[Senate Hearing 107-906]
[From the U.S. Government Publishing Office]



                                                        S. Hrg. 107-906
 
                     CANCER RESEARCH AND PREVENTION
=======================================================================

                                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


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                                 senate

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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
                                 ------                                

 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

                              ----------                              
                                                                   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

                              ----------                              


                         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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