[Senate Hearing 107-297]
[From the U.S. Government Publishing Office]
. S. Hrg. 107-297
BREAST CANCER RESEARCH AND DEVELOPMENT
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HEARING
before a
SUBCOMMITTEE OF THE
COMMITTEE ON APPROPRIATIONS UNITED STATES SENATE
ONE HUNDRED SEVENTH CONGRESS
FIRST SESSION
__________
SPECIAL HEARING
MAY 9, 2001--WASHINGTON, DC
__________
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COMMITTEE ON APPROPRIATIONS
TED STEVENS, Alaska, Chairman
THAD COCHRAN, Mississippi ROBERT C. BYRD, West Virginia
ARLEN SPECTER, Pennsylvania DANIEL K. INOUYE, Hawaii
PETE V. DOMENICI, New Mexico ERNEST F. HOLLINGS, South Carolina
CHRISTOPHER S. BOND, Missouri PATRICK J. LEAHY, Vermont
MITCH McCONNELL, Kentucky TOM HARKIN, Iowa
CONRAD BURNS, Montana BARBARA A. MIKULSKI, Maryland
RICHARD C. SHELBY, Alabama HARRY REID, Nevada
JUDD GREGG, New Hampshire HERB KOHL, Wisconsin
ROBERT F. BENNETT, Utah PATTY MURRAY, Washington
BEN NIGHTHORSE CAMPBELL, Colorado BYRON L. DORGAN, North Dakota
LARRY CRAIG, Idaho DIANNE FEINSTEIN, California
KAY BAILEY HUTCHISON, Texas RICHARD J. DURBIN, Illinois
MIKE DeWINE, Ohio TIM JOHNSON, South Dakota
MARY L. LANDRIEU, Louisiana
Steven J. Cortese, Staff Director
Lisa Sutherland, Deputy Staff Director
James H. English, Minority Staff Director
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Subcommittee on Departments of Labor, Health and Human Services, and
Education, and Related Agencies
ARLEN SPECTER, Pennsylvania, Chairman
THAD COCHRAN, Mississippi TOM HARKIN, Iowa
JUDD GREGG, New Hampshire ERNEST F. HOLLINGS, South Carolina
LARRY CRAIG, Idaho DANIEL K. INOUYE, Hawaii
KAY BAILEY HUTCHISON, Texas HARRY REID, Nevada
TED STEVENS, Alaska HERB KOHL, Wisconsin
MIKE DeWINE, Ohio PATTY MURRAY, Washington
MARY L. LANDRIEU, Louisiana
ROBERT C. BYRD, West Virginia
(Ex officio)
Professional Staff
Bettilou Taylor
Mary Dietrich
Jim Sourwine
Ellen Murray (Minority)
Administrative Support
Correy Diviney
Carole Geagley (Minority)
C O N T E N T S
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Page
Opening statement of Senator Arlen Specter....................... 1
Statement of Richard Klausner, M.D., Director, National Cancer
Institute, National Institutes of Health, Department of Health
and Human Services............................................. 2
Prepared statement........................................... 5
Statement of James S. Marks, M.D., M.P.H., Director, National
Center for Chronic Disease Prevention and Health Promotion,
Centers for Disease Control and Prevention, Department of
Health and Human Services...................................... 13
Prepared statement........................................... 14
Opening statement of Senator Tom Harkin.......................... 20
Statement of Nancy G. Brinker, Founding Chairman, Susan G. Komen
Breast Cancer Foundation....................................... 22
Prepared statement........................................... 23
Statement of Christine Carpenter, member, National Breast Cancer
Coalition...................................................... 25
Prepared statement........................................... 27
Statement of Peri Gilpin, actress and breast cancer advocate,
member, National Breast Cancer Coalition....................... 28
Prepared statement........................................... 30
Statement of LaSalle D. Leffall, Jr., M.D., F.A.C.S., chairman-
elect of the Susan G. Komen Breast Cancer Foundation........... 31
Prepared statement........................................... 32
Statement of Dr. John Seffrin, chief executive officer, American
Cancer Society................................................. 33
Prepared statement........................................... 35
Statement of Fran Visco, J.D., president, National Breast Cancer
Coalition...................................................... 38
Prepared statement........................................... 40
Opening statement of Senator Patty Murray........................ 42
Questions submitted to the National Cancer Institute............. 50
Questions submitted by Senator Arlen Specter..................... 50
Questions submitted to the Centers for Disease Control and
Prevention..................................................... 54
Questions submitted by Senator Arlen Specter..................... 54
BREAST CANCER RESEARCH AND DEVELOPMENT
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WEDNESDAY, MAY 9, 2001
U.S. Senate,
Subcommittee on Labor, Health and Human
Services, and Education, and Related Agencies,
Committee on Appropriations,
Washington, DC.
The subcommittee met at 9:30 a.m., in room SD-124, Dirksen
Senate Office Building, Hon. Arlen Specter (chairman)
presiding.
Present: Senators Specter, Harkin, and Murray.
opening statement of senator arlen specter
Senator Specter. Good morning, ladies and gentlemen. It is
precisely 9:30. The hearing of the Subcommittee on Labor,
Health, Human Services and Education will commence.
We have one of our most important hearings of the year
today. And that is the hearing on breast cancer. This
subcommittee, as is generally known, has taken the lead on
increasing the funding for the National Institutes of Health. I
frequently say, because I think it to be true, that the NIH is
the crown jewel of the Federal Government. And I sometimes add,
to the displeasure of some, perhaps the only jewel in the
Federal Government.
Senator Tom Harkin and I have taken the lead on funding for
NIH crossing party lines. I learned a long time ago that if you
want to get anything done in Washington, you have to be willing
to cross party lines. The Senate passed a resolution 98 to
nothing to double the funding of the NIH in 5 years. But the
Senate is well known for druthers and not dollars.
Five years ago, Senator Harkin and I sought to increase the
funding by $1 billion as a step toward that goal. And we were
defeated on the floor by a vote of 63 to 37. So we got out our
sharp pencils and found the $1 billion elsewhere establishing
priorities.
Having lost on our budget resolution effort to increase
funding $1 billion the next year, we decided to try for $2
billion. And again, we were defeated, this time by a narrower
vote. But again we found money within the budget establishing
priorities to give the money to NIH. And without giving the
details on my vote on this budget resolution, we passed 96 to
4, an increase of $3.4 billion, which would bring the funding
for NIH to almost $24 billion, right at $24 billion, which
would be just about a doubling.
This funding has produced really remarkable results in
research advances, one of the notable ones being what has
happened with stem cells. Right now we are in the midst of a
battle to try to remove a prohibition which says Federal
funding cannot be used on research on stem cells. Federal
funding is permitted under a ruling by the general counsel for
the Department of Health and Human Services for research on
stem cells after they are removed. We have legislation pending
which would remove the prohibition entirely.
I think mistakenly it gets caught up in the pro-choice/pro-
life argument. We are not dealing with the issue of any of
these embryos which would be used to produce life. They are to
be discarded. There are extras which are created for in vitro
fertilization. And these stem cells have remarkable
capabilities already demonstrated on Parkinson's, spinal cord,
diabetes and, perhaps, it is not determined yet, on
Alzheimer's.
One of the issues we are going to discuss here today is
what the impact is on cancers, whether it may reach there.
The issue of breast cancer is--well, I will just put it,
there is no more important issue in medical research than
breast cancer. It has competitors with ovarian cancer, prostate
cancer, lymphoma, and heart ailments, and many other maladies.
But it has claimed the lives of one woman out of nine. There
has been an enormous increase in funding. I will put those
statistics into the record, not to take too much time now.
[The information follows:]
Breast Cancer Statistics
The National Cancer Institute (NCI) estimates that 1 in 8 women
will develop breast cancer during her lifetime. This year approximately
238,600 women will be diagnosed with breast cancer and over 40,000 will
die as a result of breast cancer. The risk of breast cancer increases
with age. The risk is also higher in obese women and those who use oral
contraceptives, ingest a high fat diet or fail to exercise. Detecting
breast cancer in its early stages is difficult since the disease is
often spread throughout the woman's body before the tumor is sufficient
size to be detected during a monthly self-examination or by a physician
on an annual examination. Mammography is more sensitive than physical
examination at detecting small breast tumors but is still relatively
insensitive since a tumor can exist for 6-10 years before growing large
enough to be detected by a mammogram. Despite this relative
insensitivity, early detection through mammography remains the best
means of controlling breast cancer. For breast cancer that is contained
within the breast, 5-year survival has increased from 72 percent in
1940 to 97 percent today. However for breast cancer that has spread
outside of the breast, 5-year survival is as low as 21 percent.
Senator Specter. The schedule has a complicated Senate. And
that is probably as true as the Senate has a complicated
schedule.
Freudian slips are probably more accurate than the straight
talk.
But we have a vote set at 9:35 today.
STATEMENT OF RICHARD KLAUSNER, M.D., DIRECTOR, NATIONAL
CANCER INSTITUTE, NATIONAL INSTITUTES OF
HEALTH, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
Senator Specter. And we will now proceed with our very
distinguished witnesses. Our lead witness is Dr. Richard
Klausner, appointed director of the National Cancer Institute
in August of 1995. He has been here on many, many occasions,
and been on the circuit. And I thank him for the trip he made
to Philadelphia, Pennsylvania, not too long ago.
Prior to that appointment, Dr. Klausner served as chief of
the Cell Biology and Metabolism Branch of the NIH, Child Health
and Human Development. He began his career at NIH in 1979 after
post-graduate work at Harvard, has his undergraduate degree
from Yale and his medical degree from Duke University.
He is accompanied by Dr. James Marks, the director of the
National Center for Chronic Disease Prevention and Health
Promotion of the Centers of Disease Control, where he has held
numerous positions over the past 25 years. An adjunct associate
professor at Emory, he received his undergraduate degree in
psychology from Williams, M.D. from the University of New York
at Buffalo, and his MPH from Yale University.
Thank you for joining us today, gentleman. Dr. Klausner, we
will turn to you. Our generalized rules are to set the lights
for a 5-minute opening, leaving a maximum amount for questions
and answers. We will have to see how we are going to do on
time. We do have a fair-sized list of witnesses.
So Dr. Klausner, we look forward to your testimony.
Dr. Klausner. Thank you, Mr. Chairman. And let me thank you
on behalf of everyone for all the support. What I want to
briefly do right now is to actually demonstrate some of the
fruits of the support for research, beginning with one measure:
What is happening to mortality rates from breast cancer.
Up until 1990, each year mortality rates were rising in
this country. From 1991 to 1995 historically, for the first
time, we saw mortality rates dropping by about 1.6 percent per
year. And that is now accelerating to about 3.5 percent per
year. We expect it to continue. We expect it to accelerate.
Even if it stopped at this level but continued over the next 10
years, that would mean a 30- to 40-percent drop in the
mortality from breast cancer.
We have achieved good dissemination of our best early
detection tool, mammography, which you will hear about. But
mammography is far from perfect. And to really effect early
detection, we need new, really new, approaches. We have
incrementally approved survival, but with relatively toxic and,
with a few exceptions, not specific treatments.
It is likely that we can continue to make these incremental
improvements. And we must make sure that all women have access
to prompt and state-of-the-art treatment. But if we are going
to do better, and we can and must, we must switch our treatment
approach so that we know the different types of breast cancer,
to treat each as a distinct disease. And we must now develop
new treatments based upon the molecular machinery of each type
of breast cancer.
So now we will do a 4-minute molecular biology lesson in
breast cancer.
For 100 years we have diagnosed breast cancer by as you see
on the left, looking under the microscope at abnormal cells.
That is pretty much what we knew. That is not what cancer is.
Cancer is a disease of molecular alterations. For the first
time now, at the beginning of the 21st century, we can switch
from looking under the microscope alone to reading genes.
And what you see there is a gene chip. To read the true
molecular profile and discern the true molecular nature of
breast cancer, there are about 30,000 genes on that little
penny-sized chip. And so What we have done is challenged the
community with an $80 million program called the Director's
Challenge to redefine breast cancer. And you see the result in
that chip, one experiment, 50,000 data points.
And as we suspected, breast cancer, while looking the same
under the microscope, is at least--next slide--five different
diseases. We could not know this before about 9 months ago. It
is hard to read this. Take my word, it is five different
molecular diseases. The most important thing is, all of these
differences, when corrected for the exact same stage of
disease, which today has been the best way of predicting
outcome, you can discern the true molecular differences between
totally different diseases that we are all lumping as breast
cancer. The result is that we see entirely different outcomes
for these different diseases, from one type having zero 3-year
survival to another type having a 95-percent 3-year survival.
What will this mean? First of all, we need to switch to
thinking about these as molecular diseases and as distinct
diseases. As you have heard me talk about, we have gone in one
generation from cancer being a black box to then, through
research, drawing the circuitry of cancer.
But with that circuitry, we do not stop. It is this
circuitry that provides the new and truly revolutionary targets
for therapy against these different diseases. And now you will
see what has happened.
From that circuitry, on the next slide we see all of the
pieces of the circuitry that we know so far to be altered in
different types of breast cancer. And in green is the list of
all of the drugs that are already entering clinical trials,
just in the last couple of years, that are now directed against
each of those points of the circuitry.
I cannot over emphasize how much this is a complete change
from the sledge hammer approach to the black box of cancer that
we have lived with for too long.
We can see how quickly we have moved from identifying the
targets, here classifying them in a new way. Fifteen classes of
molecular targets in breast cancer, 68 individual targets
identified specifically. And now already, 130 trials supported
by the NCI and industry directed against all of these targets.
It is these therapies that you have heard me talking about
for several years. The difference is, 5 years ago, if I would
have drawn this, it basically would have been almost blank. One
hundred thirty trials, 68 different targets, about 85 agents,
this is the immediate effect of all of this research that you
have supported.
Prepared statement
And we now know that each of these targets are not present
in breast cancer, per se, but in these different molecular
forms. For the first time, these brand new technologies that
have been now developed and disseminated to the research
community, will allow us for the first time to think about the
right treatment for the right disease.
And I will stop there and hopefully answer questions later.
[The statement follows:]
Prepared Statement of Richard Klausner
Good morning Senator Specter and Members of the Subcommittee. I am
Richard Klausner, M.D., Director of the National Cancer Institute
(NCI). I am pleased to have this opportunity to speak with you today
about breast cancer research.
Over the past two decades, intensive research sponsored by the NCI
into all aspects of breast cancer has led to many important
discoveries. We understand more than ever before how a healthy breast
cell becomes cancerous, how breast cancer spreads, why some tumors are
more aggressive than others, and why some women suffer more severely
and are more likely to die of their disease. We are having increasing
success in translating these discoveries into therapies that extend
cancer-free survival and improve the quality of life for those
continuing to live with the disease. Likewise, our discoveries are
leading to more refined technologies for detecting and diagnosing
breast cancer, better supportive care and improved outcomes for
patients during and after treatment, and finally, we are getting closer
to identifying effective strategies for preventing the disease
altogether.
Though these advances have been significant and provide hope for
the future, we still have far to go to remove the threat of breast
cancer from women's lives. In 2001, it is estimated that 192,200 women
will be diagnosed with breast cancer (another 1,500 cases will occur in
men), and 40,600 will die from breast cancer. It is the most common
cancer among women in each of five major population groups (white,
black, Asian and Pacific Islanders, American Indians and Alaska
Natives, and Hispanics), and the second leading cause of cancer
mortality for women in all major population groups with the exception
of Hispanics, for whom it is ranked first.
The breast cancer incidence rate in women has increased
substantially, going from 83 (per 100,000 women) in 1973 to 118 (per
100,000 women) in 1998. Analysis of more recent trends (1992-1998),
indicate that incidence is increasing by slightly over 1 percent per
year among white women and is relatively flat among black women. In
contrast to incidence, breast cancer death rates have decreased by 3.4
percent per year since 1995, including a significant decline in rates
for white women and relatively stable rates for black women.
The increase in detection and diagnosis of breast cancer occurs for
women of all ages but is greatest among those over 50 years of age,
particularly women 50-64 years of age. Consistent with increasing
utilization of mammography, the greatest increase in breast cancer
incidence rates occurs in women diagnosed with early stage malignant
disease as well as in women with premalignant tumors.
risk and prevention
Approximately one out of every eight American women will develop
breast cancer in her lifetime. About half of the incidence can be
explained on the basis of identified risk factors, including heritable
gene mutations associated with breast cancer, and investigators
continue to search for the elements of breast cancer causation and
understand how they influence each other. Undoubtedly, changing
childbearing practices are important, since studies have repeatedly
shown large increases in risk among women who have remained childless
or who have delayed childbirth until their later reproductive years.
Breastfeeding may reduce risk, although probably not for the durations
practiced by most American women. It is widely accepted that risk is
increased among women who are heavier consumers of alcoholic beverages
and who are overweight (this latter relationship being true only for
postmenopausal breast cancer). Since both of these factors are
modifiable, they are viewed as important means by which disease
incidence could potentially be reduced.
A great deal of attention has focused on the role of exogenous
hormones, given the widespread exposure of women to both oral
contraceptives and menopausal hormones. For oral contraceptives, there
appears to be a slight increase in risk for current users of the
preparations, although risk dissipates five years after
discontinuation. More concern relates to menopausal estrogen use, since
long-term use (10+ years) appears to increase risk to a moderate
extent. This risk may be even further increased if progestins are added
to the regimen.
Other factors are under investigation, but the relationship of risk
to most of these factors remains controversial. There has been great
emphasis on identifying dietary means of reducing disease risk,
although there is little consensus as to which constituents of diet
might be important (enthusiasm over a potential role of dietary fat has
been tempered by recent studies that have failed to show much evidence
for an effect). The role of physical activity is also not clearly
understood. Extensive attention has focused on understanding the role
of environmental agents, including ones to which women have been
increasingly exposed, although studies to date have provided
inconsistent results.
Cancer susceptibility is a critical piece of the puzzle. We know
that disruption of fundamental cellular processes contributes to the
development and progression of the more common, non-hereditary forms of
cancer. Even among individuals who have inherited cancer-predisposing
genes, the risk of developing cancer appears to be modified by other
genetic and environmental factors. There is mounting evidence that a
person's genetic make-up may influence susceptibility or even
resistance to cancer-causing exposures. Opportunities now exist to
determine how variations in these genes combine with environmental and
other factors to induce cancer in the general population. There is
great hope that controversies regarding many of the poorly understood
risk factors may be resolved by assessing the interactions between
genes and the environment.
Single mutations in major cancer-associated genes are thought to
account for 5-10 percent of all breast cancer. Among the most important
of these genes are BRCA 1 and BRCA 2 which are thought to account for
nearly 80 percent of families with inherited predispositions to breast
cancer. Women with these mutations are also at an increased risk for
ovarian cancer. A variety of other much less common conditions caused
by mutations in other genes contribute to an increased risk of breast
and/or ovarian cancer in other families.
While these major breast cancer risk factor genes play an important
role in determining who gets breast cancer in such families, not all
who inherit such a mutation will get breast cancer. Though early
studies suggested that the lifetime risk of breast cancer for those
inheriting mutations in BRCA 1 and 2 might be as high as 80 percent,
more recent studies suggest a much lower, though still quite elevated,
risk in the range of 37-56 percent for breast cancer, and 16 percent
for ovarian cancer. Whether these risks are the same for all of the
more than 600 different identified mutations in BRCA 1 or more than 450
identified mutations in BRCA 2 is unknown. What is clear is that other
modifier genes or environmental and lifestyle risk factors must play
some important roles. In addition, current evidence suggests that the
mechanisms that produce breast cancer linked to BRCA 1 & 2 mutations
may differ in important ways from those that lead to other more common
breast cancers. The evidence suggests that these genes have important
roles in DNA repair and regulation of the cell cycle and therapeutic
and preventive interventions should be tailored to these mechanisms in
order to be effective.
The use of prophylactic surgery, such as mastectomy or
oophorectomy, as a prevention method for high-risk mutation carriers
has had extensive consideration and is sometimes offered to such women.
However, the effectiveness of such treatment has been less clear.
Recently, investigators sponsored by the NCI have produced significant
evidence that such an approach can have real benefits. For instance, a
1999 study of women at high risk for breast cancer suggested a 90
percent reduction in risk of breast cancer after prophylactic
mastectomy, and it has also been reported that BRCA 1 carriers who have
bilateral prophylactic oophorectomy may have a reduction in breast
cancer risk in the vicinity of 50 percent, even if they receive hormone
replacement after surgery. Surgical approaches to prevention of cancer
have significant adverse consequences and may not be acceptable to many
women at-risk.
While tamoxifen has not been shown to reduce the risk of breast
cancer specifically among high-risk mutation carriers, NCI's Breast
Cancer Prevention Trial, including 13,000 women at increased risk for
breast cancer, demonstrated that women taking the drug tamoxifen for an
average of four years reduced their chance of developing breast cancer
by 49 percent. Other health benefits were noted as well, but tamoxifen
is not without potential harm, particularly for postmenopausal women,
who had an increased risk of developing life-threatening health
problems: endometrial cancer, pulmonary embolism, and deep vein
thrombosis.
It is now vital to find effective preventive agents that cause
fewer or no side effects. For example, raloxifene has action similar to
that of tamoxifen, and was originally studied in the treatment and
prevention of osteoporosis. Scientists noted then that woman who took
raloxifene developed fewer invasive breast cancers than those who were
given placebo. Raloxifene is believed to have fewer side effects than
tamoxifen; to date, studies have not shown an increased risk of
endometrial cancer from the drug. NCI began the Study of Tamoxifen and
Raloxifene (STAR) in 1999 to compare the two drugs. As of April 1,
2001, 9,359 postmenopausal women at high risk for developing breast
cancer have joined STAR, which is seeking 22,000 women. Lessons learned
from BCPT have improved outreach to minorities, and 500 minority women
have joined STAR. This is more than five percent of the total number of
women on the trial.
Both tamoxifen and raloxifene block estrogen receptors in breast
tissue, dramatically reducing the development of breast tumors that
exhibit estrogen receptors (ER+). But neither drug seems to affect
estrogen receptor-negative (ER-) tumors, which are more prevalent in
women under age 50, in black women, and in women at risk due to a
mutation in their BRCA 1 gene. About 20 percent to 30 percent of breast
cancers are ER-. NCI is sponsoring new research to discover strategies
for preventing ER- breast cancer. Preclinical studies using animal
models are critical for identifying new agents to prevent cancer:
creation of animal models of ER- breast cancer (using the Mouse Models
for Human Cancer Consortium) allows the development of protocols aimed
at finding specific and potent agents to prevent ER- breast cancer.
Agents to be studied in clinical trials to prevent ER- breast cancers
include kinase inhibitors, nonsteroid anti-inflammatory drugs such as
COX-2 inhibitors, and retinoids.
screening and early detection
Analysis of the data from the National Health Interview Surveys
revealed that in the last decade, utilization trends for several cancer
screening modalities, including mammography, Pap smears, fecal occult
blood tests, sigmoidoscopy, and digital rectal examination, all
increased. The most dramatic increase was seen in the use of
mammography. Mammography was first monitored nationally in 1987, when
less than thirty percent of all women 40 and older reported having a
recent breast X-ray. Between 1987 and 1992, use of mammography almost
doubled, and by 1998, 67 percent of women reported receiving
mammography within the last two years. Utilization rates vary by age
group. In 1998, 73 percent of women aged 50-64 reported recent
mammography, while women in age groups 40-49 and those over age 65
received mammography at the rate of 63 percent.
For breast cancer screening, high-quality mammography, an X-ray
technique to visualize the internal structure of the breast, is the
most effective technology presently available. Randomized trials in
women screened for breast cancer with conventional mammography have
shown reductions in mortality by 16 percent to 30 percent. We feel
there is potential for improvement in the way screening is done.
Problems with screen film conventional mammography include difficulty
in detecting early lesions in women with dense breast tissue, false
negatives with up to 10-20 percent of breast cancers detected by
physical examination not being visible on screen-film, and false
positives with only 5-40 percent of lesions detected by mammography
being malignant on biopsy. The screen-film has limitations, based on
the fact that film is the medium of imaging acquisition, storage, and
display. Once the mammogram is obtained, the image cannot be altered or
manipulated to obtain an improved view. These limitations pose a
challenge for the technology developers to devise improved technologies
for detection.
Digital mammography has potential advantages over conventional
mammography, which include: improved detection and breast lesion
characterization due to due to a more representative breast image;
image acquisition and display are separated, and each component in this
process can be optimized; image storage, transmission, and retrieval
can be improved; and there is software to assist the radiologist in
interpreting the images.
Over the past year, the NCI has been actively involved in
facilitating the development of a rigorously designed trial with the
American College of Radiology Imaging Network, four competing device
manufacturers, the Center for Devices and Radiologic Health, Food and
Drug Administration, and the Health Care Financing Administration
(HCFA). The trial will start this summer, and will be conducted in
women presenting for screening mammography at one of 20 participating
sites. Approximately 49,500 women will be enrolled over 1.5 years and
followed for an additional year. One fourth of the participants will be
screened on each of the four digital mammography devices, and it is
estimated that approximately 16 percent will be age 65 or older. Each
woman will be screened with two mammograms--one will be a conventional
screen-film, and the other will be a digital mammogram. Abnormalities
on either screening test will be evaluated, and normal screens will be
re-evaluated at one year with conventional mammograms.
The NCI continues to explore new ways to improve imaging methods
for breast cancer screening. We are sponsoring research on non-X-ray
based technologies such as magnetic resonance imaging (MRI), and
breast-specific positron emission tomography (PET) to detect the
disease. Scientists are also evaluating the use of several forms of
non-ionizing radiation in the diagnosis of breast cancer. Promising
areas of investigation include elastography, electrical impedence
spectroscopy, and infrared spectroscopy. The possibility for the future
of breast imaging is to use one or more of these technological
approaches to enhance or even replace X-ray mammography as the
screening study for breast cancer.
molecular approaches to early detection
As we understand more fully cancer's fundamental nature, our
capacity to use a variety of tools to detect the molecular changes
associated with a tumor cell promises to vastly improve our ability to
detect and stage tumors, select treatments and monitor the
effectiveness of a treatment, and determine progress. As the science
advances, seeing how the processes and pathways inside a cell change as
the cell transforms from normal to cancerous will allow us to detect
changes in people earlier, and eventually we expect to be able to
visualize the actual molecular signatures of a cancer. We will be able
to tell which genes are being expressed in a patient's cells, and we
will be able to translate this information directly into better
management of the disease.
The NCI is furthering early cancer detection by establishing a new
national effort toward discovery and development of novel markers for
all cancers: the Early Detection Research Network (EDRN). The objective
of the EDRN is to develop and test molecular tools capable of detecting
early cancer and assessing cancer risk. To do this, the EDRN is
unveiling cellular anomalies of early cancers, known as a cell's
signature, which are signposts of a cell's progression towards cancer.
By harnessing the uniqueness of these molecular signatures, the EDRN is
turning these signatures into molecular tools--biological markers for
screening and detection efforts.
The EDRN was specifically formed to address the unique testing
strategies required for early cancer or risk assessment biomarkers.
Because of low tumor burden in individuals with early stages of cancer
or at risk for developing cancer, the testing strategy for these
biomarkers is necessarily stringent. Not only does the biomarker need
to be clinically adaptable, it must be highly sensitive and specific,
be capable of identifying few abnormal cells among billions of normal
cells, and be available for minimally-invasive testing if it is to be
used for screening. To help address the specific testing requirements
of early cancer and risk biomarkers, the EDRN distributes cancer
researchers into separate, yet coordinated, development, validation,
and clinical laboratories.
The EDRN's approach to biomarker research is also novel because it
encourages leading cancer researchers to focus their research on highly
prevalent cancers, like breast cancer. Of the 31 centers in the EDRN,
nine are developing biomarkers to identify early breast cancer or an
individual's risk of developing breast cancer. This comprehensive,
collaborative approach to breast cancer research merges genetic
pursuits with protein approaches, providing a systematic view of how
the molecular signatures of breast cancer can be used as a unique,
identifying mark.
Genetic approaches to breast cancer detection and risk assessment
are currently underway in five EDRN developmental and clinical
laboratories. Research encompasses biomarker discovery strategies, such
as examining the patterns of active genes, known as gene expression, by
comparing genes expressed in normal cells with cancerous or
precancerous breast cells. Additionally, several laboratories are
examining the gain, change, or loss of genetic material. Some studies
involve genes whose levels are abnormally elevated in breast cancer,
like BRCA-1 and Ki-ras oncogenes, and the p53 tumor suppressor gene.
Others focus on genes that are inactivated by genetic changes, like the
DNA repair gene XPD, and promising research of genetic loss on
chromosome 4 in high-risk populations is underway. Hereditary studies
are also proceeding to amass detailed information and biological
samples from breast cancer prone families.
Complementary to gene-based research, protein-based efforts provide
a view of how genetic gains, changes, and losses affect the proteins
arising from such altered genes. State-of-the-art protein biomarker
research for breast cancer is underway in four developmental and
validation laboratories. Similar to gene expression pattern research,
protein patterns are being explored in three developmental
laboratories. In one laboratory, breast nipple fluid protein patterns
are compared between normal and abnormal breast tissues.
Nipple aspirate fluid (NAF) is a substance that circulates in the
breast ducts, the very structures where breast cancer originates.
Because proteins associated with the biology of the breast are secreted
into this fluid, examination of the fluid should provide a ``snapshot''
of the breast environment. The fluid can be extracted using a method
similar to a breast milk pump, which is non-invasive and easily
performed. The first goal of this research is to identify a protein
signature in breast tumor tissue, then see if this signature can be
reliably detected in NAF. Using the Surface-Enhanced Laser Diffraction
Ionization (SELDI) Time-Of-Flight (TOF), with as little as one drop of
NAF, investigators have demonstrated that different protein peaks could
be identified in the samples from the cancerous breast compared to the
normal breast in the same woman. Further studies are in progress to
determine the validity of this approach with a large number of
specimens.
a revolution in diagnosis
Future attempts to advance our understanding of the etiology of
breast cancer will undoubtedly require a better understanding of the
natural history of this complex and multifactorial disease. It will be
important to consider breast cancer not as one disease but as a
collection of possibly heterogeneous diseases. A number of biomarkers
should be useful in advancing thinking regarding breast cancer. Efforts
are underway to distinctly classify tumors by a variety of parameters,
including hormone receptor status, histologic patterns, and presence of
oncogenes. This approach challenges conventional thinking, but it
conveys the opportunity to target common precursor cells as well as
divergent targets later in the developmental pathway.
The most pressing diagnostic challenges for breast cancer relate to
directing therapeutic choices. Earlier detection of breast cancer is
resulting in a shift to smaller tumors, and in over 50 percent of
cases, there is no apparent spread to the axillary lymph nodes.
Clinical practice guidelines suggest that all breast cancer patients be
considered for some sort of adjuvant therapy, often involving toxic
chemotherapy regimens. About 70 percent of lymph node-negative patients
will actually be cured by definitive surgery plus local/regional
radiotherapy. We do not know how to separate, with sufficient
certainty, the patients with a high risk for recurrence from those in
whom their cancer will not recur.
When patients have metastatic disease, either at the time of their
initial diagnosis or at the time of recurrence, choices must be made
about which therapeutic regimens will be most effective. As new,
targeted therapies, such as Herceptin, are developed, it is important
to be able to identify the patients most likely to benefit.
Both the decisions regarding which patients should be treated and
the choice of treatment require greater understanding of the underlying
biology of breast cancer and of the specific lesion present in the
patient. New comprehensive molecular technologies are allowing
researchers to look at the full spectrum of alterations that have taken
place in the formation of a given tumor. The NCI initiative
``Director's Challenge: Toward a Molecular Classification of Tumors''
is funding investigators to develop profiles of molecular alterations
in human tumors using DNA, RNA, or protein-based comprehensive analysis
technologies. These ``molecular signatures'' are intended to redefine
tumor classification, moving from morphology-based to molecular-based
classification schemes. Tumor classification, based on morphology, or
the tumor's structure, does not always accurately predict the patient's
clinical behavior. Molecular profiles are expected to provide more
informative molecular classification schemes for human cancers by
identifying clinically important tumor subsets within morphological
classes. The goal of the Director's Challenge projects is to have these
new molecular classification schemes developed and ready for clinical
validation by the end of the initial five-year funding period.
A group of Director's Challenge investigators has developed
molecular profiles that identify subsets of node negative breast cancer
patients. Tumors in one subset appear to arise from luminal cells in
breast glands. Tumors in the second subset appear to arise from basal
cells. Patients with basal cell tumors appear to have a significantly
worse outcome and may represent those node negative breast cancer
patients at greater risk for recurrence. Studies are underway to
confirm and extend these initial findings. Another group that was just
funded under the Director's Challenge initiative is attempting to use a
different comprehensive analysis technique to characterize early breast
cancer lesions.
Other research teams are working on development of robust
techniques for analysis and detection of alterations in tumors. It is
likely that patients who do not appear to have involvement of their
regional lymph nodes but later have a recurrence of breast cancer have,
in fact, released cells from the primary tumor site. A number of
investigators are assessing methods for detecting residual disease and
evaluating the clinical significance of their findings. The NCI will be
holding a meeting in the autumn of 2001 to assess the state of the
science of detecting minimal disease and to determine what the research
agenda should be.
Development of tests to identify patients who will respond to
particular therapies or classes of drugs requires considerable
coordination and generally large numbers of patients or specimens from
patients. The NCI has just launched a new effort, the Program for the
Assessment of Clinical Cancer Tests (PACCT), to ensure the translation
of new knowledge about cancer and new technologies to clinical
practice. The initial focus of PACCT is on breast and colon cancer. As
part of the effort to evaluate new markers and to validate the utility
of some known markers/tests, the NCI is putting together reference sets
of specimens. These specimens will be made available to academic and
industry researchers to facilitate the development process. The PACCT
is also developing criteria to help determine the data that are needed
to move a marker test forward to clinical practice.
NCI is accelerating discovery and development of imaging methods
that use new technologies to identify biological and molecular
properties of precancerous and cancerous cells in order to predict
clinical course and response to interventions. Scientists are studying
women with estrogen receptor-positive (ER+) breast cancer before and
just after initiation of tamoxifen therapy using PET, enhanced by the
administration of a chemical agent that indicates estrogen receptor
status, to evaluate whether this technique can be used to predict
responsiveness to hormone therapy in this group of patients. Others are
developing novel radiolabeled estrogen receptor binding molecules as
potential tools for imaging and possible therapeutic applications. NCI-
sponsored researchers are identifying a number of other molecules that
can be conveniently labeled for imaging studies to target and
characterize multi-drug resistance factors in tumors as well as other
tumor-specific features.
new strategies for treatment
The convergence of scientific advances in the areas of cancer
biology, synthetic and biosynthetic chemistry, and high throughput
screening has resulted in the potential to exploit molecular targets
for cancer treatment and the opportunity to revolutionize cancer drug
discovery. We are developing a whole new generation of cancer
treatments: ``smart'' drugs that target the molecular features
characteristic of a particular type of cancer. Even within cancers,
like breast cancer, that have been historically classified only on the
basis of tumor site, we now know that significant heterogeneity exists
in terms of molecular profile. For example, about 35 percent of breast
cancers display higher than normal numbers of receptors for epidermal
growth factor, whereas only 5 percent overexpress a protein called MDM-
2. As many as 75 percent of breast cancers may have altered function of
the p53 protein. Since in reality, multiple forms of breast cancer
exist, the truly effective therapies of the future will be tailored to
the molecular characteristics of the tumor being treated.
Every point of difference between premalignant or malignant cells
and their normal counterparts is a potential target of opportunity for
drug discovery. Targets may be revealed by understanding the
consequences of fundamental molecular changes in cancer, such as those
that spur blood vessel growth to nourish tumors or the means by which
tumors spread by invading surrounding tissue and migrating from their
site of origin. For breast cancer, more than 75 potential targets,
representing over a dozen classes of targets, have already been
identified. NCI is involved in testing over 50 new agents directed at
these targets, and many others are being tested within the private
sector. Scientists report new findings in cancer cell biology every
day, giving us new targets to explore. The opportunities for discovery
in this area are boundless.
As the most promising treatment strategies emerge from
developmental testing, they progress to evaluation in clinical trials,
the final crucial step in translating new discoveries into effective
therapies for patients. In September 2000, the Early Breast Cancer
Trialists' Collaborative Group, a world-wide collaboration of
scientists studying breast cancer, reported that 5 years of tamoxifen
therapy reduces the absolute death rate from breast cancer by 9 percent
in women with hormone-sensitive cancers followed for as long as 15
years after the start of treatment. A majority of the patients that
form the database for this international overview participated via NCI-
sponsored tamoxifen studies. These long-term survival results prove the
principle that targeting a specific biologic feature of the breast
tumor cell, the estrogen receptor in the case of tamoxifen, can lead to
improved outcomes. Furthermore, development of this targeted treatment
demonstrates a prime example of the incremental manner in which
successive clinical trials can result in important improvement in
outcomes. The approach tests new agents initially in advanced disease
and then moves the successful agents into earlier stage treatment aimed
at improving survival.
An even more recent example of this targeted therapeutic approach
is presented by the agent Herceptin. Recently approved by the FDA for
treatment of advanced breast cancer, Herceptin is a recombinant
antibody that targets a specific receptor on the breast cancer cell
membrane. This agent has been shown to improve survival by an average
of 5 months in women with advanced cancer whose tumors express this
receptor. Two definitive studies sponsored by NCI are now underway to
test whether this agent will improve survival even more markedly in
women with earlier stage disease. It is plausible that Herceptin might
follow the same path as tamoxifen and be useful for prevention of
breast cancer, especially in the case of the hormone-insensitive
variety that doesn't respond to tamoxifen. We still have much to learn
about the optimal use of Herceptin and are actively studying ways to
combine it with other active drugs without enhancing side effects. The
NCI is sponsoring ten trials currently with this agent, while
Genentech, the maker of Herceptin, is sponsoring five trials, and there
are 35 investigator-sponsored trials worldwide.
Based upon discoveries in the research lab, there is a plethora of
breast cancer targets with active agents under development. Among the
leading candidates that NCI is studying in clinical trials in advanced
breast cancer at present is an agent that interferes with a prime
growth pathway for breast cancer cells, the epidermal growth factor
pathway. Phase II studies combining the agent with Herceptin and with
chemotherapy will begin shortly. A humanized monoclonal antibody that
interferes with the development of tumor blood supply (angiogenesis) by
blocking vascular endothelial growth factor is also under
investigation. A phase III study testing this agent in combination with
standard chemotherapy has recently been approved by NCI. Another phase
III trial is testing an inhibitor of an enzyme (matrix metallo-
proteinase) that destroys the supporting tissue around tumors,
administered after conventional chemotherapy in patients with advanced
disease. Still another example of a promising new therapy under
evaluation is one of the first selective estrogen receptor degradation
(SERDS) agents. Early work has shown activity in patients whose tumors
are resistant to tamoxifen and a large trial is planned by NCI to test
this agent in early stage disease.
Clinical trials for breast cancer treatment have demonstrated
remarkable success and are a vital component of the NCI's research
program. Currently our clinical trials database contains descriptions
of over 165 treatment trials for breast cancer, including 103 NCI-
sponsored trials. Of these, 81 are Phase I and/or Phase II studies in
which novel approaches to treating breast cancer are tested for safety
and efficacy, and 22 are Phase III trials representing interventions
that are closest to general medical practice. The NCI Clinical Trials
Cooperative Group program performs definitive, large-scale trials to
determine whether new treatments actually improve upon results seen
with current standard approaches. Presently, several new promising
treatments are being evaluated in Phase II and III Cooperative Group
trials. For breast cancer treatment, this effort is the largest single
therapeutics development effort in the world.
While we are working steadily to find new and improved cancer
therapies for breast cancer, we must be certain that the research
results of our trials are communicated effectively to physicians and
patients around the country. In November 2000, the NCI sponsored a
Consensus Development Conference on Adjuvant Therapy For Breast Cancer
that addressed major questions confronting physicians and their
patients once a diagnosis of regionally advanced breast cancer has been
made. An independent, non-governmental panel of breast cancer experts
reviewed the results of clinical trials, and summarized what we have
learned about breast cancer treatment and discussed promising research
directions. Recommendations from this conference were widely
disseminated in both the lay and professional media.
It is imperative that the questions we ask in breast cancer
treatment studies reflect the needs of real people who are coping with
breast cancer. The NCI has developed a new way to describe breast
cancer as a series of clinical states that represent decision points
confronted by patients and physicians. Each of the clinical states is
characterized by tumor features and degree of disease progression, and
lends itself to a tailored management plan based on its collection of
defining traits. A woman who is faced with a diagnosis of breast cancer
today has choices. As she consults with her physician she will learn
about specific aspects of her own disease--the type of tumor she has,
the number of affected lymph nodes, the presence or absence of estrogen
receptors and tumor-specific antigens, and whether or not the disease
has spread to other organs. She and her physician can make informed
decisions about which treatments have potential benefits and which
treatments have risks that outweigh their benefits in her particular
case. And our clinical trials portfolio can be organized to correspond
to the clinical states of breast cancer so we can ensure that our
research is relevant and comprehensive.
survivorship
Although cancer remains among the worst fears of Americans, it is
becoming increasingly clear that cancer is not the ``death sentence''
it once was. More than 7 million Americans alive today have a history
of cancer. The past ten years have seen an explosion of effective,
well-tolerated treatments for cancer. Researchers continue to develop
interventions that will help ameliorate the worst side effects of the
treatment, and measurement of a patient's quality of life now is
included routinely as a component of most NCI-supported clinical
trials.
In one of the largest follow-up studies conducted to date, NCI
funded researchers surveyed the quality of life of almost two thousand
breast cancer survivors, looking at the woman's physical, social,
emotional and sexual functioning post-cancer treatment. Results of this
study confirmed earlier findings that while most breast cancer
survivors continue to do well, women who receive adjuvant treatment
experience poorer functioning long term. Fatigue, though not a
significant problem for the majority of breast cancer survivors in this
study, was closely linked with depression, bodily pain and sleep
disturbance in those who did report fatigue. Lymphedema subsequent to
surgery was found to be more of a problem than previously acknowledged
clinically. Problems with arm swelling were reported by 46 percent of
women undergoing mastectomy alone, 24 percent of women with lumpectomy
and 26 percent of women with mastectomy plus reconstruction.
A descriptive profile of the demographic, clinical, and survival
characteristics of breast cancer survivors diagnosed over a 24-year
period in nine SEER areas in the United States was developed by NCI. An
improvement in the relative survival by decade of diagnosis was
confirmed, and additional analysis was done to compare married and
unmarried survivors. Findings indicated improved survival rates for
married survivors for each decade, reflecting the possible role of
social support or economic advantage in better outcomes.
There are deficits in memory and concentration associated with
breast cancer treatment. NCI funded a study to look at breast cancer
survivor's intellectual ability, quality of life, and normal activities
and roles following breast cancer treatment. Breast cancer survivors
treated with systemic chemotherapy in addition to standard local
treatment, were compared with age-matched breast cancer survivors who
had received local treatment alone. Results of the study showed
significant differences across a variety of neuropsychological tests
between the two groups.
As more cancer patients are successfully treated, we must learn
more from the experiences of long-term cancer survivors. The NCI will
continue to support research covering the entire spectrum of challenges
facing cancer survivors as this need continues to rise.
conclusion
Last year, NCI invested $439 million in breast cancer research,
including $3.5 million in proceeds from the sale of the breast cancer
semi-postal stamp. We expect this to grow to $464 million in 2001 and
$510 million in 2002 in accordance with the President's 2002 budget
request for NCI as part of the National Institutes of Health.
Illustrating our commitment to accelerate progress against breast
cancer, the NCI convened a Progress Review Group (PRG) in 1998 to
conduct an intensive review of our research portfolio in breast cancer.
This initiative, the first of a highly beneficial series of PRG's
fitting within NCI's new disease-specific planning framework, featured
expert panels who provided a comprehensive view of the state of our
current knowledge, and many of our research priorities reflect their
recommendations. We have learned the value of including as broad a
constituency as possible in our review, advisory, and planning
activities, and we have forged new relationships with patients,
practitioners, scientists in different fields of research and medicine,
other government agencies, private sector companies, innovators in
technology, and many other partners where such alliances were rare or
non-existent only a few years ago.
We are making progress against breast cancer. The diligence of all
the people of the breast cancer community is fulfilling the long
awaited promise of science. We have reached an exciting point where we
have a molecular window on cancer and our new strategy of looking at
all aspects of breast cancer from a molecular point of view is bearing
fruit. The pace of discovery is rapid. Our challenge is to translate
this new knowledge into useful and effective screening, preventive,
diagnostic, and treatment tools as quickly as possible to ease the
suffering caused by breast cancer and relieve families of this terrible
burden.
Thank you, Mr. Chairman, for inviting me to appear before the
Committee today and to share with you the progress we have made against
breast cancer. I will be pleased to answer any questions the Committee
may have.
Senator Specter. Well, thank you very much, Dr. Klausner.
There are quite a few questions, and we will come to that in
just a few moments.
We turn now to Dr. Marks. Thank you very much for joining
us, Dr. Marks, and providing the two-front war from NIH and
CDC.
STATEMENT OF JAMES S. MARKS, M.D., M.P.H., DIRECTOR,
NATIONAL CENTER FOR CHRONIC DISEASE
PREVENTION AND HEALTH PROMOTION, CENTERS
FOR DISEASE CONTROL AND PREVENTION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Dr. Marks. Thank you, Mr. Chairman. I am especially pleased
to be here today to talk with you about CDC's national breast
and cervical cancer early detection program. It is in its 11
year of providing free mammograms and pap smears to low income
American women. The program has saved lives and raised the
consciousness of Americans everywhere about the importance of
screening.
And I especially want to put our program in context with
what you have just heard from Rick. When the research is done,
it needs to get out and get out quickly to the American public,
to those in great need. As he described, we know how to save
many of the deaths that now occur from breast cancer.
Mammography is currently the single-most effective method for
diagnosing breast cancer early. And the longer the breast
cancer remains undetected and untreated, the greater the
likelihood it will spread and eventually result in death.
We fund programs in all 50 States, the 6 U.S. territories,
and in 12 Native-American, Alaskan-Native tribal organizations.
In addition, we provide health education to the public, to
health professionals, and a pay for variety of the medical
procedures that are needed to confirm diagnosis.
Through September of 2000, we have provided over 3 million
screenings. About 1.4 million of those were mammograms. And
about 9,500 women have been diagnosed with breast cancer
through the program and helped to find prompt treatment.
If this program did not exist, these women would still have
cancer, but they would not be able to afford mammography, and
the diagnosis would have been delayed for 1, 2, even 3 years
until they could feel the cancer themselves. They would not
have had someone working on their behalf to find treatment for
them. And thus, for many of the women, their treatment also
would have been substantially delayed.
The program's success is due in large part to a large
network of professionals, coalitions and national organizations
dedicated to the early detection and treatment of breast and
cervical cancer. And you will hear from some of them today. But
they include more than 7,000 individuals, who are members of
this national network, that work with the State health
departments in support of this program.
If we could, I would like to ask you to turn your attention
to the maps on mammography use. As Rick described the declines
in mortality, I want to show one of the predecessors to that
decline. And that is the rapid change in mammography
utilization. Here seen in the nineties, the darker States in
1999 are those where over 80 percent of women say that they
have had a mammogram in the last 2 years.
And see where we were at the beginning of the nineties,
where most States had less than 60 percent of women stating
they had a mammogram in the previous 2 years. So there has been
a substantial increase in the number of women getting
mammography recently.
And we are especially pleased that, in fact, the racial and
ethnic disparities that existed early in the nineties have now
been reduced substantially.
What is our vision for the future of this? Quite simply, we
want no woman to die because she lacked the knowledge, the
access, or the finances for mammography screening or whatever
test turns out to be more effective in the future. But we have
far to go. We currently screen about 12 to 15 percent of the
target population of 3.6 million eligible women; that is, women
with no health insurance, ages 40 to 64, who are in need of
mammography annually.
Identifying and educating and motivating these women, who
have rarely or never been screened because of cost and
geographic access, is challenging and labor intensive and
often, in some communities, becomes a door-to-door, one-on-one
campaign.
We know that mammography is not perfect. It misses some
cancers. And it finds lumps that are benign that cause women to
undergo further tests and needless anxiety. When research
determines other methods to be more effective or accurate, we
are prepared to move quickly to help women receive the benefits
of the new proven screening or diagnostic technologies.
I will tell you one story as an example of what is
happening in States around the country. A woman named Beth's
husband lost his job after 28 years. Before he lost his job, it
provided their health insurance, and she received a mammogram
every year. This time she waited 5 years before she got another
mammogram. She might never have had another one had she not
found out about Vermont's Ladies First program, the screening
program there.
She went in for her free mammogram, and it turned out to be
none too soon. It showed a lesion that was cancer. The good
news is that it was caught early and treated successfully.
Without that Lady's First program and the help to get
treatment, though, she also would not have been able to afford
treatment. As such, she it got her treatment and was able to
reduce that financial burden for her and her husband. She
credits it with saving her life.
There are many stories like this out there. And while we
like to hear them, we are also concerned about the ones we do
not hear about, who did not get screening because they did not
know about it. And we hope we can reach more of these women and
catch their cancer early.
Prepared statement
If more research from NIH or elsewhere provides us with
something even better than mammography, we will use the CDC-
supported programs and community networks to get that science
to women as quickly as possible.
Thank you.
[The statement follows:]
Prepared Statement of James S. Marks
Mr. Chairman, members of the committee, I am especially pleased to
be here today to talk with you about the Center for Disease Control and
Prevention's (CDC) National Breast and Cervical Cancer Early Detection
Program. Now in its 11th year of providing free mammograms and Pap
smears to low-income American women, this program has saved lives, and
contributed to the increased awareness of many American women about the
importance of screening and early detection in preventing deaths from
cancer.
Today I will talk about why we are so committed to this program,
why now is such an important time for this program, and what our vision
for the future is.
Recognizing the value of appropriate cancer screening, Congress
passed the Breast and Cervical Cancer Mortality Prevention Act of 1990
(Public Law 101-354) which enables CDC's National Breast and Cervical
Cancer Early Detection Program to provide critical breast and cervical
cancer screening services to underserved and uninsured women, including
older women, women with low incomes, and women of racial and ethnic
minorities. Breast health services are available for women aged 40-64.
Appropriations have increased from $5 million in fiscal year 1990 to
approximately $180 million in fiscal year 2001. There have been great
successes and advances in detecting breast and cervical cancers with
the help of this program, but challenges remain.
CDC supports early detection programs in all 50 states, six U.S.
territories, the District of Columbia, and 12 American Indian and
Alaska Native organizations. The program establishes, expands, and
improves community-based screening services for women to reduce breast
and cervical cancer mortality. The success of the breast and cervical
cancer program depends on screening, education and outreach,
partnership development, case management, and mechanisms to assure the
quality of tests and procedures, all of which, are part of the program.
Through September 2000, more than 3 million screening tests have
been provided to more than 1.8 million women. That number includes 1.6
million Pap tests and 1.4 million mammograms. Almost half of these
screenings were to minority women, who have traditionally had less
access to these services. More than 9,500 women have been diagnosed
with breast cancer, more than 40,000 women were diagnosed with
precancerous cervical lesions, and 715 women were found to have
invasive cervical cancer.
CDC collects data from all funded programs to monitor and evaluate
each clinical service program. For each woman enrolled in the program,
information is collected on demographic characteristics, mammogram
results, breast exams, Pap tests, diagnostic procedures and outcomes,
cancer diagnoses, and, for women diagnosed with cancer, information on
the onset of treatment.
The program's success is due in part to the dedication of a large
network of professionals, coalitions and national organizations devoted
to detecting breast and cervical cancer early.
--An estimated 27,000 health professionals are involved in providing
breast and cervical cancer screening services to underserved
and uninsured women.
--More than 18,000 health educators and outreach workers are
educating women on the importance of early detection and
helping them access critical screening and follow-up services.
Many of these individuals are local employees and volunteers,
most of whom are contracted with support from CDC.
--More than 7,000 individuals are now members of a national network
of coalitions that have joined together with State health
departments in support of this program.
The percentage of women ages 40 and older who reported ever having
a mammogram increased from 64 percent in 1989 to 85 percent in 1997,
and the percentage of women who reported receiving a mammogram within
the previous two years increased from 54 percent in 1989 to 71 percent
in 1997. Disparity rates for mammography utilization among most
minority groups have either been eliminated or reduced, and overall,
there has also been a recent decline in the rate of breast cancer
mortality among all women. While much remains to be done, our most
recent mortality data reflect that 19.4 women per 100,000 die of breast
cancer, surpassing our Healthy People 2000 goal of reducing mortality
from 23 to 20.6 women per 100,000.
Please refer to the maps that use CDC Behavioral Risk Factor
Surveillance Survey data. These maps show trends in the states
reporting women aged 50 years and older who had a recent mammogram in
the years 1991, 1995, and 1999. The darker colors have the higher rates
of recent mammography utilization. Although this is encouraging news,
the maps show that we still have many more women to reach.
Breast and cervical cancers are very serious concerns for American
women. During the past decade, almost one-half million women have died
of breast and cervical cancer. In 2001, the American Cancer Society
estimates that 192,200 women will be diagnosed with breast cancer and
40,600 will die of the disease.
Preventing or curing all cancers is our collective goal. But let me
be clear. We know today how to prevent up to 30 percent of all deaths
from breast cancer. It is not a new scientific breakthrough; it is
mammography. This technology has been around since the late 1970s.
Additionally, the Guide to Community Preventive Services has
recommended routine mammography screening since the 1980s. Mammography
is currently the single most effective method for diagnosing breast
cancer early. The longer breast cancer remains undetected and
untreated, the greater the likelihood it will spread. The five-year
survival rate drops from 97 percent when breast cancer is diagnosed at
the local stage, to 21 percent when it is detected after having spread.
Mammography, however, is not perfect. According to the Institute of
Medicine, routine screening in clinical trials resulted in a 25 to 30
percent decrease in breast cancer mortality among women between the
ages of 50 and 70. When research determines other methods to be more
effective or accurate, CDC is prepared to move quickly to help women
receive the benefits of new proven screening or diagnostic
technologies. Our goal is that all women should have access to existing
and future detection methods and treatments so that breast cancer could
eventually no longer kill so many.
To that end, we are working with the National Cancer Institute and
an independent non-Federal Task Force on Community Preventive Services,
to develop a Guide to Community Preventive Services. This Community
Guide provides an in depth review of community health care
interventions that are shown to be effective at promoting health and
preventing disease. We are examining the community-wide interventions
to increase the appropriate use of screening for breast, cervical, and
colorectal cancer and the evaluation of the effectiveness of
interventions to improve use of cancer screening. The review will be
completed within the next 18 months and will be a useful resource to
our screening programs in states to guide them on the most effective
strategies to increase screening utilization. CDC will also be funding
several research projects this year that will be designed to test the
effectiveness of interventions to increase use for screening of breast
and cervical cancer.
In October 2000, the Breast and Cervical Cancer Treatment Act of
2000 became law. This new law gives states the option of providing full
Medicaid benefits to uninsured women who are diagnosed with breast or
cervical cancer by the CDC screening program. We commend Congress, this
committee, the National Breast Cancer Coalition, and the American
Cancer Society for this unprecedented legislation.
Much progress has been made in making the Medicaid option a reality
for many women in need of treatment. CDC and the Health Care Financing
Administration (HCFA) have developed and distributed the necessary
materials and instructions for states to implement this Medicaid
optional benefit. On January 4, 2001 a guidance letter was sent to
health officials in all 50 states to encourage their participation
through the submission of a Medicaid plan amendment. Detailed questions
and answers regarding the new benefit have also been provided. CDC and
HCFA have hosted conference calls with national organizations, state
breast and cervical cancer programs and state Medicaid agencies to
encourage all states to consider this Medicaid option. To date, more
than half of the States have taken action, including the introduction
or enactment of legislation, revision or enactment of regulations, or
the submission of revised Medicaid plans. Three States, Maryland, New
Hampshire, and West Virginia, have U.S. Department of Health and Human
Services (DHHS) approved amended Medicaid Plans; Rhode Island's plan is
currently under review. Information about the Medicaid Treatment Act
and its progress toward implementation can be located on CDC's Web
site: http://www.cdc.gov/cancer/nbccedp/law106-354.htm and on the HCFA
web site http://www.hcfa.gov/medicaid/BCCPT/default.htm and an
electronic mailbox [email protected].
What's our vision for the future of the breast and cervical cancer
early detection program? Quite simply, we want no woman to die because
she lacked knowledge, access or finances for mammography screening.
Identifying, educating and motivating women who have rarely or never
been screened for breast cancer is an enormous challenge. To be
successful in these cases, the outreach efforts of CDC's program in
communities often become a door-to-door, one-on-one campaign to reduce
community and individual barriers that impede a woman's ability or
decision to obtain the lifesaving benefits of early detection. Barriers
such as fear, lack of transportation and child care, linguistic and
cultural differences, and lack of physician referral are all common
hurdles that must be overcome. Many outreach strategies are employed to
overcome these barriers.
More and more women every year are reaching the age for regular
screening-in fact, every eight seconds a baby-boomer reaches the age of
50--the age when the likelihood of developing breast cancer begins to
increase rapidly--and a large number of these women are underserved or
uninsured. To date, we have screened 12-15 percent of the target
population representing 3.6 million women aged 40-64 in need of
mammography services annually.
Let me end by telling you a story. It's Beth's story. Beth's
husband David lost his job after 28 years. Before David lost his job,
Beth made sure to get a mammogram every year. This time, Beth waited
five years before she was checked. She might never have had another one
if she hadn't found out about Ladies First, the Vermont breast and
cervical cancer screening program. When Beth went in for her free
mammogram, it was none too soon. Beth's mammogram showed a lesion that
turned out to be cancer. The good news is that doctors caught Beth's
cancer early enough to treat it successfully. With other help from
Ladies First, the cancer treatment was not a financial burden for Beth
or her husband. Beth credits Ladies First with saving her life.
There are many Beths out there, and we love to hear their stories.
But what concerns us most are the women we don't hear about, the women
who are not getting regular screening. Awareness of the program isn't
the issue; not being screened is. We hope that we can reach more of
these women and catch their cancer early. And when research provides us
something even better than mammography, we will use the CDC-funded
programs to get that science to women as quickly as possible. Thank
you.
PROGRESS AGAINST CANCER
Senator Specter. Thank you very much, Dr. Marks.
Dr. Klausner, starting with you, it is really very dramatic
what you are testifying about today, with the total
reevaluation as you analyze breast cancer with the molecular
analysis and six different potential causative factors. We are
looking for a very, very big increase in NIH funding this year.
We are looking at $3.4 billion.
And there is always a question raised, as to, is the money
being wisely used. Are we putting too much money into NIH too
fast to have it assimilated? And the other question, which is
the corollary, how much progress is being made? And as you
know, I make it a practice to ask you for a prognosis as to a
cure date.
I realize that it is very difficult. I realize that it is
perhaps impossible. But we finally got the researchers in
Parkinson's to give us a five-year time interval. And to the
extent that you can make a projection, it is very helpful to us
on the subcommittee to carry the day for this very substantial
increase in funding, if we are able to give some indication as
to when there might be a cure.
Dr. Klausner. Yes. I think we are going to have----
Senator Specter. This week in Philadelphia it is the Race
for the Cure.
Dr. Klausner. Right. I think----
Senator Specter. So what do you think?
Dr. Klausner [continuing]. We are going to have cures, but
I think there are going to be numerous cures. They are going to
have to be aligned to the different types of diseases, as I
have shown you. A date, as you know, is very hard to say. What
I can say is that what is lined up at the starting gate, which
is what I showed you, for the first time are the types of drugs
and the types of targets that will give us the cure.
What is limiting the time, or knowing the time that we will
have the answers about these is how many, how quickly, get out
of the laboratory and into clinical trials. That is limited
right now not by whether we have the targets, or whether we are
beginning to have the drugs, but in fact by funding.
My feeling is----
Senator Specter. Are you saying that you could use even
more funding----
Dr. Klausner. Yes.
Senator Specter [continuing]. Wisely?
Dr. Klausner. Yes. I mean----
Senator Specter. If you had your absolute druthers, what
would the figure be?
Dr. Klausner. In our strategic plan, where we know exactly
what is coming in and exactly what our priorities say we want
to fund, we have already produced a budget for NCI, as we are
legally required to do, requiring a 20-percent increase over
fiscal year 2001 in order to make sure that the pipeline I have
shown you that is ready to be filled is filled.
Senator Specter. A 20-percent increase?
Dr. Klausner. Yes.
Senator Specter. What do you project you would get if our
figure of $3.4 billion increase for NIH is finally approved?
Dr. Klausner. An 11.8-percent increase.
Senator Specter. Can you give the subcommittee some
specification as to where you would use that extra money?
Dr. Klausner. Absolutely. Would you want me to do that in
writing, or would you like that----
Senator Specter. Oh, I think you had better do it in
writing because of the time limitation.
Dr. Klausner. Yes. We are happy to do that.
Senator Specter. That would be very helpful. And if you
could amplify in writing your projection as to the results that
you would anticipate. This is a three-part writing. Number one,
what have you been able to do with the existing increases? Two,
what will you be able to do with an 11-percent increase? And
three, what will you be able to do with a 20-percent increase?
Dr. Klausner. Yes, sir.
Senator Specter. Dr. Marks, the Centers for Disease Control
is an enormously importantly institution. But it has not gotten
nearly the kind of attention that the National Institute of
Health has. And I think something needs to be done to elevate
the public perception there. I had heard about how bad the
physical facilities were in Atlanta and finally decided to make
a trip there last year and was shocked to see how bad they
were.
And that picture had never been adequately presented to the
subcommittee. We just had never known really how bad it was. So
we added the $170 million to your budget last year, looking for
a long-range plan in excess of $1 billion. While it is not
directly on this point, I would be interested--well, it is
directly on this point, because if you do not have an adequate
physical plant, you cannot conduct your work on breast cancer.
What are your needs and how badly are you hurt by the
current state of deterioration?
Dr. Marks. The CDC's long-range plan for fixing its
physical plant is, as you stated, about $1 billion over a 5- to
10-year period of time. And with the monies that you supported
and the Senate supported last year, that plan is well under
way, especially in building on the Clifton Road complex, but
also on the complex that is out in Chamblee. CDC currently has,
in addition, 22 sites around Atlanta, mostly of rental space.
And you saw specifically the situation in the laboratories,
where, quite clearly, using World War II quonset huts as the
labs is affecting the quality of that work.
Senator Specter. And that has impacted on your work on
breast cancer, among others.
Dr. Marks. It impacts all of our work. It impacts our work
in several ways. One is that in some of the concerns that
States have around potential environmental causes, those labs
work on those. The other is that being spread out--in fact,
much of the synergy that might occur between programs, in fact,
is blocked----
Senator Specter. Let me interrupt you at that point----
Dr. Marks. Sure.
Senator Specter [continuing]. And ask you to supplement it
in writing.
Dr. Marks. Sure.
Senator Specter. Let me ask you now about the mammography.
We had a big controversy not too long ago as to whether there
should be mammograms for women between 40 and 50. And this
subcommittee took a very forceful position that those
mammograms ought to continue. And we were accused of being
political.
I had a hard time understanding that accusation. I do
understand it sometimes. But I had a little trouble there. And
I thought that if priorities were to be set, they ought to be
set by the Congress as to where we wanted to spend the money.
Dr. Marks, what is your view of the importance of
mammograms for women between 40 and 50?
Dr. Marks. You know what the science has said, the
consensus conference that came out of NIH. We believe that the
data is becoming increasingly strong that mammography at those
ages finds cancer early, that it can save lives. And in our
program we support the States screening women in those ages.
That was not the case at the beginning of the decade, when
the recommendations were for women 50 and older. But it is the
case now. And we are seeing those screening rates go up.
Senator Specter. And one final question, on the issue of
racial and ethnic differences, you say they are lesser now. How
much differences are there on racial and ethnic lines?
Dr. Marks. There still remains substantial differences in
mortality rates by race. What we are seeing, though, is that
the screening rates have narrowed substantially. And they
appear to have been eliminated for African-Americans and for
Asian-Americans. There are still some differences----
Senator Specter. I am going to have to go vote right now,
because there is just a few minutes left on the vote. Actually
no time, but we have a grace period of 5 minutes, which it will
take me to get to the floor. But I would be interested to know
what differentials are and what you would need to correct
those.
Dr. Marks. That would be fine.
Senator Specter. Okay. We will recess now, and I will be
back just as soon as I can. Thank you.
Dr. Marks. Thank you very much.
Senator Specter. The hearing of the Subcommittee on Labor,
Health, Human Services and Education will continue. And after
hearing from our distinguished ranking member, we will turn to
panel number two.
Senator Harkin.
Senator Harkin. Thank you very much, Mr. Chairman.
Senator Specter. Before you had arrived, I was excessively
laudatory about you.
Senator Harkin. Maybe I should not say anything.
Senator Specter. Well, it would be hard to improve your
position over where it is now, but that never stops any of us
from trying.
Senator Harkin. We are in the Senate, are we not?
OPENING STATEMENT OF SENATOR TOM HARKIN
Thank you, Mr. Chairman, for calling this hearing and for
your many years of dedication and leadership on this issue that
means so much to all of us and some of us, perhaps, more
poignantly than others.
As many of you know, both of my sisters, my only two
sisters, both died of breast cancer at quite an early age. I
often think that if they had had access to better screening and
better care and earlier interventions, they would have lived
much longer and still be alive today.
So I have often thought that we had to declare a war on
breast cancer. We have come a long way, come a long way in the
last 10 years or more. But we are still not there yet. We have
to continue our efforts.
About a decade ago, when we first looked at this issue and
how much money was going into research, I found that only about
$90 million was going into breast cancer. And so with the help
of many of you in this room--and I see a lot of familiar faces
from that battle of, well, it will be almost a decade ago now,
when we offered the amendment to take $210 million from the
Defense Department budget and put it into breast cancer
research, we did that.
I also want to publicly thank a member of our committee who
is not here, but who was singularly also responsible for
helping make that happen and to make sure that we have kept
that in every year. We have maintained the funding at DOD every
year. It doubled the funding for breast cancer research. And
without the help of Senator Inouye from Hawaii, who serves both
on this subcommittee and on the Defense Appropriations
Subcommittee, I do not think that would have been possible. So
I want to publicly thank Senator Inouye for his help in this
effort.
This year I am proud to say that between DOD and NIH the
Federal Government will invest about $600 million on finding a
cure or improving therapy for breast cancer. Again, this
tremendous increase in a relatively short period of time is due
in large part to the tremendous work of women across the
country who have become activists and who have demanded
actions.
As I said to a friend, it is not timidity that gets you
anything around this joint. And I am glad that you are not
timid.
But our investments are beginning to pay off through the
National Cancer Institute. And I am sorry I missed Dr.
Klausner's presentation earlier, but I am delighted that he is
here, because he also has been in the forefront of ensuring
that we get funds and the focus on breast cancer research.
Researchers are making exciting discoveries about
prevention, detection, diagnosis, treatment and control. We
know better than ever before how a healthy cell becomes
cancerous, how it spreads, why some breast cancer tumors are
more aggressive than others, why some women suffer more
severely than others.
The discovery of the BRCA1 gene has led us to better
identify women who are risk of breast cancer so the disease can
be caught early and treated. Of course, the development of
cancer-fighting drugs, like Tamoxifen, owe a great deal to our
Federal research investment.
But again, building our research enterprise would be
pointless if breakthroughs in diagnosis, treatment and cures
are not available to patients. And hopefully, we are making
progress on that front. About a decade ago, we added
mammography screening as a Medicare benefit. And this
subcommittee began funding a nationwide breast and cervical
cancer screening effort for younger women who do not have
insurance coverage. This initiative, which is run by the
Centers for Disease Control and Prevention, has been a great
success.
To date, in just a decade, more than 1 million low income
American women have been screened, 9,000 in my own State of
Iowa. So we are making progress. But as I said, this is an
ongoing war, and we cannot let up now. We have to dedicate our
resources, both on the research end and the outreach end, to
make sure that we win this war.
Mr. Chairman, I am pleased that we have such a
distinguished panel of guests with us this morning. I
especially want to extend a special welcome to Christine
Carpenter, who is visiting here from Peter Falls, Iowa. Her
courage as a breast cancer survivor is matched only by the
courage she shows as a breast cancer activist.
I am glad you are that. So I welcome you, Christine, and I
welcome all of you to this hearing.
And again, Mr. Chairman, thank you for your leadership and
your steadfastness in making sure we have the funds to continue
our research and our outreach prevention programs, detection
programs, at the Centers for Disease Control and Prevention.
Senator Specter. Thank you very much, Senator Harkin.
We have a very distinguished panel. Senator Harkin called
special attention to Ms. Carpenter, an Iowan. And I similarly
call special attention to Ms. Fran Visco, a Pennsylvanian.
It is always hard with a panel of this quality to know what
the order of sequence should be. So that is solved by Bettilou
Taylor, the clerk of this subcommittee, who alphabetizes.
So we have not shown any undue preference for Pennsylvania
or Iowa. So you know what we are thinking about.
We turn now to Ms. Nancy Brinker, who is founder of the
Susan Komen Breast Cancer Foundation, which she started 20
years ago in memory of her sister Susie, who died of the
disease. To date, this foundation has raised over $300 million
to further research, education and treatment of breast cancer.
She has served on numerous boards and advisory panels and is
the recipient of numerous awards, including the Champions of
Excellence Award presented by the CDC, Ladies Home Journal's
100 Most Powerful Women of the 20th Century, and Biography
Magazine's 10 Most Powerful Women in America.
And although it is not on her introduction, I am sure the
next group will classify her in the 10 most prominent women of
some other group, if not the most powerful.
Nancy, the floor is yours.
STATEMENT OF NANCY G. BRINKER, FOUNDING CHAIRMAN, SUSAN
G. KOMEN BREAST CANCER FOUNDATION
Ms. Brinker. Thank you, Mr. Chairman, very much for that
kind introduction.
And thank you, Senator Harkin and distinguished members of
the subcommittee, for your enduring commitment to our cause. We
do so appreciate it.
Many of you have been long-time supporters of the Komen
Foundation and Race for the Cure. And I am here to thank you.
And I am also pleased to be joined today by the chair elect of
the Komen Foundation, Dr. Lasalle Leffall, who will also have a
few brief remarks.
But I am here today neither as a physician nor researcher,
but as a patient advocate and a breast cancer survivor myself.
I began the Komen Foundation, as you pointed out, Mr. Chairman,
when my older sister, Susie, died of the disease in 1980 at the
age of 36. We did not start with much, a few hundred dollars,
some friends, and a lot of will. But we had something more
important. We had a mission. And it was to eradicate breast
cancer as a life-threatening disease.
And to achieve that goal, we had to change both the
clinical and the cultural environment in this country. And we
have. The Komen Foundation has become the largest private
funder of breast cancer research in America, expanded knowledge
of biology, new treatment regimes, better screening and
diagnostics techniques and public education and outreach, they
have all improved the outlook for many women and are
responsible for declining breast cancer rates.
Among women in the United States, the death rate from
breast cancers have been decreasing by about 2 percent
annually, suggesting that the awareness, early detection, and
improved therapy are indeed having an impact.
When the Komen Foundation was first established, the
Federal Government, as you pointed out, Mr. Chairman, was only
beginning to recognize the importance of funding research. And
as Federal funding has increased, strong public-private
partnerships have produced real clinical results and a better
quality of life for thousands of women and men. And the Komen
Foundation and my colleagues, I am proud of them all, have
forged many of these public-private partnerships. We have
awarded more than $68 million in grants for innovative
research.
These grants often leverage Federal research dollars and
enable world-class scientists in some of the Nation's most
prestigious research organizations to investigate new ideas and
advance research. But until a cure is found, the Komen
Foundation believes that we must do everything within our power
to promote the life-saving message of early detection and
appropriate high-quality treatment.
Our public awareness efforts are crucial to our mission.
And our grassroots approach has achieved extraordinary results.
There are 118 affiliates across the country and abroad. We
identify local community needs and fund non-duplicative
education screening and treatment programs to meet these needs.
And thanks to innovative research, what we now know about
breast cancer is at an all-time high. And the push for research
and development of new technologies and therapies continues.
However, while our knowledge base is rapidly increasing, the
gap between what the scientific community knows and what women
and men in their own communities receive is widening. The Komen
Foundation is committed to closing this gap. We believe that to
eradicate this disease we must not only invest in research and
a cure for future generations, but we must meet the immediate
needs of women and their families facing the disease today.
Whether it is cutting-edge research, grassroots education,
screening or treatment, our progress at Komen and as a society
is simply not possible without significant government support.
We have dedicated millions of our own volunteer hours and
privately raised dollars. But I assure you that we will
continue our mission. But I must also emphasize that we know
that we are not in this alone, and we need your help, your
continued help.
I urge Congress and the President to increase funding for
the National Cancer Institute for fiscal year 2002 to $5
billion and expand funding for the NIH by 16.7 percent over the
fiscal year 2001 level. The NIH increase is necessary to keep
on track with the commitment of Congress to double the NIH
budget between fiscal year 1999 and fiscal year 2003. I assure
you that we will continue to add value to your investment.
And we need continued strong Federal support for the
National Breast and Cervical Cancer Early Detection Program.
This program provides screening, outreach and case management
services to high-risk, low income women in all 50 States. To
date, over 1 million women have been screened and thousands
have been diagnosed. Yet because of current funding
limitations, the program only research approximately 15 percent
of all eligible women.
To ensure that many of this Nation's low income women are
served, we urge an increase in Federal funding to a level of at
least $210 million.
Prepared statement
And finally, we urge you to work with us as we explore and
conquer the economic, cultural and knowledge barriers to
bringing the fruits of scientific progress to the patients who
desperately need them. We have made significant strides. I
believe we are on the edge of real breakthrough that can save
more and more lives. But we must have the funding to go the
last mile in this race for the cure. We must close the gap
between what we know about breast cancer and the care that we
deliver. I assure you that the Komen Foundation will continue
its commitment to closing this gap.
Thank you for this opportunity.
[The statement follows:]
Prepared Statement of Nancy G. Brinker
Chairman Specter, Senator Harkin and distinguished Members of the
Subcommittee, thank you for the opportunity to testify on the state of
breast cancer today and for bringing attention to this very important
issue.
I am here today neither as a doctor nor a researcher, but as a
patient advocate of more than twenty years. I began the Susan G. Komen
Breast Cancer Foundation in 1982 after my older sister, Suzy Komen,
died of breast cancer at the age of 36. We didn't start with much--a
few hundred dollars, an office in my home, and a few friends. But we
had something more important--a mission--to eradicate breast cancer as
a life-threatening disease. To achieve that goal, we had to change both
the clinical and cultural landscape of breast cancer, and we have.
Today, the Komen Foundation has become the largest private funder
of breast cancer research in America. Expanded knowledge of biology,
new treatment regimens, better screening and diagnostic techniques and
public education and outreach have improved the outlook for many women
and are responsible for declining breast cancer rates. Among women in
the United States, the death rate from breast cancer has been
decreasing by about 2 percent annually over the past decade, suggesting
that public awareness, early detection and improved therapy are having
an impact on the disease.
When the Komen Foundation was established, the federal government
was only beginning to recognize the importance of funding research. As
federal funding for breast cancer research has increased, strong
public-private partnerships have produced real clinical results and a
better quality of life for thousands of women and men living with
breast cancer.
The Komen Foundation has forged many of these public-private
partnerships. We have awarded over $68 million in grants for innovative
research. These grants often leverage federal research dollars and
enable world-class scientists in some of the nation's most prestigious
research institutions to investigate exciting new ideas that advance
breast cancer research.
Until a cure for breast cancer is found, the Komen Foundation
believes that we must do everything within our power to promote the
life-saving message of early detection and treatment. Our public
awareness efforts are crucial to our mission, and our grassroots
approach has achieved extraordinary results. Through 118 Affiliates
across this country and abroad, we identify local community needs and
fund non-duplicative education, screening and treatment programs to
meet those needs.
Thanks to innovative research, what we now know about breast cancer
is at an all time high; and the push for research and development of
new technologies and therapies continues. However, while our knowledge
base is rapidly increasing, the gap between what the scientific
community knows, and what women and men in their own communities
receive, is widening. The Komen Foundation is committed to closing this
gap. We believe that to eradicate breast cancer as a life-threatening
disease, we must not only invest in research for a cure for future
generations, but we must meet the immediate needs of women and their
families facing the disease today.
Meeting those needs will require greater access to current
technologies and innovative therapies, particularly in medically
underserved communities. Quality care can only be assured if all cancer
patients are guaranteed medically appropriate and timely access to
specialists and specialized treatment.
And we must also ensure adequate levels of reimbursement of new and
existing technologies and therapies by private and public third party
payers, so that the delivery of quality care and the dissemination of
the results of our cutting edge research and development are not
compromised.
The Komen Foundation's commitment to the delivery of quality care
is steadfast. Through a landmark research study, the Komen Foundation
has joined the American Society of Clinical Oncology (ASCO), Harvard
School of Public Health and the Rand Corporation to address the serious
lack of information about the quality of care cancer patients receive.
We want to know if patients are getting appropriate screenings and
timely diagnoses; if physicians are accessible; if we are effectively
managing pain; if patients are getting the full recommended dose of
chemotherapy or radiation therapy; and how long it takes to get
referred to a specialist. We also want to know if patients are given
the option to participate in a clinical trial, a key to advancing new
cancer therapies. And we want to know what is there for all patients,
or only some.
Whether it's cutting-edge research, grassroots education,
screening, or treatment programs, our progress at the Komen Foundation
and as a society is simply not possible without significant government
support. The Komen Foundation has dedicated millions of our own
volunteer hours and privately raised dollars towards eradicating breast
cancer as a life-threatening disease. I assure you that we will
continue our mission, but I must also emphasize that we know we are not
in this alone. We need your help.
I urge Congress and the President to increase funding for the
National Cancer Institute (NCI) for fiscal year 2002 to five (5)
billion dollars and expand funding for the National Institutes of
Health (NIH) by 16.7 percent over the fiscal year 2001 level. The NIH
increase is necessary to keep on track with the commitment of Congress
to double the NIH budget between fiscal year 1999 and fiscal year 2003.
I assure you that the Komen Foundation will continue to look to add
value to your investment.
And we need continued strong federal support for the National
Breast and Cervical Cancer Early Detection Program (NBCCEDP). I was
very disappointed to learn of the Administration's proposed budget cuts
to this life-saving program. This program provides screening, outreach
and case-management services to assist high-risk, low-income women in
all fifty states, who otherwise do not have access to health care. To
date, over one million women have been screened, and thousands of
breast and cervical cancers have been diagnosed. Yet, because of
current funding limitations, the program only reaches approximately 15
percent of all eligible women. To ensure that many more of this
nation's low-income, medically-underserved women have access to this
life-saving program, the Komen Foundation urges an increase in federal
funding to a level of at least $210 million. Komen is fighting hard for
this increase in funding, and I hope you will join with us.
And finally, we urge you to work with us as we explore and conquer
the economic, cultural, and knowledge barriers to bringing the fruits
of scientific progress to the patients who so desperately need them.
We have made significant strides in the war against breast cancer.
I believe we are on the edge of real breakthroughs that could save
thousands of lives, but we must have the funding to go the last mile,
and we must close the gap between what we know about breast cancer and
what care we deliver. I assure you that the Komen Foundation will
continue its commitment to closing this gap.
Thank you very much.
Senator Specter. Thank you very much, Ms. Brinker.
STATEMENT OF CHRISTINE CARPENTER, MEMBER, NATIONAL
BREAST CANCER COALITION
Senator Specter. We turn now to Ms. Christine Carpenter, a
school psychologist from Cedar Falls, Iowa, diagnosed with
breast cancer in 1993 at the age of 45. She is the founder and
president of an Iowa breast cancer education and advocacy
group. She received her master's degree in education with
administration from Illinois State University, a master's
degree in human psychological services from Bradley, and a
bachelor's degree in special education from the University of
Northern Iowa.
Welcome, Ms. Carpenter, and we look forward to your
testimony.
Ms. Carpenter. Thank you. Good morning. My name is
Christine Carpenter, and I am from Cedar Falls.
I am a 7-year breast cancer survivor, and I am also a
mother, a wife, a school psychologist, and a member of the
National Breast Cancer Coalition.
Thank you, Chairman Specter, members of the committee, and
especially Senator Harkin, for your leadership and work on the
issue of breast cancer. It is an honor to have the opportunity
to testify today.
When I was diagnosed with breast cancer in 1993 at the age
of 45, I did not think I would live to see my daughter, who was
14 at the time, graduate from high school. I am thrilled that I
have lived long enough to attend her college graduation this
month.
Although 7\1/2\ years have passed since my breast cancer
diagnosis, there is not a day that goes by that I do not fear
for the future. I am haunted by studies showing that more than
half of the women diagnosed with invasive breast cancer die
within 20 years.
Breast cancer came as a shock. I had always been healthy,
ate right, exercised regularly, never smoked, rarely drank
alcohol. I was vigilant about doing monthly breast self-exams
and had yearly mammograms. I had even breast-fed my daughter
for several years. And I had no significant family history of
breast cancer. So how could this happen to me?
After doing a self-breast exam and feeling a lump, I was
relieved when a mammogram showed nothing. But then a later
biopsy confirmed breast cancer. I had been diagnosed with a
disease for which there is no known cause, no prevention, no
foolproof way of detecting, and no cure.
In the fall of 1993, I began my breast cancer treatment. I
had a modified radical mastectomy and 6 months of chemotherapy.
I got intravenous injections that made me feel tired and
agitated. My whole body hurt. I lost my hair.
I had to take pills to counter the side effects of the side
effects of medication. I felt shock, grief, and depression
about what was happening to me. There were moments during my
treatment when I was in such physical and emotional misery that
death looked appealing. However, I would look to my loving
family and realize that for them I had to get through this.
Following my treatment, I started to consider how many
across the country were going through the same thing I was
going through. I also thought about all the women who will go
through this, but do not even know it yet. And I thought about
my own daughter and realized that I must do something to end
this disease.
In 1997 I gathered a small but mighty group of women in the
Cedar Falls/Waterloo area. And together we created Iowa Breast
Cancer Edu-Action, an education and advocacy group. Our first
mission was to help women diagnosed with breast cancer make
decisions about how to receive quality health care. With the
distribution of 7,000 free copies of the Iowa Breast Cancer
Resource Guide, our goal was to begin to empower Iowa women and
men and help them seek the best possible treatment and healing.
And empower them we did.
We joined forces with others and created an all Iowa
network to advocate for the prevention and cure for breast
cancer. At the same time, we joined more than 500 other
organizations and tens of thousands of individuals and became
members of the National Breast Cancer Coalition.
My participation in breast cancer activism has helped me to
heal. It has also helped me channel my own fear and anger into
advocacy and action. And perhaps most importantly, it has made
me realize that we must not stop fighting until we have
eradicated this disease.
Fortunately I am not alone in my determination. The
momentum across the country around this issue is extraordinary.
Women and their families affected by this disease have refused
to take no for an answer. They have demanded that more continue
to be done until we have a cure for this disease.
Just yesterday I was reminded of this incredible passion
and power as I walked the halls of Congress with nearly 600
activists in town to advocate for the National Breast Cancer
Coalition's agenda. We urged our senators and representatives
to increase funding for peer-reviewed research, to increase
access to high-quality treatment for all women diagnosed with
breast cancer, and to ensure that breast cancer advocates have
a seat at the table where decisions about breast cancer are
made.
I urge you, Chairman Specter and Senator Harkin and members
of the committee, please continue to make funding for breast
cancer research a priority.
Prepared statement
With your continued support, perhaps we will be able to
answer the question of why, when someone is diagnosed with
breast cancer. Perhaps we will be able to prevent another woman
from getting it in the first place. And perhaps, if the
research moves quickly enough, then I will be around to watch
my daughter grow into a woman.
Thank you.
[The statement follows:]
Prepared Statement of Christine Carpenter
Good morning. My name is Christine Carpenter, and I am from Cedar
Falls Iowa. I am a 7-year breast cancer survivor. I am also a mother, a
wife, a school psychologist, and a member of the National Breast Cancer
Coalition.
Thank you, Chairman Specter, members of the Committee, and
especially Senator Harkin, for your leadership and work on the issue of
breast cancer. It is an honor to have the opportunity to testify today.
When I was diagnosed with breast cancer in 1993 at the age of 45, I
did not think I would live to see my daughter, who was fourteen at the
time, graduate from high school. I am thrilled that I lived long enough
to attend her college graduation this month. Although seven and a half
years have passed since my breast cancer diagnosis, there is not a day
that goes by that I don't fear for the future. I am haunted by studies
showing that more than half of the woman diagnosed with invasive breast
cancer die within twenty years.
Breast cancer came as a shock. I had always been healthy--ate
right, exercised regularly, never smoked, rarely drank alcohol. I was
vigilant about doing monthly breast self-exams and had yearly
mammograms. I had even breast fed my daughter for several years. And, I
had no significant family history of breast cancer. So how could this
happen to me?
After doing a self-breast exam and feeling a lump, I was relieved
when a mammogram showed nothing. But then, a later biopsy confirmed
breast cancer. I had been diagnosed with a disease for which there is
no known cause, no prevention, no fool proof way of detecting, and no
cure.
In the fall of 1993, I began my breast cancer treatment. I had a
modified radical mastectomy, and six months of chemotherapy. I got
intravenous injections that made me feel tired, achy and agitated. My
whole body hurt. I lost my hair. I had to take pills to counter the
side effects of the side effects medication. I felt shock, grief and
depression about what was happening to me. There were moments during my
treatment when I was in such physical and emotional misery that death
looked appealing. However, I would look to my loving family and realize
that for them, I had to get through this.
Following my treatment, I started to consider how many women across
the country were going through the same thing as I was going through. I
also thought of all the women who will go through this--but don't even
know it yet. And I thought about my own daughter, and realized that I
must do something to help ensure and end to this disease.
It 1997, I gathered a small but mighty group of women in the Cedar
Falls/Waterloo area and together we created the Iowa Breast Cancer Edu-
action, an education and advocacy group. Our first mission was to help
women who had been diagnosed with breast cancer make decisions about
how to receive quality health care. With the distribution of 7,000 free
copies of our Breast Cancer Resource Guide, our goal was to begin to
empower Iowa women and men, and help them seek the best possible
treatment and healing.
And empower them we did.
In a few short years, we joined forces with others and created an
all Iowa network to advocate for the prevention and cure for breast
cancer. At the same time, we joined more than 500 other organizations
and tens of thousands of individuals and became members of the National
Breast Cancer Coalition.
My participation in breast cancer activism has helped me to heal.
It has also helped me to channel my own fear and anger into advocacy
and action. And, perhaps most importantly, it has made me realize that
we must not stop fighting until we have eradicated this disease.
Fortunately, I am not alone in my determination. The momentum
across the country around this issue is extraordinary. Women and their
families who have been affected by this disease have refused to take
``no'' for an answer. They have demanded that more continue to be done
until we have a cure for this disease.
Just yesterday, I was reminded of this incredible passion and power
as I walked the halls of Congress with nearly six hundred activists in
town to advocate for the National Breast Cancer Coalition's agenda. We
urged our Senators and Representatives to increase funding for peer
reviewed research, to increase access to high quality treatment for all
women diagnosed with breast cancer, and to ensure that breast cancer
advocates have a seat at the table where decisions about breast cancer
are made.
I urge you, Chairman Specter and Senator Harkin--and members of the
Committee--please continue to make funding for breast cancer research a
priority. With your continued support, perhaps we will be able to
answer the question ``why'' when someone is diagnosed with breast
cancer. Perhaps we will be able to prevent another woman from getting
it in the first place. And perhaps, if the research moves quickly
enough, then I will be around to watch my daughter grow into a woman.
Senator Specter. Thank you very much, Ms. Carpenter, for
sharing those very personal insights with us. We appreciate it
very much.
STATEMENT OF PERI GILPIN, ACTRESS AND BREAST CANCER
ADVOCATE, MEMBER, NATIONAL BREAST CANCER
COALITION
Senator Specter. We turn now to Ms. Peri Gilpin, who has
appeared on numerous television and theater productions, but is
best known for her role as Roz Doyle in the NBC series
``Frazier.'' She is a member of the National Breast Cancer
Coalition.
Along with ``Frazier'' co-star Jane Leeves, she has started
a production company, Crystal Cities, where they are developing
film and television projects. She studied drama at the
University of Texas and the British-American Academy in London.
Welcome, Ms. Gilpin, and we look forward to your testimony.
Ms. Gilpin. Thank you.
Senator Specter. And just remember, you are being
televised.
Ms. Gilpin. Thank you. As if I was not nervous enough.
Thank you very much for the opportunity to testify before
the Senate Labor, Health and Human Services Subcommittee today.
My name is Peri Gilpin, and I am a wife, an actress, and the
daughter of a wonderful woman who died of cancer. I am also a
proud breast cancer advocate and a member of the National
Breast Cancer Coalition.
I want to begin by thanking, Chairman Specter and Senator
Harkin and other members of this committee, for your
outstanding commitment to the fight against breast cancer.
Under your leadership and through the tireless work of breast
cancer advocates like the women and men who make up the
National Breast Cancer Coalition, breast cancer research
funding has been significantly increased in the last decade.
Because of your unyielding commitment to furthering this
critical research, developments in the past few years have
begun to offer real hope that we will soon eradicate this
disease. And now is the time to continue the investment you
have made.
I am very pleased to be here on behalf of the millions of
women who are living with breast cancer, or who are at risk for
this deadly disease. As the daughter of a woman who died of
cancer, I am also grateful for the opportunity to testify on
behalf of families like mine, whose lives are tragically
forever changed by the ravages of this disease.
Yesterday I had the unique opportunity to spend the day on
Capitol Hill with hundreds of extraordinary women, most of them
breast cancer survivors and their families, to lobby Members of
Congress on the National Breast Cancer Coalition's legislative
agenda. Their spirit, focus and determination are incredible.
And their sophisticated understanding of the NBCC's legislative
agenda spoke to their commitment to furthering substantive
breast cancer policy.
Their dedication represents the unbelievable momentum from
all across the country to eradicate breast cancer. Not only was
I empowered by their commitment and strength, but it reinforced
my belief that breast cancer is not just a medical issue, but a
political issue. My participation in the advocacy efforts of
the coalition is teaching me what an incredible impact
grassroots advocacy can have on an issue.
The work of these vibrant individuals has not just led to
an increase in breast cancer research funding, but it has
helped to ensure that more women have access to high-quality
breast cancer treatment and a seat at the table where important
decisions about breast cancer are made.
It is my belief that the grassroots advocates of the
National Breast Cancer Coalition have been successful not only
because of their passion and determination, but also because
they refuse to accept that things have to remain the same. They
are willing to fight the status quo and envision a new way of
doing things. That is why they have been able to bring about
vast increases in breast cancer funding. That is why they have
been successful in increasing access to quality care for women
diagnosed with breast cancer, and that is why, together with
your support, they are going to be successful in eradicating
this disease.
My mother would have loved to have been a member of the
National Breast Cancer Coalition and to have participated in
these advocacy activities. As she battled her illness, she
advocated for a higher quality of care and for a meaningful
role in the decisions regarding her treatment.
Unfortunately, my mother had to suffer not only through her
illness, but also through a lack of information and mis-
information that affected the quality of her treatment. I know
my mom would have enthusiastically joined NBCC advocates to
fight for a change in the system. She would have been in the
front of the line to advocate for a higher quality of care and
for answers about how to cure her disease and how to make sure
others would not have to suffer through what she was going
through.
I will never forget a story my mom and dad told me about a
meeting with one of their physicians. The doctor had very
solemnly told my mother that her radiology report looked very
bad and that she probably only had 6 months to live. My parents
were shocked by the doctor's remark. And they told him that it
did not make any sense. Fortunately, they were very much on top
of her care, and they pulled out a more recent report and said
to him, ``Look at this report. It does not say that at all.''
And the doctor looked and said, ``Oh, I am sorry. I must
have been looking at an old report. You are right. This one
looks pretty good.''
The National Breast Cancer Coalition has given women like
my mother a place to channel their determination, frustration
and fear into advocacy and action. It has empowered them to be
their own advocates and to have the courage to keep fighting so
that others will not have to suffer what they are suffering.
And it has given hope and emotional support to millions of
women around the country who realize that they are not alone.
Most importantly, these efforts have resulted in substantial
change in breast cancer care.
Even though I am sad that my mother cannot be here today to
thank you in person for your commitment to increasing critical
breast cancer research, and even though she is not here to
pound the pavement with other women like her, who have come to
Capitol Hill to demand that Congress work with them to
eradicate this disease, I am proud to be here on her behalf and
in her memory.
Prepared statement
I am here also so that we do not leave the legacy of this
disease for yet another generation. I urge you not to give up
on your commitment to ending this disease and to continue your
important work with the National Breast Cancer Coalition to
enact substantive breast cancer policy which will move us
forward to prevent any more mothers, daughters, wives, or
friends from losing their battle with cancer.
Thank you very much for the opportunity to testify today.
[The statement follows:]
Prepared Statement of Peri Gilpin
Thank you for the opportunity to testify before the Senate Labor
Health and Human Services Subcommittee today.
I am Peri Gilpin, and I am a wife, an actress, and the daughter of
someone who died of cancer. I am also a proud breast cancer advocate
and a member of the National Breast Cancer Coalition.
I want to begin by thanking you, Chairman Specter, Senator Harkin,
and other members of this Committee, for your outstanding commitment to
the fight against breast cancer. Under your leadership, and through the
tireless work of breast cancer advocates like the women and men who
make up the National Breast Cancer Coalition, breast cancer research
funding has been significantly increased in the last decade. Because of
your unyielding commitment to furthering this critical research,
developments in the past few years have begun to offer real hope that
we will soon eradicate this disease. Now is the time to continue the
investment that you have made.
I am very pleased to be here on behalf of the millions of women who
are living with breast cancer, or who are at risk for this deadly
disease. As the daughter of a woman who died of cancer, I am also
grateful for the opportunity to testify on behalf of families like mine
whose lives are forever changed by this type of tragedy.
Yesterday, I had the unique opportunity to spend the day on Capitol
Hill with hundreds of extraordinary women--most of them breast cancer
survivors--and their families, to lobby Members of Congress on the
National Breast Cancer Coalition's legislative agenda. Their spirit,
focus and determination are incredible, and their sophisticated
understanding of NBCC's legislative agenda spoke to their commitment to
furthering substantive breast cancer policy. Their dedication
represents the unbelievable momentum from all across the country to
eradicate this deadly disease.
Not only was I empowered by their commitment and strength, but it
reinforced my belief that breast cancer is not just a medical issue,
but that it is also a political issue. My participation in the advocacy
efforts of the Coalition is teaching me what an incredible impact
grassroots advocacy can have on an issue. The work of these tireless
individuals has not just led to an increase in breast cancer research
funding, but it has helped to ensure that more women have access to
high quality breast cancer treatment and a seat at the table where
important decisions about breast cancer are made.
It is my belief that the grassroots advocates of the National
Breast Cancer Coalition have been successful not only because of their
passion and determination, but also because they refuse to accept that
things have to remain the same. They are willing to fight the status
quo, and envision a new way of doing things. That is why they have been
able to bring about vast increases in breast cancer funding. That is
why they have been successful in increasing access to quality care for
women diagnosed with breast cancer. That is why, together with your
support, they are going to be successful in eradicating this disease.
My mother would have loved to have been a member of the National
Breast Cancer Coalition, and participated in these advocacy activities.
As she battled her illness, she advocated for a higher quality of care,
and for a meaningful role in the decisions regarding her treatment.
Unfortunately, my mother had to suffer not only through her illness,
but also through a lack of information and misinformation that affected
the quality of her treatment. I know my mother would have
enthusiastically joined NBCC advocates to fight for a change in the
system--to advocate for a higher quality of care--and for answers about
how to cure her disease, and how to make sure others wouldn't have to
suffer through what she was going through.
I will never forget the time my mother and father told me about
their meeting with my mother's physician. The doctor, very solemn, told
my mother that her radiology report looked very bad, and that she
probably had only six months to live. My parents, shocked by the
doctor's remark, told him that didn't make any sense. They were very
much on top of her care, pulled out a very recent report and said to
him: ``Look at this report! It doesn't say that at all!'' The doctor
looked, and said, ``Oh, I'm sorry, I must have been looking at an old
report. Yes, you're right, this one looks great.''
The National Breast Cancer Coalition has given women, like my
mother, a place to channel their determination, frustration and fear
into advocacy and action. It has empowered them to be their own
advocates, and to have the courage to keep fighting so that others will
not have to suffer what they are suffering . And, it has given hope and
emotional support to millions of women around the country who realize
that, they are not alone. Most importantly, these efforts have resulted
in substantial change in breast cancer care.
Even though I am sad that my mother can't be here today to thank
you in person for your commitment to increasing critical breast cancer
research; and even though she is not hear to pound the pavement with
women like her--who have come to Capitol Hill to demand that Congress
work with them to eradicate this disease--I am proud to be here on her
behalf, and in her memory. I am also here so that we do not leave the
legacy of this disease for another generation. I urge you not to give
up on your commitment to ending this disease, and to continue your
important work with the National Breast Cancer Coalition to enact
substantive breast cancer policy which will move us forward to prevent
any more mothers, daughters, wives or friends from losing their battle
with breast cancer.
Thank you very much for the opportunity to testify today.
Senator Specter. Thank you very much, Ms. Gilpin.
It is very important to hear from daughters, sisters, as
Ms. Brinker testified, and Ms. Carpenter, a breast cancer
survivor herself, to give greater insight into the issue and to
aware the public, which will be seeing this through the
courtesy of C-SPAN.
STATEMENT OF LaSALLE D. LEFFALL, JR., M.D., F.A.C.S.,
CHAIRMAN-ELECT OF THE SUSAN G. KOMEN BREAST
CANCER FOUNDATION
Senator Specter. We now turn to Dr. LaSalle Leffall,
professor of surgery at the Howard University College of
Medicine. He was chairman of the Department of Surgery at
Howard from 1970 to 1995. The first African-American to become
president of the American Cancer Society, Society of Surgical
Oncology, Society of Surgical Chairmen, Washington Academy of
Surgery. In 2001 he became chair-elect of the Susan Komen
Breast Cancer Foundation.
At the young age of 18, he received his bachelor's degree
Summa Cum Laude from Florida A&M and four years later his
medical degree from Howard University, ranking first in his
class.
Well, you bring extraordinary credentials to your new job,
Dr. Leffall, and to this committee. I have asked Senator Harkin
to take the gavel for the next few minutes, because I have to
go to a Judiciary Committee meeting, where we are confirming
the new Assistant Attorney General of the Criminal Division.
But I shall return very, very briefly.
Dr. Leffall, the floor is yours. And, Senator Harkin, the
gavel is yours.
Senator Harkin [presiding]. Thank you.
Dr. Leffall. Thank you, Mr. Chairman. I was told that I had
one minute for my testimony. And this morning I was told,
Senator Harkin, I had five. But I am going to stick with my
original thought that you had expressed, that I just stick to
the one minute. And that, I will do. I hope the committee will
appreciate that.
And I want to thank you, Senator Harkin and Senator Murray
and the members who are not here, for the opportunity to be
with you today to testify.
As a surgeon, oncologist, and medical educator, I have
devoted most of my professional life to the study of cancer,
especially as it relates to African-Americans. I joined the
faculty at the Howard University College of Medicine in 1962.
And as you heard, from 1970 to 1995 I was chairman of the
Department of Surgery. In 1992 I became the Charles R. Drew
professor of surgery at Howard, a position that I currently
hold.
The Komen Foundation has accomplished much in its last 19
years, having raised more than $300 million in the fight
against breast cancer since 1982. As chair-elect, I look
forward to moving the bar yet a notch higher. I will serve one
year as chair-elect before beginning a two-year term next year
as the chairman of the Susan G. Komen Breast Cancer Foundation
Board.
One of the many reasons I have chosen to align myself with
the Komen Foundation is its commitment through Komen affiliates
across the country to funding non-duplicative breast cancer
outreach projects for the medically underserved in their local
communities. Efforts to stifle overall health care expenditures
should not impede a patient's ability to receive necessary
services. A patient's diagnosis, not fiscal constraints, should
determine how and what care is provided.
Prepared statement
I assure you that I will utilize my position as chair-elect
of the Komen Foundation to further the interests of minorities
and the medically underserved.
Thank you very much, Mr. Chairman.
[The statement follows:]
Prepared Statement of LaSalle D. Lefall, Jr.
Thank you Chairman Specter, Senator Harkin and distinguished
Members of the Subcommittee for the opportunity to be here with you
this morning to testify.
As a surgeon, oncologist and medical educator, I have devoted most
of my professional life to the study of cancer, especially as it
relates to African Americans. I joined the faculty at Howard University
in 1962 as assistant professor. In 1970, I became chairman of the
department of surgery, a position I've held for 25 years.
The Komen Foundation has accomplished much in the last 19 years,
having raised more than 300 million dollars in the fight against breast
cancer since 1982. As Chair-Elect, I look forward to moving the bar yet
a notch higher. I will serve one year as chair-elect before beginning a
two-year term as chairman in 2002.
One of the many reasons I have chosen to align myself with the
Komen Foundation is its commitment, through Komen Affiliates across the
country, to funding non-duplicative breast cancer outreach projects for
the medically underserved in their local communities.
Efforts to stifle overall health care expenditures should not
impede a patient's ability to receive necessary services. A patient's
diagnosis, not fiscal constraints, should determine how and what care
is provided.
I assure you that I will utilize my position as Chair-Elect of the
Komen Foundation to further the interests of minorities and the
medically underserved.
Senator Harkin. Thank you very much, Dr. Leffall.
STATEMENT OF DR. JOHN SEFFRIN, CHIEF EXECUTIVE OFFICER,
AMERICAN CANCER SOCIETY
Senator Harkin. Next we turn to John Seffrin. Dr. Seffrin
is the Chief Executive Officer of the American Cancer Society,
a group he has volunteered with for the past 20 years. He has
served on the advisory committee to Congress on tobacco policy
and public health and on the advisory committee to the Director
of the U.S. Centers for Disease Control and Prevention.
Dr. Seffrin holds a doctorate of philosophy in health
education at Purdue University, master science degree in health
education from the University of Illinois.
Dr. Seffrin, welcome.
Dr. Seffrin. Good morning, Senator Harkin, distinguished
members of the subcommittee. I am truly honored to be here
today and want to thank you on behalf of our 28 million
volunteers and supporters for the great and sustained
leadership that you have given to this cause, the cause of
breast cancer research and control, and indeed for other
matters of importance relative to biomedical research.
As you know, Senator Harkin, the American Cancer Society is
the Nation's largest community-based voluntary health
organization. And we have some 28 million supporters and
volunteers, 2 million of those volunteers are virtually full-
time volunteers representing 3,000 communities across the
country. And the society strongly believes that a significant
reduction in the number of U.S. citizens suffering and dying
from cancer in general, and breast cancer in particular, is not
only feasible, but will happen, if we do the right thing.
But achieving this goal is not easy, and it depends on the
continued and enhanced investment in and application of cancer
research. Mr. Chairman, you have asked me to testify about a
disease that for too long has been devastating the lives of
women and their families across this country, as you have heard
so poignantly here this morning. Indeed among American women,
breast cancer is the second leading cause of cancer death and
the most frequently diagnosed.
According to the American Cancer Society's database, we
estimate that 192,000 new cases will be diagnosed this year.
And over 40,000 women, our mothers, wives, sisters, daughters,
and loved ones, will die of breast cancer, many of them, most
of them, needlessly. Regrettably, many of these deaths and
cases will occur disproportionately among women from
predominantly low income and medically underserved communities.
For example, my friend, Dr. Lasalle Leffall, referred to
the death rates among African-American women are 28 percent
higher than among white women. We know that one of the
contributing factors to this disparity is lower utilization of
screening tests, such as mammography.
We have many challenges in beating this disease. But in
cases in which we have the tools available that can help us
detect this disease early, when it is most treatable, we must
ensure that these tests are available to all who need them.
Now despite these grave statistics, it is becoming
increasingly clear that breast cancer is not the automatic
death sentence it once was. Indeed, we were looking at our
data, and we have had great success in treating the disease
when detected early, when it is localized and it has not
spread.
According to the American Cancer Society's data, in the
1940s the 5-year survival rate for localized breast cancer was
about 72 percent. With the development and use of improved
early detection and better treatment methods, the 5-year
survival rate for localized breast cancer has increased to 97
percent today.
Now we have come a long way, but, of course, there is much,
much that still needs to be done. For example, while we know
that early detection is currently a key to survival, we also
know that the majority of Americans are not getting appropriate
screening.
To help ensure that new scientific knowledge will be
forthcoming to answer these yet-unanswered questions, we
believe we must expand the national investment in breast cancer
research. And therefore, the American Cancer Society and its
partners in one voice against cancer believe strongly that
Congress must remain steadfast in its commitment to double the
NIH budget by 2003. And to that end, we are here today
requesting a funding level of $27.3 billion for fiscal year
2002 for the NIH.
We are also advocating $5 billion to provide full funding
of Dr. Klausner's, the Director of the NCI, bypass budget. This
increase will allow the NCI to move forward with additional
approved, yet currently unfunded, research grants and foster
the development of new drugs to treat breast cancer more
successfully.
Mr. Chairman and members of the committee, if we are to
reduce the number of American women dying from breast cancer
now in the immediate future, we must also provide adequate
funding for the Centers for Disease Control and Prevention. The
CDC is actually on this Nation's front lines in the battle
against cancer, and their programs are critical to winning this
war. We are advocating $315 million for the cancer-related
programs at our Centers for Disease Control and Prevention.
While all of these programs are important in our Nation's
cancer control efforts, I will focus today on the National
Breast and Cervical Cancer Early Detection Program in
particular. It is extremely important, Senator Harkin, that we
redouble our efforts in this area, because we are only reaching
about 15 percent of the women who could benefit from this
intervention program. A relatively small amount of money
invested here of $315 million could expand dramatically the
number of women who need this important service.
prepared statement
In conclusion, Senator Harkin and members of the committee,
I want to thank you and the committee for your continued
commitment to fighting the war on cancer. Because of this
Nation's past commitment to research and its application, the
diagnosis of breast cancer is no longer a death sentence for
many women. But we have much work to do before we can say we
have truly overcome this huge public health problem.
I thank you for this opportunity to testify, and the
American Cancer Society stands ready to help you and our other
partners in any way we can.
[The statement follows:]
Prepared Statement of Dr. John Seffrin
Good morning, Mr. Chairman, Senator Harkin, and distinguished
members of the Committee. I am John Seffrin, Chief Executive Officer of
the American Cancer Society. I am honored to be here today, and I want
to thank you on behalf of the more than 28 million volunteers and
supporters of the Society for the opportunity to testify before you
about the importance of research and prevention in breast cancer care.
I am also pleased to have the opportunity to publicly thank both of you
for your continued leadership in the Senate on behalf of cancer
patients. It is no secret that the 8.9 million Americans with a history
of cancer have benefited from the contributions that both of you and
this Committee have made over the years in research and its
application. Your personal commitment to defeating this disease, and
your ability to work in a bipartisan fashion to lead the nation in the
right direction, are to be applauded.
The American Cancer Society is the nationwide community-based
voluntary health organization dedicated to eliminating cancer as a
major health problem by preventing cancer, saving lives and diminishing
suffering from cancer through research, education, advocacy and
service. Nationwide, more than 28 million volunteers and supporters,
including cancer survivors, researchers, healthcare providers and
educators, contribute their time and resources to help advance the
Society's goals. As the nation's largest cancer-fighting organization,
we too are making hard choices and setting priorities for our community
cancer control activities based on an evaluation of the success of
current programs and interventions. The American Cancer Society has set
ambitious goals for the year 2015 to reduce the number of people dying
from and being diagnosed with cancer and to significantly improve the
quality of life for all cancer patients, survivors, and their families.
While we believe that national achievement of these goals is possible,
we know that our success depends on the continued investment in and
application of cancer research.
We have made tremendous progress in the battle against cancer. When
the American Cancer Society was founded in 1913, cancer was a poorly
understood disease that killed the great majority of people who had it.
Today, because of what we have learned from research and its
application, the diagnosis of cancer is no longer a death sentence.
More and more people are surviving this disease and enjoying productive
lives. We are learning more each day about how cancer cells develop and
how environmental agents cause disease. This basic knowledge about the
nature of cancer is providing critical insights into how we can prevent
and detect cancer more effectively. And it is giving us the opportunity
to improve treatments that lead to improved quality of life and longer
survival.
To that end, I appreciate having the opportunity to share with you
today the Society's views on the importance of research and prevention
efforts in reducing the number of new breast cancer cases as well as
the need for continued investments in this area.
current breast cancer statistics
Mr. Chairman, you have asked me to testify about a disease that for
too long has been disrupting and devastating the lives of women and
their families across this country. Over the last decade alone, breast
cancer has taken the lives of nearly one-half million American women.
Indeed, among women, breast cancer is the second leading cause of
death behind lung cancer, and, after skin cancer, is the most
frequently diagnosed. This year an estimated 40,600 women--our mothers,
wives, sisters, daughters, and other loved ones--will die of breast
cancer, and 192,000 new cases will be diagnosed. Regrettably, many of
these deaths and cases will occur disproportionately among women from
predominantly low income and medically underserved communities. An
estimated 19,300 new cases of breast cancer and 5,800 deaths are
expected to occur among African-American women in 2001. Breast cancer
is the most common cancer among African-American women and the death
rates are 28 percent higher than among white women.
This disease is also the most commonly diagnosed cancer among
Hispanic women. An estimated 8,600 Hispanic women will be diagnosed
with breast cancer and 1,800 will ultimately lose their battle with
this disease. For Hispanic women, breast cancer is frequently diagnosed
at a later stage and is the leading cause of cancer death. One of the
contributing factors to later diagnosis among this population group is
thought to be lower utilization of screening tests such as mammography.
Like many other forms of cancer, the risk of breast cancer
increases with age. This means that as a woman grows older her chances
of being stricken with and suffering from this terrible disease
increase. According to the National Cancer Institute, about 70 percent
of breast cancer cases are diagnosed in women age 55 and older; and 77
percent of deaths due to breast cancer occur in women age 55 and older.
Furthermore, underneath these staggering statistics lie behavioral,
genetic, environmental and other factors that continue to challenge our
fight against this deadly disease.
progress--breast cancer research
Mr. Chairman, and Members of the Committee, there is little
question that breast cancer is having a terrible impact on women in
this country, and that this disease, in particular, is
disproportionately affecting women who are socioeconomically
disadvantaged and medically underserved. However, despite these grave
statistics, it is becoming increasingly clear that cancer, including
breast cancer, is not the automatic death sentence it once was. In the
1940s, the five-year survival rate for localized breast cancer was only
72 percent. Through the development and use of improved early detection
and treatment methods, the five-year survival rate for localized breast
cancer has increased to 97 percent today. We have come a long way, but
there is still much that needs to be done.
At the cornerstone of our progress in the war on breast cancer are
breakthroughs in applied and behavioral science and the continued
widespread use of preventive and early detection measures. However, our
progress relies also on a continued investment in federal efforts that
build the biomedical infrastructure necessary to improve the health of
the Nation. One of the most important of these efforts is the continued
emphasis on research that will result in answers to how breast cancer
is best detected, treated and prevented.
Nearly every day, we are discovering and learning about new ways to
combat this terrible disease. And, nowhere are the results of these
discoveries more apparent than in the intensive breast cancer research
being conducted at the National Institutes of Health (NIH),
particularly through the National Cancer Institute (NCI), and at the
Department of Defense (DOD).
Through the painstaking work of scientists and researchers in these
programs, we have been able to make significant progress in further
understanding the complexities of breast cancer. Indeed, we understand
more than ever before how breast cancer cells develop and spread, the
role environmental agents play, how nutrition and lifestyle are a
factor, and why some women are more likely than others to be afflicted
by the disease. Also, we are doing more to develop new treatments and
medicines, like Tamoxifen, that appear to translate into longer
survival and improved quality of life for breast cancer patients.
Similarly, through research we are doing more to translate laboratory
findings into real life applications that improve the prevention,
detection, diagnosis and treatment of breast cancer.
However, while these advancements have been noteworthy, we still
have a long way to go toward finding a cure for breast cancer and
saving more people from succumbing to the disease. In fact, to date,
the specific cause of breast cancer is unknown, and our current
knowledge about the role of human genes vis-a-vis breast cancer is
incomplete.
To help ensure that new scientific knowledge will be forthcoming to
answer many of these questions, we must expand and increase the
national investment in breast cancer research. For example, with a
significant increase in funding as outlined in the Director's bypass
budget, NCI will be able to move forward with additional approved--yet
currently unfunded--research grants, and foster the development of new
drugs to treat breast cancer successfully. In addition, they will be
able to enhance methods of breast cancer detection and prevention,
improve the quality of life for all cancer patients, and better
understand and control cancer in minority and medically underserved
communities and the disparities among ethnic and socioeconomic groups.
hope & answers--breast cancer prevention and early detection
Mr. Chairman, and Members of the Committee, one of the efforts that
is playing an important role in helping us win this war is that of
screening and early detection, which are two of the key weapons in
fighting breast cancer. Unfortunately, not all women have been able to
access appropriate screening and early detection tools.
Research studies have proven that screening and early detection are
critical for decreasing the mortality rates of breast cancer, and that
increased use of mammography and other early detection methods can play
an important role in helping to further reduce mortality rates. In
fact, according to the Centers for Disease Control and Prevention
(CDC), screening could prevent approximately 15-30 percent of all
deaths from breast cancer among women over 40. However, despite making
progress in increasing awareness about the importance of screening and
early detection in fighting breast cancer, some groups of women
continue to be left out when it comes to having access to these life
saving services.
Mr. Chairman, and Members of the Committee, I am referring to women
who are predominantly poor, medically underserved, and
disproportionately impacted by breast cancer. These women continue to
face financial, socio-cultural, geographic and educational barriers to
screening and early detection services that threaten their ability to
live a productive life. We cannot expect to reduce the incidence of
breast cancer in this country, unless we do more to effectively reach
and serve those who are the least likely to have access to the very
services that could save their lives.
The CDC's National Breast and Cervical Cancer Early Detection
Program (NBCCEDP) is making an impact on the detection of this disease
in poor and underserved women at earlier stages when the survival rates
are highest. The NBCCEDP provides breast and cervical cancer
screenings, outreach, and post screening diagnostic 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 existing public health infrastructure and
involves all sectors of the community in outreach and delivery of
services. The NBCCEDP has provided more than 2.7 million screening
examinations, and has diagnosed over 8,600 breast cancers and 39,400
precancerous cervical lesions. Nearly half of all screenings were for
minority women. In addition, the program has been successful in
reaching women at earlier stages of their cancer, where more options
are available for treatment and for improved quality of life.
Furthermore, the program has enabled behavioral changes in participants
that ensure continual care.
Cancer registries are also critical in our efforts to improve
outreach and screening programs. For example, thanks to data from the
Kentucky Central Cancer Registry, areas in the state with high
incidence of breast cancer diagnosed at a late-stage were identified
and effective outreach programs were developed through the NBCCEDP. The
result was a shift from late-stage to early-stage diagnosis for many
patients, meaning a greater chance for survival for those individuals,
since we know that cancers caught earlier are more likely to be
treatable. Cancer registry data was then linked to Medicare treatment
cost data. The data analysis showed that Medicare treatment costs were
reduced by more than $4.7 million in a 2.5 year time period, proving
that increasing early stage breast cancer diagnosis can have a
significant impact on health care system costs.
Yet despite these successes, it has become evident that the NBCCEDP
faces challenges in providing needed program services to eligible low-
income and uninsured women. In fact, according to the CDC, while
funding for the program in fiscal year 2001 was $174 million, this
amount allows the NBCCEDP to reach only approximately 12 percent to 15
percent of all eligible women. Like many of the other programs included
in the CDC's Chronic Disease and Health Promotion budget line, this
program received a cut in funding in the President's fiscal year 2002
budget. ACS and members of One Voice Against Cancer (OVAC) are
advocating for a $35.5 million increase in this program and we are
concerned that the proposed budgetary cuts will lead to more women
being left behind--particularly among the underserved populations that
currently rely on this program for screening. There is little doubt
that without additional funding, the NBCCEDP will be hard pressed to
sustain the successes it has achieved since its inception and will be
unable to reach more eligible women. ACS looks forward to working with
this Committee to ensure that funding for this vital cancer prevention
and control program is increased.
Mr. Chairman, and Members of the Committee, the uncertainty of
access to quality and timely care, coupled with the additional
financial pressure of extreme financial burdens, are significant
barriers that could preclude low-income and medically underserved women
from getting the treatment they desperately need, and in some cases,
could cost them their lives.
Fortunately, as part of the effort to tackle this problem, Congress
passed the Breast and Cervical Cancer Treatment Act (BCCTPA) last year,
which gives states the option to extend Medicaid coverage to women
diagnosed with breast or cervical cancer under the CDC program. This
landmark program offers women served through the CDC screening program
peace of mind by providing explicit access to and coverage for
treatment services, thereby allowing them the ability to focus their
energies on fighting and conquering this disease.
Currently three states--Maryland, New Hampshire, and West
Virginia--have already taken advantage of the Breast and Cervical
Cancer Treatment and Prevention Act. ACS is working with the rest of
the states to ensure that they too enact the necessary legislation at
the state level. ACS is also working to ensure that the Native American
Breast and Cervical Cancer Treatment Technical Amendment Act is adopted
this year so that Native American women with breast or cervical cancer
are also eligible for treatment.
Additionally, the Society is working on advancing the ``Assure
Access to Mammography Act.'' This legislation, introduced by Senator
Harkin and co-sponsored by Senator Specter and many others, will help
us to ensure that this nation's capacity to provide mammography
services is preserved for future generations of American women. We have
all grown concerned by recent reports that raise red flags about the
availability of mammography screening services for all women who need
them, and this legislation leads the way toward quality data to assess
the problem and a means to address it so women will be adequately
served.
conclusion
Mr. Chairman, and Members of the Committee, I want to thank you and
the Committee for your commitment to fighting the war on breast cancer.
I could spend the rest of the day talking to you about all of the great
projects and research being done on breast cancer, and how close we are
to eradicating the disease. Today, because of what we have learned from
research and its application, and through prevention and early
detection, the diagnosis of breast cancer is no longer a death sentence
for many women. More and more people are surviving this disease,
enjoying productive lives and, most importantly, are living longer. But
the point I want to make clear today is that research and its
application are the keys to removing breast cancer as a threat in the
lives of women. If this nation is serious about winning the War on
Cancer, we must commit ourselves to investing the resources necessary
to get us there. With the number of lives at stake, we cannot afford do
anything less. The American Cancer Society looks forward to working
with you in partnership to ensure that this benefit reaches all women.
Senator Harkin. Dr. Seffrin, thank you very much.
STATEMENT OF FRAN VISCO, J.D., PRESIDENT, NATIONAL
BREAST CANCER COALITION
Senator Harkin. Now we turn to Ms. Fran Visco. Ms. Visco is
President of the National Breast Cancer Coalition, a member of
its board of directors. Formed in May of 1991, the coalition is
a grassroots advocacy group of more than 500 member
organizations and over 60,000 individual members. Ms. Visco has
been a member of the President's Cancer Panel and the
President's Special Commission on Breast Cancer. She earned a
bachelor's degree from St. Joseph University and a J.D. from
Villanova Law School, where she was the editor of the Villanova
Law Review.
Fran, welcome again to the committee.
Ms. Visco. Thank you very much. I want to thank you,
Senator Harkin, and my chairman, Senator Specter, Senator
Murray, and the other Members of the committee, not just for
inviting me to testify today, but also for your long-standing
support of appropriations for quality breast cancer research.
You have heard Dr. Klausner talk about how far we have come
in terms of research. And we are beginning to find some of the
answers. And more important, we are actually beginning to know
which questions to ask. This is an important time to focus our
resources on breast cancer, because we do know so much, and we
are ready to move to the next level.
I am proud to be here as a breast cancer survivor, a 14-
year breast cancer survivor, on behalf of the National Breast
Cancer Coalition. Over the past several days, I have walked
with more than 700 women and men from around the country who
came here to Washington, D.C., to learn about advocacy, to
learn about the update in breast cancer research, to meet with
their members of Congress, to gain the skills and the tools
they need to advocate, to be a political voice in the fight
against breast cancer, and also advocates for themselves. They
understand the importance of our collaboration with Congress.
They understand the importance of the political fight against
breast cancer.
We have found by your side for 10 years now. We are going
into our 10th year. Working together, we have brought about
significant increases at NIH and NCI for breast cancer
research. And we are very proud of the fact that working
together, and with you especially Senator Harkin, we brought
about the Department of Defense peer-reviewed breast cancer
research program, which to date has brought about more than $1
billion of new funding for breast cancer research.
But it is not just about research. We know it is not enough
simply to put more dollars to the disease. We have to make
certain those funds are well spent. And so we, the National
Breast Cancer Coalition, educate and train our advocates. We
train them in the language and concept of science and in the
system and structure of research, so that we are able to
collaborate not just with you but with the scientific and
medical community, to make sure that research is well designed
and funds are spent appropriately.
In addition, we are giving our advocates the understanding,
the skills and the tools to understand what is quality care.
There is a great push for quality care and access to care. But
we ask ourselves the question: What does that mean? What is
quality care? What is quality care in breast cancer? How do I
understand what it is I and my colleagues should be getting?
And so we have developed a project to help women answer
that question, not give them the answers, but give them the
tools and the skills that they need, so they can make their own
decisions. And I am very proud and would like to introduce into
the record the National Breast Cancer Coalition Fund's ``Guide
to Quality Breast Cancer Care,'' which was just released over
this past weekend at our conference.
We know that we have come a long way in treating breast
cancer. While the 5-year cure rates have gone up, we do not
believe a 5-year rate is a cure for anyone. We need to make
certain that we truly know how to cure this disease for all
women. We need to make certain that the treatments we give
women are not toxic. And most importantly, we have to learn how
to prevent this disease, so that women do not get breast
cancer, so we can protect our daughters and future generations
from getting this disease.
One component in our strategy to find that answer is, we
are asking for support for the National Institute of
Environmental Health Sciences with a $30 million grant over 5
years to fund collaborative centers of excellence that will
begin to look in a multi-disciplinary, interdisciplinary way at
the links between the environment and breast cancer. We simply
can no longer afford to do this in a haphazard manner. People
think we know the answer. We do not know the answer. We need an
overall strategy to achieve that.
Dr. Klausner spoke about the complexity of this disease.
And we, as advocates, have learned over 10 years how complex it
is. We are beginning to understand the molecular basis of
breast cancer and of many diseases. But we do not have
protection in place for genetic discrimination, when we have
predisposition to those diseases.
What is going to happen when we know more about who will
get breast cancer, when we know more about whose breast cancer
will respond to treatment and whose will not? The
discrimination possibilities are overwhelming. Science must
move forward, but we need to protect women and men in this
country while that happens. We need strong genetic
discrimination legislation.
Prepared statement
I again am here proud to represent the women and men who
have raised their voices and come together to focus on breast
cancer, to make a difference in the fight to eradicate this
disease. And I thank you for walking alongside with us. And I
know we will reach our goal of eradicating this disease.
Thank you.
[The statement follows:]
Prepared Statement of Fran Visco
Thank you, Mr. Chairman and members of the Subcommittee for your
dedication and leadership in working with the National Breast Cancer
Coalition (NBCC) to help in our fight to eradicate breast cancer.
I especially want to thank Chairman Specter and Senator Harkin for
your longstanding support for the invaluable research at the Department
of Defense (DOD) Peer Reviewed Breast Cancer Research Program. Without
your leadership, we would not be where we are today.
I am Fran Visco, a breast cancer survivor, a wife and mother, a
lawyer, and President of the National Breast Cancer Coalition. On
behalf of NBCC, and the more than 2.6 million women living with breast
cancer, I would like to thank you for the opportunity to testify today.
As you know, the National Breast Cancer Coalition is a grassroots
organization dedicated to ending breast cancer through the power of
action and advocacy. The Coalition's main goals are to increase federal
funding for breast cancer research and collaborate with the scientific
community to design and implement new models of research; improve
access to high quality health care and breast cancer clinical trials
for all women, and; expand the influence of breast cancer advocates in
all aspects of the breast cancer decision making process. Nearly 600
NBCC advocates were up on the Hill yesterday to lobby their Senators
and Representatives on a legislative agenda that reflects these goals.
I truly believe that with their extraordinary determination and
unbelievable spirit, combined with your continued support for high
quality breast cancer research, we will be able to eradicate this
deadly disease.
In the meantime, we also educate and train our advocates about how
to become part of the research process. Through our advocacy training
programs and publications, we empower advocates to collaborate with the
breast cancer research and healthcare community to help find answers,
to critically analyze information and to ensure access to high quality
breast cancer treatment. Mr. Chairman, I would like permission to enter
into the record NBCCF's recently issued ``Guide to Quality Breast
Cancer Care'' which is a resource for breast cancer patients.
I want to focus my testimony on three major points:
First, I want to emphasize the advancements in breast cancer
research that have come as a result of your longstanding support for
this issue. Developments in the past few years have begun to offer
breast cancer researchers fascinating insights into the biology of
breast cancer and have brought into sharp focus the areas of research
that hold promise and will build on the knowledge we have gained. We
are at a point in where so much has been learned about the disease that
we are now able to target genes and begin to know how to address one
woman's breast cancer in a different way from another's woman's. This
breakthrough is leading us forward in finding the answers to how to
prevent breast cancer, as well as how to detect it earlier, and treat
it more effectively. Now is precisely the time to continue your support
for this important research.
Second, I want to urge your support for increased appropriations
for breast cancer research at the National Institute of Environmental
Health Sciences (NIEHS). Recently, Senators Chafee, Reid, Hatch and
Leahy introduced S. 830, the Breast Cancer and Environmental Research
Act. (Representatives Lowey and Myrick introduced the House companion
bill, H.R. 1723.) This legislation would establish Breast Cancer and
Environmental Research Centers of Excellence at the National Institute
of Environmental Health Sciences to support research on environmental
factors that may be related to the etiology of breast cancer.
We recommend that the Committee provide $30 million to fund up to 8
multi-institutional, multi-disciplinary breast cancer and environmental
research centers, which would make grants using a peer review and
programmatic review process that involves consumers. NBCC urges the
Committee to use the tremendously success DOD BCRP as a model for the
structure of this research program.
It is generally believed that the environment plays some role in
the development of this disease, but the extent of that role is not yet
understood. NBCC believes that a strategy must be developed and more
research done to determine the impact of the environment on breast
cancer. It is only when we understand what causes this disease that we
will have a better idea of how to prevent it, how to treat it more
effectively, and how to cure it.
Finally, I want to discuss the issue of accountability and
collaboration among consumer advocates, NIH and Congress, to create
mechanisms to ensure a higher level of accountability for federally
funded breast cancer research. The National Breast Cancer Coalition
understands that the level of funding is meaningless unless the funds
are allocated appropriately.
I have been a member of the President's Cancer Panel and the
National Cancer Policy Board, and sit on various committees at the
Institute of Medicine, and in the private sector. Despite NBCC's
inclusion in scientific decision-making, we still don't see a strategy
on how to best use the federally funded breast cancer resources
appropriately. The National Breast Cancer Coalition would like to work
with Members of this Committee on this issue.
As we are all aware, this is the taxpayer's money. We owe it to all
our constituencies to assure them that this investment is spent wisely.
The National Breast Cancer Coalition supports increased appropriations
for breast cancer research so that we can eradicate this disease as
soon as possible. It is vital that the public understand how the funds
are being spent.
We believe that NIH and NCI are as committed as we are to finding a
cure for this disease. However, it is often difficult when one is
involved in a process to be able to evaluate that process. We urge the
Committee to explore the question of whether changes may be needed in
the grant mechanisms and the research structure at these Institutes.
Any time an institution exists and grows for so many years, outside
evaluation is necessary to update processes or to uproot outmoded or
duplicative efforts that no longer make sense.
We believe that the call for increased accountability should be a
collaborative effort--and want to work with the Committee and with NIH
and NCI. The Programmatic Review Group (PRG), which Dr. Klausner
convened in 1998 to provide an account of NCI's plan to eradicate
breast cancer, was a good beginning.
But many questions remain.
Chairman Specter, Senator Harkin, and members of the Subcommittee,
thank you again for the incredible investment you have made in helping
us work to eradicate breast cancer. NBCC looks forward to continuing to
work with you to end this disease. Thank you again for the opportunity
to testify today. I would be happy to answer any questions.
Senator Harkin. Thank you very much, Fran.
Thank you all on the panel for your very poignant
testimony.
I am now going to recognize Senator Murray for any opening
statement or comments that Senator Murray might have. We would
like to do that at this time. And if you have any questions for
the panel, you can just follow up.
Opening statement of Senator Patty Murray
Senator Murray. Very good.
Well, first of all, Senator Harkin, thank you to you and
the chairman, Senator Specter, for having this hearing. This is
really incredible, sitting here and having a hearing on breast
cancer.
I think how far we have come. I remember talking to my
mother several years back about having heard of one more friend
who had been diagnosed with breast cancer whether not in her
generation there had been this many women who were my age, when
she was my age, who had been diagnosed with breast cancer. And
she thought about it, and she said, ``You know, there may have
been, but we did not talk about it.''
We are talking about it. And I am just really grateful to
all of you who have taken time out of your lives and taken your
lives to participate in this really, really important
discussion. I think we all want to find a cure, but we all want
to know what we can do when we are young, whether it is
something we are not supposed to eat or something we are not
supposed to be around, tell us, because we want to prevent this
disease from happening.
And I am delighted to be a co-sponsor of Senator Chafee's
bill on the environmental study issue. I think that is
critically important, so we know what we can do to prevent this
disease. And frankly, that is what many young women say to me,
when I travel to colleges in my State. Do the research and tell
me what I can do to protect myself. So it is a sound investment
for us to move in that direction.
I want to really thank the Susan G. Komen Foundation for
the incredible work you do. It is, I think, so important for
all of us to be aware of this issue, to talk about it, to be
able to share our experiences. And one of my treasures in my
office is this huge poster of me with a number of women from
the Race for the Cure, hundreds of women behind me.
And the only reason you can find me is I am the only one
without a pink hat. And I am so proud of that picture and the
women who participated in that and the women who support the
women in that race. And you have made an incredible difference,
and I really appreciate it.
There is so much we can do. Certainly research in many,
many areas. And we also have to talk about what we do for women
who have been diagnosed with breast cancer to cure them, but we
also have to talk about what happens to those women after they
have had mastectomies. And I think one of my biggest concerns
coming up in the last few years is the lack of attention and
focus on recovery and rehabilitation needs for women who have
undergone mastectomies or other radical surgery.
And I have seen insurance companies deny reimbursement. I
have talked to women who have just had tragic experiences after
all they have gone through, after they have had a mastectomy
and just trying to get insurance coverage for recovery. And I
have offered amendments during patient bill of rights. I hope
that we can bring that back up, so we can get that through and
have its help.
But I would like to ask, I am concerned that there is
little done within the research community on outcomes of
mastectomies and little focus on providing post-operative care.
And I would really appreciate any comments you have on that end
of this whole discussion from any of you.
Ms. Visco. Well, if I could, I can speak certainly to the
Department of Defense in terms of the behavioral aspect of the
research and the psycho-social aspect of the research, in that
last year recognizing how underfunded that was, that we
established--it was a $20 million set-aside to fund Centers of
Excellence around the country, looking at that issue in breast
cancer. And it is certainly an issue that is of utmost
importance to the grassroots advocates of the National Breast
Cancer Coalition.
So we support your call for that. And we know that we need
more in that area.
Senator Murray. I appreciate that. And I want to work with
you on that.
And the other area I wanted to just ask about is, getting
access for minority women is a real concern of mine. We know
that they are three times more likely to die from breast
cancer. And certainly there are cultural language barriers that
prevent them from somehow being diagnosed early, whether they
are Asian or Native American or African-American. Are we doing
more to find out how we can reach out to minority women and
better those numbers about the survival rates?
Dr. Leffall. I would like to respond to that, if I may. The
answer to that is yes. We are doing more, but we are still not
doing enough. The Susan Komen Foundation, the American Cancer
Society, particularly, the Breast Cancer Coalition, all have
programs related to outreach for those population groups that
really do not take advantage of the opportunities that are
there for screening, for diagnosis.
So more and more funds are being given for that. But still,
we must do more to be sure that that disparity, or those
disparities, do not exist.
Senator Murray. Ms. Brinker.
Ms. Brinker. Thank you. And it is again, Senator, a great
honor to be here. And thank you for your kind remarks. I think
being here, however, is not really where all cancer occurs in
the United States. We at the Komen Foundation know that one of
the greatest battles we have is at the community level and
meeting the needs of medically underserved patients.
While it is beautiful, wonderful and exciting for all of us
to consider what is happening in the research lab, we know that
you cannot cure disease in the laboratory alone. And until we
fully fix the transportation system, the translation of what
happens from the laboratory into the deepest, darkest pockets
of this country, we will have no cure. We will have cancer.
Breast cancer, particularly, is now two diseases. It really is
a disease of a medically underserved population and those of us
who are served well.
And it is frightening to me, who has been in this movement
for over 25 years, to see that we still have not made enough
noticeable progress. And there are all kinds of cultural
barriers. It is not all the fault of the health care delivery
system.
But we have to fix it. And it is so deadly because so many
women are now single mothers. And it is a disease mostly women,
as you know, are diagnosed with. But there are so many single
mothers today raising children, who, when this disease strikes,
it is often at the prime of their life, just when they are
reaching income levels where they can educate, feed, clothe
their children.
So it is a prime concern of ours. And we are as perplexed
as anyone as to how to make more significant gains. We are
working on it, and we continue to want to fund the highest
levels possible. But it is going to take a concentrated effort
in this country to really make progress.
Senator Murray. I agree with you. And there are cultures
within our communities where they still are not allowed to talk
about this----
Ms. Brinker. Right.
Senator Murray [continuing]. Or to admit that it is a
health problem in their own family. And we have to continue to
work to make sure that that happens, because there are women
who are very frightened today and not telling anybody and not
talking about it and not getting treated.
Ms. Brinker. Right.
Senator Murray. And until we get past that, we will not
have solved this. So I really appreciate your attention and
would love to work with you in any way we can towards that
goal.
But again, thank you to all of you for your passion and
your advocacy. And as we work to increase the levels for
spending on all of these issues, I will keep all of our
advocates in mind, all the people who are survivors, but
certainly all of the women I have known in my own life who are
not here. They are the ones who we will remember the most.
So thank you very much.
Senator Specter [presiding]. Thank you very much, Senator
Murray.
Again, I express my regrets for having missed some of the
testimony, but the schedules here frequently place us in
several committees at the same time. And the Assistant Attorney
General for the Criminal Division is a very important part of
the Judiciary Committee work. So I had to excuse myself for a
few moments, but I have reviewed the testimony of Dr. Leffall,
Dr. Seffrin and Ms. Visco.
And I would like to turn to Ms. Visco for the first
question, regarding your request for $30 million to fund up to
eight multi-institutional, multi-disciplinary breast cancer and
environmental research centers, and on the issues which were
raised on environmental concerns. I would like to have you
expand on your thinking and your views with your broad
experience in the field, to devote that much money to this
specific kind of a project.
Ms. Visco. Well, Senator Specter, we spend a great deal of
time at the National Breast Cancer Coalition doing research and
analysis before we come to a position. And what we have seen
over the past 10 years is that there is much talk and much
focus in particular communities about the issue of the
environment and breast cancer. We have already invested a great
deal of money, not enough, but a great deal of money, in
looking at specific links to breast cancer.
So what we have said as an organization is, what we really
need is a strategy. We should not just have pockets of this
research happening. We should not have people convinced that it
is pesticides, another group that it is chemicals or air. Let
us actually focus money on looking at an overall strategy, the
right way to ask the questions. Let us see what we have already
answered and yet no one knows. Let us make certain we do it in
a multi-disciplinary, interdisciplinary way.
So we felt that this was the best approach and, in the long
run, the most cost-effective approach that will get us the
questions more quickly.
Senator Specter. Thank you.
Moving to another subject, the issue of stem cells is in
the forefront of medical research today. And there have been
extraordinary achievements on stem cells since it burst upon
the scene in November of 1998. This subcommittee has held seven
hearings on the subject. And legislation has been introduced by
Senator Harkin, other Senators, and myself to remove the
prohibition which eliminates Federal funding for research on
stem cells, rather to extract stem cells from embryos.
There is an opinion by the general counsel to the
Department of Labor, the Department of Health and Human
Services, that Federal funds can be used for research on the
stem cells once extracted. It is my view that when those
embryos are going to be destroyed because they are more created
for in vitro fertilization than can be used, that it makes good
sense to use them to save lives, since they are not going to be
used to produce life.
I would be interested, Dr. Leffall and Dr. Seffrin--and we
may turn back to our first panel on this for a brief comment as
well--as to your views on the prospects for stem cells on
breast cancer. We have already seen the preliminary success on
Parkinson's, spinal cords, juvenile diabetes, and some early
indicators on Alzheimer's.
Dr. Seffrin, you are nodding in the affirmative. What do
you think about the potential for stem cells on breast cancer?
Dr. Seffrin. Well, let me say that we took about a 6-month
period of time, our board of directors did, and looked into
this matter. And I think there is no question but what stem
cell research in general, and embryonic stem cell research in
particular, holds great promise for virtually any disease
process that we are currently aware of.
Senator Specter. Including breast cancer?
Dr. Seffrin. Including breast cancer.
Senator Specter. Let me get Dr. Leffall before my time runs
out.
Dr. Leffall. Yes. I agree with that, Senator Specter. It
seems as though some very good information, some vital
information, can be gained if we do stem cell research, not
only for breast cancer but for other diseases, too. And we
believe that the information that we gain can be of value in
helping us not only in the diagnosis, treat, but perhaps even
prevent breast disease.
Senator Specter. Dr. Klausner, aye or nay on stem cell
placenta potential for breast cancer?
Dr. Klausner. There are multiple ways that I think----
Senator Specter. Rick, the yellow light is on.
I want to get Dr. Marks before the red light goes on.
Dr. Klausner. Yes. We think there are several ways in which
stem cell research can benefit.
Senator Specter. Dr. Marks, yes or no?
Dr. Marks. The CDC program, once those things are found, we
want to get it out then to the women that need it.
Senator Specter. Well, I raise that question here because
the Breast Cancer Coalition is one of the most powerful, if not
the most powerful, in our society.
And we need some active contacts with Members of Congress
to cut the restrictions on medical science on developing stem
cells. And you have heard four prominent physicians testify in
the affirmative.
My red light is on. And unless there is something else from
the panel members, I am going to conclude the hearing.
You have not asked any questions? The hearing is
concluded--no, no.
Senator Harkin, I did not realize you had not asked
questions.
Senator Harkin. Just Senator Murray.
Again, I thank the panel. I want to get into two areas, one
that Ms. Brinker brought up about the translation of the
research and the things out to the general community. And you
pointed out time and again that there is this gap. And you made
mention that it is not just the medical community's fault. It
has to do with, I think, backgrounds, perhaps cultural
influences, things like that.
But I still want to get a better handle on why we cannot do
a better job of getting the information we have out to women
all over this country in a meaningful manner. Now we have
utilized the Centers for Disease Control and Prevention in
terms of the Breast Cancer and Cervical Screening Program. And
that has done a tremendous job of reaching low income women
around America. But we know that in certain areas it has not
been that effective.
So I just want to elaborate a little bit more with you and
perhaps anyone else on the panel as to how we can get a better
translation of the findings and what we know now out to the
general populace of women. Is there anything more we can do
here to stimulate that, to promote that?
Ms. Brinker. Senator, in answer to your question, I think,
first of all, we have to continue with our levels of funding. I
think we have to fix some of the issues with HCFA, I think in
some of the States which Medicaid is not existent or there are
gaps between payment for services.
I mean, in every area of health care delivery and health
care receipt, there is a major problem. And you have pointed
some of them out already, the cultural problem, there is the
payment problem, there is the physician problem, in that
sometimes there are not enough physicians to get around to get
to rural communities, to outreach to people who live there.
They will not come and cannot come for treatment.
There are cultural and treatment problems with patients
arriving at public hospitals. And by the way, in the United
States we have some of the finest public hospitals in different
communities. But there is a problem when a patient actually
comes to the hospital. And the Komen Foundation in that effort
has funded sort of a widespread program in some of our
communities called Patient Navigator Programs, where people are
met and spoken to in the language they can understand, if that
is the issue, walked through the treatment system.
But then again, there are issues with women leaving their
jobs to be treated, transportation. And it keeps going down the
line, child care--it is such a multifaceted problem. However,
we do believe that along the way there are solutions to each of
these problems.
But it will take a sustained examination of what they are,
setting realistic goals, and including, again not just
government payment--and I keep stressing this. Though dollars
are greater here, it is not always government dollars that make
things happen, particularly in communities. It is a steady and
a concentrated combination of the private and public sector
working together to make things happen.
Ms. Visco. Senator Harkin, can I say, too, though, that I
think one of the largest problems we have in this country is
that we do not have universal access to quality health care in
this country. And we can try to get the word out, and we do try
to get the early detection word out. But detecting cancer is
only the very first step. We need to treat it. And people do
not have access to treatment. And we need to change that in
this country. And then I think we will take a major step
forward to addressing cultural issues.
Because I think one of the major issues we hear from a very
diverse constituency is that, who is going to pay for my care,
if I step forward? Who is going to pay for it? And we need to
address that issue.
Senator Harkin. It is a most human, I think, reaction to
say, ``Why? Why should I go in and get screened, if in fact I
cannot do anything about, and I do not have the money? I do not
know anything about it. Maybe it will go away.''
I think that is what is happening.
Ms. Visco. And charity care is not enough.
Senator Harkin. I am sorry?
Ms. Visco. Charity care; the system of charity care in this
country is not enough. Women have to understand that there is a
system that they can depend on that will be there for them when
they step forward.
Senator Harkin. Closely akin to this--I want to get back to
Dr. Klausner--is clinical trials, and what is happening with
the mix of clinical trials, and are we doing more clinical
trials so that it gets out to the public. What is the status of
that now?
Dr. Klausner. Well, we are doing more clinical trials. But
the clinical trial system is still underfunded, so that the
time it takes to get an answer is too slow. Before you came in,
Senator, I listed a large number of entirely new drugs
beginning to enter the clinical trial system, 130 different
trials that are beginning to test targeted therapies against
breast cancer.
The problem is the system is very underfunded, at all
levels, so that the speed by which the trial happens, the rate
at which we can open these trials, in order to get these
answers very quickly that Senator Specter asked me when we are
going to get the answers, is way too slow by, I think, at least
a factor of two to three.
Senator Harkin. What are you doing--I see just one area
here that there has been a lot of focus on lately. And that is
angiogenesis. Are you doing some more trials?
Dr. Klausner. We are. We are doing a large number of trials
on about 50 to 60 different agents that are attempting to block
the development of new blood vessels, or to destroy the new
blood vessels, that nourish tumors.
As I said, there are a lot of clinical trials. We do not
yet know, and so far there have been no overwhelming home runs
with these, it is still in early days. It is an area of great
interest and a lot of research.
Senator Harkin. I have just two other things. Christine,
you have done a lot of work in terms of getting more knowledge
out to people and sort of how you get people more aware. Any
further thoughts that you might have on anything that we might
be looking at here or coordinating with the private sector,
with great organizations like the Breast Cancer Coalition, the
Komen Foundation, others? I mean, I guess the thing is, it is
just awareness and understanding and how you get that out,
especially to young people, getting it out to our schools.
I will say something else publicly, that it seems to me
that there is a reticence among our education system in the
secondary level. I do not know whether it is school boards or
superintendents or teachers or maybe it is just--Senator Murray
said breast cancer is just something we did not talk about.
And I find a great reticence in our secondary schools to
have teaching about bringing awareness to young women in our
secondary schools about the importance of self-examination,
mammogram screening, and early detection and warning signs. It
is just something you do not talk about. How do you get over
that?
Ms. Carpenter. Well, as a school psychologist who is
working in the schools, one of the things is our school day is
still 5\1/2\ hours, as it was 5 years ago--I mean 50 years ago.
And think of the massive amount of new information.
And so teachers are trying to teach all this new
information; you know, technology and all the new science and
all the--you know, just all of the things that we know that we
did not know in the past 50 years. And so there is always the
problem of fitting one more thing into the curriculum.
Then, you know, sometimes communities are a little
sensitive about touching those body part issues.
Senator Harkin. That is what I am talking about.
Ms. Carpenter. Right. And so teachers will just not do it,
so that they do not have to take the flack occasionally.
Senator Harkin. That is right. We need your help in
overcoming that. You have done a great job in Iowa. We just
need others to get over this and get this information out.
Ms. Carpenter. Right. You know, Iowa is becoming more and
more diverse. And we have created the Iowa Breast Cancer
Resource Guide, and we have had requests now for copies in
Spanish. And we have a great Bosnian population. So I have had
a request for Serbian-Croatian.
And I am having a hard time figuring out how to get it
translated, because I do not know--and I want it to be perfect.
So I am even having a hard time figuring out how to get it
translated.
Senator Harkin. Well, thank you. I see my red light is on.
Let me just close with this. I thank you all for the many hours
that all of you have spent, professionals, the
nonprofessionals, those of you who have been volunteering.
Senator Specter, Senator Murray and I, and I can speak for
other members on this panel, we are committed to making sure
that we fulfill our obligation to double the funding for NIH
over 5 years.
We are going to move aggressively. We have formed a great
partnership, Senator Specter and I have, in moving this forward
and making sure that we have the money in the budget and that
we appropriate the money for it in our appropriations process.
So we are committed to that.
We need your help to continue to work with others here and
in the administration, so that we have the backing that we need
to get this through.
Lastly, do not forget about the tremendous need we have to
continue the funding for the Center for Disease Control and
Prevention for outreach, for breast and cervical cancer
screening. That has been cut in this next budget. We cannot
allow that to happen. So do not take your eyes off of that.
Please continue to advocate and to fight as strong as you
can to make sure that we not only continue but that we expand,
as has been so eloquently stated here, to minority sections, to
new immigrants in this country, to rural areas, where we need
to really expand the breast and cervical cancer screening. It
has proven it has done a great job in the past, but we are only
reaching a fraction of the people that we need to.
So I really ask for your help in helping us get the funding
we need for the Center for Disease Control and Prevention.
With that, I thank you so much.
Senator Specter. Thank you, Senator Harkin.
I thank you, Senator Murray.
Additional Committee Questions
Thank you very much. There will be some additional
questions which will be submitted for your response in the
record.
[The following questions were not asked at the hearing, but
were submitted to the Department for response subsequent to the
hearing:]
Questions Submitted to the National Cancer Institute
Questions Submitted by Senator Arlen Specter
Question. If you could identify in writing your projections as to
the results that you anticipate, this is a three-part writing.
Number one, what have you been able to do with the existing
increases?
Answer. The funding increases in fiscal year 2001 and earlier years
have supported a sorely needed expansion of cancer research. A point in
evidence of this pent up need is that although we are funding
substantially more awards, our success rate, or the percent of quality
grant applications funded, has dropped from 33 percent in fiscal year
1998 to 26 percent in fiscal year 2000. To date, the funding increases
have allowed us to:
--Fund an additional 1000 research project grants (RPGs), increasing
the number of RPGs funded from 3,744 in fiscal year 1997 to
4,747 in fiscal year 2001.
--Support a rapid, substantial increase in minority training, from
144 trainees in fiscal year 1999 to 363 trainees in fiscal year
2001.
--Increase transdisciplinary cancer research: as an example,
increased the number of Special Programs of Research Excellence
(SPOREs) from 14 to 29 SPORES.
--Launch NCI's Center to Reduce Cancer Health Disparities.
--More than double the amount of money supporting minority health and
assistance, from $124 million in fiscal year 1997 to $263
million in fiscal year 2001.
--Increase support for cancer clinical trials by 61 percent or $256
million; from $418 million to $674 million. Currently NCI
supports 1200 cancer clinical trials.
priority setting and strategic planning
NCI uses several well-defined processes for priority setting and
strategic planning. The results of these strategic reviews are updated
and articulated annually in our Bypass Budget Request, The Nation's
Investment in Cancer Research, (http://plan.cancer.gov).
An integral part of our priority-setting and strategic-planning
processes is the extensive, formal use of experts that include
prominent members of the scientific, medical, industry and advocacy
communities in addition to NCI's inhouse staff and leadership. Through
the use of Progress Review Groups, program reviews, several external
advisory boards and panels, and specialized annual review groups, the
broad spectrum of cancer research activities are reviewed. Emerging
technologies are examined, new advances in knowledge are identified,
existing research portfolios are evaluated, and scientific
opportunities are identified and prioritized.
The Bypass Budget is the primary tool we use to identify to the
public and the scientific research community, including NCI staff, a
prioritized, annual snapshot on scientific research direction and
opportunities in cancer research. As additional funds become available,
we allocate these funds to the initiatives and priorities identified in
the Bypass. Some specific examples of what the funding increases have
supported include:
--Mouse Models of Human Cancer Consortium (MMHCC)--this recently
launched initiative is designed to develop mouse models that
closely mimic human cancers. These models will help
researchers, in pre-clinical settings, to greatly improve our
understanding of molecular changes associated with the
development, prevention and treatment of human cancers. In
fiscal year 2001, the additional funding has allowed MMHCC
investigators to: develop a novel mouse cross-breeding strategy
to localize a human breast cancer modifier gene in record time
and to verify its function; use a new lung cancer model to
initiate prevention trials of COX2 inhibitors, therapy trials
of signal pathway inhibitors, and localize a human tumor
suppressor gene; and make 8 new mouse models (2 breast, 1
leukemia and 5 colon cancers) available to the research
community.
--Transdisciplinary Tobacco Use Research Centers (TTURCs)--is an
initiative funded in late 1999, in collaboration with the
National Institute on Drug Abuse (NIDA) and the Robert Wood
Johnson Foundation (RWJF), to study new ways to combat tobacco
use and its consequences. Each center is organized around a
special theme and researchers are tackling a wide range of
studies that include culture, genetics, animal models of
behavior, innovative treatments, and tobacco policy. The TTURCs
were highlighted as a model in a recent Institute of Medicine
report entitled Bridging Disciplines in the Brain, Behavioral
and Clinical Sciences. Results emerging from the first year of
funding include:
--Created a computer-based system to help control depression, using
cognitive behavior therapy, for people trying to quit
smoking;
--Created a special mouse strain to study the relationship between
nicotine receptors and depression;
--Developed a spectroscopic positron emission computed tomography
(SPECT) radiopharmaceutical to quantify nicotine receptor
levels in the human brain to enable scientists to
investigate, via neuroimaging, the effects of smoking on
the brain;
--Developed new measures of culture and smoking that will help
develop a multicultural and culturally-adapted curriculum
to prevent smoking in youths of Chinese, Vietnamese,
Korean, Filipino, Mexican, South and Central American, and
Middle East descent.
--Special Programs of Research Excellence (SPORES) program--SPORES
support innovative, multidisciplinary research with the
potential to have an immediate impact on cancer care and
prevention. The increase in fiscal year 2001 funding along
with the exceptionally high quality of SPORE applications
have given NCI the opportunity to support more SPOREs than
was thought possible, even as recently as a few months ago.
As many as 7 additional SPORES will be funded, bringing a
breadth and depth to research in areas of breast, ovarian,
prostate, genitourinary, lung, and gastrointestinal cancers
that is both promising and exciting.
--NCI's Surveillance, Epidemiology and End Result (SEER) program
has been the gold standard for cancer registries worldwide
for over 30 years. In fiscal year 2001, through our
increase in funds, we are funding a major expansion of the
program that will include California, Louisiana, Kentucky
and New Jersey. SEER will now cover 26 percent of the U.S.
population and will increase the coverage of the rural
population by 150 percent, the population below the poverty
line by 200 percent, Asian Americans by 200 percent, non-
Mexican Hispanics by 70 percent and Native Americans by 36
percent.
molecular targeting
One broad set of research areas that is particularly reaping the
benefit of increased funding is molecular targeting, encompassing a
wide range of initiatives aimed at using emerging knowledge of the
human genome to revolutionize the way we detect, diagnose, treat and
prevent cancer.
--Cancer Genome Anatomy Project (CGAP).--Will complete its Human
Tumor Gene Index in fiscal year 2001, ahead of schedule,
thereby providing key information to the research community
toward reading the molecular signatures of cancer. This online
resource is used widely by the community and has become the
preeminent gene expression database of human cancer. CGAP also
built an online version of the Mitleman Database of Chromosomal
Aberrations in Cancer, thereby displaying in a user friendly
format, information from years of cancer chromosomal analysis
and providing a means to link changes in the genome with
changes in gene expression patterns. Although this project was
not expected to be launched this year, its progress was
accelerated based on scientific opportunity and the increased
appropriations.
--Early Detection Research Network (EDRN).--A major new initiative
made possible through NCI's increased funding, is one of the
new approaches, based on genomics and other emerging
technologies, to systematically pursue the goal of developing
effective and reliable tests for the earliest possible
detection of all cancers and even of pre-cancers. EDRN will
create, for the first time, a national R&D enterprise to
discover molecular biomarkers of cancer, develop reliable tests
and validate them with clinical studies. EDRN is a partnership
of NCI, other government agencies, industry and academics. In
its first year, dozens of potential markers are being studied
and 3 are moving toward validation studies.
--Director's Challenge--Toward a Molecular Classification.--Initiated
2 years ago, results are emerging and demonstrate that cancers
currently diagnosed as a single type of cancer are actually
several, molecularly distinct diseases. This molecular
distinction may explain why some patients do well with current
therapy but other patients, with the same diagnosis, fare
poorly. For instance, it appears that diffuse large B-cell
lymphoma is actually at least 2 different diseases, one of
which is almost always cured by current therapy and the other
of which is almost never cured.
--Molecular Targets Drug Discovery (MTDD).--This new initiative will
support researchers who will identify and use molecular targets
for the discovery of new anticancer agents based on the
molecular mechanisms that underlie cell transformation to
cancer, cancer growth and metastasis--over 170 applications
were received and 37 grants funded.
--Interdisciplinary Research Teams for Molecular Target Assessment
(IRT/MTA).--Is a new approach to developing clinically useful
assays to measure and monitor cancer in patients according to
the actual molecular targets where the treatment is directed.
We expect to fund 2 to 3 teams/centers.
--Chemistry/Biology Centers of Excellence.--Funded 6 centers to bring
chemists and biologists together to discover chemicals that
report on or affect the molecular machinery of cancer.
--National Molecular Target Laboratories (MTLs).--MTLs are envisioned
as genomic-scale efforts to discover molecular probes for all
potential cancer relevant molecular targets. We hope to
establish 1 to 3 large laboratories.
--Rapid Access to Interventional Development (RAID) and the Rapid
Access to Preventive Intervention Development (RAPID)
programs.--Closely related to the above initiatives, these
programs were established in 1999 and 2000, respectively, to
take potential therapeutics from academic or small business
laboratories and turn them into drugs ready to be tested in
phase I clinical trials. These programs are intended to remove
the most common barriers between laboratory discoveries and
clinical trials of new molecular entities. In its first two
years, RAID is supporting 51 novel agents and we hope that 11
will reach the clinic by the end of this year. During its first
year, RAPID is supporting 12 novel agents and we hope 1 to 3
will reach the clinic by the end of 2002.
--In vivo Cellular and Molecular Imaging Centers (ICMICs).--NCI
recently initiated major efforts to nurture and develop an
exciting new field of research called ``molecular imaging,''
which has the potential to substantially improve the way we
detect, diagnose and treat cancer. Molecular imaging integrates
the rapid advances in molecular biology, genomics, and
chemistry with cutting-edge imaging techniques. This field
requires communications between diverse groups of scientists
who usually did not interact together in the past, and thus, is
in its very infancy. The additional funding support we received
enabled NCI to support 16 planning grants, and in fiscal year
2001, the startup of 3 multidisciplinary ICMICs.
As a final example, the additional funds have allowed NCI to
accelerate the implementation of our strategic plan to address pressing
questions in cancer disparities through our Quality of Cancer Care
initiatives, our newly formed Center to Reduce Cancer Health
Disparities and our Comprehensive Minority Biomedical Programs.
Eighteen Special Population Networks for Cancer Awareness, Research and
Training have been launched as have 12 new partnership programs between
NCI-funded Cancer Centers and Minority Serving Institutions. These and
other activities are aimed at increasing our understanding of cancer
disparities, increasing the participation of minority and underserved
communities in the cancer research enterprise, and finding ways to
address the disparities in cancer burden.
Question. Two, what will you be able to do with an 11 percent
increase?
Answer. The 11.8 percent increase in the fiscal year 2002
President's Budget will allow NCI to support about 250 more research
projects in fiscal year 2002 than in fiscal year 2001. While many of
the new research projects will be investigator-initiated and therefore,
hard to identify at this time, we have identified through NCI's fiscal
year 2002 Congressional Justification and the fiscal year 2002 Bypass
Budget a wide range of research or research support activities that NCI
will initiate or expand as funding and scientific opportunities permit.
Examples of activities NCI will support at the 11.8 percent funding
level include:
--Centers of Excellence in Cancer Communications.--This initiative
reflects the broadening awareness that effective communications
can and should be used to narrow the enormous gap between
research discovery and its application, and to help reduce
health disparities among our citizens. The centers will provide
essential infrastructure to facilitate rapid advances in
knowledge about cancer communications, translate theory and
programs into practice, and train scientists in health
communications. We expect to fund 4 to 5 centers in fiscal year
2002.
--Mouse Models of Human Cancer Consortium (MMHCC).--Expand from 10 to
30 mouse models that mimic human cancers.
--Cancer Genome Anatomy Project (CGAP)--Accelerate the completion of
the Mouse Tumor Gene Index to fiscal year 2002.
--Specialized Projects of Research Excellence (SPOREs).--Fund a total
of 2 more SPOREs among the following research areas: head and
neck, brain, lymphoma and gynecologic cancers.
--Minority Serving Institution/Cancer Center Partnership and
Collaboration.--Initiatives to develop partnerships or close
collaborations between cancer centers and minority serving
institutions such as historical black colleges or universities,
hispanic serving institutions or tribal institutions/colleges.
The overarching goal is to develop a stronger national cancer
program aimed at understanding the reasons behind the
significant cancer disparities and its impact on minority
populations. We expect to fund 2 comprehensive grants and 24
planning grants in collaboration with the National Center on
Minority Health and Health Disparities.
--In vivo Cellular and Molecular Imaging Centers (ICMICs).--Continues
our support of this new field of ``molecular imaging'' and we
expect to fund 2 additional ICMICs in fiscal year 2002.
--Rapid Access to Interventional Development (RAID) program.--We can
support the initial, pre-clinical development of 3 to 6 highly
promising drugs in fiscal year 2002.
--Rapid Access to Preventive Intervention Development (RAPID)
program.--We can support the initial, pre-clinical development
of 3 to 5 highly promising cancer prevention agents.
--Molecular Targets Drug Discovery (MTDD).--This initiative continues
our efforts from fiscal year 2001 and is designed to support
researchers who will identify and use molecular targets for the
discovery of new anticancer agents based on the molecular
mechanisms that underlie cell transformation to cancer, cancer
growth and metastasis. We expect to fund about 10 grants.
--Clinical Trials.--Expand the number of clinical trials that NCI
supports by 30 to 50 so that more cancer patients may have
access to enrolling in a clinical trial.
Question. And three, what will you be able to do with a 20 percent
increase?
Answer. In our Bypass Budget, we have set forth, based on our best
professional judgment, the realistic goals, objectives, and milestones
we feel we could achieve in fiscal year 2002 with the appropriate
funding. In general, the larger the funding increase is, the more
initiatives in the Bypass we can support. A 20 percent funding increase
will allow us to support almost 50 percent of the initiatives in the
Bypass. The following are examples of some of our major initiatives:
--Centers for Population Health.--Create 2 to 4 centers to accelerate
advances in our knowledge of finding ways to reduce cancer-
related health disparities through fundamental cancer control
and population research.
--Special Populations Networks for Cancer Awareness Research and
Training (SPN).--Fund an additional 2 to 6 SPN sites to enhance
research infrastructure and training to underserved
communities.
--Cancer Centers.--Establish 6 to 10 Advanced Technology Programs and
Informatics Planning Activities in cancer centers to accelerate
the access of the newest technologies and informatics
capabilities to solve important problems in cancer research.
--SPOREs.--Fund an additional 4 to 6 SPOREs among the following
research areas: head and neck, brain, lymphoma and gynecologic
cancers.
--Molecular Targets Drug Discovery (MTDD).--Expand the MTDD program
to fund an additional 20 to 30 grants.
--Interdisciplinary Research Teams for Molecular Target Assessment
(IRT/MTA).--Expand from 2 or 3 centers to 7 to 10 centers to
develop a ``toolbox'' of valid assays for assessing a drug's
effect on its intended target, thereby speeding movement of
candidate drug molecules to the clinic.
--Clinical Trials Outreach Program.--Create this program to increase
participation by underrepresented populations; establish
clinical trials units at historically black medical
institutions; strengthen clinical trials units at minority-
based community oncology sites.
--Clinical Trials.--Fund Cooperative Groups and other programs to
allow physician and patient participation in clinical trials to
increase by at least 20 percent.
--Phased Innovation Awards.--Double the number of Phased Innovation
Awards in the Innovative Molecular Analysis Technologies (IMAT)
Program to 20 new awards to accelerate development of
technologies relevant to discovering and measuring molecular
signatures of cancer and precancer.
--Early Detection Research Network.--Expand funding for additional
work in the discovery, development, and validation of new early
detection tests for all major human cancers.
--Research Project Grants (RPGs).--Fund an additional 100 to 200
investigator initiated RPGs.
--RAID and RAPID.--Expand funding to support the development of an
additional 5 to 8 highly-promising drugs in each program.
______
Questions Submitted to the Centers for Disease Control and Prevention
Questions Submitted by Senator Arlen Specter
Question. What will be the impact of fiscal year 2002 cut in
funding for Cancer Prevention and Control, specifically breast and
cervical cancer?
Answer. A $9.2 million reduction in fiscal year 2002 appropriations
in the Breast and Cervical Cancer Mortality Prevention Act line would
result in CDC's National Breast and Cervical Cancer Early Detection
Program receiving a decrease of $5.6 million awarded to States for the
early detection of breast and cervical cancer. This reduction will
result in average cut to States, tribes, and territories of $81,159 and
an estimated 26,880 screenings for breast or cervical cancer would not
be provided to underserved women (approximately 336 women per program.
wouldn't be screened). About one half of the women who benefit from
these screens are women of racial/ethnic minorities. In addition, CDC
would be forced to assess its work with partners and cut back on
support for key national organizations. The organizations are currently
funded to increase utilization of breast and cervical cancer early
detection services, particularly minority and older women. A cut of
this magnitude could result in the dismantling of networks,
partnerships and the public health infrastructure for breast and
cervical cancer early detection at both the State and national levels.
States are mandated to spend a minimum of 60 percent of their awards
for screening and follow-up services, therefore, there is a direct link
between the amount of the appropriation and the number of screenings
provided.
Question. How does CDC view mammography screening for women ages 40
and above?
Answer. Mammography is currently the single most effective method
for diagnosing breast cancer early, with an estimated ability to detect
abnormalities between 76 and 94 percent of the time. The longer breast
cancer remains undetected and untreated, the greater the likelihood it
will spread. Death from breast cancer can be reduced substantially if
the tumor is discovered at an early stage Early detection and
appropriate follow-up could prevent approximately 15-30 percent of
breast cancer deaths in women over age 40. Through the National Breast
and Cervical Cancer Early Detection Program (NBCCEDP), CDC provides low
or no cost screening services (a physical examination of the breasts
and mammography) to women who are at or below 250 percent of the
Federal poverty level, uninsured, underinsured, and ages 40 to 64 for
mammography or older but not otherwise eligible for Medicare services
part B.
Question. What would it take to reduce racial/ethnic differences in
breast cancer?
Answer. Racial and ethnic differences in breast cancer could be
reduced by: modifying current authorizing language to permit more
funding for expand outreach efforts for these hard to reach women;
fully funding CDC's program and allocating funding to specifically
target these women so they are screened; taking advantage of the Breast
and Cervical Cancer Prevention and Treatment Act of 2000 to provide
medical care and treatment for women diagnosed through CDC's program;
and, examining the quality of cancer care these women receive.
Identifying, educating and motivating women who have rarely or
never been screened for breast cancer is an enormous challenge. To be
successful in these cases, the community outreach efforts of CDC's
program often become a door-to-door, one-on-one campaign to reduce
community and individual barriers that impede a woman's ability or
decision to obtain the lifesaving benefits of early detection. Barriers
such as fear, lack of transportation and child care, linguistic and
cultural differences, and lack of physician referral are all common
hurdles that must be overcome. Many outreach strategies are employed to
overcome these barriers.
Moreover, NBCCEDP authorizing language (Public Law 101-354)
constrains the states' level of effort in conducting outreach
activities stating that no more than 40 percent of a Federal grant
awarded to a state may be spent on such activities as: public education
and outreach, coalitions and partnerships, management, professional
education, and surveillance and evaluation. Increasing the percentage
allocated for outreach efforts in the authorizing language would enable
states to better reach these women.
Although CDC has received increases in funding, we are continuing
to only screen 15 percent of the eligible women. Over the years, more
and more women have become eligible for screening under CDC's program
(i.e., more women are underinsured or uninsured). Even though increases
in funding have permitted CDC to screen more women over time, the
number of women eligible increased at the same rate. Fully funding
CDC's NBCCEDP could contribute to creating parity among all racial and
ethnic groups. CDC estimates that there are approximately 3.6 million
women aged 40 to 64 who are eligible for the NBCCEDP. The Federal costs
of reaching these women would be about $1 billion.
Even after outreach and screening occur, minority women (and all
women for that matter) need access to treatment. States need to take
advantage of the recently passed ``Breast and Cervical Cancer
Prevention and Treatment Act of 2000''. This Act allows States the
option to choose Federal Medicaid matching funds to provide medical
care and treatment to low-income women who have been diagnosed with
breast or cervical cancer through CDC's program. As of May 11th, HCFA
approved requests from Maryland, New Hampshire, Rhode Island, and West
Virginia to use this option and it has received requests from North
Dakota and Utah. Other States are in various stages of their own
approval processes.
Finally, we need to review the type of care these women are
receiving. Using cancer registry data, CDC can monitor and assess
patterns of cancer care to help ensure that quality cancer care is
being provided.
Senator Specter. Thank you, ladies and gentlemen who have
come in to testify. The groups who have worked so hard to fight
breast cancer are of enormous importance. The National Breast
Cancer Coalition, the Komen Foundation, and the others are
really of enormous, enormous help and have stimulated a lot of
congressional support to lead us to the kind of increases that
we have made.
And Senator Harkin puts his finger right on the critical
issue about acquainting women, young women, middle-aged women,
older women, all women, about the problems of breast cancer.
And that really has to be done.
And the avant-garde issue now is the stem cell issue. And
again, I say to you that that is where we really need to focus
our attention right now, because that may be in the Senate for
a vote during this month or perhaps next month, so globalize
one of the greatest advocacy groups in America.
CONCLUSION OF HEARING
Thank you all very much for being here, that concludes our
hearing. The subcommittee will stand in recess subject to the
call of the Chair.
[Whereupon, at 11:33 p.m., Wednesday, May 9, the hearing
was concluded, and the subcommittee was recessed, to reconvene
subject to the call of the Chair.]
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