in 1975 and in 1981 on biological
therapeutics. He left the National Cancer Institute in 1985 to
establish the University of Pittsburgh Cancer Institute and has
done remarkable work there. It is a good example of how the
National Cancer Institute has produced experts who have moved
on to distinguished educational institutions like the
University of Pittsburgh where he is now an administrator as
well as a scientist.
Thank you for all that you have done, Dr. Herberman, and
thank you for joining us here today.
Dr. Herberman. Thank you, Mr. Chairman and members of the
subcommittee. Good morning. I am Dr. Ronald Herberman and the
director of the University of Pittsburgh Cancer Institute. The
UPCI for short is an NCI-designated comprehensive cancer
center, and one of the particular areas of emphasis that our
center has is to hasten the translation from the basic
laboratory discoveries into clinical application to benefit
patients with cancer.
In order to do that we, as well as like centers around the
country, are extensively involved in clinical trials research.
Our own initiated clinical research has garnered national
recognition for advances in the treatment of melanoma and a
variety of other cancers, including brain tumors, head and neck
cancer, prostate cancer.
We are particularly appreciative of this subcommittee's
leadership in doubling the NIH budget. This is certainly
capitalizing on the recent dramatic progress in molecular
biology and genetics and immunology. As a cancer researcher for
my entire career, I am really in awe of the almost explosive
increase in our understanding of the causes of cancer, and
equally so in what goes on to lead to progression of cancer and
the metastasis which is really the heart of the problem that we
have to face. We now are increasingly able to identify
molecular changes in the cells that make them malignant or
allows them to progress. It is now possible to detect in a very
sensitive and specific way new drugs that can specifically
target the molecular changes and to arrest them.
But for all of these areas of progress, as you, Mr.
Chairman, alluded to before in your comments to Secretary
Thompson, all of these laboratory steps need to be evaluated in
patients through clinical trials. It is the requisite path for
our advances to apply them to patients with cancer.
The clinical trials mechanism in the United States has been
really very impressive. As Senator Specter alluded to, I
finished my medical training in the mid-1960's. At that time,
if one did not have the ability to find a cancer early and to
cure it by either surgery or radiation therapy, there was
uniform fatality from cancer. As the chairman has already
alluded to, the situation for several types of cancer is much
better than that. There are now cures of certain types of
cancer even when they are diagnosed at advanced stages. All of
this has come from effective clinical research.
There, unfortunately, are a number of problems with the
current clinical research mechanisms in the United States. The
problems are multiple. They include an insufficient number of
well-trained investigators. We are overly burdened with
inefficient regulatory mechanisms. There also are not enough
specific resources to make the clinical trials mechanism
function as effectively as possible. And unfortunately, there
are infrequent, but in some cases serious lapses in protection
of human subjects.
How can we do better than that? Well, first of all, I think
it is important to promote more effective partnering between
the Federal Government, academic medical centers like ours, and
the pharmaceutical industry.
A second issue is education and credentialing. I think we
need to provide more resources to increase the pool of
physician scientists. We need to train physicians and other
health professionals to more properly carry out clinical
research. I think credentialing is also worthy of more
attention. I believe that both institutions to perform clinical
research and individual investigators need to be credentialed.
The process for approving and implementing clinical trials
is a very cumbersome one, and to do the very large scale
clinical trials, to prove that something is really effective
requires participation of multiple institutions across the
United States. Right now that process requires repeated reviews
at various institutions which are often even divergent with
each other. I and a number of my colleagues believe that this
could be done much more efficiently by having a centralized
institutional review board that could review these right once
and get things approved and into clinical trials more
effectively. This centralized process could also more
effectively oversee the occurrence of serious adverse events.
One final point that I would like to touch on is that once
one collects the necessary data from clinical trials research,
one does have to get approval by the FDA. Although we are very
pleased the Gleevec came through the approval process in record
time, unfortunately most of the cancer drugs take considerably
longer than that. I believe that it would be better to have an
integrated oncology approval mechanism at the FDA that could
deal with this more efficiently and to put more reliance on
what we know about the molecular targets, use biomarkers and
other surrogate endpoints to help accelerate the approval
process.
I see my time is up, and in closing I would like to
reiterate the enormous opportunities that lie before us. As has
already been alluded to, we are at the cusp of some of the
greatest advances imaginable. There is a tremendous opportunity
to translate the burgeoning biologic knowledge and our
technical capabilities and apply them for either prevention or
treatment of cancer. But I feel strongly that we need to
restructure our clinical trials mechanism to make it more
efficient so that we can more rapidly get these promising
preventive or therapeutic agents into the hands of health care
professionals to actually deal with the problems of patients.
prepared statement
Thank you for the opportunity to testify. I look forward to
working with you to improve this critically important system
and would be happy to answer any questions you might have.
[The statement follows:]
Prepared Statement of Dr. Ronald B. Herberman
Mr. Chairman and members of the Subcommittee: Good Morning, I am
Dr. Ronald Herberman and I serve as director of the University of
Pittsburgh Cancer Institute (UPCI). Today, I am here on behalf of the
Academic Health Centers Clinical Research Forum, an organization
comprised of more than 20 of this nation's leading academic
institutions.
As a National Cancer Institute-designated Comprehensive Cancer
Center, UPCI's missions are to provide specialized cancer prevention,
diagnosis, and treatment services and to conduct cutting-edge research
to better understand the causes of cancer and its progression, and to
develop more effective ways to relieve the burden of cancer. UPCI's
particular emphasis is to hasten the translation of new insights in the
laboratory into new approaches for the prevention and treatment of
cancer in patients. To that end, UPCI is extensively involved in
clinical trials research. UPCI-initiated clinical research has garnered
national recognition for advances in the treatment of melanoma, and
brain, lung, head and neck, prostate and ovarian cancers.
We are very appreciative of this Subcommittee's leadership in
doubling the NIH's budget, to capitalize on the recent dramatic
progress in molecular biology, genetics and immunology. As a cancer
researcher, I am in awe of the almost explosive increase in our
understanding of the causes of cancer and the opening of entirely new
avenues for cancer treatment and prevention. The identification of
molecular changes that cause a normal cell to become cancerous or cause
a locally growing cancer cell to spread to other parts of the body is
leading to new anti-cancer agents that specifically target these
changes. Potential new drugs can be screened against hundreds if not
thousands of new molecularly targets and those that appear to be
promising in the laboratory must then be evaluated in patients through
clinical trials. This is the requisite path for developing innovative
and more effective treatments for patients with cancer.
Across the country, clinical trials have enhanced our armamentarium
to combat cancer by providing solid evidence of the safety and
effectiveness of new modalities for cancer treatment and diagnosis.
When I completed my medical training in the mid-1960's, most cancers
that were not detected early and cured by surgery or radiotherapy were
uniformly fatal. Now, as a direct result of clinical research, a
variety of malignancies including children's cancers, Hodgkin's disease
and testicular cancer are usually curable even in advanced stages. Just
in the past few years, clinical trials have continued to contribute to
improvements in survival and quality of life for patients with many
types of cancer.
For example, last year, STI-571 (GleevecTM) received FDA
approval for the treatment of chronic myeloid leukemia following
demonstration of effectiveness by clinical trials. Gleevec is an
excellent example of the rapidly expanding array of molecularly
targeted cancer drugs that, in contrast to typical chemotherapy drugs,
can selectively eliminate cancer cells without damaging normal cells.
Unfortunately, at the same time we have such unprecedented
opportunities to make major advances in the treatment or prevention of
cancer and other life-threatening diseases, the clinical trials process
in the United States has become endangered by a combination of:
--an insufficient number of well-trained investigators,
--inefficient and overly burdensome regulatory mechanisms,
--insufficient or inefficiently deployed resources, and
--infrequent but serious lapses in protection of human subjects.
The Academic Health Centers Clinical Research Forum and also the
Clinical Trials Team of the National Dialogue on Cancer have been
considering these issues in depth. To effectively and rapidly avail
ourselves of the great opportunities to improve the care of patients
with cancer and other life-threatening diseases, we must develop a new
paradigm for the initiation and successful completion of clinical
trials. The American clinical trials system must be streamlined and
well supported, while also maximizing the safety of patients who
participate in clinical trials.
To accomplish these objectives, we propose the following:
--Promotion of more effective partnering among academic research
centers, the pharmaceutical industry, and the federal
government, to accelerate the pace of translation of promising
laboratory insights into clinical applications.
--Increase in the number of physician scientists, who can provide the
needed leadership for implementation of well-designed clinical
trials. To keep pace with new basic science discoveries, the
NIH should expand its training support for junior investigators
(K23 awards) and career support for established clinical
investigators (K24 awards). Increased support by NIH for the
recently launched loan repayment program for extramural
clinical researchers would also facilitate this goal.
--Development of an effective program for education of health
professionals in the importance of clinical research and
training in good clinical research practices. Physician
investigators, clinical research coordinators, and members of
Institutional Review Boards (IRBs) need to be well trained in
the conduct of clinical trials and protection of human
subjects. This can be readily accomplished by internet-based
education and certification, as has been recently implemented
and made mandatory for all involved in clinical research at the
University of Pittsburgh.
--Development of an effective process for credentialing and oversight
of institutions to perform high quality clinical research.
Promising national initiatives in this important direction have
recently been undertaken.
--Credentialing and oversight of investigators performing clinical
research. This function should probably be assumed by each
institution performing clinical trials, e.g. by the local IRBs.
--Streamline the review and oversight of multi-institutional clinical
trials. For demonstration of efficacy and safety of a new
treatment, large numbers of subjects need to be entered at
multiple institutions. Currently, before approval for
implementation, such trials undergo redundant and often
divergent reviews by a variety of private and governmental
entities, which slow the process, consume many resources but do
not increase the quality of the studies or better promote the
protection of the research subjects. Rather, we propose that
for such multi-institutional trials, a well-constituted central
IRB perform the reviews and receive reports of any serious
adverse reactions.
--Provide sufficient resources and better utilize existing resources
for the performance of high quality clinical trials. For
example, to better enable physicians to participate in clinical
research and accrue patients onto clinical trials, the NCI
recommends increasing reimbursement to $3,500 per patient, from
the current level of about $2,000 per patient. Such steps seem
warranted to substantially improve the current unacceptable
statistics of only about 3 percent of cancer patients
participating in clinical trials and large-scale trials taking
an average of 5 years to complete.
--Promote more streamlined and efficient analysis of the data needed
for approval of new drugs by the FDA. For example, with
oncology drugs, we recommend an integrated office for review of
all oncology treatments, whether drugs or biologics, and
greater emphasis on the use of surrogate biomarkers and the
improvement in the clinical course of disease, rather than the
current predominant focus on significant increase in survival.
In closing, I would like to reiterate the enormous opportunities
that lie before us. Medicine and science are on the cusp of some of
their greatest advances yet. There has never been a greater opportunity
to translate biological knowledge and technical capability into
powerful tools for preventing and treating cancer. But we need to
restructure our current clinical trials system to more efficiently
transform these discoveries in the lab into beneficial clinical
applications for the patient.
Thank you for this opportunity to testify. I look forward to
working with you to improve this critically important system.
Thank you for this opportunity to testify. I would be glad to
answer any questions you may have.
Senator Harkin. Thank you, Dr. Herberman.
STATEMENT OF SUSIE NOVIS, PRESIDENT, INTERNATIONAL
MYELOMA FOUNDATION
Senator Harkin. Now we will turn to Ms. Susie Novis. Ms.
Novis is the president of the International Myeloma Foundation,
which she founded in 1990. Over the past 12 years, the
foundation has been active in over 64 countries, establishing a
myeloma registry with over 90,000 members, and has raised over
$13 million for program support. Quite a remarkable
achievement. Welcome to the committee.
Ms. Novis. Thank you. I am very pleased to be here on
behalf of the International Myeloma Foundation and One Voice
Against Cancer.
Multiple myeloma is an incurable cancer of the bone marrow
plasma cells. Myeloma patients represent 1 percent of all
cancers diagnosed and 2 percent of all cancer mortality in the
United States. Myeloma patients experience painful bone
fractures, particularly in the vertebrae, ribs, and hips.
Additional complications include kidney failure, anemia, and
infection that ultimately lead to death.
As I said, I am here representing not just the multiple
myeloma community, but all cancers represented by One Voice
Against Cancer. One Voice Against Cancer is a coalition of more
than 40 national and community-based organizations that
represents tens of millions of Americans. One Voice was formed
to unify the public health community on the need for a
comprehensive, targeted Federal approach to develop cures for
the spectrum of cancers affecting our Nation.
On behalf of One Voice, I would like to ask this committee
to fulfill the following appropriations requests for fiscal
year 2003. $27.3 billion for the National Institutes of Health
to fulfill the 5-year doubling pledge. $5.69 billion for the
National Cancer Institute to fulfill the NCI Director's bypass
budget recommendation. $199.6 million for the National Center
for Minority Health and Health Disparities to lower the
disproportionate rate of cancer incidence and mortality among
under-served communities, and $348 million for the Centers for
Disease Control and Prevention for its cancer programs to
enhance education, outreach, prevention, and screening.
We are particularly supportive of the idea that Congress
fully fund the NCI Director's bypass budget. Fully funding the
bypass budget will provide hope to those Americans who will be
diagnosed with rare, deadly forms of cancer. Patients diagnosed
with the deadliest cancers, which include myeloma, kidney, and
pancreatic cancer, face the bleakest choices. The 5-year
survival rates range from 4 percent for pancreatic cancer to 28
percent for myeloma. So, without dramatic increases in research
funding, the outlook for these patients will remain bleak.
Fulfilling the bypass budget will provide resources for new
research for cancers that have been traditionally underfunded
by NCI and allowing NCI Director Andrew von Eschenbach to
implement the new paradigm for cancer research. This approach
will lead to targeted therapies that treat cancer at the
molecular level. This molecular level is, indeed, the ultimate
expression of a rising tide lifting all boats.
Today is a very emotional day for me. It is my anniversary.
Thirteen years ago today, June 4, Brian Novis and I were
married. Brian was diagnosed with multiple myeloma when he went
in for a simple blood test in preparation for our marriage. He
was only 33 years old. His doctor told him he had 3 to 5 years
to live. We prayed that the doctors were wrong and that we
would be able to raise a family and have a long and happy life
together. But Brian died in 1992, just 4 years after his
diagnosis.
But even though we never had children, we did create a
family. With the help of Dr. Brian Durie, the International
Myeloma Foundation was created, a family comprised of patients,
caregivers, and professionals.
I would like to take a moment and introduce you to some
members of our family. Mary Goodwin is a nurse from Cedar
Raids, Iowa. Mary was diagnosed with myeloma in 1996 after
injuring her back while lifting a patient preparing for
surgery. Mary's husband of 20 years runs a family-owned
restaurant, and her 14-year-old daughter Lanessa sitting next
to her has spent almost half her life knowing that her mother
is fighting a rare and debilitating cancer. But Mary said to me
the other day, Susie, I just need to keep on going. The other
choices are not so good.
Brad High of Haverford, Pennsylvania believed strongly in
One Voice Against Cancer. He understood the need for cancer
advocates to work together and to avoid the inclination to say
one cancer is more important than another. Now, Brad had
planned to be here today, but he lost his 7-year battle with
myeloma on May 22.
Everyone in this room has been touched by cancer. I lost my
husband to myeloma, my mother to colon cancer, and I have lost
many dear friends to all forms of cancer. Mr. Chairman, you
know as well as anyone that cancer destroys not just the
person. It destroys the family. It destroys the community. It
breaks hearts and it crushes dreams.
When Brian Novis decided to start the International Myeloma
Foundation, I was skeptical, but he looked at me and he said,
Susie, one person can make a difference, but two people can
make a miracle. As I look around this room today, I see many
people who can make miracles happen. Cancer can be cured. It is
going to take money and commitment to get the job done,
especially for cancers like myeloma.
Some of you may be thinking how can we afford to increase
the funding for cancer research, but I say, how can we afford
not to. We are one voice against cancer. Our voices must be
heard. We are your voice too.
Thank you very much.
[The statement follows:]
Prepared Statement of Susie Novis
Mr. Chairman, my name is Susie Novis and I serve as the president
of the International Myeloma Foundation, the world's oldest and largest
nonprofit organization supporting the needs of the multiple myeloma
community. I want to thank you for the opportunity to present the views
of the IMF in support of the One Voice Against Cancer coalition agenda.
I am here representing not just the multiple myeloma community I serve,
but all cancers.
multiple myeloma: an incurable cancer
Multiple myeloma is an incurable cancer of the plasma cells of the
bone marrow. The myeloma patient population represents one percent of
all cancer diagnoses and two percent of the cancer mortality rate.
Approximately 15,000 Americans will be diagnosed with myeloma this year
and about 12,000 will die. Myeloma patients experience bone fractures,
particularly in the vertebrae and hips, and continuous, degenerative
symptoms of bone loss that ultimately leads to death. Additional
complications include kidney failure, severe anemia, pneumonia,
shingles, and, in advanced cases, physical disability.
Patients live an average of three to five years after diagnosis,
although some survive significantly longer. The five-year survival rate
for myeloma patients between 1974 and 1993 increased from 24 to 28
percent, suggesting that little progress has been achieved. The one
thing that has improved, thanks to drugs like bisphosphonates--a bone
strengthening drug--and thalidomide, is the general quality of life of
most patients.
No categorical causes of myeloma are known. Myeloma incidence may
be linked to prolonged or excessive environmental exposures to toxins
or other agents. These suspected linkages cause patients to live in
tragic uncertainties that something related to their careers or choice
of home may have had something to do with their illness. They wonder if
by serving their country in foreign wars they may have exposed
themselves to the things that cause myeloma. They wonder if that good
job at the refinery may have raised their short-term income at the cost
of their long-term health. They wonder if those afternoons spent
planting the crops may have sown the seeds of an incurable disease.
They wonder, with research suggesting a possible linkage between
myeloma and viruses, if they could possibly infect a loved one. They
search in vain for definitive answers because the current state of
research is too inconclusive to answer their questions.
Research has found that myeloma is more prevalent in western
industrialized countries. Within those countries, higher rates of
occurrence have been observed in coastal, industrial zones,
agricultural belts, and in areas with high concentrations of
population. In other words, it is cancer associated with modern living.
As the world becomes more industrialized, it is not illogical to assume
that rates of myeloma incidence will rise accordingly.
the international myeloma foundation: putting patients first
Today is a very special and emotional day--it is an anniversary for
me. Thirteen years ago today, my late husband Brian Novis and I were
married. Brian was diagnosed with multiple myeloma in 1988 at the age
of 33. He found out he had the disease after taking a life insurance
physical examination prior to our wedding. Like virtually all myeloma
patients, the first time he heard about the disease was when he was
diagnosed. Among his greatest frustrations was a lack of access to
knowledge about the disease and specialists.
So he responded by founding the IMF in 1990 with the help of other
patients, doctors, and researchers who were interested in the field.
The first, and in many ways, still the most important, project of the
IMF was the establishment of a toll-free hotline that provided
information to patients and family members when they most needed it.
The IMF has grown to become the foremost resource about the disease for
patients and doctors alike. In 1992, the IMF hosted the first worldwide
clinical conference ever held for MM specialists. The results of that
conference led to the initial publication of Myeloma Today, which, at
the time, was the only periodical focused exclusively on MM research
and patient issues.
Now in its twelfth year, the IMF has a membership of more than
90,000 individuals worldwide. We have conducted more than 41 Patient/
Family Seminars to provide individuals access to the latest knowledge
and the foremost experts. That, in turn, points out the value of the
most important service the IMF provides. Through use of the hotline and
mail requests, the IMF sends out--at no charge--more than 1,000 patient
information packets per month. In fact, if you are affected by myeloma,
you know about the IMF--because it is likely the first source of
comprehensive information you ever received about the disease. And
since 1994, the IMF has funded 42 Brian D. Novis Research Grants
totaling $2.7 million.
Brian's doctor said he had three to five years to live. Our family
and friends hoped and prayed that he was wrong, that we would be able
to raise a family and have a long and happy life together. We were
wrong--the doctor was right. Brian died in 1992, just four years after
his diagnosis at the age of 37. Our life together, however brief, was
happy. And even though we never had children we did create a family.
Our family became the International Myeloma Foundation; a family
comprised of patients, family members, caregivers, scientists, health
care professionals, and friends. I would like to introduce you to two
members of our family.
Mary Goodwin, who is here with me today, is from Cedar Rapids,
Iowa. Mary's story is typical, unfortunately, of so many myeloma
patients. Mary, who works as a nurse, was diagnosed with myeloma in
1996 after injuring her back while lifting a patient preparing for
surgery. Although she is a nurse, Mary had to go back to her college
text to find out what myeloma was after being told she had it. The old
text informed her that the disease was terminal and had a life
expectancy of one year. Mary's husband of 20 years runs a family-owned
restaurant. Her 14 year-old daughter has spent almost half her life
knowing that her mother is fighting a rare, debilitating cancer. And
Mary must continue to work in order to keep her life insurance, for
which the annual deductible has been paid by February of each year.
But, as she said to me, she would ``just like to keep on going. The
other choices aren't so good.''
Brad High of Haverford, Pennsylvania lost his seven-year battle
with myeloma on May 22. Brad attended the first two annual One Voice
Advocacy Days and had made plans to be here today. Brad was the leader
of our Philadelphia Multiple Myeloma Networking Group, arguably the
most active myeloma support group in the nation. He had had two stem
cell transplants and went back to the University, of Pennsylvania
hospital in late April to receive a third. Brad had his own business
making wedding cakes. He loved to be with people and make them happy.
He was an inspirational leader of the networking group who believed in
advocacy to raise awareness and federal research funding; although he
realized that he would likely not benefit him. Brad believed in One
Voice Against Cancer because he understood the need for all cancer
advocates to work together and avoid the inclination to say that his
cancer was any more or less important than anyone else's.
one voice against cancer
The IMF became involved in public policy advocacy in September
1998, during The March for Cancer Research on the Mall here in
Washington, DC. Our initial focus, working in large part with this
Committee was to include report language on myeloma in the annual
appropriations bills. But since then, we have learned that this
committee does not appropriate funds according to specific disease
categories. And for our constituency to be effective, we would have to
reach out to join forces with other groups fighting cancer. That is why
we have become so supportive and active in One Voice Against Cancer.
One Voice Against Cancer is a coalition of more than 40 national
and community-based organizations and collectively represent tens of
millions of Americans. One Voice Against Cancer focuses its advocacy on
the funding of cancer research and application programs at the National
Institutes of Health (NIH), the National Cancer Institute (NCI), the
National Center for Minority Health and Health Disparities (NCMHHD),
and the Centers for Disease Control and Prevention (CDC).
One Voice Against Cancer was formed more than two years ago to
unify the public health community on a clear and consistent message
regarding the need for a comprehensive, targeted federal approach to
cures for the spectrum of cancers affecting our nation. In our view,
this would lead to the discoveries needed to make available better
prevention and early detection strategies, treatments, and therapies
that will ultimately lead to cures for the various cancers.
One Voice supports the following appropriations priorities for
fiscal year 2003:
--$27.3 billion for the NIH to fulfill the commitment to double NIH
funding by fiscal year 2003.
--$5.69 billion for the NCI, the full amount recommended in the NCI
Director's Bypass Budget.
--$199.6 million for the NIH Center for Minority Health and Health
Disparities to enable the Center to fulfill its important
mission, particularly as it concerns the disproportionate
incidence, morbidity, and mortality that cancer has in many
racial and ethnic minority populations.
--$348 million for the CDC cancer education, outreach, prevention and
screening efforts that apply the important research done at NIH
to those affected by or at risk for cancer. Specifically, OVAC
recommends the following funding levels for CDC cancer-related
programs:
--$10 million for the Comprehensive Cancer Control Initiative;
--$55 million for the National Cancer Registries Program;
--$25 million for the Colorectal Cancer Prevention and Control
Initiative;
--$20 million for the Prostate Cancer Control Initiative;
--$220 million for the National Breast and Cervical Cancer Early
Detection Program;
--$8 million for the Ovarian Cancer Control Initiative; and
--$10 million for the National Skin Cancer Prevention Education
Program.
Funding for all of these critical agencies and programs must be
efficiently and effectively utilized so that the American people reap
clear and rapid benefits from research and its application. To that
end, we look forward to working with you to ensure that these federal
agencies responsibly meet their obligations.
the bypass budget
We would like to highlight in our testimony the importance of
funding at the level recommended by its Director in the Bypass Budget.
Under the National Cancer Act of 1971, NCI's Director is required to
submit directly to the President an annual budget estimate to provide
the national cancer research program with the technology and investment
it needs. This Bypass Budget is prepared and submitted prior to the
submission of the annual budget to Congress, and is unique among all
federal medical research institutes. At current funding levels, which
have fallen short of the requested amount each year, NCI is able to
fund only about 28 percent of its peer-reviewed and approved grants.
In the view of the IMF, fully funding the Bypass Budget would offer
hope to those Americans who will be diagnosed with rarer, deadly forms
of cancer that still lack early detection tools or treatment options.
We feel this is especially true since Congress does not appropriate
funds for specific medical research programs, projects, specific
diseases, or cancers. It does not take much of a stretch to understand
what achieving the Bypass Budget could potentially do to find better
treatments and cures.
Fulfilling the Bypass Budget would provide resources for new
research initiatives for the cancers that have been traditionally
neglected by NCI. Patients diagnosed with one of the seven deadliest
cancers--esophageal, kidney, liver, lung, multiple myeloma, pancreatic,
and stomach--generally face the bleakest choices of all those diagnosed
with cancer. The five-year relative survival rates for these cancers
range from a low of 4 percent for pancreatic cancer to 28 percent for
multiple myeloma. Without dramatic increases in research on each of the
deadly cancers, the outlook for diagnosed patients will remain gloomy.
the new paradigm
We strongly believe in NCI Director Andrew von Eschenbach's
emphasis on the New Paradigm for cancer research. The New Paradigm
focuses on expanding and translational research--applying discoveries
in the lab toward more immediate and direct applications for patients.
The New Paradigm also puts more emphasis on the most promising, state-
of-the-art research of genomics--drugs and therapies that target and
treat cancer at the molecular level.
The New Paradigm, which replaces the ``search and destroy'' mindset
with ``command and control,'' demonstrated with drugs like Gleevec for
chronic myelogenous leukemia, Iressa for lung cancer, or Herceptin for
breast cancer, targets the molecular mechanisms that trigger growth of
cancers without debilitating or destroying healthy cells, organs, or
systems. The new genomic drugs have proven to be successful in
diminishing--or eliminating--many side effects of treatment. Moreover,
they have the potential for increasing long-term survival and enhancing
quality of life for people living with cancer.
When we look at cancer through the genomic lenses of the New
Paradigm, molecular targets will not be conveniently categorized by
body parts or tumor types. The key is to identify, through research,
the targets that trigger the malignant growth of cancer cells. For
cancers like myeloma, there may be dozens, if not hundreds, of targets
to be identified. And some of the targets for certain cancer types, at
the molecular level, may look more like other cancer types. For
example, hematological cancers like myeloma or leukemia may actually
have some targets in common with targets in cancers of the lung, colon,
kidney, or pancreas rather than other hematological cancers.
In our view, fulfillment of the One Voice Against Cancer
recommendations would provide resources for a New Paradigm linking
federal support to the translational research needed to produce the
drugs and therapies for all cancer patients. Most importantly, however,
the future of the cancer research would not be dictated by trying to
carve out turf for particular cancer disease categories.
It would, instead, ensure that all cancer types are represented in
the new research and create a logical, transparent system of cancer
research leading down a path from incurable condition to chronic,
manageable disease to, ultimately, cures for all cancer types. It would
provide the framework to encourage cancer researchers to focus more on
molecularly targeted therapies. It would allow NCI to engage in
programs to explore research initiatives in the smaller, deadlier
cancers that have few market incentives to develop new drugs and
therapies. And it would do so based on scientific opportunity, not
political popularity contests. This molecular approach is indeed the
ultimate expression of ``a rising tide lifting all boats.''
Mr. Chairman, we at the IMF applaud the recent advances in cancer
research. But our patients and family members become more impatient for
results about their disease the more they hear about advances in other
fields. Everyone in this room has been touched by cancer. Everyone in
this room knows someone who has cancer. I lost my husband to myeloma,
my mother died of colon cancer, and I have lost innumerable friends to
every form cancer chooses to take. As you know as well as anyone, Mr.
Chaimian, cancer destroys not just the person; it destroys the family,
the community. It breaks hearts and it crushes dreams.
When Brian Novis first decided to start the International Myeloma
Foundation I was somewhat skeptical--but he looked at me and said
``Susie, one person can make a difference two people can make a
miracle.'' As I look around this room I see lots of people--you have
the ability to make miracles happen. We can cure cancer. But it is
going to take money and sustained commitment, especially for cancers
like myeloma. Some of you may be thinking how can we afford to increase
the funding for cancer research--but I say--how can we afford not to?
We are One Voice Against Cancer--and our voices must be heard.
We're your voice too.
Senator Harkin. Thank you, Ms. Novis.
Thank you for a very, very powerful statement.
STATEMENT OF MICHAEL BRUENE, CANCER SURVIVOR
Senator Harkin. Next we turn to Mr. Michael Bruene. Michael
was born and raised in Iowa and now resides in West Des Moines
with his wife Nicole, who is here with him today. On March 30,
2000, Michael was diagnosed with brain cancer and is currently
participating in a clinical trial that compares the
reoccurrence of tumors between patients treated with radiation
versus those treated with chemotherapy. Michael, thank you and
your wife so much for being here and thank you for being a
brave example for all of us in confronting this and being on
the cutting edge of these clinical trials. Please proceed.
Mr. Bruene. Thank you, Mr. Chairman and members of this
committee, for giving me the opportunity today to share my
story.
As Mr. Harkin said, on Thursday, March 30 at the age of 29,
I heard the three words that changed my life forever: ``You
have cancer.'' In my case, it is a cancerous brain tumor.
Before this date, I was relatively symptom-free. Like everyone,
I had occasional headaches, but I never gave them much thought
as they occurred at very stressful times in either my job or my
life. An over-the-counter pain medication always relieved them.
Then on March 29 something changed. I had what I thought
were two muscle spasms while I was at work. My left arm sort of
tightened up. I did not think too much of them because I was a
relatively healthy man at the time. Then on my drive home from
work at a very busy intersection, the entire left side of my
body locked up and my car swerved into the oncoming lane of
traffic. If it was not for the fact that there were no cars
coming at that time, my story may have ended right there.
Luckily for me I was able to steer my car to the side of the
road where I sat paralyzed and feeling helpless until the
paralysis wore off. It was at that point I realized something
was dreadfully wrong.
When I arrived home, I told my wife Nicole that she needed
to call an ambulance. She was lying on the couch and could not
see me, and she thought I was just pulling one of my numerous
jokes and she responded with her usual response of
``whatever.''
Then she saw the look on my face and immediately called
911. While waiting for the ambulance to arrive and on the ride
to the hospital, the episodes--what I now know were seizures--
became more frequent and more severe.
At the hospital, the doctors were able to give me
medication to stop the seizures and I continue taking that
today to prevent them from reoccurring.
For me that marked the end of one life and the start of
another.
Once in the emergency room, a CAT scan revealed a tumor
about the size of a small rock growing in the right frontal
portion of my brain. I was immediately admitted for surgery.
The next morning further tests indicated that the tumor was, in
fact, more the size of an egg or a lime. In medical terms, I
have a grade 2 astrocytoma. Most astrocytomas cannot be cured
because they spread widely throughout the surrounding normal
brain tissue.
If there is one silver lining in my diagnosis, it is that
my tumor is considered very slow growing. Still, the average
survival time for these types of tumors is only 6 to 8 years.
With other faster growing tumors of the same type, the survival
time can drop to as low as 12 to 18 months.
After my surgery, the neurosurgeon informed my wife that he
was able to remove 90 to 95 percent of the tumor, but he
stopped when it became impossible to distinguish between cancer
and healthy brain cells. What that means for me is a life
expectancy of 3 to 8 years, of which 2 years have already
passed.
Two days after surgery I was discharged from the hospital.
This was a scary time for both me and my wife, as we knew very
little about cancer and even less about brain tumors. I have
since found out that brain tumors are very rare. They only
account for 1.4 percent of all cancers and 2.4 percent of all
deaths. I have also found out that the majority of brain
cancers are not associated with any risk factors. They just
simply happen. There are no blood tests or other screening
examinations currently available to detect brain tumors at an
early stage. In most cases, survival of the patient with a
brain tumor depends on the type of tumor and its location, not
how early it is detected.
The standard treatment for brain tumors is radiation, but
there have been some great advances in combining radiation with
chemotherapy. Because I did not want to face cancer with a
negative attitude and because I understand the value that
research holds, I decided to enter a phase III study that is
comparing the reoccurrence of tumors with radiation only versus
reoccurrence with combined radiation and chemotherapy. As a
member of the control group, I receive 30 doses of high intense
radiation over the course of 6 weeks. The radiation had
tremendous effects on myself and my family. All of my hair fell
out. I was emotionally and physically exhausted to the point
that I could not work.
As for my prognosis, it is reevaluated every 6 months on a
sliding scale. I will never truly be in remission as a portion
of the tumor remains lodged in my brain. That is why I consider
the diagnosis the start of a new life. Right now the tumor is
currently stable; that is to say, it is not growing or
spreading.
Senator Harkin. Take your time, Michael. Take your time.
Mr. Bruene. This Friday will mark the fifth wedding
anniversary for my wife and myself. We have tried to live our
lives as though the tumor is not there, but in the back of my
mind, I know that there is a clock ticking and that one day the
clock will expire and the tumor will start to grow back.
As a person living with cancer, I am here to tell you that
we should not become complacent. We should remember that this
is still one of the most deadliest causes of death in this
country. We should remember that rarer, deadlier, and more
difficult to detect and treat cancers like brain cancer require
more research dollars in order to find more effective
treatments, earlier detection, and to gain a better
understanding of the disease.
In short, I am here not only to tell you my story, but the
story of the more than 1 million people who will be diagnosed
with and the half a million people who will die this year of
cancer. We ask you to please support additional funding for
cancer research and prevention programs. They hold the promise
for all of us.
Thank you.
[The statement follows:]
Prepared Statement of Michael Bruene
Mr. Chairman and Members of this Committee, thank you for the
opportunity to share my story this morning. On Thursday, March 30,
2000, at the age of 29, I heard three words that changed my life
forever--You have cancer. In my case it is a cancerous brain tumor.
I was relatively symptom-free before the diagnosis. Like everyone
else, I had occasional headaches but never gave them much thought
because they occurred at stressful moments in my job or life and over-
the-counter pain relievers always got rid of them.
Then, on March 29, while at work, I had what I thought were muscle
spasms in my left arm. I had two of them. They were mild and spread
apart by several hours. For a relatively healthy man of my age, I
didn't think too much of them. However, on my way home that evening--at
a busy intersection--the entire left side of my body became immobile.
My car swerved into the oncoming lane of traffic. If it weren't for the
fact that there were no oncoming cars, perhaps my story would have
ended there. Yet, I managed to steer my car safely to the side of the
road where I sat for what seemed like an eternity waiting for the
paralysis on the left side of my body to end. As I waited, the
frightening realization that this was not a simple muscle spasm began
to sink in.
When I arrived home, I told my wife Nicole to call an ambulance.
She thought I was pulling one of my numerous jokes--and came back with
the usual response of ``whatever''--until the seriousness of the
situation became apparent on my face.
While waiting for the ambulance to arrive and throughout the ride
to the hospital, the ``episodes''--what I now know were seizures--
became more frequent and severe. At the hospital, the doctors were able
to stop the terrifying seizures through the use of medication.
For me, that day marked the end of one life and the beginning of
another.
Once in the emergency room, a CAT scan revealed a growth about the
size of a small rock in the frontal portion of my brain. I was
immediately admitted for surgery. Additional tests the next day
revealed that the tumor was, in fact, the size of an egg or a lime. In
medical terms, I had a grade two astrocytoma. Most astrocytomas cannot
be cured because they spread widely throughout the surrounding normal
brain tissue or along the cerebrospinal fluid pathways.
My tumor was considered a slow growing tumor. Still, the average
survival time for these types of tumors is only 6 to 8 years. With
other, faster growing, tumors of the same type the average survival
time drops to as low as 12 to 18 months.
After my surgery, the neurosurgeon informed my wife that he was
able to remove 90-95 percent of the tumor but stopped when it became
impossible to distinguish cancer from health brain cells. What this
means to me is a life expectancy of between 3 and 8 years.
Two days after the surgery, I was discharged from the hospital.
This was a very scary time for me and my family. We knew little about
cancer and even less about brain tumors. I have since found out that
approximately 17,000 malignant tumors of the brain and spinal cord
(cancers of the central nervous system) will be diagnosed in the United
States this year and approximately 13,100 people will die from these
malignant tumors.
Brain and spinal cord tumors are rate--accounting for approximately
1.4 percent of all cancers and 2.4 percent of all cancer-related
deaths. I found out that the majority of brain cancers are not
associated with any definite risk factors--they simply happen for (what
I am told is) no apparent reason. There are no blood tests or other
screening examinations currently available to detect brain tumors at an
early stage. In most cases, survival of the patient with a brain tumor
depends on the type of tumor and its location, not how early it is
detected.
The standard treatment for brain tumors is radiation, but there
have been some great advances in combining radiation with
chemotherapy--improving survival time somewhat. Because I didn't want
to face cancer with a defeatist attitude, and because I understand the
value that research holds, I decided to enter a Phase III study that is
comparing the reoccurrence of tumors with radiation versus reoccurrence
with combined radiation and chemotherapy treatment. As a member of the
control group, I receive 30 doses of targeted radiation over the course
of 30 days. As for the prognosis of my condition--it is re-evaluated
every six months on a sliding scale. That is why I consider the
diagnosis the start of a new life. ``Certainty'' has new meaning for
me. Right now, the tumor is considered stable--that is to say not
growing or spreading. For me, in my new consciousness, that is the only
certainty I can count on.
As a person living with cancer, I am here to tell you that we
should not become complacent. We should remember that it is still one
of the leading causes of death in this country. We should remember that
rarer, deadlier and more difficult to detect and treat cancers (like
brain cancer) require more research dollars in order to find more
effective treatments, earlier detection mechanisms and to gain a better
understanding of the epidemiology of the disease.
So, in short, I am here not only to tell my story, but the story of
the 1.2 million diagnosed with and 500,000 that die of cancer a year.
We ask you to please support additional funding for cancer research and
prevention programs at the National Institutes of Health and the
Centers for Disease Control and Prevention. They hold the promise for
all of us.
michael bruene
Michael Bruene was diagnosed with brain cancer on March 30, 2000.
After several years of headaches and immediately following the onset of
seizures, doctors diagnosed Michael with a Grade II Astrocytoma, a slow
growing malignant tumor, in the right frontal portion of his brain.
Initially the doctors thought the tumor was the size of a small
rock, but it ended up being closer to the size of an egg or lime. The
neurosurgeon was able to remove 90-95 percent of tumor.
Although told the normal life expectancy is 3 to 8 years, Michael
is hopeful that through positive thinking and continued research, there
will be a cure or a treatment found soon. He entered a Phase III
clinical study that is comparing the reoccurrence of tumors with
radiation only to those patients that also receive chemotherapy. He is
in the control group and receives 30 doses of targeted radiation over
the course of 30 days. Michael's condition is evaluated every six
months and to date the tumor is stable and he remains healthy.
Born and raised Iowa, Michael worked as a TV news producer for five
years in California. He now resides with his wife Nicole in Des Moines
and works as a marketing strategist for Fortune 500 companies. Both are
actively involved in the American Cancer Society's Relay For Life and
are serving as volunteer chairs for this year's Greater Des Moines
event in July.
Senator Harkin. Thank you, Michael.
Senator Specter. Mr. Bruene, I have asked Senator Harkin to
allow me to make a comment at this time in light of your very
moving testimony where it is apparent the impact when you are
given a death sentence. It is pretty hard to take.
But I want to tell you that I had similar advice and it was
wrong. I had tightening of my shirt collar and light pains
running down my head, and the doctors could not find out what
was wrong. And finally I asked for an MRI and they said, it
will not do any good. And I said, well, it is not invasive. I
want one. And I had an MRI and it showed a golf ball right in
the front of my head. And the doctor who looked at the films
was very pessimistic. He said you have got 3 to 6 weeks to live
and that was on June 11th of 1993.
It so happened that on that weekend, my wife was joining me
here in Washington to take a trip down to Little Washington to
a fancy restaurant. So, I sort of said involuntarily, well,
gee, my wife is coming down to go to Little Washington for the
weekend. As strange as this may sound, the doctor said to me,
go and have a good time. And I said, give me my films. I am
going to Philadelphia.
I went to Philadelphia, and some other people looked at the
films and were not quite so sure. But you never now. That was a
Friday afternoon, and Monday morning I had an operation, a
resection. They took it out, and then they even had to slice it
down to see whether it was benign or malignant.
I then studied the issue and found out that these
characterizations are very tenuous. They depend upon an
analysis of how many particles are moving. That does not
qualify for a scientific opinion, but that was my
interpretation. But it was uncertain.
At any rate, like you, they did not get it all, and it
started to grow back. Then I investigated the advances in
medical science and found out there was a thing called a gamma
knife. Are you familiar with it?
Mr. Bruene. Yes.
Senator Specter. Have you explored whether it would work
for you?
Mr. Bruene. I have not at this point.
Senator Specter. You ought to do that because with the
stereotactic gamma knife, they put a helmet on you and they
send beams, 200 of them, which concentrate on that spot, so
that unlike your surgeon who stopped the operation when he got
to what he considered healthy brain, it just zeroes in right on
the spot.
Dr. Herberman can take you to the University of Pittsburgh
to Dr. Dade Lunsford. He is the fellow who did it.
I had this procedure done in 1996 and it has regressed. So,
sometimes the predictions are not correct, and I tell you that
not only for yourself but for other people who are listening.
This is on C-SPAN. Maybe they will play it some day. Who knows.
Some insomniac may see it at 3:00 a.m.
That is the time they feature hearings for Senator Harkin
and me.
But listen carefully to the doctors and their pessimism and
take it very seriously, but inquire yourself. My recounting to
you is just one of many, many who have defied the odds.
Your hair is growing back. You look pretty good.
Mr. Bruene. Thank you.
Senator Specter. Good luck to you, Mr. Bruene. If you want
some more details, I would be glad to provide them to you.
Mr. Bruene. Thank you.
Senator Harkin. Thank you very much, Arlen. That was great.
Now we turn to one of the great entrepreneurial giants and
entrepreneurial geniuses of our time.
STATEMENT OF STEVE CASE, CHAIRMAN, AOL TIME WARNER
Senator Harkin. Mr. Case is I think another great example
of what one person with vision and drive can do in a free
society to profoundly change the way we live and work and
communicate. Mr. Case is now applying those abilities and his
leadership to his fight on cancer. And, Mr. Case, we are
honored by our presence here today. Please proceed.
Mr. Case. Well, thank you, Chairman Harkin for this
opportunity to be here, and Senator Specter, for your very
constructive and moving remarks, and Senator Murray, for being
here. I know it is a busy day here in the Senate, so the fact
that you are taking the time to be here this morning is
appreciated.
Obviously, I am impressed, as you all were, I am sure, by
this panel. I am a little daunted to be the clean-up hitter
because people have been so impressive.
But as you said, my name is Steve Case. I am the chairman
of AOL Time Warner, and in that role, I have testified many
times before many Senate subcommittees, but never about a
matter so close to my heart. I am here today not as a chairman
of a company, but as the brother of a brave man who is fighting
a terrible illness and as a concerned citizen who is determined
to help accelerate a cure for brain cancer.
My older brother Dan was diagnosed with brain cancer, stage
4, glioblastoma, in March of 2001, and our lives have never
been the same. As Dan has struggled to overcome his illness,
our family has struggled to learn as much as we can about brain
cancer to educate ourselves about the most effective forms of
treatment and promising new therapies and, of course, to come
to terms the enormous emotional toll cancer takes, as you have
heard, on an entire family.
In this, we are like the millions of Americans whose lives
are profoundly affected by cancer when a loved one becomes
seriously ill. And like so many others, including so many
dedicated people in this room today, we did not want to just
wait passively for a cure. We wanted to try to take some
action.
As a business person who believes strongly in
entrepreneurial models of active engagement, innovation, and
partnership, I felt--I hoped--we could apply some of those
lessons to the challenge of accelerating a cure for brain
cancer. So, together with my brother and the Case Foundation
and leading scientists and entrepreneurs from across the
country, we formed ABC2, a foundation designed to assess the
state of brain cancer research, treatment, and prevention and
to try to find new ways to improve our progress using an
entrepreneurial model.
It has been a long and interesting journey, but there is
still a long way to go. I would like to take a moment to tell
you about what we have learned so far, what we think is
working, and what we think we could be doing better.
Let us start with what is working. At one end of the
spectrum, we have learned--and you heard this this morning also
from Secretary Thompson--that basic research is well handled by
large Government institutions and academic centers, although I
do hasten to add and reinforce what you heard earlier that we
really must increase the funding for cancer research at both
the National Cancer Institute and the National Institutes of
Health.
At the other end of the spectrum, we have seen how patient
advocacy and support groups are doing a great job of providing
information, resources, and comfort to cancer patients and
their friends and families.
We have also seen a real lack in what is known to you all
as translational research, the translation of great basic
science into practical clinical realities for patients.
We have also seen a tremendous need for commercial
sponsorship, without which no drug can really be successfully
developed or marketed. This is particularly critical when it
comes to a disease like brain cancer since the relatively small
number of patients discourages pharmaceutical companies from
committing the funds to develop products to treat the disease.
We have also seen that even as promising new treatments are
envisioned, the implementation and aggregation of good ideas is
lagging somewhat behind.
So, this is a very basic background. I want to tell you
what ABC is doing to try to change the equation for a brain
cancer patient such as Michael and my brother Dan.
As I mentioned a moment ago, ABC2 is founded on the idea of
entrepreneurialism, which depends on innovation and rapid
response and partnership and results-driven strategies that can
actually leverage existing developments and accelerate
therapies that could help cure brain cancer.
So, what does that really mean?
First in the year since we launched ABC2, we have awarded
grants to 21 investigators at nine leading academic
institutions to accelerate therapies from the lab into the
clinic. Just as important, we actively track these researchers'
progress to ensure accountability, help them overcome
obstacles, and improve the outcomes of the projects we support.
Second, ABC2 has created a preclinical evaluation center at
Duke University, a leader in brain cancer work, to test
promising cancer therapies in preclinical models of the
disease. This we think is a cost effective way of seeing what
is working and then if the early results are favorable, working
together to move these therapies more rapidly into clinical
trials.
Third, ABC2 created its first collaboration with a for-
profit entity Genentech. This unique collaborative effort helps
Genentech to improve its risk/reward ratio so it can develop
new therapies specifically for brain cancer. The way it works
is Genentech does the basic research and presents its results
to ABC2. If the results are favorable, ABC2 then steps up to
share development costs through phase I and II clinical trials
and share the great relationships we are building with leading
academic centers. If these early trials are positive, then
Genentech itself takes the next step funding the phase III
trials and marketing of the product, and ABC2 receives a small
royalty on product sales which it can then reinvest back into
the research process.
We think this is a good example of how an entrepreneurial
model can work in this new arena, developing and accelerating a
new therapy to treat brain cancer by reducing the business risk
and fast-tracking the testing cycle.
I am pleased to tell you that ABC2 has already received
inquiries from other companies to pursue similar arrangements,
and I really think this is a promising step on this road, this
journey to a cure.
But let me be clear. I am by no means suggesting that the
market alone can find a cure for brain cancer or that someone
like me or our family can singlehandedly fund a new treatment
for cancer. In fact, I am suggesting the opposite.
No single entity will find a cure for brain cancer by
working alone. The only way we can find a cure for brain cancer
is by working together.
Many of you may not know that my brother Dan is a somewhat
legendary venture capitalist in Silicon Valley, someone who
seeks out great ideas and transforms them into profitable
action. And because of his life's work and passion, many, many
businesses have thrived. So, I think it is fitting that that
same spirit of entrepreneurialism that Dan has always supported
may in the end help to cure my brother and so many others like
him.
prepared statement
In closing I want to say this. We came together as a family
to support my brother Dan and to seek the best possible
treatment for him. But to find a cure for brain cancer, we all
need to come together like a family, a family of health care
professionals, researchers, lawmakers, community leaders and
family members themselves. That is how we will find a cure for
brain cancer and so many other cancers, and I am confident
that, working together, we some day will.
Thank you again for this opportunity to be with your
committee.
Senator Harkin. Thank you, Mr. Case.
[The statement follows:]
Prepared Statement of Steve Case
Thank you, Chairman Harkin, for this opportunity to share my
thoughts here today before this subcommittee.
My name is Steve Case and I am the Chairman of AOL Time Warner. In
that role, I have often testified before Senate Subcommittees--but
never before about a matter so close to my heart.
I am here today not as the chairman of a company, but as the
brother of a brave man who is fighting a terrible illness--and as a
concerned citizen who is determined to help accelerate a cure for brain
cancer.
My older brother Dan was diagnosed with brain cancer in March of
2001--and our lives have never been the same.
As Dan has struggled to overcome his illness, our family has
struggled to learn as much as we can about brain cancer . . . to
educate ourselves about the most effective forms of treatment and
promising new therapies . . . and, of course, to come to terms with
the enormous emotional toll cancer takes on an entire family.
In this, we are like the millions of Americans whose lives are
profoundly affected by cancer when a loved one becomes seriously ill.
And, like so many others, we didn't want to wait passively for a
cure--we wanted to take action.
As a business person who believes strongly in the entrepreneurial
model of active engagement, innovation and partnership, I felt we could
apply some of those lessons to the challenge of accelerating a cure for
brain cancer.
So, together with the Case Foundation and leading scientists and
entrepreneurs from around the country, we formed ABC2--a foundation
designed to assess the state of brain cancer research, treatment and
prevention and find new ways to improve our progress, using an
entrepreneurial model.
It has been a long journey--and there is still far to go. So I'd
like to take a moment to tell you about what we have learned, what we
think is working and what we think we could be doing better.
Let's start with what's working.
At one end of the spectrum, we have learned that basic research is
well handled by large governmental institutions and academic centers--
although I hasten to add that we must increase funding for brain cancer
research at both the National Cancer Institute and the National
Institute of Health.
At the other end of the spectrum, we've seen how patient advocacy
and support groups are doing a great job providing information,
resources and comfort to cancer patients and their friends and
families.
But, we have also seen a real lack in what is known as
``translational research''--the translation of great basic science into
practical clinical realities for patients.
We have also seen a tremendous need for commercial sponsorship--
without which no drug can be successfully developed or marketed.
This is particularly critical when it comes to brain cancer, since
the relatively small number of patients discourages pharmaceutical
companies from committing the funds to develop products to treat this
disease.
And, we have also seen that even as promising new treatments are
envisioned, the implementation and aggregation of good ideas is lagging
behind.
So, with this as a very basic background, I want to tell you about
what ABC2 is doing to change the equations for brain cancer patients.
As I mentioned a moment ago, ABC2 is founded on the idea that
entrepreneurialism--which depends on innovation, rapid response,
partnership and results-driven strategies--can actually leverage
existing developments and accelerate therapies to cure brain cancer.
How does that translate in real terms?
First, in the year since we launched ABC2, we have awarded grants
awards to 21 investigators at 9 leading academic institutions to
accelerate therapies from the lab into the clinic.
Just as important--and what makes this unique--is that we track
these researchers' progress, to ensure accountability, help them
overcome obstacles and improve the outcomes of projects we support.
Second, ABC2 has also created a preclinical evaluation center at
Duke University--a leading academic institution--to test promising
cancer therapies in preclinical models of the disease.
This is a cost-effective way of seeing what's working--and then, if
results are favorable, working together to move these therapies more
rapidly into clinical trials.
Third, ABC2 created our first collaboration with a for-profit
entity, Genentech, consistent with our charitable mission. This unique
collaborative effort helps Genentech to improve its risk/reward ratio
so it can develop new therapies specifically for brain cancer.
Let me sketch out how this works.
Genetech does basic research and presents its results to ABC2. If
results are favorable, ABC2 will share development costs through Phase
I and II clinical trials--and share our great relationships with
leading academic centers. If early trials are positive, Genentech funds
Phase III and markets the product, and ABC2 receives a royalty on
product sales.
It's a perfect example of how the entrepreneurial model can work in
this new arena--developing and accelerating a new therapy to treat
brain cancer.
I'm proud to tell you that ABC2 has already received inquiries from
other companies to pursue similar agreements--and I really think this
is a very promising step on the road to a cure.
But let me be clear. I am by no means suggesting that the market
alone can find a cure for brain cancer, or that someone like me can
singlehandedly fund a new treatment. In fact, I am suggesting the
opposite.
No single entity will find a cure for brain cancer by working
alone.
The only way we will find a cure for brain cancer is by working
together. And that is the most important lesson we have learned.
Many of you may not know that my brother Dan is a legendary venture
capitalist--someone who seeks out great ideas and transforms them into
profitable action. Because of his life's work and passion, many new
businesses have thrived.
So I think it's fitting that the same spirit of entrepreneurialism
that Dan has always supported may, in the end, help to cure my brother
and so many others like him.
In closing, I want to say this: We came together as a family to
support my brother Dan and to seek the best possible treatment for him.
To find a cure for brain cancer, we all need to come together like a
family--a family of health care professionals, researchers, law makers
and community leaders, and family members themselves.
That's how we'll find a cure for brain cancer--and I am confident
that, working together, we will.
Thank you again for this opportunity.
Senator Harkin. Mr. Case, the development of how ABC2 is
working. Sounds like a great model. Can you tell me, have you
reached out to other foundations? Are they also looking at
doing something like this too, other than just the Case
Foundation?
Mr. Case. Oh, absolutely. It is not really directly related
to the Case Foundation. It is a new foundation that was created
called Accelerate Brain Cancer Cure, and the first step is
trying to partner with as many organizations as possible.
One thing that we found as we started looking into this--I
am sure people in this room and people like yourselves who have
been looking at this for many years have known this for some
time, but it was relatively new to me--was how fragmented, how
silo-ized the developments are within the cancer field, how
some people focus on prostate cancer and some people focus on
brain cancer, and the work tends to be fairly fragmented. So,
trying to figure out where you can connect the dots--indeed,
probably some of the most promising therapies for a specific
cancer like brain cancer may be coming from other cancers that
have been studied for a longer period of time. But right now,
there is not enough focus on trying to translate that to apply
to brain cancer. So, we are trying to partner with as many
different organizations as we can to identify those promising
therapies, partner with institutions like a Duke to accelerate
their research, partner with companies like a Genentech so they
can accelerate the process of moving that from trials into the
field. It is something that really does require a ``connecting
the dots'' mentality and a real spirit of partnership.
Senator Harkin. So, you feel that this is definitely
working and can work even more to bridge that gap, to fill in
that translational research that we mentioned earlier about
getting more than just 3 percent of adults with cancer into
clinical trials.
Mr. Case. Absolutely. I think we all know that there is no
silver bullet here. There needs to be continued and accelerated
funding and basic research. I actually think one of the things
we are starting to see is it would be helpful to have more of a
platform approach to cancer, more of an integrated model,
whether it be informatics or other things that might accelerate
the exchange of knowledge and insight between different fields.
There needs to be more effort on the translational side and
more investment in clinical trials, more people aware of the
different options and so forth, and then better models to
accelerate, particularly for the more specialized cancers like
brain cancer.
What is difficult about brain cancer is not just the number
of people who get it is relatively small, but unfortunately, as
Senator Specter says, it is a little bit of a death sentence.
The life span is relatively short. So, from a business
standpoint, it is not going to hit the radar screen of
pharmaceutical companies. So, we need to figure out new models
that reduce the risk from an investment standpoint and also
reduce the burden from a regulatory standpoint.
One thing we have heard from many companies is even though
they think some of their drugs may be applicable to brain
cancer, they are reluctant to begin that journey because if
they are unsuccessful in their efforts, it may taint their
review by the FDA or others as it relates to other cancers. So,
they believe they have something that might be helpful, but
they believe the risk, from a business standpoint and a
regulatory standpoint, is too great. So, trying to look at ways
to reduce that risk through public-private partnerships like
ABC2 and I am sure the things you are looking at in terms of
regulatory reform I think could be very helpful particularly
for these more specialized cancers.
Senator Harkin. You have hit on one thing that--I forgot
the name for it, but where drugs are developed for one thing,
but they believe through certain bench kinds of experiments
that it may be applicable somewhere else. But we really have a
tough time in moving in that direction. I am not certain why. I
do not know the answer to that, but obviously you are again
focused on that too with this foundation. In other words, how
do you get FDA to be more supportive of allowing some of these
experimental drugs to overlap into other areas where it looks
like they might be applicable. We have had a problem with that
and I do not know the answer.
Mr. Case. Others here probably have a better answer, but I
would say from a company standpoint, regulatory reform there is
necessary so it can reduce the risk. One thought would be, to
the extent they do, to take the risk of taking a particular
therapy and applying it to a particular cancer with a belief
that it might work but not certainly the certainty that it
might work, if in that particular area it does not work, it
does not strike me as if that should taint the results related
to some other cancer. If it is developed for prostate cancer,
it is working for prostate cancer, you say, you know, given the
nature of this therapy, the nature of this particular disease,
and particularly as you get better molecular--we think this
actually could apply to brain cancer or some other cancer, if
they are willing to give it a shot, they are willing to put
some money behind that, it does not seem fair to penalize them
if it does not work. That it seems to me what the regulatory
process right now does.
I understand the concern about patient safety, but frankly,
when you have a situation like you heard with Michael or my
brother and Senator Specter had 10 years ago and somebody says
you have 6 weeks or 6 months or 2 years or what have you to
live, it is not particularly comforting to hear about the
regulatory process that has been put in place with lots of
safeguards when you are willing to roll the dice because the
risk/reward clearly is in favor of taking a risk.
Senator Harkin. Well, I have a bill that I have introduced,
and I have been trying to get it through for some time now. It
is called the Access to Medical Treatment Act. Basically what
it says is simply this, Mr. Case. It says that if you are a
licensed practitioner in a State, licensed by the State, and
you want to apply a certain therapy to a patient and that
patient gives informed consent and furthermore, that therapy
has not proven in the past to be harmful--there is no
indication it has ever been harmful--you give informed consent.
It is done by a licensed practitioner in a State, an oncologist
and others. You ought to be able to have it. But we cannot even
do that. And sometimes we have people who are facing short
sentences.
I remember when one of my brothers passed away with cancer
and trying to get some experimental drugs. My brother said,
what have I got to lose. He said you might as well. He was like
you. He was a businessman, and he said, of course, let me try
whatever is out there. As long as it has not proven to be
harmful, why should I not try it?
So, this is another one of those hurdles that we just
confront all the time with FDA and others. So, any insight and
suggestions you can give--and you have given us some on how to
get over that.
Dr. Huerta, I just want to say again to Mr. Case here that
next year, not this committee, another committee I chair, will
be having hearings and reauthorizing the child nutrition
programs, school lunch, school breakfast, and the others. We
know that what you eat later in life probably started early.
You talk about nutrition and diets and things like that. I may
call you back at that time to testify.
But you are talking about getting information out to
people. Well, there is no one who knows more about getting
information out to people than Mr. Case here. This seems to me
again something that we have got to know more about. How do we
get information out to groups of people on the risks they face,
what they need to do to cut down on smoking, and how they can
do it, or their diets, what nutrition they need to have?
Dr. Huerta. Thank you, Mr. Chairman. Very briefly. What I
do, for example, is I write a radio show every single day.
Every single day it broadcasts three times a day and that show
is distributed among 90 radio stations across the United
States, Puerto Rico, and Latin America. Then every day I have a
1-hour talk show on health on radio because they built a radio
studio in my office. So, I see patients during the morning. I
take a break. I am connected live with the public. I talk to
them on health issues, encouraging them to do health promotion,
health prevention, and then I say, see you tomorrow, lunch, and
next patient 2:30 in the afternoon. Saturday we have a
television show. So, the idea is that we need to be consistent.
I ask you and I ask the members of the panel and the
public, do you conceive of your 11 o'clock news without a
sports guy?
Probably not. What happens if he sports guy if he does not
show up? Why can we not have health information every single
day? Every night at 8:03 p.m. on National Public Radio here in
Washington, D.C. there is a wonderful show about the stars,
Stars Watch. I am learning a lot, where Venus is, Mars is.
Senator Harkin. When I am driving home, I hear it.
Dr. Huerta. Exactly. Where is the health show every single
day on National Public Radio to educate us about health? It is
lacking.
At NIH, they have a wonderful infrastructure. They have so
many institutes, so many offices. They would have an enormous
amount of material to put out for the public. We are lacking
that.
Senator Harkin. One last thing. I just want to say to all
of you who are here thank you for being here. You have been a
great audience. But more than that, use your time on the Hill
to--I will not say lobby, but educate Members of the House and
the Senate. Senator Specter knows full well we will try to do
our job here, but we do not run everything around here. We have
our committee, but we need help in making sure that we get the
allocation of funds that we need in order to be able to meet
these obligations. So, we need your help in going around and
talking to others about the need for the necessary funds to
fight cancer. So, I hope that you will meet as many Senators
and Congresspeople as you can while you are here.
I know time is running out, but I want to recognize Senator
Specter.
Senator Specter. Well, thank you, Mr. Chairman.
Just a few questions. Mr. Case, thank you for what ABC2 is
doing. It is great to have the entrepreneurs in the field to
make an independent analysis. You have a little different view
than the NIH, the National Institutes of Health. Senator Harkin
and I for years have been trying to push clinical trials again
and again and again. There is a lot of skepticism or there is a
lot of concern about taking any money away from research. But
if you do not know how to apply it, all the research in the
world cannot give you the ultimate answers.
Your ways of trying to get companies to research and
develop drugs, cures for ailments like brain tumors is really
commendable because it does just hit a small percentage. But if
you are that percentage, Mr. Bruene and I can tell you we need
the help on that.
Dr. Herberman, you testified that there are cures for
certain types of cancers. Could you amplify that? Which ones do
you include in that category?
Dr. Herberman. Well, the ones that I was particularly
alluding to which I think are most impressive are childhood
leukemias, Hodgkin's disease, and testicular cancer. With
these, quite remarkably, even when they are diagnosed at
advanced stages, chemotherapy or some other treatment can cause
a complete cure.
Senator Specter. Well, I think that is very important to
emphasize, that when you talk about cures, most of the time in
popular parlance, there is a view that there is no cure for
cancer. So, when you identify some forms of cancer which can be
cured, I think that gives heart to a lot of people.
Then the issue is to find cures for the other forms of
cancer. I am convinced that there are cures out there, that if
we open enough doors on scientific research, that we can find
cures for all these problems. Medical science has wonders just
to no end to what can be done. So, I think that identifying
some cures is very important.
You then said that there are tremendous opportunities. Are
you referring to research opportunities with even more funding?
Dr. Herberman. Yes, very much so. I think we now understand
in great detail that essentially any type of cancer represents
a molecular abnormality in the genes of the cancer cell. By
understanding what those particular genes that are
misfunctioning are, we are able to molecularly target these
genes and correct the abnormalities. These are the
extraordinary opportunities that are referred to.
Senator Specter. So, you think if we look hard enough, we
can find answers, cures for all these molecular abnormalities?
Dr. Herberman. I am very optimistic. If not find cures for
all of them, to at least convert what is a rapidly fatal
situation to one where we could at least stabilize and have
prolonged quality of life for people with cancer. It is not so
bad to live with cancer for a long time as long as one has good
quality of life during that period.
Senator Specter. Well, prolonged quality of life is second
best. The best is a cure.
Dr. Herberman. Absolutely.
Senator Specter. Senator Harkin and I are going to press
you to find cures if we are going to give you all this money.
Dr. Herberman. We are working very hard at this, Senator.
Senator Specter. Okay. Keep working.
Last question. You talked about restructuring the clinical
mechanisms. We would like you to give us a writing on that.
Give us your ideas as to how to restructure the clinical
mechanisms. We cannot take it up in the course of an
abbreviated hearing, but when Senator Ellen and Senator Betty
Lou write the appropriation report, they have great powers in
their pens to give direction to NIH and CDC and everybody else.
But we need to know what to say. I know it will shock you, but
we do not have all the answers. So, when we have you high-
powered experts, we like you to tell us what you would suggest
on restructuring the clinical mechanism, and we will try to
help you make it happen.
Dr. Herberman. Well, thank you very much, Senator. I very
much welcome that opportunity and I will forward you detailed
thoughts about doing exactly that.
Senator Specter. Thank you very much. Thank you, Mr.
Chairman.
Senator Harkin. Thank you, Senator Specter.
Again, I want to thank all of you. I want to thank
especially the Iowans who came here. I want to thank you, of
course, Michael, for your bravery and Nicole, your wife.
Senator Specter. I want to thank the Iowans too. Now, will
you thank the Pennsylvanians?
Senator Harkin. Well, you can thank them.
Thank you very much, Mary and Lanessa, for being here,
Serge, Threase. Thank you all for being here today.
Just one last thing. I bring this up not every hearing we
have on cancer, but almost every one. I have in my office a
book. It is called a Compendium of Spontaneous Remissions. It
was given to me by Senator Claiborne Pell before he left. It is
a book of known cases, diagnosed cases of cancer, in which
after certain treatments or maybe not some treatments, there
was spontaneous remission. They just went away. I happen to
have a friend of mine in Sioux City who came to NIH some 30
years ago with a rare form of cancer. They did a few things.
She went home and never had cancer again.
I have often wondered why has the research community not
taken all of these and put them in some kind of a matrix. Who
are these people? How did they live? What did they eat? What
did they do? Is there some connective thing there on why these
people had spontaneous remissions and others do not? I have
never yet been able to get an answer to that question. So, I
just leave it at that and I hope that you will maybe ponder it
and think about it, and if you have some suggestions for me,
please let me know.
But you have been a great panel. We thank you all very,
very much for being here. We will do what we can.
Do you have any last statements that anybody wanted to make
before I close down? Steve or Michael, Susie, Dr. Herberman,
Dr. Huerta?
Dr. Herberman. Maybe I will just respond to the spontaneous
remission issue, which has also fascinated me for many years. I
am actually an immunologist and focus particularly on how the
body can fight against cancer. I think this provides a very
important clue. The body has a remarkable ability to recognize
in some cases cancer and fight against it. I think by
understanding those cases, that really is an important clue to
broaden this and make it more frequent.
Senator Harkin. I hope we do more research.
Susie.
Ms. Novis. My closing comment would just be that again I
urge you to fully fund the bypass budget. Information we
received from the NCI says that 72 percent of all approved
grants do not get funded, and it is apparent that we need
research. They have been approved, but there just is not the
funding to make them happen.
Senator Harkin. Excuse me. I thought it was higher than 28
percent.
Ms. Novis. No. The information that we have received from
the National Cancer Institute was that figure.
Senator Harkin. How far does that data go back? Because we
have doubled the funding in the last 5 years in order to get
that rate up to in the 40 to 50 percent.
Ms. Novis. I am told that that information is 2 years old.
But still we have a long way to go, so again I urge you fully
fund the bypass budget.
Senator Harkin. Well, I urge you to please get a hold of
your Congressmen and Senators and others and tell them that we
need the allocation for it in our budget in order to do it.
Once we get our allocation, that is all we have got to fight
hard to get the requisite money.
Let me close on this. We talk and people say, well, my
gosh, we put how much money into research? Where is that figure
that we put into cancer research this last year? You had all
those figures, Susie. NIH was $5 billion. We have doubled the
funding to $27 billion. And people say, my gosh, that is a lot
of money. If you cannot find a cure for cancer with that, I
mean, you are not going to find it. That is a lot of money.
I keep pointing out that we started this doubling in 1998.
In the 2 years previous to that, 1996 and 1997, we spent more
money as a Nation on military research and development than we
have on--are you ready for this--all medical research since the
turn of the century. I will repeat that. We spent more on
military research and development in 2 years than we as a
country spent on all medical research since the turn of the
20th century. That means everything from polio to smallpox to
everything else.
Now, I do not bemoan the fact that we spent that much on
the military. Obviously it has made us the most powerful nation
on earth. It is preserving our freedom. But you put it in
context, you think, my gosh, we have not even scratched the
surface in the amount of money that we can put out for
biomedical research.
This basic research is, as I have often said, like you have
got 10 doors. You do not know what is behind them. If you open
one door, what are your odds against finding the answer? If you
open two doors, what are your odds? If you open three doors?
That is where we are now, as you pointed out, about 28 percent.
What if we opened five or six or seven doors? Then the odds are
much greater.
Ms. Novis. Exactly. And now with targeted research, this
opened a huge door. We need to have the money to go through
that door.
Senator Harkin. That is right, exactly.
Dr. Huerta. Mr. Chairman, we need to also focus on that
research. It is not only the biology of the tumor. It is not
only the antibodies. It is not only the marker. It is also the
person, as you said. So, in addition to focusing on the tumor
of the person, we need to focus on the person himself or
herself. It is extremely important.
Senator Harkin. I agree.
PREPARED STATEMENTS
We have received the prepared statements of Senator Mary L.
Landrieu and Senator Ernest F. Hollings. They will be made part
of the record.
[The statements follow:]
Prepared Statement of Senator Mary L. Landrieu
Thank you Mr. Chairman. To understand the huge impact Cancer has
had on the lives of most Americans, one need only ask themselves the
question: How many people do I know or have I known who have this
disease? For most of us, the answer is easily in the double digits. In
2002, roughly 21,900 people in Louisiana will be diagnosed with cancer.
What's more, 9,500 Louisianians will die from this debilitating disease
this year alone. This number is growing with each year. It is predicted
that the number of people diagnosed annually with cancer will double
over the next fifty years, from 1.3 million to 2.6. By 2050, more than
1.1 million people seventy five years or older will be diagnosed with
cancer each year.
The human toll of this disease is incomparable. 1,500 Americans
lose their lives to this disease daily. 1,400 children under the age of
14 will lose their battle each year. Yet, what is almost as staggering
is the fiscal cost of cancer nationwide. In 2001, the overall cost of
cancer was estimated to be $156.7 billion dollars, $56.4 billion for
direct medical costs, $15.6 billion for lost productivity due to
illness, and $84.7 billion for lost productivity due to premature
death.
Like with many diseases, the fight against cancer is two fold; the
race for a cure and working towards preventing and treating the
disease. The American Cancer Society reports that one third of all
cancer deaths in 2002 will be related to nutrition, physical
inactivity, obesity and other lifestyle factors that might have been
prevented. Smoking is responsible for 87 percent of lung cancers and at
least 30 percent of all cancer deaths. We need to be doing more to
educate people about how they can take charge of their lives and
protect themselves against this horrible fate. I encourage the NIH and
the CDC to continue to work together, through efforts such as the CDC
Cancer Prevention and Control programs, to improve the public education
in this area, especially to our young people. Rates of obesity and
teenage smoking among girls are on the rise. Changing this mind set
early will reduce the number of people who fall victim to diseases such
as cancer.
Another key area is early detection. In most every form of cancer,
the patient's survival rates are greatly increased if the disease is
caught and treated early. Right now, the CDC's Breast and Cervical
Cancer Early Detection Program is only reaching 18 percent of those
eligible to receive these services. With more funding, this program
would be able to serve and protect all women and thereby reduce the
both the human toll and the financial cost of this deadly disease. In
addition, we must work to ensure that the promise of prevention, early
detection and treatment are available to all Americans. When compared
with the general population, significant disparities are found among
racial and ethnic groups and the medically under served. Under current
law, the National Center for Minority Health and Health Disparities is
charged with the mission of ensuring that these populations receive the
attention they need and deserve. Increasing the funding for within the
NIH for cancer research, treatment and prevention will mean nothing if
we do not also remove the barriers to quality medical care that exist
today.
Like the majority of my colleagues on the committee, I fully
support the goal of doubling the NIH budget in five years. If we meet
the President's request of $27.3 billion we will have met that
commitment. Right now, the NIH is using these dollars to support over
36,000 research projects. Each of these projects holds the promise of a
cure or a more effective treatment for an American who is suffering.
For those suffering from Cancer, it is the hope of these answers that
keeps them going. While I understand that our budget is limited this
year, I hope we can find the resources necessary to meet the National
Cancer Institute's needs.
Again, thank you Mr. Chairman for holding this important hearing
and I look forward to hearing from the Secretary and the other
witnesses here this morning.
______
Prepared Statement of Senator Ernest F. Hollings
I would like to thank the Chairman for bringing such a
distinguished panel before the Subcommittee today. Cancer is a disease
that affects families of all backgrounds in all parts of the country.
However, cancer affects more families in my state than most others. We
hold the unfortunate distinction of ranking among the top five in the
nation in rates of multiple myeloma and oral, prostate, pancreatic, and
esophageal cancer. We are also not far behind in regard to cervical and
larynx cancer.
Through the significant investment this Subcommittee has made in
cancer research, we have enabled scientists across the country to
expand our basic understanding of cell growth and death and to develop
effective forms of treatment and prevention. Much of this work was
accomplished in NCI-designated comprehensive cancer centers. I am
troubled that these centers tend to cluster in the Northeast and along
the Pacific Coast, and bear little correlation to cancer incidence or
mortality rates. In fact, only three of the fifteen states with the
highest cancer mortality rates have a comprehensive cancer center.
While we should continue to fund the best and brightest in their
efforts to find cures for cancer, I believe the current concentration
of comprehensive cancer centers deprives us of gaining valuable
knowledge in the parts of the country where cancer is most prevalent. I
would hope that as the National Institutes of Health designates new
comprehensive center centers, they will make awards to institutions in
states with the highest cancer rates, those truly on the front lines of
the war against cancer.
Secretary Thompson, I look forward to hearing your testimony and
look forward to working with the distinguished Chairman and Ranking
Member of this Subcommittee to provide you with the resources necessary
to bring more comprehensive cancer centers to states and communities
across the country.
I thank the chair.
CONCLUSION OF HEARING
Senator Harkin. Thank you all very much for being here,
that concludes our hearing.
[Whereupon, at 11:25 a.m., Tuesday, June 4, the hearing was
concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
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